PART 174—PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371. Source: 66 FR 37814, July 19, 2001, unless otherwise noted. Subpart A—General Provisions § 174.1 Scope and purpose. The characteristics of plant-incorporated protectants such as their production and use in plants, their biological properties, and their ability to spread and increase in quantity in the environment distinguish them from traditional chemical pesticides. Therefore, plant-incorporated protectants are subject to some different regulatory requirements and procedures than traditional chemical pesticides. This part sets forth regulatory requirements, criteria, and procedures applicable to plant-incorporated protectants under FIFRA and FFDCA. When applied to plant-incorporated protectants, the definitions and regulations in this part supersede the regulations found in parts 150 through 180 of this chapter to the extent that the regulations conflict. Unless otherwise superseded by this part, the regulations in parts 150 through 180 of this chapter apply to plant-incorporated protectants. § 174.3 Definitions. Terms used in this part have the same meaning as in FIFRA. In addition, the following terms have the meaning set forth in this section. Active ingredient Administrator Bridging crosses between plants Cell fusion in vitro Conventional breeding i.e. EPA Exudate FFDCA et seq. FIFRA et seq. Food Food plant in toto, Gene, Genetic engineering Genetic material necessary for the production Genome In a living plant Inert ingredient, Living plant Loss-of-function plant-incorporated protectant i.e., Native allele Native gene Noncoding, nonexpressed nucleotide sequences Nucleic acids Pesticidal substance, Plant, Plant-incorporated protectant Produce thereof, Recipient plant Recombinant DNA in vitro Regulatory region Sexually compatible, Source Vegetative reproduction (1) In seed plants, reproduction by apomixis, or (2) In other plants, reproduction by fragmentation, or division of the somatic body. Wide crosses in vitro [66 FR 37814, July 19, 2001, as amended at 88 FR 34776, May 31, 2023] § 174.9 Confidential business information claims for plant-incorporated protectant submissions. Although it is strongly recommended that the submitter minimize the amount of data and other information claimed as Confidential Business Information (CBI), a submitter may assert a claim of confidentiality for all or part of the information submitted to EPA in a submission for a plant-incorporated protectant. (See part 2, subpart B of this chapter.) To assert such a claim, the submitter must comply with all of the following procedures: (a) Any claim of confidentiality must accompany the information at the time the information is submitted to EPA. Failure to assert a claim at that time constitutes a waiver of confidentiality for the information submitted, and the information may be made available to the public, subject to section 10(g) of FIFRA, with no further notice to the submitter. (b) Any claim of confidentiality must be accompanied, at the time the claim is made, by comments substantiating the claim and explaining why the submitter believes that the information should not be disclosed. The submitter must address each of the points listed in § 2.204(e)(4) of this chapter in the substantiation. EPA will consider incomplete all plant-incorporated protectant submissions containing information claimed as CBI that are not accompanied by substantiation, and will suspend any applicable review of such submissions until the required substantiation is provided. Subpart B—Exemptions § 174.21 General qualifications for exemptions. A plant-incorporated protectant is exempt from the requirements of FIFRA, other than the requirements of § 174.71, if it meets the exemption criteria in paragraphs (a) through (d) of this section. Plant-incorporated protectants that are not exempt from the requirements of FIFRA under this subpart are subject to all the requirements of FIFRA. (a) The active ingredient of the plant-incorporated protectant meets the exemption criteria listed in at least one of the sections in §§ 174.25 through 174.50. (b) When the plant-incorporated protectant is intended to be produced and used in a crop used as food, the residues of the active ingredient of the plant-incorporated protectant are either exempted from the requirement of a tolerance under FFDCA (21 U.S.C. 321 et seq. (c) Any inert ingredient that is part of the plant-incorporated protectant is listed as an approved inert ingredient in subpart X of this part. (d) For plant-incorporated protectants listed in the subparagraphs below, the exemption applies only if the developer is compliant with the general recordkeeping requirements specified in § 174.73 per sections 8 and 9 of FIFRA, 7 U.S.C. 136f and 136g, and only after compliance with the relevant eligibility determination procedures specified in § 174.90: (1) Plant-incorporated protectant created through genetic engineering from a sexually compatible plant. (2) Loss-of-function plant-incorporated protectant. [88 FR 34776, May 31, 2023] § 174.25 Active ingredient of a plant-incorporated protectant from a sexually compatible plant created through conventional breeding. The active ingredient is exempt if all of the following conditions are met: (a) The genetic material that encodes the pesticidal substance or leads to the production of the pesticidal substance is from a plant that is sexually compatible with the recipient plant. (b) The genetic material has never been derived from a source that is not sexually compatible with the recipient plant. (c) The genetic material is transferred from the source plant to the recipient plant only through conventional breeding. [66 FR 37814, July 19, 2001, as amended at 88 FR 34777, May 31, 2023] § 174.26 Active ingredient of a plant-incorporated protectant created through genetic engineering from a sexually compatible plant. The active ingredient is exempt if the conditions in paragraphs (a) and (b) of this section are met. (a) The active ingredient is characteristic of the population of plants sexually compatible with the recipient plant and is created through genetic engineering from either an insertion of a native gene into the recipient plant as specified in paragraph (a)(1) of this section or a modification of an existing native gene in the recipient plant as specified in paragraph (a)(2) of this section. (1) Insertion. (2) Modification. (b) This exemption does not apply until the requirements in § 174.21(d) have been met. [88 FR 34777, May 31, 2023] § 174.27 Active ingredient of a loss-of-function plant-incorporated protectant. The active ingredient is exempt if the following conditions are met: (a) The genetic material of a native gene is modified using genetic engineering to result in a pesticidal effect through the reduction or elimination of the activity of that gene; and (b) This exemption does not apply until the requirements in § 174.21(d) have been met. [88 FR 34777, May 31, 2023] Subpart C—Registration Procedures and Requirements [Reserved] Subpart D—Monitoring and Recordkeeping § 174.71 Submission of information regarding adverse effects. (a) Any person who produces, for sale or distribution, a plant-incorporated protectant exempt under subpart B of this part, who obtains any information regarding adverse effects on human health or the environment alleged to have been caused by the plant-incorporated protectant must submit such information to EPA. This requirement does not apply to any person who does not produce a plant-incorporated protectant exempt under subpart B of this part. This may include, for example, researchers performing field experiments, breeders making crosses among plant varieties with the goal of developing new plant varieties, or a person who only sells propagative materials (e.g., seed) to farmers without producing the propagative materials themselves. EPA must receive the report within 30 calendar days of the date the producer first possesses or knows of the information. (b) Adverse effects on human health or the environment for purposes of plant-incorporated protectant means at a minimum information about incidents affecting humans or other nontarget organisms where both: (1) The producer is aware, or has been informed, that a person or nontarget organism allegedly suffered a toxic or adverse effect due to exposure to (e.g., ingestion of) a plant-incorporated protectant. (2) The producer has or could reasonably obtain information concerning where the incident occurred. (c) All of the following information, if available, must be included in a report. (1) Name of reporter, address, and telephone number. (2) Name, address, and telephone of contact person (if different than reporter). (3) Description of incident. (4) Date producer became aware of incident. (5) Date of incident. (6) Location of incident. (d) Reports and questions should be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). [66 FR 37814, July 19, 2001, as amended at 71 FR 35546, June 21, 2006] § 174.73 General recordkeeping requirements for exemptions. For 5 years, starting with the effective date of a plant-incorporated protectant exemption, any person who is required to submit documentation for the determination of eligibility for a plant-incorporated protectant listed under § 174.21(d) must do both of the following: (a) Maintain documentation of either the request for EPA confirmation or the letter of self-determination (or both, if applicable) along with all supporting documentation for the specific exemption listed in subpart E of this part. (b) Make the documentation outlined in paragraph (a) of this section available to EPA upon request. [88 FR 34777, May 31, 2023] Subpart E—Exemption Eligibility Determination Process and Requirements Source: 88 FR 34777, May 31, 2023, unless otherwise noted. § 174.90 Determining eligibility. (a) Options for determining eligibility. (1) EPA confirmation. (2) Self-determination. (i) A loss-of-function plant-incorporated protectant eligible for exemption under § 174.27. (ii) [Reserved] (b) Where to submit a request for EPA confirmation or letter of self-determination. (c) Claims of confidentiality. (d) Overlapping determinations of eligibility. (e) Revisiting eligibility determination. (f) Extension of exemption. (1) Plant-incorporated protectant created through genetic engineering from a sexually compatible plant. (2) Loss of function plant-incorporated protectant. (g) No duplication necessary. § 174.91 Submitting a letter of self-determination. To self-determine eligibility for the exemption of a plant-incorporated protectant listed under § 174.90(a)(2), a developer must comply with all of the following requirements. (a) When to submit a letter of self-determination. (b) Contents of a letter of self-determination. (1) Provide the name and contact information for the submitter (including telephone number and email address), company name, or other affiliation. (2) Identify the plant-incorporated protectant by providing: the identity of the recipient plant (genus and species), a unique identifier for the native gene from the National Center for Biotechnology Information (NCBI) at the National Library of Medicine of the National Institutes of Health (NLM) at the National Institutes of Health (NIH) ( i.e., (3) Complete and submit the certification statement provided in the electronic submission portal. The statement must be dated and signed by the certifying official identified in the certification statement. (c) EPA response. (d) Effective date of exemption. § 174.93 Requesting EPA confirmation. To request EPA confirmation of eligibility for exemption of a plant-incorporated protectant listed under § 174.21(d), a developer must comply with all of the following requirements. (a) When to submit a request for EPA confirmation. (b) Contents of a request for EPA confirmation of exemption eligibility. (c) EPA review and response. (d) Effective date of exemption. § 174.95 Documentation for an exemption for a plant-incorporated protectant created through genetic engineering from a sexually compatible plant. A developer requesting EPA confirmation of exemption eligibility for a plant-incorporated protectant created through genetic engineering from a sexually compatible plant pursuant to § 174.93 must submit the information in the following paragraphs to EPA. The following documentation must be maintained by a developer of a plant-incorporated protectant created through genetic engineering from a sexually compatible plant per § 174.73: (a) Biology of the plant. (2) If the plant-incorporated protectant was derived from a plant species other than the recipient plant species, provide the identity of the source plant including genus and species and information to support the determination that the recipient plant and the source plant are sexually compatible (e.g., through peer-reviewed literature rationale). (b) Description of the pesticidal trait and how the trait was engineered into the plant. (c) Molecular characterization of the plant-incorporated protectant. (1) For § 174.26(a)(1), sequences in the source plant and in the recipient plant. (2) For § 174.26(a)(2), sequences in the recipient plant before the modification, after the modification, and the sequence in the source plant. The polymorphic site(s) must be indicated. (d) Information on the history of safe use of the plant-incorporated protectant. i.e., (2) If the source plant is a wild relative of the recipient plant, describe why the plant-incorporated protectant is not anticipated to pose a hazard to humans or the environment (e.g., Are levels of the pesticidal substance produced in the recipient plant within the ranges of levels generally seen in plant varieties currently on the market and/or known to produce food safe for consumption? Is the pesticidal mode of action non-toxic? Does the plant-incorporated protectant lack sequence similarity to known mammalian toxins, toxicants, or allergens? Is the plant-incorporated protectant a commonly screened substance and therefore familiar to plant breeders?). § 174.96 Documentation for an exemption for a loss-of-function plant-incorporated protectant. A developer requesting EPA confirmation of exemption eligibility for a loss-of-function plant-incorporated protectant pursuant to § 174.93 must submit the information in the following paragraphs to EPA along with the developer's request for exemption confirmation. The following documentation must be maintained by a developer of a loss-of-function plant-incorporated protectant per § 174.73: (a) Biology of the plant: The identity of the recipient plant, including genus and species. (b) Description of the pesticidal trait that results from the loss-of-function and how the trait was engineered into the plant. Include a description of the steps that were taken to ensure that no engineering components (e.g., Cas proteins) remain in the plant and the measures taken to maximize the likelihood that the modification to the recipient plant is limited to the intended modification. Subpart F [Reserved] Subpart G—Labeling [Reserved] Subpart H—Data Requirements [Reserved] Subpart I [Reserved] Subpart J—Good Laboratory Practices [Reserved] Subpart K—Export Requirements [Reserved] Subparts L-T [Reserved] Subpart U—Experimental Use Permits [Reserved] Subpart V [Reserved] Subpart W—Tolerances and Tolerance Exemptions § 174.500 Scope and purpose. This subpart lists the tolerances and exemptions from the requirement of a tolerance for residues of plant-incorporated protectants in or on food commodities. [72 FR 20434, Apr. 25, 2007] § 174.501 Bacillus thuringiensis Residues of Bacillus thuringiensis [73 FR 45624, Aug. 6, 2008] § 174.502 Bacillus thuringiensis (a) Residues of Bacillus thuringiensis Bacillus thuringiensis (b) Residues of Bacillus thuringiensis [74 FR 39543, Aug. 7, 2009, as amended at 80 FR 25950, May 6, 2015] § 174.504 Bacillus thuringiensis Residues of Bacillus thuringiensis [79 FR 8295, Feb. 12, 2014] § 174.505 Bacillus thuringiensis Residues of Bacillus thuringiensis [72 FR 20434, Apr. 25, 2007] § 174.506 Bacillus thuringiensis Residues of Bacillus thuringiensis [72 FR 20434, Apr. 25, 2007] § 174.507 Nucleic acids that are part of a plant-incorporated protectant; exemption from the requirement of a tolerance. Residues of nucleic acids that are part of a plant-incorporated protectant are exempt from the requirement of a tolerance. [66 FR 37830, July 19, 2001. Redesignated at 72 FR 20434, April 25, 2007] § 174.508 Pesticidal substance of a plant-incorporated protectant from a sexually compatible plant created through conventional breeding; exemption from the requirement of a tolerance. Residues of a pesticidal substance are exempt from the requirement of a tolerance if all the following conditions are met: (a) The genetic material that encodes for the pesticidal substance or leads to the production of the pesticidal substance is from a plant that is sexually compatible with the recipient food plant. (b) The genetic material has never been derived from a source that is not sexually compatible with the recipient food plant. (c) The genetic material is transferred from the source plant to the recipient plant only through conventional breeding. (d) The residues of the pesticidal substance are not present in food from the plant at levels that are injurious or deleterious to human health. [66 FR 37854, July 19, 2001. Redesignated at 72 FR 20434, April 25, 2007; 88 FR 34779, May 31, 2023] § 174.509 Bacillus thuringiensis Residues of Bacillus thuringiensis [72 FR 20435, Apr. 25, 2007] § 174.510 Bacillus thuringiensis Residues of Bacillus thuringiensis [72 FR 20435, Apr. 25, 2007] § 174.511 Bacillus thuringiensis Residues of Bacillus thuringiensis [72 FR 20435, Apr. 25, 2007] § 174.512 Coat Protein of Potato Virus Y; exemption from the requirement of a tolerance. Residues of Coat Protein of Potato Virus Y are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in or on all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.513 Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 gene); exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of the plant-incorporated protectant Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 gene) in or on all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.514 Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow Mosaic Virus; exemption from the requirement for a tolerance. Residues of Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow Mosaic Virus are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in or on all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.515 Coat Protein of Papaya Ringspot Virus; exemption from the requirement of a tolerance. Residues of Coat Protein of Papaya Ringspot Virus are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in or on all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.516 Coat protein of cucumber mosaic virus; exemption from the requirement of a tolerance. Residues of Coat Protein of Cucumber Mosaic Virus are exempt from the requirement of a tolerance when used as a plant-incorporated protectant in or on all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.517 Bacillus thuringiensis The plant-incorporated protectant Bacillus thuringiensis [72 FR 20435, Apr. 25, 2007] § 174.518 Bacillus thuringiensis Residues of Bacillus thuringiensis [72 FR 20435, Apr. 25, 2007] § 174.519 Bacillus thuringiensis (a) Residues of Bacillus thuringiensis (b) Residues of Bacillus thuringiensis [80 FR 25604, May 5, 2015] § 174.521 Neomycin phosphotransferase II; exemption from the requirement of a tolerance. Residues of the neomycin phosphotransferase II (NPTII) enzyme are exempted from the requirement of a tolerance in all food commodities when used as a plant-incorporated protectant inert ingredient. [72 FR 20435, Apr. 25, 2007] § 174.522 Phosphinothricin Acetyltransferase (PAT); exemption from the requirement of a tolerance. Residues of the Phosphinothricin Acetyltransferase (PAT) enzyme are exempt from the requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.523 CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase in all plants; exemption from the requirement of a tolerance. Residues of the CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase enzyme in all plants are exempt from the requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.524 Glyphosate Oxidoreductase GOX or GOXv247 in all plants; exemption from the requirement of a tolerance. Residues of the Glyphosate Oxidoreductase GOX or GOXv247 enzyme in all plants are exempt from the requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.525 E. coli B-D-glucuronidase enzyme as a plant-incorporated protectant inert ingredient; exemption from the requirement of a tolerance. Residues of E. coli [72 FR 20435, Apr. 25, 2007] § 174.526 Hygromycin B phosphotransferase (APH4) marker protein in all plants; exemption from the requirement of a tolerance. Residues of the Hygromycin B phosphotransferase (APH4) enzyme in all plants are exempt from the requirement of a tolerance when used as a plant-incorporated protectant inert ingredient in cotton. [72 FR 20435, Apr. 25, 2007] § 174.527 Phosphomannose isomerase in all plants; exemption from the requirement of a tolerance. Residues of the phosphomannose isomerase (PMI) enzyme in plants are exempt from the requirement of a tolerance when used as plant-incorporated protectant inert ingredients in all food commodities. [72 FR 20435, Apr. 25, 2007] § 174.529 Bacillus thuringiensis Residues of Bacillus thuringiensis [73 FR 40764, July 16, 2008] § 174.530 Bacillus thuringiensis Residues of Bacillus thuringiensis Bacillus thuringiensis [77 FR 6475, Feb. 8, 2012] § 174.531 Coat protein of plum pox virus; exemption from the requirement of a tolerance. Residues of the coat protein of plum pox virus in or on the food commodities of fruit, stone, Group 12; and almond, are exempt from the requirement of a tolerance in these food commodities when expressed by the plant-incorporated protectant, coat protein gene of plum pox virus, and used in accordance with good agricultural practices. [75 FR 29435, May 26, 2010] § 174.532 Bacillus thuringiensis Residues of Bacillus thuringiensis Bacillus thuringiensis [77 FR 47291, Aug. 8, 2012] § 174.533 Glycine max Residues of Glycine max [78 FR 9321, Feb. 8, 2013] § 174.534 VNT1 protein; exemption from the requirement of a tolerance. Residues of VNT1 protein in potato are exempt from the requirement of a tolerance when the Rpi-vnt1 [82 FR 11515, Feb. 24, 2017] § 174.535 Spinach Defensin proteins; temporary exemption from the requirement of a tolerance. Residues of the defensin proteins SoD2, SoD2*, SoD7, and SoD8 derived from spinach ( Spinacia oleracea [86 FR 51004, Sept. 14, 2021] § 174.536 Bacillus thuringiensis Residues of the protein mCry51Aa2 in or on the food and feed commodities of cotton: Cotton, undelinted seed; cotton, gin byproducts; cotton, forage; cotton, hay; cotton, hulls; cotton, meal; and cotton, refined oil are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant in cotton plants in accordance with the terms of Experimental Use Permit No. 524-EUP-108. This temporary exemption from the requirement of a tolerance expires on February 28, 2019. [82 FR 18230, Apr. 18, 2017] § 174.537 HPPD-4 protein; exemption from the requirement of a tolerance. Residues of the HPPD-4 protein, which is a modified protein derived from the 4-hydroxyphenylpyruvate dioxygenase enzyme of Pseudomonas fluorescens, [82 FR 57140, Dec. 4, 2017] § 174.539 Cry51Aa2.834__16 protein; exemption from the requirement of a tolerance. Residues of the Cry51Aa2.834__16 protein, which is a modified protein derived from the Cry51Aa2 protein of Bacillus thuringiensis, [83 FR 3603, Jan. 26, 2018] § 174.540 Bacillus thuringiensis Cry14Ab-1 protein; exemption from the requirement of a tolerance. Residues of Bacillus thuringiensis [85 FR 35008, June 8, 2020] § 174.541 Pesticidal substance of a plant-incorporated protectant created through genetic engineering from a sexually compatible plant; exemption from the requirement of a tolerance. Residues of a pesticidal substance are exempt from the requirements of a tolerance if the conditions in paragraphs (a) through (c) of this section are met. (a) The pesticidal substance is characteristic of the population of plants sexually compatible with the recipient food plant and is created through genetic engineering from either an insertion of a native gene into the recipient food plant as specified in paragraph (a)(1) of this section or a modification of an existing native gene in the recipient food plant as specified in paragraph (a)(2) of this section. (1) Insertion. (2) Modification. (b) The residues of the pesticidal substance are not present in food from the plant at levels that are injurious or deleterious to human health. (c) This exemption does not apply until the requirements in § 174.90 have been met. [88 FR 34779, May 31, 2023] § 174.542 Bacillus thuringiensis Cry1Ab/Cry2Aj protein in corn; exemption from the requirement of a tolerance. Residues of Bacillus thuringiensis [86 FR 3830, Jan. 15, 2021] § 174.543 G10evo-EPSPS protein in all plants; exemption from the requirement of a tolerance. Residues of G10evo-Enolpyruvylshikimate-3-phosphate synthase (G10evo-EPSPS) protein in or on all food or feed commodities, are exempt from the requirement of a tolerance when used as an inert ingredient in a plant-incorporated protectant. [86 FR 3830, Jan. 15, 2021] § 174.544 Modified potato acetolactate synthase (StmALS) in potato; exemption from the requirement of a tolerance. Residues of modified potato acetolactate synthase (StmALS) in potato are exempt from the requirement of a tolerance when used as a plant-incorporated protectant inert ingredient. [88 FR 95188, Mar. 15, 2023] § 174.545 BLB2 and AMR3 proteins in potato; temporary exemption from the requirement of a tolerance. Residues of BLB2 and AMR3 proteins in potato are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant in potato in accordance with the terms of Experimental Use Permit No. 8917-EUP-3. This temporary exemption from the requirement of a tolerance expires on March 31, 2025. [89 FR 31651, Apr. 25, 2024] § 174.546 Bacillus thuringensis Cry1B.868 and Cry1Da_7 proteins; exemption from the requirement of a tolerance. Residues of Bacillus thuringensis [89 FR 43331, May 17, 2024] § 174.547 Ophioglossum pendulum Residues of Ophioglossum pendulum [89 FR 64810, Aug. 8, 2024] § 174.548 Pseudomonas chlororaphis IPD072Aa protein; exemption from the requirement of a tolerance. Residues of Pseudomonas chlororaphis [89 FR 68785, Aug. 28, 2024] § 174.549 Bacillus thuringiensis Residues of Bacillus thuringiensis [89 FR 100749, Dec. 13, 2024] § 174.550 Streptomyces sviceus DGT-28 EPSPS (5-enolpyruvylshikimate-3-phosphate synthase) protein; exemption from the requirement of a tolerance. Residues of Streptomyces sviceus [89 FR 100751, Dec. 13, 2024] § 174.551 Brevibacillus laterosporus Residues of Brevibacillus laterosporus [89 FR 101941, Dec. 17, 2024] § 174.552 Bacillus thuringiensis Residues of Bacillus thuringiensis [89 FR 101941, Dec. 17, 2024] § 174.553 Bacillus thuringiensis Residues of Bacillus thuringiensis [90 FR 10599, Feb. 25, 2025] § 174.554 Bacillus thuringiensis Residues of Bacillus thuringiensis [90 FR 37800, Aug. 6, 2025] § 174.555 Bacillus thuringiensis Residues of Bacillus thuringiensis [90 FR 37800, Aug. 6, 2025] § 174.556 SpCas9 protein; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance for residues of SpCas9 protein in or on the food and feed commodities of Citrus when used as a Plant-Incorporated Protectant in accordance with label directions and good agricultural practices. [90 FR 58170, Dec. 16, 2025] § 174.557 Bacillus thuringensis An exemption from the requirement of a tolerance for residues of Bacillus thuringensis [91 FR 31957, May 29, 2026] § 174.558 Bacillus thuringensis An exemption from the requirement of a tolerance for residues of Bacillus thuringensis [91 FR 31957, May 29, 2026] § 174.559 Adiantum trapeziforme braziliense An exemption from the requirement of a tolerance for residues of Adiantum trapeziforme braziliense [91 FR 31958, May 29, 2026] § 174.560 Bacillus thuringiensis Residues of Bacillus thuringiensis [91 FR 51071, Aug. 7, 2026] Subpart X—List of Approved Inert Ingredients § 174.700 Scope and purpose. This subpart lists the inert ingredients that have been exempted from FIFRA and FFDCA section 408 requirements and may be used in a plant-incorporated protectant listed in subpart B of this part. [66 FR 37814, July 19, 2001. Redesignated at 72 FR 20434, Apr. 25, 2007] § 174.705 Inert ingredients from sexually compatible plant. An inert ingredient, and residues of the inert ingredient, are exempt if all of the following conditions are met: (a) The genetic material that encodes the inert ingredient or leads to the production of the inert ingredient is derived from a plant sexually compatible with the recipient food plant. (b) The genetic material has never been derived from a source that is not sexually compatible with the recipient food plant. (c) The residues of the inert ingredient are not present in food from the plant at levels that are injurious or deleterious to human health. [66 FR 37814, July 19, 2001. Redesignated at 72 FR 20434, Apr. 25, 2007] Subparts Y-Z [Reserved]