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| 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 |
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| 10:10:2.0.1.1.24.0.142.1 | 10 | Energy | I | 170 | PART 170—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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 § 170.11, the regulations in this part apply to a person who is: (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; (b) An applicant for or holder of a specific source material license issued pursuant to part 40 of this chapter; (c) An applicant for or holder of a specific special nuclear material license issued pursuant to part 70 of this chapter; (d) An applicant for or holder of specific approval of spent fuel casks and shipping containers issued pursuant to part 71 of this chapter; (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; (f) An applicant for or holder of a specific approval of sealed sources and devices containing byproduct material, source material, or special nuclear material; (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; (h) Required to have examinations and tests performed to qualify or requalify individuals as part 55 reactor operators; (i) Required to have routine and non-routine safety and safeguards inspections of activities licensed pursuant to the requirements of this chapter; (j) [Reserved] (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; (l) Applying for or already has applied for review of a standardized spent fuel facility design; or (m) Applying for or has applied for since March 23, 1978, review of an item under the category of spec… | ||||||
| 10:10:2.0.1.1.24.0.142.3 | 10 | Energy | I | 170 | PART 170—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 170.3 Definitions. | NRC | [33 FR 10924, Aug. 1, 1968] | As used in this part: Act means the Atomic Energy Act of 1954 (68 Stat. 919) including any amendments thereto; Advanced nuclear reactor applicant means an entity that has submitted to the Commission a “qualifying application,” as defined in this part. Advanced nuclear reactor pre-applicant means an entity that has submitted to the Commission a licensing project plan for the purposes of submitting a future “qualifying application,” as defined in this part. Agency 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. Agreement 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. “Nonagreement State” means any other State. Application means any request filed with the Commission for a permit, license, approval, exemption, certificate, other permission, or for any other service. Byproduct material means— (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; (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 a… | ||||||
| 10:10:2.0.1.1.24.0.142.4 | 10 | Energy | I | 170 | PART 170—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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: (1) A special project that is a request/report submitted to the NRC— (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; (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 (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. (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. (3) [Reserved] (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: (i) Human use; (ii) Remunerated services to other persons; (iii) Distribution of byproduct material, source material, or special nuclear material or products contain… | ||||||
| 10:10:2.0.1.1.24.0.142.8 | 10 | Energy | I | 170 | PART 170—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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. (b) Licensing fees. (1) Licensing fees will be assessed to recover full costs for— (i) The review of applications for new licenses and approvals; (ii) The review of applications for amendments to and renewal of existing licenses or approvals; (iii) Preapplication consultations and reviews; and (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). (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. (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. (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. (c) Inspection fees. (1)… | ||||||
| 10:10:2.0.1.1.24.0.142.9 | 10 | Energy | I | 170 | PART 170—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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 §§ 170.21 and 170.31 will be calculated using the professional staff-hour rate of $318 per hour. (b) For advanced nuclear reactor applicants: (1) Prior to October 1, 2025, fees under § 170.21 will be calculated using the professional staff-hour rate of $318 per hour. (2) Effective on October 1, 2025, fees under § 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. (c) For advanced nuclear reactor pre-applicants: (1) Prior to October 1, 2025, fees under § 170.21 will be calculated using the professional staff-hour rate of $318 per hour. (2) Effective on October 1, 2025, fees under § 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. (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—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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: Table 1 to § 170.21—Schedule of Facility Fees [See footnotes at end of table] 1 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. 2 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 “full cost fees” described in the table for advanced nuclear reactor applicants and advanced nuclear reactor pre-applicants will be assessed consistent with § 170.20(b) and (c). 3 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 t… | ||||||
| 10:10:2.0.1.1.24.0.143.11 | 10 | Energy | I | 170 | PART 170—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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. Table 1 to § 170.31—Schedule of Materials Fees [See footnotes at end of table] 1 Types of fees —Separate 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: (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. (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. (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. (2) Licensing fees. Fees for reviews of applications for new licenses, renewals, and amendments to existing li… | ||||||
| 10:10:2.0.1.1.24.0.143.12 | 10 | Energy | I | 170 | PART 170—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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 § 170.31. | ||||||
| 10:10:2.0.1.1.24.0.144.13 | 10 | Energy | I | 170 | PART 170—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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—FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED | § 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—ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES | A | Subpart A—General | § 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—ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES | A | Subpart A—General | § 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— Air 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. Air 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. Air 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. Air traffic controller means a person authorized to provide air traffic service, specifically en route and terminal control personnel. Aircraft 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. (1) Local operations mean operations performed by aircraft which: (i) Operate in the local traffic pattern or within sight of the airport; (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 (iii) Execute simulated instrument approaches or low passes at the airport. (2) Itinerant operations mean all aircraft operations other than local operations. Airport 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. Alternate airport means an airport, specified on a flight plan, to which a flight may proceed when a landing at the point o… | |||
| 14:14:3.0.1.4.32.2.3.1 | 14 | Aeronautics and Space | I | J | 170 | PART 170—ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES | B | Subpart B—Airport Traffic Control Towers | § 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—ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES | B | Subpart B—Airport Traffic Control Towers | § 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: (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; (2) The airport must be recognized by and contained within the National Plan of Integrated Airport Systems; (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; (4) The FAA must be furnished appropriate land without cost for construction of the ATCT; and (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.) (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 § 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). BPV/CPV≥1.0 (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—ESTABLISHMENT AND DISCONTINUANCE CRITERIA FOR AIR TRAFFIC CONTROL SERVICES AND NAVIGATIONAL FACILITIES | B | Subpart B—Airport Traffic Control Towers | § 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): BPV/CMPV<1.0 | ||||
| 17:17:2.0.1.1.30.1.1.1 | 17 | Commodity and Securities Exchanges | I | 170 | PART 170—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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 § 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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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: (a) Take vigorous action against those who engage in activities in violation of association rules; (b) Conduct proceedings in a manner consistent with the fundamental elements of due process; and (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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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—REGISTERED FUTURES ASSOCIATIONS | A | Subpart A—Standards Governing Commission Review of Applications for Registration as a Futures Association Under Section 17 of the Act | § 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—REGISTERED FUTURES ASSOCIATIONS | B | Subpart B—Registration Statement of Futures Associations to be Submitted to the Commission | § 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. (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. (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—REGISTERED FUTURES ASSOCIATIONS | B | Subpart B—Registration Statement of Futures Associations to be Submitted to the Commission | § 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 §§ 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—REGISTERED FUTURES ASSOCIATIONS | C | Subpart C—Membership in a Registered Futures Association | § 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. (b) The requirements of paragraph (a) of this section shall not apply to a futures commission merchant registered in accordance with § 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—REGISTERED FUTURES ASSOCIATIONS | C | Subpart C—Membership in a Registered Futures Association | § 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—REGISTERED FUTURES ASSOCIATIONS | C | Subpart C—Membership in a Registered Futures Association | § 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 § 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—FOOD ADDITIVES | A | Subpart A—General Provisions | § 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: (a) Secretary means the Secretary of Health and Human Services. (b) Department means the Department of Health and Human Services. (c) Commissioner means the Commissioner of Food and Drugs. (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). (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. “Affecting the characteristics of food” 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. (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 § 170.39, and food contact substances used in accordance with a notification submitted under section 409(h) of the act that is effective. (3) A food contact substance is any substance that is intended for u… | |||
| 21:21:3.0.1.1.1.1.1.2 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | A | Subpart A—General Provisions | § 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: “A food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health”. (b) Since enactment of the Food Additives Amendment, the Food and Drug Administration has advised such inquirers that an article: (1) Is a food additive within the meaning of section 201(s) of the act; or (2) Is generally recognized as safe (GRAS); or (3) Has prior sanction or approval under that amendment; or (4) Is not a food additive under the conditions of intended use. (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. (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. (e) The prior op… | |||
| 21:21:3.0.1.1.1.1.1.3 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | A | Subpart A—General Provisions | § 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. (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. (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 § 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—FOOD ADDITIVES | A | Subpart A—General Provisions | § 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. (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—FOOD ADDITIVES | A | Subpart A—General Provisions | § 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: (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: Caution. Contains a new food additive for investigational use only in laboratory research animals or for tests in vitro. Not for use in humans. Caution. Contains a new food additive for investigational use only in laboratory research animals or for tests in vitro. Not for use in humans. (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 § 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: Caution. Contains a new food additive for use only in investigational animals. Not for use in humans. 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. Caution. Contains a new food additive for use only in investigational animals. Not for use in humans. 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. (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—FOOD ADDITIVES | A | Subpart A—General Provisions | § 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. (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. (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. (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: (1) Determine the quantity of each residue present. (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. (3) Add the percentages so obtained for all residues present. (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—FOOD ADDITIVES | A | Subpart A—General Provisions | § 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—FOOD ADDITIVES | B | Subpart B—Food Additive Safety | § 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. (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—FOOD ADDITIVES | B | Subpart B—Food Additive Safety | § 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 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—FOOD ADDITIVES | B | Subpart B—Food Additive Safety | § 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 § 170.3(i)). (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. (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. (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 primar… | |||
| 21:21:3.0.1.1.1.2.1.4 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | B | Subpart B—Food Additive Safety | § 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. (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. (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. (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 § 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. (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 § 170.38. | |||
| 21:21:3.0.1.1.1.2.1.5 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | B | Subpart B—Food Additive Safety | § 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 § 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. (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 § 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. (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. (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. (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: (1) It may promulgate a food additive regulation governing use of the additive. (2) It may promulgate an inter… | |||
| 21:21:3.0.1.1.1.2.1.6 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | B | Subpart B—Food Additive Safety | § 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: (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.); (2) The substance presents no other health or safety concerns because: (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 (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; (3) The substance has no technical effect in or on the food to which it migrates; and (4) The substance use has no significant adverse impact on… | |||
| 21:21:3.0.1.1.1.3.1.1 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | C | Subpart C—Specific Administrative Rulings and Decisions | § 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 § 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—FOOD ADDITIVES | C | Subpart C—Specific Administrative Rulings and Decisions | § 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: (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. (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. Therefore, 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. (b) The Commissioner of Food and Drugs concludes that by May 8, 1971, manufacturers: (1) Shall reformulate food products for human use to eliminate added glycine and its salts; or (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. (c) The status of glycine as generally recognized as safe for use in animal feed, as prescribed in § 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—FOOD ADDITIVES | C | Subpart C—Specific Administrative Rulings and Decisions | § 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 §§ 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. (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 §§ 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—FOOD ADDITIVES | D | Subpart D—Premarket Notifications | § 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. (1) An FCN must contain all of the information described in § 170.101. (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. (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. (b) FDA may choose not to accept an FCN for either of the following: (1) A use of a food contact substance that is the subject of a regulation in parts 173 through 189 of this chapter; or (2) A use of a food contact substance that is the subject of an exemption under the threshold of regulation process described in § 170.39. (c) A petition must be submitted under § 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. (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 (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. (d) A manufacturer or supplier for which a noti… | ||||
| 21:21:3.0.1.1.1.4.1.2 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | D | Subpart D—Premarket Notifications | § 170.101 Information in a premarket notification for a food contact substance (FCN). | FDA | An FCN must contain the following: (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: (1) Discuss all information and data submitted in the notification; and (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. (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. (c) A good laboratory practice statement for each nonclinical laboratory study, as defined under § 58.3(d) of this chapter, that is submitted as part of the FCN, in the form of either: (1) A signed statement that the study was conducted in compliance with the good laboratory practice regulations under part 58 of this chapter; or (2) A brief signed statement listing the reason(s) that the study was not conducted in compliance with part 58 of this chapter. (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. (d) Information to address FDA's responsibility under the National Environmental Policy Act, in the form of either: (1) A claim of categorical exclusion under § 25.30 or § 25.32 of this chapter; or (2) An environmental assessment complying with § 25.40 of this chapter. (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—FOOD ADDITIVES | D | Subpart D—Premarket Notifications | § 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. (b) FDA will not disclose publicly the information in an FCN that is withdrawn prior to the completion of FDA's review. (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. (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. (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 § 170.103; and on the date of publication in the Federal Register of an FDA determination that an FCN is no longer effective. (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. (2) A protocol for a test or study, unless it is exempt from disclosure under § 20.61 of this chapter. (3) A list of all ingredients contained in a food contact substance, excluding information that is exempt from disclosure under § 20.61 of this chapter. Where applicable, an ingredient list will be identified as incomplete. (4) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is exempt f… | |||
| 21:21:3.0.1.1.1.4.1.4 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | D | Subpart D—Premarket Notifications | § 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—FOOD ADDITIVES | D | Subpart D—Premarket Notifications | § 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. (b) If an FCN is complete when received, the 120-day review period begins on the date FDA receives the FCN. (1) If any element required under § 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. (2) If FDA accepts an FCN, then FDA will acknowledge in writing its receipt of that FCN. (c) Objection to an FCN: (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. (2) If FDA objects to an FCN within the 120-day period for FDA review, the FCN will not become effective. (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. (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—FOOD ADDITIVES | D | Subpart D—Premarket Notifications | § 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: (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. (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. (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. (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. (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 f… | |||
| 21:21:3.0.1.1.1.4.1.7 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | D | Subpart D—Premarket Notifications | § 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. (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. (c) An NFCSF must contain the following: (1) A completed and signed FDA Form No. 3479; and (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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 170.203 Definitions. | FDA | The definitions and interpretations of terms in § 170.3 apply to such terms when used in this subpart. The following definitions also apply: Amendment means any data and information that you submit regarding a filed GRAS notice before we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3). GRAS means generally recognized as safe. GRAS 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 § 170.30. Notified substance means the substance that is the subject of your GRAS notice. Notifier 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. Qualified 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. Supplement means any data and information that you submit regarding a filed GRAS notice after we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3). We, our, and us refer to the United States Food and Drug Administration (FDA). You 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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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: (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; (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 § 170.255; (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; (c) You must either: (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 (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; (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 (e) For non-public, safety-related data and information considered in reaching a conclusion of GRAS status, you must explain how there could … | ||||
| 21:21:3.0.1.1.1.5.1.12 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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 § 170.250(a)(1). (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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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 § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3). (b) At any time before we respond to your GRAS notice in accordance with § 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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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. (2) If we file your submission as a GRAS notice, we will send you a letter that informs you of the date of filing. (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. (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. (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. (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. (3) If you ask us to cease to evaluate your GRAS notice in accordance with § 170.260(b), we will send you a letter informing you of our decision regarding your request. (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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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: (a) When applicable, you must include in your GRAS notice a statement as to whether you: (1) Authorize us to send any trade secrets to FSIS; or (2) Ask us to exclude any trade secrets from the copy of the GRAS notice that we will send to FSIS. (b)(1) We will forward a copy of a GRAS notice or relevant portions thereof to FSIS; (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 (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. (d) As appropriate, we will inform you of the advice we receive from FSIS in the letter we send you in accordance with § 170.265(b)(1). | ||||
| 21:21:3.0.1.1.1.5.1.16 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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: (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 (2) Available for public disclosure in accordance with part 20 of this chapter as of the date that we receive your GRAS notice. (b) We will make the following readily accessible to the public: (1) A list of filed GRAS notices, including the information described in § 170.225(c)(2) through (c)(5); (2) The text of any letter that we issue under § 170.265(b)(1) or (c); and (3) The text of any letter that we issue under § 170.265(b)(3) if we grant your request that we cease to evaluate your notice. (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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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 § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3). | ||||
| 21:21:3.0.1.1.1.5.1.18 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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. (a) On October 17, 2016, we will close the docket for any GRAS affirmation petition that is still pending as of October 17, 2016. (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 § 170.215. | ||||
| 21:21:3.0.1.1.1.5.1.2 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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. (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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 170.220 General requirements applicable to a GRAS notice. | FDA | (a) A GRAS notice has seven parts as required by §§ 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. (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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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. (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. (c) In Part 1 of your GRAS notice, you must: (1) Inform us that you are submitting a GRAS notice in accordance with this subpart; (2) Provide the name and address of your organization; (3) Provide the name of the notified substance, using an appropriately descriptive term; (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; (5) Inform us of the statutory basis for your conclusion of GRAS status ( i.e., through scientific procedures in accordance with § 170.30(a) and (b) or through experience based on common use in food in accordance with § 170.30(a) and (c)); (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; (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: (i) Agree to make the data and information available to us; and (ii) Agree to both of the following procedures for making the data and information available to us: (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 (B) Upon our request, you will provide us with a complete copy of the data an… | ||||
| 21:21:3.0.1.1.1.5.1.7 | 21 | Food and Drugs | I | B | 170 | PART 170—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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: (a) Scientific data and information that identifies the notified substance. (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. (2) When the source of a notified substance is a biological material, you must include data and information sufficient to identify: (i) The taxonomic source ( e.g., genus, species) including, as applicable, data and information at the sub-species level ( e.g., variety, strain); (ii) The part of any plant or animal used as the source; and (iii) Any known toxicants that could be in the source; (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; (c) Specifications for food-grade material; and (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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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: (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 (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); (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); (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 (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—FOOD ADDITIVES | E | Subpart E—Generally Recognized as Safe (GRAS) Notice | § 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—WORKER PROTECTION STANDARD | A | Subpart A—General Provisions | § 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—WORKER PROTECTION STANDARD | A | Subpart A—General Provisions | § 170.2 Implementation and expiration dates. | EPA | [80 FR 67556, Nov. 2, 2015] | (a) Implementation date. Beginning January 2, 2017, the requirements of §§ 170.301 through 170.609 of this part shall apply to any pesticide product that bears the statement “Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR part 170”. (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—WORKER PROTECTION STANDARD | A | Subpart A—General Provisions | § 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: Agricultural 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. Agricultural establishment means any farm, forest, nursery, or greenhouse. Agricultural 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. Chemigation means the application of pesticides through irrigation systems. Commercial pesticide handling establishment means any establishment, other than an agricultural establishment, that: (1) Employs any person, including a self-employed person, to apply on an agricultural establishment, pesticides used in the production of agricultural plants. (2) Employs any person, including a self-employed person, to perform on an agricultural establishment, tasks as a crop advisor. Crop 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. Early 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. Farm means any operation, other than a nursery or forest, engaged in the outdoor production of agricultural plants. Forest means any operation engaged in the outdoor production of any agricultural plant to produce wood fiber or timber products. Fumigant means any pest… | ||||
| 40:40:26.0.1.1.19.1.19.4 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | A | Subpart A—General Provisions | § 170.7 General duties and prohibited actions. | EPA | (a) General duties. The agricultural employer or the handler employer, as appropriate, shall: (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. (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. (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. (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. (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—WORKER PROTECTION STANDARD | A | Subpart A—General Provisions | § 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 “to use any registered pesticide in a manner inconsistent with its labeling.” 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 “use” to include: (1) Preapplication activities, including, but not limited to: (i) Arranging for the application of the pesticide; (ii) Mixing and loading the pesticide; and (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. (2) Application of the pesticide. (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. (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. (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. (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 violate… | ||||
| 40:40:26.0.1.1.19.2.19.1 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 170.102 Applicability of this subpart. | EPA | [60 FR 21952, May 3, 1995] | Except as provided by §§ 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—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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. (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 § 170.311(a)(3) meet the requirements of this paragraph. (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 § 170.311(a)(3)(ix) meet the requirements of this paragraph. (2) The agricultural employer shall inform workers promptly of any change to the information on emergency medical care facilities. (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. (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. (e) Accessibility. Workers shall be informed of the location of the information and shall be allowed access to it. (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—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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: (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; (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. (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. (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. (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. (3) The agricultural employer shall provide soap and single-use towels in quantities sufficient to meet worker's needs. (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 § 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 vehicl… | |||
| 40:40:26.0.1.1.19.2.19.12 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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: (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. (b) Provide to that person or to treating medical personnel, promptly upon request, any obtainable information on: (1) Product name, EPA registration number, and active ingredients of any product to which that person might have been exposed. (2) Antidote, first aid, and other medical information from the product labeling. (3) The circumstances of application or use of the pesticide on the agricultural establishment. (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—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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: (a) For mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored by governmental entities; (b) On livestock or other animals, or in or about animal premises; (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; (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; (e) By injection directly into agricultural plants. Direct injection does not include “hack and squirt,” “frill and spray,” chemigation, soil-incorporation, or soil-injection; (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; (g) For control of vertebrate pests; (h) As attractants or repellents in traps; (i) On the harvested portions of agricultural plants or on harvested timber; and (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—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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. (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: (i) Section 170.112(c)(5) through (9). (ii) Section 170.112(c)(5) through (9) as referenced in §§ 170.112(d)(2)(iii) and 170.112(e). (iii) Section 170.120. (iv) Section 170.122. (v) Section 170.130. (vi) Section 170.135. (vii) Section 170.150. (viii) Section 170.160. (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. (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: (i) Section 170.150. (ii) Section 170.160. A 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. (2) Conditions of exemption. (i) The certification or licensing program requires pesticide safety training that includes, at least, all the information in § 170.230(c)(4). (ii) Applies only when performing crop advising tasks in the treated area. (iii) The crop advisor must make specific determinations regarding the appropriate personal protective equipm… | |||
| 40:40:26.0.1.1.19.2.19.4 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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. (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. Table 1—Entry-Restricted Areas in Nurseries During Pesticide Applications (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. (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 § 170.112. (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: (i) Ten air exchanges are completed; or (ii) Two hours of ventilation using fans or other mechanical … | ||||
| 40:40:26.0.1.1.19.2.19.5 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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. (2) Entry-restricted areas in greenhouses are specified in column D in table 2 under § 170.110(c)(4). (3) When two or more pesticides are applied at the same time, the restricted-entry interval shall be the longest of the applicable intervals. (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. (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: (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 (2) No such entry is allowed until any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by § 170.110(c)(3) or in the labeling have been met. (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: (1) No hand labor activity is performed. (2) The time in treated areas under a restricted-entry interval for any worker does not exceed 1 hour in any 24-hour period. (3) No such entry is allowed for the first 4 hours following the end of the application, and no such entry is allowe… | |||
| 40:40:26.0.1.1.19.2.19.6 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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. (1) All pesticide applications shall be posted in accordance with paragraph (c) of this section. (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. (3) Notice need not be given to a worker if the agricultural employer can assure that one of the following is met: (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 (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. (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. (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. (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… | |||
| 40:40:26.0.1.1.19.2.19.7 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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. (a) Location, accessibility, and legibility. The information shall be displayed in the location specified for the pesticide safety poster in § 170.135(d) and shall be accessible and legible, as specified in § 170.135 (e) and (f). (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. (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. (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. (c) Required information. The information shall include: (1) The location and description of the treated area. (2) The product name, EPA registration number, and active ingredient(s) of the pesticide. (3) The time and date the pesticide is to be applied. (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—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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 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: (a) Specific location and description of any such areas; and (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—WORKER PROTECTION STANDARD | B | Subpart B—Standard for Workers | § 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 —(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. (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 § 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. (3) Requirements for other agricultural workers —(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. (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. (b) Exceptions. The following persons need not be trained under this section: (1) A worker who is currently … | |||
| 40:40:26.0.1.1.19.3.19.1 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | C | Subpart C—Standard for Pesticide Handlers | § 170.202 Applicability of this subpart. | EPA | [60 FR 21952, May 3, 1995] | Except as provided by §§ 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—WORKER PROTECTION STANDARD | C | Subpart C—Standard for Pesticide Handlers | § 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. (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 § 170.311(a)(3) meet the requirements of this paragraph. (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 § 170.311(a)(3)(ix) meet the requirements of this paragraph. (2) The handler employer shall inform handlers promptly of any change to the information on emergency medical care facilities. (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. (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. (e) Accessibility. Handlers shall be informed of the location of the information and shall be allowed access to it. (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—WORKER PROTECTION STANDARD | C | Subpart C—Standard for Pesticide Handlers | § 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. (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. (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. (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. (1) When “chemical-resistant” 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. (2) When “waterproof” 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. (3) When a “chemical-resistant suit” 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. (4) When “coveralls” 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 … | |||
| 40:40:26.0.1.1.19.3.19.12 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | C | Subpart C—Standard for Pesticide Handlers | § 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. (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. (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. (3) The handler employer shall provide soap and single-use towels in quantities sufficient to meet handlers' needs. (4) The handler employer shall provide one clean change of clothing, such as coveralls, for use in an emergency. (c) Location. The decontamination supplies shall be located together and be reasonably accessible to and not more than 1/4 mile from each handler during the handling activity. (1) Exception for mixing sites. For mixing activities, decontamination supplies shall be at the mixing site. (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. (3) Exception for handling pesticides in remote areas. When handling activities are performed more than 1/4 mile from the nearest place of vehicular access: (i) The soap, single-use towels, clean change of clothing, and water may be at the nearest place of vehicular access. (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 t… | |||
| 40:40:26.0.1.1.19.3.19.13 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | C | Subpart C—Standard for Pesticide Handlers | § 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: (a) Make available to that person prompt transportation from the place of employment or the handling site to an appropriate emergency medical facility. (b) Provide to that person or to treating medical personnel, promptly upon request, any obtainable information on: (1) Product name, EPA registration number, and active ingredients of any product to which that person might have been exposed. (2) Antidote, first aid, and other medical information from the product labeling. (3) The circumstances of handling of the pesticide. (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—WORKER PROTECTION STANDARD | C | Subpart C—Standard for Pesticide Handlers | § 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: (a) For mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored by governmental entities. (b) On livestock or other animals, or in or about animal premises. (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. (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. (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. (f) For control of vertebrate pests. (g) As attractants or repellents in traps. (h) On the harvested portions of agricultural plants or on harvested timber. (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—WORKER PROTECTION STANDARD | C | Subpart C—Standard for Pesticide Handlers | § 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. (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: (i) Section 170.210(b) and (c). (ii) Section 170.222. (iii) Section 170.230. (iv) Section 170.232. (v) Section 170.234. (vi) Section 170.235. (vii) Section 170.240(e) through (g). (viii) Section 170.250. (ix) Section 170.260. (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. (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: (i) Section 170.232. (ii) Section 170.240. (iii) Section 170.250. (iv) Section 170.260. A 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. (2) Conditions of exemption. (i) The certification or licensing program requires pesticide safety training that includes, at least, all the information in § 170.230(c)(4). (ii) No entry into the treated area occurs until after application ends. (iii) Applies only when performing crop advising tasks in the treated area. (iv) The crop advisor must make specific determinations regarding … | |||
| 40:40:26.0.1.1.19.3.19.4 | 40 | Protection of Environment | I | E | 170 | PART 170—WORKER PROTECTION STANDARD | C | Subpart C—Standard for Pesticide Handlers | § 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. (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. (c) Fumigant applications in greenhouses. The handler employer shall assure: (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. (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. |
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chapter TEXT,
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