{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 170 sorted by section_id", "rows": [["10:10:2.0.1.1.24.0.142.1", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.1 Purpose.", "NRC", "", "", "[86 FR 32170, June 16, 2021]", "The regulations in this part set out fees charged for licensing services, inspection services, and special projects rendered by the Nuclear Regulatory Commission as authorized under title V of the Independent Offices Appropriation Act, 1952 (31 U.S.C. 9701(a))."], ["10:10:2.0.1.1.24.0.142.2", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.2 Scope.", "NRC", "", "", "[49 FR 21301, May 21, 1984, as amended at 52 FR 8242, Mar. 17, 1987; 54 FR 15399, Apr. 18, 1989; 56 FR 31499, July 10, 1991; 58 FR 7737, Feb. 9, 1993; 64 FR 31469, June 10, 1999; 66 FR 32469, June 14, 2001; 70 FR 30543, May 26, 2005; 72 FR 49565, Aug. 28, 2007; 81 FR 41186, June 24, 2016]", "Except for persons who apply for or hold the permits, licenses, or approvals exempted in \u00a7 170.11, the regulations in this part apply to a person who is:\n\n(a) An applicant for or holder of a specific byproduct material license issued pursuant to parts 30 and 32 through 36 and 39 of this chapter;\n\n(b) An applicant for or holder of a specific source material license issued pursuant to part 40 of this chapter;\n\n(c) An applicant for or holder of a specific special nuclear material license issued pursuant to part 70 of this chapter;\n\n(d) An applicant for or holder of specific approval of spent fuel casks and shipping containers issued pursuant to part 71 of this chapter;\n\n(e) An applicant for or holder of a specific license to possess power reactor spent fuel and other radioactive materials associated with spent fuel storage in an independent spent fuel storage installation issued pursuant to part 72 of this chapter;\n\n(f) An applicant for or holder of a specific approval of sealed sources and devices containing byproduct material, source material, or special nuclear material;\n\n(g) An applicant for or holder of a production or utilization facility construction permit or operating license issued under 10 CFR part 50, or an early site permit, standard design certification, standard design approval, manufacturing license, or combined license issued under 10 CFR part 52;\n\n(h) Required to have examinations and tests performed to qualify or requalify individuals as part 55 reactor operators;\n\n(i) Required to have routine and non-routine safety and safeguards inspections of activities licensed pursuant to the requirements of this chapter;\n\n(j) [Reserved]\n\n(k) Applying for or already has applied for review, under appendix Q to 10 CFR part 50 of a facility site before the submission of an application for a construction permit;\n\n(l) Applying for or already has applied for review of a standardized spent fuel facility design; or\n\n(m) Applying for or has applied for since March 23, 1978, review of an item under the category of special projects in this chapter that the Commission completes or makes whether or not in conjunction with a license application on file or that may be filed.\n\n(n) An applicant for or holder of a license, approval, determination, or other authorization issued by the Commission pursuant to 10 CFR part 61.\n\n(o) Requesting preapplication/licensing review assistance by consulting with the NRC and/or by filing preliminary analyses, documents, or reports.\n\n(p) An applicant for or a holder of a specific import or export license issued pursuant to 10 CFR part 110.\n\n(q) An Agreement State licensee who files for or is holder of a general license under the reciprocity provisions of 10 CFR 150.20.\n\n(r) An applicant for or a holder of a certificate of compliance issued under 10 CFR Part 76.\n\n(s) A holder of a general license granted by 10 CFR Part 31 who is required to register a device(s).\n\n(t) An owner or operator of an unlicensed site in decommissioning being conducted under NRC oversight.\n\n(u) Submitting a Touhy request, pursuant to 10 CFR 9.200 through 9.204, as defined in \u00a7 170.3."], ["10:10:2.0.1.1.24.0.142.3", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.3 Definitions.", "NRC", "", "", "[33 FR 10924, Aug. 1, 1968]", "As used in this part:\n\nAct  means the Atomic Energy Act of 1954 (68 Stat. 919) including any amendments thereto;\n\nAdvanced nuclear reactor applicant  means an entity that has submitted to the Commission a \u201cqualifying application,\u201d as defined in this part.\n\nAdvanced nuclear reactor pre-applicant  means an entity that has submitted to the Commission a licensing project plan for the purposes of submitting a future \u201cqualifying application,\u201d as defined in this part.\n\nAgency support (corporate support and the IG)  means resources located in executive, administrative, and other support offices such as the Office of the Commission, the Office of the Secretary, the Office of the Executive Director for Operations, the Offices of Congressional and Public Affairs, the Office of the Inspector General, the Office of Administration, the Office of the Chief Financial Officer, the Office of the Chief Information Officer, the Office of the Chief Human Capital Officer and the Office of Small Business and Civil Rights. These resources administer the corporate or shared efforts that more broadly support the activities of the agency. These resources also include information technology services, human capital services, financial management, and administrative support.\n\nAgreement State  means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Act. \u201cNonagreement State\u201d means any other State.\n\nApplication  means any request filed with the Commission for a permit, license, approval, exemption, certificate, other permission, or for any other service.\n\nByproduct material  means\u2014\n\n(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;\n\n(2)(i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or\n\n(ii) Any material that\u2014\n\n(A) Has been made radioactive by use of a particle accelerator; and\n\n(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and\n\n(3) Any discrete source of naturally occurring radioactive material, other than source material, that\u2014\n\n(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and\n\n(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.\n\nGovernment agency  means any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government.\n\nGreater Than Class C Waste  or  GTCC Waste  means low-level radioactive waste that exceeds the concentration limits of radionuclides established for Class C waste in 10 CFR 61.55.\n\nHigh Enriched Uranium  means uranium enriched to 20 percent or greater in the isotope uranium-235.\n\nHuman use  means the internal or external administration of byproduct, source, or special nuclear material, or the radiation therefrom, to human beings.\n\nInspections  means:\n\n(1) Routine inspections designed to evaluate the licensee's activities within the context of the licensee having primary responsibility for protection of the public and environment;\n\n(2) Non-routine inspections in response or reaction to an incident, allegation, follow up to inspection deficiencies or inspections to determine implementation of safety issues. A non-routine or reactive inspection has the same purpose as the routine inspection;\n\n(3) Reviews and assessments of licensee performance;\n\n(4) Evaluations, such as those performed by Diagnostic Evaluation Teams; or\n\n(5) Incident investigations.\n\nLow Enriched Uranium  means uranium enriched below 20 percent in the isotope uranium-235.\n\nManufacturing license  means a license pursuant to Appendix M of part 52 of this chapter to manufacture a nuclear power reactor(s) to be operated at sites not identified in the license application.\n\nMaterials license  means a license, certificate, approval, registration, or other form of permission issued or granted by the NRC under the regulations in 10 CFR Parts 30, 31 through 36, 39, 40, 61, 70, 72, and 76.\n\nMission-direct program salaries and benefits  means resources that are allocated to perform core work activities committed to fulfilling the agency's mission of protecting the public health and safety, promoting the common defense and security, and protecting the environment. These resources include the core work activities assigned within the major program business lines (Operating Reactors, New Reactors, Fuel Facilities, Nuclear Materials Users, Decommissioning and Low-Level Waste, and Spent Fuel Storage and Transportation).\n\nMission-indirect program support  means resources that support the core mission-direct activities. These resources include supervisory and nonsupervisory support and mission travel and training. Supervisory and nonsupervisory support and mission travel and training resources assigned under direct business line structure are considered mission-indirect due to their supporting role of the core mission activities.\n\nNon-power production or utilization facility  means a production or utilization facility licensed under 10 CFR 50.21(a) or (c), or 10 CFR 50.22, as applicable, that is not a nuclear power reactor or production facility as defined under paragraphs (1) and (2) of the definition of \u201cproduction facility\u201d in 10 CFR 50.2.\n\nNonprofit educational institution  means a public or nonprofit educational institution whose primary function is education, whose programs are accredited by a nationally recognized accrediting agency or association, who is legally authorized to provide a program of organized instruction or study, who provides an educational program for which it awards academic degrees, and whose educational programs are available to the public.\n\nNuclear reactor  means an apparatus, other than an atomic weapon, designed or used to sustain nuclear fission in a self-supporting chain reaction.\n\nOther production or utilization facility  means a facility other than a nuclear reactor licensed by the Commission under the authority of section 103 or 104 of the Atomic Energy Act of 1954, as amended (the Act), and pursuant to the provisions of part 50 of this chapter.\n\nPart 55 Reviews  as used in this part means those services provided by the Commission to administer requalification and replacement examinations and tests for reactor operators licensed pursuant to 10 CFR part 55 of the Commission's regulations and employed by part 50 licensees. These services also include related items such as the preparation, review, and grading of the examinations and tests.\n\nPerson  as used in this part has the same meaning as found in parts 30, 40, 50, and 70 of title 10 of the Code of Federal Regulations.\n\nPower reactor  means a nuclear reactor designed to produce electrical or heat energy licensed by the Commission under the authority of section 103 or subsection 104b of the Act and pursuant to the provisions of \u00a7 50.21(b) or \u00a7 50.22 of this chapter.\n\nProduction facility  means:\n\n(1) Any nuclear reactor designed or used primarily for the formation of plutonium or uranium-233; or\n\n(2) Any facility designed or used for the separation of the isotopes of plutonium, except laboratory scale facilities designed or used for experimental or analytical purposes only; or\n\n(3) Any facility designed or used for the processing of irradiated materials containing special nuclear material except:\n\n(i) Laboratory scale facilities designed or used for experimental or analytical purposes;\n\n(ii) Facilities in which the only special nuclear materials contained in the irradiated material to be processed are uranium enriched in the isotope U\n 235  and plutonium produced by the irradiation, if the material processed contains not more than 10 \u22126  grams of plutonium per gram of U\n 235  and has fission product activity not in excess of 0.25 millicurie of fission products per gram of U\n 235 ; and\n\n(iii) Facilities in which processing is conducted pursuant to a license issued under parts 30 and 70 of this chapter, or equivalent regulations of an Agreement State, for the receipt, possession, use, and transfer of irradiated special nuclear material, which authorizes the processing of the irradiated material on a batch basis for the separation of selected fission products and limits the process batch to not more than 100 grams of uranium enriched in the isotope 235 and not more than 15 grams of any other special nuclear material.\n\nQualifying application  means an application that:\n\n(1) is for an advanced nuclear reactor as defined in section 3 of the Nuclear Energy Innovation and Modernization Act (42 U.S.C. 2215 note); and\n\n(2) is for an operating license, combined license, manufacturing license, construction permit, early site permit, limited work authorization, design certification, or standard design approval.\n\nResearch reactor  means a non-power production or utilization facility, as defined in 10 CFR 50.2, that is a nuclear reactor licensed under 10 CFR 50.21(c):\n\n(i) For which a safety assessment demonstrates accident radiation doses consistent with 10 CFR 50.34(a)(1)(i); and\n\n(ii) That is not a testing facility.\n\nSealed source  means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.\n\nSmall modular reactor (SMR)  for the purposes of calculating fees, means the class of power reactors having a licensed thermal power rating less than or equal to 1,000 MWt per module. This rating is based on the thermal power equivalent of an SMR with an electrical power generating capacity of 300 MWe or less per module.\n\nSmall modular reactor site (SMR site)  is the geographically bounded location of one or more SMRs and a basis on which SMR fees are calculated.\n\nSource material  means:\n\n(1) Uranium or thorium, or any combination thereof, in any physical or chemical form; or\n\n(2) Ores which contain by weight one-twentieth of one percent (0.05%) or more of\n\n(i) Uranium,\n\n(ii) Thorium, or\n\n(iii) Any combination thereof. Source material does not include special nuclear material.\n\nSpecial nuclear material  means:\n\n(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material which the Commission, pursuant to the provisions of section 51 of the Act, determines to be special nuclear material but does not include source material; or\n\n(2) Any material artificially enriched by any of the foregoing, but does not include source material.\n\nSpecial projects  means specific services provided by the Commission for which fees are not otherwise specified in this chapter. This includes, but is not limited to, contested hearings on licensing actions directly related to U.S. Government national security initiatives (as determined by the NRC), topical report reviews, early site reviews, waste solidification activities, activities related to the tracking and monitoring of shipment of classified matter, services provided to certify licensee, vendor, or other private industry personnel as instructors for 10 CFR part 55 reactor operators, reviews of financial assurance submittals that do not require a license amendment, reviews of responses to Confirmatory Action Letters, reviews of uranium recovery licensees' land-use survey reports, and reviews of 10 CFR 50.71 final safety analysis reports. Special projects does not include activities otherwise exempt from fees under this part. It also does not include those contested hearings for which a fee exemption is granted in \u00a7 170.11(a)(2), including those related to individual plant security modifications.\n\nTesting facility  is defined at 10 CFR 50.2.\n\nTouhy request  means a request for NRC records or NRC testimony that is made pursuant to the NRC's regulations at 10 CFR 9.200 through 9.204.\n\nUranium enrichment facility  means:\n\n(1) Any facility used for separating the isotopes of uranium or enriching uranium in the isotope 235, except laboratory scale facilities designed or used for experimental or analytical purposes only; or\n\n(2) Any equipment or device, or important component part especially designed for this equipment or device, capable of separating the isotopes of uranium or enriching uranium in the isotope 235.\n\nUtilization  facility means:\n\n(1) Any nuclear reactor other than one designed or used primarily for the formation of plutonium or U-233; or\n\n(2) An accelerator-driven subcritical operating assembly used for the irradiation of materials containing special nuclear material and described in the application assigned docket number 50-608."], ["10:10:2.0.1.1.24.0.142.4", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.4 Interpretations.", "NRC", "", "", "[33 FR 10924, Aug. 1, 1968; 33 FR 11587, Aug. 15, 1968, as amended at 90 FR 55634, Dec. 3, 2025]", "Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by an officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the  Federal Register  announcing its determination and revising or removing this section accordingly."], ["10:10:2.0.1.1.24.0.142.5", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.5 Communications.", "NRC", "", "", "[68 FR 58825, Oct. 10, 2003, as amended at 74 FR 62686, Dec. 1, 2009; 80 FR 74982, Dec. 1, 2015]", "All communications concerning the regulations in this part should be addressed to the NRC's Chief Financial Officer, either by mail to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at  http://www.nrc.gov/site-help/e-submittals.html;  by e-mail to  MSHD.Resource@nrc.gov;  or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information."], ["10:10:2.0.1.1.24.0.142.6", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.8 Information collection requirements: OMB approval", "NRC", "", "", "[62 FR 52191, Oct. 6, 1997]", "This part contains no information collection requirements and therefore is not subject to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501  et seq. )."], ["10:10:2.0.1.1.24.0.142.7", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.11 Exemptions.", "NRC", "", "", "[33 FR 10924, Aug. 1, 1968]", "(a) No application fees, license fees, renewal fees, inspection fees, or special project fees shall be required for:\n\n(1) A special project that is a request/report submitted to the NRC\u2014\n\n(i) In response to a generic letter or NRC bulletin, where the request/report does not result in an amendment to the license, does not result in the review of an alternate method or reanalysis to meet the requirements of the generic letter, or does not involve an unreviewed safety issue;\n\n(ii) When the NRC, at the time the request/report is submitted, plans to use the information to assist the NRC in generic regulatory improvements or efforts (e.g., rules, regulatory guides, regulations, policy statements, generic letters, or bulletins); or\n\n(iii) When the NRC, at the time the request/report is submitted, plans to use the information in response to an NRC request from the Office Director level or above to resolve an identified safety, safeguards, or environmental issue.\n\n(2) A contested hearing conducted by the NRC on a specific application or the authorizations and conditions of a specific NRC license, certificate, or other authorization, including those involving individual plant security modifications. This exemption does not apply to a contested hearing on a licensing action that the NRC determines directly involves a U.S. Government national security-related initiative, including those specifically associated with Presidentially-directed national security programs.\n\n(3) [Reserved]\n\n(4) A construction permit or license applied for by, or issued to, a non-profit educational institution for a production or utilization facility, other than a power reactor, or for the possession and use of byproduct material, source material, or special nuclear material. This exemption does not apply to those byproduct, source or special nuclear material licenses which authorize:\n\n(i) Human use;\n\n(ii) Remunerated services to other persons;\n\n(iii) Distribution of byproduct material, source material, or special nuclear material or products containing byproduct material, source material or special nuclear material; or\n\n(iv) Activities performed under a Government agency contract.\n\n(5)-(8) [Reserved]\n\n(9) Federally-owned and State-owned research reactors used primarily for educational training and academic research purposes. For purposes of this exemption, the term research reactor means a nuclear reactor that\u2014\n\n(i) Is licensed by the Nuclear Regulatory Commission under section 104c. of the Atomic Energy Act of 1954 (42 U.S.C. 2134(c)) at a thermal power level of 10 megawatts or less; and\n\n(ii) If so licensed at a thermal power level of more than 1 megawatt, does not contain\u2014\n\n(A) A circulating loop through the core in which the licensee conducts fuel experiments;\n\n(B) A liquid fuel loading; or\n\n(C) An experimental facility in the core in excess of 16 square inches in cross-section.\n\n(10) Activities of the Commission undertaken, pursuant to part 75 of this chapter, solely for the purpose of implementation of the US/IAEA Safeguards Agreement.\n\n(11) [Reserved]\n\n(12) A performance assessment or evaluation for which the licensee volunteers at the NRC's request and which is selected by the NRC.\n\n(b) The Commission may, upon application by an interested person, or upon its own initiative, grant such exemptions from the requirements of this part as it determines are authorized by law and are otherwise in the public interest. Applications for exemption under this paragraph may include activities such as, but not limited to, the use of licensed materials for educational or noncommercial public displays or scientific collections.\n\n(c) For purposes of paragraph (a)(1) of this section, a request for a fee exemption must be submitted to the Chief Financial Officer within 90 days of the date of the NRC's receipt of the request/report.\n\n(d) All fee exemption requests must be submitted in writing to the Chief Financial Officer in accordance with \u00a7 170.5, and the Chief Financial Officer will grant or deny such requests in writing."], ["10:10:2.0.1.1.24.0.142.8", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.12 Payment of fees.", "NRC", "", "", "[64 FR 31469, June 10, 1999, as amended at 65 FR 11204, Mar. 2, 2000; 65 FR 36959, June 12, 2000; 66 FR 32469, June 14, 2001; 67 FR 64037, Oct. 17, 2002; 72 FR 31420, June 6, 2007; 79 FR 37144, June 30, 2014; 81 FR 41186, June 24, 2016; 87 FR 37214, June 22, 2022; 88 FR 39140, June 15, 2023; 89 FR 51811, June 20, 2024]", "(a)  Application and registration fees.  Each application or registration for which a fee is prescribed must be accompanied by a remittance for the full amount of the fee. The NRC will not issue a new license or an amendment increasing the scope of an existing license to a higher fee category before receiving the prescribed application fee. The application or registration fee(s) is charged whether the Commission approves the application or not. The application or registration fee(s) is also charged if the applicant withdraws the application or registration.\n\n(b)  Licensing fees.  (1) Licensing fees will be assessed to recover full costs for\u2014\n\n(i) The review of applications for new licenses and approvals;\n\n(ii) The review of applications for amendments to and renewal of existing licenses or approvals;\n\n(iii) Preapplication consultations and reviews; and\n\n(iv) The full cost for project managers assigned to a specific plant or facility, excluding leave time and time spent on generic activities (such as rulemaking).\n\n(2) Full cost fees will be determined based on the professional staff time and appropriate contractual support services expended. The full cost fees for professional staff time will be determined at the professional hourly rates in effect the time the service was provided. The full cost fees are payable upon notification by the Commission.\n\n(3) The NRC intends to bill each applicant or licensee at quarterly intervals for all accumulated costs for each application the applicant or licensee has on file for NRC review, until the review has been brought to an end, whether by issuance of a permit, license, approval, certificate, exemption, or other form of permission; by denial, withdrawal, or suspension of review of the application; or by postponement of action on the application by the applicant.\n\n(4) The NRC intends to bill each applicant or licensee for costs related to project manager time on a quarterly basis. Each bill will identify the costs related to project manager time.\n\n(c)  Inspection fees.  (1) Inspection fees will be assessed to recover full cost for each resident inspector (including the senior resident inspector), assigned to a specific plant or facility. The fees assessed will be based on the number of hours that each inspector assigned to the plant or facility is in an official duty status ( i.e.,  all time in a non-leave status), excluding time spent by a resident inspector in support of activities at another site. The hours will be billed at the appropriate hourly rate established in 10 CFR 170.20. Resident inspectors' time related to a specific inspection will be included in the fee assessed for the specific inspection in accordance with paragraph (c)(2) of this section.\n\n(2) Inspection fees will be assessed to recover the full cost for each specific inspection, including plant- or licensee-specific performance reviews and assessments, evaluations, and incident investigations. For inspections that result in the issuance of an inspection report, fees will be assessed for costs incurred up to approximately 30 days after the inspection report is issued. The costs for these inspections include preparation time, time on site, documentation time, and follow-up activities and any associated contractual service costs, but exclude the time involved in the processing and issuance of a notice of violation or civil penalty.\n\n(3) The NRC intends to bill for resident inspectors' time and for specific inspections subject to full cost recovery on a quarterly basis. The fees are payable upon notification by the Commission.\n\n(d)  Special project fees.  (1) All special projects performed by the Commission, unless otherwise exempt from fees or for which fees are otherwise specified in this part, will be assessed fees to recover the full cost of the service provided. Special projects means specific services provided by the Commission, including but not limited to\u2014\n\n(i) Topical reports;\n\n(ii) Financial assurance submittals that do not require a license amendment;\n\n(iii) Responses to Confirmatory Action Letters;\n\n(iv) Uranium recovery licensees' land-use survey reports;\n\n(v) 10 CFR 50.71 final safety analysis reports;\n\n(vi) Contested hearings on licensing actions directly involving U.S Government national security initiatives, as determined by the NRC; and\n\n(vii) Responses to Touhy requests that require the NRC staff to expend more than 50 hours of official time. Fees for Touhy requests will be billed at the appropriate hourly rate established in \u00a7 170.20.\n\n(2) The NRC intends to bill each applicant or licensee at quarterly intervals until the special project is completed. Each bill will identify the special project, including any documents submitted for review or the specific contested hearing, and the related costs. The fees are payable upon notification by the Commission.\n\n(e)  Part 55 review fees.  Fees for Part 55 review services are based on NRC time spent in administering the examinations and tests and any related contractual costs. The fees assessed will also include related activities such as preparing, reviewing, and grading of the examinations and tests. The NRC intends to bill the costs at quarterly intervals to the licensee employing the operators.\n\n(f)  Method of payment.  All fee payments under this part are to be made payable to the U.S. Nuclear Regulatory Commission. The payments are to be made in U.S. funds using the electronic payment methods accepted at  www.Pay.gov.  Specific instructions for making payments may be obtained by contacting the Office of the Chief Financial Officer at 301-415-7554. In accordance with Department of the Treasury requirements, refunds will only be made upon receipt of information on the payee's financial institution and bank accounts.\n\n(g)  Collection of underpayment of fees.  The NRC is entitled to collect any underpayment of fees as a result of an error by the NRC."], ["10:10:2.0.1.1.24.0.142.9", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.20 Average cost per professional staff-hour.", "NRC", "", "", "[90 FR 26753, June 24, 2025]", "(a) Except as provided in paragraphs (b) and (c) of this section, fees for permits, licenses, amendments, renewals, special projects, 10 CFR part 55 re-qualification and replacement examinations and tests, other required reviews, approvals, and inspections under \u00a7\u00a7 170.21 and 170.31 will be calculated using the professional staff-hour rate of $318 per hour.\n\n(b) For advanced nuclear reactor applicants:\n\n(1) Prior to October 1, 2025, fees under \u00a7 170.21 will be calculated using the professional staff-hour rate of $318 per hour.\n\n(2) Effective on October 1, 2025, fees under \u00a7 170.21 relating to the review of the submitted application for the advanced nuclear reactor applicant will be calculated using the reduced hourly rate of $148 per hour.\n\n(c) For advanced nuclear reactor pre-applicants:\n\n(1) Prior to October 1, 2025, fees under \u00a7 170.21 will be calculated using the professional staff-hour rate of $318 per hour.\n\n(2) Effective on October 1, 2025, fees under \u00a7 170.21 relating to the review of submitted materials as described in the licensing project plan will be calculated using the reduced hourly rate of $148 per hour.\n\n(3) Paragraph (c) of this section shall cease to be effective on September 30, 2030."], ["10:10:2.0.1.1.24.0.143.10", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.21 Schedule of fees for production and utilization facilities, review of standard referenced design approvals, special projects, inspections and import and export licenses.", "NRC", "", "", "[53 FR 52648, Dec. 29, 1988]", "Applicants for construction permits, manufacturing licenses, operating licenses, import and export licenses, approvals of facility standard reference designs, re-qualification and replacement examinations for reactor operators, and special projects and holders of construction permits, licenses, and other approvals shall pay fees for the following categories of services:\n\nTable 1 to \u00a7 170.21\u2014Schedule of Facility Fees\n\n[See footnotes at end of table]\n\n1  Fees will be charged for approvals issued under a specific exemption provision of the Commission's regulations under title 10 of the  Code of Federal Regulations  (e.g., 10 CFR 50.12, 10 CFR 73.5) and any other sections in effect now or in the future, regardless of whether the approval is in the form of a license amendment, letter of approval, safety evaluation report, or other form.\n\n2  Full cost fees will be determined based on the professional staff time and appropriate contractual support services expended. For applications currently on file and for which fees are determined based on the full cost expended for the review, the professional staff hours expended for the review of the application up to August 25, 2025, will be determined at the professional hourly rate in effect when the service was provided. Effective October 1, 2025, the \u201cfull cost fees\u201d described in the table for advanced nuclear reactor applicants and advanced nuclear reactor pre-applicants will be assessed consistent with \u00a7 170.20(b) and (c).\n\n3  Inspections covered by this schedule are both routine and non-routine safety and safeguards inspections performed by the NRC for the purpose of review or follow-up of a licensed program. Inspections are performed through the full term of the license to ensure that the authorized activities are being conducted in accordance with the Atomic Energy Act of 1954, as amended, other legislation, Commission regulations or orders, and the terms and conditions of the license. Non-routine inspections that result from third-party allegations will not be subject to fees.\n\n4  Imports only of major components for end-use at NRC-licensed reactors are authorized under NRC general import license in 10 CFR 110.27.\n\n5  Full cost fees will be assessed once NRC work on a Touhy request exceeds 50 hours, in accordance with \u00a7 170.12(d).\n\n6  Because the resources for import and export licensing activities are identified as a fee-relief activity to be excluded from the fee-recoverable budget, import and export licensing actions will not incur fees."], ["10:10:2.0.1.1.24.0.143.11", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.31 Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses.", "NRC", "", "", "[71 FR 30747, July 31, 2006, as amended at 75 FR 34235, June 16, 2010; 76 FR 36797, June 22, 2011; 76 FR 72087, Nov. 22, 2011; 77 FR 35827, June 13, 2012; 78 FR 32341, May 29, 2013; 78 FR 39428, July 1, 2013; 78 FR 54959, Sept. 9, 2013; 79 FR 37145, June 30, 2014; 79 FR 51471, Aug. 29, 2014; 80 FR 37455, June 30, 2015; 81 FR 41186, June 24, 2016; 82 FR 30699, June 30, 2017; 83 FR 29646, June 25, 2018; 84 FR 22350, May 17, 2019; 85 FR 37271, June 19, 2020; 86 FR 32171, June 16, 2021; 87 FR 37215, June 22, 2022; 88 FR 39140, June 15, 2023; 89 FR 51811, June 20, 2024; 90 FR 26754, June 24, 2025]", "Applicants for materials licenses, import and export licenses, and other regulatory services, and holders of materials licenses or import and export licenses shall pay fees for the following categories of services. For those fee categories identified to be subject to full cost fees, full cost fees will be assessed for all licensing and inspection activities, unless otherwise indicated.\n\nTable 1 to \u00a7 170.31\u2014Schedule of Materials Fees\n\n[See footnotes at end of table]\n\n1   Types of fees \u2014Separate charges, as shown in the schedule, will be assessed for pre-application consultations and reviews; applications for new licenses, approvals, or license terminations; possession-only licenses; issuances of new licenses and approvals; certain amendments and renewals to existing licenses and approvals; safety evaluations of sealed sources and devices; generally licensed device registrations; and certain inspections. The following guidelines apply to these charges:\n\n(1)  Application and registration fees.  Applications for new materials licenses and export and import licenses; applications to reinstate expired, terminated, or inactive licenses, except those subject to fees assessed at full costs; applications filed by Agreement State licensees to register under the general license provisions of 10 CFR 150.20; and applications for amendments to materials licenses that would place the license in a higher fee category or add a new fee category must be accompanied by the prescribed application fee for each category.\n\n(i) Applications for licenses covering more than one fee category of special nuclear material or source material must be accompanied by the prescribed application fee for the highest fee category.\n\n(ii) Applications for new licenses that cover both byproduct material and special nuclear material in sealed sources for use in gauging devices will pay the appropriate application fee for fee category 1.C. only.\n\n(2)  Licensing fees.  Fees for reviews of applications for new licenses, renewals, and amendments to existing licenses, pre-application consultations and other documents submitted to the NRC for review, and project manager time for fee categories subject to full cost fees are due upon notification by the Commission in accordance with \u00a7 170.12(b).\n\n(3)  Amendment fees.  Applications for amendments to export and import licenses must be accompanied by the prescribed amendment fee for each license affected. An application for an amendment to an export or import license or approval classified in more than one fee category must be accompanied by the prescribed amendment fee for the category affected by the amendment, unless the amendment is applicable to two or more fee categories, in which case the amendment fee for the highest fee category would apply.\n\n(4)  Inspection fees.  Inspections resulting from investigations conducted by the Office of Investigations and nonroutine inspections that result from third-party allegations are not subject to fees. Inspection fees are due upon notification by the Commission in accordance with \u00a7 170.12(c).\n\n(5)  Generally licensed device registrations under 10 CFR 31.5.  Submittals of registration information must be accompanied by the prescribed fee.\n\n2  Fees will be charged for approvals issued under a specific exemption provision of the Commission's regulations under title 10 of the  Code of Federal Regulations  ( e.g.,  10 CFR 30.11, 40.14, 70.14, 73.5, and any other sections in effect now or in the future), regardless of whether the approval is in the form of a license amendment, letter of approval, safety evaluation report, or other form. In addition to the fee shown, an applicant may be assessed an additional fee for sealed source and device evaluations as shown in fee categories 9.A. through 9.D.\n\n3  Full cost fees will be determined based on the professional staff time multiplied by the appropriate professional hourly rate established in \u00a7 170.20 in effect when the service is provided, and the appropriate contractual support services expended.\n\n4  Licensees paying fees under categories 1.A., 1.B., and 1.E. are not subject to fees under categories 1.C., 1.D. and 1.F. for sealed sources authorized in the same license, except for an application that deals only with the sealed sources authorized by the license.\n\n5  Persons who possess radium sources that are used for operational purposes in another fee category are not also subject to the fees in this category. (This exception does not apply if the radium sources are possessed for storage only.)\n\n6  Licensees subject to fees under fee categories 1.A., 1.B., 1.E., or 2.A. must pay the largest applicable fee and are not subject to additional fees listed in this table.\n\n7  Licensees paying fees under 3.C., 3.C.1, or 3.C.2 are not subject to fees under 2.B. for possession and shielding authorized on the same license.\n\n8  Licensees paying fees under 7.C. are not subject to fees under 2.B. for possession and shielding authorized on the same license.\n\n9  Licensees paying fees under 3.N. are not subject to paying fees under 3.P., 3.P.1, or 3.P.2 for calibration or leak testing services authorized on the same license.\n\n10  Licensees paying fees under 7.B., 7.B.1, or 7.B.2 are not subject to paying fees under 7.C., 7.C.1, or 7.C.2. for broad scope licenses issued under parts 30, 35, 40, and 70 of this chapter for human use of byproduct material, source material, and/or special nuclear material, except licenses for byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devices authorized on the same license.\n\n11  A materials license (or part of a materials license) that transitions to fee category 14.A is assessed full-cost fees under 10 CFR part 170, but is not assessed an annual fee under 10 CFR part 171. If only part of a materials license is transitioned to fee category 14.A, the licensee may be charged annual fees (and any applicable 10 CFR part 170 fees) for other activities authorized under the license that are not in decommissioning status.\n\n12  Because the resources for import and export licensing activities are identified as a fee-relief activity to be excluded from the fee-recoverable budget, import and export licensing actions will not incur fees.\n\n13  Licensees paying fees under 4.A., 4.B. or 4.C. are not subject to paying fees under 3.N. licenses that authorize services for other licensees authorized on the same license."], ["10:10:2.0.1.1.24.0.143.12", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.32 Schedule of fees for health and safety, and safeguards inspections for materials licenses.", "NRC", "", "", "[53 FR 52652, Dec. 29, 1988]", "Materials licensees shall pay inspection fees as set forth in \u00a7 170.31."], ["10:10:2.0.1.1.24.0.144.13", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.41 Failure by applicant or licensee to pay prescribed fees.", "NRC", "", "", "[66 FR 32474, June 14, 2001]", "If the Commission determines that an applicant or a licensee has failed to pay a prescribed fee required in this part, the Commission will not process any application and may suspend or revoke any license or approval issued to the applicant or licensee. The Commission may issue an order with respect to licensed activities that the Commission determines to be appropriate or necessary to carry out the provisions of this part, parts 30, 31, 32 through 35, 40, 50, 61, 70, 71, 72, 73, and 76 of this chapter, and of the act."], ["10:10:2.0.1.1.24.0.144.14", 10, "Energy", "I", "", "170", "PART 170\u2014FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED", "", "", "", "\u00a7 170.51 Right to dispute assessed fees.", "NRC", "", "", "[86 FR 32176, June 16, 2021]", "All debtors' disputes of fees assessed must be submitted in accordance with 10 CFR 15.31."], ["14:14:3.0.1.4.32.1.3.1", 14, "Aeronautics and Space", "I", "J", "170", "PART 170\u2014ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES", "A", "Subpart A\u2014General", "", "\u00a7 170.1 Scope.", "FAA", "", "", "", "This subpart sets forth establishment and discontinuance criteria for navigation aids operated and maintained by the United States."], ["14:14:3.0.1.4.32.1.3.2", 14, "Aeronautics and Space", "I", "J", "170", "PART 170\u2014ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES", "A", "Subpart A\u2014General", "", "\u00a7 170.3 Definitions.", "FAA", "", "", "[56 FR 341, Jan. 3, 1991, as amended by Amdt. 170-3, 66 FR 21067, Apr. 27, 2001; Docket FAA-2017-0733, Amdt. 170-4, 82 FR 34400, July 25, 2017]", "For purposes of this subpart\u2014\n\nAir navigation facility  (NAVAID) means any facility used, available for use, or designated for use in the aid of air navigation. Included are landing areas; lights; signaling, radio direction-finding, or radio or other electronic communication; and any other structure or mechanism having a similar purpose of guiding or controlling flight or the landing or takeoff of aircraft.\n\nAir traffic clearance  means an authorization by air traffic control for an aircraft to proceed under specified traffic conditions within controlled airspace for the purpose of preventing collision between known aircraft.\n\nAir traffic control  (ATC) means a service that promotes the safe, orderly, and expeditious flow of air traffic, including airport, approach, departure, and en route air traffic control.\n\nAir traffic controller  means a person authorized to provide air traffic service, specifically en route and terminal control personnel.\n\nAircraft operations  means the airborne movement of aircraft in controlled or noncontrolled airport terminal areas, and counts at en route fixes or other points where counts can be made. There are two types of operations: local and itinerant.\n\n(1)  Local operations  mean operations performed by aircraft which:\n\n(i) Operate in the local traffic pattern or within sight of the airport;\n\n(ii) Are known to be departing for, or arriving from flight in local practice areas located within a 20-mile radius of the airport; or\n\n(iii) Execute simulated instrument approaches or low passes at the airport.\n\n(2)  Itinerant operations  mean all aircraft operations other than local operations.\n\nAirport traffic control tower  means a terminal facility, which through the use of air/ground communications, visual signaling, and other devices, provides ATC services to airborne aircraft operating in the vicinity of an airport and to aircraft operating on the airport area.\n\nAlternate airport  means an airport, specified on a flight plan, to which a flight may proceed when a landing at the point of first intended landing becomes inadvisable.\n\nApproach  means the flight path established by the FAA to be used by aircraft landing on a runway.\n\nApproach control facility  means a terminal air traffic control facility providing approach control service.\n\nArrival  means any aircraft arriving at an airport.\n\nBenefit-cost ratio  means the quotient of the discounted life cycle benefits of an air traffic control service or navigation aid facility ( i.e. , ATCT) divided by the discounted life cycle costs.\n\nCeiling  means the vertical distance between the ground or water and the lowest layer of clouds or obscuring phenomena that is reported as \u201cbroken,\u201d \u201covercast,\u201d or \u201cobstruction.\u201d\n\nControl Tower \u2014See Airport Traffic Control Tower.\n\nCriteria  means the standards used by the FAA for the determination of establishment or discontinuance of a service or facility at an airport.\n\nDeparture  means any aircraft taking off from an airport.\n\nDiscontinuance  means the withdrawal of a service and/or facility from an airport.\n\nEstablishment  means the provision of a service or facility at a candidate airport.\n\nInstrument approach  means a series of predetermined maneuvers for the orderly transfer of an aircraft under instrument flight conditions from the beginning of the initial approach to a landing, or to a point from which a landing may be made visually. It is prescribed and approved for a specific airport by competent authority.\n\nInstrument flight rules  (IFR) means rules governing the procedures for conducting flight under instrument meteorological conditions (IMC) instrument flight.\n\nInstrument landing system  (ILS) means an instrument landing system whereby the pilot guides his approach to a runway solely by reference to instruments in the cockpit. In some instances, the signals received from the ground can be fed into the automatic pilot for automatically controlled approaches.\n\nInstrument meteorological conditions  (IMC) means weather conditions below the minimums prescribed for flight under Visual Flight Rules (VFR).\n\nInstrument operation  means an aircraft operation in accordance with an IFT flight plan or an operation where IFR separation between aircraft is provided by a terminal control facility or air route traffic control center (ARTCC).\n\nLife cycle benefits  means the value of services provided to aviation users over the life span of a facility or service.\n\nLife cycle costs  means the value of research and development costs, investment costs, operation costs, maintenance costs, and termination costs over the life span of a facility or service.\n\nMaintenance costs  means the costs incurred in servicing and maintaining a facility after establishment.\n\nMean sea level  (MSL) means the base commonly used in measuring altitudes.\n\nMicrowave landing system  (MLS) means a landing system which enables equipped aircraft to make curved and closely spaced approaches to properly instrumented airports.\n\nNoncommercial traffic  means all aircraft operations that are conducted free of compensation.\n\nNonprecision approach procedure  means an FAA standard for approaching an IFR runway where no electronic glide slope is available.\n\nNonscheduled commercial service  means the carriage by aircraft in air commerce of persons or property for compensation or hire that are not operated in regularly scheduled service such as charter flights.\n\nPresent value  (PV) means the value of a stream of future benefits or costs that are discounted to the present.\n\nPVB  or  BPV  means the discounted value of life cycle benefits.\n\nPVC  or  CPV  means the discounted value of life cycle benefits.\n\nPVCM  or  CMPV  means the discounted value of operations and maintenance costs less termination costs over a facility's remaining life cycle.\n\nRunway  means a defined rectangular area on a land airport prepared for the landing and takeoff of aircraft along its length.\n\nRunway visual range  means an instrumentally derived value based on standard calibrations that represent the horizontal distance a pilot will see down the runway from the approach end.\n\nScheduled commercial service  means the carriage by aircraft in air commerce under parts 121 and 135 of persons or property for compensation or hire based on published flight schedules.\n\nSeparation  means the spacing of aircraft in flight and while landing and taking off to achieve their safe and orderly movement.\n\nTakeoff clearance  means authorization by an airport traffic control tower for an aircraft to take off.\n\nTower cab  means an ATC facility located at an airport. Controllers at these facilities direct ground traffic, takeoffs, and landings.\n\nTraffic advisories  means advisories issued to alert pilots to other known or observed air traffic which may be in such proximity to the position or intended route of flight of their aircraft to warrant attention.\n\nTraffic pattern  means the flow of aircraft operating on and in the vicinity of an airport during specified wind conditions as established by appropriate authority.\n\nVFR traffic  means aircraft operated solely in accordance with Visual Flight Rules.\n\nVisual flight rules  (VFR) means rules that govern the procedures for conducting flight under visual conditions. The term \u201cVFR\u201d is also used in the United States to indicate weather conditions that are equal to or greater than minimum VFR requirements. In addition, \u201cVFR\u201d is used by pilots and controllers to indicate the type of flight plan.\n\nVisual meteorological conditions  (VMC) means meteorological conditions expressed in terms of visibility, distance from clouds, and ceiling equal to or better than specified minima."], ["14:14:3.0.1.4.32.2.3.1", 14, "Aeronautics and Space", "I", "J", "170", "PART 170\u2014ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES", "B", "Subpart B\u2014Airport Traffic Control Towers", "", "\u00a7 170.11 Scope.", "FAA", "", "", "", "This subpart sets forth establishment and discontinuance criteria for Airport Traffic Control Towers."], ["14:14:3.0.1.4.32.2.3.2", 14, "Aeronautics and Space", "I", "J", "170", "PART 170\u2014ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES", "B", "Subpart B\u2014Airport Traffic Control Towers", "", "\u00a7 170.13 Airport Traffic Control Tower (ATCT) establishment criteria.", "FAA", "", "", "", "(a) The following criteria along with general facility establishment standards must be met before an airport can qualify for an ATCT:\n\n(1) The airport, whether publicly or privately owned, must be open to and available for use by the public as defined in the Airport and Airway Improvement Act of 1982;\n\n(2) The airport must be recognized by and contained within the National Plan of Integrated Airport Systems;\n\n(3) The airport owners/authorities must have entered into appropriate assurances and covenants to guarantee that the airport will continue in operation for a long enough period to permit the amortization of the ATCT investment;\n\n(4) The FAA must be furnished appropriate land without cost for construction of the ATCT; and\n\n(5) The airport must meet the benefit-cost ratio criteria specified herein utilizing three consecutive FAA annual counts and projections of future traffic during the expected life of the tower facility. (An FAA annual count is a fiscal year or a calendar year activity summary. Where actual traffic counts are unavailable or not recorded, adequately documented FAA estimates of the scheduled and nonscheduled activity may be used.)\n\n(b) An airport meets the establishment criteria when it satisfies paragraphs (a)(1) through (a)(5) of this section and its benefit-cost ratio equals or exceeds one. As defined in \u00a7 170.3 of this part, the benefit-cost ratio is the ratio of the present value of the ATCT life cycle benefits (BPV) to the present value of ATCT life cycle costs (CPV).\n\nBPV/CPV\u22651.0\n\n(c) The satisfaction of all the criteria listed in this section does not guarantee that the airport will receive an ATCT."], ["14:14:3.0.1.4.32.2.3.3", 14, "Aeronautics and Space", "I", "J", "170", "PART 170\u2014ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES", "B", "Subpart B\u2014Airport Traffic Control Towers", "", "\u00a7 170.15 ATCT discontinuance criteria.", "FAA", "", "", "", "An ATCT will be subject to discontinuance when the continued operation and maintenance costs less termination costs (CMPV) of the ATCT exceed the present value of its remaining life-cycle benefits (BPV):\n\nBPV/CMPV<1.0"], ["17:17:2.0.1.1.30.1.1.1", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.1 Demonstration of purposes (section 17(b)(1) of the Act).", "CFTC", "", "", "", "A futures association must demonstrate that it will be able to carry out the purposes of section 17 of the Act. Since a basic purpose of a futures association is to regulate the practices of its members, an association should demonstrate that it will require its members to adhere to regulatory requirements governing their business practices at least as stringent as those imposed by the Commission. For example, the association should be prepared to establish and maintain in accordance with \u00a7 1.52 of this chapter, a financial compliance program for those members of the association who are futures commission merchants."], ["17:17:2.0.1.1.30.1.1.10", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.10 Proficiency examinations (sections 4p and 17(p) of the Act).", "CFTC", "", "", "[48 FR 35305, Aug. 3, 1983]", "A futures association may prescribe different training standards and proficiency examinations for persons registered in more than one capacity:  Provided,  That nothing contained in the Act or these regulations, including any exemption from registration for persons registered in another capacity, shall be deemed to preclude the establishment of training standards and a proficiency examination requirement for functions performed in such other capacity."], ["17:17:2.0.1.1.30.1.1.2", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.2 Membership restrictions (section 17(b)(2) of the Act).", "CFTC", "", "", "[48 FR 35305, Aug. 3, 1983]", "If it appears to the Commission to be necessary or appropriate in the public interest and to carry out the purposes of section 17 of the Act, a futures association may restrict its membership to individuals registered by the Commission in a particular capacity or to individuals doing business in a particular geographical region or to firms having a particular level of capital assets or which engage in a specified amount of business per year."], ["17:17:2.0.1.1.30.1.1.3", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.3 Fair and equitable representation of members (section 17(b)(5) of the Act).", "CFTC", "", "", "", "A futures association must assure fair and equitable representation of the views and interests of all association members in the procedures providing for the adoption, amendment or repeal of any association rule, in an association's procedure for the selection of association officers and directors and in all other phases of the association's affairs and activities, including disciplinary and membership hearings. No single group or class of association members shall dominate or otherwise exercise disproportionate influence on any governing board of an association or on any disciplinary or membership panel of such an association. Non-members of the association shall be represented wherever practicable on any board or hearing panel of the association."], ["17:17:2.0.1.1.30.1.1.4", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.4 Allocation of dues (section 17(b)(6) of the Act).", "CFTC", "", "", "", "Dues imposed on members of a futures association must be allocated equitably among members and may not be structured in a manner constituting a barrier to entry of any person seeking to engage in commodity-related business activities."], ["17:17:2.0.1.1.30.1.1.5", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.5 Prevention of fraudulent and manipulative practices (section 17(b)(7) of the Act).", "CFTC", "", "", "[47 FR 57020, Dec. 22, 1982]", "A futures association must establish and maintain a program for the protection of customers and option customers, including the adoption of rules to protect customers and option customers and customer funds and to promote fair dealing with the public. These rules shall set forth the ethical standards for members of the association in their business dealings with the public. An applicant association must also demonstrate its capability to foster a professional atmosphere among its members, including an acceptance of an adherence to the ethical standards, and to monitor and enforce compliance with the customer and option customer protection program and rules."], ["17:17:2.0.1.1.30.1.1.6", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.6 Disciplinary proceedings (sections 17(b)(8) and (b)(9) of the Act).", "CFTC", "", "", "[44 FR 20651, Apr. 6, 1979, as amended at 46 FR 63036, Dec. 30, 1981]", "A futures association must provide a fair and orderly procedure with respect to disciplinary actions brought against association members or persons associated with members. These rules governing such disciplinary actions shall contain, at a minimum, the procedural safeguards contained in section 17(b)(9) of the Act. In addition, an association, in disciplining its members should demonstrate that it will:\n\n(a) Take vigorous action against those who engage in activities in violation of association rules;\n\n(b) Conduct proceedings in a manner consistent with the fundamental elements of due process; and\n\n(c) Impose discipline which is fair and has a reasonable basis in fact."], ["17:17:2.0.1.1.30.1.1.7", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.7 Membership denial (section 17(b)(9) of the Act).", "CFTC", "", "", "[44 FR 20651, Apr. 6, 1979, as amended at 46 FR 63036, Dec. 30, 1981]", "A futures association must provide a fair and orderly procedure for processing membership applications and for affording any person to be denied membership an opportunity to submit evidence in response to the grounds for denial stated by the association. The procedures governing denials of membership in the association shall contain, at a minimum, the procedural safeguards contained in section 17(b)(9) of the Act."], ["17:17:2.0.1.1.30.1.1.8", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.8 Settlement of customer disputes (section 17(b)(10) of the Act).", "CFTC", "", "", "[66 FR 42288, Aug. 10, 2001]", "A futures association must be able to demonstrate its capacity to promulgate rules and to conduct proceedings that provide a fair, equitable and expeditious procedure, through arbitration or otherwise, for the voluntary settlement of a customer's claim or grievance brought against any member of the association or any employee of a member of the association. Such rules shall conform to and be consistent with section 17(b)(10) of the Act and be consistent with the guidelines and acceptable practices for dispute resolution found within appendix A and appendix B to part 38 of this chapter."], ["17:17:2.0.1.1.30.1.1.9", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "A", "Subpart A\u2014Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act", "", "\u00a7 170.9 General standard.", "CFTC", "", "", "", "An applicant seeking registration as a futures association by the Commission must demonstrate the association's ability to comply with standards and requirements set forth in this part. The applicant must also demonstrate its ability to satisfy the provisions of section 17 of the Act as well as other applicable legal considerations, including that the association will promote fair and open competition among its members and will conduct its affairs consistent with the public interest to be protected by the antitrust laws. The Commission shall not register an applicant association unless the Commission finds that the applicant has satisfied the conditions and requirements of section 17 of the Act and of this part and that registration will be in the public interest."], ["17:17:2.0.1.1.30.2.1.1", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "B", "Subpart B\u2014Registration Statement of Futures Associations to be Submitted to the Commission", "", "\u00a7 170.11 Form of registration statement; review of registration statement.", "CFTC", "", "", "[44 FR 20651, Apr. 6, 1979, as amended at 46 FR 63036, Dec. 30, 1981; 60 FR 49336, Sept. 25, 1995; 89 FR 71820, Sept. 4, 2024]", "(a) Any association seeking registration by the Commission as a futures association must file with the Commission a letter requesting that the association be registered by the Commission as a futures association and accompany the letter with the following: (1) The constitution, charter or articles of incorporation of the association, (2) the bylaws of the association, (3) any other rules, resolutions or regulations of the association corresponding to the foregoing, (4) a detailed description of the association's organization, membership and rules of procedure and (5) a detailed statement of the association's capability to comply with the provisions of section 17 of the Act and this part. This letter and the accompanying information shall be considered as the registration statement of the association. This letter and the accompanying information shall be filed with the Secretariat of the Commission at the Commission's DC headquarters.\n\n(b) At any time after an applicant's registration statement has been filed, the applicant association shall submit to the Commission any supporting or additional information concerning the application of the association as the Commission may request.\n\n(c) If it appears to the Commission, after reviewing any registration statement filed by an applicant association, that the applicant has not satisfied the requirements for registration set forth in section 17 of the Act or of this part, the Commission may, in its discretion, notify the applicant in writing to that effect. Such notice shall specify those requirements of section 17 or of this part which do not appear to have been satisfied and shall afford the applicant a period of at least 60 days in which to respond to the Commission's notice by demonstrating or achieving compliance with the requirements specified by the Commission or otherwise. An applicant may withdraw its registration statement from Commission consideration at any time within such 60 day period."], ["17:17:2.0.1.1.30.2.1.2", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "B", "Subpart B\u2014Registration Statement of Futures Associations to be Submitted to the Commission", "", "\u00a7 170.12 Delegation of Authority to Director of the Market Participants Division.", "CFTC", "", "", "[44 FR 20651, Apr. 6, 1979, as amended at 67 FR 62353, Oct. 7, 2002; 78 FR 22419, Apr. 16, 2013; 89 FR 71820, Sept. 4, 2024]", "The Commission hereby delegates, until the Commission orders otherwise, to the Director of the Market Participants Division the authority to take any of the actions enumerated in \u00a7\u00a7 170.11 (b) and (c). Notwithstanding the provisions of this section, if the Director believes it appropriate, he may submit the matter to the Commission for its consideration."], ["17:17:2.0.1.1.30.3.1.1", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "C", "Subpart C\u2014Membership in a Registered Futures Association", "", "\u00a7 170.15 Futures commission merchants.", "CFTC", "", "", "[66 FR 43083, Aug. 17, 2001, as amended at 72 FR 2615, Jan. 22, 2007]", "(a) Except as provided in paragraph (b) of this section, each person registered as a futures commission merchant must become and remain a member of at least one futures association that is registered under section 17 of the Act and that provides for the membership therein of such futures commission merchant, unless no such futures association is so registered.\n\n(b) The requirements of paragraph (a) of this section shall not apply to a futures commission merchant registered in accordance with \u00a7 3.10(a)(3) of this chapter."], ["17:17:2.0.1.1.30.3.1.2", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "C", "Subpart C\u2014Membership in a Registered Futures Association", "", "\u00a7 170.16 Swap dealers and major swap participants.", "CFTC", "", "", "[77 FR 2629, Jan. 19, 2012]", "Each person registered as a swap dealer or major swap participant must become and remain a member of at least one futures association that is registered under section 17 of the Act and that provides for the membership therein of such swap dealer or major swap participant, as the case may be, unless no such futures association is so registered."], ["17:17:2.0.1.1.30.3.1.3", 17, "Commodity and Securities Exchanges", "I", "", "170", "PART 170\u2014REGISTERED FUTURES ASSOCIATIONS", "C", "Subpart C\u2014Membership in a Registered Futures Association", "", "\u00a7 170.17 Introducing brokers, commodity pool operators, and commodity trading advisors.", "CFTC", "", "", "[80 FR 55029, Sept. 14, 2015]", "Each person registered as an introducing broker, commodity pool operator, or commodity trading advisor must become and remain a member of at least one futures association that is registered under Section 17 of the Act and that provides for the membership therein of introducing brokers, commodity pool operators, or commodity trading advisors, as the case may be, unless no such futures association is so registered; provided, however that a person registered as a commodity trading advisor shall not be required to become or remain a member of such a futures association, solely in respect of its registration as a commodity trading advisor, if such person is eligible for the exemption from registration as such pursuant to \u00a7 4.14(a)(9) of this chapter."], ["21:21:3.0.1.1.1.1.1.1", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.3 Definitions.", "FDA", "", "", "[42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 53 FR 16546, May 10, 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, July 17, 1995; 67 FR 35729, May 21, 2002; 81 FR 55047, Aug. 17, 2016]", "For the purposes of this subchapter, the following definitions apply:\n\n(a)  Secretary  means the Secretary of Health and Human Services.\n\n(b)  Department  means the Department of Health and Human Services.\n\n(c)  Commissioner  means the Commissioner of Food and Drugs.\n\n(d) As used in this part, the term  act  means the Federal Food, Drug, and Cosmetic Act approved June 25, 1936, 52 Stat. 1040  et seq.,  as amended (21 U.S.C. 301-392).\n\n(e)(1)  Food additives  includes all substances not exempted by section 201(s) of the act, the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food. A material used in the production of containers and packages is subject to the definition if it may reasonably be expected to become a component, or to affect the characteristics, directly or indirectly, of food packed in the container. \u201cAffecting the characteristics of food\u201d does not include such physical effects, as protecting contents of packages, preserving shape, and preventing moisture loss. If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive. A substance that does not become a component of food, but that is used, for example, in preparing an ingredient of the food to give a different flavor, texture, or other characteristic in the food, may be a food additive.\n\n(2)  Uses of food additives not requiring a listing regulation.  Use of a substance in a food contact article (e.g., food-packaging or food-processing equipment) whereby the substance migrates, or may reasonably be expected to migrate, into food at such levels that the use has been exempted from regulation as a food additive under \u00a7 170.39, and food contact substances used in accordance with a notification submitted under section 409(h) of the act that is effective.\n\n(3)  A food contact substance  is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.\n\n(f)  Common use in food  means a substantial history of consumption of a substance for food use by a significant number of consumers.\n\n(g) The word  substance  in the definition of the term \u201cfood additive\u201d includes a food or food component consisting of one or more ingredients.\n\n(h)  Scientific procedures  include the application of scientific data (including, as appropriate, data from human, animal, analytical, or other scientific studies), information, and methods, whether published or unpublished, as well as the application of scientific principles, appropriate to establish the safety of a substance under the conditions of its intended use.\n\n(i)  Safe  or  safety  means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Safety may be determined by scientific procedures or by general recognition of safety. In determining safety, the following factors shall be considered:\n\n(1) The probable consumption of the substance and of any substance formed in or on food because of its use.\n\n(2) The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet.\n\n(3) Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food and food ingredients, are generally recognized as appropriate.\n\n(j) The term  nonperishable processed food  means any processed food not subject to rapid decay or deterioration that would render it unfit for consumption. Examples are flour, sugar, cereals, packaged cookies, and crackers. Not included are hermetically sealed foods or manufactured dairy products and other processed foods requiring refrigeration.\n\n(k)  General recognition of safety  shall be in accordance with \u00a7 170.30.\n\n(l)  Prior sanction  means an explicit approval granted with respect to use of a substance in food prior to September 6, 1958, by the Food and Drug Administration or the United States Department of Agriculture pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry Products Inspection Act, or the Meat Inspection Act.\n\n(m)  Food  includes human food, substances migrating to food from food-contact articles, pet food, and animal feed.\n\n(n) The following general food categories are established to group specific related foods together for the purpose of establishing tolerances or limitations for the use of direct human food ingredients. Individual food products will be included within these categories according to the detailed classifications lists contained in Exhibit 33B of the report of the National Academy of Sciences/National Research Council report, \u201cA Comprehensive Survey of Industry on the Use of Food Chemicals Generally Recognized as Safe\u201d (September 1972), which is incorporated by reference. Copies are available from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:  http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.\n\n(1) Baked goods and baking mixes, including all ready-to-eat and ready-to-bake products, flours, and mixes requiring preparation before serving.\n\n(2) Beverages, alcoholic, including malt beverages, wines, distilled liquors, and cocktail mix.\n\n(3) Beverages and beverage bases, nonalcoholic, including only special or spiced teas, soft drinks, coffee substitutes, and fruit and vegetable flavored gelatin drinks.\n\n(4) Breakfast cereals, including ready-to-eat and instant and regular hot cereals.\n\n(5) Cheeses, including curd and whey cheeses, cream, natural, grating, processed, spread, dip, and miscellaneous cheeses.\n\n(6) Chewing gum, including all forms.\n\n(7) Coffee and tea, including regular, decaffeinated, and instant types.\n\n(8) Condiments and relishes, including plain seasoning sauces and spreads, olives, pickles, and relishes, but not spices or herbs.\n\n(9) Confections and frostings, including candy and flavored frostings, marshmallows, baking chocolate, and brown, lump, rock, maple, powdered, and raw sugars.\n\n(10) Dairy product analogs, including nondairy milk, frozen or liquid creamers, coffee whiteners, toppings, and other nondairy products.\n\n(11) Egg products, including liquid, frozen, or dried eggs, and egg dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and frozen multicourse egg meals, but not fresh eggs.\n\n(12) Fats and oils, including margarine, dressings for salads, butter, salad oils, shortenings and cooking oils.\n\n(13) Fish products, including all prepared main dishes, salads, appetizers, frozen multicourse meals, and spreads containing fish, shellfish, and other aquatic animals, but not fresh fish.\n\n(14) Fresh eggs, including cooked eggs and egg dishes made only from fresh shell eggs.\n\n(15) Fresh fish, including only fresh and frozen fish, shellfish, and other aquatic animals.\n\n(16) Fresh fruits and fruit juices, including only raw fruits, citrus, melons, and berries, and home-prepared \u201cades\u201d and punches made therefrom.\n\n(17) Fresh meats, including only fresh or home-frozen beef or veal, pork, lamb or mutton and home-prepared fresh meat-containing dishes, salads, appetizers, or sandwich spreads made therefrom.\n\n(18) Fresh poultry, including only fresh or home-frozen poultry and game birds and home-prepared fresh poultry-containing dishes, salads, appetizers, or sandwich spreads made therefrom.\n\n(19) Fresh vegetables, tomatoes, and potatoes, including only fresh and home-prepared vegetables.\n\n(20) Frozen dairy desserts and mixes, including ice cream, ice milks, sherbets, and other frozen dairy desserts and specialties.\n\n(21) Fruit and water ices, including all frozen fruit and water ices.\n\n(22) Gelatins, puddings, and fillings, including flavored gelatin desserts, puddings, custards, parfaits, pie fillings, and gelatin base salads.\n\n(23) Grain products and pastas, including macaroni and noodle products, rice dishes, and frozen multicourse meals, without meat or vegetables.\n\n(24) Gravies and sauces, including all meat sauces and gravies, and tomato, milk, buttery, and specialty sauces.\n\n(25) Hard candy and cough drops, including all hard type candies.\n\n(26) Herbs, seeds, spices, seasonings, blends, extracts, and flavorings, including all natural and artificial spices, blends, and flavors.\n\n(27) Jams and jellies, home-prepared, including only home-prepared jams, jellies, fruit butters, preserves, and sweet spreads.\n\n(28) Jams and jellies, commercial, including only commercially processed jams, jellies, fruit butters, preserves, and sweet spreads.\n\n(29) Meat products, including all meats and meat containing dishes, salads, appetizers, frozen multicourse meat meals, and sandwich ingredients prepared by commercial processing or using commercially processed meats with home preparation.\n\n(30) Milk, whole and skim, including only whole, lowfat, and skim fluid milks.\n\n(31) Milk products, including flavored milks and milk drinks, dry milks, toppings, snack dips, spreads, weight control milk beverages, and other milk origin products.\n\n(32) Nuts and nut products, including whole or shelled tree nuts, peanuts, coconut, and nut and peanut spreads.\n\n(33) Plant protein products, including the National Academy of Sciences/National Research Council \u201creconstituted vegetable protein\u201d category, and meat, poultry, and fish substitutes, analogs, and extender products made from plant proteins.\n\n(34) Poultry products, including all poultry and poultry-containing dishes, salads, appetizers, frozen multicourse poultry meals, and sandwich ingredients prepared by commercial processing or using commercially processed poultry with home preparation.\n\n(35) Processed fruits and fruit juices, including all commercially processed fruits, citrus, berries, and mixtures; salads, juices and juice punches, concentrates, dilutions, \u201cades\u201d, and drink substitutes made therefrom.\n\n(36) Processed vegetables and vegetable juices, including all commercially processed vegetables, vegetable dishes, frozen multicourse vegetable meals, and vegetable juices and blends.\n\n(37) Snack foods, including chips, pretzels, and other novelty snacks.\n\n(38) Soft candy, including candy bars, chocolates, fudge, mints, and other chewy or nougat candies.\n\n(39) Soups, home-prepared, including meat, fish, poultry, vegetable, and combination home-prepared soups.\n\n(40) Soups and soup mixes, including commercially prepared meat, fish, poultry, vegetable, and combination soups and soup mixes.\n\n(41) Sugar, white, granulated, including only white granulated sugar.\n\n(42) Sugar substitutes, including granulated, liquid, and tablet sugar substitutes.\n\n(43) Sweet sauces, toppings, and syrups, including chocolate, berry, fruit, corn syrup, and maple sweet sauces and toppings.\n\n(o) The following terms describe the physical or technical functional effects for which direct human food ingredients may be added to foods. They are adopted from the National Academy of Sciences/National Research Council national survey of food industries, reported to the Food and Drug Administration under the contract title \u201cA Comprehensive Survey of Industry on the Use of Food Chemicals Generally Recognized as Safe\u201d (September 1972), which is incorporated by reference. Copies are available from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:  http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.\n\n(1)  Anticaking agents and free-flow agents : Substances added to finely powdered or crystalline food products to prevent caking, lumping, or agglomeration.\n\n(2)  Antimicrobial agents : Substances used to preserve food by preventing growth of microorganisms and subsequent spoilage, including fungistats, mold and rope inhibitors, and the effects listed by the National Academy of Sciences/National Research Council under \u201cpreservatives.\u201d\n\n(3)  Antioxidants : Substances used to preserve food by retarding deterioration, rancidity, or discoloration due to oxidation.\n\n(4)  Colors and coloring adjuncts : Substances used to impart, preserve, or enhance the color or shading of a food, including color stabilizers, color fixatives, color-retention agents, etc.\n\n(5)  Curing and pickling agents : Substances imparting a unique flavor and/or color to a food, usually producing an increase in shelf life stability.\n\n(6)  Dough strengtheners : Substances used to modify starch and gluten, thereby producing a more stable dough, including the applicable effects listed by the National Academy of Sciences/National Research Council under \u201cdough conditioner.\u201d\n\n(7)  Drying agents : Substances with moisture-absorbing ability, used to maintain an environment of low moisture.\n\n(8)  Emulsifiers and emulsifier salts : Substances which modify surface tension in the component phase of an emulsion to establish a uniform dispersion or emulsion.\n\n(9)  Enzymes : Enzymes used to improve food processing and the quality of the finished food.\n\n(10)  Firming agents : Substances added to precipitate residual pectin, thus strengthening the supporting tissue and preventing its collapse during processing.\n\n(11)  Flavor enhancers : Substances added to supplement, enhance, or modify the original taste and/or aroma of a food, without imparting a characteristic taste or aroma of its own.\n\n(12)  Flavoring agents and adjuvants : Substances added to impart or help impart a taste or aroma in food.\n\n(13)  Flour treating agents : Substances added to milled flour, at the mill, to improve its color and/or baking qualities, including bleaching and maturing agents.\n\n(14)  Formulation aids : Substances used to promote or produce a desired physical state or texture in food, including carriers, binders, fillers, plasticizers, film-formers, and tableting aids, etc.\n\n(15)  Fumigants : Volatile substances used for controlling insects or pests.\n\n(16)  Humectants : Hygroscopic substances incorporated in food to promote retention of moisture, including moisture-retention agents and antidusting agents.\n\n(17)  Leavening agents : Substances used to produce or stimulate production of carbon dioxide in baked goods to impart a light texture, including yeast, yeast foods, and calcium salts listed by the National Academy of Sciences/National Research Council under \u201cdough conditioners.\u201d\n\n(18)  Lubricants and release agents : Substances added to food contact surfaces to prevent ingredients and finished products from sticking to them.\n\n(19)  Non-nutritive sweeteners : Substances having less than 2 percent of the caloric value of sucrose per equivalent unit of sweetening capacity.\n\n(20)  Nutrient supplements : Substances which are necessary for the body's nutritional and metabolic processes.\n\n(21)  Nutritive sweeteners : Substances having greater than 2 percent of the caloric value of sucrose per equivalent unit of sweetening capacity.\n\n(22)  Oxidizing and reducing agents : Substances which chemically oxidize or reduce another food ingredient, thereby producing a more stable product, including the applicable effect listed by the National Academy of Sciences/National Research Council under \u201cdough conditioners.\u201d\n\n(23)  pH control agents : Substances added to change or maintain active acidity or basicity, including buffers, acids, alkalies, and neutralizing agents.\n\n(24)  Processing aids : Substances used as manufacturing aids to enhance the appeal or utility of a food or food component, including clarifying agents, clouding agents, catalysts, flocculents, filter aids, and crystallization inhibitors, etc.\n\n(25)  Propellants, aerating agents, and gases : Gases used to supply force to expel a product or used to reduce the amount of oxygen in contact with the food in packaging.\n\n(26)  Sequestrants : Substances which combine with polyvalent metal ions to form a soluble metal complex, to improve the quality and stability of products.\n\n(27)  Solvents and vehicles : Substances used to extract or dissolve another substance.\n\n(28)  Stabilizers and thickeners : Substances used to produce viscous solutions or dispersions, to impart body, improve consistency, or stabilize emulsions, including suspending and bodying agents, setting agents, jellying agents, and bulking agents, etc.\n\n(29)  Surface-active agents : Substances used to modify surface properties of liquid food components for a variety of effects, other than emulsifiers, but including solubilizing agents, dispersants, detergents, wetting agents, rehydration enhancers, whipping agents, foaming agents, and defoaming agents, etc.\n\n(30)  Surface-finishing agents : Substances used to increase palatability, preserve gloss, and inhibit discoloration of foods, including glazes, polishes, waxes, and protective coatings.\n\n(31)  Synergists : Substances used to act or react with another food ingredient to produce a total effect different or greater than the sum of the effects produced by the individual ingredients.\n\n(32)  Texturizers : Substances which affect the appearance or feel of the food."], ["21:21:3.0.1.1.1.1.1.2", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.6 Opinion letters on food additive status.", "FDA", "", "", "[42 FR 14483, Mar. 15, 1977, as amended at 54 FR 24896, June 12, 1989; 81 FR 49896, July 29, 2016]", "(a) Over the years the Food and Drug Administration has given informal written opinions to inquiries as to the safety of articles intended for use as components of, or in contact with, food. Prior to the enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929; Sept. 6, 1958), these opinions were given pursuant to section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, which reads in part: \u201cA food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health\u201d.\n\n(b) Since enactment of the Food Additives Amendment, the Food and Drug Administration has advised such inquirers that an article:\n\n(1) Is a food additive within the meaning of section 201(s) of the act; or\n\n(2) Is generally recognized as safe (GRAS); or\n\n(3) Has prior sanction or approval under that amendment; or\n\n(4) Is not a food additive under the conditions of intended use.\n\n(c) In the interest of the public health, such articles which have been considered in the past by the Food and Drug Administration to be safe under the provisions of section 402(a)(1), or to be generally recognized as safe for their intended use, or to have prior sanction or approval, or not to be food additives under the conditions of intended use, must be reexamined in the light of current scientific information and current principles for evaluating the safety of food additives if their use is to be continued.\n\n(d) Because of the time span involved, copies of many of the letters in which the Food and Drug Administration has expressed an informal opinion concerning the status of such articles may no longer be in the file of the Food and Drug Administration. In the absence of information concerning the names and uses made of all the articles referred to in such letters, their safety of use cannot be reexamined. For this reason all food additive status opinions of the kind described in paragraph (c) of this section given by the Food and Drug Administration are hereby revoked.\n\n(e) The prior opinions of the kind described in paragraph (c) of this section will be replaced by qualified and current opinions if the recipient of each such letter forwards a copy of each to the Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, along with a copy of his letter of inquiry, on or before July 23, 1970.\n\n(f) This section does not apply to food additive status opinion letters pertaining to articles that were considered by the Food and Drug Administration to be food additives nor to articles included in regulations in parts 170 through 189 of this chapter if the articles are used in accordance with the requirements of such regulations."], ["21:21:3.0.1.1.1.1.1.3", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.10 Food additives in standardized foods.", "FDA", "", "", "", "(a) The inclusion of food ingredients in parts 170 through 189 of this chapter does not imply that these ingredients may be used in standardized foods unless they are recognized as optional ingredients in applicable food standards. Where a petition is received for the issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the Act, which proposes the inclusion of a food additive in such definition and standard of identity, the provisions of the regulations in this part shall apply with respect to the information that must be submitted with respect to the food additive. Since section 409(b)(5) of the Act requires that the Secretary publish notice of a petition for the establishment of a food-additive regulation within 30 days after filing, notice of a petition relating to a definition and standard of identity shall also be published within that time limitation if it includes a request, so designated, for the establishment of a regulation pertaining to a food additive.\n\n(b) If a petition for a definition and standard of identity contains a proposal for a food-additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a food-additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in this part.\n\n(c) A regulation will not be issued allowing the use of a food additive in a food for which a definition and standard of identity is established, unless its issuance is in conformity with section 401 of the Act or with the terms of a temporary permit issued under \u00a7 130.17 of this chapter. When the contemplated use of such additive complies with the terms of a temporary permit, the food additive regulation will be conditioned on such compliance and will expire with the expiration of the temporary permit."], ["21:21:3.0.1.1.1.1.1.4", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.15 Adoption of regulation on initiative of Commissioner.", "FDA", "", "", "[42 FR 14486, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]", "(a) The Commissioner upon his own initiative may propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such additive may be safely used. Notice of such proposal shall be published in the  Federal Register  and shall state the reasons for the proposal.\n\n(b) Action upon a proposal made by the Commissioner shall proceed as provided in part 10 of this chapter."], ["21:21:3.0.1.1.1.1.1.5", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.", "FDA", "", "", "[42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22, 1978]", "A food additive or food containing a food additive intended for investigational use by qualified experts shall be exempt from the requirements of section 409 of the Act under the following conditions:\n\n(a) If intended for investigational use in vitro or in laboratory research animals, it bears a label which states prominently, in addition to the other information required by the act, the warning:\n\nCaution.  Contains a new food additive for investigational use only in laboratory research animals or for tests in vitro. Not for use in humans.\n\nCaution.  Contains a new food additive for investigational use only in laboratory research animals or for tests in vitro. Not for use in humans.\n\n(b) If intended for use in animals other than laboratory research animals and if the edible products of the animals are to be marketed as food, permission for the marketing of the edible products as food has been requested by the sponsor, and authorization has been granted by the Food and Drug Administration in accordance with \u00a7 511.1 of this chapter or by the Department of Agriculture in accordance with 9 CFR 309.17, and it bears a label which states prominently, in addition to the other information required by the Act, the warning:\n\nCaution.  Contains a new food additive for use only in investigational animals. Not for use in humans.\n \n Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.\n\nCaution.  Contains a new food additive for use only in investigational animals. Not for use in humans.\n\nEdible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.\n\n(c) If intended for nonclinical laboratory studies in food-producing animals, the study is conducted in compliance with the regulations set forth in part 58 of this chapter."], ["21:21:3.0.1.1.1.1.1.6", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.18 Tolerances for related food additives.", "FDA", "", "", "", "(a) Food additives that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects and will be considered as related food additives.\n\n(b) Tolerances established for such related food additives may limit the amount of a common component that may be present, or may limit the amount of biological activity (such as cholinesterase inhibition) that may be present or may limit the total amount of related food additives that may be present.\n\n(c) Where food additives from two or more chemicals in the same class are present in or on a food, the tolerance for the total of such additives shall be the same as that for the additive having the lowest numerical tolerance in this class, unless there are available methods that permit quantitative determination of the amount of each food additive present or unless it is shown that a higher tolerance is reasonably required for the combined additives to accomplish the physical or technical effect for which such combined additives are intended and that the higher tolerance will be safe.\n\n(d) Where residues from two or more additives in the same class are present in or on a food and there are available methods that permit quantitative determination of each residue, the quantity of combined residues that are within the tolerance may be determined as follows:\n\n(1) Determine the quantity of each residue present.\n\n(2) Divide the quantity of each residue by the tolerance that would apply if it occurred alone, and multiply by 100 to determine the percentage of the permitted amount of residue present.\n\n(3) Add the percentages so obtained for all residues present.\n\n(4) The sum of the percentage shall not exceed 100 percent."], ["21:21:3.0.1.1.1.1.1.7", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.19 Pesticide chemicals in processed foods.", "FDA", "", "", "", "When pesticide chemical residues occur in processed foods due to the use of raw agricultural commodities that bore or contained a pesticide chemical in conformity with an exemption granted or a tolerance prescribed under section 408 of the Act, the processed food will not be regarded as adulterated so long as good manufacturing practice has been followed in removing any residue from the raw agricultural commodity in the processing (such as by peeling or washing) and so long as the concentration of the residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity. But when the concentration of residue in the processed food when ready to eat is higher than the tolerance prescribed for the raw agricultural commodity, the processed food is adulterated unless the higher concentration is permitted by a tolerance obtained under section 409 of the Act. For example, if fruit bearing a residue of 7 parts per million of DDT permitted on the raw agricultural commodity is dried and a residue in excess of 7 parts per million of DDT results on the dried fruit, the dehydrated fruit is adulterated unless the higher tolerance for DDT is authorized by the regulations in this part. Food that is itself ready to eat, and which contains a higher residue than allowed for the raw agricultural commodity, may not be legalized by blending or mixing with other foods to reduce the residue in the mixed food below the tolerance prescribed for the raw agricultural commodity."], ["21:21:3.0.1.1.1.2.1.1", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "B", "Subpart B\u2014Food Additive Safety", "", "\u00a7 170.20 General principles for evaluating the safety of food additives.", "FDA", "", "", "", "(a) In reaching a decision on any petition filed under section 409 of the Act, the Commissioner will give full consideration to the specific biological properties of the compound and the adequacy of the methods employed to demonstrate safety for the proposed use, and the Commissioner will be guided by the principles and procedures for establishing the safety of food additives stated in current publications of the National Academy of Sciences-National Research Council. A petition will not be denied, however, by reason of the petitioner's having followed procedures other than those outlined in the publications of the National Academy of Sciences-National Research Council if, from available evidence, the Commissioner finds that the procedures used give results as reliable as, or more reliable than, those reasonably to be expected from the use of the outlined procedures. In reaching a decision, the Commissioner will give due weight to the anticipated levels and patterns of consumption of the additive specified or reasonably inferrable. For the purposes of this section, the principles for evaluating safety of additives set forth in the abovementioned publications will apply to any substance that may properly be classified as a food additive as defined in section 201(s) of the Act.\n\n(b) Upon written request describing the proposed use of an additive and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will yield data adequate for an evaluation of the safety of the additive."], ["21:21:3.0.1.1.1.2.1.2", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "B", "Subpart B\u2014Food Additive Safety", "", "\u00a7 170.22 Safety factors to be considered.", "FDA", "", "", "", "In accordance with section 409(c)(5)(C) of the Act, the following safety factors will be applied in determining whether the proposed use of a food additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted a tolerance that will exceed \n 1/100 th of the maximum amount demonstrated to be without harm to experimental animals."], ["21:21:3.0.1.1.1.2.1.3", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "B", "Subpart B\u2014Food Additive Safety", "", "\u00a7 170.30 Eligibility for classification as generally recognized as safe (GRAS).", "FDA", "", "", "[42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 53 FR 16546, May 10, 1988; 81 FR 55047, Aug. 17, 2016]", "(a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. General recognition of safety requires common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is reasonable certainty that the substance is not harmful under the conditions of its intended use (see \u00a7 170.3(i)).\n\n(b) General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive. General recognition of safety through scientific procedures shall be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.\n\n(c)(1) General recognition of safety through experience based on common use in food prior to January 1, 1958, may be achieved without the quantity or quality of scientific procedures required for approval of a food additive. General recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information. An ingredient not in common use in food prior to January 1, 1958, may achieve general recognition of safety only through scientific procedures.\n\n(2) A substance used in food prior to January 1, 1958, may be generally recognized as safe through experience based on its common use in food when that use occurred exclusively or primarily outside of the United States if the information about the experience establishes that the substance is safe under the conditions of its intended use within the meaning of section 201(u) of the Federal Food, Drug, and Cosmetic Act (see also \u00a7 170.3(i)). Common use in food prior to January 1, 1958, that occurred outside of the United States shall be documented by published or other information and shall be corroborated by information from a second, independent source that confirms the history and circumstances of use of the substance. The information used to document and to corroborate the history and circumstances of use of the substance must be generally available; that is, it must be widely available in the country in which the history of use has occurred and readily available to interested qualified experts in the United States. A person who concludes that a use of a substance is GRAS through experience based on its common use in food outside of the United States should notify FDA of that view in accordance with subpart E of this part.\n\n(d) The food ingredients listed as GRAS in part 182 of this chapter or affirmed as GRAS in part 184 or part 186 of this chapter do not include all substances that are generally recognized as safe for their intended use in food. Because of the large number of substances the intended use of which results or may reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of food, it is impracticable to list all such substances that are GRAS. A food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to January 1, 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to January 1, 1958, and for which no known safety hazard exists, will ordinarily be regarded as GRAS without specific inclusion in part 182, part 184 or part 186 of this chapter.\n\n(e) Food ingredients were listed as GRAS in part 182 of this chapter during 1958-1962 without a detailed scientific review of all available data and information relating to their safety. Beginning in 1969, the Food and Drug Administration has undertaken a systematic review of the status of all ingredients used in food based on the view that they are GRAS under the conditions of their intended use or subject to a prior sanction. All affirmations of GRAS status or determinations of food additive status or prior sanction status pursuant to this review shall be handled pursuant to \u00a7\u00a7 170.35, 170.38, and 180.1 of this chapter. Affirmation of GRAS status shall be announced in part 184 or part 186 of this chapter.\n\n(f) [Reserved]\n\n(g) A food ingredient that is not GRAS or subject to a prior sanction requires a food additive regulation promulgated under section 409 of the act before it may be directly or indirectly added to food.\n\n(h) A food ingredient that is listed as GRAS in part 182 of this chapter or affirmed as GRAS in part 184 or part 186 of this chapter shall be regarded as GRAS only if, in addition to all the requirements in the applicable regulation, it also meets all of the following requirements:\n\n(1) It complies with any applicable food grade specifications of the Food Chemicals Codex, 2d Ed. (1972), or, if specifically indicated in the GRAS affirmation regulation, the Food Chemicals Codex, 3d Ed. (1981), which are incorporated by reference, except that any substance used as a component of articles that contact food and affirmed as GRAS in part 186 of this chapter shall comply with the specifications therein, or in the absence of such specifications, shall be of a purity suitable for its intended use. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:  http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.\n\n(2) It performs an appropriate function in the food or food-contact article in which it is used.\n\n(3) It is used at a level no higher than necessary to achieve its intended purpose in that food or, if used as a component of a food-contact article, at a level no higher than necessary to achieve its intended purpose in that article.\n\n(i) If a substance is affirmed as GRAS in part 184 or part 186 of this chapter with no limitation other than good manufacturing practice, it shall be regarded as GRAS if its conditions of use are not significantly different from those reported in the regulation as the basis on which the GRAS status of the substance was affirmed. If the conditions of use are significantly different, such use of the substance may not be GRAS. In such a case a manufacturer may not rely on the regulation as authorizing the use but must independently establish that the use is GRAS or must use the substance in accordance with a food additive regulation.\n\n(j) If an ingredient is affirmed as GRAS in part 184 or part 186 of this chapter with specific limitation(s), it may be used in food only within such limitation(s) (including the category of food(s), the functional use(s) of the ingredient, and the level(s) of use). Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation.\n\n(k) Pursuant to \u00a7 170.35, a food ingredient may be affirmed as GRAS in part 184 or part 186 of this chapter for a specific use(s) without a general evaluation of use of the ingredient. In addition to the use(s) specified in the regulation, other uses of such an ingredient may also be GRAS. Any affirmation of GRAS status for a specific use(s), without a general evaluation of use of the ingredient, is subject to reconsideration upon such evaluation.\n\n(l) New information may at any time require reconsideration of the GRAS status of a food ingredient. Any change to the GRAS status of a food ingredient in parts 182, 184, or 186 of this chapter shall be accomplished pursuant to \u00a7 170.38."], ["21:21:3.0.1.1.1.2.1.4", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "B", "Subpart B\u2014Food Additive Safety", "", "\u00a7 170.35 Affirmation of generally recognized as safe (GRAS) status.", "FDA", "", "", "[42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, July 29, 1997; 65 FR 51762, Aug. 25, 2000; 81 FR 55048, Aug. 17, 2016; 88 FR 17718, Mar. 24, 2023]", "(a) The Commissioner, on his own initiative, may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use.\n\n(b)(1) If the Commissioner proposes on his own initiative that a substance is entitled to affirmation as GRAS under the conditions of its intended use, he will place all of the data and information on which he relies on public file in the office of the Dockets Management Staff and will publish in the  Federal Register  a notice giving the name of the substance, its proposed uses, and any limitations proposed for purposes other than safety.\n\n(2) The  Federal Register  notice will allow a period of 60 days during which any interested person may review the data and information and/or file comments with the Dockets Management Staff. Copies of all comments received shall be made available for examination in the Dockets Management Staff's office.\n\n(3) The Commissioner will evaluate all comments received. If he concludes that there is convincing evidence that the substance is GRAS under the conditions of its intended use as described in \u00a7 170.30, he will publish a notice in the  Federal Register  listing the GRAS conditions of use of the substance in part 184 or part 186 of this chapter, as appropriate.\n\n(4) If, after evaluation of the comments, the Commissioner concludes that there is a lack of convincing evidence that a substance is GRAS under the conditions of its intended use and that it should be considered a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act, he shall publish a notice thereof in the  Federal Register  in accordance with \u00a7 170.38."], ["21:21:3.0.1.1.1.2.1.5", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "B", "Subpart B\u2014Food Additive Safety", "", "\u00a7 170.38 Determination of food additive status.", "FDA", "", "", "[42 FR 14488, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 54 FR 24896, June 12, 1989; 81 FR 55048, Aug. 17, 2016; 88 FR 17718, Mar. 24, 2023]", "(a) The Commissioner may, in accordance with \u00a7 170.35(b)(4), publish a notice in the  Federal Register  determining that a substance is not GRAS under the conditions of its intended use and is a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act.\n\n(b)(1) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may issue a notice in the  Federal Register  proposing to determine that a substance is not GRAS and is a food additive subject to section 409 of the Act. Any petition shall include all relevant data and information of the type described in \u00a7 171.130(b). The Commissioner will place all of the data and information on which he relies on public file in the office of the Dockets Management Staff and will include in the  Federal Register  notice the name of the substance, its known uses, and a summary of the basis for the determination.\n\n(2) The  Federal Register  notice will allow a period of 60 days during which any interested person may review the data and information and/or file comments with the Dockets Management Staff. Copies of all comments shall be made available for examination in the Dockets Management Staff's office.\n\n(3) The Commissioner will evaluate all comments received. If he concludes that there is a lack of convincing evidence that the substance is GRAS or is otherwise exempt from the definition of a food additive in section 201(s) of the Act, he will publish a notice thereof in the  Federal Register.  If he concludes that there is convincing evidence that the substance is GRAS, he will publish an order in the  Federal Register  listing the substance as GRAS in part 182, part 184, or part 186 of this chapter, as appropriate.\n\n(c) A  Federal Register  notice determining that a substance is a food additive shall provide for the use of the additive in food or food contact surfaces as follows:\n\n(1) It may promulgate a food additive regulation governing use of the additive.\n\n(2) It may promulgate an interim food additive regulation governing use of the additive.\n\n(3) It may require discontinuation of the use of the additive.\n\n(4) It may adopt any combination of the above three approaches for different uses or levels of use of the additive.\n\n(d) If the Commissioner of Food and Drugs is aware of any prior sanction for use of the substance, he will concurrently propose a separate regulation covering such use of the ingredient under part 181 of this chapter. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the Act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under part 181 of this chapter, incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal."], ["21:21:3.0.1.1.1.2.1.6", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "B", "Subpart B\u2014Food Additive Safety", "", "\u00a7 170.39 Threshold of regulation for substances used in food-contact articles.", "FDA", "", "", "[60 FR 36595, July 17, 1995, as amended at 62 FR 40599, July 29, 1997; 65 FR 56479, Sept. 19, 2000; 81 FR 49896, July 29, 2016; 88 FR 17718, Mar. 24, 2023]", "(a) A substance used in a food-contact article (e.g., food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food will be exempted from regulation as a food additive because it becomes a component of food at levels that are below the threshold of regulation if:\n\n(1) The substance has not been shown to be a carcinogen in humans or animals, and there is no reason, based on the chemical structure of the substance, to suspect that the substance is a carcinogen. The substance must also not contain a carcinogenic impurity or, if it does, must not contain a carcinogenic impurity with a TD 50  value based on chronic feeding studies reported in the scientific literature or otherwise available to the Food and Drug Administration of less than 6.25 milligrams per kilogram bodyweight per day (The TD 50 , for the purposes of this section, is the feeding dose that causes cancer in 50 percent of the test animals when corrected for tumors found in control animals. If more than one TD 50  value has been reported in the scientific literature for a substance, the Food and Drug Administration will use the lowest appropriate TD50 value in its review.);\n\n(2) The substance presents no other health or safety concerns because:\n\n(i) The use in question has been shown to result in or may be expected to result in dietary concentrations at or below 0.5 parts per billion, corresponding to dietary exposure levels at or below 1.5 micrograms/person/day (based on a diet of 1,500 grams of solid food and 1,500 grams of liquid food per person per day); or\n\n(ii) The substance is currently regulated for direct addition into food, and the dietary exposure to the substance resulting from the proposed use is at or below 1 percent of the acceptable daily intake as determined by safety data in the Food and Drug Administration's files or from other appropriate sources;\n\n(3) The substance has no technical effect in or on the food to which it migrates; and\n\n(4) The substance use has no significant adverse impact on the environment.\n\n(b) Notwithstanding paragraph (a) of this section, the Food and Drug Administration reserves the right to decline to grant an exemption in those cases in which available information establishes that the proposed use may pose a public health risk. The reasons for the agency's decision to decline to grant an exemption will be explained in the Food and Drug Administration's response to the requestor.\n\n(c) A request for the Food and Drug Administration to exempt a use of a substance from regulation as a food additive shall include three copies of the following information (If part of the submitted material is in a foreign language, it must be accompanied by an English translation verified to be complete and accurate in accordance with \u00a7 10.20(c)(2) of this chapter):\n\n(1) The chemical composition of the substance for which the request is made, including, whenever possible, the name of the chemical in accordance with current Chemical Abstract Service (CAS) nomenclature guidelines and a CAS registry number, if available;\n\n(2) Detailed information on the conditions of use of the substance (e.g., temperature, type of food with which the substance will come into contact, the duration of the contact, and whether the food-contact article will be for repeated or single use applications);\n\n(3) A clear statement as to whether the request for exemption from regulation as a food additive is based on the fact that the use of the substance in the food-contact article results in a dietary concentration at or below 0.5 parts per billion, or on the fact that it involves the use of a regulated direct food additive for which the dietary exposure is at or below 1 percent of the acceptable dietary intake (ADI);\n\n(4) Data that will enable the Food and Drug Administration to estimate the daily dietary concentration resulting from the proposed use of the substance. These data should be in the form of:\n\n(i) Validated migration data obtained under worst-case (time/temperature) intended use conditions utilizing appropriate food simulating solvents;\n\n(ii) Information on the amount of the substance used in the manufacture of the food-contact article; or\n\n(iii) Information on the residual level of the substance in the food-contact article. For repeat-use articles, an estimate of the amount of food that contacts a specific unit of surface area over the lifetime of the article should also be provided. (In cases where data are provided only in the form of manufacturing use levels or residual levels of the substance present in the food-contact article, the Food and Drug Administration will calculate a worst-case dietary concentration level assuming 100 percent migration.) A detailed description of the analytical method used to quantify the substance should also be submitted along with data used to validate the detection limit.\n\n(iv) In cases where there is no detectable migration into food or food simulants, or when no residual level of a substance is detected in the food-contact article by a suitable analytical method, the Food and Drug Administration will, for the purposes of estimating the dietary concentration, consider the validated detection limit of the method used to analyze for the substance.\n\n(5) The results of an analysis of existing toxicological information on the substance and its impurities. This information on the substance is needed to show whether an animal carcinogen bioassay has been carried out, or whether there is some other basis for suspecting that the substance is a carcinogen or potent toxin. This type of information on the impurities is needed to show whether any of them are carcinogenic, and, if carcinogenic, whether their TD50 values are greater than 6.25 milligrams per kilogram bodyweight per day in accordance with paragraph (a)(1) of this section.\n\n(6) Information on the environmental impact that would result from the proposed use of the substance. The request should contain either a claim for categorical exclusion as specified in \u00a7 25.32 of this chapter or an environmental assessment as specified in \u00a7 25.40 of this chapter.\n\n(d) Data to be reviewed under this section shall be submitted to the Food and Drug Administration's Office of Food Additive Safety (HFS-200), 5001 Campus Dr., College Park, MD 20740.\n\n(e) The Food and Drug Administration will inform the requestor by letter whether the specific food-contact application is exempt from regulation as a food additive or not. Although a substance that migrates to food at a level that results in a dietary concentration at or below the threshold of regulation will not be the subject of a regulation published in the  Federal Register  and will not appear in the Code of Federal Regulations, the Food and Drug Administration will maintain a list of substances exempted from regulation as food additives under this section on display at the Dockets Management Staff. This list will include the name of the company that made the request, the chemical name of the substance, the specific use for which it has received an exemption from regulation as a food additive, and any appropriate limitations on its use. The list will not include any trade names. This list will enable interested persons to see the types of uses of food-contact materials being exempted under the regulation. Interested persons may also obtain a copy of the list of exempted substances by contacting the Food and Drug Administration's Office of Food Additive Safety (HFS-200), 5001 Campus Dr., College Park, MD 20740. For actions requiring an environmental assessment, the agency's finding of no significant impact and the evidence supporting that finding, contained in the petitioner's environmental assessment, also will be available for public inspection at the Dockets Management Staff in accordance with \u00a7 25.51(b)(2) of this chapter. Requests for copies of releasable information contained in submissions requesting exemptions from the food additive regulations will be handled in accordance with the Food and Drug Administration's Freedom of Information Act procedures, as described in part 20 of this chapter. In particular, data and information that fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure in accordance with \u00a7 20.61(c) of this chapter.\n\n(f) If the request for an exemption from regulation as a food additive is not granted, the requestor may submit a petition to the Food and Drug Administration for reconsideration of the decision in accordance with the provisions of \u00a7 10.33 of this chapter.\n\n(g) If the Food and Drug Administration receives significant new information that raises questions about the dietary concentration or the safety of a substance that the agency has exempted from regulation, the Food and Drug Administration may reevaluate the substance. If the Food and Drug Administration tentatively concludes that the information that is available about the substance no longer supports an exemption for the use of the food-contact material from the food additive regulations, the agency will notify any persons that requested an exemption for the substance of its tentative decision. The requestors will be given an opportunity to show why the use of the substance should not be regulated under the food additive provisions of the act. If the requestors fail to adequately respond to the new evidence, the agency will notify them that further use of the substance in question for the particular use will require a food additive regulation. This notification will be placed on public display at the Dockets Management Staff as part of the file of uses of substances exempted from regulation as food additives. The Food and Drug Administration recognizes that manufacturers other than those that actually made a request for exemption may also be using exempted substances in food-contact articles under conditions of use (e.g., use levels, temperature, type of food contacted, etc.) that are similar to those for which the exemption was issued. Because only requestors will be notified as part of the revocation process described in this section, the Food and Drug Administration plans to notify other manufacturers by means of a notice published in the  Federal Register  of its decision to revoke an exemption issued for a specific use of a substance in a food contact article.\n\n(h) Guidance documents to assist requestors in the preparation of submissions seeking exemptions from the food additive regulations are available from the Food and Drug Administration's Office of Food Additive Safety (HFS-200), 5001 Campus Dr., College Park, MD 20740. Interested persons are encouraged to obtain specific guidance from the Food and Drug Administration on the appropriate protocols to be used for obtaining migration data, on the validation of the analytical methods used to quantify migration levels, on the procedures used to relate migration data to dietary exposures, and on any other issue not specifically covered in the Food and Drug Administration's guidance documents."], ["21:21:3.0.1.1.1.3.1.1", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "C", "Subpart C\u2014Specific Administrative Rulings and Decisions", "", "\u00a7 170.45 Fluorine-containing compounds.", "FDA", "", "", "[42 FR 14483, Mar. 15, 1977, as amended at 72 FR 10357 Mar. 8, 2007]", "The Commissioner of Food and Drugs has concluded that it is in the interest of the public health to limit the addition of fluorine compounds to foods (a) to that resulting from the fluoridation of public water supplies, (b) to that resulting from the fluoridation of bottled water within the limitation established in \u00a7 165.110(d) of this chapter, and (c) to that authorized by regulations (40 CFR part 180) under section 408 of the Act."], ["21:21:3.0.1.1.1.3.1.2", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "C", "Subpart C\u2014Specific Administrative Rulings and Decisions", "", "\u00a7 170.50 Glycine (aminoacetic acid) in food for human consumption.", "FDA", "", "", "", "(a) Heretofore, the Food and Drug Administration has expressed the opinion in trade correspondence that glycine is generally recognized as safe for certain technical effects in human food when used in accordance with good manufacturing practice; however:\n\n(1) Reports in scientific literature indicate that adverse effects were found in cases where high levels of glycine were administered in diets of experimental animals.\n\n(2) Current usage information indicates that the daily dietary intake of glycine by humans may be substantially increasing due to changing use patterns in food technology.\n\nTherefore, the Food and Drug Administration no longer regards glycine and its salts as generally recognized as safe for use in human food and all outstanding letters expressing sanction for such use are rescinded.\n\n(b) The Commissioner of Food and Drugs concludes that by May 8, 1971, manufacturers:\n\n(1) Shall reformulate food products for human use to eliminate added glycine and its salts; or\n\n(2) Shall bring such products into compliance with an authorizing food additive regulation. A food additive petition supported by toxicity data is required to show that any proposed level of glycine or its salts added to foods for human consumption will be safe.\n\n(c) The status of glycine as generally recognized as safe for use in animal feed, as prescribed in \u00a7 582.5049 of this chapter, remains unchanged because the additive is considered an essential nutrient in certain animal feeds and is safe for such use under conditions of good feeding practice."], ["21:21:3.0.1.1.1.3.1.3", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "C", "Subpart C\u2014Specific Administrative Rulings and Decisions", "", "\u00a7 170.60 Nitrites and/or nitrates in curing premixes.", "FDA", "", "", "", "(a) Nitrites and/or nitrates are food additives when combined in curing premixes with spices and/or other flavoring or seasoning ingredients that contain or constitute a source of secondary or tertiary amines, including but not limited to essential oils, disodium inosinate, disodium guanylate, hydrolysates of animal or plant origin (such as hydrolyzed vegetable protein), oleoresins of spices, soy products, and spice extractives. Such food additives may be used only after the establishment of an authorizing food additive regulation. A food additive petition submitted pursuant to \u00a7\u00a7 171.1 and 171.100 of this chapter, supported by data demonstrating that nitrosamines are not formed in curing premixes containing such food additives, is required to establish safety.\n\n(b) Nitrites and/or nitrates, when packaged separately from flavoring and seasoning in curing premixes, may continue to be used under prior sanctions in the commercial curing of meat and meat products and poultry products and in accordance with the provisions of \u00a7\u00a7 172.170 and 172.175 of this chapter that apply to meat curing preparations for the home curing of meat and meat products, including poultry and wild game. To assure safe use of such ingredients the labeling of the premixes shall bear instructions to the user that such separately packaged ingredients are not to be combined until just prior to use. Encapsulating or coating some or all of the ingredients does not constitute separate packaging."], ["21:21:3.0.1.1.1.4.1.1", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "D", "Subpart D\u2014Premarket Notifications", "", "\u00a7 170.100 Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA).", "FDA", "", "", "", "(a) An FCN is effective for the food contact substance manufactured or prepared by the manufacturer or supplier identified in the FCN submission. If another manufacturer or supplier wishes to market the same food contact substance for the same use, that manufacturer or supplier must also submit an FCN to FDA.\n\n(1) An FCN must contain all of the information described in \u00a7 170.101.\n\n(2) An FCN may incorporate by reference any information in FDA's files provided that the manufacturer or supplier is authorized to reference the information. The FCN must include information establishing that the manufacturer or supplier is authorized to reference information in FDA's files.\n\n(3) Any material submitted in or referenced by an FCN that is in a foreign language must be accompanied by an English translation verified to be complete and accurate.\n\n(b) FDA may choose not to accept an FCN for either of the following:\n\n(1) A use of a food contact substance that is the subject of a regulation in parts 173 through 189 of this chapter; or\n\n(2) A use of a food contact substance that is the subject of an exemption under the threshold of regulation process described in \u00a7 170.39.\n\n(c) A petition must be submitted under \u00a7 171.1 of this chapter to authorize the safe use of a food contact substance in either of the following circumstances, unless FDA agrees to accept an FCN for the proposed use.\n\n(1) The use of the food contact substance increases the cumulative dietary concentration to a certain level. For a substance that is a biocide (e.g., it is intended to exert microbial toxicity), this level is equal to or greater than 200 parts per billion in the daily diet (0.6 milligram (mg)/person/day). For a substance that is not a biocide, this level is equal to or greater than 1 part per million in the daily diet (3 mg/person/day); or\n\n(2) There exists a bioassay on the food contact substance, FDA has not reviewed the bioassay, and the bioassay is not clearly negative for carcinogenic effects.\n\n(d) A manufacturer or supplier for which a notification is effective must keep a current address on file with FDA.\n\n(1) The current address may be either the manufacturer's (or supplier's) address or the address of the manufacturer's (or supplier's) agent.\n\n(2) FDA will deliver correspondence to the manufacturer's or supplier's current address."], ["21:21:3.0.1.1.1.4.1.2", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "D", "Subpart D\u2014Premarket Notifications", "", "\u00a7 170.101 Information in a premarket notification for a food contact substance (FCN).", "FDA", "", "", "", "An FCN must contain the following:\n\n(a) A comprehensive discussion of the basis for the manufacturer's or supplier's determination that the use of the food contact substance is safe. This discussion must:\n\n(1) Discuss all information and data submitted in the notification; and\n\n(2) Address any information and data that may appear to be inconsistent with the determination that the proposed use of the food contact substance is safe.\n\n(b) All data and other information that form the basis of the determination that the food contact substance is safe under the intended conditions of use. Data must include primary biological data and chemical data.\n\n(c) A good laboratory practice statement for each nonclinical laboratory study, as defined under \u00a7 58.3(d) of this chapter, that is submitted as part of the FCN, in the form of either:\n\n(1) A signed statement that the study was conducted in compliance with the good laboratory practice regulations under part 58 of this chapter; or\n\n(2) A brief signed statement listing the reason(s) that the study was not conducted in compliance with part 58 of this chapter.\n\n(3) Data from any study conducted after 1978 but not conducted in compliance with part 58 of this chapter must be validated by an independent third party prior to submission to the Food and Drug Administration (FDA), and the report and signed certification of the validating party must be submitted as part of the notification.\n\n(d) Information to address FDA's responsibility under the National Environmental Policy Act, in the form of either:\n\n(1) A claim of categorical exclusion under \u00a7 25.30 or \u00a7 25.32 of this chapter; or\n\n(2) An environmental assessment complying with \u00a7 25.40 of this chapter.\n\n(e) A completed and signed FDA Form No. 3480."], ["21:21:3.0.1.1.1.4.1.3", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "D", "Subpart D\u2014Premarket Notifications", "", "\u00a7 170.102 Confidentiality of information related to premarket notification for a food contact substance (FCN).", "FDA", "", "", "[67 FR 35729, May 21, 2002, as amended by 89 FR 20315, Mar. 22, 2024]", "(a) During the 120-day period of the Food and Drug Administration (FDA) review of an FCN, FDA will not disclose publicly any information in that FCN.\n\n(b) FDA will not disclose publicly the information in an FCN that is withdrawn prior to the completion of FDA's review.\n\n(c) Once FDA completes its review of an FCN, the agency will make its conclusion about the FCN publicly available. For example, if FDA objects to a notification 90 days after the date of receipt, the agency would make available its objection at that time.\n\n(d) By submitting an FCN to FDA, the manufacturer or supplier waives any claim to confidentiality of the information required to adequately describe the food contact substance and the intended conditions of use that are the subject of that FCN.\n\n(e) The following data and information are available for public disclosure, unless extraordinary circumstances are shown, on the 121st day after receipt of the notification by FDA, except that no data or information are available for public disclosure if the FCN is withdrawn under \u00a7 170.103; and on the date of publication in the  Federal Register  of an FDA determination that an FCN is no longer effective.\n\n(1) All safety and functionality data and information submitted with or incorporated by reference into the notification, or submitted in reference to an effective FCN. Safety and functionality data include all studies and tests of a food contact substance on animals and humans and all studies and tests on a food contact substance for establishing identity, stability, purity, potency, performance, and usefulness.\n\n(2) A protocol for a test or study, unless it is exempt from disclosure under \u00a7 20.61 of this chapter.\n\n(3) A list of all ingredients contained in a food contact substance, excluding information that is exempt from disclosure under \u00a7 20.61 of this chapter. Where applicable, an ingredient list will be identified as incomplete.\n\n(4) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is exempt from disclosure under \u00a7 20.61 of this chapter.\n\n(5) All correspondence and written summaries of oral discussions relating to the notification or to FDA's determination that an FCN is no longer effective, except information that is exempt under \u00a7 20.61 of this chapter.\n\n(6) All other information not subject to an exemption from disclosure under subpart D of part 20 of this chapter."], ["21:21:3.0.1.1.1.4.1.4", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "D", "Subpart D\u2014Premarket Notifications", "", "\u00a7 170.103 Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).", "FDA", "", "", "", "A manufacturer or supplier may withdraw an FCN without prejudice to a future submission to the Food and Drug Administration (FDA) if FDA has not completed review of the FCN. For the purpose of this section, FDA's review is completed when FDA has allowed 120 days to pass without objecting to the FCN or FDA has issued an objection letter."], ["21:21:3.0.1.1.1.4.1.5", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "D", "Subpart D\u2014Premarket Notifications", "", "\u00a7 170.104 Action on a premarket notification for a food contact substance (FCN).", "FDA", "", "", "", "(a) If the Food and Drug Administration (FDA) does not object to an FCN within the 120-day period for FDA review, the FCN becomes effective.\n\n(b) If an FCN is complete when received, the 120-day review period begins on the date FDA receives the FCN.\n\n(1) If any element required under \u00a7 170.101 is missing from an FCN, then FDA will not accept that FCN and FDA will send an FCN nonacceptance letter to the manufacturer or supplier. If the manufacturer or supplier submits the missing information before FDA sends an FCN nonacceptance letter, the 120-day review period begins on the date of receipt of the missing information.\n\n(2) If FDA accepts an FCN, then FDA will acknowledge in writing its receipt of that FCN.\n\n(c) Objection to an FCN:\n\n(1) If FDA objects to an FCN, then FDA will send an FCN objection letter. The date of the letter will be the date of FDA's objection for purposes of section 409(h)(2)(A) of the act.\n\n(2) If FDA objects to an FCN within the 120-day period for FDA review, the FCN will not become effective.\n\n(3) FDA may object to an FCN if any part of FDA's 120-day review occurs during a period when this program is not funded as required in section 409(h)(5) of the act.\n\n(d) If FDA and a manufacturer or supplier agree that the notifier may submit a food additive petition proposing the approval of the food contact substance for the use in the manufacturer's or supplier's FCN, FDA will consider that FCN to be withdrawn by the manufacturer or supplier on the date the petition is received by FDA."], ["21:21:3.0.1.1.1.4.1.6", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "D", "Subpart D\u2014Premarket Notifications", "", "\u00a7 170.105 The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective.", "FDA", "", "", "[89 FR 20316, Mar. 22, 2024]", "(a) FDA may determine that an FCN is no longer effective if:\n\n(1) Data or other information available to FDA, including data not submitted by the manufacturer or supplier, demonstrate that the intended use of a food contact substance is no longer safe.\n\n(i) FDA will inform the affected manufacturer or supplier specified in the FCN, in writing, of FDA's concerns regarding the safety of the intended use of the food contact substance. FDA will specify the date by which the manufacturer or supplier must provide FDA with data or other information to respond to FDA's safety concerns.\n\n(ii) If the manufacturer or supplier fails, by the specified date, to supply either the data or other information necessary to address the safety concerns regarding the notified use or a request described in paragraph (a)(2)(i) of this section, FDA may determine that the FCN is no longer effective because there is no longer a basis to conclude that the intended use is safe.\n\n(iii) If FDA denies a request described in paragraph (a)(2)(i) of this section, and FDA had previously informed the manufacturer or supplier of FDA's concerns regarding the safety of the intended use of the food contact substance as described in paragraph (a)(1)(i) of this section, FDA may determine that an FCN is no longer effective because there is no longer a basis to conclude that the intended use is safe. Alternatively, FDA may provide the manufacturer or supplier with additional time to provide FDA with data or other information to respond to FDA's safety concerns. If the manufacturer or supplier fails, by the specified date, to supply the data or other information necessary to address the safety concerns regarding the notified use, FDA may determine that the FCN is no longer effective because there is no longer a basis to conclude that the intended use is safe.\n\n(2) Data or other information available to FDA demonstrate that the manufacturer or supplier specified in the FCN has ceased or intends to cease producing, supplying, or using a food contact substance for the intended use. Such data or other information includes, but is not limited to:\n\n(i) A request from the manufacturer or supplier.\n\n(A) The manufacturer or supplier specified in the FCN may request in writing that FDA determine that an FCN is no longer effective on the basis that it has ceased producing, supplying, or using a food contact substance for the intended food contact use in the United States or that it intends to cease producing, supplying, or using a food contact substance for the intended food contact use in the United States by a specified date. The request must include information or a basis to support the estimated date for the food contact substance, as well as food contact articles that contain such food contact substance, produced, supplied, or used by the manufacturer or supplier to clear the U.S. market. FDA will notify the manufacturer or supplier whether FDA is granting the request.\n\n(B) If FDA grants the request, FDA may determine that the FCN is no longer effective on the basis that the manufacturer or supplier has ceased producing, supplying, or using a food contact substance for the intended use in the United States or that it intends to cease producing, supplying, or using a food contact substance for the intended food contact use in the United States by a specified date. When such a request is based on the intent to cease producing, supplying, or using a food contact substance for the intended food contact use in the United States at a future date, FDA will include in the notice described in paragraph (b) of this section the date specified in the request as the compliance date by which the manufacturer or supplier will cease producing, supplying, or using the food contact substance for the intended food contact use in the United States.\n\n(ii) Other data or information available to FDA.\n\n(A) If other data or information available to FDA demonstrate that a manufacturer or supplier specified in the FCN has ceased producing, supplying, or using a food contact substance for the intended use in the United States, FDA will inform the affected manufacturer or supplier in writing. FDA will include a specified time period by which the manufacturer or supplier must respond in writing indicating whether the manufacturer or supplier continues, or intends to continue in the future, to produce, supply, or use a food contact substance for the intended use in the United States.\n\n(B) If the manufacturer or supplier fails, by the specified date, to respond in writing indicating that the manufacturer or supplier continues, or intends to continue in the future, to produce, supply, or use a food contact substance for the intended use in the United States; or if the manufacturer or supplier confirms that it has ceased producing, supplying, or using the food contact substance for the intended food contact use in the United States, FDA may determine that the FCN is no longer effective.\n\n(3) The intended use of the food contact substance identified in the FCN is authorized by a food additive regulation.\n\n(i) FDA will inform the manufacturer or supplier specified in the FCN in writing that the intended use of the food contact substance identified in the FCN is authorized by a food additive regulation. FDA will include a specified time period by which the manufacturer or supplier must respond to FDA with data or other information about whether the food contact substance and its intended use meet the identity limitations and specifications authorized by the cited food additive regulation.\n\n(ii) If a manufacturer or supplier fails, by the specified date, to supply data or other information that demonstrates that the intended use of the food contact substance identified in the FCN is not authorized by a food additive regulation, FDA may determine that the FCN is no longer effective on the basis that the intended use of the food contact substance is authorized under a food additive regulation.\n\n(4) The intended use of the food contact substance identified in the FCN is the subject of an issued threshold of regulation exemption.\n\n(i) FDA will inform the manufacturer or supplier specified in the authorizing FCN in writing that the intended use of the food contact substance identified in the FCN is the subject of an issued threshold of regulation exemption. FDA will include a specified time period by which the manufacturer or supplier must respond to FDA with data or other information about whether the food contact substance and its intended use meet the identity limitations and specifications listed in the cited threshold of regulation exemption.\n\n(ii) If a manufacturer or supplier fails, by the specified date, to supply data or other information that demonstrates that the intended use of the food contact substance identified in the FCN is not exempt through an issued threshold of regulation exemption, FDA may determine that the FCN is no longer effective on the basis that the intended use of the food contact substance is the subject of an issued threshold of regulation exemption.\n\n(b) If FDA determines that an FCN is no longer effective, FDA will publish a notice of its determination in the  Federal Register,  stating that a detailed summary of the basis for FDA's determination that the FCN is no longer effective has been placed on public display and that copies are available upon request. If FDA determines it would be protective of public health, FDA may include a separate compliance date for the use of the food contact substance in food contact articles, including food contact substances that were produced, supplied, or used by the manufacturer or supplier before publication of the notice in the  Federal Register  or before the compliance date described in paragraph (a)(2)(i)(B) of this section. The date that the notice publishes in the  Federal Register  is the date on which the notification is no longer effective. FDA's determination that an FCN is no longer effective is final Agency action subject to judicial review.\n\n(c) FDA's determination that an FCN is no longer effective does not preclude any manufacturer or supplier from submitting a new FCN for the same food contact substance, including for the same intended use, after FDA has determined that an FCN is no longer effective, unless the intended use of the food contact substance is authorized by a food additive regulation or the subject of an issued threshold of regulation exemption. The new submission must be made under \u00a7\u00a7 170.100 and 170.101."], ["21:21:3.0.1.1.1.4.1.7", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "D", "Subpart D\u2014Premarket Notifications", "", "\u00a7 170.106 Notification for a food contact substance formulation (NFCSF).", "FDA", "", "", "", "(a) In order for the Food and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the formulation must be authorized for its intended use in that NFCSF.\n\n(b) FDA may publish a notice in the  Federal Register  stating that the agency has insufficient resources to review NFCSFs. From the date that this notice publishes in the  Federal Register,  FDA will no longer accept NFCSFs.\n\n(c) An NFCSF must contain the following:\n\n(1) A completed and signed FDA Form No. 3479; and\n\n(2) Any additional documentation required to establish that each component of the formulation already may be marketed legally for its intended use."], ["21:21:3.0.1.1.1.5.1.1", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.203 Definitions.", "FDA", "", "", "", "The definitions and interpretations of terms in \u00a7 170.3 apply to such terms when used in this subpart. The following definitions also apply:\n\nAmendment  means any data and information that you submit regarding a filed GRAS notice before we respond to your notice by letter in accordance with \u00a7 170.265(b)(1) or cease to evaluate your notice in accordance with \u00a7 170.265(b)(3).\n\nGRAS  means generally recognized as safe.\n\nGRAS notice  means a submission that informs us of your view that a substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on your conclusion that the substance is GRAS under the conditions of its intended use in accordance with \u00a7 170.30.\n\nNotified substance  means the substance that is the subject of your GRAS notice.\n\nNotifier  means the person ( e.g.,  an individual, partnership, corporation, association, or other legal entity) who is responsible for the GRAS notice, even if another person (such as an attorney, agent, or qualified expert) prepares or submits the notice or provides an opinion about the basis for a conclusion of GRAS status.\n\nQualified expert  means an individual who is qualified by scientific training and experience to evaluate the safety of substances under the conditions of their intended use in food.\n\nSupplement  means any data and information that you submit regarding a filed GRAS notice after we respond to your notice by letter in accordance with \u00a7 170.265(b)(1) or cease to evaluate your notice in accordance with \u00a7 170.265(b)(3).\n\nWe, our,  and  us  refer to the United States Food and Drug Administration (FDA).\n\nYou  and  your  refer to a notifier."], ["21:21:3.0.1.1.1.5.1.10", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.245 Part 5 of a GRAS notice: Experience based on common use in food before 1958.", "FDA", "", "", "", "If the statutory basis for your conclusion of GRAS status is through experience based on common use in food, in Part 5 of your GRAS notice you must include evidence of a substantial history of consumption of the notified substance for food use by a significant number of consumers prior to January 1, 1958."], ["21:21:3.0.1.1.1.5.1.11", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.250 Part 6 of a GRAS notice: Narrative.", "FDA", "", "", "", "In Part 6 of your GRAS notice, you must include a narrative that provides the basis for your conclusion of GRAS status, in which:\n\n(a)(1) You must explain why the data and information in your notice provide a basis for your view that the notified substance is safe under the conditions of its intended use. In your explanation, you must address the safety of the notified substance, considering all dietary sources and taking into account any chemically or pharmacologically related substances in such diet;\n\n(2) In your explanation, you must identify what specific data and information that you discuss in accordance with paragraph (a)(1) of this section are generally available, and what specific data and information that you discuss in accordance with paragraph (a)(1) of this section are not generally available, by providing citations to the list of data and information that you include in Part 7 of your GRAS notice in accordance with \u00a7 170.255;\n\n(b) You must explain how the generally available data and information that you rely on to establish safety in accordance with paragraph (a) of this section provide a basis for your conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use;\n\n(c) You must either:\n\n(1) Identify, discuss, and place in context, data and information that are, or may appear to be, inconsistent with your conclusion of GRAS status, regardless of whether those data and information are generally available; or\n\n(2) State that you have reviewed the available data and information and are not aware of any data and information that are, or may appear to be, inconsistent with your conclusion of GRAS status;\n\n(d) If you view any of the data and information in your notice as exempt from disclosure under the Freedom of Information Act, you must identify the specific data and information; and\n\n(e) For non-public, safety-related data and information considered in reaching a conclusion of GRAS status, you must explain how there could be a basis for a conclusion of GRAS status if qualified experts do not have access to such data and information."], ["21:21:3.0.1.1.1.5.1.12", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.255 Part 7 of a GRAS notice: List of supporting data and information in your GRAS notice.", "FDA", "", "", "", "(a) In part 7 of your GRAS notice, you must include a list of all of the data and information that you discuss in Part 6 of your GRAS notice to provide a basis for your view that the notified substance is safe under the conditions of its intended use as described in accordance with \u00a7 170.250(a)(1).\n\n(b) You must specify which data and information that you list in accordance with paragraph (a) of this section are generally available, and which data and information are not generally available."], ["21:21:3.0.1.1.1.5.1.13", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.260 Steps you may take before FDA responds to your GRAS notice.", "FDA", "", "", "", "(a) You may submit a timely amendment to your filed GRAS notice, to update your GRAS notice or in response to a question from us, before we respond to your notice by letter in accordance with \u00a7 170.265(b)(1) or cease to evaluate your notice in accordance with \u00a7 170.265(b)(3).\n\n(b) At any time before we respond to your GRAS notice in accordance with \u00a7 170.265(b)(1), you may request in writing that we cease to evaluate your GRAS notice. Your request does not preclude you from submitting a future GRAS notice in accordance with this subpart with respect to the notified substance."], ["21:21:3.0.1.1.1.5.1.14", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.265 What FDA will do with a GRAS notice.", "FDA", "", "", "", "(a)(1) We will conduct an initial evaluation of your submission to determine whether to file it as a GRAS notice for evaluation of your view that the notified substance is GRAS under the conditions of its intended use.\n\n(2) If we file your submission as a GRAS notice, we will send you a letter that informs you of the date of filing.\n\n(3) If we do not file your submission as a GRAS notice, we will send you a letter that informs you of that fact and provides our reasons for not filing the submission as a GRAS notice.\n\n(4) We will consider any timely amendment that you submit to a filed GRAS notice, to update your GRAS notice or in response to a question from us, before we respond to you by letter in accordance with paragraph (b)(1) of this section, if we deem that doing so is feasible within the timeframes established in paragraph (b) of this section. If we deem that considering your amendment is not feasible within the timeframes established in paragraph (b) of this section or if we have granted your request to cease to evaluate your notice, we will inform you that we are not considering your amendment.\n\n(b)(1) Within 180 days of filing, we will respond to you by letter based on our evaluation of your notice. We may extend the 180 day timeframe by 90 days on an as needed basis.\n\n(2) If we extend the timeframe, we will inform you in writing of the extension as soon as practicable but no later than within 180 days of filing.\n\n(3) If you ask us to cease to evaluate your GRAS notice in accordance with \u00a7 170.260(b), we will send you a letter informing you of our decision regarding your request.\n\n(c) If circumstances warrant, we will send you a subsequent letter about the notice."], ["21:21:3.0.1.1.1.5.1.15", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.270 Procedures that apply when the intended conditions of use of a notified substance include use in a product or products subject to regulation by the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture.", "FDA", "", "", "", "If the intended conditions of use of the notified substance include use in a product or products subject to regulation by FSIS under statutes that it administers:\n\n(a) When applicable, you must include in your GRAS notice a statement as to whether you:\n\n(1) Authorize us to send any trade secrets to FSIS; or\n\n(2) Ask us to exclude any trade secrets from the copy of the GRAS notice that we will send to FSIS.\n\n(b)(1) We will forward a copy of a GRAS notice or relevant portions thereof to FSIS;\n\n(2) We will exclude any trade secrets unless you have authorized us to do so in accordance with paragraph (a)(1) of this section; and\n\n(c) We will ask FSIS to advise whether the intended conditions of use comply with applicable statutes and regulations, or, if not, whether the use of the substance would be permitted in products under FSIS' jurisdiction under specified conditions or restrictions.\n\n(d) As appropriate, we will inform you of the advice we receive from FSIS in the letter we send you in accordance with \u00a7 170.265(b)(1)."], ["21:21:3.0.1.1.1.5.1.16", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.275 Public disclosure of a GRAS notice.", "FDA", "", "", "", "(a) The data and information in a GRAS notice (including data and information submitted in any amendment or supplement to your GRAS notice or incorporated into your GRAS notice) are:\n\n(1) Considered a mandatory, rather than voluntary, submission for purposes of their status under the Freedom of Information Act and our public information requirements in part 20 of this chapter; and\n\n(2) Available for public disclosure in accordance with part 20 of this chapter as of the date that we receive your GRAS notice.\n\n(b) We will make the following readily accessible to the public:\n\n(1) A list of filed GRAS notices, including the information described in \u00a7 170.225(c)(2) through (c)(5);\n\n(2) The text of any letter that we issue under \u00a7 170.265(b)(1) or (c); and\n\n(3) The text of any letter that we issue under \u00a7 170.265(b)(3) if we grant your request that we cease to evaluate your notice.\n\n(c) We will disclose all remaining data and information that are not exempt from public disclosure in accordance with part 20 of this chapter."], ["21:21:3.0.1.1.1.5.1.17", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.280 Submission of a supplement.", "FDA", "", "", "", "If circumstances warrant, you may submit a supplement to a filed GRAS notice after we respond to your notice by letter in accordance with \u00a7 170.265(b)(1) or cease to evaluate your notice in accordance with \u00a7 170.265(b)(3)."], ["21:21:3.0.1.1.1.5.1.18", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.285 Disposition of pending GRAS affirmation petitions.", "FDA", "", "", "", "Because the procedure to submit a GRAS notice is replacing the former process to submit a GRAS affirmation petition, the following will happen to a filed GRAS affirmation petition that is pending on October 17, 2016.\n\n(a) On October 17, 2016, we will close the docket for any GRAS affirmation petition that is still pending as of October 17, 2016.\n\n(b) Any person who submitted a GRAS affirmation petition described in this section may submit a GRAS notice as described in this subpart and request that we incorporate the GRAS affirmation petition as described in \u00a7 170.215."], ["21:21:3.0.1.1.1.5.1.2", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.205 Opportunity to submit a GRAS notice.", "FDA", "", "", "", "Any person may notify FDA of a view that a substance is not subject to the premarket approval requirements of section 409 of the Federal Food, Drug, and Cosmetic Act based on that person's conclusion that the substance is GRAS under the conditions of its intended use."], ["21:21:3.0.1.1.1.5.1.3", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.210 How to send your GRAS notice to FDA.", "FDA", "", "", "", "(a) Send your GRAS notice to the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.\n\n(b) When you submit your GRAS notice, you may do so either in an electronic format that is accessible for our evaluation or on paper. If you send your GRAS notice on paper, a single paper copy is sufficient."], ["21:21:3.0.1.1.1.5.1.4", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.215 Incorporation into a GRAS notice.", "FDA", "", "", "", "You may incorporate into your GRAS notice either specifically identified data and information that you previously submitted to the Center for Food Safety and Applied Nutrition (CFSAN), or specifically identified publicly available data and information submitted by another party, when such data and information remain in CFSAN's records, such as data and information contained in a previous GRAS notice or a food additive petition."], ["21:21:3.0.1.1.1.5.1.5", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.220 General requirements applicable to a GRAS notice.", "FDA", "", "", "", "(a) A GRAS notice has seven parts as required by \u00a7\u00a7 170.225 through 170.255. You must submit the data and information specified in each of these parts on separate pages or sets of pages.\n\n(b) You must include each of the seven parts in your GRAS notice. If you do not include a part, you must include with your GRAS notice an explanation of why that part does not apply to your GRAS notice."], ["21:21:3.0.1.1.1.5.1.6", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.225 Part 1 of a GRAS notice: Signed statements and certification.", "FDA", "", "", "", "(a) Part 1 of your GRAS notice must be dated and signed by a responsible official of your organization, or by your attorney or agent.\n\n(b) Except as required by paragraph (c)(8) of this section, you must not include any information that is trade secret or confidential commercial information in Part 1 of your GRAS notice.\n\n(c) In Part 1 of your GRAS notice, you must:\n\n(1) Inform us that you are submitting a GRAS notice in accordance with this subpart;\n\n(2) Provide the name and address of your organization;\n\n(3) Provide the name of the notified substance, using an appropriately descriptive term;\n\n(4) Describe the intended conditions of use of the notified substance, including the foods in which the substance will be used, the levels of use in such foods, and the purposes for which the substance will be used, including, when appropriate, a description of a subpopulation expected to consume the notified substance;\n\n(5) Inform us of the statutory basis for your conclusion of GRAS status ( i.e.,  through scientific procedures in accordance with \u00a7 170.30(a) and (b) or through experience based on common use in food in accordance with \u00a7 170.30(a) and (c));\n\n(6) State your view that the notified substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on your conclusion that the notified substance is GRAS under the conditions of its intended use;\n\n(7) State that, if we ask to see the data and information that are the basis for your conclusion of GRAS status, either during or after our evaluation of your notice, you will:\n\n(i) Agree to make the data and information available to us; and\n\n(ii) Agree to both of the following procedures for making the data and information available to us:\n\n(A) Upon our request, you will allow us to review and copy the data and information during customary business hours at the address you specify for where these data and information will be available to us; and\n\n(B) Upon our request, you will provide us with a complete copy of the data and information either in an electronic format that is accessible for our evaluation or on paper;\n\n(8) State your view as to whether any of the data and information in Parts 2 through 7 of your GRAS notice are exempt from disclosure under the Freedom of Information Act, 5 U.S.C. 552 ( e.g.,  as trade secret or as commercial or financial information that is privileged or confidential).\n\n(9) Certify that, to the best of your knowledge, your GRAS notice is a complete, representative, and balanced submission that includes unfavorable information, as well as favorable information, known to you and pertinent to the evaluation of the safety and GRAS status of the use of the substance;\n\n(10) State both the name and position or title of the person who signs the GRAS notice; and\n\n(11) When applicable, state as required by \u00a7 170.270 whether you:\n\n(i) Authorize us to send any trade secrets to the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture; or\n\n(ii) Ask us to exclude any trade secrets from the copy of the GRAS notice that we will send to FSIS."], ["21:21:3.0.1.1.1.5.1.7", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.230 Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect.", "FDA", "", "", "", "In Part 2 of your GRAS notice, you must include:\n\n(a) Scientific data and information that identifies the notified substance.\n\n(1) Examples of appropriate data and information include the chemical name, applicable registry numbers (such as a Chemical Abstracts Service (CAS) registry number or an Enzyme Commission (EC) number), empirical formula, structural formula, quantitative composition, and characteristic properties.\n\n(2) When the source of a notified substance is a biological material, you must include data and information sufficient to identify:\n\n(i) The taxonomic source ( e.g.,  genus, species) including, as applicable, data and information at the sub-species level ( e.g.,  variety, strain);\n\n(ii) The part of any plant or animal used as the source; and\n\n(iii) Any known toxicants that could be in the source;\n\n(b) A description of the method of manufacture of the notified substance in sufficient detail to evaluate the safety of the notified substance as manufactured;\n\n(c) Specifications for food-grade material; and\n\n(d) When necessary to demonstrate safety, relevant data and information bearing on the physical or other technical effect the notified substance is intended to produce, including the quantity of the notified substance required to produce such effect."], ["21:21:3.0.1.1.1.5.1.8", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.235 Part 3 of a GRAS notice: Dietary exposure.", "FDA", "", "", "", "In part 3 of your GRAS notice, you must provide data and information about dietary exposure ( i.e.,  the amount of relevant substances that consumers are likely to eat or drink as part of a total diet), regardless of whether your conclusion of GRAS status is through scientific procedures or through experience based on common use in food, as follows:\n\n(a) You must provide an estimate of dietary exposure to the notified substance that includes exposure from its intended use and all sources in the diet; and\n\n(b) When applicable, you must provide an estimate of dietary exposure to any other substance that is expected to be formed in or on food because of the use of the notified substance ( e.g.,  hydrolytic products or reaction products);\n\n(c) When applicable, you must provide an estimate of dietary exposure to any other substance that is present with the notified substance either naturally or due to its manufacture ( e.g.,  contaminants or by-products);\n\n(d) You must describe the source of any food consumption data that you use to estimate dietary exposure in accordance with paragraphs (a) through (c) of this section; and\n\n(e) You must explain any assumptions you made to estimate dietary exposure in accordance with paragraphs (a) through (c) of this section."], ["21:21:3.0.1.1.1.5.1.9", 21, "Food and Drugs", "I", "B", "170", "PART 170\u2014FOOD ADDITIVES", "E", "Subpart E\u2014Generally Recognized as Safe (GRAS) Notice", "", "\u00a7 170.240 Part 4 of a GRAS notice: Self-limiting levels of use.", "FDA", "", "", "", "In circumstances where the amount of the notified substance that can be added to food is limited because food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical, in Part 4 of your GRAS notice you must include data and information on such self-limiting levels of use."], ["40:40:26.0.1.1.19.1.19.1", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.1 Scope and purpose.", "EPA", "", "", "", "This part contains a standard designed to reduce the risks of illness or injury resulting from workers' and handlers' occupational exposures to pesticides used in the production of agricultural plants on farms or in nurseries, greenhouses, and forests and also from the accidental exposure of workers and other persons to such pesticides. It requires workplace practices designed to reduce or eliminate exposure to pesticides and establishes procedures for responding to exposure-related emergencies."], ["40:40:26.0.1.1.19.1.19.2", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.2 Implementation and expiration dates.", "EPA", "", "", "[80 FR 67556, Nov. 2, 2015]", "(a)  Implementation date.  Beginning January 2, 2017, the requirements of \u00a7\u00a7 170.301 through 170.609 of this part shall apply to any pesticide product that bears the statement \u201cUse this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR part 170\u201d.\n\n(b)  Expiration date.  Sections 170.1 through 170.260 of this part shall expire on, and will no longer be effective after January 2, 2017."], ["40:40:26.0.1.1.19.1.19.3", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.3 Definitions.", "EPA", "", "", "", "Terms used in this part have the same meanings they have in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, the following terms, when used in this part, shall have the following meanings:\n\nAgricultural employer  means any person who hires or contracts for the services of workers, for any type of compensation, to perform activities related to the production of agricultural plants, or any person who is an owner of or is responsible for the management or condition of an agricultural establishment that uses such workers.\n\nAgricultural establishment  means any farm, forest, nursery, or greenhouse.\n\nAgricultural plant  means any plant grown or maintained for commercial or research purposes and includes, but is not limited to, food, feed, and fiber plants; trees; turfgrass; flowers, shrubs; ornamentals; and seedlings.\n\nChemigation  means the application of pesticides through irrigation systems.\n\nCommercial pesticide handling establishment  means any establishment, other than an agricultural establishment, that:\n\n(1) Employs any person, including a self-employed person, to apply on an agricultural establishment, pesticides used in the production of agricultural plants.\n\n(2) Employs any person, including a self-employed person, to perform on an agricultural establishment, tasks as a crop advisor.\n\nCrop advisor  means any person who is assessing pest numbers or damage, pesticide distribution, or the status or requirements of agricultural plants. The term does not include any person who is performing hand labor tasks.\n\nEarly entry  means entry by a worker into a treated area on the agricultural establishment after a pesticide application is complete, but before any restricted-entry interval for the pesticide has expired.\n\nFarm  means any operation, other than a nursery or forest, engaged in the outdoor production of agricultural plants.\n\nForest  means any operation engaged in the outdoor production of any agricultural plant to produce wood fiber or timber products.\n\nFumigant  means any pesticide product that is a vapor or gas, or forms a vapor or gas on application, and whose method of pesticidal action is through the gaseous state.\n\nGreenhouse  means any operation engaged in the production of agricultural plants inside any structure or space that is enclosed with nonporous covering and that is of sufficient size to permit worker entry. This term includes, but is not limited to, polyhouses, mushroom houses, rhubarb houses, and similar structures. It does not include such structures as malls, atriums, conservatories, arboretums, or office buildings where agricultural plants are present primarily for aesthetic or climatic modification.\n\nHand labor  means any agricultural activity performed by hand or with hand tools that causes a worker to have substantial contact with surfaces (such as plants, plant parts, or soil) that may contain pesticide residues. These activities include, but are not limited to, harvesting, detasseling, thinning, weeding, topping, planting, sucker removal, pruning, disbudding, roguing, and packing produce into containers in the field. Hand labor does not include operating, moving, or repairing irrigation or watering equipment or performing the tasks of crop advisors.\n\nHandler  means any person, including a self-employed person:\n\n(1) Who is employed for any type of compensation by an agricultural establishment or commercial pesticide handling establishment to which subpart C of this part applies and who is:\n\n(i) Mixing, loading, transferring, or applying pesticides.\n\n(ii) Disposing of pesticides or pesticide containers.\n\n(iii) Handling opened containers of pesticides.\n\n(iv) Acting as a flagger.\n\n(v) Cleaning, adjusting, handling, or repairing the parts of mixing, loading, or application equipment that may contain pesticide residues.\n\n(vi) Assisting with the application of pesticides.\n\n(vii) Entering a greenhouse or other enclosed area after the application and before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria established by this part (\u00a7 170.110(c)(3)) or in the labeling has been met:\n\n(A) To operate ventilation equipment.\n\n(B) To adjust or remove coverings used in fumigation.\n\n(C) To monitor air levels.\n\n(viii) Entering a treated area outdoors after application of any soil fumigant to adjust or remove soil coverings such as tarpaulins.\n\n(ix) Performing tasks as a crop advisor:\n\n(A) During any pesticide application.\n\n(B) Before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria established by this part (\u00a7 170.110(c)(3)) or in the labeling has been met.\n\n(C) During any restricted-entry interval.\n\n(2) The term does not include any person who is only handling pesticide containers that have been emptied or cleaned according to pesticide product labeling instructions or, in the absence of such instructions, have been subjected to triple-rinsing or its equivalent.\n\nHandler employer  means any person who is self-employed as a handler or who employs any handler, for any type of compensation.\n\nImmediate family  includes only spouse, children, stepchildren, foster children, parents, stepparents, foster parents, brothers, and sisters.\n\nNursery  means any operation engaged in the outdoor production of any agricultural plant to produce cut flowers and ferns or plants that will be used in their entirety in another location. Such plants include, but are not limited to, flowering and foliage plants or trees; tree seedlings; live Christmas trees; vegetable, fruit, and ornamental transplants; and turfgrass produced for sod.\n\nOwner  means any person who has a present possessory interest (fee, leasehold, rental, or other) in an agricultural establishment covered by this part. A person who has both leased such agricultural establishment to another person and granted that same person the right and full authority to manage and govern the use of such agricultural establishment is not an owner for purposes of this part.\n\nRestricted-entry interval  means the time after the end of a pesticide application during which entry into the treated area is restricted.\n\nTreated area  means any area to which a pesticide is being directed or has been directed.\n\nWorker  means any person, including a self-employed person, who is employed for any type of compensation and who is performing activities relating to the production of agricultural plants on an agricultural establishment to which subpart B of this part applies. While persons employed by a commercial pesticide handling establishment are performing tasks as crop advisors, they are not workers covered by the requirements of subpart B of this part."], ["40:40:26.0.1.1.19.1.19.4", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.7 General duties and prohibited actions.", "EPA", "", "", "", "(a)  General duties.  The agricultural employer or the handler employer, as appropriate, shall:\n\n(1) Assure that each worker subject to subpart B of this part or each handler subject to subpart C of this part receives the protections required by this part.\n\n(2) Assure that any pesticide to which subpart C of this part applies is used in a manner consistent with the labeling of the pesticide, including the requirements of this part.\n\n(3) Provide, to each person who supervises any worker or handler, information and directions sufficient to assure that each worker or handler receives the protections required by this part. Such information and directions shall specify which persons are responsible for actions required to comply with this part.\n\n(4) Require each person who supervises any worker or handler to assure compliance by the worker or handler with the provisions of this part and to assure that the worker or handler receives the protections required by this part.\n\n(b)  Prohibited actions.  The agricultural employer or the handler employer shall not take any retaliatory action for attempts to comply with this part or any action having the effect of preventing or discouraging any worker or handler from complying or attempting to comply with any requirement of this part."], ["40:40:26.0.1.1.19.1.19.5", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "A", "Subpart A\u2014General Provisions", "", "\u00a7 170.9 Violations of this part.", "EPA", "", "", "", "(a) Under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136  et seq. ) (FIFRA) section 12(a)(2)(G) it is unlawful for any person \u201cto use any registered pesticide in a manner inconsistent with its labeling.\u201d When this part is referenced on a label, users must comply with all of its requirements except those that are inconsistent with product-specific instructions on the labeling. For the purposes of this part, EPA interprets the term \u201cuse\u201d to include:\n\n(1) Preapplication activities, including, but not limited to:\n\n(i) Arranging for the application of the pesticide;\n\n(ii) Mixing and loading the pesticide; and\n\n(iii) Making necessary preparations for the application of the pesticide, including responsibilities related to worker notification, training of handlers, decontamination, use and care of personal protective equipment, emergency information, and heat stress management.\n\n(2) Application of the pesticide.\n\n(3) Post-application activities necessary to reduce the risks of illness and injury resulting from handlers' and workers' occupational exposures to pesticide residues during the restricted-entry interval plus 30 days. These activities include, but are not limited to, responsibilities related to worker training, notification, and decontamination.\n\n(4) Other pesticide-related activities, including, but not limited to, providing emergency assistance, transporting or storing pesticides that have been opened, and disposing of excess pesticides, spray mix, equipment wash waters, pesticide containers, and other pesticide-containing materials.\n\n(b) A person who has a duty under this part, as referenced on the pesticide product label, and who fails to perform that duty, violates FIFRA section 12(a)(2)(G) and is subject to a civil penalty under section 14. A person who knowingly violates section 12(a)(2)(G) is subject to section 14 criminal sanctions.\n\n(c) FIFRA section 14(b)(4) provides that a person is liable for a penalty under FIFRA if another person employed by or acting for that person violates any provision of FIFRA. The term \u201cacting for\u201d includes both employment and contractual relationships.\n\n(d) The requirements of this part, including the decontamination requirements, shall not, for the purposes of section 653(b)(1) of title 29 of the U.S. Code, be deemed to be the exercise of statutory authority to prescribe or enforce standards or regulations affecting the general sanitary hazards addressed by the OSHA Field Sanitation Standard, 29 CFR 1928.110, or other agricultural, nonpesticide hazards."], ["40:40:26.0.1.1.19.2.19.1", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.102 Applicability of this subpart.", "EPA", "", "", "[60 FR 21952, May 3, 1995]", "Except as provided by \u00a7\u00a7 170.103 and 170.104, this subpart applies when any pesticide product is used on an agricultural establishment in the production of agricultural plants."], ["40:40:26.0.1.1.19.2.19.10", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.135 Posted pesticide safety information.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992, as amended at 80 FR 67556, Nov. 2, 2015]", "(a)  Requirement.  When workers are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the agricultural employer shall display, in accordance with this section, pesticide safety information.\n\n(b)  Pesticide safety poster.  A safety poster must be displayed that conveys, at a minimum, the pesticide safety concepts listed in paragraphs (b)(1)(i) through (vii) and (b)(2) of this section. Displays conforming to \u00a7 170.311(a)(3) meet the requirements of this paragraph.\n\n(c)  Emergency medical care information.  (1) The name, address, and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. Displays conforming to \u00a7 170.311(a)(3)(ix) meet the requirements of this paragraph.\n\n(2) The agricultural employer shall inform workers promptly of any change to the information on emergency medical care facilities.\n\n(d)  Location.  (1) The information shall be displayed in a central location on the farm or in the nursery or greenhouse where it can be readily seen and read by workers.\n\n(2) The information shall be displayed in a location in or near the forest in a place where it can be readily seen and read by workers and where workers are likely to congregate or pass by, such as at a decontamination site or an equipment storage site.\n\n(e)  Accessibility.  Workers shall be informed of the location of the information and shall be allowed access to it.\n\n(f)  Legibility.  The information shall remain legible during the time it is posted."], ["40:40:26.0.1.1.19.2.19.11", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.150 Decontamination.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33212, June 26, 1996]", "(a)(1)  Requirement.  The agricultural employer must provide decontamination supplies for workers in accordance with this section whenever:\n\n(i) Any worker on the agricultural establishment is performing an activity in the area where a pesticide was applied or a restricted-entry interval (REI) was in effect within the last 30 days, and;\n\n(ii) The worker contacts anything that has been treated with the pesticide, including, but not limited to soil, water, plants, plant surfaces, and plant parts.\n\n(2)  Exception.  The 30-day time period established in paragraph (a)(1)(i) of this section shall not apply if the only pesticides used in the treated area are products with an REI of 4 hours or less on the label (but not a product without an REI on the label). When workers are in such treated areas, the agricultural employer shall provide decontamination supplies for not less than 7 days following the expiration of any applicable REI.\n\n(b)  General conditions.  (1) The agricultural employer shall provide workers with enough water for routine washing and emergency eyeflushing. At all times when the water is available to workers, the employer shall assure that it is of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed.\n\n(2) When water stored in a tank is to be used for mixing pesticides, it shall not be used for decontamination or eyeflushing, unless the tank is equipped with properly functioning valves or other mechanisms that prevent movement of pesticides into the tank.\n\n(3) The agricultural employer shall provide soap and single-use towels in quantities sufficient to meet worker's needs.\n\n(4) To provide for emergency eyeflushing, the agricultural employer shall assure that at least 1 pint of water is immediately available to each worker who is performing early-entry activities permitted by \u00a7 170.112 and for which the pesticide labeling requires protective eyewear. The eyeflush water shall be carried by the early-entry worker, or shall be on the vehicle the early-entry worker is using, or shall be otherwise immediately accessible.\n\n(c)  Location.  (1) The decontamination supplies shall be located together and be reasonably accessible to and not more than \n 1/4  mile from where workers are working.\n\n(2) For worker activities performed more than \n 1/4  mile from the nearest place of vehicular access:\n\n(i) The soap, single-use towels, and water may be at the nearest place of vehicular access.\n\n(ii) The agricultural employer may permit workers to use clean water from springs, streams, lakes, or other sources for decontamination at the remote work site, if such water is more accessible than the water located at the nearest place of vehicular access.\n\n(3) The decontamination supplies shall not be maintained in an area being treated with pesticides.\n\n(4) The decontamination supplies shall not be maintained in an area that is under a restricted-entry interval, unless the workers for whom the supplies are provided are performing early-entry activities permitted by \u00a7 170.112 and involving contact with treated surfaces and the decontamination supplies would otherwise not be reasonably accessible to those workers.\n\n(d)  Decontamination after early-entry activities.  At the end of any exposure period for workers engaged in early-entry activities permitted by \u00a7 170.112 and involving contact with anything that has been treated with the pesticide to which the restricted-entry interval applies, including, but not limited to, soil, water, air, or surfaces of plants, the agricultural employer shall provide, at the site where the workers remove personal protective equipment, soap, clean towels, and a sufficient amount of water so that the workers may wash thoroughly."], ["40:40:26.0.1.1.19.2.19.12", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.160 Emergency assistance.", "EPA", "", "", "", "If there is reason to believe that a person who is or has been employed on an agricultural establishment to perform tasks related to the production of agricultural plants has been poisoned or injured by exposure to pesticides used on the agricultural establishment, including, but not limited to, exposures from application, splash, spill, drift, or pesticide residues, the agricultural employer shall:\n\n(a) Make available to that person prompt transportation from the agricultural establishment, including any labor camp on the agricultural establishment, to an appropriate emergency medical facility.\n\n(b) Provide to that person or to treating medical personnel, promptly upon request, any obtainable information on:\n\n(1) Product name, EPA registration number, and active ingredients of any product to which that person might have been exposed.\n\n(2) Antidote, first aid, and other medical information from the product labeling.\n\n(3) The circumstances of application or use of the pesticide on the agricultural establishment.\n\n(4) The circumstances of exposure of that person to the pesticide."], ["40:40:26.0.1.1.19.2.19.2", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.103 Exceptions.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR 21952, May 3, 1995]", "Exceptions.  This subpart does not apply when any pesticide is applied on an agricultural establishment in the following circumstances:\n\n(a) For mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored by governmental entities;\n\n(b) On livestock or other animals, or in or about animal premises;\n\n(c) On plants grown for other than commercial or research purposes, which may include plants in habitations, home fruit and vegetable gardens, and home greenhouses;\n\n(d) On plants that are in ornamental gardens, parks, and public or private lawns and grounds that are intended only for aesthetic purposes or climatic modification;\n\n(e) By injection directly into agricultural plants. Direct injection does not include \u201chack and squirt,\u201d \u201cfrill and spray,\u201d chemigation, soil-incorporation, or soil-injection;\n\n(f) In a manner not directly related to the production of agricultural plants, including, but not limited to, structural pest control, control of vegetation along rights-of-way and in other noncrop areas, and pasture and rangeland use;\n\n(g) For control of vertebrate pests;\n\n(h) As attractants or repellents in traps;\n\n(i) On the harvested portions of agricultural plants or on harvested timber; and\n\n(j) For research uses of unregistered pesticides."], ["40:40:26.0.1.1.19.2.19.3", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.104 Exemptions.", "EPA", "", "", "[60 FR 21952, May 3, 1995, as amended at 73 FR 75598, Dec. 12, 2008]", "The workers listed in this section are exempt from the specified provisions of this subpart.\n\n(a)  Owners of agricultural establishments.  (1) The owner of an agricultural establishment is not required to provide to himself or members of his immediate family who are performing tasks related to the production of agricultural plants on their own agricultural establishment the protections of:\n\n(i) Section 170.112(c)(5) through (9).\n\n(ii) Section 170.112(c)(5) through (9) as referenced in \u00a7\u00a7 170.112(d)(2)(iii) and 170.112(e).\n\n(iii) Section 170.120.\n\n(iv) Section 170.122.\n\n(v) Section 170.130.\n\n(vi) Section 170.135.\n\n(vii) Section 170.150.\n\n(viii) Section 170.160.\n\n(2) The owner of the agricultural establishment must provide the protections listed in paragraph (a)(1)(i) through (viii) of this section to other workers and other persons who are not members of his immediate family.\n\n(b)  Crop advisors.  (1) Provided that the conditions of paragraph (b)(2) of this section are met, a person who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, and persons performing crop advising tasks under such qualified crop advisor's direct supervision, are exempt from the provisions of:\n\n(i) Section 170.150.\n\n(ii) Section 170.160.\n\nA person is under the direct supervision of a crop advisor when the crop advisor exerts the supervisory controls set out in paragraphs (b)(2)(iii) and (iv) of this section. Direct supervision does not require that the crop advisor be physically present at all times, but the crop advisor must be readily accessible to the employees at all times.\n\n(2) Conditions of exemption. (i) The certification or licensing program requires pesticide safety training that includes, at least, all the information in \u00a7 170.230(c)(4).\n\n(ii) Applies only when performing crop advising tasks in the treated area.\n\n(iii) The crop advisor must make specific determinations regarding the appropriate personal protective equipment, appropriate decontamination supplies, and how to conduct the tasks safely. The crop advisor must convey this information to each person under his direct supervision in a language that the person understands.\n\n(iv) Before entering a treated area, the certified or licensed crop advisor must inform, through an established practice of communication, each person under his direct supervision of the pesticide product and active ingredient(s) applied, method of application, time of application, the restricted entry interval, which tasks to undertake, and how to contact the crop advisor."], ["40:40:26.0.1.1.19.2.19.4", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.110 Restrictions associated with pesticide applications.", "EPA", "", "", "", "(a)  Farms and forests.  During the application of any pesticide on a farm or in a forest, the agricultural employer shall not allow or direct any person, other than an appropriately trained and equipped handler, to enter or to remain in the treated area.\n\n(b)  Nurseries.  In a nursery, during any pesticide application described in column A of Table 1 of this paragraph, the agricultural employer shall not allow or direct any person, other than an appropriately trained and equipped handler, to enter or to remain in the area specified in column B of Table 1 of this paragraph. After the application is completed, until the end of any restricted-entry interval, the entry-restricted area is the treated area.\n\nTable 1\u2014Entry-Restricted Areas in Nurseries During Pesticide Applications\n\n(c)  Greenhouses.  (1) When a pesticide application described in column A of Table 2 under paragraph (c)(4) of this section takes place in a greenhouse, the agricultural employer shall not allow or direct any person, other than an appropriately trained and equipped handler, to enter or to remain in the area specified in column B of Table 2 until the time specified in column C of Table 2 has expired.\n\n(2) After the time specified in column C of Table 2 under paragraph (c)(4) of this section has expired, until the expiration of any restricted-entry interval, the agricultural employer shall not allow or direct any worker to enter or to remain in the treated area as specified in column D of Table 2 under paragraph (c)(4) of this section, except as provided in \u00a7 170.112.\n\n(3) When column C of Table 2 under paragraph (c)(4) of this section specifies that ventilation criteria must be met, ventilation shall continue until the air concentration is measured to be equal to or less than the inhalation exposure level the labeling requires to be achieved. If no inhalation exposure level is listed on the labeling, ventilation shall continue until after:\n\n(i) Ten air exchanges are completed; or\n\n(ii) Two hours of ventilation using fans or other mechanical ventilating systems; or\n\n(iii) Four hours of ventilation using vents, windows or other passive ventilation; or\n\n(iv) Eleven hours with no ventilation followed by 1 hour of mechanical ventilation; or\n\n(v) Eleven hours with no ventilation followed by 2 hours of passive ventilation; or\n\n(vi) Twenty-four hours with no ventilation.\n\n(4) The following Table 2 applies to paragraphs (c) (1), (2), and (3) of this section.\n\nTable 2\u2014Greenhouse Entry Restrictions Associated With Pesticide Applications"], ["40:40:26.0.1.1.19.2.19.5", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.112 Entry restrictions.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992, as amended at 59 FR 30264, June 10, 1994; 60 FR 21954, May 3, 1995; 62 FR 52003, Oct. 3, 1997; 69 FR 53346, Sept. 1, 2004; 71 FR 35546, June 21, 2006; 73 FR 75598, Dec. 12, 2008]", "(a)  General restrictions.  (1) After the application of any pesticide on an agricultural establishment, the agricultural employer shall not allow or direct any worker to enter or to remain in the treated area before the restricted-entry interval specified on the pesticide labeling has expired, except as provided in this section.\n\n(2) Entry-restricted areas in greenhouses are specified in column D in table 2 under \u00a7 170.110(c)(4).\n\n(3) When two or more pesticides are applied at the same time, the restricted-entry interval shall be the longest of the applicable intervals.\n\n(4) The agricultural employer shall assure that any worker who enters a treated area under a restricted-entry interval as permitted by paragraphs (c), (d), and (e) of this section uses the personal protective equipment specified in the product labeling for early-entry workers and follows any other requirements on the pesticide labeling regarding early entry.\n\n(b)  Exception for activities with no contact.  A worker may enter a treated area during a restricted-entry interval if the agricultural employer assures that both of the following are met:\n\n(1) The worker will have no contact with anything that has been treated with the pesticide to which the restricted-entry interval applies, including, but not limited to, soil, water, air, or surfaces of plants; and\n\n(2) No such entry is allowed until any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by \u00a7 170.110(c)(3) or in the labeling have been met.\n\n(c)  Exception for short-term activities.  A worker may enter a treated area during a restricted-entry interval for short-term activities if the agricultural employer assures that the following requirements are met:\n\n(1) No hand labor activity is performed.\n\n(2) The time in treated areas under a restricted-entry interval for any worker does not exceed 1 hour in any 24-hour period.\n\n(3) No such entry is allowed for the first 4 hours following the end of the application, and no such entry is allowed thereafter until any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by \u00a7 170.110(c)(3) or in the labeling have been met.\n\n(4) The personal protective equipment specified on the product labeling for early entry is provided to the worker. Such personal protective equipment shall conform to the following standards:\n\n(i) Personal protective equipment (PPE) means devices and apparel that are worn to protect the body from contact with pesticides or pesticide residues, including, but not limited to, coveralls, chemical-resistant suits, chemical-resistant gloves, chemical-resistant footwear, respiratory protection devices, chemical-resistant aprons, chemical-resistant headgear, and protective eyewear.\n\n(ii) Long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes, socks, and other items of work clothing are not considered personal protective equipment for the purposes of this section and are not subject to the requirements of this section, although pesticide labeling may require that such work clothing be worn during some activities.\n\n(iii) When \u201cchemical-resistant\u201d personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of the pesticide being used through the material during use.\n\n(iv) When \u201cwaterproof\u201d personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of water or aqueous solutions through the material during use.\n\n(v) When a \u201cchemical-resistant suit\u201d is specified by the product labeling, it shall be a loose-fitting, one- or two-piece, chemical-resistant garment that covers, at a minimum, the entire body except head, hands, and feet.\n\n(vi) When \u201ccoveralls\u201d are specified by the product labeling, they shall be a loose-fitting, one- or two-piece garment, such as a cotton or cotton and polyester coverall, that covers, at a minimum, the entire body except head, hands, and feet. The pesticide product labeling may specify that the coveralls be worn over a layer of clothing. If a chemical-resistant suit is substituted for coveralls, it need not be worn over a layer of clothing.\n\n(vii)(A) Gloves shall be of the type specified on the pesticide product labeling. Gloves made of leather, cotton, or other absorbent materials must not be worn for early-entry activities, unless gloves made of these materials are listed as acceptable for such use on the product labeling. If chemical-resistant gloves with sufficient durability and suppleness are not obtainable, leather gloves may be worn on top of chemical-resistant gloves. However, once leather gloves have been worn for this use, they shall not be worn thereafter for any other purpose, and they shall only be worn over chemical-resistant gloves.\n\n(B) Separable glove liners may be worn beneath chemical-resistant gloves, unless the pesticide product labeling specifically prohibits their use. Separable glove liners are defined as separate glove-like hand coverings made of lightweight material, with or without fingers. Work gloves made from lightweight cotton or poly-type material are considered to be glove liners if worn beneath chemical-resistant gloves. Separable glove liners may not extend outside the chemical-resistant gloves under which they are worn. Chemical-resistant gloves with non-separable absorbent lining materials are prohibited.\n\n(C) If used, separable glove liners must be discarded immediately after a total of no more than 10 hours of use or within 24 hours of when first put on, whichever comes first. The liners must be replaced immediately if directly contacted by pesticide. Used glove liners shall not be reused. Contaminated liners must be disposed of in accordance with any Federal, State, or local regulations.\n\n(viii) When \u201cchemical-resistant footwear\u201d is specified by the product labeling, it shall be one of the following types of footwear: chemical-resistant shoes, chemical-resistant boots, or chemical-resistant shoe coverings worn over shoes or boots. If chemical-resistant footwear with sufficient durability and a tread appropriate for wear in rough terrain is not obtainable for workers, then leather boots may be worn in such terrain.\n\n(ix) When \u201cprotective eyewear\u201d is specified by the product labeling, it shall be one of the following types of eyewear: goggles; face shield; safety glasses with front, brow, and temple protection; or a full-face respirator.\n\n(x) When \u201cchemical-resistant headgear\u201d is specified by the product labeling, it shall be either a chemical-resistant hood or a chemical-resistant hat with a wide brim.\n\n(5) The agricultural employer shall assure that the worker, before entering the treated area, either has read the product labeling or has been informed, in a manner that the worker can understand, of all labeling requirements related to human hazards or precautions, first aid, symptoms of poisoning, personal protective equipment specified for early entry, and any other labeling requirements related to safe use.\n\n(6) The agricultural employer shall assure that:\n\n(i) Workers wear the personal protective equipment correctly for its intended purpose and use personal protective equipment according to manufacturer's instructions.\n\n(ii) Before each day of use, all personal protective equipment is inspected for leaks, holes, tears, or worn places, and any damaged equipment is repaired or discarded.\n\n(iii) Personal protective equipment that cannot be cleaned properly is disposed of in accordance with any applicable Federal, State, and local regulations.\n\n(iv) All personal protective equipment is cleaned according to manufacturer's instructions or pesticide product labeling instructions before each day of reuse. In the absence of any such instructions, it shall be washed thoroughly in detergent and hot water.\n\n(v) Before being stored, all clean personal protective equipment is dried thoroughly or is put in a well-ventilated place to dry.\n\n(vi) Personal protective equipment contaminated with pesticides is kept separately and washed separately from any other clothing or laundry.\n\n(vii) Any person who cleans or launders personal protective equipment is informed that such equipment may be contaminated with pesticides, of the potentially harmful effects of exposure to pesticides, and of the correct way(s) to handle and clean personal protective equipment and to protect themselves when handling equipment contaminated with pesticides.\n\n(viii) All clean personal protective equipment is stored separately from personal clothing and apart from pesticide-contaminated areas.\n\n(ix) Each worker is instructed how to put on, use, and remove the personal protective equipment and is informed about the importance of washing thoroughly after removing personal protective equipment.\n\n(x) Each worker is instructed in the prevention, recognition, and first aid treatment of heat-related illness.\n\n(xi) Workers have a clean place(s) away from pesticide-storage and pesticide-use areas for storing personal clothing not in use; putting on personal protective equipment at the start of any exposure period; and removing personal protective equipment at the end of any exposure period.\n\n(7) When personal protective equipment is required by the labeling of any pesticide for early entry, the agricultural employer shall assure that no worker is allowed or directed to perform the early-entry activity without implementing, when appropriate, measures to prevent heat-related illness.\n\n(8) During any early-entry activity, the agricultural employer shall provide a decontamination site in accordance with \u00a7 170.150.\n\n(9) The agricultural employer shall not allow or direct any worker to wear home or to take home personal protective equipment contaminated with pesticides.\n\n(d)  Exception for an agricultural emergency.  (1) An \u201cagricultural emergency\u201d means a sudden occurrence or set of circumstances which the agricultural employer could not have anticipated and over which the agricultural employer has no control, and which requires entry into a treated area during a restricted-entry interval, when no alternative practices would prevent or mitigate a substantial economic loss. A substantial economic loss means a loss in profitability greater than that which would be expected based on the experience and fluctuations of crop yields in previous years. Only losses caused by the agricultural emergency specific to the affected site and geographic area are considered. The contribution of mismanagement cannot be considered in determining the loss.\n\n(2) A worker may enter a treated area under a restricted-entry interval in an agricultural emergency to perform tasks, including hand labor tasks, necessary to mitigate the effects of the agricultural emergency, if the agricultural employer assures that all the following criteria are met:\n\n(i) A State, Tribal, or Federal Agency having jurisdiction declares the existence of circumstances that could cause an agricultural emergency on that agricultural establishment.\n\n(ii) The agricultural employer determines the agricultural establishment is subject to the circumstances declared under paragraph (d)(2)(i) of this section that result in an agricultural emergency meeting the criteria of paragraph (d)(1) of this section.\n\n(iii) The requirements of paragraphs (c) (3) through (9) of this section are met.\n\n(e)  Exception requiring Agency approval.  The Agency may, in accordance with paragraphs (e) (1) through (3) of this section, grant an exception from the requirements of this section. An exception may be withdrawn in accordance with paragraph (e)(6) of this section.\n\n(1)  Exception requiring agency approval.  A request for an exception must be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b) and must be accompanied by two copies of the following information:\n\n(i) The name, address, and telephone number of the submitter.\n\n(ii) The time period for which the exception is requested.\n\n(iii) A description of the crop(s) and specific crop production task(s) for which the exception is requested. Such a description must include an explanation as to the necessity of applying pesticides of a type and at a frequency such that the restricted-entry interval would interfere with necessary and time-sensitive hand labor tasks for the period for which the exception is sought.\n\n(iv) A description of the geographic area for which the exception is requested. If the exception request is for a limited geographic area, the explanation must include a description as to why the circumstances of exposure or economic impact resulting from the prohibition of routine hand labor tasks during the restricted-entry interval are unique to the geographic area named in the exception.\n\n(v) An explanation as to why, for each requested crop-task combination, alternative practices would not be technically or financially viable. Such alternative practices might include: rescheduling the pesticide application or hand labor activity; using a non-chemical pest control alternative; using an alternative to the hand labor tasks, such as machine cultivation; or substituting a pesticide with a shorter restricted-entry interval. This information should include estimates or data on per acre revenue and cost of production for the crop and area for which the exception is requested. These estimates or data should include: the situation prior to implementation of this final rule, the situation after implementation of this final rule if the exception is not granted, the situation after implementation of this final rule if the exception is granted, and specific information on individual factors which cause differences in revenues and costs among the three situations.\n\n(vi) A description or documentation of the safety and feasibility of such an exception, including, but not limited to, the feasibility of performing the necessary hand labor activity while wearing the personal protective equipment required for early entry for the pesticide(s) expected to be applied, the means of mitigating heat-related illness concerns, the period of time required daily per worker to perform the hand labor activity, any suggested methods of reducing the worker's exposure, and any other mitigating factors, such as the availability of running water for routine and emergency decontamination and mechanical devices that would reduce the workers' contact with the treated surfaces. The information should include the costs associated with early-entry, such as decontamination facilities, special information and training for the workers, heat stress avoidance procedures, and provision, inspection, cleaning, and maintenance of personal protective equipment. EPA will not grant exceptions where the costs of early entry equal or exceed the expected loss in value of crop yield or quality.\n\n(2)  Notice of receipt.  (i) When a request for an exception is submitted to the Agency along with all of the information required in paragraph (e)(1) of this section, the Agency shall issue a notice in the  Federal Register  stating that an exception is being considered, describing the nature of the exception, and allowing at least 30 days for interested parties to comment.\n\n(ii) If a request for an exception is submitted to the Agency without all of the information required in paragraph (e)(1) of this section, the Agency shall return the request to the submitter.\n\n(3)  Exception decision.  EPA will publish in the  Federal Register  its decision whether to grant the request for exception. EPA will base its decision on whether the benefits of the exception outweigh the costs, including the value of the health risks attributable to the exception. If the exception is granted, the notice will state the nature of and reasons for the exception.\n\n(4)  Presumptive denial.  (i) Except as provided in paragraph (e)(4)(ii) of this section, persons requesting an exception may assume that the exception has been denied if EPA has not issued its decision whether to grant the exception within 9 months from the comment-closure date specified in the  Federal Register  notice in which the Agency announced, in accordance with paragraph (e)(2) of this section, that it would consider the exception.\n\n(ii) Persons requesting an exception may not assume that the request has been denied as provided by paragraph (e)(4)(i) of this section if the Agency has taken action to extend its review period for a specified time interval due to the complexity of the exception request or to the number of exception requests concurrently under Agency review. EPA shall state the reason(s) for the delay in issuing a decision on the exception request. A notice of such an action may be published in the  Federal Register  or persons who requested the exception may be directly notified of the action.\n\n(5)  Agricultural employer duties.  When a worker enters a treated area during a restricted-entry interval under an exception granted under paragraph (e) of this section, the agricultural employer shall assure that the requirements of paragraphs (c) (3) through (9) of this section are met, unless the notice granting the exception specifically indicates otherwise.\n\n(6)  Withdrawing an exception.  An exception may be withdrawn by the Agency at any time if the Agency receives poisoning information or other data that indicate that the health risks imposed by this early-entry exception are unacceptable or if the Agency receives other information that indicates that the exception is no longer necessary or prudent. If the Agency determines that an exception should be withdrawn, it will publish a notice in the  Federal Register,  stating the basis for its determination. Affected parties would then have 30 days to request a hearing on the Agency's determination. The exception, however, would be discontinued as of the date specified by EPA in the notice, which may include any of the 30-day period and the time required for any subsequent hearing process. Thereafter the Agency will decide whether to withdraw the exception and will publish a notice in the  Federal Register  stating its decision.\n\n(7)  List of exceptions granted by EPA.  The following administrative exceptions from the requirements of this section have been granted by EPA. Each exception listed in paragraph (e)(7) of this section contains a reference to the  Federal Register  notice in which EPA has granted the exception and the effective dates of the exception. The terms and conditions of the exception appear in the referenced  Federal Register  notice.\n\n(i) Exception to perform irrigation tasks under specified conditions published in the  Federal Register  of May 3, 1995.\n\n(ii) Exceptions to perform limited contact tasks under specified conditions published in the  Federal Register  of May 3, 1995."], ["40:40:26.0.1.1.19.2.19.6", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.120 Notice of applications.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33207, June 26, 1996]", "(a)  Notification to workers of pesticide applications in greenhouses.  The agricultural employer shall notify workers of any pesticide application in the greenhouse in accordance with this paragraph.\n\n(1) All pesticide applications shall be posted in accordance with paragraph (c) of this section.\n\n(2) If the pesticide product labeling has a statement requiring both the posting of treated areas and oral notification to workers, the agricultural employer shall also provide oral notification of the application to the worker in accordance with paragraph (d) of this section.\n\n(3) Notice need not be given to a worker if the agricultural employer can assure that one of the following is met:\n\n(i) From the start of the application until the end of the application and during any restricted-entry interval, the worker will not enter, work in, remain in, or pass through the greenhouse; or\n\n(ii) The worker applied (or supervised the application of) the pesticide for which the notice is intended and is aware of all information required by paragraphs (d)(1) through (3) of this section.\n\n(b)  Notification to workers on farms, in nurseries, or in forests of pesticide applications.  The agricultural employer shall notify workers of any pesticide application on the farm or in the nursery or forest in accordance with this paragraph.\n\n(1) If the pesticide product labeling has a statement requiring both the posting of treated areas and oral notification to workers, the agricultural employer shall post signs in accordance with paragraph (c) of this section and shall provide oral notification of the application to the worker in accordance with paragraph (d) of this section.\n\n(2) For any pesticide other than those for which the labeling requires both posting and oral notification of applications, the agricultural employer shall give notice of the application to the worker either by the posting of warning signs in accordance with paragraph (c) of this section or orally in accordance with paragraph (d) of this section, and shall inform the workers as to which method of notification is in effect.\n\n(3) Notice need not be given to a worker if the agricultural employer can assure that one of the following is met:\n\n(i) From the start of the application until the end of the application and during any restricted-entry interval, the worker will not enter, work in, remain in, or pass through on foot the treated area or any area within \n 1/4  mile of the treated area; or\n\n(ii) The worker applied (or supervised the application of) the pesticide for which the notice is intended and is aware of all information required by (d)(1) through (3) of this section.\n\n(c)  Posted warning signs.  The agricultural employer shall post warning signs in accordance with the following criteria:\n\n(1) The warning sign shall have a background color that contrasts with red. The words \u201cDANGER\u201d and \u201cPELIGRO,\u201d plus \u201cPESTICIDES\u201d and \u201cPESTICIDAS,\u201d shall be at the top of the sign, and the words \u201cKEEP OUT\u201d and \u201cNO ENTRE\u201d shall be at the bottom of the sign. Letters for all words must be clearly legible. A circle containing an upraised hand on the left and a stern face on the right must be near the center of the sign. The inside of the circle must be red, except that the hand and a large portion of the face must be in a shade that contrasts with red. The length of the hand must be at least twice the height of the smallest letters. The length of the face must be only slightly smaller than the hand. Additional information such as the name of the pesticide and the date of application may appear on the warning sign if it does not detract from the appearance of the sign or change the meaning of the required information. A black-and-white example of a warning sign meeting these requirements, other than the size requirements, follows:\n\n(2) The standard sign shall be at least 14 inches by 16 inches with letters at least 1 inch in height. Farms and forests shall use the standard size sign unless a smaller sign is necessary because the treated area is too small to accommodate a sign of this size. In nurseries and greenhouses, the agricultural employer may, at any time, use a sign smaller than the standard size sign. Whenever a small sign is used on any establishment, there are specific posting distances depending on the size of the lettering and symbol on the sign. If a sign is used with DANGER and PELIGRO in letters at least \n 7/8  inch in height and the remaining letters at least \n 1/2  inch in height and a red circle at least 3 inches in diameter containing an upraised hand and a stern face, the signs shall be no further than 50 feet apart. If a sign is used with DANGER and PELIGRO in letters at least \n 7/16  inch in height and the remaining letters at least \n 1/4  inch in height and a red circle at least 1\n 1/2  inches in diameter containing an upraised hand and a stern face, the signs shall be no further than 25 feet apart. A sign with DANGER and PELIGRO in letters less than \n 7/16  inch in height or with any words in letters less than \n 1/4  inch in height or a red circle smaller than 1\n 1/2  inches in diameter containing an upraised hand and a stern face will not satisfy the requirements of the rule. All signs must meet the requirements of paragraph (c)(1) of this section.\n\n(3) The employer may replace the Spanish portion of the warning sign with a non-English language read by the largest group of workers who do not read English. The replacement sign must be in the same format as the original sign and be visible and legible.\n\n(4) On farms and in forests and nurseries, the signs shall be visible from all usual points of worker entry to the treated area, including at least each access road, each border with any labor camp adjacent to the treated area, and each footpath and other walking route that enters the treated area. When there are no usual points of worker entry, signs shall be posted in the corners of the treated area or in any other location affording maximum visibility.\n\n(5) In greenhouses, the signs shall be posted so they are visible from all usual points of worker entry to the treated area including each aisle or other walking route that enters the treated area. When there are no usual points of worker entry to the treated area, signs shall be posted in the corners of the treated area or in any other location affording maximum visibility.\n\n(6) The signs shall:\n\n(i) Be posted no sooner than 24 hours before the scheduled application of the pesticide.\n\n(ii) Remain posted throughout the application and any restricted-entry interval.\n\n(iii) Be removed within 3 days after the end of the application and any restricted-entry interval and before agricultural-worker entry is permitted, other than entry permitted by \u00a7 170.112.\n\n(7) The signs shall remain visible and legible during the time they are posted.\n\n(8) When several contiguous areas are to be treated with pesticides on a rotating or sequential basis, the entire area may be posted. Worker entry, other than entry permitted by \u00a7 170.112, is prohibited for the entire area while the signs are posted.\n\n(d)  Oral warnings.  The agricultural employer shall provide oral warnings to workers in a manner that the worker can understand. If a worker will be on the premises during the application, the warning shall be given before the application takes place. Otherwise, the warning shall be given at the beginning of the worker's first work period during which the application is taking place or the restricted-entry interval for the pesticide is in effect. The warning shall consist of:\n\n(1) The location and description of the treated area.\n\n(2) The time during which entry is restricted.\n\n(3) Instructions not to enter the treated area until the restricted-entry interval has expired."], ["40:40:26.0.1.1.19.2.19.7", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.122 Providing specific information about applications.", "EPA", "", "", "", "When workers are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the agricultural employer shall display, in accordance with this section, specific information about the pesticide.\n\n(a)  Location, accessibility, and legibility.  The information shall be displayed in the location specified for the pesticide safety poster in \u00a7 170.135(d) and shall be accessible and legible, as specified in \u00a7 170.135 (e) and (f).\n\n(b)  Timing.  (1) If warning signs are posted for the treated area before an application, the specific application information for that application shall be posted at the same time or earlier.\n\n(2) The information shall be posted before the application takes place, if workers will be on the establishment during application. Otherwise, the information shall be posted at the beginning of any worker's first work period.\n\n(3) The information shall continue to be displayed for at least 30 days after the end of the restricted-entry interval (or, if there is no restricted-entry interval, for at least 30 days after the end of the application) or at least until workers are no longer on the establishment, whichever is earlier.\n\n(c)  Required information.  The information shall include:\n\n(1) The location and description of the treated area.\n\n(2) The product name, EPA registration number, and active ingredient(s) of the pesticide.\n\n(3) The time and date the pesticide is to be applied.\n\n(4) The restricted-entry interval for the pesticide."], ["40:40:26.0.1.1.19.2.19.8", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.124 Notice of applications to handler employers.", "EPA", "", "", "", "Whenever handlers who are employed by a commercial pesticide handling establishment will be performing pesticide handling tasks on an agricultural establishment, the agricultural employer shall provide to the handler employer, or assure that the handler employer is aware of, the following information concerning any areas on the agricultural establishment that the handler may be in (or may walk within \n 1/4  mile of) and that may be treated with a pesticide or that may be under a restricted-entry interval while the handler will be on the agricultural establishment:\n\n(a) Specific location and description of any such areas; and\n\n(b) Restrictions on entering those areas."], ["40:40:26.0.1.1.19.2.19.9", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "B", "Subpart B\u2014Standard for Workers", "", "\u00a7 170.130 Pesticide safety training for workers.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992, as amended at 60 FR 21947, 21952, May 3, 1995; 73 FR 75598, Dec. 12, 2008]", "(a)  General requirement \u2014(1)  Agricultural employer assurance.  The agricultural employer shall assure that each worker, required by this section to be trained, has been trained according to this section during the last 5 years, counting from the end of the month in which the training was completed.\n\n(2)  Requirement for workers performing early-entry activities.  Before a worker enters a treated area on the agricultural establishment during a restricted-entry interval to perform early-entry activities permitted by \u00a7 170.112 and contacts anything that has been treated with the pesticide to which the restricted-entry interval applies, including but not limited to, soil, water, or surfaces of plants, the agricultural employer shall assure that the worker has been trained.\n\n(3)  Requirements for other agricultural workers \u2014(i)  Information before entry.  Except as provided in paragraph (a)(2) of this section, before a worker enters any areas on the agricultural establishment where, within the last 30 days a pesticide to which this subpart applies has been applied or the restricted-entry interval for such pesticide has been in effect, the agricultural employer shall assure that the worker has been provided the pesticide safety information specified in paragraph (c) of this section, in a manner that agricultural workers can understand, such as by providing written materials or oral communication or by other means. The agricultural employer must be able to verify compliance with this requirement.\n\n(ii)  Training before the 6th day of entry.  Except as provided in paragraph (a)(2) of this section, before the 6th day that a worker enters any areas on the agricultural establishment where, within the last 30 days a pesticide to which this subpart applies has been applied or a restricted-entry interval for such pesticide has been in effect, the agricultural employer shall assure that the worker has been trained.\n\n(b)  Exceptions.  The following persons need not be trained under this section:\n\n(1) A worker who is currently certified as an applicator of restricted-use pesticides under part 171 of this chapter.\n\n(2) A worker who satisfies the training requirements of part 171 of this chapter.\n\n(3) A worker who satisfies the handler training requirements of \u00a7 170.230(c).\n\n(4) A worker who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, provided that a requirement for such certification or licensing is pesticide safety training that includes all the information set out in \u00a7 170.230(c)(4).\n\n(c)  Pesticide safety information.  The pesticide safety information required by paragraph (a)(3)(i) shall be presented to workers in a manner that the workers can understand. At a minimum, the following information shall be provided:\n\n(1) Pesticides may be on or in plants, soil, irrigation water, or drifting from nearby applications.\n\n(2) Prevent pesticides from entering your body by:\n\n(i) Following directions and/or signs about keeping out of treated or restricted areas.\n\n(ii) Washing before eating, drinking, using chewing gum or tobacco, or using the toilet.\n\n(iii) Wearing work clothing that protects the body from pesticide residues.\n\n(iv) Washing/showering with soap and water, shampoo hair, and put on clean clothes after work.\n\n(v) Washing work clothes separately from other clothes before wearing them again.\n\n(vi) Washing immediately in the nearest clean water if pesticides are spilled or sprayed on the body. As soon as possible, shower, shampoo, and change into clean clothes.\n\n(3) Further training will be provided within 5 days.\n\n(d)  Training programs.  (1) General pesticide safety information shall be presented to workers either orally from written materials or audiovisually. The information must be presented in a manner that the workers can understand (such as through a translator) using nontechnical terms. The presenter also shall respond to workers' questions.\n\n(2) The person who conducts the training shall meet at least one of the following criteria:\n\n(i) Be currently certified as an applicator of restricted-use pesticides under part 171 of this chapter; or\n\n(ii) Be currently designated as a trainer of certified applicators or pesticide handlers by a State, Federal, or Tribal agency having jurisdiction; or\n\n(iii) Have completed a pesticide safety train-the-trainer program approved by a State, Federal, or Tribal agency having jurisdiction; or\n\n(iv) Satisfy the training requirements in part 171 of this chapter or in \u00a7 170.230(c).\n\n(3) Any person who issues an EPA-approved Worker Protection Standard worker training certificate must assure that the worker who receives the training certificate has been trained in accordance with paragraph (d)(4) of this section.\n\n(4) The training materials shall convey, at a minimum, the following information:\n\n(i) Where and in what form pesticides may be encountered during work activities.\n\n(ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.\n\n(iii) Routes through which pesticides can enter the body.\n\n(iv) Signs and symptoms of common types of pesticide poisoning.\n\n(v) Emergency first aid for pesticide injuries or poisonings.\n\n(vi) How to obtain emergency medical care.\n\n(vii) Routine and emergency decontamination procedures, including emergency eyeflushing techniques.\n\n(viii) Hazards from chemigation and drift.\n\n(ix) Hazards from pesticide residues on clothing.\n\n(x) Warnings about taking pesticides or pesticide containers home.\n\n(xi) Requirements of this subpart designed to reduce the risks of illness or injury resulting from workers' occupational exposure to pesticides, including application and entry restrictions, the design of the warning sign, posting of warning signs, oral warnings, the availability of specific information about applications, and the protection against retaliatory acts.\n\n(e)  Verification of training.  (1) Except as provided in paragraph (e)(2) of this section, if the agricultural employer assures that a worker possesses an EPA-approved Worker Protection Standard worker training certificate, then the requirements of paragraph (a) and (c) of this section will have been met.\n\n(2) If the agricultural employer is aware or has reason to know that an EPA-approved Worker Protection Standard worker training certificate has not been issued in accordance with this section, or has not been issued to the worker bearing the certificate, or the training was completed more than 5 years before the beginning of the current month, a worker's possession of that certificate does not meet the requirements of paragraph (a) of this section."], ["40:40:26.0.1.1.19.3.19.1", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "C", "Subpart C\u2014Standard for Pesticide Handlers", "", "\u00a7 170.202 Applicability of this subpart.", "EPA", "", "", "[60 FR 21952, May 3, 1995]", "Except as provided by \u00a7\u00a7 170.203 and 170.204, this subpart applies when any pesticide is handled for use on an agricultural establishment."], ["40:40:26.0.1.1.19.3.19.10", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "C", "Subpart C\u2014Standard for Pesticide Handlers", "", "\u00a7 170.235 Posted pesticide safety information.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992, as amended at 80 FR 67556, Nov. 2, 2015]", "(a)  Requirement.  When handlers (except those employed by a commercial pesticide handling establishment) are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the handler employer shall display, in accordance with this section, pesticide safety information.\n\n(b)  Pesticide safety poster.  A safety poster must be displayed that conveys, at a minimum, the pesticide safety concepts listed in paragraphs (b)(1)(i) through (vii) and (b)(2) of this section. Displays conforming to \u00a7 170.311(a)(3) meet the requirements of this paragraph.\n\n(c)  Emergency medical care information.  (1) The name, address, and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. Displays conforming to \u00a7 170.311(a)(3)(ix) meet the requirements of this paragraph.\n\n(2) The handler employer shall inform handlers promptly of any change to the information on emergency medical care facilities.\n\n(d)  Location.  (1) The information shall be displayed in a central location on the farm or in the nursery or greenhouse where it can be readily seen and read by handlers.\n\n(2) The information shall be displayed in a location in or near the forest in a place where it can be readily seen and read by handlers and where handlers are likely to congregate or pass by, such as at a decontamination site or an equipment storage site.\n\n(e)  Accessibility.  Handlers shall be informed of the location of the information and shall be allowed access to it.\n\n(f)  Legibility.  The information shall remain legible during the time it is posted."], ["40:40:26.0.1.1.19.3.19.11", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "C", "Subpart C\u2014Standard for Pesticide Handlers", "", "\u00a7 170.240 Personal protective equipment.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992, as amended at 69 FR 53346, Sept. 1, 2004]", "(a)  Requirement.  Any person who performs tasks as a pesticide handler shall use the clothing and personal protective equipment specified on the labeling for use of the product.\n\n(b)  Definition.  (1) Personal protective equipment (PPE) means devices and apparel that are worn to protect the body from contact with pesticides or pesticide residues, including, but not limited to, coveralls, chemical-resistant suits, chemical-resistant gloves, chemical-resistant footwear, respiratory protection devices, chemical-resistant aprons, chemical-resistant headgear, and protective eyewear.\n\n(2) Long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes, socks, and other items of work clothing are not considered personal protective equipment for the purposes of this section and are not subject to the requirements of this section, although pesticide labeling may require that such work clothing be worn during some activities.\n\n(c)  Provision.  When personal protective equipment is specified by the labeling of any pesticide for any handling activity, the handler employer shall provide the appropriate personal protective equipment in clean and operating condition to the handler.\n\n(1) When \u201cchemical-resistant\u201d personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of the pesticide being used through the material during use.\n\n(2) When \u201cwaterproof\u201d personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of water or aqueous solutions through the material during use.\n\n(3) When a \u201cchemical-resistant suit\u201d is specified by the product labeling, it shall be a loose-fitting, one- or two-piece chemical-resistant garment that covers, at a minimum, the entire body except head, hands, and feet.\n\n(4) When \u201ccoveralls\u201d are specified by the product labeling, they shall be a loose-fitting, one- or two-piece garment, such as a cotton or cotton and polyester coverall, that covers, at a minimum, the entire body except head, hands, and feet. The pesticide product labeling may specify that the coveralls be worn over another layer of clothing.\n\n(5)(i) Gloves shall be of the type specified on the pesticide product labeling. Gloves made of leather, cotton, or other absorbent materials may not be worn while mixing, loading, applying, or otherwise handling pesticides, unless gloves made of these materials are listed as acceptable for such use on the product labeling.\n\n(ii) Separable glove liners may be worn beneath chemical-resistant gloves, unless the pesticide product labeling specifically prohibits their use. Separable glove liners are defined as separate glove-like hand coverings, made of lightweight material, with or without fingers. Work gloves made from lightweight cotton or poly-type material are considered to be glove liners if worn beneath chemical-resistant gloves. Separable glove liners may not extend outside the chemical-resistant gloves under which they are worn. Chemical-resistant gloves with non-separable absorbent lining materials are prohibited.\n\n(iii) If used, separable glove liners must be discarded immediately after a total of no more than 10 hours of use or within 24 hours of when first put on, whichever comes first. The liners must be replaced immediately if directly contacted by pesticide. Used glove liners shall not be reused. Contaminated liners must be disposed of in accordance with any Federal, State, or local regulations.\n\n(6) When \u201cchemical-resistant footwear\u201d is specified by the product labeling, one of the following types of footwear must be worn:\n\n(i) Chemical-resistant shoes.\n\n(ii) Chemical-resistant boots.\n\n(iii) Chemical-resistant shoe coverings worn over shoes or boots.\n\n(7) When \u201cprotective eyewear\u201d is specified by the product labeling, one of the following types of eyewear must be worn:\n\n(i) Goggles.\n\n(ii) Face shield.\n\n(iii) Safety glasses with front, brow, and temple protection.\n\n(iv) Full-face respirator.\n\n(8) When a \u201cchemical-resistant apron\u201d is specified by the product labeling, an apron that covers the front of the body from mid-chest to the knees shall be worn.\n\n(9) When a respirator is specified by the product labeling, it shall be appropriate for the pesticide product used and for the activity to be performed. The handler employer shall assure that the respirator fits correctly.\n\n(10) When \u201cchemical-resistant headgear\u201d is specified by the product labeling, it shall be either a chemical resistant hood or a chemical-resistant hat with a wide brim.\n\n(d)  Exceptions to personal protective equipment specified on product labeling \u2014(1)  Body protection.  (i) A chemical-resistant suit may be substituted for \u201ccoveralls,\u201d and any requirement for an additional layer of clothing beneath is waived.\n\n(ii) A chemical-resistant suit may be substituted for \u201ccoveralls\u201d and a chemical-resistant apron.\n\n(2)  Boots.  If chemical-resistant footwear with sufficient durability and a tread appropriate for wear in rough terrain is not obtainable, then leather boots may be worn in such terrain.\n\n(3)  Gloves.  If chemical-resistant gloves with sufficient durability and suppleness are not obtainable, then during handling activities with roses or other plants with sharp thorns, leather gloves may be worn over chemical-resistant glove liners. However, once leather gloves are worn for this use, thereafter they shall be worn only with chemical-resistant liners and they shall not be worn for any other use.\n\n(4)  Closed systems.  If handling tasks are performed using properly functioning systems that enclose the pesticide to prevent it from contacting handlers or other persons, and if such systems are used and are maintained in accordance with that manufacturer's written operating instructions, exceptions to labeling-specified personal protective equipment for the handling activity are permitted as provided in paragraphs (d)(4)(i) and (ii) of this section.\n\n(i) Persons using a closed system to mix or load pesticides with a signal word of DANGER or WARNING may substitute a long-sleeved shirt, long pants, shoes, socks, chemical-resistant apron, and any protective gloves specified on the labeling for handlers for the labeling-specified personal protective equipment.\n\n(ii) Persons using a closed system to mix or load pesticides other than those in paragraph (d)(4)(i) of this section or to perform other handling tasks may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment.\n\n(iii) Persons using a closed system that operates under pressure shall wear protective eyewear.\n\n(iv) Persons using a closed system shall have all labeling-specified personal protective equipment immediately available for use in an emergency.\n\n(5)  Enclosed cabs.  If handling tasks are performed from inside a cab that has a nonporous barrier which totally surrounds the occupants of the cab and prevents contact with pesticides outside of the cab, exceptions to personal protective equipment specified on the product labeling for that handling activity are permitted as provided in paragraphs (d)(5) (i) through (iv) of this section.\n\n(i) Persons occupying an enclosed cab may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If a respiratory protection device is specified on the pesticide product labeling for the handling activity, it must be worn.\n\n(ii) Persons occupying an enclosed cab that has a properly functioning ventilation system which is used and maintained in accordance with the manufacturer's written operating instructions and which is declared in writing by the manufacturer or by a governmental agency to provide respiratory protection equivalent to or greater than a dust/mist filtering respirator may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If a respiratory protection device other than a dust/mist-filtering respirator is specified on the pesticide product labeling, it must be worn.\n\n(iii) Persons occupying an enclosed cab that has a properly functioning ventilation system which is used and maintained in accordance with the manufacturer's written operating instructions and which is declared in writing by the manufacturer or by a governmental agency to provide respiratory protection equivalent to or greater than the vapor- or gas-removing respirator specified on pesticide product labeling may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If an air-supplying respirator or a self-contained breathing apparatus (SCBA) is specified on the pesticide product labeling, it must be worn.\n\n(iv) Persons occupying an enclosed cab shall have all labeling-specified personal protective equipment immediately available and stored in a chemical-resistant container, such as a plastic bag. They shall wear such personal protective equipment if it is necessary to exit the cab and contact pesticide-treated surfaces in the treated area. Once personal protective equipment is worn in the treated area, it must be removed before reentering the cab.\n\n(6)  Aerial application \u2014(i)  Use of gloves.  The wearing of chemical-resistant gloves when entering or leaving an aircraft used to apply pesticides is optional, unless such gloves are required on the pesticide product labeling. If gloves are brought into the cockpit of an aircraft that has been used to apply pesticides, the gloves shall be kept in an enclosed container to prevent contamination of the inside of the cockpit.\n\n(ii)  Open cockpit.  Persons occupying an open cockpit shall use the personal protective equipment specified in the product labeling for use during application, except that chemical-resistant footwear need not be worn. A helmet may be substituted for chemical-resistant headgear. A visor may be substituted for protective eyewear.\n\n(iii)  Enclosed cockpit.  Persons occupying an enclosed cockpit may substitute a long-sleeved shirt, long pants, shoes, and socks for labeling-specified personal protective equipment.\n\n(7)  Crop advisors.  Crop advisors entering treated areas while a restricted-entry interval is in effect may wear the personal protective equipment specified on the pesticide labeling for early-entry activities instead of the personal protective equipment specified on the pesticide labeling for handling activities, provided:\n\n(i) Application has been completed for at least 4 hours.\n\n(ii) Any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by \u00a7 170.110(c)(3) or in the labeling have been met.\n\n(e)  Use of personal protective equipment.  (1) The handler employer shall assure that personal protective equipment is used correctly for its intended purpose and is used according to the manufacturer's instructions.\n\n(2) The handler employer shall assure that, before each day of use, all personal protective equipment is inspected for leaks, holes, tears, or worn places, and any damaged equipment is repaired or discarded.\n\n(f)  Cleaning and maintenance.  (1) The handler employer shall assure that all personal protective equipment is cleaned according to the manufacturer's instructions or pesticide product labeling instructions before each day of reuse. In the absence of any such instructions, it shall be washed thoroughly in detergent and hot water.\n\n(2) If any personal protective equipment cannot be cleaned properly, the handler employer shall dispose of the personal protective equipment in accordance with any applicable Federal, State, and local regulations. Coveralls or other absorbent materials that have been drenched or heavily contaminated with an undiluted pesticide that has the signal word DANGER or WARNING on the label shall be not be reused.\n\n(3) The handler employer shall assure that contaminated personal protective equipment is kept separately and washed separately from any other clothing or laundry.\n\n(4) The handler employer shall assure that all clean personal protective equipment shall be either dried thoroughly before being stored or shall be put in a well ventilated place to dry.\n\n(5) The handler employer shall assure that all personal protective equipment is stored separately from personal clothing and apart from pesticide-contaminated areas.\n\n(6) The handler employer shall assure that when dust/mist filtering respirators are used, the filters shall be replaced:\n\n(i) When breathing resistance becomes excessive.\n\n(ii) When the filter element has physical damage or tears.\n\n(iii) According to manufacturer's recommendations or pesticide product labeling, whichever is more frequent.\n\n(iv) In the absence of any other instructions or indications of service life, at the end of each day's work period.\n\n(7) The handler employer shall assure that when gas- or vapor-removing respirators are used, the gas- or vapor-removing canisters or cartridges shall be replaced:\n\n(i) At the first indication of odor, taste, or irritation.\n\n(ii) According to manufacturer's recommendations or pesticide product labeling, whichever is more frequent.\n\n(iii) In the absence of any other instructions or indications of service life, at the end of each day's work period.\n\n(8) The handler employer shall inform any person who cleans or launders personal protective equipment:\n\n(i) That such equipment may be contaminated with pesticides.\n\n(ii) Of the potentially harmful effects of exposure to pesticides.\n\n(iii) Of the correct way(s) to clean personal protective equipment and to protect themselves when handling such equipment.\n\n(9) The handler employer shall assure that handlers have a clean place(s) away from pesticide storage and pesticide use areas where they may:\n\n(i) Store personal clothing not in use.\n\n(ii) Put on personal protective equipment at the start of any exposure period.\n\n(iii) Remove personal protective equipment at the end of any exposure period.\n\n(10) The handler employer shall not allow or direct any handler to wear home or to take home personal protective equipment contaminated with pesticides.\n\n(g)  Heat-related illness.  When the use of personal protective equipment is specified by the labeling of any pesticide for the handling activity, the handler employer shall assure that no handler is allowed or directed to perform the handling activity unless appropriate measures are taken, if necessary, to prevent heat-related illness."], ["40:40:26.0.1.1.19.3.19.12", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "C", "Subpart C\u2014Standard for Pesticide Handlers", "", "\u00a7 170.250 Decontamination.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33213, June 26, 1996]", "(a)  Requirement.  During any handling activity, the handler employer shall provide for handlers, in accordance with this section, decontamination supplies for washing off pesticides and pesticide residues.\n\n(b)  General conditions.  (1) The handler employer shall provide handlers with enough water for routine washing, for emergency eyeflushing, and for washing the entire body in case of an emergency. At all times when the water is available to handlers, the handler employer shall assure that it is of a quality and temperature that will not cause illness or injury when it contacts the skin or eyes or if it is swallowed.\n\n(2) When water stored in a tank is to be used for mixing pesticides, it shall not be used for decontamination or eye flushing, unless the tank is equipped with properly functioning valves or other mechanisms that prevent movement of pesticides into the tank.\n\n(3) The handler employer shall provide soap and single-use towels in quantities sufficient to meet handlers' needs.\n\n(4) The handler employer shall provide one clean change of clothing, such as coveralls, for use in an emergency.\n\n(c)  Location.  The decontamination supplies shall be located together and be reasonably accessible to and not more than \n 1/4  mile from each handler during the handling activity.\n\n(1)  Exception for mixing sites.  For mixing activities, decontamination supplies shall be at the mixing site.\n\n(2)  Exception for pilots.  Decontamination supplies for a pilot who is applying pesticides aerially shall be in the airplaine or at the aircraft loading site.\n\n(3)  Exception for handling pesticides in remote areas.  When handling activities are performed more than \n 1/4  mile from the nearest place of vehicular access:\n\n(i) The soap, single-use towels, clean change of clothing, and water may be at the nearest place of vehicular access.\n\n(ii) The handler employer may permit handlers to use clean water from springs, streams, lakes, or other sources for decontamination at the remote work site, if such water is more accessible than the water located at the nearest place of vehicular access.\n\n(4)  Decontamination supplies in treated areas.  The decontamination supplies shall not be in an area being treated with pesticides or in an area under a restricted-entry interval, unless:\n\n(i) The decontamination supplies are in the area where the handler is performing handling activities;\n\n(ii) The soap, single-use towels, and clean change of clothing are in enclosed containers; and\n\n(iii) The water is running tap water or is enclosed in a container.\n\n(d)  Emergency eyeflushing.  To provide for emergency eyeflushing, the handler employer shall assure that at least 1 pint of water is immediately available to each handler who is performing tasks for which the pesticide labeling requires protective eyewear. The eyeflush water shall be carried by the handler, or shall be on the vehicle or aircraft the handler is using, or shall be otherwise immediately accessible.\n\n(e)  Decontamination after handling activities.  At the end of any exposure period, the handler employer shall provide at the site where handlers remove personal protective equipment, soap, clean towels, and a sufficient amount of water so that the handlers may wash thoroughly."], ["40:40:26.0.1.1.19.3.19.13", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "C", "Subpart C\u2014Standard for Pesticide Handlers", "", "\u00a7 170.260 Emergency assistance.", "EPA", "", "", "", "If there is reason to believe that a person who is or has been employed by an agricultural establishment or commercial pesticide handling establishment to perform pesticide handling tasks has been poisoned or injured by exposure to pesticides as a result of that employment, including, but not limited to, exposures from handling tasks or from application, splash, spill, drift, or pesticide residues, the handler employer shall:\n\n(a) Make available to that person prompt transportation from the place of employment or the handling site to an appropriate emergency medical facility.\n\n(b) Provide to that person or to treating medical personnel, promptly upon request, any obtainable information on:\n\n(1) Product name, EPA registration number, and active ingredients of any product to which that person might have been exposed.\n\n(2) Antidote, first aid, and other medical information from the product labeling.\n\n(3) The circumstances of handling of the pesticide.\n\n(4) The circumstances of exposure of that person to the pesticide."], ["40:40:26.0.1.1.19.3.19.2", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "C", "Subpart C\u2014Standard for Pesticide Handlers", "", "\u00a7 170.203 Exceptions.", "EPA", "", "", "[57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR 21952, May 3, 1995]", "Exceptions.  This subpart does not apply when any pesticide is handled for use on an agricultural establishment in the following circumstances:\n\n(a) For mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored by governmental entities.\n\n(b) On livestock or other animals, or in or about animal premises.\n\n(c) On plants grown for other than commercial or research purposes, which may include plants in habitations, home fruit and vegetable gardens, and home greenhouses.\n\n(d) On plants that are in ornamental gardens, parks, and public or private lawns and grounds and that are intended only for aesthetic purposes or climatic modification.\n\n(e) In a manner not directly related to the production of agricultural plants, including, but not limited to, structural pest control, control of vegetation along rights-of-way and in other noncrop areas, and pasture and rangeland use.\n\n(f) For control of vertebrate pests.\n\n(g) As attractants or repellents in traps.\n\n(h) On the harvested portions of agricultural plants or on harvested timber.\n\n(i) For research uses of unregistered pesticides."], ["40:40:26.0.1.1.19.3.19.3", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "C", "Subpart C\u2014Standard for Pesticide Handlers", "", "\u00a7 170.204 Exemptions.", "EPA", "", "", "[60 FR 21953, May 3, 1995, as amended at 73 FR 75599, Dec. 12, 2008]", "The handlers listed in this section are exempt from the specified provisions of this subpart.\n\n(a)  Owners of agricultural establishments.  (1) The owner of an agricultural establishment is not required to provide to himself or members of his immediate family who are performing handling tasks on their own agricultural establishment the protections of:\n\n(i) Section 170.210(b) and (c).\n\n(ii) Section 170.222.\n\n(iii) Section 170.230.\n\n(iv) Section 170.232.\n\n(v) Section 170.234.\n\n(vi) Section 170.235.\n\n(vii) Section 170.240(e) through (g).\n\n(viii) Section 170.250.\n\n(ix) Section 170.260.\n\n(2) The owner of the agricultural establishment must provide the protections listed in paragraphs (a)(1) (i) through (ix) of this section to other handlers and other persons who are not members of his immediate family.\n\n(b)  Crop advisors.  (1) Provided that the conditions of paragraph (b)(2) of this section are met, a person who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, and persons performing crop advising tasks under such qualified crop advisor's direct supervision, are exempt from the provisions of:\n\n(i) Section 170.232.\n\n(ii) Section 170.240.\n\n(iii) Section 170.250.\n\n(iv) Section 170.260.\n\nA person is under the direct supervision of a crop advisor when the crop advisor exerts the supervisory controls set out in paragraphs (b)(2)(iv) and (v) of this section. Direct supervision does not require that the crop advisor be physically present at all times, but the crop advisor must be readily accessible to the employees at all times.\n\n(2)  Conditions of exemption.  (i) The certification or licensing program requires pesticide safety training that includes, at least, all the information in \u00a7 170.230(c)(4).\n\n(ii) No entry into the treated area occurs until after application ends.\n\n(iii) Applies only when performing crop advising tasks in the treated area.\n\n(iv) The crop advisor must make specific determinations regarding the appropriate PPE, appropriate decontamination supplies, and how to conduct the tasks safely. The crop advisor must convey this information to each person under his direct supervision in a language that the person understands.\n\n(v) Before entering a treated area, the certified or licensed crop advisor must inform, through an established practice of communication, each person under his direct supervision of the pesticide products and active ingredient(s) applied, method of application, time of application, the restricted entry interval, which tasks to undertake, and how to contact the crop advisor."], ["40:40:26.0.1.1.19.3.19.4", 40, "Protection of Environment", "I", "E", "170", "PART 170\u2014WORKER PROTECTION STANDARD", "C", "Subpart C\u2014Standard for Pesticide Handlers", "", "\u00a7 170.210 Restrictions during applications.", "EPA", "", "", "", "(a)  Contact with workers and other persons.  The handler employer and the handler shall assure that no pesticide is applied so as to contact, either directly or through drift, any worker or other person, other than an appropriately trained and equipped handler.\n\n(b)  Handlers handling highly toxic pesticides.  The handler employer shall assure that any handler who is performing any handling activity with a product that has the skull and crossbones symbol on the front panel of the label is monitored visually or by voice communication at least every 2 hours.\n\n(c)  Fumigant applications in greenhouses.  The handler employer shall assure:\n\n(1) That any handler who handles a fumigant in a greenhouse, including a handler who enters the greenhouse before the acceptable inhalation exposure level or ventilation criteria have been met to monitor air levels or to initiate ventilation, maintains continuous visual or voice contact with another handler.\n\n(2) That the other handler has immediate access to the personal protective equipment required by the fumigant labeling for handlers in the event entry into the fumigated greenhouse becomes necessary for rescue."]], "truncated": false, "filtered_table_rows_count": 188, "expanded_columns": [], "expandable_columns": [], "columns": ["section_id", "title_number", "title_name", "chapter", "subchapter", "part_number", "part_name", "subpart", "subpart_name", "section_number", "section_heading", "agency", "authority", "source_citation", "amendment_citations", "full_text"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select 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