cfr_sections
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118 rows where part_number = 158 and title_number = 40 sorted by section_id
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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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| 40:40:26.0.1.1.9.1.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.1 Purpose and scope. | EPA | [72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013; 87 FR 22474, Apr. 15, 2022] | (a) Purpose. The purpose of this part is to specify the kinds of data and information EPA requires in order to make regulatory judgments under FIFRA secs. 3, 4, and 5 about the risks and benefits of pesticide products. Further, this part specifies the data and information needed to determine the safety of pesticide chemical residues under FFDCA sec. 408. (b) Scope. (1) This part describes the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the reregistration of a pesticide product; support the maintenance of a pesticide registration by means of the data call-in process, e.g., as used in the registration review program; or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. (2) This part establishes general policies and procedures associated with the submission of data in support of a pesticide regulatory action. (3) This part does not include study protocols, methodology, or standards for conducting or reporting test results; nor does this part describe how the Agency uses or evaluates the data and information in its risk assessment and risk management decisions, or the regulatory determinations that may be based upon the data. (c) Scope of individual subparts. (1) Conventional pesticides. Subparts A, B, C, D, E, F, G, K, L, N, O, and R apply to conventional pesticides. (2) Biochemical pesticides. Subparts A, B, E, R, and U apply to biochemical pesticides. (3) Microbial pesticides. Subparts A, B, E, R, and V apply to microbial pesticides. (4) Antimicrobial pesticides. Subparts A, B, C, D, E, R, and W of this part apply to antimicrobial pesticides. | |||
| 40:40:26.0.1.1.9.1.1.10 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.70 Satisfying data requirements. | EPA | (a) General policy. The Agency will determine whether the data submitted or cited to fulfill the data requirements specified in this part are acceptable. This determination will be based on the design and conduct of the experiment from which the data were derived, and an evaluation of whether the data fulfill the purpose(s) of the data requirement. In evaluating experimental design, the Agency will consider whether generally accepted methods were used, sufficient numbers of measurements were made to achieve statistical reliability, and sufficient controls were built into all phases of the experiment. The Agency will evaluate the conduct of each experiment in terms of whether the study was conducted in conformance with the design, good laboratory practices were observed, and results were reproducible. The Agency will not reject data merely because they were derived from studies which, when initiated, were in accordance with an Agency-recommended protocol, even if the Agency subsequently recommends a different protocol, as long as the data fulfill the purposes of the requirements as described in this paragraph. (1) The provisions in this part 158 should be read in conjunction with the provisions in § 152.85 to claim eligibility for the formulators' exemption. (2) [Reserved] (b) Good laboratory practices. Applicants must adhere to the good laboratory practice (GLP) standards described in 40 CFR part 160 when conducting studies. Applicants must also adhere to GLP standards when conducting a study in support of a waiver request of any data requirement which is within the scope of the GLP requirements. (c) Agency guidelines. EPA has published Test Guidelines that contain standards for conducting acceptable tests, guidance on the evaluation and reporting of data, definition of terms, and suggested study protocols. Copies of the Test Guidelines may be obtained by visiting the agency's website at www.epa.gov/pesticides. (d) Study protocols —(1) General. Any appropriate protocol may be used to generate the d… | ||||
| 40:40:26.0.1.1.9.1.1.11 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.75 Requirements for additional data. | EPA | The data routinely required by this part may not be sufficient to permit EPA to evaluate every pesticide product. If the information required under this part is not sufficient to evaluate the potential of the product to cause unreasonable adverse effects on man or the environment, additional data requirements will be imposed. However, EPA expects that the information required by this part will be adequate in most cases for an assessment of the properties and effects of the pesticide. | ||||
| 40:40:26.0.1.1.9.1.1.12 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.80 Use of other data. | EPA | (a) Data developed in foreign countries. With certain exceptions, laboratory and field study data developed outside the United States may be submitted in support of a pesticide registration. Data generated in a foreign country which the Agency will not consider include, but are not limited to, data from tests which involved field test sites or a test material, such as a native soil, plant, or animal, that is not characteristic of the United States. Applicants submitting foreign data must take steps to ensure that U.S. materials are used, or be prepared to supply data or information to demonstrate the lack of substantial or relevant differences between the selected material or test site and the U.S. material or test site. Once submitted, the Agency will determine whether or not the data meet the data requirements. (b) Data generated for other purposes. Data developed for purposes other than satisfaction of FIFRA data requirements, such as monitoring studies, may also satisfy data requirements in this part. Consultation with the Agency should be arranged if applicants are unsure about suitability of such data. | ||||
| 40:40:26.0.1.1.9.1.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.3 Definitions. | EPA | All terms defined in sec. 2 of the Federal Insecticide, Fungicide, and Rodenticide Act apply to this part and are used with the meaning given in the Act. Applicable terms from the Federal Food, Drug, and Cosmetic Act also apply to this part. Individual subparts may contain definitions that pertain solely to that subpart. The following additional terms apply to this part: Applicant means any person or entity, including for the purposes of this part a registrant, who submits, or is required to submit, to the Agency any application, petition, or submission intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following: (1) An application for registration or amended registration of a pesticide product under FIFRA sec. 3 or 24. (2) A submission of data required in conjunction with reregistration of a currently registered product under FIFRA sec. 4. (3) An application for an experimental use permit under FIFRA sec. 5. (4) A submission of data in response to a notice issued by EPA under FIFRA sec. 3(c)(2)(B). (5) A petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under FFDCA sec. 408. Registration includes a new registration, amended registration and reregistration, unless stated otherwise. | ||||
| 40:40:26.0.1.1.9.1.1.3 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.5 Applicability. | EPA | (a) The requirements of this part apply to the following submissions: (1) An application for new or amended registration under FIFRA sec. 3 or 24. (2) An application for experimental use permit under FIFRA sec. 5. (3) A submission of data or information to support the continuation of a registration under FIFRA sec. 3, 4, or 24. (4) A petition to establish, modify or revoke a tolerance or exemption from a tolerance under FFDCA sec. 408. (b) The information specified in this part must be furnished with each submission described in paragraph (a) of this section if it has not been submitted previously, or if any previous submission is not accurate or complete. | ||||
| 40:40:26.0.1.1.9.1.1.4 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.30 Flexibility. | EPA | (a) FIFRA provides EPA flexibility to require, or not require, data and information for the purposes of making regulatory judgments for pesticide products. EPA has the authority to establish or modify data needs for individual pesticide chemicals. The actual data required may be modified on an individual basis to fully characterize the use and properties, characteristics, or effects of specific pesticide products under review. The Agency encourages each applicant to consult with EPA to discuss the data requirements particular to its product prior to and during the registration process. (b) The Agency cautions applicants that the data routinely required in this part may not be sufficient to permit EPA to evaluate the potential of the product to cause unreasonable adverse effects to man or the environment. EPA may require the submission of additional data or information beyond that specified in this part if such data or information are needed to appropriately evaluate a pesticide product. (c) This part will be updated as needed to reflect evolving program needs and advances in science. | ||||
| 40:40:26.0.1.1.9.1.1.5 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.32 Format of data submissions. | EPA | (a) General. (1) All data submitted under this part must be formatted in accordance with this section. (2) The requirements of this section do not apply to administrative materials accompanying a data submission, including forms, labeling, and correspondence. (b) Transmittal document. Each submission in support of a regulatory action must be accompanied by a transmittal document, which includes: (1) Identity of the submitter. (2) The transmittal date. (3) Identification of the regulatory action with which the submission is associated, e.g., the registration or petition number. (4) A list of the individual documents included in the submission. (c) Individual documents. Unless otherwise specified by the Agency, each submission must be in the form of individual documents or studies. Previously submitted documents should not be resubmitted unless specifically requested by the Agency, but should be cited with adequate information to identify the previously submitted document. Each study or document should include the following: (1) A title page including the following information: (i) The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed. (ii) The author(s) of the study. (iii) The date the study was completed. (iv) If the study was performed in a laboratory, the name and address of the laboratory, project numbers or other identifying codes. (v) If the study is a commentary on or supplement to another previously submitted study, full identification of the other study with which it should be associated in review. (vi) If the study is a reprint of a published document, all relevant facts of publication, such as the journal title, volume, issue, inclusive page numbers, and date of publication. (2) The appropriate statement(s) regarding any data confidentiality claims as described in § 158.33. (3) A statement of compliance or non-compliance with respect to Good Laboratory Practice Standards as required by 40 CFR 160.12, if applicabl… | ||||
| 40:40:26.0.1.1.9.1.1.6 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.33 Confidential data. | EPA | (a) Definitions. For the purposes of this section: (1) Registered or previously registered pesticide means any pesticide containing an active ingredient contained in a product that is, or has ever been, an active ingredient in a product registered under sec. 3 of FIFRA. A registered pesticide that is the subject of an application for a new use falls within the category of “registered or previously registered pesticide.” (2) Safety and efficacy information means information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered or previously registered pesticide or its separate ingredients, impurities, or degradation products, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment, including, but not limited to, data on safety to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persistence, translocation and fate in the environment, and metabolism. (b) Applicability. (1) This section applies to information submitted pursuant to this part. It supplements the general confidentiality procedures in 40 CFR part 2, subpart B, including FIFRA confidentiality procedures at 40 CFR 2.307. To the extent that provisions in this section conflict with those in 40 CFR part 2, subpart B, the provisions in this section take precedence. The provisions of 40 CFR 2.308 do not apply to information to which this section applies. In addition to complying with the requirements of this section, any confidentiality claims for information subject to 40 CFR part 174 (plant-incorporated protectants) must be substantiated at the time of submission as described in § 174.9 of this chapter. (2) FFDCA sec. 408(i) protects confidential information submitted in connection with an application for a tolerance or exemption to the same extent as FIFRA sec. 10. References in this section to FIFRA sec. 10 are deemed to apply equally to information submitted pursua… | ||||
| 40:40:26.0.1.1.9.1.1.7 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.34 Flagging of studies for potential adverse effects. | EPA | (a) Any applicant who submits a study of a type listed in paragraph (b) of this section must submit with the study a statement in accordance with paragraph (c) of this section. (b) The following table indicates the study types and the criteria to be applied to each. Column 1 lists the study types by name. Column 2 lists the associated Pesticide Assessment Guideline number. Column 3 lists the criteria applicable to each type of study. Column 4 lists the reporting code to be included in the statement specified in paragraph (c) of this section when any criterion is met or exceeded. Table—Flagging Criteria (c) Identification of studies. For each study of a type identified in paragraph (b) of this section, the applicant shall include the appropriate one of the following two statements, together with the signature of the authorized representative of the company, and the date of signature: (1) Study does not meet or exceed criteria. I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study neither meets nor exceeds any of the applicable criteria. I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study neither meets nor exceeds any of the applicable criteria. (2) Study meets or exceeds criteria. I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study meets or exceeds the criteria numbered [insert all applicable reporting codes]. I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study meets or exceeds the criteria numbered [insert all applicable reporting codes]. | ||||
| 40:40:26.0.1.1.9.1.1.8 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.45 Waivers. | EPA | (a) The data requirements specified in this part as applicable to a category of products will not always be appropriate for every product in that category. Some products may have unusual physical, chemical, or biological properties or atypical use patterns which would make particular data requirements inappropriate, either because it would not be possible to generate the required data or because the data would not be useful in the Agency's evaluation of the risks or benefits of the product. The Agency will waive data requirements it finds are inappropriate, but will ensure that sufficient data are available to make the determinations required by the applicable statutory standards. (b)(1) Applicants are encouraged to discuss a data waiver request with the Agency before developing and submitting supporting data, information, or other materials. (2) All waiver requests must be submitted to the Agency in writing. The request must clearly identify the data requirement(s) for which a waiver is sought along with an explanation and supporting rationale why the applicant believes the data requirement should be waived. In addition, the applicant must describe any unsuccessful attempts to generate the required data, furnish any other information which the applicant(s) believe(s) would support the request, and when appropriate, suggest alternative means of obtaining data to address the concern which underlies the data requirement. (c) The Agency will review each waiver request and subsequently inform the applicant in writing of its decision. If the decision could apply to more than the requested product, the Agency, in its discretion, may choose to send a notice to all registrants or publish a notice in the Federal Register announcing the decision. An Agency decision denying a written request to waive a data requirement is a final Agency action. | ||||
| 40:40:26.0.1.1.9.1.1.9 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | A | Subpart A—General Provisions | § 158.60 Minor use data policies. | EPA | FIFRA sec. 2(ll) defines the term “minor use”and FIFRA provides a number of statutory provisions concerning minor uses. In addition, EPA has established policies with respect to minor uses of pesticides, including, but not limited to, the following: (a) A new data requirement pertinent to both an unregistered minor use and a registered major use will not be applied to a minor use applicant until it is applied to the major use registration. (b) EPA will accept appropriate and adequate extrapolations and regional data to support establishment of individual minor use tolerances. | ||||
| 40:40:26.0.1.1.9.10.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | L | Subpart L—Spray Drift | § 158.1100 Spray drift data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the spray drift data requirements for a particular pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. (b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. Data are also required for the general use patterns of forestry use, residential outdoor use, and indoor use. (c) Key. CR = Conditionally required; NR = Not required; TEP = Typical end-use product; MP = Manufacturing use product; EP = End-use product. (d) Table. The following table lists the data requirements that pertain to spray drift. The table notes are shown in paragraph (e) of this section. Table—Spray Drift Data Requirements (e) Test notes. The following notes apply to the requirements in the table to paragraph (d) of this section: 1. This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants. 2. [Reserved] 1. This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlif… | ||||
| 40:40:26.0.1.1.9.12.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | N | Subpart N—Environmental Fate | § 158.1300 Environmental fate data requirements table. | EPA | (a) General. All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for registration. (b) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes the general use patterns of aquatic food crop, and aquatic nonfood. The greenhouse use pattern includes both food and nonfood uses. The indoor use pattern includes food, nonfood, and residential indoor uses. (2) Data are also required for the general use patterns of forestry use and residential outdoor use. (c) Key. CR = Conditionally required; NR = Not required; R = Required; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. (d) Table. The following table shows the data requirements for environmental fate. The test notes are shown in paragraph (e) of this section. Table—Environmental Fate Data Requirements (e) Test notes. The following test notes apply to the requirements in the table to paragraph (d) of this section: 1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives. 2. Not required when the electronic absorption spectra, measured at pHs 5, 7, and 9, of the chemical and its hydrolytic products, if any, show no absorption or tailing between 290 and 800 nm. 3. Not required when the chemical is to be applied only by soil injection or is incorporated in the soil. 4. Requirement based on use patterns and other pertinent factors including, but not limited to, the Henry's Law Constant of the chemical. In view of methodological difficulties with the study of photodegradation in air, prior consultation with the Agency regarding the protocol is recommended before the test is performed. 5. Required fo… | ||||
| 40:40:26.0.1.1.9.13.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | O | Subpart O—Residue Chemistry | § 158.1400 Definitions. | EPA | The following terms are defined for the purposes of this subpart: Livestock , for the purposes of this section, includes all domestic animals that are bred for human consumption, including, but not limited to, cattle, swine, sheep, and poultry. Plant or animal metabolite means a pesticide chemical residue that is the result of biological breakdown of the parent pesticide within the plant or animal. Residue of concern means the parent pesticidal compound and its metabolites, degradates, and impurities of toxicological concern. Tolerance , for the purposes of this section, includes the establishment of a new tolerance or tolerance exemption, or amended tolerance or tolerance exemption. | ||||
| 40:40:26.0.1.1.9.13.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | O | Subpart O—Residue Chemistry | § 158.1410 Residue chemistry data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. (b) Use patterns. (1) Data are required or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops are grown. Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use. (2) Data may be required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses will be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases. (c) Key. R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active ingredient radio-labeled; Residue of concern= the active ingredient and its metabolites, degradates, and impurities of toxicological concern; TEP = Typical end-use product. (d) Table. The following table list the data requirements for residue chemistry related to food uses. The table notes are shown in paragraph (e) of this section. Table—Residue Chemistry Data Requirements for Food Uses (e) Test notes. The following test notes apply to the data requirements in the table to paragraph (d) of this section. 1. Required if indoor use could result in pesticide residues in or on food or feed. 2. Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200. 3. Required for residential outdoor uses on food crops if the corresponding agricultural use is not… | ||||
| 40:40:26.0.1.1.9.15.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1700 General requirements. | EPA | (a) General. Each applicant must ensure through testing that their product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency may require, as specified herein and on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment. (1) Test substance. All product performance testing is performed using the end-use product. (2) Test organism. All product performance testing must report the species tested. (3) Testing. All products are to be tested to support the claim(s) made on the labeling of the pesticide product. (4) Data requirements. To determine the specific product performance data required to support the registration of each pesticide product, the applicant must refer to the applicable sections of this subpart. (b) Product performance data submission. Each product that bears a claim subject to this subpart, must be supported by submission of product performance data, as listed in this subpart. This product performance data must be submitted with any application for registration or amended registration. For the pest-specific claims listed in this subpart, data must be for the species specified to support the claim. For pests listed as part of a group or subgroup, pest-specific data would also need to be submitted to support a pest-specific claim. | ||||
| 40:40:26.0.1.1.9.15.1.10 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1712 Mites (excluding chiggers). | EPA | (a) General. The tables and test notes in this section apply to dust, human itch or scabies, and dog follicle mites. The claim stated on the pesticide product labeling determines the required test species. The required test species for a specific type of mite claim appear in paragraph (b) of this section and the required performance standards appear in paragraph (c) of this section. (b) Test species. For pesticide products making a claim against mites, the required test species appear in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Mites [Excluding chiggers] (c) Performance standards. (1) For the dog follicle mite, the performance standard is 100 percent. (2) For the human itch or scabies mite, the performance standard is 100 percent. | ||||
| 40:40:26.0.1.1.9.15.1.11 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1714 Chiggers. | EPA | If the pesticide product labeling makes a claim against chiggers, then testing is required using the following test species: Chigger ( Trombicula alfreddugesi ). | ||||
| 40:40:26.0.1.1.9.15.1.12 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1718 Ticks. | EPA | (a) General. The table and test notes in this section apply to hard ticks (including cattle ticks) and soft ticks. The claim stated on the pesticide product labeling determines the required test species. The required test species for a specific type of tick claim appear in paragraph (b) of this section. Specific parameters that apply to individual tests appear in paragraph (c) of this section. For a claim against any specific species of “ticks,” that individual species and all the listed representative species for “ticks” must be tested, but not the representative species for cattle ticks or soft ticks. Claims against ticks in association with tick borne diseases are also subject to the requirements in § 158.1709. (b) Test species. For pesticide products making a claim against ticks, the required test species appear in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Ticks (c) Specific parameters. The following parameters are required. 1. For products applied to dogs, testing is required on three species: Blacklegged tick ( Ixodes scapularis ), American dog tick ( Dermacentor variabilis ), and Brown dog tick ( Rhipicephalus sanguineus ). 2. For products applied to cats, testing is required on three species: Blacklegged tick ( Ixodes scapularis ), Lone star tick ( Amblyomma americanum ), and American dog tick ( Dermacentor variabilis ). | ||||
| 40:40:26.0.1.1.9.15.1.13 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1722 Scorpions. | EPA | If the pesticide product labeling makes a claim against scorpions, then testing is required using one of the following test species: Striped bark scorpion ( Centruroides vittatus ) or Arizona bark scorpion ( Centrurioides sculpturatus ). | ||||
| 40:40:26.0.1.1.9.15.1.14 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1726 Spiders. | EPA | (a) General. The table in this section applies to spiders. The product labeling claim determines the required test species. The required test species for spider labeling claims appear in paragraph (b) of this section. (b) Test species. For products making a claim against spiders, the test species for labeling claims appear in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Spiders | ||||
| 40:40:26.0.1.1.9.15.1.15 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1732 Centipedes. | EPA | (a) General. The table in this section applies to centipedes. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of the section. (b) Test species. For products making a claim against centipedes, the required test species for a labeling claim is set forth in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Centipedes | ||||
| 40:40:26.0.1.1.9.15.1.16 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1736 Lice. | EPA | (a) General. The table in this section applies to human lice. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section. The required performance standards appear in paragraph (c) of this section. (b) Test species. For products making a claim against lice, the required test species for a labeling claim appear in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Lice (c) Performance standards. For labeling claims against lice, a performance standard of 100 percent is required. | ||||
| 40:40:26.0.1.1.9.15.1.17 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1740 Fleas. | EPA | (a) General. The table in this section applies to fleas. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section. (b) Test species. For products making a claim against fleas, the required test species for a labeling claim is set forth in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Fleas | ||||
| 40:40:26.0.1.1.9.15.1.18 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1744 Cockroaches. | EPA | (a) General. The table in this section applies to cockroaches. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section. (b) Test species. For products making a claim against cockroaches, the required test species for a labeling claim for cockroaches and the test species for pest-specific label claims appear in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Cockroaches | ||||
| 40:40:26.0.1.1.9.15.1.19 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1748 Keds, screwworms, and bot flies. | EPA | (a) General. The table in this section applies to keds, screwworms, and bot flies. The product labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section. (b) Test species. For products making a claim against keds, screwworms, and bot flies, the required test species for a labeling claim appear in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Keds, Screwworms, and Bot Flies | ||||
| 40:40:26.0.1.1.9.15.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1701 Definitions. | EPA | Definitions. The following terms are defined for purposes of this subpart. Complete protection time (CPT) means the time from application of a skin-applied insect repellent until efficacy failure, which is described in Product Performance Test Guideline 810.3700. Introduction means the intentional or unintentional escape, release, dissemination, or placement of a species into an ecosystem as a result of human activity. Invasive species means with respect to a particular ecosystem, any species that is not native to that ecosystem, and whose introduction does or is likely to cause economic or environmental harm or harm to human health. Performance standard means a benchmark or reference against which the efficacy of the pesticide is compared (including, but not limited to, the ability of the pesticide product to control, kill, or repel an invertebrate pest species). Pest group labeling claim means a claim or statement on the labeling of the pesticide product that the product is effective against a group of related species or taxa demonstrating adequate similarity in basic biology and life history characteristics to permit identification of representative test species for the entire assemblage of taxa. Pest-specific labeling claim means a claim or statement on the labeling of the pesticide product that the product is effective against a particular arthropod species, such as German cockroach or house fly. Pest sub-group labeling claim means a claim or statement on the labeling of the pesticide product that the product is effective against a set of related species or taxa demonstrating adequate similarity in basic biology and life history characteristics to permit identification of representative test species and part of a larger identified taxonomic grouping (e.g., Biting flies) that includes other pest species, which may or may not have a specified pest group. Skin-applied insect repellent means a product intended to disrupt the host-seeking behavior of insects or other arthropods, driving or keepin… | ||||
| 40:40:26.0.1.1.9.15.1.20 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1752 Flies. | EPA | (a) General. The table in this section applies to flies. The product labeling claim determines the required test species. The required test species for a labeling claim against flies appear in paragraph (b) of this section. (b) Test species. For products making a claim against flies, the required test species for a labeling claim against flies appear in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Flies | ||||
| 40:40:26.0.1.1.9.15.1.21 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1756 Mosquitoes. | EPA | (a) General. The tables and test notes in this section apply to mosquitoes. The required test species for a labeling claim against mosquitoes appears in paragraph (b) of this section. For a claim against any specific species of mosquito, that individual species and all the required test genera must be tested. Claims against mosquitos in association with mosquito-borne diseases are also subject to the requirements in § 158.1709. (b) Test species. For products making a claim against mosquitoes, the required test species for a labeling claim is set forth in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Mosquitoes | ||||
| 40:40:26.0.1.1.9.15.1.22 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1768 Bed bugs. | EPA | (a) General. The table in this section applies to bed bugs. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section. (b) Test species. For products making a claim against bed bugs, the required test species for a labeling claim appear in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Bed Bugs | ||||
| 40:40:26.0.1.1.9.15.1.23 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1772 Conenose bugs and kissing bugs. | EPA | (a) General. The table in this section applies to Conenose bugs and Kissing bugs. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section. (b) Test species. For products making a claim against either the conenose and/or kissing bugs, the required test species for a labeling claim is set forth in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Conenose and Kissing Bugs | ||||
| 40:40:26.0.1.1.9.15.1.24 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1776 Ants (excluding carpenter ants). | EPA | (a) General. The table in this section applies to ants (excluding carpenter ants). The product labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section. (b) Test species. For products making a claim against ants (excluding carpenter ants), the required test species for a labeling claim appear in the following table, unless otherwise specified in paragraphs (c) or (d) of this section. The group and sub-group claims in this paragraph are for direct kill and residual surface application claims against foraging ants only (excluding colony claims). Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Ants [Excluding carpenter ants] (c) Colony Claims. For colony claims, testing must be done for each species listed or each representative species, in the case of a group. For colony claims against the red and/or black imported fire ants, testing may be done on, S. invicta, S. richteri, or their hybrid. (d) Bait products or claims involving outdoor use. The group and sub-group claims in paragraph (b) of this section are for direct kill and residual surface application claims against foraging ants only (excluding colony claims). For bait products or claims involving outdoor use, testing must be specific to the species listed or each representative species, in the case of a group. | ||||
| 40:40:26.0.1.1.9.15.1.25 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1780 Bees, wasps, yellowjackets, and hornets. | EPA | (a) General. The table in this section applies to bees, wasps, yellowjackets, and hornets. The labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section. (b) Test species. For products making a claim against bees, wasps, yellowjackets, and hornets, the required test species for a labeling claim appear in the following table, unless otherwise specified in paragraph (c) of this section. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Bees, Wasps, Yellowjackets, and Hornets (c) Colony claims. For colony claims, except Vespula spp., testing must be specific to the species listed. Acceptable data for any Vespula species may support a yellowjacket colony claim for ground nesting Vespula species; however, species-specific claims need to be supported by data from testing of the specific species. Colony claims have a performance standard of 100%. | ||||
| 40:40:26.0.1.1.9.15.1.26 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1782 Carpenter ants. | EPA | (a) General. The table in this section applies to carpenter ants. The product labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section. The required performance standards appear in paragraph (c) of this section. (b) Test species. For products making a claim against carpenter ants, the required test species for a labeling claim appear in the following table. The group and sub-group claims in this paragraph are for direct kill and residual surface application claims against foraging ants only (excluding colony claims). Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Carpenter Ants (c) Performance standards. The performance standards for pesticide products making certain claims against carpenter ants appear in the following table and in paragraphs (d) and (e)of this section. The performance standards for labeling claims not covered in this section appear in § 158.1704. Table 2 to Paragraph (c) —Performance Standards for Certain Claims Against Carpenter Ants (d) Colony Claims. For colony claims, testing must be done for each species listed or each representative species, in the case of a group. (e) Bait products or claims involving outdoor use. The group and sub-group claims in paragraph (b) of this section are for direct kill and residual surface application claims against foraging ants only (excluding colony claims). For bait products or claims involving outdoor use, testing must be specific to the species listed or each representative species, in the case of a group. | ||||
| 40:40:26.0.1.1.9.15.1.27 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1784 Wood-destroying beetles. | EPA | (a) General. The tables and test notes in this section apply to wood-destroying beetles. The labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section. The required performance standards appear in paragraph (c) of this section. (b) Test species. For products making a claim against wood-destroying beetles, the required test species for a labeling claim is set forth in the following table. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Wood-Destroying Beetles (c) Performance standards. The performance standards for pesticide products making certain claims against wood-destroying beetles appear in the following table. The performance standards for labeling claims that are not specifically provided in the following table appear in § 158.1704. Table 2 to Paragraph (c) —Performance Standards for Certain Claims Against Wood-Destroying Beetles | ||||
| 40:40:26.0.1.1.9.15.1.28 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1786 Termites. | EPA | (a) General. The tables and test notes in this section apply to the subterranean termite, desert subterranean termite, Formosan subterranean termite, drywood termite, and dampwood termite. The labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section. The required performance standards appear in paragraph (c) of this section. (b) Test species. For products making a claim against termites, the required test species for a labeling claim appear in the following table. For the structural protection and wood preservative claim categories, a claim against any specific genus of subterranean termite must be supported by data on that individual genus and all the required test genera for a subterranean termite claim must be tested and submitted. Table 1 to Paragraph (b) —Required Test Species for Products Making a Claim Against Termites (c) Performance standards. The performance standards for pesticide products making certain claims against termites appear in the following table. The performance standards for labeling claims not provided in the following table appear in § 158.1704. Table 2 to Paragraph (c) —Performance Standards for Certain Claims Against Termites | ||||
| 40:40:26.0.1.1.9.15.1.3 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1703 Application categories. | EPA | The following terms are defined for purposes of this subpart. Bait treatment means a pesticide product intended to be ingested by the target pest that kills or controls an invertebrate pest such as ants, cockroaches, or termites. This is normally through the insect feeding on the product directly, but may also include products which the target will contact and later ingest during grooming/cleaning. The attractiveness of these products is through the use of a palatable food base, however they may also incorporate an attractant (e.g., pheromone) which is intended to attract the target pests over a greater distance. Soil-applied termiticides means pesticide products that are applied to the soil beneath and/or adjacent to the structure, pre- or post-construction, to kill or control termites. Treatments can be preventive ( i.e., to provide structural protection before a termite infestation is present) or remedial ( i.e., to kill and control a termite infestation when present). Spatial repellents include treatments of both indoor and outdoor sites where the product is applied into the air rather than onto a surface or the skin in order to drive away insects or other arthropods from that space. They are intended to repel the target pest through the dispersal of pesticide into the atmosphere of a room or other open space. Structural protection means the prevention of termite or other wood-destroying pest activity in an entire structure as the result of an application of a pesticide product. Wood protectants and other non-structural protection means the prevention of termite or other wood-destroying pest activity only to the treated wood (or other treated material), whereas structural protectants, however applied, claim to prevent damage to the structure. | ||||
| 40:40:26.0.1.1.9.15.1.4 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1704 Performance standards for data acceptability. | EPA | (a) General. The claim stated on the pesticide product labeling (such as knockdown, control, mortality, or repellency) determines the performance standard that must be met. In the absence of specific pest/labeling claims/performance standards specified in §§ 158.1708 through 158.1786, the performance standards of paragraphs (b) and (c) of this section apply. (b) Skin-applied insect repellent labeling claims. (1) For skin-applied insect repellent labeling claims, the performance standard must be greater than or equal to 2-hours complete protection time. (2) Any testing required under this part which involves any human subjects must comply with all applicable requirements under 40 CFR part 26. For example, 40 CFR part 26 requirements are pertinent to the part 158 testing requirement if the testing involves intentional exposure of human subjects. Protocols for such testing must be submitted to EPA for review prior to study initiation. Those protocols determined by EPA to involve intentional exposure of human subjects also require review by EPA's Human Studies Review Board (HSRB)) prior to study initiation. If you are uncertain about the applicability of the 40 CFR part 26 requirements to this 40 CFR part 158 testing requirement or uncertain about the nature of your planned testing (such as, for example, whether the testing would involve intentional exposure of human subjects or whether the testing would be an observational study), you should contact the Agency prior to initiating the testing. (c) Labeling claims for products other than skin-applied insect repellents. Unless otherwise specified in §§ 158.1712 through 158.1786, a minimum performance standard of 90 percent is required, except skin-applied insect repellents as specified in paragraph (b) of this section, and non-wearable spatial repellents, where a minimum performance standard of 75 percent is required. | ||||
| 40:40:26.0.1.1.9.15.1.5 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1705 Test guidelines. | EPA | EPA has published the Harmonized Test Guidelines, which set forth the recommended approach to generate the data required in this subpart. The Product Performance Guidelines (Series 810, Group C—Invertebrate Control Agent Test Guidelines) are available on the Agency's website. These guidelines cover some, but not all, of the tests that would be used to generate data under this subpart. In instances where there is a conflict between one of the Harmonized Test Guidelines and the provisions of this subpart, this subpart will control. | ||||
| 40:40:26.0.1.1.9.15.1.6 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1707 Data requirement modifications. | EPA | The data requirements (including the performance standards associated with the data requirements) specified in this subpart as applicable to a category of products will not always be appropriate for every product in that category. Data requirements may, on a case-by-case basis, be modified by EPA in response to requests for novel technologies or products that have unusual physical, chemical, or biological properties or atypical use patterns which would make a particular data requirement, or data performance standard, inappropriate. Requests for such data requirement modifications must be submitted in the same manner as waiver requests submitted under 40 CFR 158.45. EPA will respond in writing to those requests. The Agency may grant the request if it finds such modifications are appropriate for the pesticide in question, and will ensure that sufficient data are available to make the determinations required by the applicable statutory standards. | ||||
| 40:40:26.0.1.1.9.15.1.7 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1708 Invasive species claims. | EPA | (a) General. In addition to those species specified in paragraph (b) of this section, if an application for registration or amended registration requests a labeling claim for effectiveness against an invasive invertebrate species, then on a case-by-case basis, EPA may require submission of product performance data and establish performance standards for those data to support those claims for effectiveness. (b) Specific. Applications for registration or amended registration requests for a labeling claim for the emerald ash borer, Agrilus planipennis, or Asian longhorned beetle, Anoplophora glabripennis, must be accompanied by product performance data to support those claims for effectiveness. | ||||
| 40:40:26.0.1.1.9.15.1.8 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1709 Invertebrate disease vector claims. | EPA | If an application for registration or amended registration requests a labeling claim specific to a disease vector (such as repels mosquitoes that may carry West Nile virus), then submission of test data conducted with the species specific to the disease vector claim and meeting the specific performance standard for that species is required even if the disease vector species is not the test species required in §§ 158.1712 through 158.1786. | ||||
| 40:40:26.0.1.1.9.15.1.9 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | R | Subpart R—Product Performance for Products Claiming Effectiveness Against Invertebrate Pests | § 158.1710 Structural and wood-destroying pest claims. | EPA | If an application for registration or amended registration requests a labeling claim specific to a structural or wood-destroying pest not identified in §§ 158.1782 through 158.1786, EPA may require submission of product performance data, with testing on that specific pest and subject to specific performance standards, to support those claims for effectiveness. | ||||
| 40:40:26.0.1.1.9.16.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | S | Subparts S—T | §§ 158.1800-158.1900 [Reserved] | EPA | |||||
| 40:40:26.0.1.1.9.17.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2000 Biochemical pesticides definition and applicability. | EPA | This subpart applies to all biochemical pesticides as defined in paragraphs (a), (b), and (c) of this section. (a) Definitions. The following terms are defined for the purposes of subpart U of this part. (1) A biochemical pesticide is a pesticide that: (i) Is a naturally-occurring substance or structurally-similar and functionally identical to a naturally-occurring substance; (ii) Has a history of exposure to humans and the environment demonstrating minimal toxicity, or in the case of a synthetically-derived biochemical pesticides, is equivalent to a naturally-occurring substance that has such a history; and (iii) Has a non-toxic mode of action to the target pest(s). (2) A Pheromone is a compound produced by a living organism or is a synthetically derived substance that is structurally similar and functionally identical to a naturally-occurring pheromone, which, alone or in combination with other such compounds, modifies the behavior of other individuals of the same species. (i) An Arthropod Pheromone is a pheromone produced by a member of the taxonomic phylum Arthropoda. (ii) A Lepidopteran Pheromone is an arthropod pheromone produced by a member of the insect order Lepidoptera. (iii) A Straight Chain Lepidopteran Pheromone is a lepidopteran pheromone consisting of an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol, aldehyde, or acetate functional group and containing up to three double bonds in the aliphatic backbone. (b) Examples. Biochemical pesticides include, but are not limited to: (1) Semiochemicals (insect pheromones and kairomones), (2) Natural plant and insect regulators, (3) Naturally-occurring repellents and attractants, and (4) Enzymes. (c) Applicability. The Agency may review, on a case-by-case basis, naturally-occurring pesticides that do not clearly meet the definition of a biochemical pesticide in an effort to ensure, to the greatest extent possible, that only the minimum testing sufficient to make scientifically sound regulatory decision… | ||||
| 40:40:26.0.1.1.9.17.1.10 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2082 Experimental use permit biochemical pesticides residue data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the biochemical pesticides residue data requirements for a particular pesticide product and the substance that needs to be tested. These data requirements apply to all biochemical pesticides, i.e. , naturally occurring insect repellents and attractants, semiochemicals (e.g., insect pheromones), natural and plant growth regulators. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. (b) Use patterns. (1) Data are required or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops are grown. Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use. Data are also conditionally required for aquatic nonfood use if there is direct application to water that could subsequently result in exposure to food. (2) Data are conditionally required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses would be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing end-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates,and impurities of toxicological concern. All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table: (d) Data table. … | ||||
| 40:40:26.0.1.1.9.17.1.11 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2083 Experimental use permit biochemical pesticides human health assessment data requirements table. | EPA | (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the human health assessment data requirements for a particular biochemical pesticide product. (2) The data in this section are not required for straight chain lepidopteran pheromones when applied up to a maximum use rate of 150 grams active ingredient/acre/year. (b) Use patterns. (1) Food use patterns, in general, include products classified under the following general uses: terrestrial food crop use; terrestrial feed crop use; aquatic food crop use; greenhouse food crop use. (2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use; aquatic nonfood residential use; aquatic nonfood outdoor use; aquatic nonfood industrial use; greenhouse nonfood crop use; forestry use; residential outdoor use; residential indoor use; indoor food use; indoor nonfood use; indoor medical use. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table: (d) Table. The following table shows the data requirements for experimental use permit biochemical pesticides human health assessment. The test notes are shown in paragraph (e) of this section. Table—EUP Biochemical Pesticides Human Health Assessment Data Requirements (e) Test notes. The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides human health assessment as referenced in the last column of the table in paragraph (d) of this section. 1. Required unless the test material is a gas or highly vola… | ||||
| 40:40:26.0.1.1.9.17.1.12 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2084 Experimental use permit biochemical pesticides nontarget organisms and environmental fate data requirements table. | EPA | (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms and fate data requirements for a particular biochemical pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. In general, for all outdoor end-use products including turf, the following studies are required: one avian acute oral, one avian dietary, one acute freshwater fish, and one acute freshwater invertebrate study. (2) The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species ( i.e. , granular formulation). (b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and nonfood use. The remaining terrestrial uses include forestry and residential outdoor use. Data are also required for the general use patterns of aquatic food and nonfood crop use. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table: (d) Table. The following table shows the d… | ||||
| 40:40:26.0.1.1.9.17.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2010 Biochemical pesticides data requirements. | EPA | (a) Sections 158.2030 through 158.2070 identify the data requirements that are required to support registration of biochemical pesticides. Sections 158.2080 through 158.2084 identify the data requirements that are required to support Experimental Use Permits (EUPs). Variations in the test conditions are identified within the test notes. Definitions that apply to all biochemical data requirements can be found in § 158.2000. (b) Each data table includes “use patterns” under which the individual data are required, with variations including food and nonfood uses for terrestrial and aquatic applications, greenhouse, indoor, forestry, and residential outdoor applications under certain circumstances. (c) The categories for each data requirement are “R”, which stands for required, and “CR” which stands for conditionally required. Generally, “R” indicates that the data are more likely required than for those data requirements with “CR.” However, in each case, the regulatory text preceding the data table and the test notes following the data table must be used to determine whether the data requirement must be satisfied. (d) Each table identifies the test substance that is required to be tested to satisfy the data requirement. Test substances may include: technical grade active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use product (TEP), residue of concern, and pure active ingredient (PAI) or all of the above (All). Commas between the test substances ( i.e. , TGAI, EP) indicate that data may be required on the TGAI or EP or both depending on the conditions set forth in the test note. (e) The data requirements are organized into a tier-testing system with specified additional studies at higher tiers being required if warranted by adverse effects observed in lower tier studies. The lower tier studies are a subset of those required for conventional pesticides, and the studies overall are generally selected from those required for conventional pesticides. (f) Two sets of guideline… | ||||
| 40:40:26.0.1.1.9.17.1.3 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2030 Biochemical pesticides product chemistry data requirements table. | EPA | (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of the section. (2) Definitions in § 158.300 apply to data requirements in this section. (b) Use patterns. Product chemistry data are required for all pesticide products and are not use specific. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. (d) Table. The following table shows the data requirements for biochemical pesticides product chemistry. The test notes are shown in paragraph (e) of this section. Table—Biochemical Pesticides Product Chemistry Data Requirements (e) Test notes. The following test notes are applicable to the data requirements for biochemical pesticides product chemistry and are referenced in the last column of the table in paragraph (d) of this section. 1. Data must be provided in accordance with § 158.320. 2. If the MP and EP are produced by an integrated formulation system (non-registered source), these data are also required on TGAI. 3. Data must be provided in accordance with §§ 158.325, 158.330, and § 158.335. 4. Data must be provided in accordance with § 158.340. 5. Data must be provided in accordance with § 158.345. Also, required to support the registration of each manufacturing-use product (including registered TGAIs) and end-use products produced by an integrated formulation system. Data on other end-use products would be required on a case-by-case basis. 6. Data must be provided in accordance with § 158.350. 7. Data must be provided in a… | ||||
| 40:40:26.0.1.1.9.17.1.4 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2040 Biochemical pesticides residue data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the biochemical pesticides residue data requirements for a particular pesticide product and the substance that needs to be tested. These data requirements apply to all biochemical pesticides, i.e. , naturally occurring insect repellents and attractants, semiochemicals (e.g., insect pheromones), natural and plant growth regulators. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. (b) Use patterns. (1) Data are required or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops are grown. Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use. Data are also conditionally required for aquatic nonfood use if there is direct application to water that could subsequently result in exposure to food. (2) Data are conditionally required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses would be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing end-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table: (d) Data require… | ||||
| 40:40:26.0.1.1.9.17.1.5 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2050 Biochemical pesticides human health assessment data requirements table. | EPA | (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the biochemical human health assessment data requirements for a particular biochemical pesticide product. (2) The data in this section are not required for straight chain lepidopteran pheromones when applied up to a maximum use rate of 150 grams active ingredient/acre/year. (b) Use patterns. (1) Food use patterns, in general, include products classified under the following general uses: terrestrial food crop use; terrestrial feed crop use; aquatic food crop use; greenhouse food crop use. (2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use; aquatic nonfood residential use; aquatic nonfood outdoor use; aquatic nonfood industrial use; greenhouse nonfood crop use; forestry use; residential outdoor use; residential indoor use; indoor food use; indoor nonfood use; indoor medical use. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table: (d) Table. The following table shows the data requirements for biochemical pesticides human health assessment. The test notes are shown in paragraph (e) of this section. Table—Biochemical Pesticides Human Health Assessment Data Requirements (e) Test notes. The following test notes are applicable to the data requirements for biochemical pesticides human health assessment as referenced in the last column of the table in paragraph (d) of this section. 1. Required unless the test material is a gas or highly volatile (vapor pressure >10 −4 torr (mm/Hg)… | ||||
| 40:40:26.0.1.1.9.17.1.6 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2060 Biochemical pesticides nontarget organisms and environmental fate data requirements table. | EPA | (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms and fate data requirements for a particular biochemical pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. In general, for all outdoor end-use products including turf, the following studies are required: one avian acute oral, one avian dietary, one acute freshwater fish, one acute freshwater invertebrate study, plant toxicity testing, and a honeybee acute contact study. (2) The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species ( i.e. , granular formulation). (b) Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and nonfood use. The remaining terrestrial uses include: forestry and residential outdoor use. Data are also required for the general use patterns of aquatic food and nonfood crop use. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the follo… | ||||
| 40:40:26.0.1.1.9.17.1.7 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2070 Biochemical pesticides product performance data requirements. | EPA | [87 FR 22484, Apr. 15, 2022] | (a) General. Product performance data must be developed for all biochemical pesticides. Each applicant must ensure through testing that the product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency may require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment. (b) Product performance data for each product that bears a claim against an invertebrate pest that is covered by subpart R of this part. The product performance data requirements and performance standards of subpart R of this part apply to biochemical products covered by this subpart. Product performance data must be submitted with any application for registration or amended registration. However, data requirements and the performance standards that determine the acceptability of data may be waived or modified on a case-by-case basis pursuant to the waiver provisions in § 158.45 and modification provisions in § 158.1707. (c) Product performance data for each product that bears a public health pest claim, excluding those covered under paragraph (b). Product performance data must be submitted with any application for registration or amended registration, if the product bears a claim to control public health pests, such as pest microorganisms infectious to humans in any area of the inanimate environment, or a claim to control vertebrates, including but not limited to, rodents, birds, bats, canids, and skunks. | |||
| 40:40:26.0.1.1.9.17.1.8 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2080 Experimental use permit data requirements—biochemical pesticides. | EPA | (a) Sections 158.2081 through 158.2084 describe the experimental use permit (EUP) data requirements for biochemical pesticides. Variations in the test conditions are identified within the test notes. Definitions that apply to all biochemical data requirements can be found in § 158.2000. (b) For general information on the data requirement tables, see § 158.2010(b)-(f). | ||||
| 40:40:26.0.1.1.9.17.1.9 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | U | Subpart U—Biochemical Pesticides | § 158.2081 Experimental use permit biochemical pesticides product chemistry data requirements table. | EPA | (a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular biochemical pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of the section. (2) Depending on the results of the required product chemistry studies, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed. (b) Use patterns. Product chemistry data are required for all pesticide products and are not use specific. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table: (d) Table. The following table shows the data requirements for experimental use permit biochemical pesticides product chemistry. The test notes are shown in paragraph (e) of this section. Table—EUP Biochemical Pesticides Product Chemistry Data Requirements (e) Test notes. The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides product chemistry and are referenced in the last column of the table in paragraph (d) of this section. 1. Data must be provided in accordance with § 158.320. 2. If the MP and EP are produced by an integrated formulation system (non-registered source), these data are also required on TGAI. 3. Data must be provided in accordance with § 158.325, § 158.330, and § 158.335. 4. Data must be provided in accordance with § 158.340. 5. Data must be provided in accordance wi… | ||||
| 40:40:26.0.1.1.9.18.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2100 Microbial pesticides definition and applicability. | EPA | [72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012] | (a) This subpart applies to all living or dead microbial pesticides as described in paragraphs (b) and (c) of this section. (b) Definition. Microbial pesticide is a microbial agent intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, that: (1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae, and fungi; (2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or (3) Is a parasitically replicating microscopic element, including, but not limited to, viruses. (c) Applicability. (1) This subpart applies to microbial pesticides as specified in paragraphs (c)(2), (c)(3), and (c)(4) of this section. (2) Each new isolate of a microbial pesticide is a new active ingredient and must be registered independently of any similarly designated and already registered microbial pesticide active ingredient. Each new isolate for which registration is sought must have a unique identifier following the taxonomic name of the microorganism, and the registration application must be supported by data required in this subpart. This does not preclude the possibility of using data from another isolate, provided sufficient similarity is established, to support registration. (3) Genetically modified microbial pesticides may be subject to additional data or information requirements on a case-by-case basis depending on the particular microbial agent and/or its parental strains, the proposed pesticide use pattern, and the manner and extent to which the organism has been genetically modified. (4) Pest control organisms such as insect predators, nematodes, and macroscopic parasites are exempt from the requirements of FIFRA as authorized by section 25(b) of FIFRA and specified in § 152.20 (a) of this chapter. | |||
| 40:40:26.0.1.1.9.18.1.10 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2172 Experimental use permit microbial pesticides residue data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements and the substance to be tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated test appear in (d) of this section, and the procedures appear in paragraph (e) of this section. (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table: (c) Table. The following table shows the data requirements for experimental use permit microbial pesticides residue. The test notes are shown in paragraph (d) of this section. Table—EUP Microbial Pesticides Residue Data Requirements (d) Test notes. The following test note is applicable to the data requirements for experimental use permit microbial pesticides residue as referenced in the last column of the table contained in paragraph (c) of this section. 1. Required when the results of testing: i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and ii. The use pattern is such that residues may be present in or on food or feed crops. 1. Required when the results of testing: i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and ii. The use pattern is such that residues may be present in or on food or feed crops. | ||||
| 40:40:26.0.1.1.9.18.1.11 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2173 Experimental use permit microbial pesticides toxicology data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the toxicology data requirements for a particular microbial pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (d) of this section. (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table: (c) Table. The following table shows the data requirements for microbial pesticide toxicology. The test notes are shown in paragraph (d) of this section. Table—EUP Microbial Pesticides Toxicology Data Requirements (d) Test notes. The following test notes are applicable to the data requirements for experimental use permit microbial pesticides toxicology as referenced in the last column of the table contained in paragraph (c) of this section: 1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern. 2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed. 3. Hypersensitivity incidents, including immediate type and delayed type reactions of humans or domestic animals occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur. 4. Data must be sub… | ||||
| 40:40:26.0.1.1.9.18.1.12 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2174 Experimental use permit microbial pesticides nontarget organisms and environmental fate data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. (b) Use patterns. Aquatic uses include: food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food and food), Indoor (food and nonfood), and Industrial. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table: (d) Table. The following table shows the data requirements for experimental use permit microbial pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section. Table—EUP Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements (e) Test notes. The following test notes are applicable to the data requirements for microbial pesticides nontarget organism and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section. 1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors. Tests to support EUP's are based on the application timing and acreage. 2. The preferred species for the avian oral study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and the avian chronic t… | ||||
| 40:40:26.0.1.1.9.18.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2110 Microbial pesticides data requirements. | EPA | (a) For all microbial pesticides. (1) The following § 158.2120 through § 158.2150 identify the data requirements that are required to support registration of microbial pesticides. The variations in the test conditions are identified within the test notes. (2) Each data table includes “use patterns” under which the individual data are required, with variations including all use patterns, food and nonfood uses for terrestrial and aquatic applications, greenhouse, indoor, forestry, and residential outdoor applications under certain circumstances. (3) The categories for each data requirement are “R,” which stands for required, and “CR” which stands for conditionally required. If a bracket appears around the “R” or “CR,” the data are required for both the registration and experimental use permit requests. Generally, “R” indicates that the data are more likely required than for those data requirements with “CR.” However, in each case, the regulatory text preceding the data table and the test notes following the data table must be used to determine whether the data requirement must be satisfied. (4) Each table identifies the test substance that is required to be tested to satisfy the data requirement. Test substances may include: technical grade active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use product (TEP), residue of concern, and pure active ingredient (PAI) or all of the above (All). Commas between the test substances ( i.e. , TGAI, EP) indicate that data may be required on the TGAI or EP or both depending on the conditions set forth in the test note. Data requirements which list two test substances ( i.e. , TGAI and EP) indicate that both are required to be tested. Data requirements that list only MP as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added. Data requirements listing the EP as the test substance apply to any EP with a… | ||||
| 40:40:26.0.1.1.9.18.1.3 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2120 Microbial pesticides product analysis data requirements table. | EPA | [72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012] | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section. (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. (c) Table. The table in this paragraph shows the data requirements for microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section. Table—Microbial Pesticides Product Analysis Data Requirements (d) Test notes. The following test notes are applicable to the data requirements for microbial pesticides product analysis as referenced in the last column of the table contained in paragraph (c) of this section. 1. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated registration(s). 2. Required to support registration of each manufacturing-use product and end-use product. This analysis must be conducted at the point in the production process after which there would be no potential for microbial contamination or microbial regrowth. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing. 3. Only required for emulsifiable liquid forms of microbial pesticides. 4. Required when microbial pesticides are packaged in metal, plastic, or paper containers. 5. Only required for liquid forms of microbial pesticides. 1. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample … | |||
| 40:40:26.0.1.1.9.18.1.4 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2130 Microbial pesticides residue data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements and the substance to be tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated test appear in paragraph (d) of this section, and the procedures appear in paragraph (e) of this section. (b) Key. R = required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table: (c) Table. The following table shows the data requirements for microbial pesticides residue. The test notes are shown in paragraph (d) of this section. Table—Microbial Pesticides Residue Data Requirements (d) Test notes. The following test note is applicable to the data requirements for microbial pesticides residue as referenced in the last column of the table contained in paragraph (c) of this section. 1. Required when the results of testing: i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and ii. The use pattern is such that residues may be present in or on food or feed crops. 1. Required when the results of testing: i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and ii. The use pattern is such that residues may be present in or on food or feed crops. | ||||
| 40:40:26.0.1.1.9.18.1.5 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2140 Microbial pesticides toxicology data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the toxicology data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (d) of this section. (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table: (c) Table. The following table shows the data requirements for microbial pesticides toxicology. The test notes are shown in paragraph (d) of this section. Table—Microbial Pesticides Toxicology Data Requirements (d) Test notes. The following test notes are applicable to the data requirements for microbial pesticides toxicology as referenced in the last column of the table contained in paragraph (c) of this section: 1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern. 2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed. 3. Hypersensitivity incidents, including immediate type and delayed-type reactions of humans or domestic animals, occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur. 4. Data must be submitted only for products whose activ… | ||||
| 40:40:26.0.1.1.9.18.1.6 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2150 Microbial pesticides nontarget organisms and environmental fate data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. (b) Use patterns. Aquatic uses include: food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food and food), Indoor (food and nonfood), and Industrial. (c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table: (d) Table. The following table shows the data requirements for microbial pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section. Table—Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements (e) Test notes. The following test notes are applicable to the data requirements for microbial pesticides nontarget organism and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section. 1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors. 2. The preferred species for the avian oral study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and the avian chronic toxicity/pathogenicity study is the upland game. There is also the option to test the passerine if th… | ||||
| 40:40:26.0.1.1.9.18.1.7 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2160 Microbial pesticides product performance data requirements. | EPA | [87 FR 22484, Apr. 15, 2022] | (a) General. Product performance data must be developed for all microbial pesticides. Each applicant must ensure through testing that the product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency may require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment. (b) Product performance data for each product that bears a claim against an invertebrate pest that is covered by subpart R of this part. The product performance data requirements and the performance standards of subpart R of this part apply to microbial products covered by this subpart. Product performance data must be submitted with any application for registration or amended registration. However, data requirements and the performance standards that determine the acceptability of data may be modified on a case-by-case basis pursuant to the waiver provisions in § 158.45 and the provisions in § 158.1707. (c) Product performance data for each product that bears a public health pest claim, excluding those covered under paragraph (b). Product performance data must be submitted with any application for registration or amended registration, if the product bears a claim to control public health pests, such as pest microorganisms infectious to humans in any area of the inanimate environment, or a claim to control vertebrates, including but not limited to, rodents, birds, bats, canids, and skunks. | |||
| 40:40:26.0.1.1.9.18.1.8 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2170 Experimental use permit data requirements—microbial pesticides. | EPA | (a) For all microbial pesticides. (1) The following §§ 158.2171 through 158.2174 identify the data requirements that are required to support experimental use permits for microbial pesticides. The variations in the test conditions are identified within the test notes. (2) For general information on the data requirement tables, see § 158.2110(a)(2)-(4). (b) Additional data requirements for genetically modified microbial pesticides. Additional requirements for genetically modified microbial pesticides may include but are not limited to: genetic engineering techniques used; the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene); information on the control region of the gene in question; a description of the “new” traits or characteristics that are intended to be expressed; tests to evaluate genetic stability and exchange; and selected Tier II environmental expression and toxicology tests. | ||||
| 40:40:26.0.1.1.9.18.1.9 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | V | Subpart V—Microbial Pesticides | § 158.2171 Experimental use permit microbial pesticides product analysis data requirements table. | EPA | [72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52613, Aug. 30, 2012] | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section. (b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. (c) Table. The table in this paragraph shows the data requirements for experimental use permit microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section. Table—EUP Microbial Pesticides Product Analysis Data Requirements (d) Test notes. The following test notes are applicable to the data requirements for experimental use permit microbial pesticides product analysis as referenced in the last column of the table contained in paragraph (c) of this section. 1. If an experimental use permit is being sought, and if the pesticide is not already under full-scale production, a schematic diagram and/or description of the manufacturing process suffices. 2. If an experimental use permit is being sought, and if the product is not already under full-scale production, a discussion of unintentional ingredients is required to be submitted to the extent this information is available. 3. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated experimental use permit(s). 4. Required to support registration of each manufacturing-use product and end-use product. This analysis must be conducted at the point in the production process after which there would be no potential for microbial contamination or microbial regrowth. For pesticides in the… | |||
| 40:40:26.0.1.1.9.19.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2200 Applicability. | EPA | [78 FR 26978, May 8, 2013, as amended at 87 FR 22484, Apr. 15, 2022] | Part 158, subpart W establishes data requirements for any pesticide product that is: (a) A pesticide that is intended for use as an “antimicrobial pesticide” within the meaning of FIFRA sec. 2(mm)(1)(A), regardless of whether it also meets the criterion of FIFRA sec. 2(mm)(1)(B). That criterion excludes from the definition any antimicrobial product that is intended for a food-use requiring a tolerance or exemption under FFDCA sec. 408 or a food additive regulation or clearance under FFDCA sec. 409. EPA will apply this subpart to all products intended for an antimicrobial use, purpose or function; the exclusion in FIFRA sec. 2(mm)(1)(B) does not exclude products from the data requirements of this subpart. (b) A product that bears both antimicrobial and non-antimicrobial uses or claims is subject to the data requirements for pesticides in subparts C through O, R, and U or V of this part with respect to its non-antimicrobial uses and claims, and to the requirements of this subpart with respect to its antimicrobial uses and claims. (c) A wood preservative, including a product that is intended to prevent wood degradation problems due to fungal rot or decay, sapstain, or molds. (d) An antifoulant, including a product that is intended to kill or repel organisms that can attach to underwater surfaces, such as boat bottoms. | ||||
| 40:40:26.0.1.1.9.19.1.10 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2260 Applicator exposure. | EPA | (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (d) of this section to determine the applicator exposure data requirements for antimicrobial pesticide products. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (e) of this section. (1) The Agency may accept surrogate exposure data estimations and/or modeling estimations from other sources to satisfy exposure data requirements. The surrogate data must meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. To be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address the applicable exposure data requirements and contain adequate monitoring events of acceptable quality. The data must reflect the specific use prescribed on the label and the activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. (2) Occupational uses include not only handlers, mixers, loaders, and applicators, but also commercial applications to residential sites. Residential uses are limited to non-occupational, i.e. , non-professional, antimicrobial applications. Both occupational and residential applicator data may be required for the same product. (b) Criteria for testing. Applicator exposure data described in the table to paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if at least one of the toxicity criteria in paragraph (b)(1) of this section, and at least one of the exposure criteria in paragraph (b)(2) of this section are met. (1) Toxicity criteria. (i) Evidence of potentially significant adverse effects have been observed in any applicable toxicity studies. (ii) Scientifically sound epidemiological or poisoning incident data with a clear cause-effect relationship indicating that adverse health effects may have… | |||||
| 40:40:26.0.1.1.9.19.1.11 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2270 Post-application exposure. | EPA | (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (d) of this section to determine the post-application exposure data requirements for antimicrobial pesticide products. The data generated during these studies are used to determine the quantity of pesticide to which people may be exposed after application. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions to the designated test, are listed in paragraph (e) of this section. (1) Post-application exposure data are required when certain toxicity criteria are met and the human activities associated with the pesticide's use pattern can lead to potential adverse exposures. (2) The Agency may accept surrogate exposure data estimations and/or modeling estimations from other sources to satisfy exposure data requirements. The surrogate data must meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. To be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address the applicable exposure data requirements and contain adequate monitoring events of acceptable quality. The data must reflect the specific use prescribed on the label and the activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. (b) Criteria for testing. Post-application exposure data described in the table to paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if at least one of the toxicity criteria in paragraph (b)(1) of this section, and at least one of the exposure criteria in paragraph (b)(2) of this section are met. (1) Toxicity criteria. (i) Evidence of potentially significant adverse effects have been observed in any applicable toxicity studies. (ii) Scientifically sound epidemiological or poisoning incident data with a clear cause-effect relationship indic… | |||||
| 40:40:26.0.1.1.9.19.1.12 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2280 Environmental fate. | EPA | (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (c) of this section to determine the environmental fate data requirements for antimicrobial pesticide products. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (d) of this section. (1) Environmental fate data are required to support the registrations of all end-use and manufacturing-use antimicrobial products. (2) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation products or leachate residues meet one of the following criteria: (i) More toxic, persistent, or bioaccumulative than the parent; (ii) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or (iii) The moiety of concern ( i.e. , functional group in the parent chemical molecule that imparts adverse effects) remains intact. (3) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns: (i) Agricultural premises and equipment. (ii) Food-handling/storage establishments, premises, and equipment. (iii) Commercial, institutional and industrial premises and equipment. (iv) Residential and public access premises. (v) Medical premises and equipment. (vi) Human drinking water systems. (vii) Materials preservatives. (viii) Swimming pools. (b) Key. MP = Manufacturing use product; EP = End-use product; R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; PAIRA = Pure active ingredient radiolabeled; ROC = residue of concern. (c) Antimicrobial environmental fate data requirements table. The following table shows the data requirements for environmental fate. The test notes appear in paragraph (d) of this section. Table—Antimicrobial Environmental Fate Data Requirements (d) Test notes.… | |||||
| 40:40:26.0.1.1.9.19.1.13 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2290 Residue chemistry. | EPA | (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (h) of this section to determine the residue chemistry data requirements for antimicrobial pesticide products. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (i) of this section. (b) Residue chemistry data are required for: (1) Antimicrobial end-use products with uses that may result in residues in or on food, including but not limited to: (i) Products that require a tolerance, tolerance exemption, or food additive regulation or clearance. (ii) Products that may be used to treat livestock or poultry drinking water, for food egg washing, or for fruit and vegetable rinses. (iii) Products that may be applied to a surface or incorporated into a material that may contact food or feed. Data are required regardless of whether the antimicrobial is applied or impregnated for the purpose of imparting antimicrobial protection to external surfaces of the substance or article, or for the purpose of protecting the substance or article itself. (iv) Products that may be applied to water that have the potential to result in residues in potable water, or in water used for livestock and poultry drinking water, irrigation of crops, or water containing fish that may be used for human food. (v) Wood preservative or antifoulant products intended for treating submerged materials that may result in food contact (e.g., lobster pots, fish cages on fish farms). (2) Each manufacturing-use product bearing directions for formulation into an end-use product bearing uses described in paragraph (b)(1) of this section. (c) Residue chemistry data are not required under paragraph (b) of this section if no adverse effects (no toxicity endpoints) are associated with dietary exposure to the active ingredient or if theoretical (high-end) dietary exposure estimates combined with the applicable toxicity endpoint result in acute and chronic dietary risks that are below the Agen… | |||||
| 40:40:26.0.1.1.9.19.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2201 Antimicrobial use patterns. | EPA | (a) Antimicrobial use patterns. The 12 general use patterns used in the data tables in this subpart are: (1) Agricultural premises and equipment. (2) Food-handling/storage establishments, premises and equipment. (3) Commercial, institutional and industrial premises and equipment. (4) Residential and public access premises. (5) Medical premises and equipment. (6) Human drinking water systems. (7) Materials preservatives. (8) Industrial processes and water systems. (9) Antifoulant paints and coatings. (10) Wood preservatives. (11) Swimming pools. (12) Aquatic areas. (b) Use site index. The Pesticide Use Site Index for Antimicrobial Pesticides is a comprehensive list of specific antimicrobial use sites. The Index associates antimicrobial use sites with one or more of the 12 antimicrobial use patterns. It is to be used in conjunction with the data tables in this subpart to determine the applicability of data requirements to specific uses. The Antimicrobial Pesticide Use Site Index, which will be updated periodically, is available from the Agency or may be obtained from the Agency's Web site at http://www.epa.gov/pesticides. | |||||
| 40:40:26.0.1.1.9.19.1.3 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2203 Definitions. | EPA | The following terms are defined for the purposes of this subpart: Disinfectant means a substance, or mixture of substances, that destroys or irreversibly inactivates bacteria, fungi and viruses, but not necessarily bacterial spores, in the inanimate environment. Fungicide means a substance, or mixture of substances, that destroys fungi (including yeasts) and fungal spores pathogenic to man or other animals in the inanimate environment. Microbiological water purifier means any unit, water treatment product or system that removes, kills or inactivates all types of disease-causing microorganisms from the water, including bacteria, viruses and protozoan cysts, so as to render the treated water safe for drinking. Sanitizer means a substance, or mixture of substances, that reduces the bacteria population in the inanimate environment by significant numbers, but does not destroy or eliminate all bacteria. Sanitizers meeting Public Health Ordinances are generally used on food contact surfaces and are termed sanitizing rinses. Sterilant means a substance, or mixture of substances, that destroys or eliminates all forms of microbial life in the inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses. Tuberculocide means a substance, or mixture of substances, that destroys or irreversibly inactivates tubercle bacilli in the inanimate environment. Virucide means a substance, or mixture of substances, that destroys or irreversibly inactivates viruses in the inanimate environment. | |||||
| 40:40:26.0.1.1.9.19.1.4 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2204 Public health and nonpublic health claims. | EPA | (a) Public health claim. An antimicrobial pesticide is considered to make a public health claim if the pesticide product bears a claim to control pest microorganisms that pose a threat to human health, and whose presence cannot readily be observed by the user, including but not limited to, microorganisms infectious to man in any area of the inanimate environment. A product makes a public health claim if one or more of the following apply: (1) A claim is made for control of specific microorganisms that are directly or indirectly infectious or pathogenic to man (or both man and animals). Examples of specific microorganisms include, but are not limited to: Mycobacterium tuberculosis, Pseudomonas aeruginosa, Escherichia coli (E. coli), human immunodeficiency virus (HIV), Streptococcus, and Staphylococcus aureus. Claims for control of microorganisms infectious or pathogenic only to animals (such as canine distemper virus or hog cholera virus) are not considered public health claims. (2) A claim is made for the pesticide product as a sterilant, disinfectant, virucide, sanitizer, or tuberculocide against microorganisms that are infectious or pathogenic to man. (3) A claim is made for the pesticide product as a fungicide against fungi infectious or pathogenic to man, or the product does not clearly state that it is intended for use only against nonpublic health fungi. (4) A claim is made for the pesticide product as a microbiological water purifier or microbial purification system. (5) A non-specific claim is made that the pesticide product will beneficially impact or affect public health at the site of use or in the environment in which it is applied, and: (i) The pesticide product contains one or more ingredients that, under the criteria in 40 CFR 153.125(a), is an active ingredient with respect to a public health microorganism and there is no other functional purpose for the ingredient in the product; or (ii) The pesticide product is similar in composition to a registered pesticide product that makes anti… | |||||
| 40:40:26.0.1.1.9.19.1.5 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2210 Product chemistry. | EPA | The product chemistry data requirements of subpart D of this part apply to antimicrobial products covered by this subpart. | |||||
| 40:40:26.0.1.1.9.19.1.6 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2220 Product performance. | EPA | (a) General —(1) Product performance requirement for all antimicrobial pesticides. Each applicant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency may require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment. (2) Product performance data for each product that bears a public health claim. Each product that bears a public health claim, as described in § 158.2204(a), must be supported by product performance data, as listed in the table in paragraph (c) of this section. Product performance data must be submitted with any application for registration or amended registration. (3) Product performance data for each product that bears a nonpublic health claim. Each product that bears a nonpublic health claim, as described in § 158.2204(b), must be supported by product performance data. Each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted practices. The Agency reserves the right to require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment. (4) Determination of data requirements. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (c) of this section to determine the product performance data requirements for antimicrobial pesticide products. (b) Key. R = Required; EP = End-use product. (c) Antimicrobial product performance data requirements table. The following table shows the data requirements for antimicrobial product performance. Table—Antimicrobial Product Performance Data Requirements | |||||
| 40:40:26.0.1.1.9.19.1.7 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2230 Toxicology. | EPA | [78 FR 26978, May 8, 2013, as amended at 84 FR 18996, May 3, 2019] | (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (g) of this section to determine the toxicology data requirements for an antimicrobial pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions are listed in paragraph (h) of this section. (b) Uses. The applicant for registration must first determine whether the use is likely to result in pesticide residues in food or water and therefore consult the “Food Use” columns of the table in paragraph (g) of this section. Generally, if the residues of the antimicrobial result from an application to a surface or if incorporated into a material that may come into contact with food or feed, and residues may be expected to transfer to such food or feed, then the “Indirect Food Uses” columns is to be consulted. (c) Tiering of data requirements. Applicants for registration of antimicrobials may perform tests in a tiered fashion. After the initially required tests are conducted, additional testing may be required if results of the initial tests trigger the need for additional data. Conditions that trigger the need for additional data are given in the test notes in paragraph (h) of this section. (d) 200 parts per billion (ppb). The 200 ppb level was originally used by the Food and Drug Administration with respect to the concentration of residues in or on food for tiering of data requirements for indirect food use biocides. The Agency has also adopted this same residue level for determining toxicology data requirements for indirect food uses of antimicrobial pesticides. The 200 ppb level is the concentration of antimicrobial residues in the total estimated daily dietary intake. (e) Use of OSHA standards. If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration (OSHA standards), provide adequate protection for a particular pesticide or a particular use pattern, additional toxicity data m… | ||||
| 40:40:26.0.1.1.9.19.1.8 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2240 Nontarget organisms. | EPA | (a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (c) of this section to determine the terrestrial and aquatic nontarget organisms data requirements for a particular antimicrobial pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions are listed in paragraph (d) of this section. (1) Terrestrial and aquatic nontarget organism data are required to support the registration of most end-use and manufacturing-use antimicrobial products. (2) Data are generally not required to support end-use products of a gas, highly volatile liquid, highly reactive solid, or a highly corrosive material. (3) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation/degradation products or leachate residues meet one of the following criteria: (i) More toxic, persistent, or bioaccumulative than the parent; (ii) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or (iii) The moiety of concern ( i.e. , functional group in the parent chemical molecule that imparts adverse effects) remains intact. (4) If an antimicrobial may be applied to a field crop, horticultural crop, or turf, then the data requirements in § 158.630 apply. (5) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns: (i) Agricultural premises and equipment. (ii) Food-handling/storage establishments, premises, and equipment. (iii) Commercial, institutional and industrial premises and equipment. (iv) Residential and public access premises. (v) Medical premises and equipment. (vi) Human drinking water systems. (vii) Materials preservatives. (viii) Swimming pools. (b) Key. MP = Manufacturing use product; EP = End-use product; R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typ… | |||||
| 40:40:26.0.1.1.9.19.1.9 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | W | § 158.2250 Nontarget plant protection. | EPA | (a) Subpart B of this part and § 158.2201 describe how to use the table in paragraph (f) of this section to determine the nontarget plant protection data requirements for a particular antimicrobial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (g) of this section. (b) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation products or leachate residues meet one of the following criteria: (1) More toxic, persistent, or bioaccumulative than the parent; (2) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or (3) The moiety of concern ( i.e. , functional group in the parent chemical molecule that imparts adverse effects) remains intact. (c) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns: (1) Agricultural premises and equipment. (2) Food-handling/storage establishments, premises, and equipment. (3) Commercial, institutional and industrial premises and equipment. (4) Residential and public access premises. (5) Medical premises and equipment. (6) Human drinking water systems. (7) Materials preservatives. (8) Swimming pools. (d) If an antimicrobial may be applied to a field crop, horticultural crop, or turf, then the data requirements in § 158.660 apply. (e) Key. MP = Manufacturing use product; EP = End-use product; R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. (f) Nontarget plant protection data requirements table. The following table shows the data requirements for nontarget plant protection. The test notes appear in paragraph (g) of this section. Table—Nontarget Plant Protection Data Requirements (g) Test notes. The following test notes apply to the data requirements in the table to para… | |||||
| 40:40:26.0.1.1.9.2.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | B | Subpart B—How To Use Data Tables | § 158.100 Pesticide use patterns. | EPA | [72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013] | (a) General use patterns for conventional, biochemical, and microbial pesticides. There are six broad use categories used in the data tables. The six broad categories include terrestrial outdoor uses, aquatic outdoor uses, greenhouse uses, forestry uses, residential outdoor uses, and indoor uses of all types. The 6 broad use categories are further subdivided into 12 general use patterns which are the bases for data requirements established by use pattern. Within the data tables, general use patterns have been combined into single columns when the data requirements are the same for the combined uses. If there are no data requirements for a specific use, the column for that use is not included in the table. The 12 general use pattern groups used in the data table in this part are: (1) Terrestrial food crop use. (2) Terrestrial feed crop use. (3) Terrestrial nonfood crop use. (4) Aquatic food crop use. (5) Aquatic nonfood use. (6) Greenhouse food crop use. (7) Greenhouse nonfood crop use. (8) Forestry use. (9) Residential outdoor use. (10) Residential indoor use. (11) Indoor food use. (12) Indoor nonfood use. (b) Pesticide use site index for conventional, biochemical, and microbial pesticides. The Pesticide Use Site Index for Conventional, Biochemical, and Microbial Pesticides is a comprehensive list of specific pesticide use sites. The index is alphabetized separately by site for all agricultural and all nonagricultural uses. The Pesticide Use Site Index associates each pesticide use site with one or more of the 12 general use patterns. It may be used in conjunction with the data tables to determine the applicability of data requirements to specific uses. The Pesticide Use Site Index for Conventional, Biochemical, and Microbial Pesticides will be updated periodically, and is available from the Agency or may be obtained from the Agency's Web site at http://www.epa.gov/pesticides. (c) Antimicrobial pesticide use patterns. The general use patterns for antimicrobial pesticides are described in § 15… | |||
| 40:40:26.0.1.1.9.2.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | B | Subpart B—How To Use Data Tables | § 158.110 Required and conditionally required data. | EPA | The tables in this part use the descriptors R (required), CR (conditionally required), and NR (not required) as a general indication of the applicability of a data requirement. In all cases, the test notes referred to in the table must be consulted to determine the actual applicability of the data requirement. (a) EPA requires data designated as “required”(R) for products with a given use pattern in order to evaluate the risks or benefits of a product having that use pattern under any conditions established by the test notes. (b) Data designated as “conditionally required” (CR) for products with a given use pattern are required by EPA to evaluate the risks or benefits of a product having that use pattern if the product meets the conditions specified in the notes accompanying the requirement. The determination of whether the data must be submitted is based on the product's use pattern, physical or chemical properties, expected exposure of nontarget organisms, and/or results of previous testing (for example, tier testing). Applicants must evaluate each applicable test note for the conditions and criteria to be considered in determining whether conditionally required data must be submitted. (c) Data not required for the Agency's assessment of the risks and benefits of a particular use pattern are designated “not required” (NR) in data tables. | ||||
| 40:40:26.0.1.1.9.2.1.3 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | B | Subpart B—How To Use Data Tables | § 158.120 Determining data requirements. | EPA | As with current practice, the actual data and studies required may be modified on an individual basis to fully characterize the use and properties of specific pesticide products under review. While EPA is attempting to assist the applicant in this subpart, it is important to emphasize that it is the applicant's obligation under FIFRA to demonstrate that an individual product meets the standard under FIFRA and/or FFDCA. Accordingly, applicants are encouraged to consult with the Agency on the appropriate data requirements as set forth here as they relate to their specific product prior to and during the registration process. (a) Finding the appropriate data table. (1) Pesticide data requirements for conventional chemical active ingredients and related substances are presented in subparts D, E, F, G, K, L, N, and O of this part in the form of a series of data tables, each addressing a particular scientific discipline or data topic. Data requirements for biochemical and microbial pest control agents are contained and are described separately within subparts U and V of this part, respectively. (2) Key to table notations. R = required data; CR = conditionally required data; NR = Not required; MP = manufacturing-use product; EP = end-use product; TEP = typical end-use product; TGAI = technical grade of the active ingredient; PAI = pure active ingredient; PAIRA = pure active ingredient, radiolabeled; Choice = choice of several test substances depending on studies required. (b) Identifying required studies. To determine the specific kinds of data needed to support the registration use of each pesticide product, the applicant may: (1) Refer to the applicable subpart(s) of this part. These subparts describe the data requirements including data tables for each subject area. (2) Select the general use pattern(s) that best cover the use pattern(s) specified on the pesticide product label as explained in § 158.100. All applicable use patterns must be included. (3) Proceed down the appropriate general use pattern colum… | ||||
| 40:40:26.0.1.1.9.2.1.4 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | B | Subpart B—How To Use Data Tables | § 158.130 Purposes of the registration data requirements. | EPA | (a) General. The data requirements for registration are intended to generate data and information necessary to address concerns pertaining to the identity, composition, potential adverse effects and environmental fate of each pesticide. (b) Product chemistry —(1) Product composition. Data on product composition are needed: (i) To support the conclusions expressed in the statement of formula; (ii) To compare to the composition of materials used in required testing under this part; and (iii) To determine whether a product is “identical or substantially similar”to another product, a determination that involves the comparison of product composition. (2) Nominal concentration and certified limits. The nominal concentration of a product, defined as that concentration that is expected to be present in a product as a result of the production or formulation process, is used to gauge the acceptability of the certified limits, which define the outer limits of the range of the product's ingredients. The certified limits are used to enforce the composition of the product and to ensure the accuracy of hazard assessments. (3) Physical and chemical characteristics. The physical and chemical characteristics of an active ingredient or product are used: (i) To confirm or provide supportive information on the identity and composition of the product; (ii) To assess the hazards of the ingredient or product; and (iii) To trigger or evaluate certain other studies required by this part. (c) Product performance. Requirements to develop data on product performance provide a mechanism to ensure that pesticide products will perform as intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. Specific performance standards are used to validate the efficacy data in the public health areas, including disinfectants used to control microorganisms infectious to man in any area of the inanimate environment and those pesticides used to control vertebrates (… | ||||
| 40:40:26.0.1.1.9.21.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | X | Subparts X-Z [Reserved] | §§ 158.2300-158.2500 [Reserved] | EPA | |||||
| 40:40:26.0.1.1.9.3.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.200 Experimental use permit data requirements tables. | EPA | Sections 158.200 through 158.270 describe how to use these tables to determine the experimental use permit data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed at the end of each table. Refer to 40 CFR part 172 for further information on experimental use permits. | ||||
| 40:40:26.0.1.1.9.3.1.10 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | §§ 158.280-158.290 [Reserved] | EPA | |||||
| 40:40:26.0.1.1.9.3.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.210 Experimental use permit data requirements for product chemistry. | EPA | All product chemistry data, as described in § 158.310, must be submitted to support a request for an experimental use permit. | ||||
| 40:40:26.0.1.1.9.3.1.3 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.220 Experimental use permit data requirements for product performance. | EPA | [72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008] | All product performance data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit. (a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use. (2) Data are also required for forestry and residential outdoor uses. (b) Key. CR = Conditionally required; NR = Not required; R = Required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product. (c) Table. The following table shows the experimental use data requirements for product performance. The test notes are shown in paragraph (d) of this section. Table—Experimental Use Permit Data Requirements for Product Performance (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section. 1. The Agency has waived the requirement to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment, or a claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy … | |||
| 40:40:26.0.1.1.9.3.1.4 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.230 Experimental use permit data requirements for toxicology. | EPA | [72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008] | All toxicology data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit. (a) Use patterns. (1) Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use. (2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use, aquatic nonfood crop use, aquatic nonfood outdoor use, greenhouse nonfood crop use, forestry use, residential outdoor use, indoor nonfood use, and indoor residential use. (b) Key. CR = Conditionally required; NR = Not required; R = Required; EP = End-use product; MP = Manufacturing-use product; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient. (c) Table. The following table shows the experimental use data requirements for toxicology. The test notes are shown in paragraph (d) of this section. Table—Experimental Use Permit Toxicity Data Requirements (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section. 1. Not required if test material is a gas or a highly volatile liquid. 2. Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5. 3. Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate). 4. Required if repeated dermal exposure is likely to occur under conditions of use. 5. Required if the test material is an organophosphorus substance, which includes uncharged organophosphorus esters, thioesters, or anhydrides of organophosphoric, organophosphonic, or organophosphoramidic acids, or of related phosphorothioic, phosponothioic, or phosphorothioamidic acids, or is structurally related to other substances that may cause the delayed neurotoxicity sometimes seen in this class of che… | |||
| 40:40:26.0.1.1.9.3.1.5 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.240 Experimental use permit data requirements for ecological effects. | EPA | All data for terrestrial nontarget organisms and aquatic nontarget organisms as described in § 158.243 must be submitted to support a request for an experimental use permit. No data for nontarget plant protection must be submitted to support a request for an experimental use permit. | ||||
| 40:40:26.0.1.1.9.3.1.6 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.243 Experimental use permit data requirements for terrestrial and aquatic nontarget organisms. | EPA | [72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008] | All terrestrial and aquatic nontarget organism data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit. (a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and indoor nonfood use. (2) Data are also required for the general use patterns of forestry and residential outdoor use. (b) Key. CR = Conditionally required; NR = Not required; R = Required; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; commas between the test substances (e.g. TGAI, TEP) indicate that data may be required on the TGAI or TEP depending on the conditions set forth in the test note. (c) Table. The following table shows the experimental use data requirements for terrestrial and aquatic nontarget organisms. The test notes are shown in paragraph (d) of this section. Table—Experimental Use Permit Terrestrial and Aquatic Nontarget Organism Data Requirements (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section. 1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to, turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile liquid, a highly reactive solid, or a highly corrosive material. 2. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated into these same end-use products or to support end-use prod… | |||
| 40:40:26.0.1.1.9.3.1.7 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.250 Experimental use permit data requirements for human exposure. | EPA | No data for applicator exposure and post-application exposure must be submitted to support a request for an experimental use permit. | ||||
| 40:40:26.0.1.1.9.3.1.8 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.260 Experimental use permit data requirements for environmental fate. | EPA | [72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008] | All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit. (a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes the general use patterns of aquatic food crop, aquatic nonfood residential, and aquatic nonfood outdoors. The greenhouse use pattern includes both food and nonfood uses. The indoor use pattern includes food, nonfood, and residential indoor uses. (2) Data are also required for the general use patterns of forestry use and residential outdoor use. (b) Key. CR = Conditionally required; NR = Not required; R = Required; PAIRA = Pure active ingredient radio-labeled; TGAI = Technical grade of the active ingredient. (c) Table. The following table shows the experimental use data requirements for environmental fate. The test notes are shown in paragraph (d) of this section. Table—Experimental Use Permit Environmental Fate Data Requirements (d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section. 1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives. 2. Required for aquatic uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to cranberry bogs and rice paddies. 3. Adsorption and desorption using a batch equilibrium method is preferred. However, in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products. 1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites inc… | |||
| 40:40:26.0.1.1.9.3.1.9 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | C | Subpart C—Experimental Use Permits | § 158.270 Experimental use permit data requirements for residue chemistry. | EPA | All residue chemistry data, as described in § 158.1410, are required for an experimental use permit for which a temporary tolerance under FFDCA section 408(r) is sought. Residue chemistry data are not required for an experimental use permit issued on a crop-destruct basis. | ||||
| 40:40:26.0.1.1.9.4.1.1 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | D | Subpart D—Product Chemistry | § 158.300 Definitions. | EPA | The following terms are defined for the purposes of this subpart: Active ingredient means any substance (or group of structurally similar substances, if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, defoliant, or nitrogen stabilizer, within the meaning of FIFRA sec. 2(b). End-use product means a pesticide product whose labeling: (1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating or regulating growth of plants, or as a nitrogen stabilizer, and (2) does not state that the product may be used to manufacture or formulate other pesticide products. Formulation means: (1) The process of mixing, blending, or dilution of one or more active ingredients with one or more other active or inert ingredients, without an intended chemical reaction, to obtain a manufacturing-use product or an end-use product, or (2) The repackaging of any registered product. Impurity means any substance (or group of structurally similar substances if specified by the Agency), in a pesticide product other than an active ingredient or an inert ingredient, including unreacted starting materials, side reaction products, contaminants, and degradation products. Impurity associated with an active ingredient means: (1) Any impurity present in the technical grade of active ingredient; and (2) Any impurity which forms in the pesticide product through reactions between the active ingredient and any other component of the product or packaging of the product. Inert ingredient means any substance (or group of structurally similar substances if designated by the Agency), other than the active ingredient, which is intentionally included in a pesticide product. Integrated system means a process for producing a pesticide product that: (1) Contains any active ingredient derived from a source that is not an EPA-registered product; or (2… | ||||
| 40:40:26.0.1.1.9.4.1.10 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | D | Subpart D—Product Chemistry | § 158.355 Enforcement analytical method. | EPA | An analytical method suitable for enforcement purposes must be provided for each active ingredient in the product and for each other ingredient or impurity that the Agency determines to be toxicologically significant. | ||||
| 40:40:26.0.1.1.9.4.1.2 | 40 | Protection of Environment | I | E | 158 | PART 158—DATA REQUIREMENTS FOR PESTICIDES | D | Subpart D—Product Chemistry | § 158.310 Product chemistry data requirements table. | EPA | (a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (f) of the section. (b) Use patterns. Product chemistry data are required for all pesticide products and are not use-specific. (c) Test substance. Data requirements that list only the manufacturing-use product as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added. (d) Key. R = Required; CR = Conditionally required; MP = Manufacturing-use product; NR = Not required; EP = End-use product; TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient. (e) Table. The following table shows the data requirements for product chemistry. The table notes are shown in paragraph (f) of this section. Product Chemistry Data Requirements (f) Test notes. The following test notes are applicable to the product chemistry data requirements in the table to paragraph (e) of this section: 1. Data must be provided in accordance with § 158.320. 2. Data must be provided in accordance with § 158.325. 3. Data must be provided in accordance with § 158.330. 4. Data must be provided in accordance with § 158.335. 5. Data must be provided in accordance with § 158.340. 6. Data must be provided in accordance with § 158.345. 7. Data must be provided in accordance with § 158.350. 8. Data must be provided in accordance with § 158.355. 9. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI. 10. Data are required if the product is produced by an integrated system. 11. Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a product produced by an integrated system… |
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