Reorganization Plan No. 3 of 1970 (5 U.S.C. App.).
The official addresses, unless otherwise noted, are as follows:
(a)
(2)
(b)
(2)
(3)
(4)
7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.
(a) Part 152 sets forth procedures, requirements and criteria concerning the registration of pesticide products under FIFRA section 3, including plant-incorporated protectants (PIPs). Unless specifically superseded by part 174, the regulations in part 152 apply to PIPs.
(b) Part 152 also describes associated regulatory activities affecting registration, as described in this paragraph.
(1)
(2)
(3)
(4)
(5)
Terms used in this part have the same meaning as in the Act. In addition, the following terms have the meanings set forth in this section.
(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 the growth of plants, and
(2) Does not state that the product may be used to manufacture or formulate other pesticide products.
(1) Hospitals and nursing homes.
(2) Schools other than preschools and day care facilities.
(3) Museums and libraries.
(4) Sports facilities.
(5) Office buildings.
(1) Any proposed use pattern that would require the establishment of, the increase in, or the exemption from the requirement of a tolerance or food additive regulation under section 408 of the Federal Food, Drug and Cosmetic Act;
(2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product
(3) Any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure, to the active ingredient of man or other organisms.
(1) Is a new animal drug under FFDCA sec. 201(w), or
(2) Is an animal drug that has been determined by regulation of the Secretary of Health and Human Services not to be a new animal drug, or
(3) Is an animal feed under FFDCA sec. 201(x) that bears or contains any substances described by paragraph (s) (1) or (2) of this section.
(1) On humans or pets,
(2) In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or
(3) In any preschool or day care facility.
An organism is declared to be a pest under circumstances that make it deleterious to man or the environment, if it is:
(a) Any vertebrate animal other than man;
(b) Any invertebrate animal, including but not limited to, any insect, other arthropod, nematode, or mollusk such as a slug and snail, but excluding any internal parasite of living man or other living animals;
(c) Any plant growing where not wanted, including any moss, alga, liverwort, or other plant of any higher order, and any plant part such as a root; or
(d) Any fungus, bacterium, virus, prion, or other microorganism, except for those on or in living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs (as defined in FFDCA
Products and substances listed in this section are excluded from FIFRA regulation if they meet the specified conditions or criteria.
(a)
(1)
(2)
(3)
(ii) Liquid chemical sterilants that bear claims solely for use on non-critical medical devices are jointly regulated by EPA and FDA.
(iii) Liquid chemical sterilants that bear claims solely for use on sites that are not medical devices, such as veterinary equipment, are not excluded and are regulated solely by EPA.
(b)
(1) The substance prevents or hinders the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria and is distributed and sold solely for those purposes and no other pesticidal purposes. For purposes of this section, living organisms are not considered to be substances, and the actions of living organisms are not relevant to whether a substance is deemed to be a nitrogen stabilizer.
(2) The substance was in “commercial agronomic use” in the United States before January 1, 1992. EPA considers a substance to be in commercial agronomic use if it is available for sale or distribution to users for direct agronomic benefit, as opposed to limited research, experimental or demonstration use.
(3) The substance was not registered under FIFRA before January 1, 1992.
(4) Since January 1, 1992, the distributor or seller has made no claim that the product prevents or hinders the process of nitrification, denitrification, ammonia volatilization or urease production. EPA considers any of the following claims (or their equivalents) to be a claim that the product prevents or hinders nitrification, denitrification, ammonia volatilization or urease production:
(i) Improves crop utilization of applied nitrogen.
(ii) Reduces leaching of applied nitrogen or reduces groundwater nitrogen contamination.
(iii) Prevents nitrogen loss.
(iv) Prolongs availability of nitrogen.
(v) Increases nitrogen uptake, availability, usage, or efficiency.
(5) A product will be considered to have met the criterion of paragraph (b)(4) of this section that no nitrogen stabilization claim has been made if:
(i) The nitrogen stabilization claim, in whatever terms expressed, is made solely in compliance with a State requirement to include the claim in materials required to be submitted to a State legislative or regulatory authority, or in the labeling or other literature accompanying the product; and
(ii) The State requirement to include the claim was in effect both before the product bearing the claim was introduced into commercial agronomic use, and before the effective date of this rule.
(6) A product that meets all of the criteria of this paragraph with respect to one State is not thereby excluded from FIFRA regulation if distributed and sold in another State whose nitrogen stabilization statement requirement does not meet the requirements of paragraph (b)(5)(ii) of this section.
(c)
(d)
(2) A “new animal drug” as defined in section 201(w) of the FFDCA, or an animal drug that FDA has determined is not a “new animal drug” is not a pesticide under section 2(u) of FIFRA. Animal drugs are regulated by the FDA under the FFDCA.
(e)
(f)
(1) The product, in the undiluted package concentration at which it is distributed or sold, meets the criteria of § 156.62 of this chapter for Toxicity Category III or IV; and
(2) The product is not intended for use on food crop sites, and is labeled accordingly.
(g)
(1) A plant nutrient product, consisting of one or more macronutrients or micronutrient trace elements necessary to normal growth of plants and in a form readily usable by plants.
(2) A plant inoculant product consisting of microorganisms to be applied to the plant or soil for the purpose of enhancing the availability or uptake of plant nutrients through the root system.
(3) A soil amendment product containing a substance or substances intended for the purpose of improving soil characteristics favorable for plant growth.
A substance or article is not a pesticide, because it is not intended for use against “pests” as defined in § 152.5, if it is:
(a) A fertilizer product not containing a pesticide.
(b) A product intended to force bees from hives for the collection of honey crops.
A product that is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or regulate the growth of plants, is not considered to be a pesticide. The following types of products or articles are not considered to be pesticides unless a pesticidal claim is made on their labeling or in connection with their sale and distribution:
(a) Deodorizers, bleaches, and cleaning agents;
(b) Products not containing toxicants, intended only to attract pests for survey or detection purposes, and labeled accordingly;
(c) Products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants, such as certain pruning paints to trees.
No person may distribute or sell any pesticide product that is not registered under the Act, except as provided in §§ 152.20, 152.25, and 152.30. A pesticide is any substance (or mixture of substances) intended for a pesticidal purpose,
(a) The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise):
(1) That the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or
(2) That the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or
(b) The substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide; or
(c) The person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose.
The pesticides or classes of pesticide listed in this section are exempt from all requirements of FIFRA. The Agency has determined, in accordance with FIFRA sec. 25(b)(1), that they are adequately regulated by another Federal agency.
(a)
(2) If the Agency determines that an individual biological control agent or class of biological control agents is no longer adequately regulated by another Federal agency, and that it should not otherwise be exempted from the requirements of FIFRA, the Agency will revoke this exemption by amending paragraph (a)(3) of this section.
(3) The following biological control agents are not exempt from FIFRA requirements:
(i) A eucaryotic microorganism including, but not limited to, protozoa, algae and fungi;
(ii) A procaryotic microorganism including, but not limited to, Eubacteria and Archaebacteria; or
(iii) A parasitically-replicating microscopic element, including, but not limited to, viruses.
(4) All living plants intended for use as biological control agents are exempt from the requirements of FIFRA. However, plant-incorporated protectants are not exempt pursuant to this section. Regulations, including exemptions, for plant-incorporated protectants are addressed in part 174 of this chapter.
(b)
The pesticides or classes of pesticides listed in this section have been determined to be of a character not requiring regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended for use, and used, only in the manner specified.
(a)
(b)
(1) For the purposes of this paragraph, a pheromone is a compound produced by an arthropod which, alone or in combination with other such compounds, modifies the behavior of other individuals of the same species.
(2) For the purposes of this paragraph, a synthetically produced compound is identical to a pheromone only when their molecular structures are identical, or when the only differences between the molecular structures are between the stereochemical isomer ratios of the two compounds, except that a synthetic compound found to have toxicological properties significantly different from a pheromone is not identical.
(3) When a compound possesses many characteristics of a pheromone but does not meet the criteria in paragraph (a)(2) of this section, it may, after review by the Agency, be deemed a substantially similar compound.
(4) For the purposes of this paragraph, a pheromone trap is a device containing a pheromone or an identical or substantially similar compound used for the sole purpose of attracting, and trapping or killing, target arthropods. Pheromone traps are intended to achieve pest control by removal of target organisms from their natural environment and do not result in increased levels of pheromones or identical or substantially similar compounds over a significant fraction of the treated area.
(c)
(2) Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of learning.
(3) Products used to preserve the integrity of milk, urine, blood, or other body fluids for laboratory analysis.
(d)
(e)
(i) The product consists totally of cedarwood or natural cedar.
(ii) The product is not treated, combined, or impregnated with any additional substance(s).
(iii) The product bears claims or directions for use solely to repel arthropods other than ticks or to retard mildew, and no additional claims are made in sale or distribution. The labeling must be limited to specific arthropods, or must exclude ticks if any general term such as “arthropods,” “insects,” “bugs,” or any other broad inclusive term, is used. The exemption does not apply to natural cedar products claimed to repel ticks.
(2) The exemption does not apply to cedar oil, or formulated products which contain cedar oil, other cedar extracts, or ground cedar wood as part of a mixture.
(f)
(2)
(3)
(i) Each product containing the substance must bear a label identifying the name and percentage (by weight) of each active ingredient and the name of each inert ingredient.
(ii) The product must not bear claims either to control or mitigate microorganisms that pose a threat to human health, including but not limited to disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.
(iii) The product must not include any false and misleading labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) through (viii).
An unregistered pesticide, or a pesticide whose registration has been cancelled or suspended, may be dis-tributed or sold, or otherwise transferred, to the extent described by this section.
(a)
(b)
(1) The transfer is solely for the purpose of further formulation, packaging, or labeling into a product that is registered;
(2) Each active ingredient in the pesticide, at the time of transfer, is present as a result of incorporation into the pesticide of either:
(i) A registered product; or
(ii) A pesticide that is produced by the registrant of the final product; and
(3) The product as transferred is labeled in accordance with part 156 of this chapter.
(c)
(2) An unregistered pesticide may be distributed or sold in accordance with the provisions of § 172.3 of this chapter, pertaining to use of a pesticide for which an experimental use permit is not required, provided the product is labeled in accordance with part 156 of this chapter.
(d)
(1) The product is prepared and packaged according to the specifications of the foreign purchaser; and
(2) The product is labeled in accordance with part 156 of this chapter.
(e)
(f)
(g)
Any person may apply for new registration of a pesticide product. Any registrant may apply for amendment of the registration of his product.
Any person seeking to obtain a registration for a new pesticide product must submit an application for registration, containing the information specified in § 152.50. An application for new registration must be approved by the Agency before the product may legally be distributed or sold, except as provided by § 152.30.
(a) A product proposed for registration must have a single, defined composition, except that EPA may approve a basic formulation and one or more alternate formulations for a single product.
(b) An alternate formulation must meet the criteria listed in paragraph (b) (1) through (4) of this section. The Agency may require the submission of data to determine whether the criteria have been met.
(1) The alternate formulation must have the same certified limits for each active ingredient as the basic formulation.
(2) If the alternate formulation contains an inert ingredient or impurity of toxicological signficance, the formulation must have the same upper certified limit for that substance as the basic formulation;
(3) The label text of the alternate formulation product must be identical to that of the basic formulation.
(4) The analytical method required under § 158.355 of this chapter must be suitable for use on both the basic formulation and the alternate formulation.
(c) Notwithstanding the criteria in this section, the Agency may determine that an alternate formulation must be separately registered. If EPA makes this determination, the Agency will notify the applicant of its determination and its reasons. Thereafter the application for an alternate formulation will be treated as an application for new registration, and the alternate formulation will be assigned a new registration number.
(a) Except as provided by § 152.46, any modification in the composition, labeling, or packaging of a registered product must be submitted with an application for amended registration. The applicant must submit the information required by § 152.50, as applicable to the change requested. If an application for amended registration is required, the application must be approved by the Agency before the product, as modified, may legally be distributed or sold.
(b) In its discretion, the Agency may:
(1) Waive the requirement for submission of an application for amended registration;
(2) Require that the applicant certify to the Agency that he has complied with an Agency directive rather than submit an application for amended registration; or
(3) Permit an applicant to modify a registration by notification or non-notification in accordance with § 152.46.
(c) A registrant may at any time submit identical minor labeling amendments affecting a number of products as a single application if no data are required for EPA to approve the amendment (for example, a change in the wording of a storage statement for designated residential use products). A consolidated application must clearly identify the labeling modification(s) to be made (which must be identical for all products included in the application), list the registration number of each product for which the modification is requested, and provide required supporting materials (for example, labeling) for each affected product.
(a)
(2) A registrant may modify a registration consistent with paragraph (a)(1) of this section and any procedures issued thereunder and distribute or sell the modified product as soon as the Agency has received the notification. Based upon the notification, the Agency may require that the registrant submit an application for amended registration. If it does so, the Agency will notify the registrant and state its reasons for requiring an application for amended registration. Thereafter, if the registrant fails to submit an application the Agency may determine that the product is not in compliance with the requirements of the Act. Notification under this paragraph is considered a report filed under the Act for the purposes of FIFRA section 12(a)(2)(M).
(b)
(c)
Each application for registration or amended registration must include the following information, as applicable:
(a)
(b)
(2)
(3)
(4)
(c)
(d)
(1) The product name;
(2) The trade name(s) (if different); and
(3) The EPA Registration Number, if currently registered.
(e)
(f)
(2) An applicant must furnish any data specified in part 158 or part 161 of this chapter, as applicable, of this chapter which are required by the Agency to determine that the product meets the registration standards of FIFRA sec. 3(c)(5) or (7). Each study must comply with:
(i) Section 158.32 of this chapter, with respect to format of data submission.
(ii) Section 158.33 of this chapter, with respect to studies for which a claim of trade secret or confidential business information is made.
(iii) Section 158.34 of this chapter, with respect to flagging for potential adverse effects.
(iv) Section 160.12 of this chapter, with respect to a statement whether studies were conducted in accordance with Good Laboratory Practices of part 160.
(3) An applicant shall furnish with his application any factual information of which he is aware regarding unreasonable adverse effects of the pesticide on man or the environment, which would be required to be reported under FIFRA sec. 6(a)(2) if the product were registered.
(g)
(h)
(i)
(2) If such residues have not been authorized, the application must be accompanied by a petition for establishment of appropriate tolerances or exemptions from the requirement of a tolerance, in accordance with part 180 of this chapter.
(j)
(2) If FIFRA sec. 33 is not in effect, the applicant shall submit any fees required by subpart U of this part, if applicable.
Applications and correspondence relating to registration should be sent to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).
This subpart E describes the information that an applicant must submit with his application for registration or amended registration to comply (and for the Agency to determine compliance) with the provisions of FIFRA sec. 3(c)(1)(F). This subpart also describes the procedures by which data submitters may challenge registration actions which allegedly failed to comply with these procedures. If the Agency determines that an applicant has failed to comply with the requirements and procedures in this subpart, the application may be denied. If the Agency determines, after registration has been issued, that an applicant failed to comply with these procedures and requirements, the Agency may issue a notice of intent to cancel the product's registration.
(a) Except as provided in paragraph (b) of this section, §§ 152.83 through 152.119 apply to:
(1) Each application for registration of a new product;
(2) Each application for an amendment of a registration; and
(3) Each application for reregistration under FIFRA section 3(g).
(b) This subpart E does not apply to:
(1) Applications for registration submitted to States under FIFRA section 24(c);
(2) Applications for experimental use permits under FIFRA section 5;
(3) Applications for emergency exemptions under FIFRA section 18;
(4) Applications to make only one or more of the following types of amendments to existing registrations, unless the Administrator or his designee finds that Agency consideration of scientific data would be necessary in order to approve the amendment under FIFRA section 3(c)(5):
(i) An increase or decrease in the percentage in the product of one or more of its active ingredients or deliberately added inert ingredients;
(ii) A revision of the identity or amount of impurities present in the product;
(iii) The addition or deletion of one or more deliberately added inert ingredients;
(iv) The deletion of one or more active ingredients;
(v) A change in the source of supply of one or more of the active ingredients used in the product, if the new source of the active ingredient is a product
(vi) Deletion of approved uses of claims;
(vii) Redesign of the label format involving no substantive changes, express or implied, in the directions for use, claims, representations, or precautionary statements;
(viii) Change in the product name or addition of an additional brand name, if no additional claims, representations, or uses are expressed or implied by the changes;
(ix) Clarification of directions for use;
(x) Correction of typographical errors;
(xi) Changes in the registrant's name or address;
(xii) Adding or deleting supplemental registrants;
(xiii) Changes in the package or container size;
(xiv) Changes in warranty, warranty disclaimer, or liability limitation statements, or addition to or deletion of such statements;
(xv) “Splitting” a label for the sole purpose of facilitating the marketing of a product in different geographic regions with appropriate labels, where each amended label will contain previously approved use instructions (and related label statements) appropriate to a particular geographic region;
(xvi) Any other type of amendment, if the Administrator or his designee determines, by written finding, that the Agency consideration of scientific data would not be necessary in order to approve the amendment under FIFRA section 3(c)(5); and
(xvii) Compliance with Agency Regulations, adjudicatory hearing decisions, notices, or other Agency announcements that unless the registration is amended in the manner the Agency proposes, the product's registration will be suspended or cancelled, or that a hearing will be held under FIFRA section 6. (However, this paragraph does not apply to amendments designed to avoid cancellation or suspension threatened under FIFRA section 3(c)(2)(B) or because of failure to submit data.)
As used in this subpart, the following terms shall have the meanings set forth in this section:
(1) The study pertains to a new active ingredient (new chemical) or new combination of active ingredients (new combination) first registered after September 30, 1978;
(2) The study was submitted in support of, or as a condition of approval of, the application resulting in the first registration of a product containing such new chemical or new combination (first registration), or an application to amend such registration to add a new use; and
(3) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B);
Provided that, a study is an exclusive use study only during the 10-year period following the date of the first registration.
All information required by this subpart should be submitted with the application, but may be submitted at any later time prior to EPA's approval of the application. The Agency will not approve any application until it determines either that the application is not subject to these requirements or that all required materials have been submitted and are acceptable.
(a)
(b)
(2) The data to which the formulators' exemption applies usually will concern the safety of one or more of the product's active ingredients, specifically, those active ingredients which are contained in the purchased product. In general, data for which the required test substance is the technical grade of the active ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product are eligible for the formulators' exemption.
(3) The formulators' exemption generally does not apply to data on the applicant's product itself, including the safety or efficacy of the product, unless the composition of the product is identical to the purchased product. In general, data for which the required test substance is the product proposed for registration are not eligible for the formulators' exemption.
(c)
(1) The application indicates that the ingredient's presence in the product is attributable solely to the purchase from another person of an identified, registered product containing that ingredient and the use of the purchased product in formulating the product; and
(2) The purchased product is a registered manufacturing-use product whose label does not prohibit its use for making an end-use product labeled for any use for which the applicant's product will be labeled; or
(3) The purchased product is a registered end-use product labeled for each use for which the applicant's product will be labeled.
(d)
(i) Identification of the applicant, and of the product by EPA registration number or file symbol.
(ii) Identification of each ingredient in the pesticide that is eligible for the formulators' exemption, and the EPA registration number of the product that is the source of that ingredient.
(iii) A statement that the listed ingredients meet the requirements for the formulators' exemption.
(iv) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula.
(v) The name, title and signature of the applicant or his authorized representative and the date of signature.
(2) An applicant for amended registration is not required to submit a
(e)
An applicant may comply with this subpart by citing all data in Agency files that are pertinent to its consideration of the requested registration under FIFRA section 3(c)(5), in accordance with the procedures in this section, as applicable.
(a)
(1) Identification of the applicant to whom the authorization is granted;
(2) Authorization to the applicant to use all pertinent studies in satisfaction of data requirements for the application in question; and
(3) The signature and title of the original data submitter or his authorized representative and date of the authorization.
(b)
(1) He has obtained from that person a written authorization that contains the information required by paragraphs (a) (1) through (3) of this section; or
(2) He has furnished to that person:
(i) A notification of his intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;
(ii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F) for any data on which the application relies;
(iii) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of any study; and
(iv) His name, address and telephone number.
(c)
[
(d)
(1) All data submitted with or specifically cited in the application; and
(2) Each other item of data in the Agency's files which:
(i) Concerns the properties or effects of the applicant's product, of any product which is identical or substantially similar to the applicant's product, or of one or more of the active ingredients in the applicant's product; and
(ii) Is one of the types of data that EPA would require to be submitted if the application sought the initial registration under FIFRA section 3(c)(5) of a product with composition and intended uses identical or substantially similar to the applicant's product, under the data requirements in effect on the date EPA approves the applicant's present application.
An applicant may comply with this subpart by listing the specific data requirements that apply to his product, its active ingredients, and use patterns, and demonstrating his compliance for each data requirement by submitting or citing individual studies, or by demonstrating that no study has
(a)
(1) If a Registration Standard has been issued for any active ingredient, the applicant must list the applicable data requirements enumerated in that Standard for the active ingredient and, if end use products are covered by the Registration Standard, for such products containing that active ingredient.
(2) If a Registration Standard has not been issued, or if an issued Registration Standard does not cover all data requirements for products containing the active ingredient in question, the applicant must list the applicable requirements as prescribed by 40 CFR part 158 or part 161, as applicable. All required (R) studies, and any studies that could be conditionally required (CR) based upon composition, use pattern, or the results of required studies, are to be listed. The applicant may demonstrate via the data gap procedures in § 152.96 that a conditional requirement need not be satisfied by the submission or citation of data at the time of application.
(b)
(1) Existence of or granting of a data waiver. Refer to § 152.91.
(2) Submission of a new valid study. Refer to § 152.92.
(3) Citation of a specific valid study previously submitted to the Agency by the applicant or another person, with any necessary written authorizations or offers to pay. Refer to § 152.93.
(4) Citation of a public literature study. Refer to § 152.94.
(5) Citation of all pertinent studies previously submitted to the Agency, with any necessary written authorizations or offers to pay. Refer to § 152.95.
(6) Documentation of a data gap. Refer to § 152.96.
The applicant may demonstrate compliance for a data requirement by documenting the existence of a waiver in accordance with paragraph (a) of this section, or by being granted a new waiver requested in accordance with paragraph (b) of this section.
(a)
(b)
(c)
An applicant may demonstrate compliance for a data requirement by submitting a valid study that has not previously been submitted to the Agency. A study previously submitted to the Agency should not be resubmitted but
An applicant may demonstrate compliance for a data requirement by citing a valid study previously submitted to the Agency. The study is not to be submitted to the Agency with the application.
(a)
(b)
(1)
(i) Identification of the applicant to whom the authorization is granted;
(ii) Identification by title, EPA Accession Number or Master Record Identification Number, and date of submission, of the study or studies for which the authorization is granted;
(iii) Authorization to the applicant to use the specified study in satisfaction of the data requirement for the application in question; and
(iv) The signature and title of the original data submitter or his authorized representative, and date of the authorization.
(2)
(i) A notification of the applicant's intent to apply for registration, including the proposed product name and a list of the product's active ingredients;
(ii) Identification of the specific data requirement involved and of the study for which the offer to pay is made (by title, EPA Accession Number or Master Record Identification Number, and date of submission, if possible);
(iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);
(iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of the study; and
(v) The applicant's name, address and telephone number.
(3)
(a) An applicant may demonstrate compliance for a data requirement by citing, and submitting to the Agency, one of the following:
(1) A valid study from the public literature.
(2) A valid study generated by, or at the expense of, any government (Federal, State, or local) agency.
(b) In no circumstances does submission of a public literature study or government-generated study confer any rights on the data submitter to exclusive use of data or compensation under FIFRA section 3(c)(1)(F).
An applicant normally may demonstrate compliance for a data requirement by citation of all studies in the Agency's files pertinent of that data requirement. The applicant who selects this cite-all option must submit to the Agency:
(a) A general offer to pay statement having the same wording as that specified in § 152.86(c) except that the offer to pay may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected;
(b) A certification that:
(1) For each person who is included on the Data Submitters List as an original data submitter of exclusive use data for the active ingredient in question, the applicant has obtained a written authorization containing the information required by § 152.86(a) for the use the any exclusive use study that would be pertinent to the applicant's product; and
(2) For each person included on the current Data Submitters List as an original data submitter of data that are not exclusive use for the active ingredient in question, the applicant has furnished:
(i) A notification of the applicant's intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;
(ii) Identification of the specific data requirement(s) for which the offer to pay for data is being made;
(iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);
(iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for use of any study; and
(v) The applicant's name, address and telephone number; and
(c) An acknowledgment having the same wording as that specified in § 152.86(d), except that it may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected.
Except as provided in paragraph (a) of this section, an applicant may defer his obligation to satisfy an applicable data requirement until the Agency requests the data if he can demonstrate, by the procedure in this section, that no other person has previously submitted to the Agency a study that would satisfy the data requirement in question.
(a)
(2) An applicant for registration of a product under FIFRA section 3(c)(7) (A) or (B) may not defer his obligation by the procedure in this section if the Agency requires the data to determine:
(i) Whether the product is identical or substantially similar to another currently registered product or differs only in ways that would not substantially increase the risk of unreasonable adverse effects on the environment;
(ii) If efficacy data are required, whether the product is efficacious; or
(iii) Whether the new use would substantially increase the risk of unreasonable adverse effects on the environment, usually required when the application involves a new use of a product which is identical or substantially similar to a currently registered product.
(b)
(c)
(1) The applicant has furnished, by certified mail, to each original data submitter on the current Data Submitters List for the active ingredient in question, a notice containing the following information:
(i) The name and address of the applicant;
(ii) The name of the product, and a statement that the applicant intends to apply for registration of that product;
(iii) The name(s) of the active ingredient(s) in the procuct;
(iv) A list of the data requirements for which the applicant intends to claim under this section that a data gap exists; and
(v) A request that the data submitter identify, within 60 days of receipt of the notice, any valid study which he has submitted to the Agency that would fulfill any of the data requirement(s) listed.
(2) The applicant has, within that 60-day period, received no response, or has received a negative response, from each person notified; and
(3) The applicant has no basis to believe that any data have been submitted to the Agency that would fulfill the data requirement, and is entitled to claim that a data gap exists.
(d)
(a)
(2) Each original data submitter who wishes to have his name added to the current Data Submitters List must submit to the Agency the following information:
(i) Name and current address;
(ii) Chemical name and common name (if any) of the active ingredient(s), with respect to which he is an original data submitter;
(iii) For each such active ingredient, the type(s) of study he has previously submitted (corresponding to Guidelines reference numbers given in tables in 40 CFR part 158 or part 161, as applicable), the date of submission, and the EPA registration number, file symbol, or other identifying reference for which it was submitted.
(3) Each applicant not already included on the Data Submitters List for a particular active ingredient must inform the Agency at the time of submission of a relevant study whether he wishes to be included on the Data Submitters List for that pesticide.
(b)
A person who possesses rights to exclusive use or compensation under FIFRA section 3(c)(1)(F) may transfer such rights to another person in accordance with this section.
(a) The original data submitter must submit to the Agency a transfer document that contains the following information:
(1) The name, address and state of incorporation (if any) of the original data submitter (the transferor);
(2) The name, address and state of incorporation (if any) of the person to whom the data rights are being transferred (the transferee);
(3) Identification of each item of data transferred including:
(i) The name of the study or item of data;
(ii) Whether the study is an exclusive use study, and, if so, when the period of exclusive use protection expires;
(iii) The name of the person or laboratory that conducted the study;
(iv) The date the study was submitted to the Agency;
(v) The EPA document number assigned to the item of data (the Master Record Identification Number or Accession Number), if known. If not known, the EPA administrative number (such as the EPA Registration Number, petition number, file symbol, or permit number) with which the item of data was submitted, such that the Agency can identify the item of data.
(vi) A statement that the transferor transfers irrevocably to the transferee all rights, titles, and interest in the items of data named;
(vii) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and
(viii) The names, signatures and titles of the transferor and transferee, and the date signed.
(b) In addition, the original data submitter must submit to the Agency a notarized statement affirming that:
(1) The person signing the transfer agreement is authorized by the original data submitter to bind the data submitter;
(2) No court order prohibits the transfer, and any required court approvals have been obtained; and
(3) The transfer is authorized under Federal, State, and local law and relevant corporate charters, bylaws or partnership agreements.
(c) The Agency will acknowledge the transfer of the data by notifying both transferor and transferee, and will state the effective date of the transfer. Thereafter the transferee will be considered to be the original data submitter of the items of data transferred for all purposes under FIFRA section 3(c)(1)(F), unless a new transfer agreement is submitted to the Agency.
An original data submitter may petition the Agency to deny or cancel the registration of a product in accordance with this section if he has submitted to the Agency a valid study which, he claims, satisfies a data requirement that an applicant purportedly has failed to satisfy.
(a)
(i) The applicant has failed to participate in an agreed-upon procedure for reaching an agreement on the amount and terms of compensation. The petitioner shall submit a copy of the agreed-upon procedure and describe the applicant's failure to participate in the procedure.
(ii) The applicant has failed to comply with the terms of an agreement on compensation. The petitioner shall submit a copy of the agreement, and shall describe how the applicant has failed to comply with the agreement.
(iii) The applicant has failed to participate in an arbitration proceeding. The petitioner shall submit evidence of such failure.
(iv) The applicant has failed to comply with the terms of an arbitration decision. The petitioner shall submit a copy of the arbitration decision, and describe how the applicant has failed to comply with the decision.
(2) When no offer to pay has been made, the petitioner shall state in his petition the basis for the challenge, and describe how the failure of the applicant to comply with the procedures of this subpart has deprived him of the rights accorded him under FIFRA section 3(c)(1)(F). Possible grounds for challenge include, but are not limited to, the following:
(i) The applicant has failed to list a data requirement applicable to his product, or has failed to demonstrate compliance with all applicable data requirements.
(ii) The applicant has submitted or cited a study that is not valid.
(iii) The applicant has submitted or cited a study that does not satisfy the data requirement for which it was submitted or cited.
(iv) The applicant has failed to comply with the procedure for showing that a data gap exists.
(v) The applicant has improperly certified that a data gap exists. An original data submitter who has failed without good cause to respond to an applicant's request for confirmation of a data gap may not petition the Agency for review on this basis.
(vi) The applicant has submitted or cited a study originally submitted by the petitioner, without the required authorization or offer to pay.
(b)
(2)
(c)
(1) If the Agency determines that the petition is without merit, it will inform the petitioner and the affected applicant or registrant that the petition is denied. Denial of a petition is a final Agency action.
(2) If the Agency determines that an applicant has acted in any way described by paragraph (a)(1) of this section, the Agency will notify the petitioner and the affected applicant or registrant that it intends to deny or cancel the registration of the product in support of which the data were cited. The affected applicant or registrant will have 15 days from the date of delivery of this notice to respond. If the Agency determines, after considering any response, that the affected applicant or registrant has acted in the ways described by paragraph (a)(1) of this section, the Agency will deny or cancel the registration without further hearing. Refer to FIFRA section 3(c)(1)(F)(ii). Denial or cancellation of a registration is a final Agency action.
(3) Except as provided in paragraph (c)(2) of this section, if the Agency determines that an applicant for registration of a product has acted in any way that deprives an original data submitter of rights under FIFRA section 3(c)(1)(F), the Agency will take steps to deny the application or cancel the registration, as appropriate. The procedures in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or cancellation is a final Agency action.
(d)
(a) The Agency will follow the procedures in this subpart for all applications for registration, except an application for registration of a pesticide that has been the subject of a previous Agency cancellation or suspension notice under FIFRA sec. 6.
(b) The Agency will follow the procedures of subpart D of part 164 of this chapter in evaluating any application for registration of a pesticide involving use of the pesticide in a manner that is prohibited by a suspension or cancellation order, to the extent required by subpart D of part 164.
The Agency will issue in the
The applicant is responsible for the accuracy and completeness of all information submitted in connection with the application. The Agency will review each application to determine whether it is complete. An application is incomplete if any pertinent item specified in § 152.50 has not been submitted, or has been incorrectly submitted (for example, data required by part 158, or part 161 of this chapter, as applicable, and not submitted in accordance with the requirements for format, claims of confidential business information, or flagging).
The Agency will not begin or continue the review of an application that is incomplete. If the Agency determines that an application is incomplete or that further information is needed in order to complete the Agency's review, the Agency will notify the applicant of the deficiencies and allow the applicant 75 days to make corrections or additions to complete the application. If the applicant believes that the deficiencies cannot be corrected within 75 days, he must notify the Agency within those 75 days of the date on which he expects to complete the application. If, after 75 days, the applicant has not responded, or if the applicant subsequently fails to complete the application within the time scheduled for completion, the Agency will terminate any action on such application, and will treat the application as if it had been withdrawn by the applicant. Any subsequent submission relating to the same product must be submitted as a new application.
(a) The Agency normally will review data submitted with an application that have not previously been submitted to the Agency.
(b) The Agency normally will review other data submitted or cited by an applicant only:
(1) As part of the process of reregistering currently registered products;
(2) When acting on an application for registration of a product containing a new active ingredient;
(3) If such data have been flagged in accordance with § 158.34 or 161.34 of this chapter; or
(4) When the Agency determines that it would otherwise serve the public interest.
(c) If the Agency finds that it needs additional data in order to determine whether the product may be registered, it will notify the applicant as early as possible in the review process.
The Agency will review all draft labeling submitted with the application.
The Agency will complete its review of applications as expeditiously as possible. Applications subject to specific timeframes under the fee schedule established by FIFRA section 33 will be reviewed within the timeframes established for the application or action type.
The Agency has discretion to review applications under either the unconditional registration criteria of FIFRA sec. 3(c)(5) or the conditional registration criteria of FIFRA sec. 3(c)(7). The type of review chosen depends primarily on the extent to which the relevant data base has been reviewed for completeness and scientific validity. EPA conducts data reviews needed to support unconditional registrations on a chemical-by-chemical basis, according to an established priority list. Except for applications for registration of a new active ingredient or in special cases where it finds immediate review to be warranted, the Agency will not commence a complete review of the existing data base on a given chemical in response to receipt of an application for registration. Instead the Agency will review the application using the criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B).
EPA will approve an application under the criteria of FIFRA sec. 3(c)(5) only if:
(a) The Agency has determined that the application is complete and is accompanied by all materials required by the Act and this part, including, but not limited to, evidence of compliance with subpart E of this part;
(b) The Agency has reviewed all relevant data in the possession of the Agency (see §§ 152.107 and 152.111);
(c) The Agency has determined that no additional data are necessary to make the determinations required by FIFRA sec. 3(c)(5) with respect to the pesticide product which is the subject of the application;
(d) The Agency has determined that the composition of the product is such as to warrant the proposed efficacy claims for it, if efficacy data are required to be submitted for the product by part 158 or part 161 of this chapter, as applicable.
(e) The Agency has determined that the product will perform its intended function without unreasonable adverse effects on the environment, and that, when used in accordance with widespread and commonly recognized practice, the product will not generally cause unreasonable adverse effects on the environment;
(f) The Agency has determined that the product is not misbranded as that term is defined in FIFRA sec. 2(q) and part 156 of this chapter, and its labeling and packaging comply with the applicable requirements of the Act, this part, and parts 156 and 157 of this chapter;
(g) If the proposed labeling bears directions for use on food, animal feed, or food or feed crops, or if the intended use of the pesticide results or may reasonably be expected to result, directly or indirectly, in pesticide residues (including residues of any active or inert ingredient of the product, or of any metabolite or degradation product thereof) in or on food or animal feed, all necessary tolerances, exemptions from the requirement of a tolerance, and food additive regulations have been issued under FFDCA sec. 408, and
(h) If the product, in addition to being a pesticide, is a drug within the meaning of FFDCA sec. 201(q), the Agency has been notified by the Food and Drug Administration (FDA) that the product complies with any requirements imposed by FDA.
(a) Except as provided in paragraph (b) of this section, the Agency may approve an application for registration or amended registration of a pesticide product, each of whose active ingredients is contained in one or more other registered peticide products, only if the Agency has determined that:
(1) It possesses all data necessary to make the determinations required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide product which is the subject of the application (including, at a minimum, data needed to characterize any incremental risk that would result from approval of the application);
(2) Approval of the application would not significantly increase the risk of any unreasonable adverse effect on the environment; and
(3) The criteria of § 152.112(a), (d), and (f) through (h) have been satisfied.
(b) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined that the applicant's product and its proposed use are identical or substantially similar to a currently registered pesticide and use, or that the pesticide and its proposed use differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.
(c) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:
(1) The pesticide is the subject of a special review, based on a use of the product that results in human dietary exposure; and
(2) The proposed new use involves use on a major food or feed crop, or involves use on a minor food or feed crop for which there is available an effective alternative registered pesticide which does not meet the risk criteria associated with human dietary exposure. The determination of available and effective alternatives shall be made with the concurrence of the Secretary of Agriculture.
An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a period of time sufficient for the generation and submission of certain of the data necessary for a finding of registrability under FIFRA sec. 3(c)(5) if the Agency determines that:
(a) Insufficient time has elapsed since the imposition of the data requirement for those data to have been developed;
(b) All other required test data and materials have been submitted to the Agency;
(c) The criteria in § 152.112(a), (b), (d), and (f) through (h) have been satisfied;
(d) The use of the pesticide product during the period of the conditional registration will not cause any unreasonable adverse effect on the environment; and
(e) The registration of the pesticide product and its subsequent use during the period of the conditional registration are in the public interest.
(a)
(b)
(1) The applicant will submit remaining required data (and interim reports if required) in accordance with a schedule approved by the Agency.
(2) The registration will expire upon a date established by the Agency, if the registrant fails to submit data as required by the Agency. The expiration date will be established based upon the length of time necessary to generate and submit the required data. If the studies are submitted in a timely manner, the registration will be cancelled if the Agency determines, based on the data (alone, or in conjuction with other data), that the product or one or more of its uses meets or exceeds any of the risk criteria established by the Agency to initiate a special review. If the Agency so determines, it will issue to the registrant a Notice of Intent to Cancel under FIFRA sec. 6(e), and will specify any provisions for sale and distribution of existing stocks of the pesticide product.
(3) The applicant will submit an annual report of the production of the product.
(c)
(d)
(a) Except as provided in paragraph (c) of this section, at least 30 days before registration of a product containing an active ingredient for which a previously submitted study is eligible for exclusive use under FIFRA sec. 3(c)(1)(F)(i), the Agency will notify the original submitter of the exclusive use study of the intended registration of the product. If requested by the exclusive use data submitter within 30 days, the Agency will also provide the applicant's list of data requirements and method of demonstrating compliance with each data requirement.
(b) Within 30 days after receipt of the Agency's notice, or of the applicant's list of data requirements, whichever is later, the exclusive use data submitter may challenge the issuance of the registration in accordance with the procedures in § 152.99 (b) and (c). If the Agency finds that the challenge has merit, it will issue a notice of denial of the application. The applicant may then avail himself of the hearing procedures provided by FIFRA sec. 3(c)(6). If the Agency finds that the challenge is without merit, it will deny the petition and register the applicant's product. Denial of the petition is a final Agency action.
(c) If an applicant has submitted to the Agency a certification from an exclusive use data submitter that he is aware of the applicant's application for registration, and does not object to the issuance of the registration, the Agency will not provide the 30-day notification described in paragraph (a) of this section to that exclusive use data submitter.
The Agency will notify the applicant of the approval of his application by a Notice of Registration for new registration, or by a letter in the case of an amended registration.
(a)
(b)
(c)
(d)
(e)
(a) The information submitted to support a registration application shall be part of the official Agency file for that registration.
(b) Within 30 days after registration, the Agency will make available for public inspection, upon request, the materials required by subpart E to be submitted with an application. Materials that will be publicly available include an applicant's list of data requirements, the method used by the applicant to demonstrate compliance for each data requirement, and the applicant's citations of specific studies in the Agency's possession if applicable.
(c) Except as provided by FIFRA sec. 10, within 30 days after registration, the data on which the Agency based its decision to register the product will be made available for public inspection, upon request, in accordance with the procedures in 40 CFR part 2.
(a) The registrant must keep the Agency informed of his current name and address of record. If the Agency's good faith attempts to contact the registrant are not successful, the Agency will issue in the
(b) The registrant must also notify the Agency if he changes his authorized agent.
If at any time the registrant receives or becomes aware of any factual information regarding unreasonable adverse effects of the pesticide on the environment that has not previously been submitted to the Agency, the registrant shall, in accordance with FIFRA section 6(a)(2) and the requirements of part 159, subpart D of this chapter, provide such information to the Agency, clearly identified as FIFRA 6(a)(2) data.
(a) A registrant may distribute or sell a registered product with the composition, packaging and labeling currently approved by the Agency.
(b) A registrant may distribute or sell a product under labeling bearing any subset of the approved directions for use, provided that in limiting the uses listed on the label, no changes would be necessary in precautionary statements, use classification, or packaging of the product.
(c) Normally, if the product labeling is amended on the initiative of the registrant, by submission of an application for amended registration, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after approval of the revision, unless an order subsequently issued by the Agency under FIFRA sec. 6 or 13 provides otherwise. However, if paragraph (d) of this section applies to the registrant's product, the time frames established by the Agency in accordance with that paragraph shall take precedence.
(d) If a product's labeling is required to be revised as a result of the issuance of a Registration Standard, a Label Improvement Program notice, or a notice concluding a special review process, the Agency will specify in the notice to the registrant the period of time that previously approved labeling may be used. In all cases, supplemental or sticker labeling may be used as an interim compliance measure for a reasonable period of time. The Agency may establish dates as follows governing when label changes must appear on labels:
(1) The Agency may establish a date after which all product distributed or sold by the registrant must bear revised labeling.
(2) The Agency may also establish a date after which no product may be distributed or sold by any person unless it bears revised labeling. This date will provide sufficient time for product in channels of trade to be distributed or sold to users or otherwise disposed of.
The registrant may distribute or sell his registered product under another person's name and address instead of (or in addition to) his own. Such distribution and sale is termed “supplemental distribution” and the product is referred to as a “distributor product.” The distributor is considered an agent of the registrant for all intents and purposes under the Act, and both the registrant and the distributor may be held liable for violations pertaining to the distributor product. Supplemental distribution is permitted upon notification to the Agency if all the following conditions are met:
(a) The registrant has submitted to the Agency for each distributor product a statement signed by both the registrant and the distributor listing the names and addresses of the registrant and the distributor, the distributor's company number, the additional brand name(s) to be used, and the registration number of the registered product.
(b) The distributor product is produced, packaged and labeled in a registered establishment operated by the same producer (or under contract in accordance with § 152.30) who produces, packages, and labels the registered product.
(c) The distributor product is not repackaged (remains in the producer's unopened container).
(d) The label of the distributor product is the same as that of the registered product, except that:
(1) The product name of the distributor product may be different (but may not be misleading);
(2) The name and address of the distributor may appear instead of that of the registrant;
(3) The registration number of the registered product must be followed by a dash, followed by the distributor's company number (obtainable from the Agency upon request);
(4) The establishment number must be that of the final establishment at which the product was produced; and
(5) Specific claims may be deleted, provided that no other changes are necessary.
(e) Voluntary cancellation of a product applies to the registered product and all distributor products distributed or sold under that registration number. The registrant is responsible for ensuring that distributors under his cancelled registration are notified and comply with the terms of the cancellation.
(a) A registrant may transfer the registration of a product to another person, and the registered product may be
(b) Persons seeking approval of a transfer of registration must provide a document signed by the authorized representative of the registrant (the transferor) and of the person to whom the registration is transferred (the transferee) that contains the following information:
(1) The name, address and State of incorporation (if any) of the transferor;
(2) The name, address and State of incorporation of the transferee;
(3) The name(s) and EPA registration number(s) of the product(s) being transferred;
(4) A statement that the transferor transfers irrevocably to the transferee all right, title, and interest in the EPA registration(s) listed in the document;
(5) A statement that the transferred registration(s) shall not serve as collateral or otherwise secure any loan or other payment arrangement or executory promise, and that the registration(s) shall not revert to the transferor unless a new transfer agreement is submitted to and approved by the Agency;
(6) A description of the general nature of the underlying transaction, e.g., merger, spinoff, bankruptcy transfer (no financial information need be disclosed);
(7) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and
(8) An acknowledgment by the transferee that his rights and duties concerning the registration under FIFRA and this chapter will be deemed by EPA to be the same as those of the transferor at the time the transfer is approved.
(c) In addition, the transferor must submit to the Agency a notarized statement affirming that:
(1) The person signing the transfer agreement is authorized by the registrant to bind the transferor;
(2) No court order prohibits the transfer, and that any required court approvals have been obtained; and
(3) The transfer is authorized under all relevant Federal, State and local laws and all relevant corporate charters, bylaws, partnerships, or other agreements.
(d) If the required documents are submitted, and no information available to the Agency indicates that the information is incorrect, the Agency will approve the transfer without requiring that the transferee obtain a new registration. The Agency will notify the transferor and transferee of its approval.
(e) The transfer will be effective on the date of Agency approval. Thereafter the transferee will be regarded as the registrant for all purposes under FIFRA.
(f) Rights to exclusive use of data or compensation under FIFRA section 3(c)(1)(F) are separate from the registration itself and may be retained by the transferor, or may be transferred independently in accordance with the provisions of § 152.98. If the registrant as the original data submitter wishes to transfer data rights at the same time as he transfers the registration, he may submit a single transfer document containing the information required by this section for both the registration and the data.
(a)
(b)
In addition to the definitions in § 152.3, the following terms are defined for the purposes of this subpart:
(a)
(b)
(a)
(1) Contain the same active ingredients.
(2) Contain the same active ingredients in a particular concentration range, formulation type, or combination of concentration range and formulation type.
(3) Have uses in common.
(4) Have other characteristics, such as toxicity, flammability, or physical properties, in common.
(b)
(1) As part of the review of an application for new registration of a product containing an active ingredient not contained in any currently registered product.
(2) As part of the review of an application for a new use of a product, if existing uses of that product previously have been classified for restricted use. Review of a restricted use product at this time is for the purpose of determining whether the new use should also be classified for restricted use. Normally the Agency will not conduct initial classification reviews for existing uses of individual products in conjunction with an application for amended registration.
(3) As part of the process of developing or amending a registration standard for a pesticide. The Agency normally will conduct classification reviews of all uses of a currently registered pesticide at this time.
(4) As part of any special review of a pesticide, in accordance with the procedures of 40 CFR part 154.
(c)
(i) A copy of the amended label and any supplemental labeling to be used as an interim compliance measure.
(ii) A statement, which the Agency considers a report under the Act, that the registrant will comply with the labeling requirements prescribed by the Agency within the timeframes prescribed by the regulation.
(iii) An application for amended registration to delete the uses which have been restricted, or to “split” the registration into two registrations, one including only restricted or all uses, and the other including only uses that have not been classified.
(2) Alternatively, EPA may notify the applicant or registrant of the classification decision and require that he
(a)
(b)
Unless modified by the Agency, the compliance dates in this section shall apply to restricted use products.
(a)
(i) Bears an approved amended label which contains the terms of restricted use imposed by the Agency and otherwise complies with part 156 of this chapter;
(ii) Bears a sticker containing the product name, EPA registration number, and any terms of restricted use imposed by the Agency; or
(iii) Is accompanied by supplemental labeling bearing the information listed in paragraph (a)(1)(ii) of this section.
(2) If the registrant chooses to delete the restricted uses from his product label, that product may not be distributed or sold after the 180th day after the effective date of classification unless the product bears amended labeling with the restricted uses deleted.
(3) Notwithstanding paragraphs (a) (1) and (2) of this section, after the 270th day after the effective date of classification, no registrant or producer may distribute or sell a product that does not bear the approved amended label. After that date, stickers and supplemental labeling described in paragraph (a)(1) (ii) and (iii) are no longer acceptable.
(b)
(a) Any product classified for restricted use shall not be advertised unless the advertisement contains a statement of its restricted use classification.
(b) The requirement in paragraph (a) of this section applies to all advertisements of the product, including, but not limited, to:
(1) Brochures, pamphlets, circulars and similar material offered to purchasers at the point of sale or by direct mail.
(2) Newspapers, magazines, newsletters and other material in circulation or available to the public.
(3) Broadcast media such as radio and television.
(4) Telephone advertising.
(5) Billboards and posters.
(c) The requirement may be satisfied for printed material by inclusion of the statement “Restricted Use Pesticide,” or the terms of restriction, prominently in the advertisement. The requirement may be satisfied with respect to broadcast or telephone advertising by inclusion in the broadcast of the spoken words “Restricted use pesticide,” or a statement of the terms of restriction.
(d) The requirements of this section shall be effective:
(1) After 270 days after the effective date of restriction of a product that is currently registered, unless the Agency specifies a shorter time period;
(2) Upon the effective date of registration of a product not currently registered.
(a)
(1) Its toxicity exceeds one or more of the specific hazard criteria in paragraph (b) or (c) of this section, or evidence described in paragraph (d) of this section substantiates that the product or use poses a serious hazard that may be mitigated by restricting its use;
(2) Its labeling, when considered according to the factors in paragraph (e)(2) of this section, is not adequate to mitigate these hazard(s);
(3) Restriction of the product would decrease the risk of adverse effects; and
(4) The decrease in risks of the pesticide as a result of restriction would exceed the decrease in benefits.
(b)
(i) The pesticide, as diluted for use, has an acute oral LD
(ii) The pesticide, as formulated, has an acute dermal LD
(iii) The pesticide, as formulated, has an acute inhalation LC
(iv) The pesticide, as formulated, is corrosive to the eye (causes irreversible destruction of ocular tissue) or results in corneal involvement or irritation persisting for more than 7 days;
(v) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or scarring) or causes severe irritation (severe erythema or edema) at 72 hours; or
(vi) When used in accordance with label directions, or widespread and commonly recognized practice, the pesticide may cause significant subchronic, chronic or delayed toxic effects on man as a result of single or multiple exposures to the product ingredients or residues.
(2)
(i) The pesticide, as formulated, has an acute oral LD
(ii) The pesticide, as formulated, has an acute dermal LD
(iii) The pesticide, as diluted for use, has an acute dermal LD
(iv) The pesticide, as formulated, has an acute inhalation LC
(v) The pesticide, as formulated, is corrosive to the eye or causes corneal involvement or irritation persisting for more than 21 days;
(vi) The pesticide, as formulated, is corrosive to the skin (causes tissue destruction into the dermis and/or scarring); or
(vii) When used in accordance with label directions, or widespread and commonly recognized practice, the pesticide may cause significant subchronic toxicity, chronic toxicity, or delayed toxic effects on man, as a result of single or multiple exposures to the product ingredients or residues.
(c)
(i) When used according to label directions, application results in residues of the pesticide, its metabolites, or its degradation products, in the diet of exposed mammalian wildlife, immediately after application, such that:
(A) The level of such residues equals or exceeds one-fifth of the acute dietary LC
(B) The amount of pesticide consumed in one feeding day (mg/kg/day) equals or exceeds one-fifth of the mammalian acute oral LD
(ii) When used according to label directions, application results, immediately after application, in residues of the pesticide, its metabolites or its
(iii) When used according to label directions, application results in residues of the pesticide, its metabolites or its degradation products, in water that equal or exceed one-tenth of the acute LC
(iv) Under conditions of label use or widespread and commonly recognized practice, the pesticide may cause discernible adverse effects on non-target organisms, such as significant mortality or effects on the physiology, growth, population levels or reproduction rates of such organisms, resulting from direct or indirect exposure to the pesticide, its metabolites or its degradation products.
(2)
(i) The formulated product has an acute avian or mammalian oral LD
(ii) It is intended to be applied in such a manner that significant exposure to birds or mammals may occur.
(d)
(e)
(2) The labeling will be judged adequate if it meets all the following criteria:
(i) The user, in order to follow label directions, would not be required to perform complex operations or procedures requiring specialized training and/or experience.
(ii) The label directions do not call for specialized apparatus, protective equipment, or materials that reasonably would not be available to the general public.
(iii) Failure to follow label directions in a minor way would result in few or no significant adverse effects.
(iv) Following directions for use would result in few or no significant adverse effects of a delayed or indirect nature through bioaccumulation, persistence, or pesticide movement from the original application site.
(v) Widespread and commonly recognized practices of use would not nullify or detract from label directions such that unreasonable adverse effects on the environment might occur.
The Agency may by regulation impose restrictions on a product or class of products if it determines that:
(a) Without such restrictions, the product when used in accordance with warnings, cautions and directions for use or in accordance with widespread and commonly recognized practices of use may cause unreasonable adverse effects on the environment; and
(b) The decrease in risks as a result of restricted use would exceed the decrease in benefits as a result of restricted use.
The following uses of pesticide products containing the active ingredients specified below have been classified for restricted use and are limited to use by or under the direct supervision of a certified applicator.
Subpart U prescribes fees to be charged for the pesticide regulatory activities set forth in § 152.403 as performed by the Environmental Protection Agency (as authorized by 31 U.S.C. 9701 and Pub. L. 100-202) and provisions regarding their payment.
No fee required by this subpart U shall be levied with respect to any application filed during the period beginning on October 25, 1988, and ending on September 30, 1997. See FIFRA section 4(i)(7) (added to FIFRA by Pub. L. 100-532, October 25, 1988, 102 Stat. 2654).
(a)
(b)
(c)
(d)
(e)
(f)
The fee prescribed by the following table must be submitted with each application for registration, amended registration or experimental use permit. Fees will be adjusted annually in accordance with § 152.410. The Agency may waive or refund fees in accordance with § 152.412.
Applicants may submit data to supplement pending applications without incurring additional charges if the proper fee was paid with submission of the original application and subsequent submissions of supplementary data do not constitute a change in the type of registration action requested.
(a) If two or more applicants apply for a new chemical registration for products having the same active ingredient and each applicant provides a set of data in support of the registration developed independently of the other applicants' data, then each applicant submitting an independent set of data shall be charged the full new chemical registration review fee.
(b) If two or more applicants apply for a new chemical registration for products having the same active ingredient and the applicants have jointly developed or paid for the joint development of a common set of data to support their applications for registration, then each applicant shall be charged an equal share of the total fee for review of the applications for all of the subject products. The total fee will include the sum of the new chemical registration review fee for one product and one old chemical registration review fee for each additional product.
(c) If an application is received for registration of a product that contains two or more new chemical active ingredients and a different set of generic data is required by the Agency for each new chemical for the purpose of registration, the applicant will be required to pay the full new chemical registration review fee for each active ingredient.
(a) The fee schedule will be adjusted annually by the same percentage as the percent change in the Federal General Schedule (GS) pay scale. Such adjustments will be published in the
(b) Processing costs and fees will be reviewed periodically and changes will be made to the schedule as necessary. Such adjustments will be published for notice and comment in the
(a)
(b)
(c)
(1)
(2)
(3)
(i) The company applying had less than $40 million in gross revenue (including all revenue sources) in the most recently concluded fiscal year of operation, and a single fee would constitute more than 3 percent of the applicant's gross revenue from pesticide sales in the most recently completed fiscal year of operation, or
(ii) The company applying had less than $40 million in gross revenue (including all revenue sources) in the most recently concluded fiscal year of operation, and the cumulative registration fees paid during the 12 months following the applicant's most recently completed fiscal year, including any registration fees paid for the applicant for which a waiver is requested, constitute more than 3 percent of the applicant's gross revenue from pesticide sales in the most recently concluded fiscal year of operation.
(iii) The Agency will not grant such a waiver if it determines that the entity submitting the application has been formed or manipulated to qualify for such a waiver.
(4)
(a)
(2) A payment of $1,200 for processing the waiver or the amount of the actual fee, whichever is less, must be submitted simultaneously to the address set forth in paragraph (b) of this section. This fee will be refunded (or applied to any resulting partial fee) if the waiver is granted. Payment of fees for the registration activities, in contrast to the waiver fee, shall not be required until the Agency makes a determination on the waiver request. Since the actual fee is submitted to an address different than the one to which the waiver request is submitted, a copy of the payment document must be submitted with the waiver request that is submitted to the Office of Pesticide Programs' Document Processing Desk as described in paragraph (a)(1) of this section. No fee is required from a person who has no financial interest in the application.
(b)
(c)
(a) A device is defined as any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom.
(b) A device is not required to be registered under FIFRA sec. 3. The Agency has issued a policy statement concerning its authority and activities with respect to devices, which was published in the
(1) FIFRA sec. 2(q)(1) and part 156 of this chapter, with respect to labeling;
(2) FIFRA sec. 7 and part 167 of this chapter, with respect to establishment registration and reporting;
(3) FIFRA sec. 8 and part 169 of this chapter, with respect to books and records;
(4) FIFRA sec. 9, with respect to inspection of establishments;
(5) FIFRA sec. 12, 13, and 14, with respect to violations, enforcement activities, and penalties;
(6) FIFRA sec. 17, with respect to import and export of devices;
(7) FIFRA sec. 25(c)(3), with respect to child-resistant packaging; and
(8) FIFRA sec. 25(c)(4), with respect to the Agency's authority to declare devices subject to certain provisions of the Act.
7 U.S.C. 136w.
(a) An ingredient will be considered an active ingredient if it is contained in a pesticide product and:
(1) The ingredient has the capability by itself, and when used as directed at the proposed use dilution, to function as a pesticide; or
(2) The ingredient has the ability to elicit or enhance a pesticidal effect in another compound whose pesticidal activity is substantially increased due to the interaction of the compounds.
(b) Normally the applicant will determine and state in his application whether an ingredient is active or inert with respect to pesticidal activity. The Agency, as part of its review of an application for registration, or in conjunction with the Registration Standard or Special Review process, may require any ingredient, to be designated as an active ingredient if the Agency finds that it meets the criteria in paragraph (a) of this section. Conversely, the Agency may determine that any ingredient designated as active by an applicant is an inert ingredient if it fails to meet those criteria.
(c) If an ingredient is designated as an active ingredient, it must be identified in the label ingredients statement. If an ingredient is designated as an inert ingredient, it must be included as part of the total inert ingredients in the label ingredients statement.
(d) Designation of a substance as a pesticidally inert ingredient does not relieve the applicant or registrant of other requirements of FIFRA with respect to labeling of inert ingredients or submission of data, or from the requirements of the Federal Food, Drug, and Cosmetic Act with respect to tolerances or other clearance of ingredients.
Section 25(c)(5) of the Act authorizes the Administrator to prescribe regulations requiring coloration or discoloration of any pesticide if the Administrator determines that such requirements are feasible and necessary for the protection of health and the environment. This subpart describes those pesticide products which must be colored or discolored.
(a) Pesticide products intended for use in treating seeds must contain an EPA-approved dye to impart an unnatural color to the seed, unless appropriate tolerances or other clearances have been established under the Federal Food, Drug and Cosmetic Act for residues of the pesticide.
(b) The following products are exempt from the requirement of paragraph (a) of this section:
(1) Products intended and labeled for use solely by commercial seed treaters, provided that the label bears a statement requiring the user to add an EPA-approved dye with the pesticide during the seed treatment process.
(2) Products intended and labeled for use solely as at-planting or hopper box treatments.
(3) Products which are gaseous in form or are used as fumigants.
(c) EPA-approved dyes for seed treatment are listed in:
(1) Sections 180.910, 180.920, and 180.950 if an exemption from the requirement of a tolerance has been established.
(2) Section 180.2010 if EPA has determined that residues of the dye will be present, if at all, at levels that are below the threshold of regulation.
(3) Section 180.2020 if it has been determined that no tolerance or exemption from the requirement of a tolerance is needed as a result of a determination by EPA that the use is unlikely to result in residues in food/feed.
7 U.S.C. 136a, d, and w.
(a)
(b)
Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply:
In making determinations under this part the Administrator shall be guided by the principle that the burden of persuasion that a pesticide product is entitled to registration or continued registration for any particular use or under any particular set of terms and conditions of registration is always on the proponent(s) of registration.
(a) The Administrator may conduct a Special Review of a pesticide use if he determines, based on a validated test or other significant evidence, that the use of the pesticide (taking into account the ingredients, impurities, metabolites, and degradation products of the pesticide):
(1) May pose a risk of serious acute injury to humans or domestic animals.
(2) May pose a risk of inducing in humans an oncogenic, heritable genetic, teratogenic, fetotoxic, reproductive effect, or a chronic or delayed toxic effect, which risk is of concern in terms of either the degree of risk to individual humans or the number of humans at some risk, based upon:
(i) Effects demonstrated in humans or experimental animals.
(ii) Known or predicted levels of exposure of various groups of humans.
(iii) The use of appropriate methods of evaluating data and relating such data to human risk.
(3) May result in residues in the environment of nontarget organisms at levels which equal or exceed concentrations acutely or chronically toxic to such organisms, or at levels which produce adverse reproductive effects in such organisms, as determined from tests conducted on representative species or from other appropriate data.
(4) May pose a risk to the continued existence of any endangered or threatened species designated by the Secretary of the Interior or the Secretary of Commerce under the Endangered Species Act of 1973, as amended.
(5) May result in the destruction or other adverse modification of any habitat designated by the Secretary of the Interior or the Secretary of Commerce under the Endangered Species Act as a critical habitat for any endangered or threatened species.
(6) May otherwise pose a risk to humans or to the environment which is of sufficient magnitude to merit a determination whether the use of the pesticide product offers offsetting social, economic, and environmental benefits that justify initial or continued registration.
(b) In making any determination that a pesticide use satisfies one of the criteria for issuance of a Special Review specified by paragraph (a) of this section, the Administrator shall consider available evidence concerning both the adverse effect in question and the magnitude and scope of exposure of humans and nontarget organisms associated with use of the pesticide.
The Administrator may evaluate a pesticide use under the criteria of § 154.7 either on his own initiative, or at the suggestion of any interested person.
(a)
(b)
(1) The Notice of Special Review, any Notice of Preliminary Determination, and any Notice of Final Determination.
(2) Any notice issued under § 154.21 or § 154.23.
(3) Any documents (other than information claimed to be confidential business information) referred to by the Agency in those notices as relied upon by the Agency in reaching its determination.
(4) Copies of all written comments or materials (other than information claimed to be confidential business information) responding to any notice furnished under § 154.21 or § 154.23 or submitted at any time during the Special Review process by any person outside of government.
(5) Any written response to the Notice of Preliminary Determination from the Secretary of Agriculture or the Scientific Advisory Panel.
(6) A transcript of all public meetings held by the Scientific Advisory Panel or conducted by the Agency for the purpose of gathering information.
(7) A memorandum describing each meeting between Agency personnel and any person or party outside of government which concerns a pending pre-Special Review or Special Review decision. Each such memorandum shall be based on notes taken at the meeting and shall specify the date and time of the meeting, the participants and their affiliations, who requested the meeting, the subject matter of the meeting, and the person who prepared the memorandum. Except for information claimed to be confidential business information, each memorandum shall describe fully and accurately all significant positions taken, arguments made, and facts presented by each participant in the meeting, and shall identify all documents, proposals, or other materials distributed or exchanged at the meeting. Any discussion of claimed confidential business information shall be identified in meeting notes and referenced in the memorandum.
(8) All comments, correspondence, or other materials concerning a pending pre-Special Review or Special Review decision provided to the Agency by a person or party outside of government (other than information claimed to be confidential business information).
(9) All documents, proposals, or other materials concerning a pending pre-Special Review or Special Review decision, provided by the Agency to any person or party outside of government (other than information claimed to be confidential business information).
(c)
(2) To assert a claim of confidentiality for all or any part of a written submission concerning a Special Review, the submitter must furnish three copies of the material. Two copies must be complete, with claimed confidential business information clearly marked in the text. Items in the document that are claimed confidential should be numbered consecutively throughout the text. The third copy must have the claimed confidential business information excised from the text without closing up or paraphrasing the remaining text. The deletions should be consecutively numbered to correspond to the numbering of the complete copies. Each copy must be marked on the cover as to whether it contains claimed confidential business information.
(3) Any written material concerning a Special Review received by the Agency that is not marked as confidential will be deemed to be nonconfidential, and may be made available through the public docket or otherwise disclosed without prior notice to the submitter.
(d)
(e)
(f)
(ii) The docket and index will be available at the OPP Regulatory Public Docket located as set forth in 40 CFR 150.17(c).
(2) Information contained in the docket shall not be disclosed to the public to the extent that FIFRA or any other statute or regulation (including, but not limited to, 5 U.S.C. 552(b)(3) or (4)) prohibits its disclosure.
(3) The Agency will distribute a compendium of indices for new materials in the public docket by mail, on a monthly basis, to those members of the public who have specifically requested such material. The Agency will announce the availability of docket indices both annually in the
(a)
(b)
If the Administrator proposes not to initiate a Special Review after having given notice under § 154.21, he shall issue a proposed decision for publication in the
(a) The Administrator shall evaluate the available information and the comments received in response to the notice under § 154.21 and any notice issued under § 154.23, and shall issue for publication in the
(b) If the Administrator determines after having given notice under § 154.21 not to initiate a Special Review, he shall issue his decision for publication
(c) If the Administrator determines after having given notice under § 154.21 that one or more of the risk criteria set forth in § 154.7 have been satisfied, the Agency shall issue a notice for publication in the
(1) Identification of the pesticide uses for which a Special Review has been initiated and an identification of the criteria which have been satisfied.
(2) A brief discussion of the Agency's reasons for determining that the criteria have been satisfied.
(3) A statement indicating that EPA has established a docket for the Special Review, the contents of the docket, the location of the docket, and the times during which the docket will be available for inspection and copying.
(4) An invitation to all interested persons to submit further information concerning the risks and benefits associated with each use of the pesticide subject to the Special Review.
(5) A brief description of the Special Review process and a statement that registrants and applicants bear an affirmative burden of supporting registration of a pesticide product.
(6) A date by which information in response to the Agency's request for further information must be submitted.
(d) In his discretion, the Administrator may request that the Scientific Advisory Panel hold a public meeting to review the scientific issues related to the Special Review.
After issuance of a Notice of Special Review that applies to a use of a pesticide product (or category of products), any person may submit to the Agency any information, argument, or both, pertinent to:
(a) Whether the use of a pesticide product satisfies any of the § 154.7 risk criteria, with respect to the composition, labeling, packaging, and restrictions on use of the product as currently registered.
(b) Whether the use of a pesticide product would satisfy any of the § 154.7 risk criteria if its composition, labeling, packaging, and restrictions on use were approved in accordance with an application for registration or amended registration pending before the Agency. For further information see § 154.27(b).
(c) Whether any risks posed by the use or proposed use of the product that satisfy the § 154.7 risk criteria are unreasonable, taking into account the economic, social, and environmental costs and benefits of the use of the product.
(d) What regulatory action, if any, the Agency should take with respect to the use of the product.
(a) In the Special Review process, to assure openness and responsiveness, no person or party outside of government will be afforded special or preferential access to Agency Special Review decisionmakers or to the Agency's Special Review process. At the same time, however, Agency personnel are free to meet and otherwise communicate with persons or parties outside of government, including registrants and manufacturers, users, trade unions, environmental groups and other interested persons, to obtain information, exchange views, explore factual and substantive positions, or discuss regulatory options concerning Special Review decisions.
(b) Meetings between EPA and any person or party outside of government will not result in undue delay in reaching Special Review decisions. During such meetings, the Agency will not commit to take any particular action concerning a pending decision. The Agency may receive and consider information and recommendations from persons or parties outside of government; however, the Agency will make the final administrative decision on a wholly independent basis and in accordance with law.
(c) Any interested person may ask to meet with Agency officials to discuss factual information available to the Agency, to present any factual information, to respond to presentations by other persons, or to discuss what regulatory actions should be taken regarding a pesticide which is or may be the subject of a Special Review. If, at its
(d) Meetings described in this section may include meetings held after issuance of a Notice of Special Review with any registrant who proposes to change voluntarily the composition, packaging, and labeling, or other terms and conditions of registration of his pesticide product in a way which he believes would reduce the risks of use of the product so that it would no longer meet or exceed the risk criteria of § 154.7. Meetings for this purpose will be most helpful and productive for both registrants and the Agency if they are requested by registrants shortly after the issuance of the Notice of Special Review.
(e) If the Agency meets with any person or party outside of government concerning a pending Special Review decision, the Agency will not issue a final Special Review decision until 30 days after inclusion of a memorandum concerning that meeting in the public docket. During those 30 days, any person or party may submit written comments to the Agency regarding the subject matter of the meeting in question. The Agency may issue a final Special Review decision without allowing this 30-day period if expedited action is necessary to protect public health or the environment, or if the Agency has invited other parties with potentially opposing viewpoints to the meeting in question (e.g., registrants, users, labor, and environmental groups).
(f) The Agency may decline to meet subsequently with any person or party who asserts unreasonable confidential business information claims pursuant to § 154.15(c) for the purpose of circumventing the docketing procedures described in § 154.15(b).
(a)
(b)
(1) The time, date, and place of the hearing.
(2) A brief description of the procedures governing participation in the hearing by interested persons.
(3) The issues to be considered at the hearing.
(c)
The Administrator shall prepare a Notice of Preliminary Determination after the close of the comment period on a Notice of Special Review.
(a)
(1) A determination whether the use satisfies any of the risk criteria set forth in § 154.7, and a discussion of the reasons for the determination.
(2) A determination of whether any changes in the composition, packaging, labeling, or restrictions on use of a pesticide product that were proposed in an application for new or amended registration submitted after issuance of the Notice of Special Review would reduce the risk so that the use no longer would satisfy any of the risk criteria in § 154.7.
(3) If the use satisfies any of the risk criteria set forth in § 154.7, a determination of whether the adverse effects posed by the use are unreasonable, taking into account the economic, social, and environmental costs and benefits of the use of the product, and a discussion of reasons for the determination.
(4) If the use is determined to pose an unreasonable adverse effect, a statement of the regulatory action, if any, which the Agency intends to initiate with respect to the use, and a discussion of the reasons for initiating that regulatory action.
(5) A statement that the Administrator is requesting comments from the Secretary of Agriculture and the Scientific Advisory Panel on the notices and analysis specified in paragraph (b) of this section, and that the notices and analysis are available on request.
(6) Instructions to interested persons on how to submit comments (including the deadline for submission of comments).
(7) The location of the docket under § 154.15 and the times during which the docket will be available for inspection and copying.
(b)
(1) Prepare a proposed form of a Notice of Intent to Cancel, a Notice of Intent to Deny Registration, a Notice of Intent to Hold a Hearing, and/or a Notice of Intent to Change Classification, as appropriate.
(2) Prepare an Agricultural Impact Analysis, analyzing the impact of the proposed action on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy.
(3) Send the proposed notices and analysis to the Secretary of Agriculture and the Scientific Advisory Panel for comment, as provided by the Act.
(4) Send the Notice of Preliminary Determination and the other notices and analysis prepared under this section to all registrants and applicants for registration of products that are subject to the Special Review.
(c)
(a)
(b)
(1) For each pesticide use subject to the Notice of Preliminary Determination, the Agency's final determination with respect to each use, along with a discussion of the reasons for the determination.
(2) Any comments submitted by the Secretary of Agriculture or the Scientific Advisory Panel, and the responses of the Administrator to these comments.
(3) The response of the Administrator to any significant public comments submitted on the Notice of Preliminary Determination.
(4) Instructions to registrants, applicants for registration, and other interested persons concerning the procedures which will be used to implement any regulatory action which the Administrator has decided upon, including instructions concerning how to request hearings, if hearings are available as of right under the Act or have been made available by the Administrator under the Act.
(5) The location of the docket under § 154.15 and the times during which the docket will be available for inspection and copying.
(c)
(a) The Agency may elect to issue a Notice of Special Review and a Notice of Preliminary Determination simultaneously; or, to initiate cancellation, suspension, or denial proceedings concerning a pesticide or any of its uses without first conducting a Special Review or issuing a Notice of Preliminary Determination.
(b) If the Agency elects to issue a simultaneous Notice of Special Review and Notice of Preliminary Determination, the Agency will make the docket for that decision available for public inspection no more than 3 months after the Agency privately notifies the registrant of its risk concerns pursuant to § 154.21(a).
(a) The Administrator will not approve an application for registration or amended registration of a pesticide product except by use of the procedures specified in paragraph (c) of this section, if:
(1) The application proposes registration of a product for a use which earlier had been the subject of a notice under § 154.21(a);
(2) After the Administrator issued the notice, he determined not to initiate a Special Review, because of a proposal by an applicant for registration or amended registration to change the terms and conditions of registration of the product in a way which would reduce the risk sufficiently to eliminate the need for a Special Review; and
(3) The application for registration or amended registration now proposes that the terms and conditions which served as the basis of the earlier determination be eliminated, or be modified in a way which might increase the risk which was the subject of the notice under § 154.21(a).
(b) The Administrator will not approve an application for registration or amended registration of a pesticide product except by use of the procedures specified in paragraph (c) of this section, if:
(1) The application proposed registration of a product for a use which earlier had been the subject of a Notice of Special Review issued under § 154.25;
(2) After the Administrator issued that Notice, he determined not to issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal by an applicant for registration or amended registration to change the terms and conditions of registration of the product in a way which would reduce the risk sufficiently to eliminate the need for issuance of a notice under FIFRA section 3(c)(6) or 6(b); and
(3) The application for registration or amended registration now proposes that the terms and conditions of registration which served as the basis for the earlier determination now be eliminated or be modified in a way which might increase the risk which was the subject of the Notice of Special Review.
(c) An application to which paragraph (a) or (b) of this section applies may not be approved until:
(1) The Administrator issues a notice for publication in the
(2) If any substantive comments are submitted in response to the notice, the Administrator issues a second notice for publication in the
7 U.S.C. 136a and 136w.
For the purposes of this part,
EPA will issue annually in the
EPA will independently (or using the services of disinterested contractors or consultants) review available data in preparation for the development of a Registration Standard, and will be responsible for the drafting of the Registration Standard based on such data reviews. The Agency will not permit registrants to prepare, or assist in the preparation of, data reviews or other Registration Standard documents. The Agency may, however, meet with registrants to discuss its pending reviews, decisions, or documents, in accordance with the meeting procedures in § 155.30, and the docketing procedures in § 155.32.
EPA personnel may, upon their own initiative or upon request of any interested person or party, meet or communicate with persons or parties outside of government concerning a Registration Standard under development. Such meetings or communications will conform to the following policies and procedures:
(a)
(b)
(c)
(2) To assert a claim of confidentiality for all or any part of a written submission concerning a Registration Standard under development, the submitter must furnish three copies of the material. Two copies must be complete, with claimed confidential business information clearly marked in the text. Items in the document that are claimed confidential should be numbered consecutively throughout the document. The third copy must have the claimed confidential business information excised from the text without closing up or paraphrasing the remaining text. The deletions should be consecutively numbered to correspond to the numbering of the complete copies. Each copy must be marked on the cover as to whether it contains claimed confidential business information.
(3) Any written material received by the Agency that is not marked as confidential will be deemed to be nonconfidential, and may be made available through the public docket or otherwise disclosed without prior notice to the submitter.
(d)
(1) The date and time of the meeting.
(2) The name of the person who requested the meeting.
(3) The names and affiliations of the participants.
(4) The subject matter of the meeting.
(5) A full and accurate description of all significant positions taken, facts presented, and arguments made by each participant (except that any discussion of claimed confidential business information will be identified in meeting notes, and referenced in the memorandum).
(6) Identification of all documents, proposals, or other materials (other than information claimed to be confidential business information) distributed or exchanged at the meeting.
(7) The name of the person who prepared the memorandum.
(a)
(2) If the Agency notifies registrants privately in accordance with 40 CFR 154.21 that one or more risk criteria set forth in 40 CFR 154.7 (leading to a special review) may have been exceeded, that notification and any subsequent communications concerning that notification will be placed in a separate docket pertaining to possible special review in accordance with the provisions of § 154.15.
(b)
(1) An index of its contents (refer to paragraph (c) of this section).
(2) A copy of each comment received in response to the notice described in § 155.25 that pertains to a pesticide for
(3) A copy of each memorandum of a meeting between the Agency and persons or parties outside of government, prepared in accordance with § 155.30(d) (within 10 working days after the meeting).
(4) A copy of each document, comment, item of correspondence or other written material concerning the Registration Standard submitted to the Agency by any person or party outside of government, whether in a meeting or separately (within 10 working days after receipt, or 15 working days if the submitter has asserted a confidential business information claim concerning the material).
(5) A copy of each document, proposal, or other item of written material concerning the Registration Standard provided by the Agency to any person or party outside of government (within 15 working days after the item is made available to such person or party).
(6) A copy of the Registration Standard;
(7) With respect to a Registration Standard for which the Agency has determined that a substantially complete chronic health and teratology data base exists, a copy of the
(8) A copy of the
(c)
(1) A list of each meeting between the Agency and any person or party outside of government, containing the date and subject of the meeting, the names of participants and the name of the person requesting the meeting.
(2) A list of each document in the docket by title, source or recipient(s), and the date the document was received or provided by the Agency.
(d)
(2) The Agency will establish and maintain a mailing list of persons who have specifically requested that they receive indices for Registration Standard dockets. On a quarterly basis, EPA will distribute the indices of new materials placed in the public docket to these persons. Annually, EPA will require that persons on the list renew their requests for inclusion on the list.
(3) The Agency will issue annually in the
(4) Each
(a) The Agency will issue in the
(1) Concerns a previously unregistered active ingredient; or
(2) Concerns a previously registered active ingredient, and the Registration Standard states that registrants will be required (under FIFRA section 3(c)(2)(B)) to submit chronic health (including, but not limited to, chronic feeding, oncogenicity and reproduction) or teratology studies.
(b) Interested persons may submit comments concerning any Registration Standard described by paragraph (a) of this section at any time.
(c) The Agency will issue in the
(a)
(1) Among other things, FIFRA requires that a pesticide generally will not cause unreasonable adverse effects on the environment. Registration review is intended to ensure that each pesticide's registration is based on current scientific and other knowledge regarding the pesticide, including its effects on human health and the environment.
(2) If a product fails to satisfy the FIFRA standard for registration, the product's registration may be subject to cancellation or other remedies under FIFRA.
(b)
(c)
(2) When the Agency determines that new data or information are necessary for a pesticide's registration review, it will require such data under FIFRA section 3(c)(2)(B).
(a)
(1)
(2) New pesticides. The Agency will assign each pesticide registered after the effective date of this regulation to an existing registration review case or to a new registration review case.
(3) A pesticide product that contains multiple active ingredients will belong to the registration review cases for each of its active ingredients.
(b)
(1) Add a new active ingredient to a registration review case. The Agency may determine that a new active ingredient is chemically and toxicologically similar to active ingredients in an existing registration review case and should be grouped with the ingredients in the existing registration review case.
(2) Split a registration review case into two or more registration review cases. For example, new data or information may suggest that active ingredients in a registration review case are not as similar as previously believed and that they belong in two or more separate registration review cases.
(3) Move an ingredient from one registration review case to another. For example, new data or information might suggest that an ingredient
(4) Merge two or more registration review cases into a single registration review case. For example, new data or information might suggest that the active ingredients in two or more registration review cases should be grouped together for registration review.
(5) Delete an active ingredient from a registration review case. For example, the Agency will remove the ingredient from the case if the registrations of all products containing an active ingredient in a registration review case are canceled.
(c)
(d)
(1) The Agency generally will not change the baseline date for a registration review case when it modifies a case by adding or deleting ingredients or products.
(2) When the Agency splits a registration review case into two or more cases, the new case(s) generally will have the baseline date of the original registration review case.
(3) When the Agency merges two or more registration review cases into a single case, the Agency generally will use the earliest baseline date as the baseline date for the new case.
(e)
The Agency will develop schedules for registration review that are generally based on the baseline date of the registration review case or on the date of the latest registration review of the registration review case. The Agency may also take into account other factors, such as achieving process efficiencies by reviewing related cases together, when developing schedules for registration review. The Agency will maintain schedules for the current year and at least two subsequent years on its website.
The Agency may determine that there is no need to reconsider a previous decision that a pesticide satisfies the standard of registration in FIFRA. In such cases, instead of establishing a pesticide registration review case docket as described in § 155.50, the Agency may propose that, based on its determination that a pesticide meets the FIFRA standard for registration, no further review will be necessary. In such circumstances, the Agency will publish a notice in the
The Agency may issue a Data Call-In notice under FIFRA section 3(c)(2)(B) at any time if the Agency believes that the data are needed to conduct the registration review. The provisions in FIFRA section 3(c)(1), (c)(2)(B), and
The Agency will initiate a pesticide's registration review by establishing a docket for each registration review case, except for cases covered under § 155.46, and opening it for public review.
(a)
(1) An overview of registration review case status;
(2) A list of current registrations and registrants, any
(3) Risk assessment documents;
(4) Bibliographies concerning current registrations;
(5) Summaries of incident data; and
(6) Any other pertinent data or information.
(b)
(c)
(1) In order to ensure that the Agency will consider data or information in the conduct of a registration review, interested persons must submit the data or information during the comment period established in the notice described in paragraph (b) of this section. The Agency may, at its discretion, consider data or information submitted at a later date.
(2) The data or information must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.
(3) Submitters must clearly identify the source of any submitted data or information.
(4) Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.
(d) For the purposes of this subpart, the provisions of subpart B do not apply.
In addition to the public participation opportunities described in § 155.50 and § 155.53(c), the Agency may meet with stakeholders regarding a forthcoming or ongoing registration review. For example, before conducting a pesticide's registration review, the Agency may consult with registrants or pesticide users regarding the use and usage of the pesticide. The Agency may consult with registrants, pesticide users, or other persons during a pesticide's registration review with regard to developing risk management options for a pesticide. The Agency may informally consult with officials of Federal, State or Tribal agencies regarding a forthcoming or ongoing registration review.
(a)
(1) 45 days after the meeting; or
(2) The date of issuance of the registration review decision.
(b)
(c)
The Agency will review data and information described in § 155.50(a), (b), and (c) or submitted in response to a Data Call-In notice that it believes should be considered in the pesticide's registration review.
(a)
(b)
(2) Individual product registrations. If the Agency finds that additional review of an individual product's registration is needed, it will review the pesticide product label, confidential statement of formula, product-specific data, or other pertinent data or information, as appropriate, to determine whether the registration of the individual product meets the FIFRA standard for registration. If the Agency determines that additional data or information are needed to conduct the review, the Agency will issue a Data Call-In notice under FIFRA section 3(c)(2)(B).
(c)
(1) The Agency might not request comments on a draft risk assessment in cases where the Agency's initial screening of a pesticide indicates that it has low use/usage, affects few if any stakeholders or members of the public, poses low risk, and/or requires little or no risk mitigation. In such cases, the Agency will make a draft risk assessment available for public review and comment when it issues a proposed decision on the registration review case.
(2) If the Agency finds that it is not necessary to conduct a new risk assessment, it will issue a proposed decision on the registration review case as described in § 155.58.
The Agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. A FIFRA 3(c)(2)(B) notice requiring the needed data or information may precede, accompany, or follow issuance of the interim registration review decision. The Agency will follow procedures in § 155.58 when issuing an interim registration review decision.
A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in FIFRA.
(a) The Agency will publish a notice in the
(b) In its proposed decision, the Agency will, among other things:
(1) State its proposed findings with respect to the FIFRA standard for registration and describe the basis for such proposed findings.
(2) Identify proposed risk mitigation measures or other remedies as needed and describe the basis for such proposed requirements.
(3) State whether it believes that additional data are needed and, if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring such data may be issued in conjunction with a proposed or final decision on the registration review case or a proposed or final interim decision on a registration review case.
(4) Specify proposed labeling changes; and
(5) Identify deadlines that it intends to set for completing any required actions.
(c) After considering any comments on the proposed decision, the Agency will issue a registration review decision or interim registration review decision. This decision will include an explanation of any changes to the proposed decision and the Agency's response to significant comments. The Agency will publish a notice in the
(d) If the registrant fails to take the action required in a registration review decision or interim registration review decision, the Agency may take appropriate action under FIFRA.
7 U.S.C. 136-136y.
Terms used in this part have the same meaning as in the Act and part 152 of this chapter. In addition, as used in this part, the following terms shall have the meanings set forth below.
(a)
(i) The name, brand, or trademark under which the product is sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or person for whom produced as prescribed in paragraph (c) of this section;
(iii) The net contents as prescribed in paragraph (d) of this section;
(iv) The product registration number as prescribed in paragraph (e) of this section;
(v) The producing establishment number as prescribed in paragraph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of this section;
(vii) Hazard and precautionary statements as prescribed in subpart D of this part for human and domestic animal hazards and subpart E of this part for environmental hazards.
(viii) The directions for use as prescribed in paragraph (i) of this section; and
(ix) The use classification(s) as prescribed in paragraph (j) of this section.
(2)
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3)
(4)
(ii)
(B)
(5)
(i) A false or misleading statement concerning the composition of the product;
(ii) A false or misleading statement concerning the effectiveness of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or devices;
(v) Any statement directly or indirectly implying that the pesticide or device is recommended or endorsed by any agency of the Federal Government;
(vi) The name of a pesticide which contains two or more principal active ingredients if the name suggests one or more but not all such principal active ingredients even though the names of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling statements required under the Act and these regulations;
(ix) Claims as to the safety of the pesticide or its ingredients, including
(x) Non-numerical and/or comparative statements on the safety of the product, including but not limited to:
(A) “Contains all natural ingredients”;
(B) “Among the least toxic chemicals known”
(C) “Pollution approved”
(6)
(ii) Clearly legible reproductions or photo reductions will be accepted for unusual labels such as those silk-screened directly onto glass or metal containers or large bag or drum labels. Such reproductions must be of microfilm reproduction quality.
(b)
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through registration or supplemental registration as an additional name pursuant to § 152.132.
(c) Name and address of producer, registrant, or person for whom produced. An unqualified name and address given on the label shall be considered as the name and address of the producer. If the registrant's name appears on the label and the registrant is not the producer, or if the name of the person for whom the pesticide was produced appears on the label, it must be qualified by appropriate wording such as “Packed for * * *,” “Distributed by * * *,” or “Sold by * * *” to show that the name is not that of the producer.
(d)
(2) If the pesticide is a liquid, the net content statement shall be in terms of liquid measure at 68 °F (20 °C) and shall be expressed in conventional American units of fluid ounces, pints, quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or pressurized, or is a mixture of liquid and solid, the net content statement shall be in terms of weight expressed as avoirdupois pounds and ounces.
(4) In all cases, net content shall be stated in terms of the largest suitable units,
(5) In addition to the required units specified, net content may be expressed in metric units.
(6) Variation above minimum content or around an average is permissible only to the extent that it represents deviation unavoidable in good manufacturing practice. Variation below a stated minimum is not permitted. In no case shall the average content of the packages in a shipment fall below the stated average content.
(7) For a pesticide product packaged in a refillable container, an appropriately sized area on the label may be left blank to allow the net weight or measure of content to be marked in by the refiller according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale of the pesticide. As required in paragraph (a)(1)(iii) of this section, the net contents must be shown clearly and prominently on the label.
(e)
(f)
(g)
(2)
(ii) The text of the ingredient statement must run parallel with other text on the panel on which it appears, and must be clearly distinguishable from and must not be placed in the body of other text.
(3)
(4)
(5)
(6)
(i) In cases where it is determined that a pesticide formulation changes chemical composition significantly, the product must bear the following statement in a prominent position on the label: “Not for sale or use after [date].”
(ii) The product must meet all label claims up to the expiration time indicated on the label.
(7)
(h) [Reserved]
(i)
(ii)
(A) If required by the Agency, such printed or graphic matter is securely attached to each package of the pesticide, or placed within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in accompanying leaflets or circulars, such as “See directions in the enclosed circular:” and
(C) The Administrator determines that it is not necessary for such directions to appear on the label.
(iii)
(
(
(
(
(B) Detailed directions for use may be omitted from the labeling of pesticide products for which sale is limited to physicians, veterinarians, or druggists, provided that:
(
(
(
(C) Detailed directions for use may be omitted from the labeling of pesticide products which are intended for use only by formulators in preparing pesticides for sale to the public, provided that:
(
(
(
(
(2)
(i) The statement of use classification as prescribed in paragraph (j) of this section immediately under the heading “Directions for Use.”
(ii) Immediately below the statement of use classification, the statement “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”
(iii) The site(s) of application, as for example the crops, animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for dilution, if required, and type(s) of application apparatus or equipment required.
(vii) The frequency and timing of applications necessary to obtain effective results without causing unreasonable adverse effects on the environment.
(viii) Worker protection statements meeting the requirements of subpart K of this part.
(ix) Specific directions concerning the storage, residue removal and disposal of the pesticide and its container, in accordance with subpart H of this part. These instructions must be grouped and appear under the heading, “Storage and Disposal.” This heading must be set in type of the same minimum sizes as required for the child hazard warning. (See table in § 156.60(b))
(x) Any limitations or restrictions on use required to prevent unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals, objects, or in or adjacent to certain areas.
(D) For total release foggers as defined in § 156.78(d)(1), the following statements must be included in the “Directions for Use.”
DO NOT use more than one fogger per room. DO NOT use in small, enclosed spaces such as closets, cabinets, or under counters or tables. Do not use in a room 5 ft.×5 ft. or smaller; instead, allow fog to enter from other rooms. Turn off ALL ignition sources such as pilot lights (shut off gas valves), other open flames, or running electrical appliances that cycle off and on (
(E) For restricted use pesticides, a statement that the pesticide may be applied under the direct supervision of a certified applicator who is not physically present at the site of application but nonetheless available to the person applying the pesticide, unless the Agency has determined that the pesticide may only be applied under the direct supervision of a certified applicator who is physically present.
(F) Other pertinent information which the Administrator determines to be necessary for the protection of man and the environment.
(j)
(1)
(2)
(i)
(B) Directly below this statement on the front panel, a summary statement of the terms of restriction imposed as a precondition to registration shall appear. If use is restricted to certified applicators, the following statement is required: “For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator's certification.” If, however, other regulatory restrictions are imposed, the Administrator will define the appropriate wording for the terms of restriction by regulation.
Each product label is required to bear hazard and precautionary statements for humans and domestic animals (if applicable) as prescribed in this subpart. Hazard statements describe the type of hazard that may occur, while precautionary statements will either direct or inform the user of actions to take to avoid the hazard or mitigate its effects.
(a)
(2)
(b)
(2)
This section establishes four Toxicity Categories for acute hazards of pesticide products, Category I being the highest toxicity category. Most human hazard, precautionary statements, and human personal protective equipment statements are based upon the Toxicity Category of the pesticide product as sold or distributed. In addition, toxicity categories may be used for regulatory purposes other than labeling, such as classification for restricted use and requirements for child-resistant packaging. In certain cases, statements based upon the Toxicity Category of the product as diluted for use are also permitted. A Toxicity Category is assigned for each of five types of acute exposure, as specified in the table in this paragraph.
(a)
(1)
(2)
(3)
(4)
(b)
(1) Bear a signal word reflecting a higher Toxicity Category than indicated by the route of exposure of highest toxicity, unless the Agency determines that such labeling is necessary to prevent unreasonable adverse effects on man or the environment;
(2) Bear a signal word reflecting a lesser Toxicity Category associated with a diluted product. Although precautionary statements for use dilutions may be included on label, the signal word must reflect the toxicity of the product as distributed or sold; or
(3) Bear different signal words on different parts of the label.
(a) Each pesticide product must bear on the front panel of the label the statement “Keep Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear on a separate line in close proximity to the signal word, if required. The statement is required on Toxicity Category IV products that do not otherwise require a signal word.
(b) In its discretion, EPA may waive the requirement, or require or permit an alternative child hazard warning, if:
(1) The applicant can demonstrate that the likelihood of exposure of children to the pesticide during distribution, marketing, storage or use is remote (for example, an industrial use product); or
(2) The pesticide is approved for use on children (for example, an insect repellent).
(c) EPA may approve an alternative child hazard warning that more appropriately reflects the nature of the pesticide product to which children may be exposed (for example, an impregnated pet collar). In this case, EPA may also approve placement on other than the front panel.
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(a)
(b)
(c)
(d)
(2) If a pesticide product is a total release fogger containing a propellant with a flash point at or below 20 °F, then the following special instructions must be added to the “Physical and Chemical Hazards” warning statement, in addition to any flammability statement required by paragraph (b) of this section:
(3) A graphic symbol depicting fire, such as illustrated in this paragraph, or an equivalent symbol, must be displayed along with the required language adjoining the “Physical and Chemical Hazards” warning statement. The graphic symbol must be no smaller than twice the size of the first character of the human hazard signal word.
(a)
(b)
(c)
(a)
(b)
(1) If a pesticide intended for outdoor use contains an active ingredient with a mammalian acute oral LD
(2) If a pesticide intended for outdoor use contains an active ingredient with a fish acute LC
(3) If a pesticide intended for outdoor use contains an active ingredient with an avian acute oral LD
(4) If either accident history or field studies demonstrate that the use of the pesticide may result in fatality to birds, fish or mammals, the statement, “This pesticide is extremely toxic to wildlife (fish)” is required.
(5) If a product is intended for or involves foliar application to agricultural crops, forests or shade trees, or mosquito abatement treatments, and contains a pesticide toxic to pollinating insects, the label must bear appropriate label cautions.
(6) If a product is intended for outdoor use other than aquatic applications, the label must bear the caution, “Keep out of lakes, ponds or streams. Do not contaminate water by cleaning of equipment or disposal of wastes.”
For products other than plant-incorporated protectants, the following statements, as applicable, must be placed on the label or container. The information may be located on any part of the container except the closure. If the statements are placed on the container, they must be durably marked on the container. Durable marking includes, but is not limited to etching, embossing, ink jetting, stamping, heat stamping, mechanically attaching a plate, molding, or marking with durable ink.
(a)
(1)
(2)
(i) “Do not reuse or refill this container.”
(ii) “Do not reuse this container to hold materials other than pesticides or dilute pesticides (rinsate). After emptying and cleaning, it may be allowable to temporarily hold rinsate or other pesticide-related materials in the container. Contact your state regulatory agency to determine allowable practices in your state.”
(iii) The following statement may be used if a product is “ready-to-use” and its directions for use allow a different product (that is a similar, but concentrated formulation) to be poured into the container and diluted by the end user: “Do not reuse or refill this container unless the directions for use allow a different (concentrated) product to be diluted in the container.”
(3)
(i) “Offer for recycling if available.”
(ii) “Once cleaned, some agricultural plastic pesticide containers can be taken to a container collection site or picked up for recycling. To find the nearest site, contact your chemical dealer or manufacturer or contact [a pesticide container recycling organization] at [phone number] or [web site]. For example, this statement could be “Once cleaned, some agricultural plastic pesticide containers can be taken to a container collection site or picked up for recycling. To find the nearest site, contact your chemical dealer or manufacturer or contact the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free) or
(iii) A recycling statement approved by EPA and published in an EPA document, such as a Pesticide Registration Notice.
(iv) An alternative recycling statement that has been reviewed and approved by EPA.
(v) “Offer for reconditioning if appropriate.”
(4)
(5)
(i) Aerosol cans.
(ii) Devices as defined in § 152.500 of this chapter.
(iii) One-time use caulking tubes and other one-time use squeezable tube containers for paste, gel, or other similar substances.
(iv) Foil packets for water soluble packaging, repellent wipes, and other one-time use products.
(v) One-time use portion control packets, such as polyethylene sleeve packages, or rodenticide placepacks.
(vi) One-time use bait stations.
(vii) One-time use cages for repellent or trapping strips.
(viii) Pet collars or animal ear tags, such as cattle ear tags.
(ix) One-time use semiochemical dispersion devices.
(x) Any container that is destroyed by the use of the product contained.
(xi) Any container that would be destroyed if reuse of the container were attempted.
(b)
(1) “Refillable Container. Refill this container with pesticide only. Do not reuse this container for any other purpose.”
(2) “Refillable Container. Refill this container with [
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(f)
(g)
The label of each dilutable (liquid or solid) pesticide product packaged in a rigid nonrefillable container must include the following residue removal instructions as appropriate.
(a)
(1) “Clean container promptly after emptying.”
(2) “Triple rinse or pressure rinse container (or equivalent) promptly after emptying.”
(3) “Triple rinse container (or equivalent) promptly after emptying.”
(b)
(1) For liquid dilutable pesticide products in containers small enough to shake, use the following instructions: “Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container
(2) For solid dilutable pesticide products in containers small enough to shake, use the following instructions: “Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank. Fill the container
(3) For containers that are too large to shake, use the following instructions: “Triple rinse as follows: Empty remaining contents into application equipment or a mix tank. Fill the container
(c)
(1) For liquid dilutable pesticide products, use the following label instruction: “Pressure rinse as follows: Empty the remaining contents into application equipment or a mix tank and continue to drain for 10 seconds after the flow begins to drip. Hold container upside down over application equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container, and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the flow begins to drip.”
(2) For solid dilutable pesticide products, use the following label instruction: “Pressure rinse as follows: Empty the remaining contents into application equipment or a mix tank. Hold container upside down over application equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container, and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the flow begins to drip.”
(d)
(2) The registrant must indicate why a non-water diluent is necessary for efficient residue removal, and must propose residue removal instructions and disposal instructions that are appropriate for the characteristics and formulation of the pesticide product and non-water diluent. The proposed residue removal instructions must identify the diluent. If the Directions for Use permit the application of a mixture of the pesticide and the non-water diluent, the instructions may allow the rinsate to be added to the application equipment or mix tank. If the Directions for Use do not identify the non-water diluent as an allowable addition to the pesticide, the instructions must require collection and storage of the rinsate in a rinsate collection system.
(3) EPA may approve the request if EPA finds that the proposed instructions are necessary and appropriate.
The label of each pesticide product packaged in a refillable container must include the residue removal instructions in this section. Instructions must be given for all pesticide products that are distributed or sold in refillable containers, including those that do not require dilution prior to application.
(a)
(1) “Cleaning the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller.”
(2) “Pressure rinsing the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller.”
(b)
(2) Subject to meeting the standard in paragraph (b)(1) of this section, the statement on residue removal instructions could include any one of the following:
(i) The refilling residue removal procedure developed by the registrant for the pesticide product.
(ii) Standard industry practices for cleaning refillable containers.
(iii) For pesticides that require dilution prior to application, the following statement: “To clean the container before final disposal, empty the remaining contents from this container into application equipment or a mix tank. Fill the container about 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. Pour or pump rinsate into application equipment or rinsate collection system. Repeat this rinsing procedure two more times.”
(iv) Any other statement the registrant considers appropriate.
Any pesticide product released for shipment by a registrant after August 16, 2011 must bear a label that complies with §§ 156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146 and 156.156.
(a)
(2) This subpart prescribes interim requirements that must be placed on the pesticide label and in pesticide labeling. These interim requirements pertain to restricted-entry intervals, personal protective equipment, and notification. On a case-by-case basis, these interim requirements will be reviewed and may be revised during reregistration or other agency review processes.
(b)
(2) The requirements of this subpart do not apply to a product that bears directions solely for uses excepted by § 170.202(b) of this chapter.
(c)
Terms in this subpart have the same meanings as they do in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, the following terms, as used in this subpart, shall have the meanings stated below:
(a)
(b)
(a)
(b)
(2) Each product shall bear the statement: “This standard contains requirements for the protection of agricultural workers on farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains requirements for training, decontamination, notification, and emergency assistance. It also contains specific instructions and exceptions pertaining to the statements on this label [in this labeling] about [use any of the following that are applicable] personal protective equipment, restricted-entry interval, and notification to workers.” These statements shall be placed immediately following the reference statement required by paragraph (b)(1) of this section, or they shall be placed in the supplemental product labeling under the heading AGRICULTURAL USE REQUIREMENTS.
(3) If the statements in paragraph (b)(2) of this section are included in supplemental labeling rather than on the label of the pesticide container, the container label must contain this statement immediately following the statement required in paragraph (b)(1) of this section: “Refer to supplemental labeling entitled AGRICULTURAL USE REQUIREMENTS in the DIRECTIONS FOR USE section of the labeling for information about this standard.”
(4) If the statements in paragraph (b)(2) of this section are included in supplemental labeling, they must be preceded immediately by the statement in paragraph (b)(1) of this section under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
(c)
(2) If the product is a fumigant, the label shall so state. The identification shall appear:
(i) As part of the product name; or
(ii) Close to the product name, as part of the product-type identification or as a separate phrase or sentence.
(d)
(e)
(a)
(b)
(2) If different restricted-entry intervals have been established for some crops or some uses of a product, the restricted-entry statement in paragraph (b)(1) of this section shall be associated on the labeling of the product with the directions for use for each crop each use to which it applies, immediately preceded or immediately followed by the words “Restricted-entry interval” (or the letters “REI”).
(c)
(2)
(ii) If the product contains only one active ingredient and it is in toxicity category II by the criteria in paragraph (c)(1) of this section, the restricted-entry interval shall be 24 hours.
(iii) If the product contains only active ingredients that are in toxicity category III or IV by the criteria in paragraph (c)(1) of this section, the restricted-entry interval shall be 12 hours.
(3)
(d)
(e)
(2) Product-specific restricted-entry intervals established for pesticide products or pesticide uses that are not covered by part 170 of this chapter shall remain in effect and shall not be placed under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
(f)
(2) Existing interim restricted-entry intervals established by the Agency for pesticide products or pesticide uses not covered by part 170 of this chapter shall remain in effect and shall not be placed under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
(a)
(b)
(2) Each product that is a fumigant and is registered for use in a greenhouse (or whose labeling allows use in a greenhouse) shall bear the statement: “For greenhouse applications, notify workers of the application by warning them orally and by posting warning signs outside all entrances to the greenhouse.”
(a)
(b)
(2) Any existing labeling statement that prohibits the use of gloves or boots overrides the corresponding requirement in paragraph (e) of this section and must be retained on the labeling.
(3) If the product labeling contains uses that are not covered by part 170 of this chapter, the registrant may adopt the personal protective equipment required in this section for those uses. However, if the personal protective equipment required in this section would not be sufficiently protective or would be onerously overprotective for uses not covered by part 170 of this chapter, the registrant must continue to apply the existing personal protective equipment requirements to those uses. The labeling must indicate which personal protective equipment requirements apply to uses covered by part 170 of this chapter and which personal protective equipment requirements apply to other uses.
(c)
(2) Personal protective equipment statements for early-entry workers. Personal protective equipment statements for early-entry workers shall be placed in the DIRECTIONS FOR USE section of the labeling under the heading AGRICULTURAL USE REQUIREMENTS and immediately after the restricted-entry statement required in § 156.208(a).
(d)
(2) The requirement for personal protective equipment is based on the acute toxicity category of the end-use product for each route of exposure as defined by § 156.62. If data to determine the acute dermal toxicity or the acute inhalation toxicity are not obtainable, the acute oral toxicity shall be used as a surrogate to determine the personal protective equipment requirements for that route of exposure. If data to determine the acute toxicity of the product by a specific route of exposure (including acute oral toxicity in lieu of acute dermal or acute inhalation toxicity) are not obtainable, the toxicity category corresponding to the signal word of the end-use product shall be used to determine personal protective equipment requirements for that route of exposure. If the signal word is “CAUTION,” toxicity category III will be used.
(3) The minimum personal protective equipment and work clothing requirements specified in this section shall be included in a statement such as the following: “Applicators and other handlers must wear: (body protection statement); (glove statement, if applicable); (footwear statement, if applicable); (protective eyewear statement, if applicable); (respirator statement, if applicable).” The format of statements given in this paragraph is optional, but it is recommended for clarity.
(e)
(f)
(1)
(2)
(3)
(4)
(5)
(g)
(i) Dust/mist filtering respirator with MSHA/NIOSH/ approval number prefix TC-21C; or
(ii) Respirator with an organic-vapor-removing cartridge and a prefilter approved for pesticides with MSHA/NIOSH approval number prefix TC-23C or with a canister approved for pesticides with MSHA/NIOSH approval number prefix TC-14G; or
(iii) Supplied-air respirator with MSHA/NIOSH approval number prefix TC-19C or self-contained breathing apparatus (SCBA) with MSHA/NIOSH approval number TC-13F.
(2)
(3)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(h)
(2)
(i)
(1) If the product is not ready-to-use and there is no existing requirement for a chemical-resistant suit, the following statement shall be included: “Mixers/Loaders: add a chemical-resistant apron.”
(2) If the application of the product may result in overhead exposure to any handler (for example, applicator exposure during airblast spraying of orchards or flagger exposure during aerial application), the following statement shall be included: “Overhead Exposure: wear chemical-resistant headgear.”
(3) If any type of equipment other than the product container may be used to mix, load, or apply the product, and there is no requirement for a chemical-resistant protective suit, the following statement shall be included: “For Cleaning Equipment: add a chemical-resistant apron.”
(j)
(1) For all pesticide products, add the statement: “For early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, wear: (list the body protection, glove, footwear, protective eyewear, and protective headgear, if applicable, statements specified for applicators and other handlers, but omit any respiratory protection statement).”
(2) If the body protection statement in the personal protective equipment requirement for handlers specifies a long-sleeved shirt and long pants, “coveralls” must be specified in the statement of personal protective equipment for early-entry workers.
(3) If there is no statement requiring gloves and no prohibition against gloves for applicators and other handlers under the heading HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) in the labeling, add a requirement for “waterproof gloves” in the statement of personal protective equipment for early-entry workers.
7 U.S.C. 136w.
This subpart prescribes requirements for child-resistant packaging of pesticide products and devices. The requirements are established under the authority of FIFRA section 25(a)(1), which authorizes the Administrator to issue regulations to carry out the purposes of the Act, and FIFRA section 25(c)(3), which authorizes the Administrator to establish standards with respect to the package, container or wrapping in which a pesticide or device is enclosed in order to protect children and adults from serious injury or illness resulting from accidental ingestion or contact with pesticides or devices regulated under the Act.
Terms used in this subpart shall have the following meanings:
(1) Directly on humans or pets;
(2) In, on, or around any structure, vehicle, article, surface or area associated with the household, including but
(3) In or around any preschool or day care facility.
Unless exempted under § 157.24, a pesticide product must be distributed and sold in child-resistant packaging complying with § 157.32 if it meets both of the following criteria:
(a)
(1) The pesticide has an acute oral LD
(2) The pesticide has an acute dermal LD
(3) The pesticide has an acute inhalation LC
(4) The pesticide is corrosive to the eye (causes irreversible destruction of ocular tissue) or causes corneal involvement or irritation persisting for 21 days or more;
(5) The pesticide is corrosive to the skin (causes tissue destruction into the dermis and/or scarring) or causes severe skin irritation (severe erythema or edema) at 72 hours; or
(6) The pesticide or device has such characteristics that, based upon human toxicological data, use history, accident data or such other evidence as is available, the Agency determines there is serious hazard of accidental injury or illness which child-resistant packaging could reduce; and
(b)
(a)
(1)
(ii) Notwithstanding the exemption in paragraph (a)(1)(i) of this section, the Agency may require the use of child-resistant packaging for a product classified for restricted use by or under the direct supervision of a certified applicator if the Agency determines that the product poses a risk of serious accidental injury or illness which child-resistant packaging could reduce. If the Agency makes such a determination, it will notify the registrant in writing and provide a short statement of the basis of its determination. The registrant will then have 30 days to request a hearing on the Agency's determination. Thereafter the Agency will decide whether to require the product to be distributed only in child-resistant packaging and will notify the registrant of its decision.
(2)
(A) If the product is a solid product, regardless of pesticide type, a size of 50 pounds or greater;
(B) If the product is a liquid product intended for use in swimming pools, a size greater than 7.5 gallons by volume;
(C) If the product is a liquid product intended for any other pesticide use, a size of 5 gallons or greater by volume;
(D) If the product is packaged as an aerosol (measured by weight), regardless of pesticide type, a weight of 2 pounds or greater.
(ii) The Agency may require that a product packaged in a size exceeding that listed in paragraphs (a)(2)(i) (A) through (D) of this section be distributed and sold only in child-resistant packaging if the Agency determines that the product is, or is intended to be, distributed or sold to homeowners
(b)
(1)
(i) The name, address, and telephone number of the requester;
(ii) The name and registration number (or file symbol) of the product(s) for which the exemption is requested;
(iii) A description of the package and the size(s) for which the exemption is requested; and
(iv) Documentation supporting the request for exemption, including the length of time for which the exemption is requested.
(2)
(3)
(i) Whether the toxicity of the product is such that it should not be allowed to be distributed or sold except in child-resistant packaging.
(ii) Whether child-resistant packaging is technically feasible, practicable, or appropriate. An exemption may be granted if the Agency determines that any one of these criteria has not been met.
(iii) Whether the composition or use pattern of the product necessitates a particular form of packaging for proper use.
(iv) Whether child-resistant packaging that is technically feasible, practicable, and appropriate is available for the product or can reasonably be made available to the registrant in sufficient quantities to meet his packaging needs. This determination does not include a consideration of whether the packaging would be adaptable to a registrant's existing package type or packaging equipment.
(v) Whether the registrant has made a timely and good faith effort to obtain child-resistant packaging for the product.
(vi) If child-resistant packaging which is technically feasible, practicable, and appropriate is not yet available, when such packaging is likely to be available.
(4) An exemption may be withdrawn by the Agency at any time if the lack of child-resistant packaging results in serious illnesses or injuries to children. If the Agency determines that an exemption should be withdrawn, it will notify the registrant, stating the basis for its determination. The registrant will then have 30 days to request a hearing on the Agency's determination. Thereafter the Agency will decide whether to withdraw the exemption, and will notify the registrant of its decision.
Pesticide products distributed or sold as an aggregate of one or more unit packages and meeting the criteria of § 157.22 must be distributed or sold in
A registrant whose product is not required to be in child-resistant packaging may distribute or sell his pesticide product in child-resistant packaging. If he does so, that packaging must meet the standards for child-resistant packaging stated in § 157.32. The registrant must certify to this effect in accordance with § 157.34, and must retain the records required by § 157.36.
(a)
(b)
(c)
(a)
(2) Certification must be submitted with each application for new registration, if applicable. If the Agency determines, in accordance with § 157.24(a)(1)(ii), (2)(ii), or (b)(4), that a currently registered product is required to be packaged in child-resistant packaging, a certification must be submitted within 6 months after the Agency finally notifies the registrant of the requirement.
(b)
(1) The name and EPA registration number of the product to which the certification applies, the registrant's name and address, the date, and the name, title and signature of the company official making the certification.
(2) A statement that the packaging that is being used for the product will meet the standards of § 157.32. The statement, “I certify that the packaging that will be used for this product meets the standards of 40 CFR 157.32,” will suffice for this purpose.
For as long as the registration of a pesticide product required to be in child-resistant packaging is in effect, the registrant must retain the records listed in this section. The registrant must, upon request by the Agency, make them available to Agency representatives for inspection and copying, or must submit them to the Agency.
(a) A description of the package, including a description of:
(1) The container and its dimensions and composition.
(2) The closure or child-resistant mechanism, including the name of its manufacturer and the manufacturer's designation for the closure or the physical working of the child-resistant packaging mechanism.
(b) A copy of the certification statement required by § 157.34.
(c) One of the following types of records verifying that each package for the product is child-resistant:
(1) Test data on the package based on the Consumer Product Safety Commission protocol in 16 CFR 1700.20.
(2) Test data, not conforming to the protocol in 16 CFR 1700.20, or a set of measurements on the package, together with an explanation as to why such data or measurements demonstrate that the package is child-resistant.
(3) Test data, whether or not conforming to the protocol in 16 CFR 1700.20, on a different package, together with an explanation of why such data demonstrate that the package being used is child-resistant.
(4) Written evidence that verifies that testing on the package has been conducted according to the protocol in 16 CFR 1700.20. Written evidence may be one of the following:
(i) A letter or literature from the packaging supplier;
(ii) A letter from the facility that conducted the testing; or
(iii) A specification in the contract between the registrant or applicant and the packaging supplier;
(5) When the container and closure are purchased separately by the registrant:
(i) Information of the kinds described in paragraphs (c) (1) through (4) of this section showing that the closure is child-resistant; and
(ii) A written explanation of why the container is child-resistant; and
(iii) Information showing that the closure and container are compatible with each other, and a written explanation of why the resulting package is child-resistant.
(6) A combination of the records listed in paragraphs (c) (1) through (5).
(d) Records verifying that the package meets the compatibility and durability standards of § 157.32(b) and (c).
7 U.S.C. 136-136y; 21 U.S.C. 346a.
(a)
(b)
(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)
(2)
(3)
(4)
At 78 FR 26978, May 8, 2013, § 158.1 was amended by revising paragraph (c)(4), effective July 8, 2013. For the convenience of the user, the revised text is set forth as follows:
(c) * * *
(4)
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:
(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.
(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.
(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.
(a)
(2) The requirements of this section do not apply to administrative materials accompanying a data submission, including forms, labeling, and correspondence.
(b)
(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)
(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 applicable.
(4) A complete and accurate English translation must be included for any information that is not in English.
(5) A flagging statement as prescribed by § 158.34, if applicable.
(a)
(1)
(2)
(b)
(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 pursuant to FFDCA sec. 408, pursuant to the authority in sec. 408(i).
(c)
(2)
(i)
No claim of confidentiality, on any basis whatsoever, is made for any information contained in this document. I acknowledge that information not designated as within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) and which pertains to a registered or previously registered pesticide is not entitled to confidential treatment and may be released to the public, subject to the provisions regarding disclosure to multinational entities under FIFRA sec. 10(g).
(ii)
Information claimed as confidential has been removed to a confidential attachment.
(3)
(ii) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) manufacturing or quality control processes must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(A).
(iii) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) the details of any methods for testing, detecting, or measuring the quantity of any deliberately added inert ingredient of a pesticide, must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(B).
(iv) All information in the confidential attachment that consists of (or whose disclosure would in turn disclose) the identity or percentage quantity of any deliberately added inert ingredient of a pesticide must be individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 10(d)(1)(C).
(v) Information in the confidential attachment that is designated in accordance with paragraphs (c)(3)(ii) - (iv) of this section must be on a separate page from information that is not so designated.
(4)
I authorize the Environmental Protection Agency to release any information contained in this document to State or foreign governments, without relinquishing proprietary rights or any confidentiality claims asserted above.
(ii) Information designated as releasable to state or foreign governments in accordance with this section may be released to such a government without further notice to the submitter. EPA will inform the State or foreign government of any of the confidentiality claims associated with the information.
(d)
(2) Information that is not entitled to be protected as confidential in accordance with FIFRA sec. 10(b), this section and with EPA confidentiality regulations at 40 CFR part 2, subpart B, may be released to the public without the affirmation of non-multinational status provided under FIFRA sec. 10(g), provided that the information does not contain or consist of any complete unpublished report submitted to EPA, or excerpts or restatements of any such report which reveal the full methodology and complete results of the study, test, or experiment, and all explanatory information necessary to understand the methodology or interpret the results.
(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)
(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.
(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].
(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
(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
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.
(a)
(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)
(c)
(d)
(2)
(e)
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.
(a)
(b)
(a)
(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)
(c) Applicants unsure of the correct use pattern for their particular product should consult the Agency.
At 78 FR 26978, May 8, 2013, § 158.100 was amended by revising the heading of paragraph (a); revising paragraph (b); redesignating paragraph (c) as paragraph (e); revising newly redesignated paragraph (e); and adding new paragraphs (c) and (d), effective July 8, 2013. For the convenience of the user, the added and revised text is set forth as follows:
(a)
(b)
(c)
(d)
(e)
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.
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)
(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)
(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 column in the table and note which tests are required (R), conditionally required (CR), or not required (NR). Required and conditionally required studies are described in § 158.110.
(4) Review the notes for each requirement to determine its applicability to the specific product proposed for registration.
(5)(i) Proceed down the Test substance columns and determine the appropriate test substance needed for that study. If the data are intended to support a manufacturing-use product, use the MP column. If the data are intended to support an end-use product, use the EP column.
(ii) The test substances columns specify which substance is to be used for testing. Applicants should note that the substance that must be used when performing the study may or may not be the product itself. For example, the data from a certain study may be required to support the registration of an end-use product, but the test substance column may state that the particular test shall be performed using the technical grade of the active ingredient(s) in the end-use product.
(iii) Manufacturing-use products (MP) and end-use products (EP) containing a single active ingredient and no intentionally added inert ingredients are considered identical in composition to each other, and to the technical grade of the active ingredient (TGAI) from which they were derived. Therefore, the data from a test conducted using any one of these as the test substance is also suitable to meet the requirement (if any) for the same test to be conducted using either of the other substances.
(6) Refer to the Pesticide Assessment Guideline reference number for each study located in the first column. See § 158.70(c) for information pertaining to the guidelines and how to obtain copies.
(a)
(b)
(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)
(3)
(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)
(d)
(1)
(2)
(3)
(4)
(5)
(i) To detect, with sensitive assay methods, the capacity of a chemical to alter genetic material in cells.
(ii) To determine the relevance of these mutagenic changes to mammals.
(iii) When mutagenic potential is demonstrated, to incorporate these findings in the assessment of heritable effects, carcinogenicity, and, possibly, other health effects.
(6)
(e)
(2)
(3)
(f)
(g)
(h)
(2)
(3)
(4)
(5)
(i)
(2) Information on the chemical identity and composition of the pesticide product, the amounts, frequency and time of the pesticide application, and results of tests on the amount of residues remaining on or in the treated food or feed, are needed to support a finding as to the magnitude and identity of residues which result in food or animal feed as a consequence of a proposed pesticide usage.
(3) Residue chemistry data are also needed to support the adequacy of one
(4)
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.
All product chemistry data, as described in § 158.310, must be submitted to support a request for an experimental use permit.
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)
(2) Data are also required for forestry and residential outdoor uses.
(b)
(c)
(d)
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 data for any pesticide product registered or proposed for registration.
2. [Reserved]
All toxicology data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
(a)
(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)
(c)
(d)
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 chemicals.
6. These studies are seldom required to support EUPs. They may be required if the dietary exposure for these EUPs occupies a large part, e.g., greater than 50%, of the reference dose.
7. The oral route, by oral intubation, is preferred unless the chemical or physical properties of the test substance or the pattern of exposure suggests a more appropriate route of exposure.
8. May be combined with the 2-generation reproduction study in rodents by utilizing a second mating of the parental animals in either generation.
9. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must also be submitted.
10. Choice of assay using either:
i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;
ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate
iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
11. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
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.
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)
(2) Data are also required for the general use patterns of forestry and residential outdoor use.
(b)
(c)
(d)
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
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 products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if there is no potential for environmental exposure.
3. Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses.
4. Data are required on waterfowl and upland game bird species.
5. Data are required on one coldwater fish and one warmwater fish for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required.
6. EP or TEP testing is required for any product which meets any of the following conditions:
i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.
ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is ≥ one-half the LC
iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
7. Data are required on one freshwater aquatic invertebrate species.
8. Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.
9. Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96 hour LC
10. Not required when:
i. The octanol/water partition coefficients of the pesticide and its major degradates are <1,000; or
ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
iii. The hydrolytic half-life is <5 days at pH 5, 7 and 9.
11. The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. A freshwater invertebrate must also be tested with the EP or TEP using the same species tested with the TGAI.
No data for applicator exposure and post-application exposure must be submitted to support a request for an experimental use permit.
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)
(2) Data are also required for the general use patterns of forestry use and residential outdoor use.
(b)
(c)
(d)
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.
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.
The following terms are defined for the purposes of this subpart:
(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.
(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
(2) The repackaging of any registered product.
(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.
(1) Contains any active ingredient derived from a source that is not an EPA-registered product; or
(2) Contains any active ingredient that was produced or acquired in a manner that does not permit its inspection by the Agency under FIFRA sec. 9(a) prior to its use in the process.
(1) Which contains no inert ingredient, other than one used for purification of the active ingredient; and
(2) Which is produced on a commercial or pilot plant production scale (whether or not it is ever held for sale).
(a)
(b)
(c)
(d)
(e)
(f)
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 when the new TGAI is first used as a formulating ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time. Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis.
12. Data on the stability to metals and metal ions are required only if the TGAI is expected to come into contact with either material.
13. Required when the product contains an oxidizing or reducing agent.
14. Required when the product contains combustible liquids.
15. Required when the product is potentially explosive.
16. Required when the product is an emulsifiable liquid and is to be diluted with petroleum solvent.
17. Required when the EP is a liquid and is to be used around electrical equipment.
18. Required when the test substance is soluble or dispersible in water.
19. Required when the product is a liquid.
20. Required when the TGAI is solid at room temperature.
21. Required when the TGAI is liquid at room temperature.
22. Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
23. Required for water insoluble test substances (>10
24. Required if technical chemical is organic and non-polar.
25. Not required for salts.
26. Data on stability of the MP and TGAI to storage at normal temperatures are required. Data on the stability of the TGAI to high temperatures are required if the TGAI is expected to be subjected to temperatures >50 °C (122 °F) during production or storage.
Information on the composition of the pesticide product must be furnished. The information required by paragraphs (a), (b), and (f) of this section must be provided for each product. In addition, if the product is produced by an integrated system, the information on impurities required by paragraphs (c) and (d) of this section must be provided.
(a)
(1) If the source of any active ingredient in the product is an EPA-registered product:
(i) The chemical and common name (if any) of the active ingredient, as listed on the source product.
(ii) The nominal concentration of the active ingredient in the product, based upon the nominal concentration of active ingredient in the source product.
(iii) Upper and lower certified limits of the active ingredient in the product, in accordance with § 158.350.
(2) If the source of any active ingredient in the product is not an EPA-registered product:
(i) The chemical name according to Chemical Abstracts Society (CAS) nomenclature, the CAS Registry Number, and any common names.
(ii) The molecular, structural, and empirical formulae and the molecular weight or weight range.
(iii) The nominal concentration.
(iv) Upper and lower certified limits of the active ingredient in accordance with § 158.350.
(v) The purpose of the ingredient in the formulation.
(b)
(1) The chemical name of the ingredient according to Chemical Abstracts
(2) The nominal concentration.
(3) Upper and lower certified limits in accordance with § 158.350.
(4) The purpose of the ingredient in the formulation.
(c)
(1) Identification of the ingredient as an impurity.
(2) The chemical name of the impurity.
(3) The nominal concentration of the impurity in the product.
(4) A certified upper limit, in accordance with § 158.350.
(d)
(1) Identification of the ingredient as an impurity.
(2) The chemical name of the impurity.
(3) The nominal concentration of the impurity in the final product.
(e)
(f)
The following information must be submitted on the materials used to produce the product:
(a)
(i) The name of the EPA-registered product.
(ii) The EPA registration number of that product.
(2) For each inert ingredient:
(i) Each brand name, trade name, common name, or other commercial designation of the ingredient.
(ii) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and, if requested by the Agency, chemical and physical properties) of the ingredient, including a copy of technical specifications, data sheets, or other documents describing the ingredient.
(iii) If requested by the Agency, the name and address of the producer of the ingredient or, if that information is not known to the applicant, the name and address of the supplier of the ingredient.
(b)
(2) The following information concerning each active ingredient that is not derived from an EPA-registered product:
(i) The name and address of the producer of the ingredient (if different from the applicant).
(ii) Information about each starting material used to produce the active ingredient, as follows:
(A) Each brand name, trade name, or other commercial designation of the starting material.
(B) The name and address of the person who produces the starting material or, if that information is not known to the applicant, the name and address of each person who supplies the starting material.
(C) All information that the applicant knows (or that is reasonably available to him), concerning the composition (and if requested by the Agency, chemical or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing it.
(3) The information required by paragraph (a)(2) of this section concerning each inert ingredient.
(c)
If the product is produced by an integrated system, the applicant must submit information on the production (reaction) processes used to produce the active ingredients in the product. The applicant must also submit information about the formulation process, in accordance with § 158.335.
(a) Information must be submitted for the current production process for each active ingredient that is not derived from an EPA-registered product. If the production process is not continuous (a single reaction process from starting materials to active ingredient), but is accomplished in stages or by different producers, the information must be provided for each such production process.
(b) The following information must be provided for each process resulting in a separately isolated substance:
(1) The name and address of the producer who uses the process, if not the same as the applicant.
(2) A general characterization of the process (e.g., whether it is a batch or continuous process).
(3) A flow chart of the chemical equations of each intended reaction occurring at each step of the process, and of the duration of each step and of the entire process.
(4) The identity of the materials used to produce the product, their relative amounts, and the order in which they are added.
(5) A description of the equipment used that may influence the composition of the substance produced.
(6) A description of the conditions (e.g., temperature, pressure, pH, humidity) that are controlled during each step of the process to affect the composition of the substance produced, and the limits that are maintained.
(7) A description of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced).
(8) A description of the procedures used to assure consistent composition of the substance produced, e.g., calibration of equipment, sampling regimens, analytical methods, and other quality control methods.
The applicant must provide information on the formulation process of the product (unless the product consists solely of a technical grade of active ingredient) as required by the following sections:
(a) Section 158.330(b)(2), pertaining to characterization of the process.
(b) Section 158.330(b)(4), pertaining to ingredients used in the process.
(c) Section 158.330(b)(5), pertaining to process equipment.
(d) Section 158.330(b)(6), pertaining to the conditions of the process.
(e) Section 158.330(b)(8), pertaining to quality control measures.
The applicant must provide a discussion of the impurities that may be present in the product, and why they may be present. The discussion should be based on established chemical theory and on what the applicant knows about the starting materials, technical grade of active ingredient, inert ingredients, and production or formulation process. If the applicant has reason to believe that an impurity that EPA
(a)
(2) Each other impurity which the registrant or applicant has reason to believe may be present in his product at any time before use at a level ≥0.1 percent (1,000 ppm) by weight of the technical grade of the active ingredient, based on what he knows about the following:
(i) The composition (or composition range) of each starting material used to produce his product.
(ii) The impurities which the applicant knows are present (or believes are likely to be present) in the starting materials, and the known or presumed level (or range of levels) of these impurities.
(iii) The intended reactions and side reactions which may occur in the production of the product, and the relative amounts of byproduct impurities produced by such reactions.
(iv) The possible degradation of the ingredients in the product after its production but prior to its use.
(v) Post-production reactions between the ingredients in the product.
(vi) The possible migration of components of packaging materials into the pesticide.
(vii) The possible carryover of contaminants from use of production equipment previously used to produce other products or substances.
(viii) The process control, purification and quality control measures used to produce the product.
(b)
(1) The possible carryover of impurities present in any registered product which serves as the source of any of the product's active ingredients. The identity and level of impurities in the registered source need not be discussed or quantified unless known to the formulator.
(2) The possible carryover of impurities present in the inert ingredients in the product.
(3) Possible reactions occurring during the formulation of the product between any of its active ingredients, between the active ingredients and inert ingredients, or between the active ingredient and the production equipment.
(4) Post-production reactions between any of the product's active ingredients and any other component of the product or its packaging.
(5) Possible migration of packaging materials into the product.
(6) Possible contaminants resulting from earlier use of equipment to produce other products.
(c)
(1) From other possible chemical reactions.
(2) Involving other ingredients.
(3) At additional points in the production or formulation process.
(a) If the product is produced by an integrated system, the applicant must provide a preliminary analysis of each technical grade of active ingredient contained in the product to identify all impurities present at 0. 1 percent or greater of the technical grade of the active ingredient. The preliminary analysis should be conducted at the point in the production process after which no further chemical reactions designed to produce or purify the substances are intended.
(b) Based on the preliminary analysis, a statement of the composition of the technical grade of the active ingredient must be provided. If the technical grade of the active ingredient cannot
The applicant must propose certified limits for the ingredients in the product. Certified limits become legally binding limits upon approval of the application. Certified limits will apply to the product from the date of production to date of use. If the product label bears a statement prohibiting use after a certain date, the certified limits will apply only until that date.
(a)
(1) An upper and lower limit for each active ingredient.
(2) An upper and lower limit for each inert ingredient.
(3) If the product is a technical grade of active ingredient or is produced by an integrated system, an upper limit for each impurity of toxicological significance associated with the active ingredient and found to be present in any sample of the product.
(4) On a case-by-case basis, certified limits for other ingredients or impurities as specified by EPA.
(b)
(2) Table of standard certified limits.
(c)
(2) If certified limits are required for impurities, the applicants must propose a certified limit. The standard certified limits may not be used for such substances.
(3) Certified limits should:
(i) Be based on a consideration of the variability of the concentration of the ingredient in the product when good manufacturing practices and normal quality control procedures are used.
(ii) Allow for all sources of variability likely to be encountered in the production process.
(iii) Take into account the stability of the ingredient in the product and the possible formation of impurities between production and sale or distribution.
(4) The applicant may include an explanation of the basis of his proposed certified limits, including how the certified limits were arrived at (e.g., sample analysis, quantitative estimate based on production process), and its accuracy and precision. This will be particularly useful if the range of the certified limit for an active or inert ingredient is greater than the standard certified limits.
(d)
(1) More precise limits.
(2) More thorough explanation of how the certified limits were determined.
(3) A narrower range between the upper and lower certified limits than that proposed.
(e)
I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the description of the composition of [
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.
(a)
(b)
(c)
(d)
(e)
1. The Agency has waived the requirement to submit product performance 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 product performance data for any pesticide product registered or proposed for registration.
2. [Reserved]
At 78 FR 26978, May 8, 2013, § 158.400 was amended in paragraph (d) by removing the heading “Efficacy of Antimicrobial Agents,” and the entries 91-2 through 91-8 under that category, effective July 8, 2013.
(a)
(b)
(2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use, aquatic nonfood use, greenhouse nonfood crop use, forestry use, residential outdoor use, and indoor nonfood use.
(c)
(d)
(e)
1. Not required if test material is a gas or a highly volatile liquid.
2. Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under § 152.170(b) or special review consideration under § 154.7(a)(1).
3. Not required if the test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
4. Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
5. Required if repeated dermal exposure is likely to occur under conditions of use.
6. 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 chemicals.
7. As determined by the Agency, additional measurements may also be required, such as cholinesterase activity for certain pesticides, e.g., organophosphates and some carbamates. The route of exposure must correspond with the primary route of exposure.
8. Required for nonfood use pesticides if oral exposure could occur.
9. The 90-day study is required in the rat for hazard characterization (possibly endpoint selection) and dose-setting for the chronic/carcinogenicity study. It is not required in the mouse, but the Agency would strongly encourage the registrant to conduct a 90-day range finding for the purposes of dose selection for the mouse carcinogenicity study to achieve adequate dosing and an acceptable study. The registrant is also encouraged to consult with the Agency on the results of the 90-day mouse study prior to conducting the carcinogenicity study.
10. Required for agricultural uses or if repeated human dermal exposure may occur. Not required if an acceptable 90-day dermal toxicity study is performed and submitted.
11. EP testing is required if the product, or any component of it, may increase dermal absorption of the active ingredient(s) as determined by testing using the TGAI, or increase toxic or pharmacologic effects.
12. Required for food uses if either of the following criteria is met:
(i) The use pattern is such that the dermal route would be the primary route of exposure; or
(ii) The active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite is the toxic moiety.
13. Required if there is the likelihood of significant repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.
14. Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., 21- or 28-days, may be sufficient to satisfy this requirement. Registrants should consult with the Agency to determine whether studies of shorter duration would meet this requirement.
15. Required if results of acute neurotoxicity study indicate significant statistical or biological effects, or if other available data indicate the potential for this type of delayed neurotoxicity, as determined by the Agency.
16. All 90-day subchronic studies in rats can be designed to simultaneously fulfill the requirements of the 90-day neurotoxicity study using separate groups of animals for testing. Although the subchronic guidelines include the measurement of neurological endpoints, they do not meet the requirement of the 90-day neurotoxicity study.
17. Required if either of the following are met:
(i) The use of the pesticide is likely to result in repeated human exposure over a considerable portion of the human lifespan, as determined by the Agency;
(ii) The use requires a tolerance or an exemption from the requirement of a tolerance.
18. Based on the results of the acute and subchronic neurotoxicity studies, or other available data, a combined chronic toxicity and neurotoxicity study may be required.
19. Studies which are designed to simultaneously fulfill the requirements of both the chronic oral and carcinogenicity studies (
(i) Chronic rodent feeding study (food use) - 24 months.
(ii) Chronic rodent feeding study (nonfood use) - 12 months.
(iii) Mouse carcinogenicity study - 18 months.
(iv) Rat carcinogenicity study - 24 months.
20. Required if any of the following, as determined by the Agency, are met:
(i) The use of the pesticide is likely to result in significant human exposure over a considerable portion of the human life span which is significant in terms of either frequency, duration, or magnitude of exposure;
(ii) The use requires a tolerance or an exemption from the requirement of a tolerance; or
(iii) The active ingredient, metabolite, degradate, or impurity (a) is structurally related to a recognized carcinogen, (b) causes mutagenic effects as demonstrated by
21. If this study is modified or waived, a subchronic 90-day oral study conducted in the same species may be required.
22. Testing in two species is required for all uses.
23. The oral route, by oral intubation, is preferred unless the chemical or physical properties of the test substance or the pattern of exposure suggests a more appropriate route of exposure.
24. Additional testing by other routes may be required if the pesticide is determined to be a prenatal developmental toxicant after oral dosing.
25. May be combined with the 2-generation reproduction study in rodents by utilizing a second mating of the parental animals in either generation.
26. Required to support products intended for food uses and to support products intended for nonfood uses if use of the product is likely to result in significant human exposure over a portion of the human life span in terms of frequency, magnitude or duration of exposure.
27. An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, pharmacokinetic, or mechanistic data) to determine whether a standard guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing animal, or in some cases to support a waiver for such testing. Registrants should submit any alternative proposed testing protocols and supporting scientific rationale to the Agency prior to study initiation.
28. Study required using a weight-of-evidence approach considering:
(i) The pesticide causes treatment-related neurological effects in adult animal studies (
(ii) The pesticide causes treatment-related neurological effects in developing animals, following pre- and postnatal exposure (
(iii) The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological studies.
(iv) The pesticide evokes a mechanism that is associated with adverse effects on the development of the nervous system (e.g., SAR relationship to known neurotoxicants, altered neuroreceptor or neurotransmitter responses).
29. The use of a combined study that utilizes the 2-generation reproduction study in rodents as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is encouraged.
30. At a minimum, an initial battery of mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must also be submitted.
31. Choice of assay using either:
(i) Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;
(ii) Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate
(iii) CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
32. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
33. Required when chronic or carcinogenicity studies are required. May be required if significant adverse effects are seen in available toxicology studies and these effects can be further elucidated by metabolism studies.
34. May be required if the product's use will result in exposure to domestic animals through, but not limited to, direct application.
35. A risk assessment assuming that dermal absorption is equal to oral absorption must be performed to determine if the study is required, and to identify the doses and duration of exposure for which dermal absorption is to be quantified.
36. A 1-year non-rodent study (
For nonfood use pesticides only, applicants have two options for generating and submitting required toxicology (§ 158.500) and human exposure (§ 158.1020, § 158.1070, and § 158.1410) studies. Applicants are to select one of the following:
(a) Acute, subchronic, chronic, and other toxicological studies on the active ingredient must be submitted together. The specific makeup of the set of toxicology study requirements is based on the anticipated exposure to the pesticide as determined by the
(b) Certain toxicological and exposure studies must be submitted simultaneously with the toxicology data submitted in a tiered system. Exposure data must be submitted along with first tier toxicology data. The requirement for additional second and third level toxicology testing will be determined by the Agency based on the results of the first tiered studies.
(1) The required first-tier toxicology studies consist of:
(i) Battery of acute studies.
(ii) A subchronic 90-day dermal study or a subchronic 90-day inhalation study.
(iii) An acute and subchronic neurotoxicity screening battery in the rat.
(iv) Prenatal developmental toxicity studies in both the rat and rabbit.
(v) Reproduction and fertility studies in rats.
(vi) Battery of mutagenicity studies.
(vii) Immunotoxicity study.
(2) The conditionally required second-tier studies include:
(i) Subchronic 90-day feeding studies in both the rodent and nonrodent.
(ii) Dermal penetration study.
(3) The conditionally required third-tier studies include:
(i) Chronic feeding studies in the rodent.
(ii) Carcinogenicity.
(iii) Metabolism study.
(iv) Additional mutagenicity testing.
(a)
(b)
(2) Data are also required for the general use patterns of forestry and residential outdoor use.
(3) In general, for all outdoor end-uses, including turf, the following studies are required: Two avian oral LD
(c)
(d)
(e)
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 products when there is no registered manufacturing-use product. Avian acute oral data are not required for liquid formulations for greenhouse and indoor uses. The study is not required if there is no potential for environmental exposure.
3. Data are required on one passerine species and either one waterfowl species or one upland game bird species for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses.
4. Data are required on waterfowl and upland game bird species.
5. Tests are required based on the results of lower tier toxicology studies, such as the acute and subacute testing, intended use pattern, and environmental fate characteristics that indicate potential exposure.
6. Higher tier testing may be required for a specific use pattern when a refined risk assessment indicates a concern based on laboratory toxicity endpoints and refined exposure assessments.
7. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
8. Data are required on one coldwater fish and one warmwater fish for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required.
9. EP or TEP testing is required for any product which meets any of the following conditions:
i. The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides and mosquito larvicides) when used as directed.
ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is ≥ one-half the LC
iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
10. Data are required on one freshwater aquatic invertebrate species.
11. Data are required on one estuarine/marine mollusk, one estuarine/marine invertebrate and one estuarine/marine fish species.
12. Data are generally not required for outdoor residential uses, other than turf, unless data indicate that pesticide residues from the proposed use(s) can potentially enter waterways.
13. Data are required on one freshwater fish species. If the test species is different from the two species used for the freshwater fish acute toxicity tests, a 96-hour LC
14. Data are required on one estuarine/marine invertebrate species.
15. Data are required on estuarine/marine species if the product meets any of the following conditions:
i. Intended for direct application to the estuarine or marine environment.
ii. Expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
iii. If the acute LC
iv. If the estimated environmental concentration (EEC) in water is ≥0.01 of the acute EC
A. Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected.
B. Physicochemical properties indicate bioaccumulation of the pesticide.
C. The pesticide is persistent in water (e.g., half-life in water >4 days).
16. Data are required on one estuarine/marine fish species.
17. Data are required on estuarine/marine species if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
18. Data are required on freshwater species if the end-use product is intended to be applied directly to water, or is expected to be transported to water from the intended use site, and when any of the following conditions apply:
i. If the estimated environmental concentration (EEC) is ≥0.1 of the no-observed-effect level in the fish early-life stage or invertebrate life cycle test;
ii. If studies of other organisms indicate that the reproductive physiology of fish may be affected.
19. Not required when:
i. The octanol/water partition coefficients of the pesticide and its major degradates are <1,000; or
ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
iii. The hydrolytic half-life is <5 days at pH 5, 7 and 9.
20. Data are required based on the results of lower tier studies such as acute and chronic aquatic organism testing, intended use pattern, and environmental fate characteristics that indicate significant potential exposure.
21. Data are required if:
i. The half-life of the pesticide in the sediment is ≤10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist:
A. The soil partition coefficient (Kd) is ≥50.
B. The log Kow is ≥3.
C. The Koc ≥1,000.
ii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.
22. Data are required if:
i. The estimated environmental concentration (EEC) in sediment is >0.1 of the acute LC
ii. The half-life of the pesticide in the sediment is >10 days in either the aerobic soil or aquatic metabolism studies and if any of the following conditions exist:
A. The soil partition coefficient (Kd) is ≥50.
B. The log Kow is ≥3.
C. The Koc ≥1,000.
iii. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.
23. Sediment testing with estuarine/marine test species is required if the product is intended for direct application to the estuarine or marine environment or the product is expected to enter this environment in concentrations which the Agency believes to be significant, either by runoff or erosion, because of its expected use or mobility pattern.
24. Data are required only when the formulation contains one or more active ingredients having an acute LD
25. Required if any of the following conditions are met:
i. Data from other sources (Experimental Use Permit program, university research, registrant submittals, etc.) indicate potential adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.);
ii. Data from residual toxicity studies indicate extended residual toxicity.
iii. Data derived from studies with terrestrial arthropods other than bees indicate potential chronic, reproductive or behavioral effects.
26. The freshwater fish test species for the TEP testing is the most sensitive of the species tested with the TGAI. Freshwater invertebrate and acute estuarine and marine organisms must also be tested with the EP or TEP using the same species tested with the TGAI.
(a)
(b)
(2) Data are also required for the general use patterns of forestry use and residential outdoor use.
(c)
(d)
(e)
1. Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
2. Not required for known phytotoxicants.
3. Generally not required for granular formulations. May be requested on a case-by-case basis.
4. Required for known phytotoxicants such as herbicides, desiccants and defoliants.
5. Required if a tested terrestrial species exhibits a 25 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the Tier I testing.
6. Required if the tested aquatic species exhibits a 50 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the tier I testing.
7. Not required for aquatic residential uses.
8. Environmental chemistry methods used to generate data must include the results of a successful confirmatory method trial by an independent laboratory.
9. Tests are required on a case-by-case basis based on the results of lower tier phytotoxicity studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.
10. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.
(a) If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration (OSHA), provide adequate protection from risk under FIFRA for a particular pesticide use pattern, exposure data may not be required for that use pattern. Applicants should consult with the Agency on appropriate testing prior to the initiation of studies.
(b) The Agency may accept surrogate exposure data estimations from other sources to satisfy applicator exposure data requirements if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. In order to be acceptable, the Agency must find that the surrogate exposure data estimations have adequate information to address applicator exposure data requirements and contain adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the applicator activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. The Agency will consider using such surrogate data for evaluating human exposure on a case-by-case basis.
Applicator exposure data described in paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, at least one of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.
(a)
(2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from handling of the pesticide.
(b)
(2) Respiratory exposure may occur during the prescribed use.
(a)
(b)
(2) Residential use patterns include residential outdoor use and residential indoor use. These use patterns are limited to nonoccupational,
(c)
(d)
(e)
1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.
2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data, provided the human pharmacokinetics of the pesticide and/or metabolite/analog compounds (
3. Data are required if the product is applied outdoors.
4. Data are required if the product is applied indoors.
5. Data reporting and calculations are required when handler exposure data are submitted.
(a) If EPA determines that industrial standards, such as the workplace standards set by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants should consult with the Agency on appropriate testing before the initiation of studies.
(b) The Agency may accept surrogate exposure data from other sources to satisfy post-application exposure data requirements if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific needs of EPA. In order to be acceptable, among other things, the Agency must find that the surrogate exposure data have adequate information to address post-application exposure data requirements and contain adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the post-application activity of concern, including formulation type, application methods and rates, type of activity, and other pertinent information. The Agency will consider using such surrogate data for evaluating human exposure on a case-by-case basis.
Exposure data described in § 158.1070(d) are required based upon toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, either or both of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.
(a)
(2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from post-application exposure to the pesticide.
(b)
(1)
(ii) Residential human post-application exposure to pesticide residues on plants or in soil could occur. Such uses may include turf grass, fruits, vegetables, and ornamentals grown at sites, including, but not limited to, homes, parks, and recreation areas.
(2)
(ii) Residential human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at residential sites, such as, but not limited to homes, daycare centers, hospitals, schools, and other public buildings.
(a)
(b)
(2) Residential use patterns include residential outdoor use and indoor residential use. These use patterns are limited to nonoccupational,
(c)
(d)
(e)
1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.
2. Bridging applicable residue dissipation data to dermal exposure data is required.
3. Turf grass transferable residue dissipation data are required when pesticides are applied to turf grass. Dislodgeable foliar residue dissipation data are required when pesticides are applied to the foliage of plants other than turf grass.
4. Data are required for occupational sites if (i) there are uses on turf grass or other plant foliage, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated foliage while participating in typical activities.
5. Data are required for residential sites if there are uses on turf grass or other plant foliage.
6. Data are required for occupational sites, if (i) there are outdoor or greenhouse uses to or around soil or other planting media, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated soil or planting media while participating in typical activities.
7. Data are required for residential sites if the pesticide is applied to or around soil or other planting media both outdoors and indoors, e.g., residential greenhouse or houseplant uses.
8. Data are required for occupational sites if the pesticide is applied to or around on non-plant surfaces, e.g., flooring or countertops, and if the human activity data indicate that workers are likely to have post-application dermal contact with treated indoor surfaces while participating in typical activities.
9. Data are required for residential sites if the pesticide is applied to or around non-plant surfaces, e.g., flooring and countertops.
10. Data are required for occupational sites if the human activity data indicate that workers are likely to have post-application exposures while participating in typical activities.
11. Data are required for residential sites if post-application exposures are likely.
12. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data provided the human pharmocokinetics of the pesticide and/or metabolite/analog compounds (
13. Data are required when passive dosimetry techniques are not applicable for a particular exposure scenario, such as a swimmer exposure to pesticides.
14. Data reporting and calculations are required when any post-application exposure monitoring data are submitted.
15. The selection of a sampling method will depend on the nondietary pathway(s) of interest. Data must be generated to consider all potential pathways of nondietary ingestion exposure that are applicable (e.g., soil ingestion, hand-to-mouth transfer, and object-to-mouth transfer of surface residues).
(a)
(b)
(c)
(d)
(e)
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]
(a)
(b)
(2) Data are also required for the general use patterns of forestry use and residential outdoor use.
(c)
(d)
(e)
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 for aquatic food and nonfood crop uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to, cranberry bogs and rice paddies.
6. 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.
7. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
8. Requirement for terrestrial uses is based on potential for aquatic exposure and if pesticide residues have the potential for persistence, mobility, nontarget aquatic toxicity or bioaccumulation. Not required for aquatic residential uses. Field testing under the terrestrial field dissipation requirement may be more appropriate for some aquatic food crops, such as rice and cranberry uses, that are managed to have a dry-land period for production. The registrant is encouraged to consult with the Agency on protocols.
9. Agency approval of a protocol is necessary prior to initiation of the study.
10. This study may be triggered if there is specific evidence that the presence of one pesticide can affect the dissipation characteristics of another pesticide when applied simultaneously or serially.
11. Required if the weight-of-evidence indicates that the pesticide and/or its degradates is likely to leach to ground water, taking into account other factors such as the toxicity of the chemicals(s), available monitoring data, and the vulnerability of ground water resources in the pesticide use area.
12. If the terrestrial dissipation study cannot assess all of the major routes of dissipation, the forestry study will be required.
The following terms are defined for the purposes of this subpart:
(a)
(b)
(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)
(d)
(e)
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 approved or the residential use is expected to produce higher residues based on the label directions.
4. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).
5. Data for fish are required for all pesticides applied directly to water inhabited, or which will be inhabited, by fish that may be caught or harvested for human consumption.
6. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
7. Required when the Agency determines that it is reasonably foreseeable that a food or feed crop could be subsequently planted on the site of pesticide application after harvest or failure of the treated crop. Typically not required for pesticide uses in permanent food crops (e.g., various tree crops, vines) or semi-permanent crops (e.g., asparagus, pineapples).
8. A residue analytical method suitable for enforcement purposes is required whenever a numeric tolerance (including temporary and time-limited tolerances) is proposed.
9. New analytical methods to be used for enforcement purposes must include results from an independent laboratory validation.
10. A residue method, storage stability data, and crop field trials are required for the nonfood crop tobacco (green, freshly harvested). Depending on the level of residues found on the green tobacco, additional data may be required on cured/dried tobacco and pyrolysis products.
11. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
12. Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
13. Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a statistical design accepted by the Agency.
14. Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal waxes or stored grain fumigants).
15. Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher than that of the raw agricultural commodity.
16. Required when the pesticide use is a direct application to livestock.
17. Data are required if pesticide residues are present in or on livestock feed items or intentionally added to drinking water. These studies, however, may not be required in cases where the livestock metabolism studies indicate negligible transfer of the pesticide's residues of concern to tissues, milk, and eggs at the maximum expected exposure level for the animals.
18. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock feeding study involving dosing with the plant metabolite(s) may also be required.
19. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
20. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
21. Data are required whenever a pesticide may be used in a food handling or feed handling establishment.
22. Required when residues at the tolerance level may result in a risk of concern. These data may include washing, cooking, processing or degradation studies as well as market basket surveys for a more precise residue determination.
23. Typically required if pesticide residues of concern greater than 0.01 ppm are found in crops at the appropriate plant back intervals (taking into account plant back restrictions on product labels) in the confined rotational crop study. If residues of concern in the confined study are greater than 0.01 ppm but less than the limit of quantitation of the analytical method to be used on field trial samples, the Agency will consider not requiring, on a case-by-case basis, the limited field trials. If there are particular toxicological concerns with the parent pesticide or any metabolites, limited field studies may be needed if such residues are identified at levels below 0.01 ppm in the confined study.
24. Crop field trials are required to establish tolerances on rotational crops when quantifiable residues of concern are observed in the field rotational crops study.
25. Not required for an exemption from a tolerance provided that dietary exposure estimates are not needed due to low toxicity or that theoretical estimates of exposure are adequate to assess dietary risk.
26. Not required for an exemption from a tolerance.
This subpart applies to all biochemical pesticides as defined in paragraphs (a), (b), and (c) of this section.
(a)
(1) A
(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
(i) An
(ii) A
(iii) A
(b)
(1) Semiochemicals (insect pheromones and kairomones),
(2) Natural plant and insect regulators,
(3) Naturally-occurring repellents and attractants, and
(4) Enzymes.
(c)
(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 (
(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 numbers are provided for some of the environmental fate data requirements. For ease of understanding, the current guidelines will be used as an interim measure until the new guidelines (in parentheses) are finalized.
(a)
(2) Definitions in § 158.300 apply to data requirements in this section.
(b)
(c)
(d)
(e)
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 accordance with § 158.355.
8. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI. EP testing may also be appropriate.
9. Required if the product contains combustible liquids.
10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
11. Required if the test substance is soluble or dispersible in water.
12. Required if the product is a liquid.
13. Required when the technical chemical is a solid at room temperature.
14. Required when the technical chemical is a liquid at room temperature.
15. Required for water insoluble test substances (>10
16. Required for organic chemicals unless they dissociate in water or are partially or completely soluble in water.
17. Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
18. True density or specific density are required for all test substances. Data on bulk density is required for MPs or EPs that are solid at room temperature.
19. Not required for salts.
(a)
(b)
(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)
(d)
(e)
1. Residue chemistry data requirements apply to biochemical pesticide products when Tier II or Tier III toxicology data are required, as specified for biochemical agents in the biochemical human health assessment data requirements, § 158.2050.
2. The same chemical identity data are required for biochemical product chemistry data requirements, § 158.2030, with an emphasis on impurities.
3. Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
4. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.
5. Required unless it is an arthropod pheromone applied at a rate less than or equal to 150 grams active ingredient per acre.
6. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).
7. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed.
8. If results from the plant metabolism study show differing metabolites in plants from those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
9. A residue analytical method suitable for enforcement of tolerances is required whenever a numeric tolerance (including temporary and time-limited tolerances) is proposed.
10. Required if indoor use could result in pesticide residues in or on food or feed.
11. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
12. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
13. Data on fish are required for all pesticides applied directly to water inhabited, or which will be inhabited by fish that may be caught or harvested for human consumption.
14. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
15. Data are required whenever a pesticide may be used in food/feed handling establishments.
16. Data on the nature and level of residue in processed food/feed are required when detectible residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher
17. Required when residues at the tolerance level may result in risk of concern. These data may include washing, cooking, processing, or degradation studies as well as market basket surveys for a more precise residue determination.
18. The proposed tolerance must reflect the maximum residue likely to occur in crops, in meat, milk, poultry, or eggs.
19. Required when a residue analytical method is required.
(a)
(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)
(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)
(d)
(e)
1. Required unless the test material is a gas or highly volatile (vapor pressure >10
2. Required unless the test material is corrosive to skin or has pH <2 or >11.5.
3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain lepidopteran pheromone.
4. Required if repeated contact with human skin is likely to occur under conditions of use.
5. Hypersensitivity incidents must be reported as adverse effects data.
6. Required for non-food uses that are likely to result in repeated oral exposure to humans.
7. Required to support uses involving purposeful application to the human skin or which would result in comparable prolonged human exposure to the product (e.g., insect repellents) and if any of the following criteria are met:
i. Data from a 90-day oral study are not required.
ii. The active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route and the metabolite is of toxicological concern.
iii. The use pattern is such that the dermal route would be the primary route of exposure.
8. Required if there is a likelihood of significant levels of repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.
9. Required if the use of the product under widespread and commonly recognized practice may reasonably be expected to result in significant exposure to female humans (e.g., occupational exposure or repeated application of insect repellents directly to the skin). Tier II data is required on a different test species from Tier I data when developmental effects are observed in the first study and information on species-to-species extrapolation is needed.
10. Required to support nonfood uses if either:
i. The use is likely to result in significant human exposure; or
ii. The active ingredient (or its metabolites) is structurally related to a known mutagen or belongs to any chemical class of compounds containing a known mutagen. Additional mutagenicity tests that may have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the available evidence.
11. Choice of assay using either:
i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;
ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate
iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
12. Required if there are effects on hematology, clinical chemistry, lymphoid organ weights, and histopathology are observed in the 90-day studies.
13. The micronucleus rodent bone marrow assay is preferred; however, rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
14. Required if adverse effects are observed in the Tier II immunotoxicity study. The protocol for evaluating adverse effects to the immune response should be developed after evaluating the effects noted in the immunotoxicity study.
15. These data are required when the data used for the human health assessment indicates that the biochemical may pose a potential hazard to the applicator/user.
16. Required if there is evidence of:
i. Endocrinological effects from the subchronic toxicity studies.
ii. Developmental effects in the prenatal developmental toxicity study(s), or
iii. Genotoxicity to mammals based on results from the mutagenicity tests.
17. Required if the potential for adverse chronic effects is indicated based on any of the following:
i. The subchronic effect level established in the following Tier I studies: 90-day oral toxicity study, 90-day dermal toxicity study, or 90-day inhalation toxicity study.
ii. The pesticide use pattern (e.g., rate, frequency, and site of application).
iii. The frequency and level of repeated human exposure that is expected.
18. Required if the product meets either of the following criteria:
i. The active ingredient (or any of its metabolites, degradation products, or impurities) produce(s) in Tier I subchronic studies a morphologic effect (e.g., hyperplasia or metaplasia) in any organ that potentially could lead to neoplastic change.
ii. Adverse cellular effects suggesting carcinogenic potential are observed in Tier II immunotoxicity and Tier III immune response study or in Tier II mammalian mutagenicity assays.
In addition, a 90-day range finding study in both rats and mice is required to determine the dose levels if carcinogenicity studies are required. If the mouse carcinogenicity study is not required, the 90-day mouse subchronic study is likewise not required.
19. Required if results from lower tiered mutation or reproductive studies indicate there is potential for chromosomal aberration to occur.
20. May be required if the product's use will result in exposure to domestic animals through, but not limited to, direct application or consumption of treated feed.
(a)
(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 (
(b)
(c)
(d)
(e)
1. Required for the EP when any end-use formulation may contain other ingredients that may be toxic to nontarget organisms or to support arthropod pheromones that would be available to avian wildlife, (e.g., a granular product).
2. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, physical/chemical properties, production volume, and other pertinent factors.
3. Not required for any use groups if the pesticide is highly volatile (estimated volatility >5 ×10
4. Preferred test species are Upland game, waterfowl, or passerine for avian acute oral toxicity studies; Upland game and waterfowl for avian dietary studies; and coldwater fish species for acute freshwater fish studies.
5. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.
6. Required on a case-by-case basis when results from Tier I studies indicate adverse effects.
7. Required when results of any one or more of the nontarget organism studies in Tier I indicate potential adverse effects on nontarget organisms and the pesticide is to be applied on land. In view of methdological difficulties with the study of photodegradation in air, prior consultation with the Agency regarding the protocol is recommended before the test is performed.
8. Required when results of any one or more of the nontarget organism studies in Tier I indicate potential adverse effects on nontarget organisms and the pesticide is to be applied in a passive dispenser.
9. Required to support registration of known phytotoxicants,
10. Required if environmental fate characteristics indicate that the estimated environmental concentration of the pesticide in the aquatic environment is >0.01 of any EC
11. Required if either of the following criteria are met:
i. Environmental fate characteristics indicate that the estimated concentration of the pesticide in the terrestrial environment is >0.20 the avian dietary LC
ii. The pesticide or any of its metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in the avian or mammalian feed.
12. Required when results of Tier I nontarget organism studies indicate potential adverse effects on nontarget insects and results of Tier II tests indicate exposure of nontarget insects. Additional insect species may have to be tested if necessary to address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., threatened or endangered species).
13. Required if the product is expected to be transported from the site of application by air, soil, or water. The extent of movement would be determined by the results of the Tier II environmental fate studies.
14. Required depending on pesticide mode of action, method and timing of application, and results of any available efficacy data. Typically the honeybee acute toxicity guideline (guideline 850.3020) satisfies this requirement, however, additional nontarget insect species may have to be tested if necessary to address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., endangered species.)
Product performance data must be developed for all biochemical pesticides. However, the Agency typically does not require applicants to submit such efficacy data unless the pesticide product bears a claim to control public health pests, such as pest microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (including but not limited to: rodents, birds, bats, canids, and skunks) or invertebrates (including but not limited to: mosquitoes and ticks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are 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 data for any pesticide product registered or proposed for registration.
(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).
(a)
(2) Depending on the results of the required product chemistry studies, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed.
(b)
(c)
(d)
(e)
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. For pesticides in the production stage, a preliminary product analytical method and data would suffice to support an experimental use permit.
6. Data must be provided in accordance with § 158.350.
7. Data must be provided in accordance with § 158.355.
8. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI. EP testing may also be appropriate.
9. Required if the product contains combustible liquids.
10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
11. Required if the test substance is soluble or dispersible in water.
12. Required if the product is a liquid.
13. Required when the technical chemical is a solid at room temperature.
14. Required when the technical chemical is a liquid at room temperature.
15. Required for water insoluble test substances (>10
16. Required for organic chemicals unless they dissociate in water or are partially or completely soluble in water.
17. Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
18. True density or specific density are required for all test substances. Data on bulk density is required for MPs or EPs that are solid at room temperature.
19. Not required for salts.
(a)
(b)
(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)
(d)
(e)
1. Residue chemistry data requirements apply to biochemical pesticide products when Tier II or Tier III toxicology data are required, as specified for biochemical agents in the biochemical human health assessment data requirements, § 158.2050.
2. The same chemical identity data are required for biochemical product chemistry data requirements,§ 158.2030 with an emphasis on impurities.
3. Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
4. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.
5. Required unless it is an arthropod pheromone applied at a rate less than or equal to 150 grams active ingredient per acre.
6. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).
7. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed. If results from
8. Livestock feeding studies are required whenever a pesticide residue is present in livestock feed or when direct application to livestock uses occurs.
9. Required if indoor use could result in pesticide residues in or on food or feed.
10. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
11. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
12. Data on fish are required for all pesticides applied directly to water inhabited, or which will be inhabited, by fish that may be caught or harvested for human consumption.
13. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
14. Data are required whenever a pesticide may be used in food/feed handling establishments.
15. Data on the nature and level of residue in processed food/feed are required when detectible residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher than that of the raw agricultural commodity.
16 Anticipated residue data are required when the assumption of tolerance level residues would result in predicted exposure at an unsafe level of exposure. Data, using single serving samples of a raw agricultural commodity, on the level or residue in food as consumed would be used to obtain a more precise estimate of potential dietary exposure. These data may also include washing, cooking, processing or degradation studies as well as market basket surveys for a more precise residue determination.
17. The proposed tolerance must reflect the maximum residue likely to occur in crops, in meat, milk, poultry, or eggs.
18. Required when a residue analytical method is required.
(a)
(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)
(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)
(d)
(e)
1. Required unless the test material is a gas or highly volatile (vapor pressure >10
2. Required unless the test material is corrosive to skin or has pH <2 or >11.5.
3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain lepidopteran pheromone.
4. Hypersensitivity incidents must be reported as adverse effects data.
5. Required if the use of the product under widespread and commonly recognized practice may reasonably be expected to result in significant exposure to female humans (e.g., occupational exposure or repeated application of insect repellents directly to the skin). Tier II data is required on a different test species from Tier I data when developmental effects are observed in the first study and information on species-to-species extrapolation is needed.
6. Required to support nonfood uses if either:
i. The use is likely to result in significant human exposure; or
ii. The active ingredient (or its metabolites) is structurally related to a known mutagen or belongs to any chemical class of compounds containing a known mutagen.
Additional mutagenicity tests that may have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the available evidence.
7. Choice of assay using either:
i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing
ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate
iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
(a)
(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 (
(b)
(c)
(d)
(e)
1. Required for the EP when any end-use formulation may contain other ingredients that may be toxic to nontarget organisms or to support arthropod pheromones that would be available to avian wildlife, (e.g., a granular product).
2. Not required for any use groups if the pesticide is highly volatile (estimated volatility >5×10
3. Preferred test species are: upland game, waterfowl, or passerine for avian acute oral toxicity studies; upland game or waterfowl for avian dietary studies; and coldwater fish for acute freshwater fish studies.
4. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.
(a) This subpart applies to all living or dead microbial pesticides as described in paragraphs (b) and (c) of this section.
(b)
(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)
(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.
(a)
(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 (
(b)
(a)
(b)
(c)
(d)
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.
(a)
(b)
(c)
(d)
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.
(a)
(b)
(c)
(d)
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 active ingredient is a virus.
5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.
6. Required when the product consists of, or under conditions of use would result in, an inhalable material (e.g., gas, volatile substances, or aerosol particulate).
7. Data required when significant toxicity, in the absence of pathogenicity and significant infectivity, is observed in acute oral, injection, or pulmonary studies (Tier I). Route(s) of exposure correspond to route(s) where toxicity was observed in Tier I studies. The toxic component of the TGAI is to be tested.
8. Data required when significant infectivity and/or unusual persistence is observed in the absence of pathogenicity or toxicity in Tier I studies. Routes of exposure (oral and/or pulmonary) correspond to routes in Tier I studies where adverse effects were noted. Data may also be required to evaluate adverse effects due to microbial contaminants or to toxic byproducts.
9. Data are required when one or more of the following criteria are met:
i. Significant infectivity of the microbial pest control agent (MPCA) was observed in test animals in the Tier II subchronic study and in which no significant signs of toxicity or pathogenicity were observed.
ii. The microbial pesticide is a virus which can persist or replicate in mammalian cell culture lines.
iii. The microbial pesticide is not amenable to thorough taxonomic classification, and is related to organisms known to be parasitic for mammalian cells.
iv. The microbial pesticide preparation is not well purified, and may contain contaminants which are parasitic for mammals.
10. Data may be required for products known to contain or suspected to contain carcinogenic viruses or for microbial components that are identified as having significant toxicity in Tier II testing.
11. Data may be required for products known to contain or suspected to contain viruses that can interact in an adverse manner with components of the mammalian immune system.
12. An analysis of human infectivity/pathogenicity potential using scientific literature, genomic analysis, and/or actual specific cell culture/animal data may be required for products known to contain or suspected of containing intracellular parasites of mammalian cells for products that exhibit pathogenic characteristics in Tier I and/or Tier II, for products which are closely related to known human pathogens based on the product analysis data, or for known human pathogens that have been “disarmed” or rendered non-pathogenic for humans.
13. Test standards may have to be modified depending on the characteristics of the microorganism. Requirements may vary for these studies depending on the active ingredient being tested. Consultation with the Agency is advised before performing these Tier III studies.
(a)
(b)
(c)
(d)
(e)
1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern,
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 there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish species are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrate testing is also required.
3. Data required when the nature of the microbial pesticide and/or its toxins indicates potential pathogenicity to birds.
4. Required on a case-by-case basis if results of tests required by § 158.2140 are inadequate or inappropriate for assessment of hazards to wild mammals.
5. Required when there will be significant exposure to aquatic organisms (fish and invertebrates).
6. Required if the product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of expected use or mobility pattern.
7. Required if the microbial pesticide is taxonomically related to a known plant pathogen.
8. Data are not required unless an active microbial ingredient controls the target insect pest by a mechanism of infectivity;
9. Required if toxic or pathogenic effects are observed in one or more of the following tests for microbial pesticides:
i. Avian acute oral or avian inhalation studies.
ii. Wild mammal studies.
iii. Nontarget plant studies (terrestrial).
iv. Honey bee studies.
v. Nontarget insect studies.
10. Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
i. Freshwater fish studies.
ii. Freshwater invertebrate studies.
iii. Nontarget plant studies (aquatic).
11. Required if product is applied on land or in fresh water or marine/estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pesticides:
i. Estuarine and marine animal toxicity and pathogenicity.
ii. Plant studies - estuarine or marine species.
12. An appropriate dose-response toxicity test is required when toxic effects on nontarget terrestrial wildlife or aquatic organisms (including plants) are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the microbial agent to the affected nontarget terrestrial wildlife or aquatic organisms. The protocols for these tests may have to be modified in accordance with results from the nontarget organism and environmental expression studies.
13. Required when one or more of the following are present:
i. Pathogenic effects are observed in Tier I avian studies.
ii. Tier II environmental expression testing indicate that long-term exposure of terrestrial animals is likely.
14. Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenicity or infectivity was observed in Tier I aquatic studies.
15. Required if, after an analysis of the microbial pesticide's ability to survive and multiply in the environment and what ecological habitat it would occupy, the intended use patterns, and the results of previous nontarget organisms and environmental expression tests, it is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments. Testing is to determine if applications of the microbial pest control would be expected to disrupt the balance of populations in the target ecosystem.
16. Tier IV studies may be conducted as a condition of registration as post-registration monitoring if the potential for unreasonable adverse effects appears to be minimal during that period of use due to implementation of mitigation measures.
17. Required when both of the following conditions occur:
i. Pathogenic effects observed at actual or expected field residue exposure levels are reported in Tier III; and
ii. The Agency determines that quarantine methods would not prevent the microbial pesticide from contaminating areas adjacent to the test area.
18. Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of available laboratory data, use patterns, and exposure rates.
19. Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and growth of natural populations are observed) are required if laboratory data indicate that adverse long-term, cumulative, or life-cycle effects may result from intended use.
20. Since test standards would be developed on a case-by-case basis, consultation with the Agency and development of a protocol is advised before performing these Tier IV studies.
Product performance data must be developed for all microbial pesticides. However, the Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control public health pests, such as pest microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (including but not limited to: rodents, birds, bats, canids, and skunks) or invertebrates (including but not limited to: mosquitoes and ticks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are 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 data for any pesticide product registered or proposed for registration.
(a)
(2) For general information on the data requirement tables, see § 158.2110(a)(2)-(4).
(b)
(a)
(b)
(c)
(d)
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 production stage, a preliminary product analytical method and data would suffice to support an experimental use permit. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing.
5. Only required for emulsifiable liquid forms of microbial pesticides.
6. Required when microbial pesticides are packaged in metal, plastic, or paper containers.
7. Only required for liquid forms of microbial pesticides.
(a)
(b)
(c)
(d)
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.
(a)
(b)
(c)
(d)
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 active ingredient is a virus.
5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.
6. Required when the product consists of, or under conditions of use that would result in an inhalable material (e.g., gas, volatile substances, or aerosol particulate).
(a)
(b)
(c)
(d)
(e)
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 toxicity/pathogenicity study is the upland game. There is also the option to test a passerine species if there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrates are preferred for invertebrate testing.
3. Required when there will be significant exposure to aquatic organisms (fish and invertebrates).
4. Required if the microbial pesticide is taxonomically related to a known plant pathogen.
5. Data are not required unless an active microbial ingredient controls the target insect pest by a mechanism of infectivity;
At 78 FR 26978, May 8, 2013, subpart W, consisting of §§ 158.2200 through 158.2290 was added, effective July 8, 2013.
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. Such a product is subject to the data requirements for pesticides in subparts C through O, 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.
(a)
(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)
The following terms are defined for the purposes of this subpart:
(a)
(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:
(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 antimicrobial public health claims.
(b)
The product chemistry data requirements of subpart D of this part apply to antimicrobial products covered by this subpart.
(a)
(2)
(3)
(4)
(b)
(c)
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
1. Not required if test material is a gas or highly volatile liquid.
2. The six end-use product (EP) acute toxicity studies are required using the product as formulated for sale and distribution. In addition, if the EP label has directions for diluting the product, then, the applicant may also need to conduct certain of the acute toxicity studies using the highest concentration labeled for dilution (
3. Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5.
4. Data are required when the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol or particulates).
5. Data are required if repeated dermal exposure is likely to occur under conditions of use.
6. For indirect food uses ≤ 200 ppb, and all other nonfood uses, data are required if the neurotoxicity screen in the 90-day oral rodent study or other data indicate neurotoxicity.
7. The 90-day dermal toxicity study and/or 90-day inhalation toxicity study are required if the Agency determines that dermal and/or inhalation exposure is the primary route of exposure.
8. All 90-day subchronic studies in the rodent can be designed to simultaneously fulfill the requirements of the 90-day neurotoxicity and/or immunotoxicity studies by adding separate groups of animals for testing of neurotoxicity and/or immunotoxicity parameters.
9. The 90-day study is required in the rodent for hazard characterization (possibly endpoint selection) and dose-setting for the chronic/carcinogenicity study. It is not required in the mouse, but the Agency would encourage the applicant to conduct a 90-day range finding study for the purposes of dose selection for the mouse carcinogenicity study to achieve adequate dosing and an acceptable study.
10. A 1-year non-rodent study (
11. Although the subchronic toxicity testing guidelines include measurement of neurological endpoints, such screens do not meet the requirement of the 90-day neurotoxicity study. For nonfood uses, if the 90-day study does not include a neurotoxicity screen, then the acute neurotoxicity study will be required.
12. Data are required if all of the following criteria are met:
i. The intended use of the antimicrobial pesticide product is expected to result in repeated dermal human exposure to the product.
ii. Data from a 90-day dermal toxicity study are not available.
iii. The 90-day dermal toxicity study has not been triggered.
13. EP testing is required if the product or any component of the product may increase dermal absorption of the active ingredient(s) or increases its toxic or pharmacologic effects, as determined by testing using the TGAI or based on available information about the toxic effects of the product or its components.
14. Data are required if the active ingredient in the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient is the toxic moiety.
15. A 90-day oral toxicity test is not required for heating, ventilation, air conditioning, and refrigeration systems (collectively referred to as HVAC&R). Instead, two 90-day toxicity tests, one by the dermal route and one by the inhalation route are required.
16. Data are required if there is the likelihood of significant repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol.
17. Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g.,
18. Based on the positive results of the acute or 90-day neurotoxicity studies, or on other data indicating neurotoxicity, a chronic neurotoxicity study (
19. Studies which are designed to simultaneously fulfill the requirements of both the chronic oral and carcinogenicity studies (
20. For indirect food uses ≤ 200 ppb, and all other nonfood uses, data are required if either of the following criteria are met:
i. The use of the pesticide is likely to result in repeated human exposure over a considerable portion of the human lifespan; or
ii. The use requires that a tolerance, tolerance exemption, or food additive regulation or clearance be established.
21. For indirect food uses ≤ 200 ppb, and all other nonfood uses, data are required if any of the following criteria, are met:
i. The use of the pesticide is likely to result in significant human exposure over a considerable portion of the human life span which is significant in terms of frequency, time, duration, and/or magnitude of exposure.
ii. The use requires that a tolerance, tolerance exemption, or food additive regulation or clearance be established.
iii. The active ingredient, metabolite, degradate, or impurity:
A. Is structurally related to a recognized carcinogen;
B. Causes mutagenic effects as demonstrated by
C. Produces a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchronic studies that may lead to a neoplastic change.
22. If the requirement for a carcinogenicity study in any species is modified or waived for any reason, then a subchronic 90-day oral study in the same species may be required.
23. Testing in two species is required for all uses.
24. The oral route, by oral intubation, is preferred, unless the chemical or physical properties of the test substance, or the pattern of human exposure, suggest a more appropriate route of exposure.
25. Additional testing by other routes of exposure may be required if the pesticide is determined to be a prenatal developmental toxicant after oral dosing.
26. The developmental toxicity study in rodents may be combined with the two-generation reproduction study in rodents by using a second mating of the parental animals in either generation. Protocols must be approved by the Agency prior to the initiation of the study.
27. A two-generation reproduction study is required.
28. An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, pharmacokinetic, or mechanistic data) to determine whether a standard guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing animal. Applicants must submit any alternative proposed testing protocols and supporting scientific rationale to the Agency. Protocols must be approved by the Agency prior to the initiation of the study.
29. The use of a combined two-generation reproduction/developmental neurotoxicity study that utilizes the two-generation reproduction study in rodents as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is encouraged.
30. A DNT study is required using a weight-of-evidence approach when:
i. The pesticide causes treatment-related neurological effects in adult animal studies (
ii. The pesticide causes treatment-related neurological effects in developing animals, following pre- or post-natal
iii. The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological studies.
iv. The pesticide evokes a mechanism that is associated with adverse effects on the development of the nervous system (
31. To facilitate the weight-of-evidence determination for the pesticide's mutagenicity, in addition to those specifically listed in this table, the Agency requires submission of other mutagenicity test results that may have been performed. A reference list of all studies and papers known to the applicant concerning the mutagenicity of the test chemical must be submitted with the required studies.
32. Due to the nature of antimicrobials, if testing with bacterial strains has not been conducted, then testing using a mammalian cell assay such as the mouse lymphoma TK ± assay is preferred. If reverse mutation assay testing with bacterial strains has already been conducted, and the testing was conducted at levels that did not cause toxicity to the bacterial strains tested, then the applicant may submit the study to fulfill this data requirement.
33. For the
34. There is a choice of assays, but the micronucleus rodent bone marrow assay is preferred; the rodent bone marrow assays using metaphase analysis (aberrations) are acceptable.
35. Data are required when chronic toxicity or carcinogenicity studies are also required.
36. Data is required if the product label directs that it be applied to domestic animals, such as cats, dogs, cattle, pigs, and horses.
37. In the absence of dermal absorption data or a repeated dose dermal toxicity study, the assumption of 100 percent dermal absorption would be used in a risk assessment to determine if a dermal penetration study is required, and to identify the doses and duration of exposure for which dermal absorption is to be quantified.
38. Required for nonfood uses, if oral exposure could occur.
39. Data may be required if significant adverse effects are seen in available toxicology studies and these effects can be further elucidated by metabolism and pharmacokinetics studies.
(a)
(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 (
(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)
(c)
(d)
1. For industrial processes and water systems, antifoulant paints and coatings, wood preservatives, and aquatic areas, data are required for two avian species: one waterfowl species and one upland game bird species. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required for one avian species.
2. Data are required on one freshwater aquatic invertebrate species.
3. For the industrial processes and water systems, antifoulant paints and coatings, wood preservatives, and aquatic use pattern areas, data are required on two species of fish, one cold water species and one warm water species. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required on one species of fish, either one cold water species or one warm water species. Testing on a second species is required if the active ingredient or principal transformation products are stable in the environment and the LC
4. Data are required on one avian species, either one waterfowl species or one upland game bird species, if the avian acute oral LD
5. If TEP testing cannot be conducted due to the physical characteristics of the test substance (for example, a paint), then the applicant should request a waiver.
6. Data are required if one or more of the following criteria are met:
i. Birds may be subjected to repeated or continued exposure to the pesticide or any of its transformation products, especially preceding or during the breeding season.
ii. The pesticide or any of its major metabolites or degradation products are stable in the environment to the extent that a potentially toxic amount may persist in avian feed.
iii. The pesticide or any of its major metabolites or degradation products are stored or accumulated in plant or animal tissues, as indicated by the octanol/water partition coefficient (K
iv. Any other information, such as that derived from mammalian reproduction studies, indicates that reproduction in terrestrial vertebrates may be adversely affected by the anticipated use of the pesticide product.
7. TEP testing is required for any product which meets one or more of the following conditions:
i. When based on deterministic modeling results: If the Estimated Environmental Concentration (EEC) in the aquatic environment is equal to or greater than one-half the LC
ii. When based on probabilistic modeling results: If the estimated 10th percentile 7Q10 Surface Water Concentration exceeds the acute concentration of concern (
iii. If an ingredient in the end-use product other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
iv. The end-use antimicrobial product will be applied directly into an aquatic environment.
8. Data are required on one estuarine/marine mollusk, one other estuarine/marine invertebrate, and one estuarine/marine fish species.
9. For the all other use patterns category (as specified in § 158.2240(a)(5)), industrial processes and water systems, wood preservatives, and aquatic areas, data are required if the pesticide residues from the parent compound and/or transformation products are likely to enter the estuarine/marine environment.
10. Testing must be conducted with the most sensitive organism (either freshwater or estuarine/marine vertebrates, or freshwater or estuarine/marine invertebrates), as determined from the results of the acute toxicity
11. Data are required on estuarine/marine species if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
12. Data are required on freshwater species if the end-use product is intended to be applied directly to water, or is expected to be transported to water from the intended use site, and when one or more of the following conditions apply:
i. When based on deterministic modeling results: If the Estimated Environmental Concentration (EEC) in water is equal to or greater than 0.1 of the no-observed-adverse-effect concentration or no-observed-adverse-effect level (NOAEC/NOAEL) in the fish early-life stage or invertebrate life cycle tests.
ii. When based on probabilistic modeling results: If the estimated 10th percentile 7Q10 Surface Water Concentration based on probabilistic modeling exceeds for 20 days or more the chronic concentration of concern (
iii. If studies of other organisms indicate that the reproductive physiology of fish may be affected.
13. Not required when:
i. The octanol/water partition coefficients of the pesticide and its major degradates are less than 1,000;
ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
iii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9.
14. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
15. Protocols must be approved by the Agency prior to the initiation of the study.
16. Data are required if the intended use pattern, and the physical/chemical properties and environmental fate characteristics of the antimicrobial indicate significant potential exposure, and, based on the results of the acute and chronic aquatic organism testing, significant impairment of nontarget aquatic organisms could result.
17. Data are required if the half-life of the pesticide in the sediment is equal to or less than 10 days in either the aerobic soil or aquatic metabolism studies, and if one or more of the following conditions are met:
i. The soil partition coefficient (K
ii. The log K
iii. The K
18. Data are required if the EEC in sediment is greater than 0.1 of the acute LC
i. The soil partition coefficient (K
ii. The log K
iii. The K
19. Sediment testing with estuarine/marine test species is required if the product is intended for direct application to the estuarine or marine environment or the product is expected to enter this environment in significant concentrations either by runoff or erosion, because of its expected use or mobility pattern.
20. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required only for beehive applications when the beehive (empty or occupied) may be treated.
21. A study similar to “Honey Bee Toxicity of Residues on Foliage” is required using treated wood instead of the foliage. Protocols must be approved by the Agency prior to the initiation of the study.
(a) Subpart B of this part and § 158.2201 describe how to use the table
(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 (
(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)
(f)
(g)
1. Data on only one plant species (rice,
2. Data are required if the risk quotient from any aquatic plant growth Tier II study exceeds a level of concern for aquatic plants.
3. Not required when:
i. There are no potential exposures to plants;
ii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9; or
iii. The results of a biodegradation study indicate that the active ingredient or principal degradation products are not biodegradable in 28 days,
4. For TEP testing, data are required for the applicant's end-use product if an ingredient in the end-use product, other than the active ingredient, is expected to enhance the toxicity of the active ingredient.
5. One Tier II (dose response) study, conducted with
6. For industrial processes and water systems, antifoulant coatings and paints, wood preservatives, and aquatic areas, Tier II (dose response) studies are required on four species (
7. Environmental chemistry methods used to generate data must include the results of a successful confirmatory method trial by an independent laboratory.
8. Tests are required on a case-by-case basis based on the results of lower tier plant protection studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.
9. Protocols must be approved by the Agency prior to the initiation of the study.
10. For the all other use patterns category (as specified in § 158.2250(c)), data are required if the aquatic (algal) plant growth Tier II study demonstrates detrimental effects at less than 1.0 ppm or mg/L.
(a)
(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,
(b)
(1)
(ii) Scientifically sound epidemiological or poisoning incident data with a clear cause-effect relationship indicating that adverse health effects may have resulted from exposure to the pesticide.
(2)
(ii) Respiratory exposure may occur during product use.
(c)
(d)
(e)
1. Prior to initiation of the study, protocols involving intentional exposure of human subjects must be submitted for review by EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the Human Studies Review Board (
2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation passive dosimetry exposure data, provided the human pharmacokinetics of the pesticide or metabolite/analog compounds (
3. For products with both indoor and outdoor uses, and similar conditions of use, data are generally required for the indoor applications only. However, data for outdoor uses are required if the Agency expects outdoor uses to result in greater exposure than indoor uses (e.g., higher use rates and application frequency, or longer exposure duration, or application methods/equipment create potential for increased dermal or inhalation exposure in outdoor versus indoor use sites). In certain cases, when a pesticide may be used both indoors and outdoors under dissimilar conditions of use, the Agency may require submission of applicator exposure data for both use patterns.
4. EPA will consider waiving this data requirement for antimicrobials applied via closed loading systems if the antimicrobial has a low vapor pressure.
5. Data reporting and calculations are required only if handler exposure data are required.
(a)
(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)
(1)
(ii) Scientifically sound epidemiological or poisoning incident data with a clear cause-effect relationship indicating that adverse health effects may have resulted from exposure to the pesticide.
(2)
(B) Residential human post-application or bystander exposure to residues of antimicrobial pesticides could occur following the application of antimicrobial pesticides to outdoor areas and spaces at residential sites, such as, but not limited to homes, daycare centers, and other public buildings.
(ii)
(B) Residential human post-application or bystander exposure to pesticide residues could occur following the application of the antimicrobial pesticide to indoor spaces or surfaces at residential sites, such as, but not limited to homes, daycare centers, hospitals, schools, and other public buildings.
(c)
(d)
(e)
1. Prior to initiation of the study, protocols involving intentional exposure of human subjects must be submitted for review by EPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the Human Studies Review Board (HSRB) (
2. For residential wood preservative uses, data may be required if soil has the potential to be an important exposure pathway, and soil is in contact with or adjacent to treated wood, including but not limited to decks, play sets, and gazebos,
3. Protocols must be approved by the Agency prior to the initiation of the study.
4. For wood preservatives, data are required for treated wood surfaces where post-application contact with treated wood is anticipated.
5. For occupational uses, data are required if the pesticide may be applied to or around surfaces, and if the human activity data indicate that workers are likely to have post-application dermal contact with treated surfaces while participating in typical activities.
6. Data are required for residential use sites, schools, and daycare institutions. This includes but is not limited to the following: Residential and public access premises; material preservatives (including those used in residential products, including but not limited to clothing and plastic toys) and wood preservatives (when contact with treated wood is likely to occur).
7. Data are required for occupational and residential uses if the human activity data indicate the potential for post-application dermal and/or inhalation exposures while participating in typical activities and no acceptable modeling options are available.
8. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation passive dosimetry exposure data provided the human pharmacokinetics of the pesticide or metabolite/analog compounds (
9. Data are required for occupational and residential uses if there is the potential for bystander exposure and the pesticide use could result in respirable and/or inhalable material (e.g., gas, vapor, aerosol, or particulates).
10. Data reporting and calculations are required only if post-application exposure data are required.
(a)
(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 (
(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)
(c)
(d)
1. For testing antifoulant paints and coatings, testing is to be performed separately with both sterile buffered distilled water and sterile synthetic seawater at pHs 5, 7, and 9.
2. Not required if:
i. 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, inclusive; or
ii. The results of the hydrolysis study at all three pHs (5, 7, and 9) demonstrates a half-life of less than 30 days.
3. The results of the activated sludge, respiration inhibition (ASRI) test determine which of the following tests are required: Ready biodegradability, porous pot, the biodegradation in activated sludge study as described in the “Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater,” or simulation test—aerobic sewage treatment: A. activated sludge units.
i. If the ASRI test EC
A. Conduct the biodegradation in activated sludge study as described in the “Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater”;
B. Conduct the porous pot test; or
C. Conduct the simulation test—aerobic sewage treatment: A. activated sludge units.
ii. If the ASRI test EC
A. Conduct a ready biodegradability study; or
B. Conduct one of the following studies: The biodegradation in activated sludge study as described in the “Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater,” the porous pot test, or the simulation test—aerobic sewage treatment: A. activated sludge units.
4. Pass criteria for the ready biodegradability study are: 70 percent removal of dissolved organic carbon (DOC) and 60 percent removal of theoretical oxygen demand (ThOD) or theoretical carbon dioxide (ThCO
5. For the all other use patterns category (as specified in § 158.2280(a)(3)), data are required based on a weight-of-evidence evaluation of the results of the hydrolysis, photodegradation in water, activated sludge sorption isotherm, biodegradability, and activated sludge, respiration inhibition tests.
6. Adsorption and desorption using a batch equilibrium method is preferred. In some cases, as when the antimicrobial 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.
7. For industrial processes and water systems, aquatic areas, and the all other use patterns category (as specified in § 158.2280(a)(3)), data are required based on a weight-of-evidence evaluation of the results of the hydrolysis, photodegradation in water, activated sludge sorption isotherm, biodegradability, and activated sludge, respiration inhibition tests.
8. The environmental media (soil, water, hydrosoil, and biota) to be utilized in these studies must be collected from areas representative of potential use sites.
9. For industrial processes and water systems, and aquatic areas, data are required for use sites that are intermittently dry.
10. Data are not required if the antimicrobial is an inorganic substance or a metal salt; or if the standardized soil
11. Analytical methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory.
12. Protocols must be approved by the Agency prior to the initiation of the study.
13. For industrial processes and water systems, wood preservatives, and the all other use patterns category (as specified in § 158.2280(a)(3)), data are required based on the potential for aquatic exposure and if the weight-of-evidence indicates that the active ingredient or principal transformation products are likely to have the potential for persistence, mobility, nontarget aquatic toxicity, or bioaccumulation.
14. Data are required if the weight-of-evidence indicates that the active ingredient or principal transformation products are likely to occur in nontarget freshwater, estuarine, or marine waters such that human or environmental exposures are likely to occur. In making that determination, the Agency takes into account other factors such as the toxicity of the chemical(s), available monitoring data and the vulnerability of the freshwater, estuarine, or marine water resources in the antimicrobial use area.
15. For wood preservatives, an aquatic leaching study is required. A soil leaching study is required if human or environmental exposures are likely to occur from leachates that contain the active ingredient or principal transformation products from wood treated with a preservative product. Protocols must be approved by the Agency prior to the initiation of the study.
16. For antifoulant paints and coatings, a leaching study is required. Protocols must be approved by the Agency prior to the initiation of the study.
17. Protocols, which include the residues of concern (such as parent, degradate/transformation product, and/or leachate residues) that would be monitored, must be approved by the Agency prior to the initiation of the study.
18. A biodegradation study is not required if the antimicrobial meets one or more of the following criteria:
i. Classified as a metal,
ii. Relatively volatile, but not hydrophobic,
iii. Highly reactive,
iv. Both the parent and all transformation/degradate products (as described under § 158.2280(a)(2)) have half-lives of less than 3 hours,
v. None of the registered or proposed product uses would result in transport of the parent and its transformation/degradate products (as described under § 158.2280(a)(2)) to a wastewater treatment plant.
19. The activated sludge sorption isotherm test is not required if the antimicrobial is:
i. Relatively volatile, but not hydrophobic;
ii. Highly reactive; or
iii. The log K
20. If the criteria of test note 19 of this paragraph are not met, then the activated sludge sorption isotherm test is required if one or more of the following criteria are also met:
i. The antimicrobial is a metal,
ii. The log K
iii. The antimicrobial is positively charged or polycationic,
iv. The EC
v. The EC
21. The activated sludge respiration inhibition study is not required if none of the registered or proposed product uses would result in transport of the parent and its transformation/degradate products (as described under § 158.2280(a)(2)) to a wastewater treatment plant.
(a)
(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 Agency levels of concern.
(d) For purposes of this section, Magnitude of the Residue Studies include the following: Food-handling, migration studies, potable water, fish, irrigated crops, meat/milk/poultry/eggs, crop field trails, processed food or feed, and anticipated residues.
(e) If the antimicrobial chemical may be applied to a field crop, then the residue chemistry data requirements of § 158.1410 apply.
(f) The following term is defined for the purposes of thissection:
(g)
(h)
(i)
1. A petition proposing a numerical tolerance or a tolerance exemption is required for any food or feed use subject to section 408 of FFDCA if the use is not covered by an existing tolerance or tolerance exemption. If the use is subject to FFDCA section 409, the applicant must identify to EPA an applicable section 409 food additive regulation or clearance, or submit a copy of a petition to FDA requesting a section 409 food additive regulation or clearance for the food or feed use.
2. An analytical reference standard is required for any food or feed use requiring a numeric tolerance or exemption. Material safety data sheets as specified by the Occupational Safety and Health Administration in 29 CFR 1910.1200 must accompany analytical standards.
3. Data are required if a pesticide may be used in a food-handling establishment unless data including, but not limited to, theoretical (high-end) estimates, radiolabeled laboratory data, or the nature of the residue on surfaces study show that residues will not occur in food or feed.
4. If an antimicrobial pesticide may be applied to a food-contact surface or impregnated into a food-contact material and if theoretical (high-end) estimates of exposure exceed EPA's risk level of concern, then the nature of the residue on surfaces study is required. Protocols must be approved by the Agency prior to the initiation of the study.
5. Based on the results of the nature of the residue on surfaces study, if residues of concern are identified, then the migration study will be required. Protocols must be approved by the Agency prior to the initiation of the study.
6. If a magnitude of the residue study, as specified in § 158.2290(d), is required, then a residue analytical method suitable for collecting data is also required. The method must be capable of determining all residues of concern, to permit calculation of dietary risk or to establish a tolerance or tolerance exemption.
7. If a magnitude of the residue study, as specified in § 158.2290(d), is required, then storage stability data are also required, unless analytical samples are stored for 30 days or less. If, during hazard characterization, a residue has been identified as “of concern” and is known to be volatile or labile, then storage stability data are required regardless of sample storage time.
8. If crop plants or metabolically active raw agricultural commodities of food crops may be directly or indirectly exposed to an antimicrobial, plant metabolism studies are required to determine the transformation products that may enter the human diet. Such exposure could include, but is not limited to:
i. Treatment of storage or shipping containers,
ii. Postharvest fruit and vegetable treatment prior to shipping or storage,
iii. Use of antimicrobial-treated water for irrigation, and
iv. Any direct food contact use.
9. If livestock may be exposed to an antimicrobial, then hen and ruminant metabolism studies are required to determine the identities of residues of concern that may enter the human diet from consumption of livestock commodities. Livestock may be exposed via the oral, dermal, or inhalation route following treatment or contamination of sites including, but not limited to, livestock premises, feed, and drinking water. Shell eggs and other metabolically active livestock products may also be treated. If livestock may be exposed to one or more residues of concern differing from those found in animals, then one or more additional livestock metabolism studies involving dosing with these residues may be required.
10. If there is a numerical tolerance or tolerance exemption level to enforce, then a residue analytical method suitable for enforcement purposes is required. The method must be supported by an independent laboratory validation.
11. If there is a numerical tolerance or tolerance exemption level to enforce, then testing is required to determine whether the Food and Drug Administration/United States Department of Agriculture multiresidue methodology would detect and identify
12. Data are required if an antimicrobial may be applied directly to water or if there is the potential that the antimicrobial-treated water could be used directly for drinking water purposes by humans or animals or that contaminated water could run-off, leach, or be discharged from treated sites or materials and make its way into potable water.
13. Data are required if an antimicrobial may be applied directly to water inhabited by fish or that will be inhabited by fish or if contaminated water could run-off, leach, or be discharged from treated sites or materials and make its way into bodies of water containing fish that may be used for human consumption.
14. Data are required if an antimicrobial may be applied directly to water used for irrigation of food crops or such that contaminated water could run-off, leach, or be discharged from treated sites or materials to make its way into water used for irrigation of food crops.
15. If the antimicrobial may be applied directly to livestock, metabolically-active livestock commodities (e.g., eggs), livestock feed or drinking water, or livestock premises, or a livestock metabolism study indicates that residues of the antimicrobial may result in livestock commodities, studies are required to determine the magnitude of the residues of concern in fat, meat, meat by-products, milk, poultry, and eggs that may be consumed by humans. These studies, however, may not be required in cases where the livestock metabolism studies indicate that transfer of pesticide residues of concern to tissues, milk, and eggs is not expected to occur at the maximum expected exposure level for the animals.
16. If food crops or raw agricultural commodities of food crops may be exposed to an antimicrobial, then residue studies are required to determine the magnitude of the residues of concern that may enter the human diet. Such exposures include, but are not limited to, postharvest fruit and vegetable treatments and application of antimicrobial chemicals to field crops, mushroom houses, empty or occupied beehives, or wood used to construct beehives.
17. Data on the nature and magnitude of residues in processed food or feed are required if antimicrobial residues could potentially concentrate on processing. If so, the establishment of a separate tolerance higher than that in the raw agricultural commodity may be required.
18. Data are required when dietary exposure values at the tolerance level or screening-level (high-end) result in estimates of dietary or aggregate risk that meet or exceed the Agency's level of concern. These data may include, but are not limited to, washing, cooking, processing, or degradation studies as well as market basket surveys for a more realistic residue determination. Protocols must be approved by the Agency prior to the initiation of the study.
7 U.S.C. 136-136y.
(a) Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) states: “If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, he shall submit such information to the Administrator.”
(b) Section 152.50(f)(3) of this chapter requires applicants to submit, as part of an application for registration, any factual information of which he is aware regarding unreasonable adverse effects of the pesticide on humans or the environment, which would be required to be reported under section 6(a)(2) if the product were registered.
(c) Compliance with this part will satisfy a registrant's obligations to submit additional information pursuant to section 6(a)(2) and will satisfy an applicant's obligation to submit additional information pursuant to § 152.50(f)(3) of this chapter.
(a) For the purposes of reporting information pursuant to FIFRA section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40 CFR part 152 apply to this part unless superseded by a definition in paragraph (b) of this section.
(b) For purposes of reporting information pursuant to FIFRA section 6(a)(2), the following definitions apply only to this subpart:
(1) Ten percent of the maximum contaminant level (MCL) established by
(2) The ambient water quality criteria for the protection of aquatic life, established by EPA pursuant to section 304(a) of the Clean Water Act.
(a) The following reportable information must be received by EPA not later than the 30th calendar day after the registrant first possesses or knows of the information:
(1) Scientific studies described in § 159.165.
(2) Information about discontinued studies described in § 159.167.
(3) Human epidemiological and exposure studies described in § 159.170.
(4) Detection of a pesticide in or on food or feed described in § 159.178(a).
(5) Detection of metabolites, degradates, contaminates, impurities described in § 159.179.
(6) Failure of performance studies described in § 159.188(a)(2), (b)(2), and (c).
(7) Other information described in § 159.195.
(b) Reportable information concerning detections of pesticides in water described in § 159.178(b), adverse effects incidents described in § 159.184(a), and efficacy failure incidents described in § 159.188(a)(1) and (b)(1) must be reported according to the time frames set forth in § 159.184(d).
(c) EPA may, in its discretion, notify a registrant in writing of a different reporting period that will apply to specific types of reportable information or eliminate reporting requirements entirely. Such notification supersedes otherwise applicable reporting requirements set forth in this part.
(d) For purposes of this part, a registrant possesses or knows of information at the time any officer, employee, agent, or other person acting for the registrant first comes into possession of, or knows of, such information; provided that, such person performs any activities for the registrant related to the development, testing, sale or registration of a pesticide or the person could be reasonably expected to come into possession of information otherwise reportable under this part. In the case of information known to or possessed by an agent or other person acting for the registrant, a registrant is responsible for such information only if the agent or other person acquired such information while acting for the registrant.
A submission under FIFRA section 6(a)(2) must be delivered to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).
(a) Include a cover letter which contains the information requested in paragraphs (d) and (e) of this section, and a prominent statement that the information is being submitted in accordance with FIFRA section 6(a)(2).
(b) Contain the name of the submitter, registrant name and registration number, date of transmittal to EPA, the type of study or incident being reported under §§ 159.165 through 159.195, and a statement of why the information is considered reportable under this part.
(c) Identify the substance tested or otherwise covered by the information (including, if known, the EPA registration number(s) to which the information pertains, and if known, the CAS Registry Number).
(d) In reporting incidents, provide the data listed in § 159.184, to the extent such information is available.
(e) In submitting scientific studies, follow the procedures set forth in § 158.32 or § 161.32 of this chapter, as applicable.
(f) If the information is part of a larger package being submitted in order to comply with another provision of FIFRA (e.g., sections 3(c)(2)(B), 4(e)(1)(E)), identify in the transmittal the individual studies being submitted under this part.
(g) If a claim of confidentiality is made under FIFRA section 10 for information relating to any part of a study or incident report contained in the submission, follow the procedures set forth in § 158.33 or § 161.33 of this chapter, as applicable regarding the identification and segregation of information claimed to be confidential.
(h) If a submission includes a study subject to the flagging requirements of § 158.34 or § 161.34 of this chapter, as applicable, comply with the requirements of that section, and, if the flagging statement is positive, identify it as 6(a)(2) information in the transmittal.
(i) If a submission is a follow-up to an earlier study or incident report submitted to EPA, the transmittal must state that fact, and must cite the earlier submission, as follows:
(1) If the earlier submission was a study to which EPA assigned a Master Record Identifier number (MRID), cite the MRID.
(2) If the previous submission was an incident report to which no MRID number was assigned, cite the date of the initial submission of the incident information or report.
(a)
(1) Who was employed or retained (directly or indirectly) by the registrant, and was likely to receive such information.
(2) From whom the registrant requested the opinion(s) or conclusion(s) in question.
(3) Who is a qualified expert as described in § 159.153(b).
(b)
(i) The registrant discovers that any analysis, conclusion, or opinion was predicated on data that were erroneously generated, recorded, or transmitted, or on computational errors.
(ii) Every author of each such analysis, conclusion, or opinion, or as many authors as can be contacted through the use of reasonable diligence, has acknowledged in writing that the analysis, conclusion, or opinion was improper and has either corrected the original analysis, conclusion, or opinion accordingly, or provided an explanation as to why it cannot be corrected.
(iii) As a result of the correction, the information is no longer required to be reported under FIFRA section 6(a)(2), or if no correction was possible, the authors agree that the original analysis, conclusion or opinion has no scientific validity.
(2)
(i) Documents officially logged in by the EPA Office of Pesticide Programs.
(ii) EPA publications, EPA hearing records, or publications cited in EPA
(iii) Any other documents which are contained in the official files and records of the EPA Office of Pesticide Programs.
(iv) Any documents officially logged in by the EPA Office of Pollution Prevention and Toxics under the provisions of section 8(e) of the Toxic Substances Control Act, provided that if the information pertains to a chemical compound which, subsequent to the submission of data under section 8(e), becomes the subject of an application for registration as a pesticide active ingredient, information is submitted to
(3)
(i) Any scientific article or publication which has been abstracted in a recognized database of scientific and medical literature, such as Medline, ENBASE, Toxline or Index Medicus, if the abstract in question clearly identified the active ingredient or the registered pesticide(s) to which the information pertains. Otherwise reportable information received by or known to the registrant prior to publication of an abstract concerning the information must be reported and may not be withheld pending such publication.
(ii) Reports or publications which have been made available to the public by any of the following Federal agencies: Centers for Disease Control and Prevention, Consumer Products Safety Commission, Department of Agriculture, Department of the Interior, Food and Drug Administration or any other agency or institute affiliated with the Department of Health and Human Services. Otherwise reportable information concerning research which was performed, sponsored, or funded by the registrant which may also appear in forthcoming Government reports or publications must be reported and may not be withheld pending publication.
(4)
(i) The compound has been eliminated from its registered product due to changes in manufacturing processes, product formulation or by other means.
(ii) The registrant has informed the appropriate product manager in the Office of Pesticide Programs in writing of the presence previously of the inert, contaminant or impurity in the product and its subsequent elimination from the product.
(a) Notwithstanding any other provision of this part, information held by registrants on August 17, 1998 which has not been previously submitted to the Agency, but which is reportable under the terms of this part, must be submitted to the Agency if it meets any of the following criteria:
(1) Information is otherwise reportable under § 159.184, and pertains to an incident that is alleged to have occurred on or after January 1, 1994, and to have involved any of the following:
(i) A fatality or hospitalization of a human being.
(ii) A fatality of a domestic animal.
(iii) A fatality or fatalities to fish or wildlife, if the incident meets the criteria for the exposure type and severity category designation “W-A” set forth in § 159.184(c)(5)(iii).
(2) Submission of the information is requested by the Agency pursuant to § 159.195(c).
(b) If a registrant possesses information required to be submitted by paragraph (a)(1) of this section, the registrant must submit on or before June 16, 1999 in accordance with § 159.156(c), (d), and (e) an inventory of the incidents that meet the requirements of paragraphs (a)(1) of this section. Such an inventory must include the separate number of incidents that meet the requirements of paragraphs (a)(1)(i), (a)(1)(ii), and (a)(1)(iii) of this section, and for each type of incident, the total numbers of fatalities or hospitalizations involved.
(c) If a registrant possesses information required to be submitted by paragraph (a)(2) of this section, the information must be submitted in accordance with any schedule contained in the Agency's request for the information.
(a)
(b)
(1) The information is first obtained by the person more than 1 year after the date on which the person ceased to hold the registration of the product to which the information pertains, and the person holds no active pesticide registrations, or for some other reason cannot reasonably be expected to receive information concerning the formerly registered product.
(2) The information is associated solely with an inert ingredient, contaminant, impurity, metabolite, or degradate contained in a product, and the information is first obtained by the person more than 1 year after the date upon which the person ceased to hold the registration of the product.
(3) The information is associated with an active ingredient or a formerly registered product, and the active ingredient or every active ingredient contained in the formerly registered product has not been contained in any pesticide product registered in the United States for any part of the 3-year period preceding the date on which the person first obtained the information.
(4) The information pertains solely to a formerly registered product that no longer meets the definition of “pesticide” in section 2(u) of FIFRA.
(c)
Adverse effects information must be submitted as follows:
(a)
(i) That is in a different organ or tissue of the test organism.
(ii) At a lower dosage, or after a shorter exposure period, or after a shorter latency period.
(iii) At a higher incidence or frequency.
(iv) In a different species, strain, sex, or generation of test organism.
(v) By a different route of exposure.
(2) Acute oral, acute dermal, acute inhalation or skin and eye irritation studies in which the only change in toxicity is a numerical decrease in the median lethal dose (LD
(b)
(1) At levels 50 percent or more lower than previous acute toxicity studies with similar species, including determinations of the median lethal dose (LD
(2) At lower levels in a chronic study than previous studies with similar species.
(3) In a study with a previously untested species the results indicate the chronic no observed effect level (NOEL) is 10 percent or less of the lowest LC
(4) For plants when tested at the maximum label application rate or less, if either of the following conditions is met:
(i) More than 25 percent of terrestrial plants show adverse effects on plant life cycle functions and growth such as germination, emergence, plant vigor, reproduction and yields.
(ii) More than 50 percent of aquatic plants show adverse effects on plant life cycle functions and growth such as germination, emergence, plant vigor, reproduction and yields.
(c) Results from a study that demonstrates any toxic effect (even if corroborative of information already known to the Agency), must be submitted if the pesticide is or has been the subject of a Formal Review based on that effect within 5 years of the time the results are received. Within 30 calendar days of the publication of a Notice of Commencement of a Formal Review in the
(d)
(1)
(i) All testing has been completed.
(ii) A preliminary data analysis or gross pathological analysis has been conducted.
(iii) Final analysis has not been completed.
(iv) A reasonable period for completion of the final analysis not longer than 90 calendar days following completion of testing has elapsed.
(v) Comparable information concerning the results of a completed study would be reportable.
(2)
(i) All testing has been completed.
(ii) A preliminary data analysis or gross pathological analysis has been conducted.
(iii) Final analysis has not been completed.
(iv) A reasonable period of completion of final analysis (not longer that 1 year following completion of testing) has elapsed.
(v) Comparable information concerning the results of a completed study would be reportable.
(3)
The fact that a study has been discontinued before the planned termination must be reported to EPA, with the reason for termination, if submission of information concerning the study is, or would have been, required under this part.
Information must be submitted which concerns any study that a person described in § 159.158(a) has concluded, or might reasonably conclude, shows that a correlation may exist between exposure to a pesticide and observed adverse effects in humans. Information must also be submitted which concerns
(a)
(b)
(i) Waters of the United States, as defined in § 122.2 of this chapter, except paragraph (d) of § 122.2.
(ii) Ground water.
(iii) Finished drinking water.
(2) If the lowest detectable amount of the pesticide is reported, the detection limit must also be reported.
(3) Information need not be submitted regarding the detection of a pesticide in waters of the United States or finished drinking water if the pesticide is registered for use in finished drinking water or surface water and the amount detected does not exceed the amounts reported by a registrant in its application for registration, as resulting in those waters from legal applications of the pesticide.
(4) Information need not be submitted concerning detections of pesticides in waters of the United States, ground water or finished drinking water if the substance detected is an inert ingredient, or a metabolite, degradate, contaminant or impurity of a pesticide product, unless EPA has established or proposed a maximum contaminant level (MCL) or health advisory level (HAL) for that substance, or has estimated a health advisory level based on an established reference dose (RfD) for that substance, and notified registrants of that level.
(5) Information to be submitted is the same as that required in § 159.184(c)(1), (2), (3), (4)(iv) and (v), and (5)(vi).
(a)
(1) The metabolite or degradate may occur or be present under conditions of use of the pesticide product, and the existence of the metabolite or degradate or the association of the metabolite or degradate with the pesticide product has not been previously reported to EPA.
(2) The metabolite or degradate has been previously reported, but it is detected at levels higher than any previously reported; and either of the following conditions is met:
(i) Any person described in § 159.158(a) has concluded that the metabolite or degradate may pose a toxicological or ecological risk based on any one or more of the following:
(A) The physical or chemical properties of the metabolite or degradate.
(B) Data regarding structurally analogous chemicals.
(C) Data regarding chemical reactivity of the metabolite or degradate and structurally analogous substances.
(D) Data on the metabolite or degradate.
(ii) The registrant has concluded, or has been advised by any person described in § 159.158(a) that the metabolite or degradate, or analogous chemicals, may have any experimentally determined half-life greater than 3 weeks as shown from laboratory aerobic soil metabolism studies or field dissipation studies, or may have any experimentally determined resistance to hydrolytic degradation, or photolytic degradation on soil or in water, under
(b)
(1) Quantities greater than 0.1 percent by weight (1,000 parts per million).
(2) Quantities that EPA considers, and so informs registrants, to be of toxicological significance.
(3) Quantities that the registrant considers to be of toxicological significance.
(4) Quantities above a level for which the registrant has information indicating that the presence of the contaminant or impurity may pose a risk to health or the environment.
(5) Quantities that a person described in § 159.158(a) has informed the registrant is likely to be of toxicological significance.
(a)
(1) The registrant is aware, or has been informed that a person or non-target organism may have been exposed to a pesticide.
(2) The registrant is aware, or has been informed that the person or non-target organism suffered a toxic or adverse effect, or may suffer a delayed or chronic adverse effect in the future.
(3) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
(b)
(1) The registrant is aware of facts which clearly establish that the reported toxic effect, or reported exposure, did not or will not occur.
(2) The registrant has been notified in writing by the Agency that the reporting requirement has been waived for this incident or category of incidents, and the registrant has not been notified in writing by the Agency that the waiver is rescinded.
(3) It concerns a toxic effect to non-target plants, which were at the use site at the time the pesticide was applied, if the label provides adequate notice of such a risk.
(4) It concerns non-lethal phytotoxicity to the treated crop if the label provides an adequate notice of such a risk.
(5) It concerns a toxic effect to pests not specified on the label, provided that such pests are similar to pests specified on the label.
(6) It concerns minor skin or eye irritation effects warned of on the label of a product which is registered for use in residential use sites, and the effects occurred as a result of use in a residential site.
(c)
(1)
(i) Name of reporter, address, and telephone number.
(ii) Name, address, and telephone number of contact person (if different than reporter).
(iii) Incident report status (e.g., new or update); if update, include the date of original submission.
(iv) Date registrant became aware of the incident.
(v) Date of incident (if appropriate, list start and end dates).
(vi) Location of incident (city, county and state).
(vii) Is incident part of a larger study.
(viii) Source if different from reporting registrant.
(2)
(i) Product name.
(ii) Active ingredient(s).
(iii) EPA Registration Number.
(iv) Diluted for use, or concentrate.
(v) Formulation, if known.
(3)
(i) Evidence the label directions were not followed (e.g., yes, no, unknown).
(ii) How exposed (e.g., spill, drift, equipment failure, container failure, mislabeling, runoff, etc.).
(iii) Situation (e.g., household use, mixing/loading, application, reentry, disposal, transportation, other (describe)).
(iv) Use site (e.g., home, yard, commercial turf, agricultural (specify crop), industrial, building/office, school, nursery, greenhouse, pond/lake/stream, well, forest/woods, other.
(v) Applicator certified (yes, no, unknown).
(vi) A brief description of the circumstances of the incident.
(4)
(i) If the incident involves humans:
(A) Route of exposure (skin, eye, respiratory, oral).
(B) List signs/symptoms/adverse effects.
(C) If laboratory tests were performed, list name of test(s) and results.
(D) If available, submit laboratory report(s).
(E) Time between exposure and onset of symptoms.
(F) Was adverse effect the result of suicide/homicide or attempted suicide/homicide.
(G) Type of medical care sought, (e.g., none, Poison Control Center, hospital emergency department, hospital inpatient, private physician, clinic, other).
(H) Demographics (sex, age, occupation).
(I) If female, pregnant?
(J) Exposure data: amount of pesticide; duration of exposure; weight of victim.
(K) Was exposure occupational; days lost due to illness.
(L) Was protective clothing worn (specify).
(ii) If domestic animal:
(A) Type of animal (e.g., livestock, poultry, bird, fish, household pet e.g., dog/cat etc.).
(B) List signs/symptoms/adverse effects.
(C) Breed/species (name and number affected, per adverse effect).
(D) Route of exposure (e.g., skin, eye, respiratory, oral).
(E) Time between exposure and onset of symptoms.
(F) If laboratory test(s) performed, list name of tests and results.
(G) If available, submit laboratory report(s).
(iii) If fish, wildlife, plants or other non-target organisms:
(A) List species affected, and number of individuals per species.
(B) List symptoms or adverse effects.
(C) Magnitude of the effect (e.g., miles of streams, square area of terrestrial habitat).
(D) Pesticide application rate, intended use site (e.g., corn, turf), and method of application.
(E) Description of the habitat and the circumstances under which the incident occurred.
(F) If plant, type of plant life (
(G) Formulation of pesticide if not indicated by brand name (granular, flowable).
(H) Distance from treatment site.
(I) If laboratory test(s) performed, list name of test(s) and results.
(J) If available, submit laboratory report(s).
(iv) If surface water:
(A) If raw water samples, water bodies sampled and approximate locations in each water body.
(B) If raw water samples, proximity of sampling locations to drinking water supply intakes and identities of systems supplied.
(C) If finished water samples, water supply systems sampled.
(D) If finished water samples, percent surface water source by specific surface water sources to water supply system(s).
(E) Sample type (grab, composite).
(F) Sampling times/frequency.
(G) Pesticides and degredates analyzed for, the detection limits, and the amount detected.
(H) Method of analysis.
(v) If ground water:
(A) Pesticides and degredates analyzed for, the analytical method used, the detection limits, and the amount detected.
(B) Sample date.
(C) Amount pesticide applied (lbs-ai/acre).
(D) Date of last application.
(E) Depth to water.
(F) Latitude/longitude.
(G) Soil series and texture (sand/silt/clay).
(H) Frequency of applications per year.
(I) Aquifer description (confined/unconfined).
(J) Method of application.
(K) Years pesticide used.
(L) Well use and well identifier.
(M) Screened interval.
(N) Annual cumulative rainfall (inches).
(O) Maximum rainfall and date.
(P) Cumulative irrigation (inches).
(Q) Hydrologic group.
(R) Hydraulic conductivity.
(S) pH.
(T) Organic matter or organic carbon (percent).
(vi) If property damage.
(A) Provide description.
(B) [Reserved]
(5)
(A) H-A: If the person died.
(B) H-B: If the person alleged or exhibited symptoms which may have been life-threatening, or resulted in adverse reproductive effects or in residual disability.
(C) H-C: If the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic nature than minor symptoms. Usually some form of treatment of the person would have been Indicated. Symptoms were not life threatening and the person has returned to his/her pre-exposure state of health with no additional residual disability.
(D) H-D: If the person alleged or exhibited some symptoms, but they were
(E) H-E: If symptoms are unknown, unspecified or are alleged to be of a delayed or chronic nature that may appear in the future.
(ii)
(A) D-A: If the domestic animal died or was euthanized.
(B) D-B: If the domestic animal exhibited or was alleged to have exhibited symptoms which may have been life-threatening or resulted in residual disability.
(C) D-C: If the domestic animal exhibited or was alleged to have exhibited symptoms which are more pronounced, more prolonged or of a more systemic nature than minor symptoms. Usually some form of treatment would have been indicated to treat the animal. Symptoms were not life threatening and the animal has returned to its pre-exposure state of health with no additional residual disability.
(D) D-D: If the domestic animal was alleged to have exhibited symptoms, but they were minimally bothersome. The symptoms resolved rapidly and usually involve skin, eye or respirator irritation.
(E) D-E: If symptoms are unknown or not specified.
(iii)
(A) Involves any incident caused by a pesticide currently in Formal Review forecological concerns.
(B) Fish: Affected 1,000 or more individuals of a schooling species or 50 or more individuals of a non-schooling species.
(C) Birds: Affected 200 or more individuals of a flocking species, or 50 or moreindividuals of a songbird species, or 5 or more individuals of a predatory species.
(D) Mammals, reptiles, amphibians: Affected 50 or more individuals of a relatively common or herding species or 5 or more individuals of a rare or solitary species.
(E) Involves effects to, or illegal pesticide treatment (misuse) of a substantial tract of habitat (greater than or equal to 10 acres, terrestrial or aquatic).
(F) Involves a major spill or discharge (greater than or equal to 5,000 gallons) of a pesticide.
(G) Involves adverse effects caused by a pesticide, to federally listed endangered or threatened species.
(iv)
(A) The effect is alleged to have occurred on more than 45 percent of the acreage exposed to the pesticide.
(B) [Reserved]
(v)
(vi)
(A) G-A: If the pesticide was detected at levels greater than the maximum contaminant level (MCL) or health advisory level (HAL) or an applicable criterion for ambient water quality.
(B) G-B: If the pesticide was detected at levels greater than 10 percent of the MCL, HAL or a criterion for ambient water quality but does not exceed the MCL or other applicable level.
(C) G-C: If the pesticide was detected at levels less than 10 percent of the MCL, HAL, or other applicable level, or there is no established level of concern.
(vii)
(A) PD-A: The product is alleged to have caused damage in a manner that could have caused direct human injury, such as fire or explosion.
(B) PD-B: The product is alleged to have caused damage in excess of $5,000.
(C) PD-C: Any allegation of property damage that does not meet the criteria of paragraphs (c)(5)(vii)(A) or (B) of this section, including cases in which the level of damages is not specified.
(d)
(1) For allegations involving human fatality (H-A), registrants must submit the required information, to the extent it is available, no later than 15 days after learning of an allegation.
(2) Information concerning incidents which meet the criteria for the following exposure and severity category labels described in paragraph (c)(5) of this section, reports of detections of pesticides in water, and efficacy failure incidents may be described in § 159.188(a)(1) and (b)(1), may be accumulated for a 30-day period, and submitted to the Agency within 30 days after the end of each 30-day accumulation period for: Humans, H-B, and H-C; Wildlife, W-A; Plants, P-A; Water, G-A; Property Damage, PD-A.
(3) Incidents or reports of detections of pesticides in water meeting all other exposure and severity label categories, information may be accumulated by registrants for 90 days and submitted within 60 days after the end of each 90-day accumulation period.
(e)
(1) The time period covered by the report.
(2) For each exposure and severity label category, a count of the number of incidents, listed by product registration number (if known) or active ingredient.
(3) A count of domestic animal incidents in categories, other than D-A or D-B, which can be added together and reported as a single number.
(f)
(1) The information concerns an alleged human fatality (H-A), and the information consists of any of the elements listed in paragraphs (c)(1) through (c)(4) of this section.
(2) The information concerns an incident originally reported as alleging a major human illness or injury (H-B), or fatality to a domestic animal (D-A), or wildlife (W-A), and the additional information consists of pesticide or circumstance information listed in paragraphs (c)(2) or (c)(3) of this section, or is a laboratory report concerning persons or animals involved in the incident.
(3) The information concerns any incident not originally reported with one of the exposure and severity labels H-A, or H-B for human incidents, or at the “A” level of severity for any other exposure or incident type, and the new information would result in labeling the incident H-A or H-B for a human incident, or at the “A” level of severity for any other exposure or incident type listed in paragraph (c)(5) of this section.
(a)
(1) Information which concerns an incident which meets all of the following conditions:
(i) The registrant has been informed that a pesticide product may not have performed as claimed against target microorganisms.
(ii) The possible failures of the pesticide to perform as claimed involved the use against microorganisms which may pose a risk to human health.
(iii) The pesticide product's use site is other than residential.
(iv) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
(2) A study which indicates that the pesticide may not perform in accordance with one or more claims made by the registrant regarding uses intended for control of microorganisms tha may pose a risk to human health, including any of the public health antimicrobials identified in part 161 of this chapter.
(b)
(1) Information which concerns an incident which meets all of the following conditions:
(i) The registrant has been informed by municipal, State, or Federal public health officials that a pesticide product may not have performed as claimed against target animals.
(ii) The possible failures of the pesticide to perform as claimed involved the use against animals that pose a risk to human health.
(iii) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
(2) A study which indicates that the pesticide may not perform in accordance with one or more claims by the registrant regarding uses intended for control of animals that pose a risk to human health, including any of the public health pesticides identified in part 158 of this chapter.
(c)
(1) The survival of the suspected pesticide-resistant pest was significantly higher than that of a known susceptible pest when both the suspected resistant and susceptible pests were treated with the pesticide under controlled conditions.
(2) Biochemical tests or DNA sequencing indicate that the pest is resistant to the pesticide.
(a) The registrant shall submit to the Administrator information other than that described in §§ 159.165 through 159.188 if the registrant knows, or reasonably should know, that if the information should prove to be correct, EPA might regard the information alone or in conjunction with other information about the pesticide as raising concerns about the continued registration of a product or about the appropriate terms and conditions of registration of a product. Examples of the types of information which must be provided if not already reportable under some other provision of this part include but are not limited to information showing:
(1) Previously unknown or unexpected bioaccumulation of a pesticide by various life forms.
(2) Greater than anticipated drift of pesticides to non-target areas.
(3) Use of a pesticide may pose any greater risk than previously believed or reported to the Agency.
(4) Use of a pesticide promotes or creates secondary pest infestations.
(5) Any information which might tend to invalidate a study submitted to the Agency to support a pesticide registration.
(b) A registrant is not obligated under paragraph (a) of this section to provide information to the Administrator if the registrant is aware of facts which establish that otherwise reportable information is not correct.
(c) The registrant shall submit to the Administrator information other than that described in §§ 159.165 through
7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w; 21 U.S.C. 346a, 371, Reorganization Plan No. 3 of 1970.
(a) This part prescribes good laboratory practices for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA. This part is intended to assure the quality and integrity of data submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, and section 408 or 409 of the Federal Food, Drug and Cosmetic Act.
(b) This part applies to any study described by paragraph (a) of this section which any person conducts, initiates, or supports on or after October 16, 1989.
As used in this part the following terms shall have the meanings specified:
(1) An application for registration, amended registration, or reregistration of a pesticide product under FIFRA sections 3, 4 or 24(c).
(2) An application for an experimental use permit under FIFRA section 5.
(3) An application for an exemption under FIFRA section 18.
(4) A petition or other request for establishment or modification of a tolerance, for an exemption for the need for a tolerance, or for other clearance under FFDCA section 408.
(5) A petition or other request for establishment or modification of a food additive regulation or other clearance by EPA under FFDCA section 409 that was submitted prior to August 3, 1996.
(6) A submission of data in response to a notice issued by EPA under FIFRA section 3(c)(2)(B).
(7) Any other application, petition, or submission sent to EPA 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.
(1) A person who initiates and supports, by provision of financial or other resources, a study;
(2) A person who submits a study to the EPA in support of an application for a research or marketing permit; or
(3) A testing facility, if it both initiates and actually conducts the study.
(1) Is the subject of an application for a research or marketing permit supported by the study, or is the contemplated subject of such an application; or
(2) Is an ingredient, impurity, degradation product, metabolite, or radioactive isotope of a substance described by paragraph (1) of this definition, or some other substance related to a substance described by that paragraph, which is used in the study to assist in characterizing the toxicity, metabolism, or other characteristics of a substance described by that paragraph.
When a sponsor or other person utilizes the services of a consulting laboratory, contractor, or grantee to perform all or a part of a study to which this part applies, it shall notify the consulting laboratory, contractor, or grantee that the service is, or is part of, a study that must be conducted in compliance with the provisions of this part.
Any person who submits to EPA an application for a research or marketing permit and who, in connection with the application, submits data from a study to which this part applies shall include in the application a true and correct statement, signed by the applicant, the sponsor, and the study director, of one of the following types:
(a) A statement that the study was conducted in accordance with this part; or
(b) A statement describing in detail all differences between the practices used in the study and those required by this part; or
(c) A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this part.
(a) A testing facility shall permit an authorized employee or duly designated representative of EPA or FDA, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies to which this part applies. The records inspection and copying requirements should not apply to quality assurance unit records of findings and problems, or to actions recommended and taken, except that EPA may seek production of these records in litigation or formal adjudicatory hearings.
(b) EPA will not consider reliable for purposes of supporting an application for a research or marketing permit any data developed by a testing facility or
(a) EPA may refuse to consider reliable for purposes of supporting an application for a research or marketing permit any data from a study which was not conducted in accordance with this part.
(b) Submission of a statement required by § 160.12 which is false may form the basis for cancellation, suspension, or modification of the research or marketing permit, or denial or disapproval of an application for such a permit, under FIFRA section 3, 5, 6, 18, or 24 or FFDCA section 406 or 409, or for criminal prosecution under 18 U.S.C. 2 or 1001 or FIFRA section 14, or for imposition of civil penalties under FIFRA section 14.
(a) Each individual engaged in the conduct of or responsible for the supervision of a study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a study.
(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
(d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test, control, and reference substances and test systems.
(e) Personnel engaged in a study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test, control, and reference substances.
(f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the study shall be excluded from direct contact with test systems, and test, control, and reference substances, and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a study.
For each study, testing facility management shall:
(a) Designate a study director as described in § 160.33 before the study is initiated.
(b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
(c) Assure that there is a quality assurance unit as described in § 160.35.
(d) Assure that test, control, and reference substances or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
(e) Assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled.
(f) Assure that personnel clearly understand the functions they are to perform.
(g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.
For each study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the
(a) The protocol, including any change, is approved as provided by § 160.120 and is followed.
(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
(c) Unforseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
(d) Test systems are as specified in the protocol.
(e) All applicable good laboratory practice regulations are followed.
(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.
(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. The quality assurance unit shall conduct inspections and maintain records appropriate to the study.
(b) The quality assurance unit shall:
(1) Maintain a copy of a master schedule sheet of all studies conducted at the testing facility indexed by test substance, and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
(2) Maintain copies of all protocols pertaining to all studies for which the unit is responsible.
(3) Inspect each study at intervals adequate to ensure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. Any problems which are likely to affect study integrity found during the course of an inspection shall be brought to the attention of the study director and management immediately.
(4) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
(5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
(6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study.
(7) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.
(c) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees or duly designated representatives of EPA or FDA.
(d) An authorized employee or a duly designated representative of EPA or FDA shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed up in accordance with this paragraph.
Each testing facility shall be of suitable size and construction to facilitate the proper conduct of studies. Testing facilities which are not located within an indoor controlled environment shall be of suitable location to facilitate the proper conduct of studies. Testing facilities shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study.
(a) A testing facility shall have a sufficient number of animal rooms or other test system areas, as needed, to ensure: proper separation of species or test systems, isolation of individual projects, quarantine or isolation of animals or other test systems, and routine or specialized housing of animals or other test systems.
(1) In tests with plants or aquatic animals, proper separation of species can be accomplished within a room or area by housing them separately in different chambers or aquaria. Separation of species is unnecessary where the protocol specifies the simultaneous exposure of two or more species in the same chamber, aquarium, or housing unit.
(2) Aquatic toxicity tests for individual projects shall be isolated to the extent necessary to prevent cross-contamination of different chemicals used in different tests.
(b) A testing facility shall have a number of animal rooms or other test system areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test, control, and reference substances known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.
(c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory test system diseases. These areas shall provide effective isolation for the housing of test systems either known or suspected of being diseased, or of being carriers of disease, from other test systems.
(d) Facilities shall have proper provisions for collection and disposal of contaminated water, soil, or other spent materials. When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.
(e) Facilities shall have provisions to regulate environmental conditions (e.g., temperature, humidity, photoperiod) as specified in the protocol.
(f) For marine test organisms, an adequate supply of clean sea water or artificial sea water (prepared from deionized or distilled water and sea salt mixture) shall be available. The ranges of composition shall be as specified in the protocol.
(g) For freshwater organisms, an adequate supply of clean water of the appropriate hardness, pH, and temperature, and which is free of contaminants capable of interfering with the study, shall be available as specified in the protocol.
(h) For plants, an adequate supply of soil of the appropriate composition, as specified in the protocol, shall be available as needed.
(a) There shall be storage areas, as needed, for feed, nutrients, soils, bedding, supplies, and equipment. Storage areas for feed nutrients, soils, and bedding shall be separated from areas where the test systems are located and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means.
(b) When appropriate, plant supply facilities shall be provided. As specified in the protocol, these include:
(1) Facilities for holding, culturing, and maintaining algae and aquatic plants.
(2) Facilities for plant growth, including, but not limited to greenhouses, growth chambers, light banks, and fields.
(c) When appropriate, facilities for aquatic animal tests shall be provided. These include, but are not limited to, aquaria, holding tanks, ponds, and ancillary equipment, as specified in the protocol.
(a) As necessary to prevent contamination or mixups, there shall be separate areas for:
(1) Receipt and storage of the test, control, and reference substances.
(2) Mixing of the test, control, and reference substances with a carrier, e.g., feed.
(3) Storage of the test, control, and reference substance mixtures.
(b) Storage areas for test, control, and/or reference substance and for test, control, and/or reference mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the substances and mixtures.
Separate laboratory space and other space shall be provided, as needed, for the performance of the routine and specialized procedures required by studies.
Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.
Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol and shall be suitably located for operation, inspection, cleaning, and maintenance.
(a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated, and/or standardized.
(b) The written standard operating procedures required under § 160.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/ or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation.
(c) Written records shall be maintained of all inspection, maintenance, testing, calibrating, and/or standardizing operations. These records, containing the dates of the operations, shall describe whether the maintenance operations were routine and followed the written standard operating procedures. Written records shall be kept of nonroutine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the defect, how and when the defect was discovered, and any remedial action taken in response to the defect.
(a) A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management.
(b) Standard operating procedures shall be established for, but not limited to, the following:
(1) Test system area preparation.
(2) Test system care.
(3) Receipt, identification, storage, handling, mixing, and method of sampling of the test, control, and reference substances.
(4) Test system observations.
(5) Laboratory or other tests.
(6) Handling of test systems found moribund or dead during study.
(7) Necropsy of test systems or postmortem examination of test systems.
(8) Collection and identification of specimens.
(9) Histopathology.
(10) Data handling, storage and retrieval.
(11) Maintenance and calibration of equipment.
(12) Transfer, proper placement, and identification of test systems.
(c) Each laboratory or other study area shall have immediately available manuals and standard operating procedures relative to the laboratory or field procedures being performed. Published literature may be used as a supplement to standard operating procedures.
(d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.
All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Deteriorated or outdated reagents and solutions shall not be used.
(a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals and other test systems.
(b) All newly received test systems from outside sources shall be isolated and their health status or appropriateness for the study shall be evaluated. This evaluation shall be in accordance with acceptable veterinary medical practice or scientific methods.
(c) At the initiation of a study, test systems shall be free of any disease or condition that might interfere with the purpose or conduct of the study. If during the course of the study, the test systems contract such a disease or condition, the diseased test systems should be isolated, if necessary. These test systems may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorization of treatment, description of treatment, and each date of treatment shall be documented and shall be retained.
(d) Warm-blooded animals, adult reptiles, and adult terrestrial amphibians used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require these test systems to be removed from and returned to their test system-housing units for any reason (e.g., cage cleaning, treatment, etc.), shall receive appropriate identification (e.g., tattoo, color code, ear tag, ear punch, etc.). All information needed to specifically identify each test system within the test system-housing unit shall appear on the outside of that unit. Suckling mammals and juvenile birds are excluded from the requirement of individual identification unless otherwise specified in the protocol.
(e) Except as specified in paragraph (e)(1) of this section, test systems of different species shall be housed in separate rooms when necessary. Test systems of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to test, control, or reference substances or test system mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification shall be made.
(1) Plants, invertebrate animals, aquatic vertebrate animals, and organisms that may be used in multispecies tests need not be housed in separate rooms, provided that they are adequately segregated to avoid mixup and cross contamination.
(2) [Reserved]
(f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds, growth chambers, and other holding, rearing and breeding areas, and accessory equipment, shall be cleaned and sanitized at appropriate intervals.
(g) Feed, soil, and water used for the test systems shall be analyzed periodically to ensure that contaminants known to be capable of interfering with
(h) Bedding used in animal cages or pens shall not interfere with the purpose or conduct of the study and shall be changed as often as necessary to keep the animals dry and clean.
(i) If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used.
(j) All plant and animal test systems shall be acclimatized to the environmental conditions of the test, prior to their use in a study.
(a) The identity, strength, purity, and composition, or other characteristics which will appropriately define the test, control, or reference substance shal1 be determined for each batch and shall be documented before its use in a study. Methods of synthesis, fabrication, or derivation of the test, control, or reference substance shall be documented by the sponsor or the testing facility, and the location of such documentation shall be specified.
(b) When relevant to the conduct of the study the solubility of each test, control, or reference substance shall be determined by the testing facility or the sponsor before the experimental start date. The stability of the test, control, or reference substance shall be determined before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
(c) Each storage container for a test, control, or reference substance shall be labeled by name, chemical abstracts service number (CAS) or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test, control, or reference substance. Storage containers shall be assigned to a particular test substance for the duration of the study.
(d) For studies of more than 4 weeks experimental duration, reserve samples from each batch of test, control, and reference substances shall be retained for the period of time provided by § 160.195.
(e) The stability of test, control, and reference substances under storage conditions at the test site shall be known for all studies.
Procedures shall be established for a system for the handling of the test, control, and reference substances to ensure that:
(a) There is proper storage.
(b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
(c) Proper identification is maintained throughout the distribution process.
(d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.
(a) For each test, control, or reference substance that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
(1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test, control, or reference substance in the mixture.
(2) When relevant to the conduct of the study, to determine the solubility of each test, control, or reference substance in the mixture by the testing facility or the sponsor before the experimental start date.
(3) To determine the stability of the test, control, or reference substance in the mixture before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
(b) Where any of the components of the test, control, or reference substance carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown.
(c) If a vehicle is used to facilitate the mixing of a test substance with a carrier, assurance shall be provided that the vehicle does not interfere with the integrity of the test.
(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain but shall not necessarily be limited to the following information:
(1) A descriptive title and statement of the purpose of the study.
(2) Identification of the test, control, and reference substance by name, chemical abstracts service (CAS) number or code number.
(3) The name and address of the sponsor and the name and address of the testing facility at which the study is being conducted.
(4) The proposed experimental start and termination dates.
(5) Justification for selection of the test system.
(6) Where applicable, the number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.
(7) The procedure for identification of the test system.
(8) A description of the experimental design, including methods for the control of bias.
(9) Where applicable, a description and/or identification of the diet used in the study as well as solvents, emulsifiers and/or other materials used to solubilize or suspend the test, control, or reference substances before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
(10) The route of administration and the reason for its choice.
(11) Each dosage level, expressed in milligrams per kilogram of body or test system weight or other appropriate units, of the test, control, or reference substance to be administered and the method and frequency of administration.
(12) The type and frequency of tests, analyses, and measurements to be made.
(13) The records to be maintained.
(14) The date of approval of the protocol by the sponsor and the dated signature of the study director.
(15) A statement of the proposed statistical method to be used.
(b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the protocol.
(a) The study shall be conducted in accordance with the protocol.
(b) The test systems shall be monitored in conformity with the protocol.
(c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.
(d) In animal studies where histopathology is required, records of gross findings for a specimen from postmortem observations shall be available to a pathologist when examining that specimen histopathologically.
(e) All data generated during the conduct of a study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the day of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change,
(a) All provisions of the GLP standards shall apply to physical and chemical characterization studies designed to determine stability, solubility, octanol water partition coefficient, volatility, and persistence (such as biodegradation, photodegradation, and chemical degradation studies) of test, control, or reference substances.
(b) The following GLP standards shall not apply to studies, other than those designated in paragraph (a) of this section, designed to determine physical and chemical characteristics of a test, control, or reference substance:
(a) A final report shall be prepared for each study and shall include, but not necessarily be limited to, the following:
(1) Name and address of the facility performing the study and the dates on which the study was initiated and was completed, terminated, or discontinued.
(2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
(3) Statistical methods employed for analyzing the data.
(4) The test, control, and reference substances identified by name, chemical abstracts service (CAS) number or code number, strength, purity, and composition, or other appropriate characteristics.
(5) Stability and, when relevant to the conduct of the study the solubility of the test, control, and reference substances under the conditions of administration.
(6) A description of the methods used.
(7) A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.
(8) A description of the dosage, dosage regimen, route of administration, and duration.
(9) A description of all circumstances that may have affected the quality or integrity of the data.
(10) The name of the study director, the names of other scientists or professionals and the names of all supervisory personnel, involved in the study.
(11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
(12) The signed and dated reports of each of the individual scientists or other professionals involved in the study, including each person who, at the request or direction of the testing facility or sponsor, conducted an analysis or evaluation of data or specimens from the study after data generation was completed.
(13) The locations where all specimens, raw data, and the final report are to be stored.
(14) The statement prepared and signed by the quality assurance unit as described in § 160.35(b)(7).
(b) The final report shall be signed and dated by the study director.
(c) Corrections or additions to a final report shall be in the form of an
(d) A copy of the final report and of any amendment to it shall be maintained by the sponsor and the test facility.
(a) All raw data, documentation, records, protocols, specimens, and final reports generated as a result of a study shall be retained. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids, do not need to be retained after quality assurance verification. Correspondence and other documents relating to interpretation and evaluation of data, other than those documents contained in the final report, also shall be retained.
(b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents of specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations.
(c) An individual shall be identified as responsible for the archives.
(d) Only authorized personnel shall enter the archives.
(e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval.
(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this subchapter.
(b) Except as provided in paragraph (c) of this section, documentation records, raw data, and specimens pertaining to a study and required to be retained by this part shall be retained in the archive(s) for whichever of the following periods is longest:
(1) In the case of any study used to support an application for a research or marketing permit approved by EPA, the period during which the sponsor holds any research or marketing permit to which the study is pertinent.
(2) A period of at least 5 years following the date on which the results of the study are submitted to the EPA in support of an application for a research or marketing permit.
(3) In other situations (e.g., where the study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued.
(c) Wet specimens, samples of test, control, or reference substances, and specially prepared material which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids, do not need to be retained after quality assurance verification. In no case shall retention be required for longer periods than those set forth in paragraph (b) of this section.
(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 160.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraph (b) of this section.
(e) Summaries of training and experience and job descriptions required to be maintained by § 160.29(b) may be retained along with all other testing facility employment records for the
(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 160.63 (b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.
(g) If a facility conducting testing or an archive contracting facility goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The EPA shall be notified in writing of such a transfer.
(h) Specimens, samples, or other non-documentary materials need not be retained after EPA has notified in writing the sponsor or testing facility holding the materials that retention is no longer required by EPA. Such notification normally will be furnished upon request after EPA or FDA has completed an audit of the particular study to which the materials relate and EPA has concluded that the study was conducted in accordance with this part.
(i) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.
7 U.S.C. 136-136y.
At 78 FR 26993, May 8, 2013, part 161 was removed, effective July 8, 2013.
(a)
(b)
(2) This part also specifies the types and minimum amounts of data and information the Agency requires to decide whether to approve applications for experimental use permits under FIFRA section 5.
(3) Finally, this part specifies the types and minimum amounts of data and information that an applicant for registration, amended registration, or reregistration must submit or cite in support of an application in order to satisfy the requirements of FIFRA section 3(c)(1)(D) and sections 3(c)(5)(B) or 3(c)(7). Use of the term “registration” in this part will pertain to new registrations and amended registrations as well as reregistration accomplished under section 3(g), unless stated otherwise.
(c)
(a) Some kinds of data and information are specified in subparts C and D of this part as “required” (“R”) for the evaluation of some or all types of products. Other kinds of data and information are specified in those sections as “conditionally required” (“CR”), that is, they are required if the product's proposed pattern of use, results of other tests, or other pertinent factors meet the criteria specified in those sections. The terms “required” and “conditionally required” are further discussed in §§ 161.100 and 161.101.
(b) The Agency recognizes that certain data requirements may not be applicable to (or should be waived for) some products, and has made provisions for such cases in this part as specified in § 161.35
This part establishes requirements for the types of data which are necessary to support the unconditional registration of a pesticide product under section 3(c)(5) of the Act. While every registered pesticide product must eventually be supported by the data required by part 161, when an applicant or registrant must initially satisfy these data requirements depends on the factors listed below in this section.
(a)
(b)
(1)
(2)
(i) Those data for which the requirement has been waived.
(ii) Those data for which the requirement was imposed so recently that the applicant has not had sufficient time to produce the data.
(3)
(i) Product chemistry data, as required by subpart C of this part.
(ii) Product performance data, to the extent required by § 161.160.
(4)
(i) Product chemistry data, as required by subpart C of this part.
(ii) Product performance data, to the extent required by § 161.160.
(iii) Other data pertaining solely to the new use. The applicant may generally determine which data pertain solely to the new use by comparing the data requirements for all existing uses of all currently registered products containing the same active ingredient(s) with those for all uses including the new use. Any differences are attributable to the new use and must be submitted with the application.
(a)
(1) The identity of the submitter, or the identity of each joint submitter and of the agent for joint submitters;
(2) The date of the submission;
(3) The identification of the Agency action in support of which the data are being submitted, such as the registration number or file symbol, petition number, experimental use permit number, or registration standard review; and
(4) A bibliography of all specific documents included in the submission and covered by the transmittal.
(b)
(2) Each study must include the following elements in addition to the study itself:
(i) A title page, as described in paragraph (c) of this section;
(ii) A Statement of Data Confidentiality Claims and, if desired, a Supplemental Statement of Data Confidentiality Claims, in accordance with § 161.33;
(iii) A certification with respect to Good Laboratory Practice standards, if required by § 160.12 of this chapter;
(iv) If the original study is not in the English language, a complete and accurate English translation under the same cover; and
(v) If the study is of a type listed in § 161.34(b), the statement prescribed by paragraph (c) of that section.
(3) Three identical copies of each study must be submitted. If the study is submitted in conjunction with a pending Special Review or Registration Standard under development, four copies must be submitted. Three copies must be identical and must conform to the requirements of § 161.33 with respect to claims of confidentiality. The fourth copy will be placed in the public docket and must conform to the requirements of § 154.15(c) of this chapter or § 155.30(c) of this chapter with respect to claimed confidential business information.
(4) All copies must be in black ink on uniform pages of white, 8
(c)
(1) The title of the study, including identification of the substance(s) tested and the test name or data requirement addressed;
(2) The author(s) of the study;
(3) The date the study was completed;
(4) If the study was performed in a laboratory, the name and address of the laboratory and any laboratory project numbers or other identifying codes;
(5) 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; and
(6) 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.
(d)
(e)
(1) The title or adequate description of the study;
(2) The transmittal information required by paragraph (a) (1), (2), and (3) of this section; and
(3) The MRID number assigned in accordance with paragraph (d) of this section.
(a)
(b)
(1) The information must be contained in a separate attachment to the study. If any information is included in the body of the study rather than in
(2) The attachment must have a cover page which is clearly marked to indicate that the material contained in the attachment falls within the scope of FIFRA sec. 10(d)(1) (A), (B), or (C).
(3) Each item in the attachment must be numbered. For each item, the submitter must cite the applicable portion of FIFRA sec. 10(d)(1) (A), (B), or (C) on which the claim of confidentiality is based. In addition, for each item, the submitter must provide a list of page numbers in the study where the item is cited (
(4) Each item in the attachment must be referenced in the body of the study by its number in the attachment.
(5) The following statement must appear on the Statement of Data Confidentiality Claims:
Information claimed confidential on the basis of its falling within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) has been removed to a confidential appendix, and is cited by cross-reference number in the body of the study.
(c)
No claim of confidentiality is made for any information contained in this study on the basis of its falling within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C).
(d)
(1) The information must be clearly marked in the body of the study as being claimed confidential.
(2) A separate Supplemental Statement of Data Confidentiality Claims must be submitted identifying by page and line number the location within the study of each item claimed confidential, and stating the basis for the claim.
(3) The Supplemental Statement of Data Confidentiality Claims must bear the name, title, and signature of the submitter or his properly designated agent, and the date of signature.
(a) Any person who submits a study of a type listed in paragraph (b) of this section to support an application for new or amended registration, or to satisfy a requirement imposed under FIFRA sec. 3(c)(2)(B), must submit with the study a statement in accordance with paragraph (c) of this section.
(b) The following table indicates that 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.
(c)
(1) “I have applied the criteria of 40 CFR 161.34 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) “I have applied the criteria of 40 CFR 161.34 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.]”
Several provisions of this part provide EPA flexibility in requiring (or not requiring) data and information for the purposes specified in § 161.20(b). These provisions are summarized in this section and discussed elsewhere in this part.
(a) The Agency encourages each applicant, particularly a person applying for registration for the first time, to consult with the Product Manager for
(b) Any applicant who believes that a data requirement is inapplicable to a specific pesticide product may request a waiver of a data requirement under § 161.45.
(c) The Agency may require an applicant to provide additional data or information beyond that specified in subparts C and D of this part when these data are not sufficient to permit EPA to evaluate the applicant's product under § 161.75.
(d) Several policies are in effect that govern the data requirements for registration of products having minor uses. These policies reduce substantially the data requirements that need to be met on the basis of limited exposures and economic equity, and allow case-by-case decision making to determine the specific needs for each kind of use under § 161.60.
(e) The data requirements and guidelines are not static documents. Section 3(c)(2) of FIFRA states that the administrator “shall revise such guidelines from time to time.” Therefore, the data requirements and guidelines will be revised periodically to reflect new scientific knowledge, new trends in pesticide development, and new Agency policies under § 161.80.
This part establishes data requirements applicable to various general use patterns of pesticide products, but some unique or unanticipated aspect of a proposed product's use pattern or composition may result in the need for conferences between registration applicants and the Agency. Such conferences may be initiated by the Agency or by registration applicants. Applicants are expected to contact their respective Product Managers to arrange discussions. The Agency welcomes suggestions for changes to improve the clarity, accuracy, or some other aspect of the data requirements set forth in this part. Specific suggestions should be forwarded to the Director of the Hazard Evaluation Division.
(a)
(2) The Agency will waive data requirements on a case-by-case basis in response to specific written requests by applicants. Because of the wide variety of types and use patterns of pesticides, it is impossible to spell out all of the circumstances which might serve as a basis for waiving data requirements. The Agency, however, will take into account, as appropriate, the factors enumerated in sections 3(c)(2)(A) and 25(a)(1) of FIFRA.
(b)
(2) To request a waiver, an applicant must submit a written request to the appropriate Product Manager. The request must specifically identify the data requirement for which a waiver is requested, explain why he thinks data requirement(s) should be waived, describe any unsuccessful attempts to generate the required data, furnish any other information which he believes would support the request, and when appropriate, suggest alternative means of obtaining data to address the concern which underlies the data requirement.
(c)
(d)
Section 25(a)(1) of FIFRA instructs the Administrator to “take into account the difference in concept and usage between various classes of pesticides and differences in environmental risk and the appropriate data for evaluating such risk between agricultural and non-agricultural pesticides.” This part distinguishes the various classes of pesticide use (e.g., crop
(a)
(1) Since the market volume for a minor use of a pesticide is intrinsically low, and the risk associated with the use often is also correspondingly low, EPA will adjust the data requirements concerning the minor use appropriately.
(2) 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 registrations.
(3) EPA will accept extrapolations and regional data to support establishment of individual minor use tolerances.
(4) Group tolerances will be established to assist applicants for registration of products for minor uses as described in 40 CFR 180.34.
(b)
The Agency has published Pesticide Assessment Guidelines, as indicated in § 161.20(d), which contain suggested protocols for conducting tests to develop the data required by this part.
(a)
(b)
(c)
(a)
(b)
(1) An analytical pure grade of an active ingredient, with or without radioactive tagging.
(2) The technical grade of an active ingredient.
(3) The representative technical grade of an active ingredient.
(4) An intentionally added inert ingredient in a pesticide product.
(5) A contaminant or impurity of an active or inert ingredient.
(6) A plant or animal metabolite or degradation product of an active or inert ingredient.
(7) The end-use pesticide product.
(8) The end-use pesticide product plus any recommended vehicles and adjuvants.
(9) Any additional substance which could act as a synergist to the product for which registration is sought.
(10) Any combination of substances in paragraphs (b) (1) through (9) of this section.
(a)
(b)
(c)
(d)
(a) Data requirements will be revised from time to time to keep up with policy changes and technology. Revisions to this part will be made in accordance with the Administrative Procedure Act (5 U.S.C. 551
(b) The Agency invites registration applicants, registrants, and the general public to suggest changes in the data requirements or the Pesticide Assessment Guidelines. Suggestions may be submitted at any time. Those making suggestions are requested to contact, in writing, the Director of the Hazard Evaluation Division. When suggestions consist of new suggested methods, representative test results should accompany the submittals.
To determine the specific kinds of data needed to support the registration of each pesticide product, the registration applicant should:
(a) Refer to subparts C and D (§§ 161.150 through 161.640). These subparts describe the data requirements, including data tables for each subject area. The corresponding subdivisions in the Pesticide Assessment Guidelines are listed in § 161.108.
(b) Select the general use pattern(s) that best covers the use pattern(s) specified on the pesticide product label. Selection of the appropriate general use pattern(s) will usually be obvious. However, unique or ambiguous cases will arise occasionally. These situations may be clarified by reference to the Use Pattern Index presented in the appendix to the Data Requirements for Registration. The applicant can look up a specific use pattern in appendix A and it will be cross referenced to the appropriate general use patterns to be used in each Data Requirement table.
(c) Proceed down the appropriate general use pattern column in the table and note which tests (listed along the left hand side of the table) are required (“R”), conditionally required (“CR”) or usually not required (“—”). After reading through each data requirement table, the applicant will have a complete list of required and conditionally required data for the pesticide product
(a) Data designated as “required” (“R”) for products with a given general use pattern are needed by EPA to evaluate the risks or benefits of a product having that use pattern unless the data requirement has been waived under § 161.45 for that particular product or unless the product is covered by a specific exception set forth in a note accompanying the requirement.
(b) Data designated as “conditionally required” (“CR”) for products with a given general use pattern are needed by EPA to evaluate the risks or benefits of a product having that use pattern if the product meets the conditions specified in the corresponding notes accompanying the data requirements table. As indicated in the notes, 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 (e.g., tier testing). Applicants must evaluate each applicable note to determine whether or not conditionally required data must be submitted as indicated by the conditions and criteria specified in the accompanying notes unless the Agency has granted a waiver request submitted by the registrant in accordance with § 161.45.
(c) For certain of the required or conditionally required data, the “R” or “CR” designations and are enclosed in brackets (
(a) Readers should be careful to distinguish between what data are required and what substance is to be tested, as specified in this part and in each corresponding section of the guidelines. Each data requirement table specifies whether a particular data requirement is required to support the registration of manufacturing-use products, end-use products, or both. The test substance column specifies which substance is to be subjected to testing. Thus, the data from a certain kind of study may be required to support the registration of each end-use product, but the test substance column may state that the particular test shall be performed using, for example, the technical grade of the active ingredient(s) in the end-use product.
(b) Manufacturing-use products (MP) and end-use products (EP) containing a single active ingredient and no inert ingredients are identical in composition to each other and to the technical grade of the active ingredient (TGAI) from which they were derived, and therefore, the data from a test conducted using any one of these as the test substance (e.g., TGAI) is also suitable to meet the requirement (if any) for the same test to be conducted using either of the other substances (
The Pesticide Assessment Guidelines contain the standards for conducting acceptable tests, guidance on evaluation and reporting of data, definition of terms, further guidance on when data are required, and examples of acceptable protocols. They are available through the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703-605-6000). The following Subdivisions of the Pesticide
(a)
(b)
(ii) Product composition data are compared to the composition of materials used in required testing under subpart D of this part. This comparison indicates which components of a pesticide product have been evaluated by a particular study, and might lead to a conclusion that another study is needed. Based on conclusions concerning the product's composition and its toxic properties, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed.
(iii) Product composition data, including certified limits of components, are used to determine whether a product is “identical or substantially similar” to another product or “differs only in ways that do not significantly increase the risk of unreasonable adverse effects on the environment” (FIFRA sec. 3(c)(7)(A)). In nearly every case,
(2)
(3)
(4)
(ii) Certain information (e.g., color, odor, physical state) is needed for the Agency to respond to emergency requests for identification of unlabeled pesticides involved in accidents or spills. Physicians, hospitals, and poison control centers also request this information to aid in their identification of materials implicated in poisoning episodes.
(iii) Certain physical and chemical data are used directly in the hazard assessment. These include stability, oxidizing and reducing action, flammability, explodability, storage stability, corrosion, and dielectric breakdown voltage. For example, a study of the corrosion characteristics of a pesticide is needed to evaluate effects of the product formulation on its container. If the pesticide is highly corrosive, measures can be taken to ensure that lids, liners, seams or container sides will not be damaged and cause the contents to leak during storage, transport, handling, or use. The storage stability study provides data on change (or lack of change) in product composition over time. If certain ingredients decompose, other new chemicals are formed whose toxicity and other characteristics must be considered.
(iv) Certain data are needed as basic or supportive evidence in initiating or evaluating other studies. For example, the octanol/water partition coefficient is used as one of the criteria to determine whether certain fish and wildlife toxicity or accumulation studies must be conducted. Vapor pressure data are needed, among other things, to determine suitable reentry intervals and other label cautions pertaining to worker protection. Data on viscosity and miscibility provide necessary information to support acceptable labeling for tank mix and spray applications.
The following terms are defined for the purposes of this subpart:
(a)
(b)
(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, and
(2) Does not state that the product may be used to manufacture or formulate other pesticide products.
(c)
(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.
(d)
(e)
(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.
(f)
(g)
(1) Contains any active ingredient derived from a source that is not an EPA-registered product; or
(2) Contains any active ingredient that was produced or acquired in a manner that does not permit its inspection by the Agency under FIFRA sec. 9(a) prior to its use in the process.
(h)
(i)
(j)
(k)
(1) Which contains no inert ingredient, other than one used for purification of the active ingredient; and
(2) Which is produced on a commercial or pilot-plant production scale (whether or not it is ever held for sale).
Information on the composition of the pesticide product must be furnished. The information required by paragraphs (a), (b) and (f) of this section must be provided for each product. In addition, if the product is produced by an integrated system, the information on impurities required by paragraphs (c) and (d) must be provided.
(a)
(1) If the source of any active ingredient in the product is an EPA-registered product:
(i) The chemical and common name (if any) of the active ingredient, as listed on the source product.
(ii) The nominal concentration of the active ingredient in the product, based upon the nominal concentration of active ingredient in the source product.
(iii) Upper and lower certified limits of the active ingredient in the product, in accordance with § 161.175.
(2) If the source of any active ingredient in the product is not an EPA-registered product:
(i) The chemical name according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names.
(ii) The molecular, structural, and empirical formulae, and the molecular weight or weight range.
(iii) The nominal concentration.
(iv) Upper and lower certified limits in accordance with § 161.175.
(v) The purpose of the ingredient in the formulation.
(b)
(1) The chemical name of the ingredient according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names (if known). If the chemical identity or chemical composition of an ingredient is not known to the applicant because it is proprietary or trade secret information, the applicant must ensure that the supplier or producer of the ingredient submits to the Agency (or has on file with the Agency) information on the identity or chemical composition of the ingredient. Generally, it is not required that an applicant know the identity of each ingredient in a mixture that he uses in his product. However, in certain circumstances, the Agency may require that the applicant know the identity of a specific ingredient in such a mixture. If the Agency requires specific knowledge of an ingredient, it will notify the applicant in writing.
(2) The nominal concentration in the product.
(3) Upper and lower certified limits in accordance with § 161.175.
(4) The purpose of the ingredient in the formulation.
(c)
(1) Identification of the ingredient as an impurity.
(2) The chemical name of the impurity.
(3) The nominal concentration of the impurity in the product.
(4) A certified upper limit, in accordance with § 161.175.
(d)
(1) Identification of the ingredient as an impurity.
(2) Chemical name of the impurity.
(3) The nominal concentration of the impurity in the final product.
(e)
(f)
The following information must be submitted on the materials used to produce the product:
(a)
(i) The name of the EPA-registered product.
(ii) The EPA registration number of that product.
(2) For each inert ingredient:
(i) Each brand name, trade name, or other commercial designation of the ingredient.
(ii) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and, if requested by the Agency, chemical and physical properties) of the ingredient, including a copy of technical specifications, data sheets, or other documents describing the ingredient.
(iii) If requested by the Agency, the name and address of the producer of the ingredient or, if that information is not known to the applicant, the name and address of the supplier of the ingredient.
(b)
(2) The following information concerning each active ingredient that is not derived from an EPA-registered product:
(i) The name and address of the producer of the ingredient (if different from the applicant).
(ii) Information on each starting material used to produce the active ingredient, as follows:
(A) Each brand name, trade name, or other commercial designation of the starting material.
(B) The name and address of the person who produces the starting material or, if that information is not known to the applicant, the name and address of each person who supplies the starting material.
(C) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and if requested by the Agency, chemical or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing it.
(3) The information required by paragraph (a)(2) of this section concerning each inert ingredient.
(c)
If the product is produced by an integrated system, the applicant must submit information on the production (reaction) processes used to produce the active ingredients in the product. The applicant must also submit information on the formulation process, in accordance with § 161.165.
(a) Information must be submitted for the current production process for each active ingredient that is not derived from an EPA-registered product. If the production process is not continuous (a single reaction process from starting materials to active ingredient), but is accomplished in stages or by different producers, the information must be provided for each such production process.
(b) The following information must be provided for each process resulting in a separately isolated substance:
(1) the name and address of the producer who uses the process, if not the same as the applicant.
(2) A general characterization of the process (e.g., whether it is a batch or continuous process).
(3) A flow chart of the chemical equations of each intended reaction occurring at each step of the process, the necessary reaction conditions, and the duration of each step and of the entire process.
(4) The identity of the materials used to produce the product, their relative amounts, and the order in which they are added.
(5) A description of the equipment used that may influence the composition of the substance produced.
(6) A description of the conditions (e.g., temperature, pressure, pH, humidity) that are controlled during each step of the process to affect the composition of the substance produced, and the limits that are maintained.
(7) A description of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced).
(8) A description of the procedures used to assure consistent composition of the substance produced, e.g., calibration of equipment, sampling regimens, analytical methods, and other quality control methods.
The applicant must provide information on the formulation process of the product (unless the product consists solely of a technical grade of active ingredient), as required by the following sections:
(a) Section 161.162(b)(2), pertaining to characterization of the process.
(b) Section 161.162(b)(4), pertaining to ingredients used in the process.
(c) Section 161.162(b)(5), pertaining to process equipment.
(d) Section 161.162(b)(6), pertaining to the conditions of the process.
(e) Section 161.162(b)(8), pertaining to quality control measures.
The applicant must provide a discussion of the impurities that may be present in the product, and why they may be present. The discussion should be based on established chemical theory and on what the applicant knows about the starting materials, technical grade of active ingredient, inert ingredients, and production or formulation process. If the applicant has reason to believe that an impurity that EPA would consider toxicologically significant may be present, the discussion must include an expanded discussion of the possible formation of the impurity and the amounts at which it might be present. The impurities which must be discussed are the following, as applicable:
(a)
(2) Each other impurity which the applicant has reason to believe may be present in his product at any time before use at a level equal to or greater than 0.1 percent (1000 ppm) by weight of the technical grade of the active ingredient, based on what he knows about the following:
(i) The composition (or composition range) of each starting material used to produce his product.
(ii) The impurities which he knows are present (or believes are likely to be present) in the starting materials, and the known or presumed level (or range of levels) of those impurities.
(iii) The intended reactions and side reactions which may occur in the production of the product, and the relative amounts of byproduct impurities produced by such reactions.
(iv) The possible degradation of the ingredients in the product after its production but prior to its use.
(v) Post-production reactions between the ingredients in the product.
(vi) The possible migration of components of packaging materials into the pesticide.
(vii) The possible carryover of contaminants from use of production equipment previously used to produce other products or substances.
(viii) The process control, purification and quality control measures used to produce the product.
(b)
(1) The possible carryover of impurities present in any registered product which serves as the source of any of the product's active ingredients. The identity and level of impurities in the registered source need not be discussed or quantified unless known to the formulator.
(2) The possible carryover of impurities present in the inert ingredients in the product.
(3) Possible reactions occurring during the formulation of the product between any of its active ingredients, between the active ingredients and inert ingredients, or between the active ingredients and the production equipment.
(4) Post-production reactions between any of the product's active ingredients and any other component of the product or its packaging.
(5) Possible migration of packaging materials into the product.
(6) Possible contaminants resulting from earlier use of equipment to produce other products.
(c)
(1) From other possible chemical reactions;
(2) Involving other ingredients; or
(3) At additional points in the production or formulation process.
(a) If the product is produced by an integrated system, the applicant must
(b) Based on the preliminary analysis, a statement of the composition of the technical grade of active ingredient must be provided. If the technical grade of active ingredient cannot be isolated, a statement of the composition of the practical equivalent of the technical grade of active ingredient must be submitted.
The applicant must propose certified limits for the ingredients in the product. Certified limits become legally binding limits upon approval of the application. Certified limits will apply to the product from the date of production to date of use, unless the product label bears a statement prohibiting use after a certain date, in which case the certified limits will apply only until that date.
(a)
(1) An upper and lower limit for each active ingredient.
(2) An upper and lower limit for each inert ingredient.
(3) If the product is a technical grade of active ingredient or is produced by an integrated system, an upper limit for each impurity of toxicological significance associated with the active ingredient and found to be present in any sample of the product.
(4) On a case-by-case basis, certified limits for other ingredients or impurities as specified by EPA.
(b)
(2) Table of standard certified limits.
(c)
(2) If certified limits are required for impurities, the applicant must propose a certified limit. The standard certified limits may not be used for such substances.
(3) Certified limits should:
(i) Be based on a consideration of the variability of the concentration of the ingredient in the product when good manufacturing practices and normal quality control procedures are used.
(ii) Allow for all sources of variability likely to be encountered in the production process.
(iii) Take into account the stability of the ingredient in the product and the possible formation of impurities between production and sale of distribution.
(4) The applicant may include an explanation of the basis of his proposed certified limits, including how the certified limits were arrived at (e.g., sample analysis, quantitative estimate based on production process), and its accuracy and precision. This will be particularly useful if the range of the certified limit for an active or inert ingredient is greater than the standard certified limits.
(d)
(1) More precise limits.
(2) More thorough explanation of how the certified limits were determined.
(3) A narrower range between the upper and lower certified limits than that proposed.
(e)
I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the description of the composition of [
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 is determined to be toxicologically significant.
(a)
(a)
(b) [Reserved]
(c)
(2) Information on the chemical identity and composition of the pesticide product, the amounts, frequency and time of pesticide application, and results of test on the amount of residues remaining on or in the treated food or feed, are needed to support a finding as to the magnitude and identity of residues which result in food or animal feed as a consequence of a proposed pesticide usage.
(3) Residue chemistry data are also needed to support the adequacy of one or more methods for the enforcement of the tolerance, and to support practicable methods for removing residues that exceed any proposed tolerance.
(d)
(2)
(3)
(4)
(5)
(6)
(e)
(1)
(2)
(3)
(4)
(5)
(i) To detect, with sensitive assay methods, the capacity of a chemical to alter genetic material in cells.
(ii) To determine the relevance of these mutagenic changes to mammals.
(iii) When mutagenic potential is demonstrated, to incorporate these findings in the assessment of heritable effects, oncogenicity, and possibly, other health effects.
(6)
(f)
(g)
(h)
(2)
(3)
(i)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
1. Identify the Pesticide Use Site Group listed below (e.g., agricultural crops, forests, ornamental plants) that covers the specific use pattern of interest to you.
2. Find your specific use pattern under the appropriate Pesticide Use Site Group.
3. Identify the general use pattern that corresponds to your specific use pattern.
4. Use the general use pattern in determining applicable data requirements on the Data Requirements tables presented in §§ 161.155 through 161.640.
1. Agricultural Crops.
2. Ornamental Plants and Forest Trees.
3. General Soil Treatment and Composting.
4. Processed or Manufactured Products, and food or feed containers or dispensers.
5. Pets and Domestic Animals.
6. Agricultural Premises and Equipment.
7. Household.
8. Wood or Wood Structure Protection Treatments.
9. Aquatic sites.
10. Noncrop, wide area, and general indoor/outdoor treatments.
11. Antifouling treatments.
12. Commercial and Industrial Uses.
13. Domestic and Human Use.
14. Miscellaneous Indoor Uses.
7 U.S.C. 136v, 136w.
(a)
(b)
Terms used in this part have the same meaning as in the Act and part 152 of this chapter. In addition, as used in this subpart, the following terms shall apply:
(1) A pest infestation and its consequences, or
(2) Any condition for which the use of plant regulators, defoliants, or desiccants would be appropriate.
(a)
(1) There is a special local need for the use within the State;
(2) The use is covered by necessary tolerances, exemptions or other clearances under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346
(3) Registration for the same use has not previously been denied, disapproved, suspended or cancelled by the Administrator, or voluntarily cancelled by the registrant subsequent to issuance by the Administrator of a notice of intent to cancel that registration, because of health or environmental concerns about an ingredient contained in the pesticide product, unless such denial, disapproval, suspension or cancellation has been superseded by subsequent action of the Administrator; and
(4) The registration is in accord with the purposes of FIFRA.
(b)
(ii) A State may register any use of a federally registered product for which registration of other uses of the product was denied, disapproved, suspended, or cancelled by the Administrator, provided that the State may register a use not considered by the Administrator in reaching such a determination only after the State consults with appropriate EPA personnel.
(iii) Except as provided in paragraph (a)(3) of this section, a State may register any use of a federally registered product for which registration of some or all uses has been voluntarily cancelled by the registrant, provided that a State may register such a use only after the State has consulted with appropriate EPA personnel.
(iv) A State may not register an amendment to a federally registered manufacturing-use product.
(2)
(A) A product which is identical in composition to a federally registered product, but which has differences in packaging, or in the identity of the formulator.
(B) A product which contains the same active and inert ingredients as a federally registered product, but in different percentages.
(C) Subject to the requirements of paragraph (b)(2)(ii) of this section, a product containing a new combination of active, or active and inert, ingredients.
(ii) A State may register a new product only if each of the active ingredients in the new product is present because of the use of one or more federally registered products and if each of the inert ingredients in the new product is contained in a federally registered product.
(iii) A State may not register a new manufacturing-use product.
(iv) A State may register any use of a new product containing an ingredient described in paragraph (a)(3) of this section, if the new product registration is for a formulation or a use not included in the denial, disapproval, suspension, or cancellation, or if the federally registered use was voluntarily cancelled without a prior notice of intent to cancel by the Administrator. However, a formulation or use of such a new product which was not considered by the Administrator during such proceedings, or which was not the subject of a notice of intent to cancel, may be registered by a State only after the State consults with appropriate EPA personnel regarding the registration application.
(c)
(2) A State may require, as a condition of distribution or use of a pesticide product within the State, that the pesticide product be registered under State law as well as under FIFRA. Neither FIFRA sec. 24(c) nor §§ 162.150-162.156 affects a State's right under its own law to revoke, suspend, cancel, or otherwise affect such a registration issued under State law. However, the federal registration, whether issued under FIFRA sec. 3 or 24(c), is not affected by such a State action.
(a)
(1) Name and address of the applicant and any other person whose name will appear on the labeling or in the directions for use.
(2) The name of the pesticide product, and, if the application is for an amendment to a federally registered product, the EPA registration number of that product.
(3) A copy of proposed labeling, including all claims made for the product as well as directions for its use to meet the special local need, consisting of:
(i) For a new product, a copy of the complete proposed labeling; or,
(ii) For an additional use of a federally registered product, a copy of proposed supplemental labeling and a copy of the labeling for the federally registered product.
(4) The complete formula of the product, if the application is for a new product registration.
(5) Any other information which is required to be reviewed prior to registration under this section.
(b)
(c)
(i) For use of a product which has a composition not similar to any federally registered product.
(ii) For use of a project involving a use pattern not similar to any federally registered use of the same product or of a product with a similar composition.
(iii) For use of a product for which other uses of the same product, or of a product with a similar composition, have had registration denied, disapproved, suspended, or cancelled by the Administrator.
(2) Determinations required by paragraph (c)(1) of this section shall be based on data and criteria consistent with those sections of part 152 of this chapter, applicable to the type of product or use under consideration. Such determinations may also involve consideration of the effect of the anticipated classification of the product or use under paragraph (g) of this section.
(d)
(e)
(2) For a new product, the State must, as a condition of the registration, require that the product be accompanied from the time it enters the stream of commerce by labeling meeting all applicable criteria of § 156.10 of this chapter. New product labeling must all contain:
(i) A statement identifying the State where registration is to be valid.
(ii) The special local need registration number assigned by the State.
(3) Except as provided in paragraph (e)(4) of this section, as a condition for a registration of an additional use of a federally registered product, the State must require that at the time of sale to users, labeling from the federally registered product be accompanied by supplemental labeling which contains:
(i) A statement identifying the State where registration is valid.
(ii) Directions for use to meet the special local need which satisfy the criteria of § 156.10(i) of this chapter.
(iii) The trade name of the product.
(iv) The name and address of the section 24(c) registrant.
(v) The EPA registration number of the federally registered product.
(vi) The special local need registration number assigned by the State.
(vii) A statement prohibiting use of the product in a manner inconsistent with all applicable directions, restrictions, and precautions found in the labeling of the federally registered product and accompanying supplemental labeling.
(4) When a federally registered product is already in the stream of commerce at the time the State issues a registration for an additional use of that product, the State must ensure that supplemental labeling for the additional use, meeting the criteria of paragraph (e)(3) of this section, is made available to purchasers and users of the product within 45 days of the date on which the State approves the final printed supplemental labeling.
(5) If a State classifies for restricted use a product or use registered by the State, which is not required to be so classified by paragraph (g) of this section, then the State may require supplemental labeling for the product or use containing additional appropriate precautions, and a statement that the product or use is for restricted use within that State.
(f)
(g)
(i) The product is identical or similar in composition to a federally registered product:
(A) For which all federally registered uses have been classified as restricted by the Administrator; or
(B) For which a use similar to the State registered use has been classified as restricted by the Administrator; or
(ii) The State registered product or use meets the criteria for classification as a restricted use pesticide under the applicable provisions of § 152.170 of this chapter.
(2) [Reserved]
(h)
(2) Notification of State registrations or amendments shall be supplemented by the State sending to EPA a copy of the final printed labeling approved by the State within 60 days after the effective date of the registration or amendment.
(3) Notification of revocation of a registration by a State shall indicate the effective date of revocation, and shall state the reasons for revocation.
(4) The Administrator or his designee may request, when appropriate, that a State submit to EPA any data used by the State to determine that unreasonable adverse effects will not be caused when the State registers any use described in paragraph (c)(1) of this section. Within 15 working days of receipt of such a request from EPA, the State shall submit two copies of the requested data.
(i)
(1) The name of the product.
(2) The name of the registrant.
(3) The registered use(s) of the product.
(4) The effective date of the State registration.
(5) If the registration is for an additional use of a federally registered product, whether the State registration involves a changed use pattern.
(j)
(a)
(i) Probable creation of unreasonable adverse effects on man or the environment by the registered use.
(ii) Refusal of the registering State to submit information supporting the registration as required by § 162.153(h).
(iii) Failure of information submitted by the State to support the State's decision to issue the registration under standards established by § 162.153.
(2) Prior to disapproval of any State registration under this paragraph, the Administrator shall notify the registering State, in writing, of the Administrator's intent to disapprove, and of the reasons for disapproval. The notice of intent will provide a reasonable time, not less than ten days from the date the notice is received by the State, for the State to respond, and will invite the State to consult with the Administrator or his designee. If the grounds for disapproval are based on actions or omissions by the State, the notice will, if possible, also provide the State with a reasonable amount of time in which to take corrective action, not to exceed the time allowed for disapproval under paragraph (c) of this section.
(3) The registering State may, within ten days of receipt of a notice of intent to disapprove, request that the Administrator, or his designee, consult with appropriate State officials prior to the Administrator's final decision on disapproval. The Administrator will consider any relevant information presented at such a consultation, or in any other timely and appropriate fashion, in deciding whether to withdraw the notice of intent to disapprove.
(b)
(i) Would constitute an imminent hazard.
(ii) May result in a residue on food or feed exceeding, or not covered by, a tolerance, exemption, or other clearance under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346a
(2) If the Administrator disapproves a registration under this paragraph, the Administrator shall provide the registering State with written notification of disapproval, in accordance with paragraph (c) of this section, as soon thereafter as practicable. Such notification will specify the grounds for disapproval and invite the State to comment on the decision.
(3) If requested by the State within ten days of its receipt of a notice of disapproval, the Administrator, or his designee, will consult with appropriate State officials. The Administrator may consider any information presented at such a consultation, or in any other appropriate fashion, in determining whether the disapproval should be rescinded.
(c)
(d)
(e)
(f)
(a)
(2) The Administrator may suspend all or any part of a State's registration authority, as appropriate.
(b)
(i) Access to appropriate scientific and technical personnel to review data and make determinations as required by § 162.153.
(ii) Registration procedures satisfying § 162.153.
(iii) Complete and accurate records of State registrations.
(iv) Adequate legal authority. (A) To deny, suspend, revoke, or amend a State registration when the registration is not in compliance with FIFRA, this subpart, or State law, or when necessary to prevent unreasonable adverse effects on the environment.
(B) To enter, at reasonable times, by consent, warrant, or other legal means, any establishment where pesticides are produced or held for distribution or sale, to inspect, sample, and observe whether pesticides are being produced or distributed in compliance with FIFRA, this subpart, State law, and the terms of any State registration.
(2) The Administrator may suspend a State's registration authority if the State fails to exercise the controls specified in paragraph (b)(1) of this section, or if the State refuses to correct within a reasonable time any other significant deficiencies in its regulatory program, as specified by the Administrator in a notice of intent to suspend.
(c)
(2) If requested by the affected State lead agency within 30 days of receipt of the notice of intent to suspend, an informal consultation between appropriate State and EPA officials will be held to discuss the proposed suspension. In such a case, the Administrator shall not make a final decision on the proposed suspension until after the consultation. The Administrator shall consider all relevant information presented at the consultation, or in any other appropriate manner, in determining whether to suspend the State's authority. If the Administrator determines, on the basis of such information, that the deficiencies listed in the notice of intent no longer exist, or will
(3) Within ten days of the date a notice of intent to suspend is published in the
(i) Schedule a public hearing to be held in that State.
(ii) Publish in the
(iii) Appoint a presiding officer who shall preside over the hearing.
(iv) Prescribe additional, appropriate procedures for the conduct of the hearing, including procedures for the presentation of relevant material evidence from the State, EPA, or members of the public who would be affected by the outcome of the hearing. Evidence may be presented in either oral or written form, at the discretion of the Administrator.
(4) Following the close of any hearing held under paragraph (c)(3) of this section, the presiding officer shall make a recommended decision that the State's authority to register pesticides under sec. 24(c) of FIFRA be suspended, in whole or in part, or that the State's authority not be suspended and that the notice of intent to suspend be withdrawn.
(5) Any recommended decision made by a presiding officer under paragraph (c)(4) of this section may be appealed to the Administrator within 30 days after its issuance by the State or by EPA. Any recommended decision which is not appealed, or which the Administrator does not review on his own initiative, will become a final Agency action 30 days after its issuance.
(6) If no hearing is requested under paragraph (c)(3) of this section, or if a recommended decision is appealed to the Administrator under paragraph (c)(5) of this section, the Administrator shall issue a final order either suspending the State's authority to register pesticides under section 24(c) of FIFRA, in whole or in part, or withdrawing the notice of intent to suspend.
(7) Any final order suspending State registration authority, issued under paragraph (c) (5) or (6) of this section, will specify the grounds therefor and an effective date for the suspension. If the suspension is merely partial, the notice of suspension will specify the types of registrations which will not be recognized as valid under sec. 24(c). All final orders issued under paragraph (c) (5) or (6) will be published in the
(d)
(e)
(a)
(i) Sec. 12(a)(1) (A) through (E), in accordance with:
(A) Sec. 2(q)(1) (A) through (G).
(B) Sec. 2(q)(2) (A) through (D).
(ii) Sec. 12(a)(2) (A) through (G) and (I) through (P).
(2) A product or use classified by a State for restricted use under § 162.153(g) may be used only by, or
(3) State registrations which are not issued in accordance with § 162.152 (a) and (b)(2) (i), (ii) and (iii) are not authorized by section 24(c) and are not considered valid for any purposes under FIFRA. When the Administrator determines that a registration is invalid, the Administrator shall notify the registering State that the registration is invalid, and may specify the reason for the invalidity.
(b)
(c)
7 U.S.C. 136d.
As used in this part, a word in the singular form shall be deemed to import the plural, and vice versa, as the case may require.
For the purposes of this part, the following terms shall be defined, as listed below:
(a) The term
(b) The term
(c) The term
(d) The term
(e) The term
(f) The term
(g)
(h) The term
(i) The term
(j) The term
(k) The term
(l) The term
(1)
(2)
(3)
(m) The term
(n) The term
(o) The term
(p) The term
(q) The term
(r) The term
(s) The term
The provisions of subpart B of this part shall govern proceedings, conducted pursuant to the provisions of the Act, concerning refusals to register, cancellations of registration, changes of classifications or hearings called by the Administrator; the provisions of subpart C of this part shall govern suspension proceedings conducted pursuant to the provisions of the Act.
(a)
(b)
(c) Whenever any information or data is required to be produced or examined and any party to the proceeding claims that such information is a trade secret or commercial or financial information, other than information relating to the formulas of a pesticide, the Administrative Law Judge, the Presiding Officer, or the Environmental Appeals Board may require production or testimony
(d) All orders, decisions, or other documents made or signed by the Administrative Law Judge, the Presiding Officer, or the Environmental Appeals Board shall be filed with the hearing clerk. The hearing clerk shall immediately serve all parties with a copy of such order, decision, or other document.
(a) All documents or papers required or authorized to be filed, shall be filed with the hearing clerk, except as provided otherwise in this part. At the same time that a party files documents or papers with the clerk, it shall serve upon all other parties copies thereof, with a certificate of service on each document or paper, including those filed with the hearing clerk. If filing is accomplished by mail addressed to the clerk, filing shall be deemed timely if the papers are postmarked on the due date except as to initial filings requesting a public hearing or responding to a notice of intent to hold a hearing, in which case such filings must be received by the hearing clerk either within the time required by statute or by the notice of intent to hold a hearing.
(b) Each document filed, other than papers commencing a proceeding, shall contain the FIFRA docket number and, if the document affects less than all of the registrations included under that docket number, the registration number or file symbol of each product which is the subject of the document.
(c) In addition to copies served on all other parties, each party shall file an original and two copies of all papers with the hearing clerk.
(a)
(b)
(c)
At no stage of a proceeding shall the Administrator, the members of the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge discuss
All notices of intention to cancel a registration, all notices of intention to change a classification, and all denials of registrations, all together with the reasons (including the factual basis therefor), and all notices of intention by the Administrator to hold a hearing, together with the statement of issues as provided by § 164.20(b) shall be sent to the registrant or applicant by registered or certified mail (return receipt requested), and published by appropriate announcement in the
(a) A proceeding shall be commenced whenever a hearing is requested by any person adversely affected by a notice of the Administrator of his refusal to register or of his intent to cancel the registration or to change the classification of a pesticide. A proceeding shall likewise be commenced whenever the Administrator decides to call a hearing to determine whether or not the registration of a pesticide should be canceled or its classification changed. Such request or notice of intent to hold a hearing shall be timely filed with the hearing clerk, and the matter shall be docketed and assigned a FIFRA docket number.
(b) If a request for a hearing is filed, the person filing the request shall, at the same time, file a document stating his objections to the Administrator's refusal to register or his intent to cancel the registration or to change the classification of a pesticide. If a notice of intent to hold a hearing is filed by
(c) Upon the filing of any objections or notice of intent to hold a hearing, the proceeding shall be referred to the Chief Administrative Law Judge by the hearing clerk. The Chief Administrative Law Judge shall refer the proceeding to himself or another Administrative Law Judge who shall thereafter be in charge of all further matters concerning the proceedings, except as otherwise provided for by order of the Chief Administrative Law Judge, the Administrator, or the Environmental Appeals Board.
(a)
(b)
(a)
(b)
(c)
(a)
(b)
Any person wishing to participate in any proceeding commenced pursuant to any notice by the Administrator of intention to hold a hearing, shall file with the hearing clerk, within the time set by the Administrator in the notice (in no case less than 30 days from the date of the notice), a written response to the statement of issues which shall include the position and interest of such person with respect thereto. If any such person is a registrant or an applicant for registration, he shall also file the registration number of the pesticide, if applicable, a copy of the currently accepted and/or proposed labeling and a list of the currently registered or proposed uses of said pesticide.
After a copy of the document setting forth the objections and requesting a public hearing is filed with the hearing clerk or a response to the statement of issues is filed, the hearing clerk shall serve a copy of the document upon Respondent and the Office of the General Counsel of the Agency, Respondent shall, by counsel, thereupon file with the hearing clerk a copy of the appropriate notice of intention to cancel, the notice of intention to change the classification or the registration refusal order.
(a)
(b)
(c)
(d)
The Chief Administrative Law Judge, by motion or sua sponte, may consolidate two or more proceedings whenever it appears that this will expedite or simplify consideration of the issues. Consolidation shall not affect the right of any party to raise issues that could have been raised if consolidation had not occurred. At the conclusion of proceedings consolidated under this section, the Administrative Law Judge shall issue one decision under § 164.90 unless one or more of the consolidated proceedings have been dismissed pursuant to § 164.91.
(a)
(b)
(2) Withdrawal sua sponte. The Administrative Law Judge may at any time withdraw from any proceedings in which he deems himself disqualified for any reason.
(c)
(d)
(e)
(a)
(1) The simplification of issues including listing of specific uses to be contested;
(2) The necessity or desirability of amendments to the objections or statement of issues, or any document filed in response thereto;
(3) The possibility of obtaining stipulations of fact and documents which will avoid unnecessary delay;
(4) Matters of which official notice may be taken;
(5) The limitation of the number of expert and other witnesses;
(6) Procedure at the hearing except as so provided in § 164.80(a);
(7) The use of verified written statements in lieu of oral direct testimony;
(8) The intent of any party to request a scientific advisory committee as defined in § 164.2(f);
(9) The issuance of subpoenas and subpoenas duces tecum for discovery and hearing purposes;
(10) A setting of a time and place for the public hearing, after giving careful consideration to the convenience of all the parties, the witnesses, the public interest and the necessity for notice in the
(11) Any other matter that may expedite the hearing or aid in the disposition of the proceeding.
(b)
(c)
(d)
(e)
(2)
(3)
(4)
(a)
(b)
(c)
(2) If the Administrative Law Judge determines the motion should be granted, he shall issue an order and appropriate subpoenas, if necessary, for the taking of such discovery together with the conditions and terms thereof.
(a)
(b)
(c)
(a) The attendance of witnesses or the production of documentary evidence may, by subpoena, be required at any designated place of hearing or place of discovery. Subpoenas may be issued by the Administrative Law Judge sua sponte or upon a showing by an applicant that evidence sought for hearing is relevant and material to the issues involved in the hearing or that the sought discovery pursuant to § 164.51 meets the standards set forth therein. The Administrative Law Judge shall be guided by the principles of the Federal Rules of Civil Procedure in making any order for the protection of a witness or the content of the documents produced.
(b)
(c)
Witnesses summoned before the Administrative Law Judge shall be paid the same fees and mileage that are paid witnesses in the courts of the United States, and persons whose depositions are taken, and the persons taking the same, shall be entitled to the same fees as are paid for like services in the courts of the United States. Fees shall be paid by the party at whose instance the witness appears or the deposition is taken.
(a) At the hearing, the proponent of cancellation or change in classification has the burden of going forward to present an affirmative case for the cancellation or change in classification of the registration. In the case of the denial of an application for registration, the applicant shall have the burden of going forward. In the case of a hearing called by the Administrator, the Respondent has the burden of going forward to present an affirmative case as to the statement of issues. The party having the burden of going forward shall have the opportunity to submit evidence on rebuttal.
(b) On all issues arising in connection with the hearing, the ultimate burden of persuasion shall rest with the proponent of the registration.
(c) If any party, other than Respondent, after being duly notified, fails to appear at the hearing, he shall be deemed to have authorized the Administrative Law Judge to dismiss the proceeding with or without prejudice, as the Administrative Law Judge may determine, unless a motion excusing the failure to appear has been made and granted. In the event that a party appears at the hearing and no representative of the Agency appears, the Administrative Law Judge shall proceed
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a)
(b) [Reserved]
(a)
(b)
(a)
(1) Untimely or insufficient objections filed pursuant to § 164.20;
(2) Failure to comply with discovery orders;
(3) Failure to comply with prehearing orders;
(4) Failure to appear or to proceed at prehearing conferences;
(5) Failure to appear at the hearing;
(6) Failure to state a claim upon which relief can be granted, or direct or collateral estoppel.
(7) Theat there is no genuine issue of any material fact and that the respondent is entitled to judgment as a matter of law; or
(8) Such other and further reasons as are just.
(b)
Except as provided herein, appeals as a matter of right shall lie to the Environmental Appeals Board only from an initial or accelerated decision of the Administrative Law Judge. Appeals from other orders or rulings shall, except as provided in this section, lie only if the Administrative Law Judge certifies such orders or rulings for appeal, or otherwise as provided. The Administrative Law Judge may certify an order or ruling for appeal to the Environmental Appeals Board when: (a) The order or ruling involves an important question of law or policy about which there is substantial ground for difference of opinion; and (b) either (1) an immediate appeal from the order and ruling will materially advance the ultimate termination of the proceeding or (2) review after the final judgment is issued will be inadequate or ineffective. The Administrative Law Judge shall certify orders or rulings for appeal only upon the request of a party. If the Environmental Appeals Board determines that certification was improvidently granted, or takes no action within thirty (30) days of the certification, the appeal shall be deemed dismissed. When an order or ruling is not certified by the Administrative Law Judge, it shall be reviewed by the Environmental Appeals Board only upon appeal from the initial or accelerated decision except when the Environmental Appeals
(a)
(2) Within 7 days of the service of exceptions, and of a brief under paragraph (a)(1) of this section, any other party or amicus curiae may file and serve a brief responding to exceptions or arguments raised by any other party. Such brief shall include references to the relevant portions of the record. Such brief shall not, however, raise additional exceptions.
(3) Five copies of all material filed under this section shall be filed with the hearing clerk.
(b)
(c)
(2) If the Environmental Appeals Board determines that additional exceptions should be argued, counsel for the parties shall be given reasonable written notice of such determination so as to permit preparation of adequate argument on all of the exceptions to be argued.
(a) Within 20 days after filing of an accelerated decision by the Administrative Law Judge, any party may file exceptions and a supporting brief with the hearing clerk, stating with particularity the grounds upon which he asserts that the decision is incorrect. The party shall include in its brief page references to the relevant portions of the record, if applicable.
(b) Within 7 days of the service of exceptions and brief under paragraph (a) of this section, any other party or amicus curiae may file and serve a brief responding thereto, with appropriate page references to the relevant portions of the record, if applicable.
(c) Ordinarily, the appeal from an accelerated decision will be decided on the basis of the submission of briefs, but the Environmental Appeals Board
Within 90 days after the close of the hearing or within 90 days from the filing of an accelerated decision, unless otherwise stipulated by the parties, the Environmental Appeals Board shall, on appeal or review from an initial or accelerated order of the Administrative Law Judge, issue its final decision and order, including its rulings on any exceptions filed by the parties; such final order may accept or reject all or part of the initial or accelerated decision of the Administrative Law Judge even if acceptable to the parties.
(a)
(b)
(c)
Within 7 days following the service of any motion provided for in § 164.110, any other party to the proceeding may file with the hearing clerk an answer thereto. As soon as practicable thereafter, the Environmental Appeals Board shall announce its decision whether to grant or to deny the motion. Unless the Environmental Appeals Board shall determine otherwise, operation of the order shall not be stayed pending the decision to grant or to deny the motion. In the event that any such motion is granted by the Environmental Appeals Board, the applicable rules of practice, as set out elsewhere herein, shall be followed.
(a) Whenever the Administrator determines that action is necessary to prevent an imminent hazard during the time required for cancellation or change in classification proceedings, but that the hazard does not constitute an emergency, he shall notify the registrant of his intention to suspend registration of the pesticide at issue.
(b) Such notice shall include findings pertaining to the question of imminent hazard and shall either be personally served on the registrant or be sent to the registrant by registered or certified mail, return receipt requested, and filed with the hearing clerk.
(a)
(2) A request for an expedited hearing is timely if made in writing or by telegram and filed with the office of the hearing clerk within 5 days of the registrant's receipt of the notice of intention to suspend.
(3) At the time of filing a request for an expedited hearing, the registrant shall also file a document setting forth objections to the Administrator's notice of intention to suspend and its findings pertaining to the question of imminent hazard. Such objections shall conform to the requirements of § 164.21.
(b)
(2) The presiding officer shall not have the authority to make an initial decision on the merits but shall make a recommended decision only.
(c)
(d)
(e)
(1) Leave to intervene will be granted only if the motion to intervene meets the standards of § 164.31 and, in addition, indicates that the movant would raise matters or introduce evidence pertinent to the issue of imminent hazard which would substantially assist in its resolution.
(2) A movant denied permission to intervene under this section but who otherwise meets the standards of § 164.31 and who is adversely affected may file proposed findings and conclusions and briefs in support thereof pursuant to paragraph (j) of this section. Any person filing under this subsection shall be deemed to have been a party to the proceeding, for all purposes of its further review.
(3) When an “emergency order” is issued pursuant to § 164.123, no person other than the respondent and the registrant shall participate in the hearing except that any person adversely affected may file proposed findings and conclusions and briefs in support thereof pursuant to paragraph (j) of this section. Any person filing under this subsection shall be deemed to have been a party to the proceeding for all purposes of its further review.
(f)
(g)
(h)
(i)
(j)
(2) Within 8 days of the conclusion of the presentation of evidence, the Presiding Officer shall submit to the parties his proposed recommended findings and conclusions and a statement of the reasons on which they are based.
(3) Within 10 days of the conclusion of the presentation of evidence the Presiding Officer shall submit to the Environmental Appeals Board his recommended findings and conclusions, together with the record.
(4) Within 12 days of the conclusion of the presentation of evidence the parties shall submit to the Environmental Appeals Board their objections to the Presiding Officer's recommended findings and conclusions and written briefs in support thereof.
(a)
(b)
(a) Whenever the Environmental Appeals Board determines that an emergency exists that does not permit him to hold a hearing before suspension, the Environmental Appeals Board may issue a suspension order in advance of notification to the registrant.
(b) The Environmental Appeals Board shall immediately notify the registrant of the suspension order. The registrant may then request a hearing in accordance with §§ 164.121 and 164.122, but the suspension order shall remain in effect during the hearing pending the issuance of a final order on suspension.
Sec. 25(a) and 6 of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended by the Federal Environmental Pesticide Control Act of 1972 (86 Stat. 997).
EPA has determined that any application under section 3 or section 18 of the Act to allow use of a pesticide at a site and on a pest for which registration has been finally cancelled or suspended by the Administrator constitutes a petition for reconsideration of such order. Because of the extensive notice and hearing opportunities mandated by FIFRA and the Administrative Procedures Act before a final cancellation or suspension order may be issued, EPA has determined that such orders may not be reversed or modified without affording interested parties—who may in fact have participated in lengthy cancellation proceedings—similar notice and hearing opportunities. The procedures set forth in this subpart D shall govern all such applications.
(a) The Administrator will review applications subject to this subpart D and supporting data submitted by the applicant to determine whether reconsideration of the Administrator's prior cancellation or suspension order is warranted. The Administrator shall determine that such reconsideration is warranted when he finds that: (1) The applicant has presented substantial new evidence which may materially affect the prior cancellation or suspension order and which was not available to the Administrator at the time he made his final cancellation or suspension determination and (2) such evidence could not, through the exercise of due diligence, have been discovered by the parties to the cancellation or suspension proceeding prior to the issuance of the final order.
(b) If after review of the application and other supporting data submitted by the applicant, the Administrator determines, in accordance with paragraph (a) of this section, that reconsideration of his prior order is not warranted, then the application will be denied without requirement for an administrative hearing. The Administrator shall publish notice in the
(c) If after review of the application and other supporting data submitted by the applicant, the Administrator determines, in accordance with paragraph (a) of this section, that reconsideration of his prior order is warranted, he will then publish notice in the
(a) The burden of proof in the hearing convened pursuant to § 164.131 shall be on the applicant and he shall proceed first. The issues in the hearing shall be whether: (1) Substantial new evidence exists and (2) such substantial new evidence requires reversal or modification of the existing cancellation or suspension order. The determination of these issues shall be made taking into account the human and environmental risks found by the Administrator in his cancellation or suspension determination and the cumulative effect of all past and present uses, including the requested use, and uses which may reasonably be anticipated to occur in the future as a result of granting the requested reversal or modification. The granting of a particular petition for use may not in itself pose a significant risk to man or the environment, but the cumulative impact of each additional use of the cancelled or suspended pesticide may re-establish, or serve to maintain, the significant risks previously found by the Administrator.
(b) The presiding officer shall make recommendations, including findings of fact and conclusions and to the extent feasible, as determined by the presiding officer, the procedures at the hearing shall follow the Rules of Practice, set forth in subparts A and B of this part 164.
(a) In the case of an application subject to this subpart D which is filed under section 18 of FIFRA, and regulations thereunder, and for which a hearing is required pursuant to § 164.131, the Administrator may dispense with the requirement of convening such a hearing in any case in which he determines:
(1) That the application presents a situation involving need to use the pesticide to prevent an unacceptable risk: (i) To human health, or (ii) to fish or wildlife populations when such use would not pose a human health hazard; and
(2) That there is no other feasible solution to such risk; and
(3) That the time available to avert the risk to human health or fish and wildlife is insufficient to permit convening a hearing as required by § 164.131; and
(4) That the public interest requires the granting of the requested use as soon as possible.
(b) Notice of any determination made by the Administrator pursuant to paragraph (a) of this section shall be published in the
7 U.S.C. 136 through 136y.
The part 165 regulations establish standards and requirements for pesticide containers, repackaging pesticides, and pesticide containment structures.
Terms used in this part have the same meaning as in the Act and part 152 of this chapter. In addition, as used in this part, the following terms shall have the meanings set forth below.
(1) The blend is prepared to the order of the customer and is not held in inventory by the blender;
(2) The blend is to be used on the customer's property (including leased or rented property);
(3) The pesticide(s) used in the blend bears end-use labeling directions which do not prohibit use of the product in such a blend;
(4) The blend is prepared from registered pesticides; and
(5) The blend is delivered to the end-user along with a copy of the end-use labeling of each pesticide used in the blend and a statement specifying the composition of the mixture.
(1) Is corrosive to the container;
(2) Causes softening, premature aging, or embrittlement of the container;
(3) Otherwise causes the container to weaken or to create the risk of discharge;
(4) Reacts in a significant chemical, electrolytic, or galvanic manner with the container, or
(5) Interacts in a way, such as the active ingredient permeating the container wall, that would cause the formulation to differ from its composition as described in the statement required in connection with its registration under FIFRA section 3.
(a)
(b)
(c)
(a)
(b)
(c)
(1) The pesticide product meets one of the following two criteria:
(i) The pesticide product is an antimicrobial pesticide as defined in FIFRA section 2(mm); or
(ii) The pesticide product: (A) Is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
(B) In the intended use is subject to a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act or a food additive regulation under section 409 of such Act.
(2) The labeling of the pesticide product includes directions for use on a site in at least one of the following antimicrobial product use categories: food handling/storage establishments premises and equipment; commercial, institutional, and industrial premises and equipment; residential and public access premises; medical premises and equipment; human drinking water systems; materials preservatives; industrial processes and water systems; antifouling coatings; wood preservatives; or swimming pools.
(3) The pesticide product is not a hazardous waste as set out in part 261 of this chapter when the pesticide product is intended to be disposed.
(4) EPA has not specifically determined that the pesticide product must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment according to the provisions of paragraph (d) of this section.
(d)
(i) EPA obtains information, data or other evidence of a problem with the containers of a certain pesticide product or related group of products.
(ii) The information, data or other evidence is reliable and factual.
(iii) The problem causes or could reasonably be expected to cause an unreasonable adverse effect on the environment.
(iv) Complying with the container regulations could reasonably be expected to eliminate the problem.
(2) If EPA determines that an antimicrobial pesticide product otherwise exempted by paragraph (c) of this section must be subject to the nonrefillable container regulations in this subpart to prevent an unreasonable adverse effect on the environment, EPA may require, by rule, that the product be distributed or sold in nonrefillable containers that comply with all or some of the requirements in this subpart. Alternatively, EPA may notify the applicant or registrant of its intent to make such a determination. After allowing the applicant or registrant a reasonable amount of time to reply, EPA may require, by notification and as a condition of registration, that the product be distributed or sold in nonrefillable containers that comply with all or some of the requirements in this subpart. For the purpose of the previous sentence, 60 days would be a reasonable amount of time to reply, although EPA may, in its discretion, provide more time. EPA may deny registration or initiate cancellation proceedings if the registrant fails to comply with the nonrefillable container regulations within the time frames established by EPA in the rule or in its notification.
(e)
(i) The pesticide product meets the criteria of Toxicity Category I as set out in § 156.62 of this chapter.
(ii) The pesticide product meets the criteria of Toxicity Category II as set out in § 156.62 of this chapter.
(iii) The pesticide product is classified for restricted use as set out in §§ 152.160 - 152.175 of this chapter.
(2) Except for manufacturing use products, plant-incorporated protectants, antimicrobial products that are exempt under (c) of this section, and other pesticide products that are regulated under paragraph (e)(1) of this section, a pesticide product must be packaged in compliance with 49 CFR 173.24. If the pesticide product meets the definition of a hazardous material in 49 CFR 171.8, the Department of Transportation requires it to be packaged according to 49 CFR parts 171-180.
(f)
(a)
(b)
(2) For the purposes of these regulations, a pesticide product that meets the definition of a hazardous material in 49 CFR 171.8 must be packaged in a nonrefillable container that, if portable, is designed, constructed, and marked to comply with the requirements of 49 CFR parts 171-180 or, if subject to a special permit, according to the applicable requirements of 49 CFR part 107 subpart B. The requirements in this paragraph apply to the pesticide product as it is packaged for transportation in commerce.
(c)
(d)
(1) Bung, 2 inch pipe size (2.375 inches in diameter), external threading, 11.5
(2) Bung, 2 inch pipe size (2.375 inches in diameter), external threading, 5 threads per inch, buttress threads.
(3) Screw cap, 63 millimeters, at least one thread revolution at 6 threads per inch.
(4) Screw cap, 38 millimeters, at least one thread revolution at 6 threads per inch. The cap may fit on a separate rigid spout or on a flexible pull-out plastic spout.
(e)
(1) Allow the contents of the nonrefillable container to pour in a continuous, coherent stream.
(2) Allow the contents of the nonrefillable container to be poured with a minimum amount of dripping down the outside of the container.
(f)
(1) If the nonrefillable container is rigid and has a capacity less than or equal to 5 gallons (18.9 liters) for liquid formulations or 50 pounds (22.7 kilograms) for solid formulations and if the pesticide product's labeling allows or requires the pesticide product to be mixed with a liquid diluent prior to application (that is, if the pesticide is dilutable), each container/formulation combination must be capable of attaining at least 99.99 percent removal of each active ingredient when tested using the EPA test procedure “Rinsing Procedures for Dilutable Pesticide Products in Rigid Containers.”
(2) The test must be conducted only if the pesticide product is a suspension concentrate or if EPA specifically requests the records on a case by case basis.
(3) For the rigid container/dilutable product standard in paragraph (f)(1) of this section, percent removal represents the percent of the original concentration of the active ingredient in the pesticide product when compared to the concentration of that active ingredient in the fourth rinse. Percent removal is calculated by the formula:
RR = rinsate ratio = Active ingredient concentration in fourth rinsate/Original concentration of active ingredient in the product
(g)
(1) EPA may waive or modify the requirements of paragraph (a) of this section regarding the DOT standards for pesticide products that are not DOT hazardous materials if EPA determines that an alternative (partial or modified) set of standards or pre-existing requirements achieves a level of safety that is at least equal to that specified in the requirements of paragraph (a) of this section.
(2) EPA may waive or modify the requirements of paragraph (b) of this section regarding the DOT standards for pesticide products that are DOT hazardous materials if EPA determines that an alternative (partial or modified) set of standards or pre-existing requirements achieves a level of safety that is at least equal to that specified in the requirements of paragraph (b) of this section. EPA will modify or waive the requirements of paragraph (b) of this section only after consulting with DOT to ensure consistency with DOT regulations and exemptions.
(3) EPA may approve a non-standard closure (that is, a closure not listed in paragraph (d) of this section) if EPA determines that both of the following conditions are satisfied:
(i) The non-standard closure is necessary for the proper mixing, loading, or application of the pesticide product.
(ii) The non-standard closure offers exposure protection to handlers during mixing and loading that is the same or greater than that provided by the standard closures.
(4) EPA may waive or modify the container dispensing capability standards in paragraph (e) of this section if EPA determines that at least one of the following conditions is satisfied:
(i) The product is typically removed from the container by a method other than pouring.
(ii) Compliance with the container dispensing capability standards would increase exposure to the pesticide container handler.
(5) EPA may waive or modify the requirements of paragraph (f) of this section regarding the residue removal standard if EPA determines that both of the following conditions are satisfied:
(i) The residue remaining in the container would not cause an unreasonable adverse effect on the environment; and
(ii) The product offers significant benefits and cannot be economically reformulated or repackaged.
(h)
(1) The name and address of the registrant; the date; and the name, title, signature, and phone number of the company official making the request.
(2) The name and EPA registration number of the pesticide product for which the waiver or modification is requested.
(3) A statement specifying the requirement or requirements from which you are requesting a waiver or a modification.
(4) A description of the nonrefillable container or containers for which the waiver or modification is requested.
(5) Documentation or justification to demonstrate that the applicable waiver or modification criteria in paragraph (g) of this section are satisfied.
(a)
(b)
(1) The name and EPA registration number of the pesticide product.
(2) A description of the nonrefillable container(s) in which the pesticide product is distributed or sold.
(3) At least one of the following records to document compliance with the requirement for closures in § 165.25(d) for each nonrefillable container used to distribute or sell the pesticide product that must comply with § 165.25(d):
(i) A letter or document from the container supplier that describes the closure.
(ii) A specification about the closure in the contract between the registrant or applicant and the container supplier.
(iii) A copy of EPA's approval of any non-standard closure.
(4) At least one of the following records pertaining to the container dispensing capability requirements in § 165.25(e) for each nonrefillable container used to distribute or sell the pesticide product that must comply with § 165.25(e):
(i) Test data or documentation demonstrating that the nonrefillable container meets the standards in § 165.25(e) when it contains the pesticide product.
(ii) Test data or documentation demonstrating that a different nonrefillable container meets the standards in § 165.25(e) when it contains the pesticide product or even a different pesticide product and a written explanation of why such data or documentation demonstrates that the container meets the standards in § 165.25(e) for the pesticide product.
(iii) A copy of EPA's approval of a request for a waiver from the container dispensing requirement.
(5) At least one of the following records pertaining to the nonrefillable container residue removal requirement in § 165.25(f) if the pesticide product is a suspension concentrate or if EPA specifically requests the records on a case-by-case basis:
(i) Test data showing that the nonrefillable container and pesticide formulation meet the standard in § 165.25(f) .
(ii) Test data showing that a different nonrefillable container with the same or a different pesticide formulation meets the standard in § 165.25(f), together with a written explanation of why such data demonstrate that the nonrefillable container and pesticide formulation meet the standard in § 165.25(f).
(iii) A copy of EPA's approval of a request for a waiver from the residue removal standard requirement.
(a)
(b)
(2) You must comply with the regulations in § 165.45(f) for stationary pesticide containers if you are a refiller of a pesticide product and you are not the registrant of the pesticide product. If the pesticide product is subject to the regulations in this subpart as set out in § 165.43, the stationary pesticide containers used to distribute or sell the product must meet the standards of § 165.45(f).
(3) If you are a refiller of a pesticide product and you are not a registrant of the pesticide product, § 165.45(a)(2) provides an exemption from some of the requirements in § 165.45(a)(1) .
(c)
(a
(b)
(c)
(1) The pesticide product meets one of the following two criteria:
(i) The pesticide product is an antimicrobial pesticide as defined in FIFRA section 2(mm); or
(ii) The pesticide product: (A) Is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
(B) In the intended use is subject to a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act or a food additive regulation under section 409 of such Act.
(2) The labeling of the pesticide product includes directions for use on a site in at least one of the following antimicrobial product use categories: food handling/storage establishments premises and equipment; commercial, institutional, and industrial premises and equipment; residential and public access premises; medical premises and equipment; human drinking water systems; materials preservatives; industrial processes and water systems; antifouling coatings; wood preservatives; or swimming pools.
(3) The pesticide product is not a hazardous waste as set out in part 261 of this chapter when the pesticide product is intended to be disposed.
(4) EPA has not specifically determined that the pesticide product must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment according to the provisions of paragraph (e) of this section.
(d)
(1) The pesticide product is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime.
(2) The labeling of the pesticide product includes directions for use on only a site or sites in the antimicrobial product use category of swimming pools.
(e)
(i) EPA obtains information, data or other evidence of a problem with the containers of a certain pesticide product or related group of products.
(ii) The information, data or other evidence is reliable and factual.
(iii) The problem causes or could reasonably be expected to cause an unreasonable adverse effect on the environment.
(iv) Complying with the container regulations could reasonably be expected to eliminate the problem.
(2) If EPA determines that an antimicrobial pesticide product otherwise
(f)
(g)
(h)
(2) The regulations in this subpart do not apply to containers that hold pesticides that are gaseous at atmospheric temperature and pressure.
(a)
(2) A refiller is not required to comply with 49 CFR 173.28(b)(2) for pesticide products that are not DOT hazardous materials if the refillable container to be reused complies with the refillable container regulations in this subpart and the refilling is done in compliance with the repackaging regulations in subpart D of this part.
(b)
(2) For the purposes of these regulations, a pesticide product that meets the definition of a hazardous material in 49 CFR 171.8 must be packaged in a refillable container that, if portable, is designed, constructed, and marked to comply with the requirements of 49 CFR parts 171-180 or, if subject to a special permit, according to the applicable
(c)
(d)
(e)
(f)
(1) Except during a civil emergency or any unanticipated grave natural disaster or other natural phenomenon of an exceptional, inevitable and irresistible character, the effects of which could not have been prevented or avoided by the exercise of due care or foresight, each stationary pesticide container (for liquid and dry pesticides) and its appurtenances must meet both of the following standards:
(i) Each stationary pesticide container and its appurtenances must be resistant to extreme changes in temperature and constructed of materials that are adequately thick to not fail and that are resistant to corrosion, puncture, or cracking.
(ii) Each stationary pesticide container must be capable of withstanding all operating stresses, taking into account static heat, pressure buildup from pumps and compressors, and any other foreseeable mechanical stresses to which the container may be subjected in the course of operations.
(2) Each stationary container of liquid pesticides must meet all of the following standards:
(i) Each stationary container of liquid pesticides must be equipped with a vent or other device designed to relieve excess pressure, prevent losses by evaporation, and exclude precipitation.
(ii) External sight gauges, which are pesticide-containing hoses or tubes that run vertically along the exterior of the container from the top to the bottom, are prohibited on stationary containers of liquid pesticides.
(iii) Each connection on a stationary container of liquid pesticides that is below the normal liquid level must be equipped with a shutoff valve which is capable of being locked closed. A shutoff valve must be located within a secondary containment unit if one is required by subpart E of this part.
(g)
(1) EPA may waive or modify the requirements of paragraph (a) of this section regarding the DOT standards for pesticide products that are not DOT hazardous materials if EPA determines that an alternative (partial or modified) set of standards or pre-existing requirements achieves a level of safety that is at least equal to that specified in the requirements of paragraph (a) of this section.
(2) EPA may waive or modify the requirements of paragraph (b) of this section regarding the DOT standards for pesticide products that are DOT hazardous materials if EPA determines that an alternative (partial or modified) set of standards or pre-existing requirements achieves a level of safety that is at least equal to that specified in the requirements of paragraph (b) of this section. EPA will modify or waive the requirements of paragraph (b) of this section only after consulting with DOT to ensure consistency with DOT regulations and exemptions.
(h)
(1) The name and address of the registrant; the date; and the name, title, signature, and phone number of the company official making the request.
(2) The name and EPA registration number of the pesticide product for which the waiver or modification is requested.
(3) A statement specifying the requirement or requirements from which you are requesting a waiver or a modification.
(4) A description of the refillable container or containers for which the waiver or modification is requested.
(5) Documentation or justification to demonstrate that the applicable waiver or modification criteria in paragraph (g) of this section are satisfied.
You are not required to report to EPA with information about your refillable containers under the regulations in this subpart. You should refer to the reporting standards in part 159 of this chapter to determine if information on container failures or other incidents involving pesticide containers must be reported to EPA under FIFRA section 6(a)(2) (7 U.S.C. 136d(a)(2)).
(a)
(b)
(c)
(a)
(b)
(c)
(1) The pesticide product meets one of the following two criteria:
(i) The pesticide product is an antimicrobial pesticide as defined in FIFRA section 2(mm); or
(ii) The pesticide product: (A) Is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
(B) In the intended use is subject to a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act or a food additive regulation under section 409 of such Act.
(2) The labeling of the pesticide product includes directions for use on a site in at least one of the following antimicrobial product use categories: food handling/storage establishments premises and equipment; commercial, institutional, and industrial premises and equipment; residential and public access premises; medical premises and equipment; human drinking water systems; materials preservatives; industrial processes and water systems; antifouling coatings; wood preservatives; or swimming pools.
(3) The pesticide product is not a hazardous waste as set out in part 261 of this chapter when the pesticide product is intended to be disposed.
(4) EPA has not specifically determined that the pesticide product must be subject to the regulations in this subpart to prevent an unreasonable adverse effect on the environment according to the provisions of paragraph (e) of this section.
(d)
(2) For the purposes of this subpart, an antimicrobial swimming pool product is a pesticide product that satisfies both of the following conditions:
(i) The pesticide product is intended to: disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime.
(ii) The labeling of the pesticide product includes directions for use on only a site or sites in the antimicrobial product use category of swimming pools.
(e)
(i) EPA obtains information, data or other evidence of a problem with the containers of a certain pesticide product or related group of products.
(ii) The information, data or other evidence is reliable and factual.
(iii) The problem causes or could reasonably be expected to cause an unreasonable adverse effect on the environment.
(iv) Complying with the container regulations could reasonably be expected to eliminate the problem.
(2) If EPA determines that an antimicrobial pesticide product otherwise exempted by paragraph (c) of this section must be subject to the repackaging regulations in this subpart to prevent an unreasonable adverse effect on the environment, EPA may require, by rule, that the product be repackaged in compliance with all or some of the requirements in this subpart. Alternatively, EPA may notify the applicant or registrant of its intent to make such a determination. After allowing the applicant or registrant a reasonable amount of time to reply, EPA may require, by notification and as a condition of registration, that the product be repackaged in compliance with all or some of the requirements in this subpart. For the purpose of the previous sentence, 60 days would be a reasonable amount of time to reply, although EPA may, in its discretion, provide more time. EPA may deny registration or initiate cancellation proceedings if the registrant fails to comply with the repackaging regulations within the time frames established by EPA in the rule or in its notification.
(f)
(g)
(h)
(2) Custom blending is not subject to the regulations in this subpart.
(3) The regulations in this subpart do not apply to containers that hold pesticides that are gaseous at atmospheric temperature and pressure.
(a)
(b)
(c)
(1) You must develop a refilling residue removal procedure that describes how to remove pesticide residue from a refillable container (portable or stationary pesticide container) before it is refilled.
(i) The refilling residue removal procedure must be adequate to ensure that the composition of the pesticide product does not differ at the time of its distribution or sale from the composition described in its confidential statement of formula that is required under FIFRA section 3.
(ii) If the refilling residue removal procedure requires the use of a solvent other than the diluent used for applying the pesticide as specified on the labeling under “Directions for Use,” or if there is no diluent used for application, the refilling residue removal procedure must describe how to manage any rinsate resulting from the procedure in accordance with applicable Federal and State regulations.
(2) You must develop a description of acceptable refillable containers (portable or stationary pesticide containers) that can be used for distributing or selling that pesticide product.
(i) An acceptable container is one that you have determined meets the standards in subpart C of this part and is compatible with the pesticide formulation intended to be distributed and sold using the refillable container.
(ii) You must identify the containers by specifying the container materials of construction that are compatible with the pesticide formulation and specifying information necessary to confirm compliance with the refillable container requirements in subpart C of this part.
(d)
(1) The establishment must be registered with EPA as a producing establishment as required by § 167.20 of this chapter.
(2) The refiller must not change the pesticide formulation unless the refiller has a registration for the new formulation.
(3) The refiller must repackage a pesticide product only into a refillable container that is identified on your description of acceptable containers for that pesticide product.
(4) The refiller may repackage any quantity of a pesticide product into a refillable container up to the rated capacity of the container. In addition, there are no general limits on the size of the refillable containers that the refiller can use.
(5) The refiller must have all of the following items at the establishment before repackaging a pesticide product into any refillable container for distribution or sale:
(i) The pesticide product's label and labeling.
(ii) The written refilling residue removal procedure for the pesticide product.
(iii) The written description of acceptable containers for the pesticide product.
(6) Before repackaging a pesticide product into any refillable container for distribution or sale, the refiller must identify the pesticide product previously contained in the refillable container to determine whether a residue removal procedure must be conducted in accordance with paragraph (f) of this section. The refiller may identify the previous pesticide product by referring to the label or labeling.
(7) The refiller must inspect each refillable container according to paragraph (e) of this section.
(8) The refiller must clean each refillable container according to paragraph (f) or (g) of this section, if required by either paragraph.
(9) The refiller must ensure that each refillable container is properly labeled according to paragraph (h) of this section.
(10) The establishment must maintain records in accordance with paragraph (i) of this section.
(11) The establishment must maintain records as required by part 169 of this chapter.
(12) The establishment must report as required by part 167 of this chapter.
(e)
(1) The integrity of the container is compromised in at least one of the following ways:
(i) The container shows signs of rupture or other damage which reduces its structural integrity.
(ii) The container has visible pitting, significant reduction in material thickness, metal fatigue, damaged threads or closures, or other significant defects.
(iii) The container has cracks, warpage, corrosion or any other damage which might render it unsafe for transportation.
(iv) There is damage to the fittings, valves, tamper-evident devices or other appurtenances that may cause failure of the container.
(2) The container does not bear the markings required by § 165.45(a), (b) and (d), or such markings are not legible.
(3) The container does not have an intact and functioning one-way valve or tamper-evident device on each opening other than a vent, if required.
(f)
(1) If required, each tamper-evident device and one-way valve is intact.
(2) The refillable container is being refilled with the same pesticide product.
(3) Both of the following conditions are satisfied:
(i) The container previously held a pesticide product with a single active ingredient and is being used to repackage a pesticide product with the same single active ingredient.
(ii) There is no change that would cause the composition of the product being repackaged to differ from the composition described in its confidential statement of formula that is required under FIFRA section 3. Examples of unallowable changes include the active ingredient concentration increasing or decreasing beyond the limits established by the confidential
(g)
(h)
(i)
(1) For each pesticide product distributed or sold in refillable containers, both of the following records must be maintained for the current operating year and for 3 years after that:
(i) The written refilling residue removal procedure for the pesticide product.
(ii) The written description of acceptable containers for the pesticide product.
(2) Each time a refiller at your establishment repackages a pesticide product into a refillable container and distributes or sells the product, the following records must be generated and maintained for at least 3 years after the date of repackaging:
(i) The EPA registration number of the pesticide product distributed or sold in the refillable container.
(ii) The date of the repackaging.
(iii) The serial number or other identifying code of the refillable container.
(a)
(b)
(1) The repackaging results in no change to the pesticide formulation.
(2) One of the following conditions regarding a registered refilling establishment is satisfied:
(i) The pesticide product is repackaged at a refilling establishment registered with EPA as required by § 167.20 of this chapter.
(ii) The pesticide product is repackaged by a refilling establishment registered with EPA as required by § 167.20 of this chapter at the site of a user who intends to use or apply the product.
(3) You have entered into a written contract with the refiller to repackage the pesticide product and to use the label of your pesticide product.
(4) The pesticide product is repackaged only into refillable containers
(5) The pesticide product is labeled with the product's label with no changes except the addition of an appropriate net contents statement and the refiller's EPA establishment number.
(c)
(d)
(e)
(f)
(1) You must develop a refilling residue removal procedure that describes how to remove pesticide residue from a refillable container (portable or stationary pesticide container) before it is refilled.
(i) The refilling residue removal procedure must be adequate to ensure that the composition of the pesticide product does not differ at the time of its distribution or sale from the composition described in its confidential statement of formula that is required under FIFRA section 3.
(ii) If the refilling residue removal procedure requires the use of a solvent other than the diluent used for applying the pesticide as specified on the labeling under “Directions for Use,” or if there is no diluent used for application, the refilling residue removal procedure must describe how to manage any rinsate resulting from the procedure in accordance with applicable Federal and State regulations.
(2) You must develop a description of acceptable refillable containers (portable or stationary pesticide containers) that can be used for distributing or selling that pesticide product.
(i) An acceptable container is one that you have determined meets the standards in subpart C of this part and is compatible with the pesticide formulation intended to be distributed and sold using the refillable container.
(ii) You must identify the containers by specifying the container materials of construction that are compatible with the pesticide formulation and specifying information necessary to confirm compliance with the refillable container requirements in subpart C of this part.
(g)
(1) Your written refilling residue removal procedure for the pesticide product.
(2) Your written description of acceptable containers for the pesticide product.
(3) The pesticide product's label and labeling.
(h)
(1) Each written contract entered into with a refiller for repackaging your pesticide product into refillable containers.
(2) Your written refilling residue removal procedure for the pesticide product.
(3) Your written description of acceptable containers for the pesticide product.
(a)
(b)
(1) The repackaging results in no change to the pesticide formulation.
(2) One of the following conditions regarding a registered refilling establishment is satisfied:
(i) The pesticide product is repackaged at a refilling establishment registered with EPA as required by § 167.20 of this chapter.
(ii) The pesticide product is repackaged by a refilling establishment registered with EPA as required by § 167.20 of this chapter at the site of a user who intends to use or apply the product.
(3) The registrant has entered into a written contract with you to repackage the pesticide product and to use the label of the registrant's pesticide product.
(4) The pesticide product is repackaged only into refillable containers that meet the standards of subpart C of this part.
(5) The pesticide product is labeled with the product's label with no changes except the addition of an appropriate net contents statement and the refillers EPA establishment number.
(c)
(d)
(e)
(1) Your establishment must be registered with EPA as a producing establishment as required by § 167.20 of this chapter.
(2) You must not change the pesticide formulation unless you have a registration for the new formulation.
(3) You must repackage a pesticide product only into a refillable container that is identified on the description of acceptable containers for that pesticide product provided by the registrant.
(4) You may repackage any quantity of a pesticide product into a refillable container up to the rated capacity of the container. In addition, there are no general limits on the size of the refillable containers that you can use.
(5) You must have all of the following items at your establishment before repackaging a pesticide product into any refillable container for distribution or sale:
(i) The written contract referred to in paragraph (b)(3) of this section from the pesticide product's registrant.
(ii) The pesticide product's label and labeling.
(iii) The registrant's written refilling residue removal procedure for the pesticide product.
(iv) The registrant's written description of acceptable containers for the pesticide product.
(6) Before repackaging a pesticide product into any refillable container for distribution or sale, you must identify the pesticide product previously contained in the refillable container to determine whether a residue removal
(7) You must inspect each refillable container according to paragraph (f) of this section.
(8) You must clean each refillable container according to paragraph (g) or (h) of this section, if required by either paragraph.
(9) You must ensure that each refillable container is properly labeled according to paragraph (i) of this section.
(10) You must maintain records in accordance with paragraph (j) of this section.
(11) You must maintain records as required by part 169 of this chapter.
(12) You must report as required by part 167 of this chapter.
(13) The stationary pesticide containers at your establishment must meet the standards in § 165.45(f).
(14) You may be required to comply with the containment standards in subpart E of this part.
(f)
(1) The integrity of the container is compromised in at least one of the following ways:
(i) The container shows signs of rupture or other damage which reduces its structural integrity.
(ii) The container has visible pitting, significant reduction in material thickness, metal fatigue, damaged threads or closures, or other significant defects.
(iii) The container has cracks, warpage, corrosion or any other damage which might render it unsafe for transportation.
(iv) There is damage to the fittings, valves, tamper-evident devices or other appurtenances that may cause failure of the container.
(2) The container does not bear the markings required by § 165.45(a), (b) and (d), or such markings are not legible.
(3) The container does not have an intact and functioning one-way valve or tamper-evident device on each opening other than a vent, if required.
(g)
(1) If required, each tamper-evident device and one-way valve is intact.
(2) The refillable container is being refilled with the same pesticide product.
(3) Both of the following conditions are satisfied.
(i) The container previously held a pesticide product with a single active ingredient and is being used to repackage a pesticide product with the same single active ingredient.
(ii) There is no change that would cause the composition of the product being repackaged to differ from the composition described in its confidential statement of formula that is required under FIFRA section 3. Examples of unallowable changes include the active ingredient concentration increasing or decreasing beyond the limits established by the confidential statement of formula or a reaction or interaction between the pesticide product being repackaged and the residue remaining in the container.
(h)
(i)
(j)
(1) For each pesticide product distributed or sold in refillable containers, all of the following records must be maintained for the current operating year and for 3 years after that:
(i) The written contract from the pesticide product's registrant for the pesticide product.
(ii) The written refilling residue removal procedure for the pesticide product.
(iii) The written description of acceptable containers for the pesticide product.
(2) Each time you repackage a pesticide product into a refillable container and distribute or sell the product, the following records must be generated and maintained for at least 3 years after the date of repackaging:
(i) The EPA registration number of the pesticide product distributed or sold in the refillable container.
(ii) The date of the repackaging.
(iii) The serial number or other identifying code of the refillable container.
(a)
(1) Storage and handling of large quantities of pesticide products.
(2) Pesticide dispensing and container-refilling operations.
(b)
(1) Refilling establishments who repackage agricultural pesticides and whose principal business is retail sale (
(2) Custom blenders of agricultural pesticides.
(3) Businesses which apply an agricultural pesticide for compensation (other than trading of personal services between agricultural producers).
(c)
(a)
(b)
(1) The container is empty, that is, all pesticide that can be removed by methods such as draining, pumping or aspirating has been removed (whether or not the container has been rinsed or washed).
(2) The container holds only pesticide rinsates or wash waters, and is labeled accordingly.
(3) The container holds only pesticides which would be gaseous when released at atmospheric temperature and pressure.
(4) The container is dedicated to non-pesticide use, and is labeled accordingly.
(a)
(1) Refillable containers of agricultural pesticide are emptied, cleaned or rinsed.
(2) Agricultural pesticides are dispensed from a stationary pesticide container designed to hold undivided quantities of agricultural pesticides equal to or greater than 500 gallons (1,890 liters) of liquid pesticide or equal to or greater than 4,000 pounds (1,818 kilograms) of dry pesticide for any purpose, including refilling or emptying for cleaning. This applies when pesticide is dispensed from the container into any vessel, including, but not limited to:
(i) Refillable containers;
(ii) Service containers;
(iii) Transport vehicles;
(iv) Application equipment.
(3) Agricultural pesticides are dispensed from a transport vehicle for purposes of filling a refillable container.
(4) Agricultural pesticides are dispensed from any other container for the purpose of refilling a refillable container for sale or distribution. Containment requirements do not apply if the agricultural pesticide is dispensed from such a container for use, application or purposes other than refilling for sale or distribution.
(b)
(1) The only pesticides in the dispensing area would be gaseous when released at atmospheric temperature and pressure.
(2) The only pesticide containers refilled or emptied within the dispensing area are stationary pesticide containers which are already protected by a secondary containment unit that complies with the provisions of this subpart.
(3) The pesticide dispensing area is used solely for dispensing pesticide from a rail car which does not remain at a facility long enough to meet the definition of a stationary pesticide container; that is, 30 days.
(a)
(1) You, as the owner or operator, have obtained all Federal, State, and local approvals or permits necessary to
(2) You have either begun a continuous on-site physical construction or installation program OR you have entered into contractual obligations. The contract must be such that it cannot be canceled or modified without substantial loss, and must be for the physical construction or installation of the containment structure within a specific and reasonable time frame.
(b)
(a)
(1) The containment structure must be constructed of steel, reinforced concrete or other rigid material capable of withstanding the full hydrostatic head, load and impact of any pesticides, precipitation, other substances, equipment and appurtenances placed within the structure. The structure must be liquid-tight with cracks, seams and joints appropriately sealed.
(2) The structure must not be constructed of natural earthen material, unfired clay, or asphalt.
(3) The containment structure must be made of materials compatible with the pesticides stored. In this case, compatible means able to withstand anticipated exposure to stored or transferred substances and still provide containment of those same or other substances within the containment area.
(b)
(1) You must protect appurtenances and pesticide containers against damage from operating personnel and moving equipment. Means of protection include, but are not limited to, supports to prevent sagging, flexible connections, the use of guard rails, barriers, and protective cages.
(2) Appurtenances, discharge outlets or gravity drains must not be configured through the base or wall of the containment structure, except for direct interconnections between adjacent containment structures which meet the requirements of this subpart. Appurtenances must be configured in such a way that spills or leaks are easy to see.
(3) The containment structure must be constructed with sufficient freeboard to contain precipitation and prevent water and other liquids from seeping into or flowing onto it from adjacent land or structures.
(4) Multiple stationary pesticide containers may be protected within a single secondary containment unit.
(c)
(1) New secondary containment units for stationary containers of liquid pesticides, if protected from precipitation, must have a capacity of at least 100 percent of the volume of the largest stationary pesticide container plus the volume displaced by other containers and appurtenances within the unit.
(2) New secondary containment units for stationary containers of liquid pesticides, if exposed to or unprotected from precipitation, must have a capacity of at least 110 percent of the volume of the largest stationary pesticide container plus the volume displaced by other containers and appurtenances within the unit.
(3) New containment pads in pesticide dispensing areas which have a pesticide container or pesticide-holding equipment with a volume of 750 gallons or greater must have a holding capacity of at least 750 gallons.
(4) New containment pads in pesticide dispensing areas which do not have a pesticide container or pesticide-holding equipment with a volume of at least 750 gallons must have a holding capacity of at least 100 percent of the volume of the largest pesticide container or pesticide-holding equipment used on the pad.
(d)
(e)
(1) Be designed and constructed to intercept leaks and spills of pesticides which may occur in the pesticide dispensing area.
(2) Have enough surface area to extend completely beneath any container on it, with the exception of transport vehicles dispensing pesticide for sale or distribution to a stationary pesticide container. For such vehicles, the surface area of the containment pad must accommodate at least the portion of the vehicle where the delivery hose or device couples to the vehicle. This exception does not apply to transport vehicles that are used for prolonged storage or repeated on-site dispensing of pesticides.
(3) Allow, in conjunction with its sump, for removal and recovery of spilled, leaked, or discharged material and rainfall, such as by a manually activated pump. Automatically-activated pumps which lack automatic overflow cutoff switches for the receiving container are prohibited.
(4) Have its surface sloped toward an area where liquids can be collected for removal, such as a liquid-tight sump or a depression, in the case of a single-pour concrete pad.
(f)
(1) The stationary containers of dry pesticides within the containment unit must be protected from wind and precipitation.
(2) Stationary containers of dry pesticides must be placed on pallets or a raised concrete platform to prevent the accumulation of water in or under the pesticide.
(3) The storage area for stationary containers of dry pesticides must include a floor that extends completely beneath the pallets or raised concrete platforms on which the stationary containers of dry pesticides must be stored.
(4) The storage area for stationary containers of dry pesticides must be enclosed by a curb a minimum of 6 inches high that extends at least 2 feet beyond the perimeter of the container.
(a)
(1) The containment structure must be constructed of steel, reinforced concrete or other rigid material capable of withstanding the full hydrostatic head, load and impact of any pesticides, precipitation, other substances, equipment and appurtenances placed within the structure. The structure must be liquid-tight with cracks, seams and joints appropriately sealed.
(2) The structure must not be constructed of natural earthen material, unfired clay, or asphalt.
(3) The containment structure must be made of materials compatible with the pesticides stored. In this case, compatible means able to withstand anticipated exposure to stored or transferred substances and still provide containment of those same or other substances within the containment area.
(b)
(1) You must protect appurtenances and pesticide containers against damage from operating personnel and moving equipment. Means of protection include, but are not limited to, supports to prevent sagging, flexible connections, the use of guard rails, barriers, and protective cages.
(2) You must seal all appurtenances, discharge outlets and gravity drains
(3) The containment structure must be constructed with sufficient freeboard to contain precipitation and prevent water and other liquids from seeping into or flowing onto it from adjacent land or structures.
(4) Multiple stationary pesticide containers may be protected within a single secondary containment unit.
(c)
(1) Existing secondary containment units for stationary containers of liquid pesticides must have a capacity of at least 100 percent of the volume of the largest stationary pesticide container plus the volume displaced by other containers and appurtenances within the unit.
(2) Existing containment pads in pesticide dispensing areas which have a pesticide container or pesticide-holding equipment with a volume of 750 gallons or greater must have a holding capacity of at least 750 gallons.
(3) Existing containment pads in pesticide dispensing areas which do not have a pesticide container or pesticide-holding equipment with a volume of at least 750 gallons must have a holding capacity of at least 100 percent of the volume of the largest pesticide container or pesticide-holding equipment used on the pad.
(d)
(e)
(1) Be designed and constructed to intercept leaks and spills of pesticides which may occur in the pesticide dispensing area.
(2) Have enough surface area to extend completely beneath any container on it, with the exception of transport vehicles dispensing pesticide for sale or distribution to a stationary pesticide container. For such vehicles, the surface area of the containment pad must accommodate at least the portion of the vehicle where the delivery hose or device couples to the vehicle. This exception does not apply to transport vehicles that are used for prolonged storage or repeated on-site dispensing of pesticides.
(3) Allow, in conjunction with its sump, for removal and recovery of spilled, leaked, or discharged material and rainfall, such as by a manually activated pump. Automatically-activated pumps which lack automatic overflow cutoff switches for the receiving container are prohibited.
(f)
(1) The stationary containers of dry pesticides within the containment unit must be protected from wind and precipitation.
(2) Stationary containers of dry pesticides must be placed on pallets or a raised concrete platform to prevent the accumulation of water in or under the pesticide.
(3) The storage area for stationary containers of dry pesticides must include a floor that extends completely beneath the pallets or raised concrete platforms on which the stationary containers of dry pesticides must be stored.
(4) The storage area for stationary containers of dry pesticides must be enclosed by a curb a minimum of 6 inches high that extends at least 2 feet beyond the perimeter of the container.
(a)
(1) Manage the structure in a manner that prevents pesticides or materials containing pesticides from escaping from the containment structure (including, but not limited to, pesticide residues washed off the containment structure by rainfall or cleaning liquids used within the structure.)
(2) Ensure that pesticide spills and leaks on or in any containment structure are collected and recovered in a manner that ensures protection of human health and the environment (including surface water and groundwater) and maximum practicable recovery of the pesticide spilled or leaked. Cleanup must occur no later than the end of the day on which pesticides have been spilled or leaked except in circumstances where a reasonable delay would significantly reduce the likelihood or severity of adverse effects to human health or the environment.
(3) Ensure that all materials resulting from spills and leaks and any materials containing pesticide residue are managed according to label instructions and applicable Federal, State and local laws and regulations.
(4) Ensure that transfers of pesticides between containers, or between containers and transport vehicles are attended at all times.
(5) Ensure that each lockable valve on a stationary pesticide container, if it is required by § 165.45(f), is closed and locked, or that the facility is locked, whenever the facility is unattended.
(b)
(1) Inspect each stationary pesticide container and its appurtenances and each containment structure at least monthly during periods when pesticides are being stored or dispensed on the containment structure. Your inspection must look for visible signs of wetting, discoloration, blistering, bulging, corrosion, cracks or other signs of damage or leakage.
(2) Initiate repair to any areas showing visible signs of damage and seal any cracks and gaps in the containment structure or appurtenances with material compatible with the pesticide being stored or dispensed no later than the end of the day on which damage is noticed and complete repairs within a time frame that is reasonable, taking into account factors such as the weather, and the availability of cleanup materials, trained staff, and equipment.
(3) Not store any additional pesticide on a containment structure if the structure fails to meet the requirements of this subpart until suitable repairs have been made.
You may combine containment pads and secondary containment units as an integrated system provided the requirements set out in this subpart for containment pads and secondary containment units in §§ 165.85(a) and (b), 165.87(a) and (b) and § 165.90, and as applicable, §§ 165.85(c)-(f) and 165.87(c)-(f) are satisfied separately.
As a facility owner or operator subject to the requirements of this subpart, you must maintain the following records, and you must furnish these records for inspection and copying upon request by an employee of EPA or any entity designated by EPA, such as a State, another political subdivision or a Tribe:
(a) Records of inspection and maintenance for each containment structure and for each stationary pesticide container and its appurtenances must be kept for 3 years and must include the following information:
(1) Name of the person conducting the inspection or maintenance;
(2) Date the inspection or maintenance was conducted;
(3) Conditions noted;
(4) Specific maintenance performed.
(b) Records for any non-stationary pesticide container designed to hold undivided quantities of agricultural pesticides equal to or greater than 500 gallons (1,890 liters) of liquid pesticide or equal to or greater than 4,000 pounds (1,818 kilograms) of dry pesticide that holds pesticide but is not protected by a secondary containment unit meeting these regulations must be kept for 3 years. Records on these non-stationary pesticide containers must include the time period that the container remains at the same location.
(c) Records of the construction date of the containment structure must be kept for as long as the pesticide containment structure is in use, and for 3 years afterwards.
(a)
(b)
(1) The State must submit a letter and any supporting documentation to EPA. Supporting documentation must demonstrate that the State's program is providing environmental protection equivalent to or more protective than that expected to be provided by the Federal regulations in this subpart.
(2) The State must identify any significant changes to State regulations which would be necessary in order to provide environmental protection equivalent to the EPA regulations, and develop an estimated timetable to effect these changes. The letter must be signed by the designated State Lead Agency.
(c)
(d)
7 U.S.C. 136p, and 136w.
(a)
(b)
(2) Subpart B of this part establishes procedures and criteria for specific, quarantine, and public health exemptions.
(3) Subpart C of this part establishes procedures and criteria for crisis exemptions.
There are four types of emergency exemptions which may be authorized: specific, quarantine, public health, and crisis exemptions.
(a) Specific exemption. A specific exemption may be authorized in an emergency condition to avert:
(1) A significant economic loss; or
(2) A significant risk to:
(i) Endangered species,
(ii) Threatened species,
(iii) Beneficial organisms, or
(iv) The environment.
(b)
(c)
(d)
Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply:
(1) No effective pesticides are available under the Act that have labeled uses registered for control of the pest
(2) No economically or environmentally feasible alternative practices which provide adequate control are available; and
(3) The situation:
(i) Involves the introduction or dissemination of an invasive species or a pesticide new to or not theretofore known to be widely prevalent or distributed within or throughout the United States and its territories; or
(ii) Will present significant risks to human health; or
(iii) Will present significant risks to threatened or endangered species, beneficial organisms, or the environment; or
(iv) Will cause significant economic loss due to:
(A) An outbreak or an expected outbreak of a pest; or
(B) A change in plant growth or development caused by unusual environmental conditions where such change can be rectified by the use of a pesticide(s).
(1) For pest activity that primarily affects the current crop or other output, one or more of the following:
(i) Yield loss greater than or equal to 20%.
(ii) Economic loss, including revenue losses and cost increases, greater than or equal to 20% of gross revenues.
(iii) Economic loss, including revenue losses and cost increases greater than or equal to 50% of net revenues.
(2) For any pest activity where EPA determines that the criteria in paragraph (1) of this definition would not adequately describe the expected loss, substantial loss or impairment of capital assets, or a loss that would affect the long-term financial viability expected from the productive activity.
(a) A State or Federal agency that obtains an exemption may notify eligible users of the availability of the exempted pesticide(s) through user groups, retail dealers, and other means. Notification may include distributing copies of the section 18 approval letter, labeling, or other information to eligible persons.
(b) As set forth more fully in § 168.22 of this chapter, EPA interprets FIFRA sections 12(a)(1) (A) and (B) as making it unlawful for any person who distributes, sells, offers for sale, holds for
(a)
(1)
(ii) Requests should identify by name and telephone number one or more qualified experts who may be contacted in case any questions arise concerning the application.
(2)
(i) For a federally registered pesticide product:
(A) A copy of the label(s) if a specific product(s) is/are requested; or the formulation(s) requested if a specific product is not requested; and
(B) A copy of any additional labeling proposed for the emergency exemption; or
(ii) For any other pesticide products:
(A) A confidential statement of formula or reference to one already submitted to the Agency; and
(B) Complete labeling to be used in connection with the proposed exemption use.
(3)
(i) Sites to be treated, including their locations within the State;
(ii) The method of application;
(iii) The rate of application in terms of active ingredient and product;
(iv) The maximum number of applications;
(v) The total acreage or other appropriate unit proposed to be treated;
(vi) The total amount of pesticide proposed to be used in terms of both active ingredient and product;
(vii) All applicable restrictions and requirements concerning the proposed use which may not appear on labeling;
(viii) The duration of the proposed use; and
(ix) Earliest possible harvest dates.
(4)
(i) A detailed explanation of why the pesticide(s) currently registered for the particular use proposed in the application is not available in adequate supplies and/or effective to the degree needed to control the emergency. If the applicant states that an available registered pesticide is ineffective for the given situation, the statement must be supported by field data which demonstrate ineffectiveness of registered pesticides, or, if such data are unavailable, statements by qualified agricultural experts, extension personnel, university personnel or other persons similarly qualified in the field of pest control; and
(ii) A detailed explanation of why alternative practices, if available, either would not provide adequate control or would not be economically or environmentally feasible.
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(b)
(1) The scientific and common name of the pest or pest complex;
(2) A discussion of the events which brought about the emergency condition;
(3) A discussion of the anticipated risks to endangered or threatened species, beneficial organisms, or the environment that would be remedied by the proposed use of the pesticide; and
(4) A discussion of the anticipated significant economic loss, together with data and other information supporting the discussion, that addresses one or more of the following, as appropriate:
(i) Yield or utilized yield reasonably anticipated in the absence of the emergency and expected losses in quantity due to the emergency;
(ii) The information in paragraph (b)(4)(i) of this section plus prices reasonably anticipated in the absence of the emergency and changes in prices and/or production costs due to the emergency;
(iii) The information in paragraph (b)(4)(ii) of this section plus operating costs reasonably anticipated in the absence of the emergency;
(iv) Any other information explaining the economic consequences of the emergency.
(5)
(i) An exemption was granted for the same pesticide at the same site to the same applicant the previous year;
(ii) The emergency condition could reasonably be expected to continue for longer than 1 year;
(iii) EPA has not declared the use ineligible for re-certification;
(iv) The use is not subject to public notice pursuant to § 166.24(a)(1) through (a)(6);
(v) The applicant certifies that all of the following are true:
(A) The emergency condition described in the preceding year's application continues to exist;
(B) Except as expressly identified, all information submitted in the preceding year's application is still accurate;
(C) Except as expressly identified, the proposed conditions of use are identical to the conditions of use EPA approved for the preceding year;
(D) Any conditions or limitations on the eligibility for re-certification identified in the preceding year's notice of approval of the emergency exemption have been satisfied;
(E) The applicant is not aware of any alternative chemical or non-chemical practice that may offer a meaningful level of pest control, or has provided documentation that each such known practice does not provide adequate control or is not economically or environmentally feasible.
(c)
(1) The scientific and common name of pest;
(2) The origin of pest and the means of its introduction or spread if known; and
(3) The anticipated impact of not controlling the pest.
(d)
(1) The scientific and common name of the pest to be controlled and, if the pest is a vector, a description of the disease it is expected to transmit;
(2) A discussion of the magnitude of the health problems which are expected to occur without the pesticide use; and
(3) Discussion of the availability of medical treatment for the health problem.
The Agency, in determining whether or not such emergency conditions exist, shall consult with the Secretary of Agriculture and the Governor of any State concerned if they request such determination.
(a)
(1) The application proposes use of a new chemical;
(2) The application proposes the first food use of an active ingredient;
(3) The application proposes any use of a pesticide if the pesticide has been subject to a suspension notice under section 6(c) of the Act;
(4) The application proposes use of a pesticide which:
(i) Was the subject of a notice under section 6(b) of the Act and was subsequently cancelled, and
(ii) Is intended for a use that poses a risk similar to the risk posed by any use of the pesticide which was the subject of the notice under section 6(b);
(5) The application proposes use of a pesticide which:
(i) Contains an active ingredient which is or has been the subject of a Special Review, and
(ii) Is intended for a use that could pose a risk similar to the risk posed by any use of the pesticide which is or has been the subject of the Special Review;
(6) The application proposes use of a pesticide which:
(i) Was voluntarily canceled under section 6(f) of the Act, and
(ii) Is intended for a use that poses a risk similar to the risk posed by any use of the pesticide which was voluntarily canceled under section 6(f);
(7) The application proposes use of a pesticide for a specific or public health exemption, if:
(i) An emergency exemption has been requested or approved for that use in any 3 previous years, or any 5 previous years if the use is supported by the IR-4 program, and
(ii) A complete application for registration of that use and/or a petition for tolerance for residues in or on the commodity has not been submitted to the Agency; or
(8) The Administrator determines that publication of notice is appropriate.
(b)
(1) The name of the applicant;
(2) The name of the active ingredient requested for use, including, if available, the common name and the Chemical Abstracts Service (CAS) number;
(3) The total amount of product or active ingredient proposed for use;
(4) The geographical location where treatment is proposed;
(5) The proposed number of acres or other appropriate units proposed to be treated;
(6) A summary of the applicant's description of the emergency conditions including the pest and the site or crop to be treated;
(7) A description of the major conditions of use of the pesticide as proposed by the applicant;
(8) If the pesticide proposed for use meets the criteria of paragraph (a) (3), (4), or (5) of this section, an identification of the types of risks that were the basis for EPA's regulatory action; and
(9) The name, telephone number, and address of a person in the Agency who can provide further information.
(c)
(a)
(1) Whether an emergency condition exists or will exist;
(2) The Agency's ability and intention to establish a time-limited tolerance(s) or exemption(s) from the requirement of a tolerance for any pesticide residues resulting from the authorized use, identifying the level of permissible residues in or on food or feed resulting from the proposed use;
(3) The anticipated benefits to be derived from the proposed use; and
(4) The potential risks to human health, endangered or threatened species, beneficial organisms, and the environment from the proposed use.
(b)
(1) He determines that:
(i) An emergency condition exists;
(ii) The use of the pesticide under the exemption will not cause unreasonable adverse effects on the environment;
(iii) Registration of the pesticide use for which the exemption is requested has not been suspended under section 6(c) of the Act or cancelled following a notice under section 6(b) of the Act,
(2) Giving due consideration to:
(i) Whether the pesticide is reasonably likely to be used in compliance with the requirements imposed by the Agency under the exemption; and
(ii) The progress which has been made toward registration of the proposed use, if a repeated specific or public health exemption is sought. It shall be presumed that if a complete application for registration of a use, which has been under a specific or public health exemption for any 3 previous years, or any 5 previous years if the use is supported for registration by the IR-4 program, has not been submitted, reasonable progress towards registration has not been made.
(a)
(b)
(a)
(1)
(2)
(ii)
(b)
(i) The name of the applicant;
(ii) The pesticide authorized for use;
(iii) The crop or site to be treated; and
(iv) The name, address, and telephone number of a person in the Agency who can provide further information.
(2) In addition, if EPA has issued a Notice of Receipt of an application for an exemption, it will issue a notice of its final decision and the reasons for that decision.
(a)
(b)
(1) Total acreage, amount of commodity or other unit treated and the total quantity of the pesticide used;
(2) A discussion of the effectiveness of the pesticide in dealing with the emergency condition;
(3) A description of any unexpected adverse effects which resulted from use of the pesticide under the exemption;
(4) The results of any monitoring required and/or carried out under the exemption;
(5) A discussion of any enforcement actions taken in connection with the exemption;
(6) Method(s) of disposition of a food crop, if required to be destroyed under an exemption; and
(7) Any other information requested by the Administrator.
(c)
(1) Locations where the pesticide was applied;
(2) Dates of application (range); and
(3) Total quantity of the pesticide used.
EPA shall review information submitted in connection with emergency exemptions and, when applicable, use it in connection with other regulatory decisions under the Act.
(a)
(1) An emergency no longer exists;
(2) Use of the pesticide under the exemption may cause unreasonable adverse effects on the environment;
(3) The pesticide authorized under the exemption is not effective at controlling the pest or conditions causing the emergency; or
(4) The terms and conditions established by the exemption and these regulations are not being complied with.
(b)
The head of a Federal or State agency, the Governor of a State, or their official designee, may issue a crisis exemption in situations involving an unpredictable emergency situation when:
(a) An unpredictable emergency condition exists;
(b) The time element with respect to the application of the pesticide is critical, and there is not sufficient time either to request a specific, quarantine, or public health exemption or, if such a request has been submitted, for EPA to complete review of the request; and
(c) EPA has provided verbal confirmation that, for food uses, a tolerance or exemption from the requirement of a tolerance can be established in a timely manner, responsive to the projected timeframe of use of the chemical and harvest of the commodity, and that, for any use, the Agency has no other objection.
The crisis provisions may not be utilized to authorize a pesticide use if any of the following has occurred:
(a) EPA has informed the head of the Federal or State agency, the Governor, or their official designee, not to issue such an exemption;
(b) The pesticide use has been suspended under section 6(c) of the Act;
(c) The pesticide use has been cancelled following a notice issued under section 6(b) of the Act;
(d) The pesticide contains a new chemical; or
(e) The application proposes the first food use of a pesticide.
(a)
(2) The State or Federal agency issuing the crisis exemption shall notify the registrant(s) or, if appropriate, the basic manufacturer(s) of the pesticide(s) being used under the crisis exemption at the same time notice is given to EPA or as soon thereafter as possible.
(b)
(1) The name of the product and active ingredient authorized for use, along with the common name and CAS number if available, including a copy of the EPA registered label and use directions appropriate to the authorized use;
(2) The site on which the pesticide is to be used or is being used;
(3) The use pattern;
(4) The date on which the pesticide use is to begin and the date when the use will end;
(5) An estimate of the level of residues of the pesticide expected to result from use under the crisis exemption;
(6) Earliest anticipated harvest date of the treated commodity;
(7) Description of the emergency situation; and
(8) Any other pertinent information available at the time.
A crisis exemption may be authorized for:
(a) Only as long as is necessary to control the pest or conditions causing the emergency; and
(b) No longer than 15 days, unless an application requesting a specific, quarantine, or public health exemption for this use has been submitted to the Agency.
(a)
(1) The name of the applicant;
(2) The pesticide authorized for use;
(3) The crop or site to be treated; and
(4) The name, address, and telephone number of a person in the Agency who can provide further information.
(b)
(1) The number of crisis exemptions declared; and
(2) The number of crisis exemptions revoked.
(a)
(b)
(2) Information to be included in the crisis exemption report includes the same information as required in § 166.32(b) and an explanation as to why there was a need to utilize the crisis provisions.
(c)
(1) Location where the pesticide was applied;
(2) Dates of application (range); and
(3) Total quantity of the pesticide used.
(a)
(b)
(i) There are insufficient data to determine the risks posed from the use;
(ii) Such action is necessary to protect man or the environment; or
(iii) The State or Federal agency is not complying with the requirements of this subpart C.
(2)
(i) Such action is necessary to protect man or the environment; or
(ii) The State or Federal agency is not complying with the requirements of this subpart C.
(c)
7 U.S.C. 136 (e) and (w).
Terms used in this part shall have the meanings set forth for such terms in the Federal Insecticide, Fungicide, and Rodenticide Act. In addition, when used in this part, the following terms shall have the meanings stated below:
(a)
(2) Any establishment where a substance is produced must be registered with the Agency if the producer intends the substance to be used as an active ingredient of a pesticide, or has actual or constructive knowledge that the substance will be used by any person as an active ingredient of a pesticide.
(3) Any domestic establishment producing a pesticidal product for export, or any unregistered pesticide, or any foreign establishment producing a pesticidal product for import into the United States must be registered. Also, any establishment, either foreign or
(b)
(1) Name and address of the company.
(2) The type of ownership (individual, partnership, cooperative association, corporation, or any organized group of persons whether incorporated or not).
(3) The name and address of each producing establishment for which registration is sought.
(c)
(d)
(e)
(f)
(a)
(b)
(c)
(d)
(a)
(b)
7 U.S.C. 136-136y.
(a) FIFRA sections 12(a)(1) (A) and (B) make it unlawful for any person to “offer for sale” any pesticide if it is unregistered, or if claims made for it as part of its distribution or sale differ substantially from any claim made for it as part of the statement required in connection with its registration under FIFRA section 3. EPA interprets these provisions as extending to advertisements in any advertising medium to which pesticide users or the general public have access.
(b) EPA regards it as unlawful for any person who distributes, sells, offers for sale, holds for sale, ships, delivers for shipment, or receives and (having so received) delivers or offers to deliver any pesticide, to place or sponsor advertisements which recommend or suggest the purchase or use of:
(1) Any pesticide for a use authorized under a FIFRA section 5 experimental use permit (EUP).
(2) Any pesticide for a use authorized under a FIFRA section 18 emergency exemption, except for advertisements that:
(i) Are placed in media which address primarily persons in the geographical area to which the exemption applies.
(ii) State the name and address of one or more retail dealers who stock the pesticide.
(iii) Contain a prominent notice of the limitations on use under the section 18 emergency exemption.
(3) Any pesticide for any use authorized only by a FIFRA section 24(c) special local need registration, unless the advertisement contains a prominent notice of the limitations on use under the section 24(c) registrations.
(4) Any unregistered pesticide for any use unless the advertisement is one permitted by paragraph (b) (2) or (3) of this section.
(5) A registered pesticide product for an unregistered use, unless the advertisement is one permitted by paragraph (b) (2) or (3) of this section. However, as a matter of policy, the Agency will not regard as unlawful the advertisement of uses permitted by FIFRA section 2(ee) provided the product is not an antimicrobial pesticide targeted against human pathogens (see 51 FR 19174; May 28, 1986).
(c) For purposes of paragraph (b) of this section, a “prominent notice of the limitations on use” is one which sets forth the limitations on use in a manner reasonably likely to be understood by persons to whom the advertisement is addressed. For printed advertising, this criterion will be met by a legend in 6-point or larger type.
(a) This subpart describes the labeling requirements applicable to pesticide products and devices that are intended solely for export from the United States under the provisions of FIFRA section 17(a). The requirements for pesticide production reporting, recordkeeping and inspection and purchaser acknowledgement provisions can be found in the following parts:
(1) Pesticide production reporting requirements under FIFRA section 7 are located in part 167 of this chapter (as referenced in § 168.85(b));
(2) Recordkeeping and inspection requirements under FIFRA section 8 are located in part 169 of this chapter (as referenced in § 168.85(a));
(3) Purchaser acknowledgement statement provisions under FIFRA section 17(a) are located in § 168.75.
(b) The labeling of pesticide products and devices intended solely for export must comply with the requirements in § 156.10(a)(4) of this chapter.
(c) The labeling of pesticide products and devices intended solely for export must comply with this regulation no later than January 21, 2014.
Terms used in this subpart have the same meanings as in the Act and as in § 152.3 of this chapter, unless otherwise defined in this section.
This subpart applies to all export pesticide products and export pesticide devices that are exported for any purpose, including any research purpose.
(a) Each export pesticide product that is registered under FIFRA section 3 or FIFRA section 24(c) must bear labeling approved by EPA for its registration and comply with the requirements of § 168.66(b).
(b) For the purposes of this subpart, a registered export pesticide product is considered to be any of the following:
(1) A pesticide product of composition, packaging and labeling as described in its registration under FIFRA section 3;
(2) A pesticide product that has been modified in compliance with the notification or non-notification provisions of § 152.46 of this chapter, and any associated procedures issued under § 156.10(e) of this chapter, regardless of whether such modification has been made for the pesticide product's registration under FIFRA section 3;
(3) A pesticide product initially registered by a State under FIFRA section 24(c), and whose Federal registration has not been disapproved by EPA under § 162.164 of this chapter.
(c) The text of the labeling of the export pesticide product must be provided in English and, if applicable, the following foreign languages:
(1) The predominant or official language of the country of final destination, if known; and
(2) The predominant or official language of the importing country.
(a) Any export pesticide product that does not meet the terms of § 168.69 is an unregistered export pesticide product for purposes of this subpart.
(b) Each unregistered export pesticide product must bear labeling that complies with all requirements of this section and § 168.66(b).
(1) The labeling must comply with all of the prominence and legibility requirements of § 156.10(a)(2) of this chapter.
(2) The labeling must comply with all the language requirements in §§ 168.69(c) and 156.10(a)(3) of this chapter.
(3) The labeling must bear the following information:
(i) The name and address of the producer, in accordance with the requirements of § 156.10(c) of this chapter;
(ii) The net weight or measure of contents, in accordance with the requirements of § 156.10(d) of this chapter;
(iii) The pesticide producing establishment number, in accordance with the requirements of § 156.10(f) of this chapter;
(iv) An ingredients statement, in accordance with the requirements of § 156.10(g) of this chapter, except that:
(A) The ingredients statement need not appear in a second language besides English if English is the official or predominant language in the importing country and the country of final destination, if known; and
(B) An export pesticide product intended solely for research and development purposes, (and which bears the statement “For research and development purposes only. Not for distribution, sale, or use,” or similar language) may bear coded ingredient information to protect confidentiality.
(v) Human hazard and precautionary statements in accordance with the requirements of subpart D of part 156 of this chapter. The statements must be true and accurate translations of the English statements.
(vi) The statement “Not Registered for Use in the United States of America,” which may be amplified by additional statements accurately describing the reason(s) why the export pesticide product is not registered in the United States, or is not registered for particular uses in the United States.
(c) This section also applies to all unregistered pesticide products and devices that are intended solely for export and that are transferred, distributed, or sold between registered establishments operated by the same producer according to § 152.30(a) of this chapter if:
(1) The transfer, distribution or sale occurs between a point in the United States and a point outside the United States, or
(2) The transfer occurs within the United States solely for the purpose of export from the United States.
(a) Each export pesticide device sold or distributed anywhere in the United States must bear labeling that complies with all requirements of this section and § 168.66(b).
(b) The labeling of each export pesticide device must meet all of the prominence and legibility requirements of § 156.10(a)(2) of this chapter.
(c) The labeling must also comply with all the language requirements in § 168.69(c) and § 156.10(a)(3) of this chapter.
(d) The labeling must bear the following information:
(1) The name and address of the producer, meeting the requirements of § 156.10(c) of this chapter;
(2) The producing establishment number, meeting the requirements of § 156.10(f) of this chapter;
(3) The statement “Not Registered for Use in the United States of America,” which may be amplified by additional statements describing the reason why the export pesticide device is not registered in the United States, such as “because pesticide devices are not required to be registered in the United States.”
(e) An export pesticide device is not required to bear an ingredients statement.
This section describes how EPA interprets and will enforce requirements of FIFRA section 17(a)(2). Section 17(a)(2) provides that any person exporting a pesticide other than a pesticide registered for use under FIFRA section 3 or sold under FIFRA section 6(a)(1), shall obtain a statement signed by the foreign purchaser prior to export, acknowledging that the purchaser understands that such pesticide is not registered for use in the United States and cannot be sold in the United States. Section 17(a)(2) requires that a copy of the statement be transmitted to an appropriate official of the government of the importing country.
(a)
(b)
(1)
(2)
(ii) If an exporter needed to repackage a product in a size to meet a foreign purchaser's specifications, that modification would not affect the registration status of the export product. Other modifications to the label used for export purposes which will not affect the export product's registration status are: the use of metric units for net contents, dosages, and other numeric expressions; the use of a different format for the label, provided that the information does not contradict the U.S. label; revision of non-mandatory U.S. label statements, consistent with 40 CFR part 156, including additions or changes required by other Federal statutes or regulations; a change of the name or address of the registrant, except for a change resulting from transfer of ownership, which requires that a registrant keep his name and address current with the Agency; and any correction of typographical or printing errors that appeared on the U.S. labeling. (See § 152.46(b)).
(3)
(i) It is permissible to add explanatory language which accurately explains the meaning of a use classification. For example, the statement “restricted use pesticide” may be expanded to read: “Restricted in the United States of America to use by certified applicators” or “Restricted Use Pesticide. In The United States this product is restricted to use by applicators determined by each state to be competent in pesticide application and the human health and environmental consequences of misuse.” If the explanatory language falsely represents or is misleading regarding the U.S. use classification, the product will be considered misbranded. In addition, a use classification can only be listed if one has been assigned pursuant to the U.S. registration.
(ii) An exporter who is also the manufacturer of a U.S. registered pesticide may add new uses to the label of that product for export purposes, without triggering the requirements of section 17(a)(2), as long as the new uses are within the same general use patterns as those for the registered product. The general pesticide use patterns are: terrestrial food crop and terrestrial non-food crop; greenhouse food crop and greenhouse nonfood crop; aquatic food crop and aquatic nonfood crop' indoor use' and forestry use. Adding new uses to the label which change the use pattern, such as changes from nonfood to food use, outdoor to indoor use, or terrestrial to aquatic use, render the product unregistered and subject to the requirements of section 17 for unregistered products. If the new use added to the label is a food or feed use, a tolerance must already be established for the use of that pesticide in or on that commodity.
(4)
(i) The formula of the exported product is within certified limits of the formula of the U.S. registered product.
(ii) An exporter, who is also the manufacturer of a U.S. registered pesticide, may decrease the percentage of the active ingredient(s) of that product by adding a List 4 inert ingredient, without causing the product to be treated as “unregistered” and triggering the
(iii) A change in the color or fragrance of the export product will not affect the product's registration status as long as the following conditions are met. The change in color must result only from the addition of a dye included on the list of the chemicals exempted from the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the dye must not be a List 1 inert. (List 1 inerts are those inerts which the Agency has identified as presenting toxicological concerns. The classification of inerts is explained in EPA's Policy Statement on Inert Ingredients in Pesticide Products. The change in fragrance must result only from the addition of a chemical included on the list of the chemicals exempted from the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the chemical must not be a List 1 inert. The change in fragrance must not result in a pesticide product containing a food or food-like fragrance. (See “Food Fragrances in Pesticide Formulations,” EPA's Office of Pesticide Programs Policy and Criteria Notice number 2155.1, November 20, 1975.) Any difference in color or fragrance of the export product in accordance with this section must be reflected in records which show the complete formula of the export product in accordance with the requirements of § 169.2 and this policy.
(5)
(i) An unregistered pesticide product exported solely for research and development purposes will not be considered to be in violation of the notification requirements if the export of the research and development product:
(A) Would not involve land uses of more than 10 acres (4.05 hectares), or be used on or affect food or feed crops which are intended for consumption.
(B) Would not involve aquatic uses of more than 1 acre (0.405 hectares), or any aquatic uses which involve water used for irrigation, drinking or recreation, or be used on or affect plants or animals taken for food or feed from such waters.
(C) Would not involve tests on animals intended for food or feed.
(ii) Shipments to different purchasers, to different countries of final destination, or which occur more than a calendar year apart will be evaluated separately. When determining whether total shipments exceed the criteria described in this paragraph, EPA will evaluate the total amount of shipments by a single exporter during a calendar year for use in a particular country.
(iii) An exporter bears the burden of demonstrating that the product meets these criteria before the research product is shipped. This may be met by documenting before the product is shipped and maintaining records for the time period required by § 169.2(h) of this chapter from the date of the last shipment relevant to such records. The records to be maintained consist of:
(A) The identity of the purchaser and country of intended use of the research product.
(B) The amount shipped.
(C) The intended research use by the purchaser, including the type of application site, rate of application, and measures taken for protection of humans from direct or dietary exposure.
(c)
(1)
(i) Name, address, and EPA identification number, if applicable, of the exporter.
(ii) Name and address of the foreign purchaser.
(iii) Identity of the product and the active ingredient(s), including:
(A) The Chemical Abstract Services (CAS) Registry number for each active ingredient.
(B) The chemical nomenclature for each active ingredient as used by the International Union of Pure and Applied Chemists (IUPAC).
(C) Other known chemical or common names; or if the export involves a research product, a code name or identification number that can be used by EPA to identify the product from the exporter's records. If a code name or identification number is used, additional information must be attached to the certification statement submitted with the purchaser acknowledgement statement which will enable EPA to identify the product. This attached information may be claimed as confidential, and EPA will not forward this information with the purchaser acknowledgement statement to foreign governments.
(iv) If known or reasonably ascertainable, the country or countries of final destination of the export shipment,
(v) A statement that indicates that the foreign purchaser understands that the product is not registered for use in the United States and cannot be sold in the United States.
(vi) The signature of the foreign purchaser.
(vii) The date of the foreign purchaser's signature.
(2)
(i)
(A) Prior to each shipment in a calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, the exporter must provide the foreign purchaser with instructions about the required information on a purchaser acknowledgement statement, and inform the foreign purchaser that the pesticide product cannot be exported from the United States until the exporter has received from the foreign purchaser a properly completed, signed, and dated acknowledgment statement.
(B) The exporter must obtain, prior to each shipment in a calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, a signed purchaser acknowledgment statement which contains the information set forth in paragraph (c)(1) of this section.
(C) The exporter must sign a statement certifying that export did not
(D) The exporter must submit the signed acknowledgement statement from the foreign purchaser, and the accompanying certification by the exporter including attachments, to EPA within 7 working days of the exporter's receipt of the purchaser acknowledgement statement, or by the date of export, whichever occurs first. This information must be transmitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Purchaser Acknowledgement Statement.
(ii)
(A) Prior to the first shipment each calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, the exporter must provide the foreign purchaser with instructions about the required information on a purchaser acknowledgement statement, and inform the foreign purchaser that the pesticide product cannot be exported from the United States until the exporter has received from the foreign purchaser a properly completed, signed, and dated purchaser acknowledgement statement.
(B) The exporter must obtain, prior to the first shipment each calendar year of an unregistered pesticide product to a particular purchaser in a foreign country, a signed purchaser acknowledgement statement which contains the information set forth in paragraph (c)(1) of this section.
(C) The exporter must sign a statement certifying that export did not take place until a signed purchaser acknowledgement statement was received, indicating that this statement is for the first shipment to a particular purchaser in a specific country for that calendar year, and that the exporter will meet all the purchaser acknowledgement statement requirements as described in this paragraph (c)(2)(ii) of this section. The exporter must also specify the chemical identity of any research product which is referred to by code in the purchaser acknowledgement statement. The information regarding the specific identity of research products, which may be included in the statement or consist of an attachment to the certification, may be claimed as confidential.
(D) The exporter must submit the signed acknowledgement statement from the foreign purchaser, and the accompanying certification by the exporter including attachments, to EPA within 7 working days of the exporter's receipt of the purchaser acknowledgement statement, or by the date of export, whichever occurs first. This information must be transmitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Purchaser Acknowledgement Statement.
(E) The exporter, who has chosen to comply with the requirements of this paragraph instead of providing per-shipment purchaser acknowledgement statements in accordance with paragraph (c)(2)(i) of this section, must submit an annual summary report to EPA. An annual summary report is required for each unregistered pesticide exported within the preceding calendar year. The report must be in writing, signed by the exporter, and include the following information:
(
(
(
(
(
(F) The exporter shall submit the annual summary no later than March 1st of the following calendar year. The annual summary shall be sent to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: Annual Summary of Exports.
(iii)
(3)
(i) Copies of the instructions provided to foreign purchasers in accordance with paragraphs (c)(2)(i)(A) and (c)(2)(ii)(A) of this section.
(ii) Copies of signed purchaser acknowledgement statements obtained according to paragraphs (c)(2)(i)(B) and (c)(2)(ii)(B) of this section.
(iii) Copies of the certification from the exporter; and copies of any accompanying information regarding the identity of coded R&D products.
(d)
This section describes other requirements found in regulations that apply to exporters of pesticides, devices, and
(a)
(b)
7 U.S.C. 136f and 136w.
Terms used in this part shall have the meanings set forth for such terms in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, as used in this part, the following terms shall have the meanings set forth below:
(a)
(b)
(c)
(d)
(e)
All producers of pesticides, devices, or active ingredients used in producing pesticides subject to this Act, including pesticides produced pursuant to an experimental use permit and pesticides, devices, and pesticide active ingredients produced for export, shall maintain the following records:
(a) Records showing the product name, EPA Registration Number, Experimental Permit Number if the pesticide is produced under an Experimental Use Permit, amounts per batch and batch identification (numbers, letters, etc.) of all pesticides produced. In cases where the product is an active ingredient used in producing a pesticide or where the product is a pesticide which is not registered, is not the subject of an application for registration, or is not produced under an Experimental Use Permit, the records shall also show the complete formula. The batch identification shall appear on all production control records. These records shall be retained for a period of two (2) years.
(b) Records showing the brand names and quantities of devices produced. These records shall be retained for a period of two (2) years.
(c) Records showing the following information regarding the receipt, by the producer, of all pesticides, devices, and active ingredients used in producing pesticides:
(1) Brand name of the pesticide or device, or common or chemical name of the pesticide active ingredient;
(2) Name and address of shipper;
(3) Name of delivering carrier;
(4) Date received; and
(5) Quantities received.
(d) Records showing the following information regarding the shipment of all pesticides, devices, and active ingredients used in producing pesticides:
(1) Brand name of pesticide or device, or the common or chemical name of the pesticide active ingredient;
(2) Name and address of consignee;
(3) Where the pesticide is produced pursuant to an experimental use permit (FIFRA section 5), a special exemption (section 18), or a special local need (section 24), the information required under these sections and any regulations promulgated thereto regarding the distribution of such pesticides;
(4) Name of originating carrier;
(5) Date shipped or delivered for shipment; and
(6) Quantities shipped or delivered for shipment.
(e) Inventory records with respect to the types and amounts of pesticides or pesticide active ingredients, or quantities of devices in stock which he has produced. These records may be disposed of when a more current inventory record is prepared.
(f) Copies of all domestic advertising of the restricted uses of any pesticide registered for restricted use which the producer caused to have prepared, including any radio or television scripts for all such pesticides. These records shall be retained for a period of two (2) years.
(g) Copies of all guarantees given pursuant to section 12(a)(2)(C) of the Act. These records shall be retained for a period of one (1) year after expiration of the guarantee.
(h) In the case of all pesticides, devices, and active ingredients used in producing pesticides intended solely for export to any foreign country:
(1) Copies of the specification or directions of the foreign purchaser for the production of such pesticides, devices, or pesticide active ingredients;
(2) Copies of labels or labeling required to comply with section 17(a)(1) of the Act; and
(3) For any pesticide other than a pesticide registered under section 3 or sold under section 6(a)(1) of the Act, copies of a statement signed by the foreign purchaser of the pesticide acknowledging that the purchaser understands that such pesticide is not registered for use in the United States and
(i) Records on the method of disposal (burial, incineration, etc.) date or dates of disposal, location of the disposal sites, and the types and amounts of pesticides or pesticide active ingredients disposed of by the producer or his contractor. With regard to the disposal of containers accumulated during production, the Agency will consider satisfactory a statement, attested to by a responsible firm official, describing in general terms the method and location of disposal, e.g., all containers are taken periodically to a certain site. Records of deviations from normal practice must be maintained. In addition, any records on the disposal of pesticides or pesticide active ingredients and/or containers specified pursuant to section 19 of the Act and any regulations promulgated thereto shall also be maintained. The above requirements apply to those products bearing label instructions for disposal and to any other products specified under any regulations promulgated pursuant to section 19. These records shall be retained for twenty (20) years or may be forwarded after three (3) years to the Environmental Protection Agency Regional Administrator for maintenance. Notwithstanding these record keeping requirements, whenever any producer of pesticides or pesticide active ingredients is complying with a rule promulgated under the authority of the Resource Conservation and Recovery Act of 1976 (RCRA) (Pub. L. 94-580, 90 Stat. 2795, October 21, 1976), for the handling or disposal of hazardous wastes, as defined by RCRA or any regulations promulgated thereunder, such producer will no longer be required to maintain records in accordance with this subsection.
(j) Records of any tests conducted on human beings whether performed by the producer himself or authorized and/or paid for by the producer. Such records shall include: The names and addresses of subjects tested, dates of tests, types of tests, written consent of subjects to test, and all information and instructions given to the subjects regarding the nature and purpose of the tests and of any physical and mental health consequences which were reasonably foreseen therefrom, and any adverse effects of the test on the subjects, including any such effects coming to the attention of the producer after completion of the tests. These records shall be retained for twenty (20) years or may be forwarded after three (3) years to the Environmental Protection Agency Regional Administrator for maintenance.
(k) Records containing research data relating to registered pesticides including all test reports submitted to the Agency in support of registration or in support of a tolerance petition,
(a)
(b) Distributors, carriers, dealers, etc. Any distributor, carrier, dealer, or any other person who sells or offers for sale, delivers or offers for delivery any pesticide, device, or active ingredient used in producing a pesticide which is subject to this Act, shall, upon request of any officer or employee of the Agency or of any State or political subdivision, duly designated by the Administrator, furnish or permit such person
(c)
(d)
(2) Where no such inability exists and any such person fails to give access to and permit copying of such records as required, such failure shall be deemed a refusal to keep records required or a refusal to allow the inspection of any such records or both.
7 U.S.C. 136w.
This part contains a standard designed to reduce the risks of illness or injury resulting from workers' and handlers' occupational exposures to pesticides used in the production of agricultural plants on farms or in nurseries, greenhouses, and forests and also from the accidental exposure of workers and other persons to such pesticides. It requires workplace practices designed to reduce or eliminate exposure to pesticides and establishes procedures for responding to exposure-related emergencies.
Terms used in this part have the same meanings they have in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In addition, the following terms, when used in this part, shall have the following meanings:
(1) Employs any person, including a self-employed person, to apply on an agricultural establishment, pesticides used in the production of agricultural plants.
(2) Employs any person, including a self-employed person, to perform on an agricultural establishment, tasks as a crop advisor.
(1) Who is employed for any type of compensation by an agricultural establishment or commercial pesticide handling establishment to which subpart C of this part applies and who is:
(i) Mixing, loading, transferring, or applying pesticides.
(ii) Disposing of pesticides or pesticide containers.
(iii) Handling opened containers of pesticides.
(iv) Acting as a flagger.
(v) Cleaning, adjusting, handling, or repairing the parts of mixing, loading, or application equipment that may contain pesticide residues.
(vi) Assisting with the application of pesticides.
(vii) Entering a greenhouse or other enclosed area after the application and before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria established by this part (§ 170.110(c)(3)) or in the labeling has been met:
(A) To operate ventilation equipment.
(B) To adjust or remove coverings used in fumigation.
(C) To monitor air levels.
(viii) Entering a treated area outdoors after application of any soil fumigant to adjust or remove soil coverings such as tarpaulins.
(ix) Performing tasks as a crop advisor:
(A) During any pesticide application.
(B) Before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria established by this part (§ 170.110(c)(3)) or in the labeling has been met.
(C) During any restricted-entry interval.
(2) The term does not include any person who is only handling pesticide containers that have been emptied or cleaned according to pesticide product labeling instructions or, in the absence of such instructions, have been subjected to triple-rinsing or its equivalent.
(a)
(1) Assure that each worker subject to subpart B of this part or each handler subject to subpart C of this part receives the protections required by this part.
(2) Assure that any pesticide to which subpart C of this part applies is used in a manner consistent with the labeling of the pesticide, including the requirements of this part.
(3) Provide, to each person who supervises any worker or handler, information and directions sufficient to assure that each worker or handler receives the protections required by this part. Such information and directions shall specify which persons are responsible for actions required to comply with this part.
(4) Require each person who supervises any worker or handler to assure compliance by the worker or handler with the provisions of this part and to assure that the worker or handler receives the protections required by this part.
(b)
(a) Under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136
(1) Preapplication activities, including, but not limited to:
(i) Arranging for the application of the pesticide;
(ii) Mixing and loading the pesticide; and
(iii) Making necessary preparations for the application of the pesticide, including responsibilities related to worker notification, training of handlers, decontamination, use and care of personal protective equipment, emergency information, and heat stress management.
(2) Application of the pesticide.
(3) Post-application activities necessary to reduce the risks of illness and injury resulting from handlers' and workers' occupational exposures to pesticide residues during the restricted-entry interval plus 30 days. These activities include, but are not limited to, responsibilities related to worker training, notification, and decontamination.
(4) Other pesticide-related activities, including, but not limited to, providing emergency assistance, transporting or storing pesticides that have been opened, and disposing of excess pesticides, spray mix, equipment wash waters, pesticide containers, and other pesticide-containing materials.
(b) A person who has a duty under this part, as referenced on the pesticide product label, and who fails to perform that duty, violates FIFRA section 12(a)(2)(G) and is subject to a civil penalty under section 14. A person who knowingly violates section 12(a)(2)(G) is subject to section 14 criminal sanctions.
(c) FIFRA section 14(b)(4) provides that a person is liable for a penalty under FIFRA if another person employed by or acting for that person violates any provision of FIFRA. The term “acting for” includes both employment and contractual relationships.
(d) The requirements of this part, including the decontamination requirements, shall not, for the purposes of section 653(b)(1) of title 29 of the U.S. Code, be deemed to be the exercise of statutory authority to prescribe or enforce standards or regulations affecting the general sanitary hazards addressed by the OSHA Field Sanitation Standard, 29 CFR 1928.110, or other agricultural, nonpesticide hazards.
Except as provided by §§ 170.103 and 170.104, this subpart applies when any pesticide product is used on an agricultural establishment in the production of agricultural plants.
(a) For mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored by governmental entities;
(b) On livestock or other animals, or in or about animal premises;
(c) On plants grown for other than commercial or research purposes, which may include plants in habitations, home fruit and vegetable gardens, and home greenhouses;
(d) On plants that are in ornamental gardens, parks, and public or private lawns and grounds that are intended only for aesthetic purposes or climatic modification;
(e) By injection directly into agricultural plants. Direct injection does not include “hack and squirt,” “frill and spray,” chemigation, soil-incorporation, or soil-injection;
(f) In a manner not directly related to the production of agricultural plants, including, but not limited to, structural pest control, control of vegetation along rights-of-way and in other noncrop areas, and pasture and rangeland use;
(g) For control of vertebrate pests;
(h) As attractants or repellents in traps;
(i) On the harvested portions of agricultural plants or on harvested timber; and
(j) For research uses of unregistered pesticides.
The workers listed in this section are exempt from the specified provisions of this subpart.
(a)
(i) Section 170.112(c)(5) through (9).
(ii) Section 170.112(c)(5) through (9) as referenced in §§ 170.112(d)(2)(iii) and 170.112(e).
(iii) Section 170.120.
(iv) Section 170.122.
(v) Section 170.130.
(vi) Section 170.135.
(vii) Section 170.150.
(viii) Section 170.160.
(2) The owner of the agricultural establishment must provide the protections listed in paragraph (a)(1)(i) through (viii) of this section to other workers and other persons who are not members of his immediate family.
(b)
(i) Section 170.150.
(ii) Section 170.160.
(2) Conditions of exemption. (i) The certification or licensing program requires pesticide safety training that includes, at least, all the information in § 170.230(c)(4).
(ii) Applies only when performing crop advising tasks in the treated area.
(iii) The crop advisor must make specific determinations regarding the appropriate personal protective equipment, appropriate decontamination supplies, and how to conduct the tasks safely. The crop advisor must convey this information to each person under his direct supervision in a language that the person understands.
(iv) Before entering a treated area, the certified or licensed crop advisor must inform, through an established practice of communication, each person under his direct supervision of the pesticide product and active ingredient(s) applied, method of application, time of application, the restricted entry interval, which tasks to undertake, and how to contact the crop advisor.
(a)
(b)
(c)
(2) After the time specified in column C of Table 2 under paragraph (c)(4) of this section has expired, until the expiration of any restricted-entry interval, the agricultural employer shall not allow or direct any worker to enter or to remain in the treated area as specified in column D of Table 2 under paragraph (c)(4) of this section, except as provided in § 170.112.
(3) When column C of Table 2 under paragraph (c)(4) of this section specifies that ventilation criteria must be met, ventilation shall continue until the air concentration is measured to be equal to or less than the inhalation exposure level the labeling requires to be achieved. If no inhalation exposure level is listed on the labeling, ventilation shall continue until after:
(i) Ten air exchanges are completed; or
(ii) Two hours of ventilation using fans or other mechanical ventilating systems; or
(iii) Four hours of ventilation using vents, windows or other passive ventilation; or
(iv) Eleven hours with no ventilation followed by 1 hour of mechanical ventilation; or
(v) Eleven hours with no ventilation followed by 2 hours of passive ventilation; or
(vi) Twenty-four hours with no ventilation.
(4) The following Table 2 applies to paragraphs (c) (1), (2), and (3) of this section.
(a)
(2) Entry-restricted areas in greenhouses are specified in column D in table 2 under § 170.110(c)(4).
(3) When two or more pesticides are applied at the same time, the restricted-entry interval shall be the longest of the applicable intervals.
(4) The agricultural employer shall assure that any worker who enters a treated area under a restricted-entry interval as permitted by paragraphs (c), (d), and (e) of this section uses the personal protective equipment specified in the product labeling for early-entry workers and follows any other requirements on the pesticide labeling regarding early entry.
(b)
(1) The worker will have no contact with anything that has been treated with the pesticide to which the restricted-entry interval applies, including, but not limited to, soil, water, air, or surfaces of plants; and
(2) No such entry is allowed until any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by § 170.110(c)(3) or in the labeling have been met.
(c)
(1) No hand labor activity is performed.
(2) The time in treated areas under a restricted-entry interval for any worker does not exceed 1 hour in any 24-hour period.
(3) No such entry is allowed for the first 4 hours following the end of the application, and no such entry is allowed thereafter until any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by § 170.110(c)(3) or in the labeling have been met.
(4) The personal protective equipment specified on the product labeling
(i) Personal protective equipment (PPE) means devices and apparel that are worn to protect the body from contact with pesticides or pesticide residues, including, but not limited to, coveralls, chemical-resistant suits, chemical-resistant gloves, chemical-resistant footwear, respiratory protection devices, chemical-resistant aprons, chemical-resistant headgear, and protective eyewear.
(ii) Long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes, socks, and other items of work clothing are not considered personal protective equipment for the purposes of this section and are not subject to the requirements of this section, although pesticide labeling may require that such work clothing be worn during some activities.
(iii) When “chemical-resistant” personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of the pesticide being used through the material during use.
(iv) When “waterproof” personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of water or aqueous solutions through the material during use.
(v) When a “chemical-resistant suit” is specified by the product labeling, it shall be a loose-fitting, one- or two-piece, chemical-resistant garment that covers, at a minimum, the entire body except head, hands, and feet.
(vi) When “coveralls” are specified by the product labeling, they shall be a loose-fitting, one- or two-piece garment, such as a cotton or cotton and polyester coverall, that covers, at a minimum, the entire body except head, hands, and feet. The pesticide product labeling may specify that the coveralls be worn over a layer of clothing. If a chemical-resistant suit is substituted for coveralls, it need not be worn over a layer of clothing.
(vii)(A) Gloves shall be of the type specified on the pesticide product labeling. Gloves made of leather, cotton, or other absorbent materials must not be worn for early-entry activities, unless gloves made of these materials are listed as acceptable for such use on the product labeling. If chemical-resistant gloves with sufficient durability and suppleness are not obtainable, leather gloves may be worn on top of chemical-resistant gloves. However, once leather gloves have been worn for this use, they shall not be worn thereafter for any other purpose, and they shall only be worn over chemical-resistant gloves.
(B) Separable glove liners may be worn beneath chemical-resistant gloves, unless the pesticide product labeling specifically prohibits their use. Separable glove liners are defined as separate glove-like hand coverings made of lightweight material, with or without fingers. Work gloves made from lightweight cotton or poly-type material are considered to be glove liners if worn beneath chemical-resistant gloves. Separable glove liners may not extend outside the chemical-resistant gloves under which they are worn. Chemical-resistant gloves with non-separable absorbent lining materials are prohibited.
(C) If used, separable glove liners must be discarded immediately after a total of no more than 10 hours of use or within 24 hours of when first put on, whichever comes first. The liners must be replaced immediately if directly contacted by pesticide. Used glove liners shall not be reused. Contaminated liners must be disposed of in accordance with any Federal, State, or local regulations.
(viii) When “chemical-resistant footwear” is specified by the product labeling, it shall be one of the following types of footwear: chemical-resistant shoes, chemical-resistant boots, or chemical-resistant shoe coverings worn over shoes or boots. If chemical-resistant footwear with sufficient durability and a tread appropriate for wear in rough terrain is not obtainable for workers, then leather boots may be worn in such terrain.
(ix) When “protective eyewear” is specified by the product labeling, it shall be one of the following types of eyewear: goggles; face shield; safety glasses with front, brow, and temple protection; or a full-face respirator.
(x) When “chemical-resistant headgear” is specified by the product labeling, it shall be either a chemical-resistant hood or a chemical-resistant hat with a wide brim.
(5) The agricultural employer shall assure that the worker, before entering the treated area, either has read the product labeling or has been informed, in a manner that the worker can understand, of all labeling requirements related to human hazards or precautions, first aid, symptoms of poisoning, personal protective equipment specified for early entry, and any other labeling requirements related to safe use.
(6) The agricultural employer shall assure that:
(i) Workers wear the personal protective equipment correctly for its intended purpose and use personal protective equipment according to manufacturer's instructions.
(ii) Before each day of use, all personal protective equipment is inspected for leaks, holes, tears, or worn places, and any damaged equipment is repaired or discarded.
(iii) Personal protective equipment that cannot be cleaned properly is disposed of in accordance with any applicable Federal, State, and local regulations.
(iv) All personal protective equipment is cleaned according to manufacturer's instructions or pesticide product labeling instructions before each day of reuse. In the absence of any such instructions, it shall be washed thoroughly in detergent and hot water.
(v) Before being stored, all clean personal protective equipment is dried thoroughly or is put in a well-ventilated place to dry.
(vi) Personal protective equipment contaminated with pesticides is kept separately and washed separately from any other clothing or laundry.
(vii) Any person who cleans or launders personal protective equipment is informed that such equipment may be contaminated with pesticides, of the potentially harmful effects of exposure to pesticides, and of the correct way(s) to handle and clean personal protective equipment and to protect themselves when handling equipment contaminated with pesticides.
(viii) All clean personal protective equipment is stored separately from personal clothing and apart from pesticide-contaminated areas.
(ix) Each worker is instructed how to put on, use, and remove the personal protective equipment and is informed about the importance of washing thoroughly after removing personal protective equipment.
(x) Each worker is instructed in the prevention, recognition, and first aid treatment of heat-related illness.
(xi) Workers have a clean place(s) away from pesticide-storage and pesticide-use areas for storing personal clothing not in use; putting on personal protective equipment at the start of any exposure period; and removing personal protective equipment at the end of any exposure period.
(7) When personal protective equipment is required by the labeling of any pesticide for early entry, the agricultural employer shall assure that no worker is allowed or directed to perform the early-entry activity without implementing, when appropriate, measures to prevent heat-related illness.
(8) During any early-entry activity, the agricultural employer shall provide a decontamination site in accordance with § 170.150.
(9) The agricultural employer shall not allow or direct any worker to wear home or to take home personal protective equipment contaminated with pesticides.
(d)
(2) A worker may enter a treated area under a restricted-entry interval in an agricultural emergency to perform tasks, including hand labor tasks, necessary to mitigate the effects of the agricultural emergency, if the agricultural employer assures that all the following criteria are met:
(i) A State, Tribal, or Federal Agency having jurisdiction declares the existence of circumstances that could cause an agricultural emergency on that agricultural establishment.
(ii) The agricultural employer determines the agricultural establishment is subject to the circumstances declared under paragraph (d)(2)(i) of this section that result in an agricultural emergency meeting the criteria of paragraph (d)(1) of this section.
(iii) The requirements of paragraphs (c) (3) through (9) of this section are met.
(e)
(1)
(i) The name, address, and telephone number of the submitter.
(ii) The time period for which the exception is requested.
(iii) A description of the crop(s) and specific crop production task(s) for which the exception is requested. Such a description must include an explanation as to the necessity of applying pesticides of a type and at a frequency such that the restricted-entry interval would interfere with necessary and time-sensitive hand labor tasks for the period for which the exception is sought.
(iv) A description of the geographic area for which the exception is requested. If the exception request is for a limited geographic area, the explanation must include a description as to why the circumstances of exposure or economic impact resulting from the prohibition of routine hand labor tasks during the restricted-entry interval are unique to the geographic area named in the exception.
(v) An explanation as to why, for each requested crop-task combination, alternative practices would not be technically or financially viable. Such alternative practices might include: rescheduling the pesticide application or hand labor activity; using a non-chemical pest control alternative; using an alternative to the hand labor tasks, such as machine cultivation; or substituting a pesticide with a shorter restricted-entry interval. This information should include estimates or data on per acre revenue and cost of production for the crop and area for which the exception is requested. These estimates or data should include: the situation prior to implementation of this final rule, the situation after implementation of this final rule if the exception is not granted, the situation after implementation of this final rule if the exception is granted, and specific information on individual factors which cause differences in revenues and costs among the three situations.
(vi) A description or documentation of the safety and feasibility of such an exception, including, but not limited to, the feasibility of performing the necessary hand labor activity while wearing the personal protective equipment required for early entry for the pesticide(s) expected to be applied, the means of mitigating heat-related illness concerns, the period of time required daily per worker to perform the hand labor activity, any suggested methods of reducing the worker's exposure, and any other mitigating factors, such as the availability of running water for routine and emergency decontamination and mechanical devices that would reduce the workers' contact
(2)
(ii) If a request for an exception is submitted to the Agency without all of the information required in paragraph (e)(1) of this section, the Agency shall return the request to the submitter.
(3)
(4)
(ii) Persons requesting an exception may not assume that the request has been denied as provided by paragraph (e)(4)(i) of this section if the Agency has taken action to extend its review period for a specified time interval due to the complexity of the exception request or to the number of exception requests concurrently under Agency review. EPA shall state the reason(s) for the delay in issuing a decision on the exception request. A notice of such an action may be published in the
(5)
(6)
(7)
(i) Exception to perform irrigation tasks under specified conditions published in the
(ii) Exceptions to perform limited contact tasks under specified conditions published in the
(a)
(1) All pesticide applications shall be posted in accordance with paragraph (c) of this section.
(2) If the pesticide product labeling has a statement requiring both the posting of treated areas and oral notification to workers, the agricultural employer shall also provide oral notification of the application to the worker in accordance with paragraph (d) of this section.
(3) Notice need not be given to a worker if the agricultural employer can assure that one of the following is met:
(i) From the start of the application until the end of the application and during any restricted-entry interval, the worker will not enter, work in, remain in, or pass through the greenhouse; or
(ii) The worker applied (or supervised the application of) the pesticide for which the notice is intended and is aware of all information required by paragraphs (d)(1) through (3) of this section.
(b)
(1) If the pesticide product labeling has a statement requiring both the posting of treated areas and oral notification to workers, the agricultural employer shall post signs in accordance with paragraph (c) of this section and shall provide oral notification of the application to the worker in accordance with paragraph (d) of this section.
(2) For any pesticide other than those for which the labeling requires both posting and oral notification of applications, the agricultural employer shall give notice of the application to the worker either by the posting of warning signs in accordance with paragraph (c) of this section or orally in accordance with paragraph (d) of this section, and shall inform the workers as to which method of notification is in effect.
(3) Notice need not be given to a worker if the agricultural employer can assure that one of the following is met:
(i) From the start of the application until the end of the application and during any restricted-entry interval, the worker will not enter, work in, remain in, or pass through on foot the treated area or any area within
(ii) The worker applied (or supervised the application of) the pesticide for which the notice is intended and is aware of all information required by (d)(1) through (3) of this section.
(c)
(1) The warning sign shall have a background color that contrasts with red. The words “DANGER” and “PELIGRO,” plus “PESTICIDES” and “PESTICIDAS,” shall be at the top of the sign, and the words “KEEP OUT” and “NO ENTRE” shall be at the bottom of the sign. Letters for all words must be clearly legible. A circle containing an upraised hand on the left and a stern face on the right must be near the center of the sign. The inside of the circle must be red, except that the hand and a large portion of the face must be in a shade that contrasts with red. The length of the hand must be at least twice the height of the smallest letters. The length of the face must be only slightly smaller than the hand. Additional information such as the name of the pesticide and the date of application may appear on the warning sign if it does not detract from the appearance of the sign or change the meaning of the required information. A
(2) The standard sign shall be at least 14 inches by 16 inches with letters at least 1 inch in height. Farms and forests shall use the standard size sign unless a smaller sign is necessary because the treated area is too small to accommodate a sign of this size. In nurseries
(3) The employer may replace the Spanish portion of the warning sign with a non-English language read by the largest group of workers who do not read English. The replacement sign must be in the same format as the original sign and be visible and legible.
(4) On farms and in forests and nurseries, the signs shall be visible from all usual points of worker entry to the treated area, including at least each access road, each border with any labor camp adjacent to the treated area, and each footpath and other walking route that enters the treated area. When there are no usual points of worker entry, signs shall be posted in the corners of the treated area or in any other location affording maximum visibility.
(5) In greenhouses, the signs shall be posted so they are visible from all usual points of worker entry to the treated area including each aisle or other walking route that enters the treated area. When there are no usual points of worker entry to the treated area, signs shall be posted in the corners of the treated area or in any other location affording maximum visibility.
(6) The signs shall:
(i) Be posted no sooner than 24 hours before the scheduled application of the pesticide.
(ii) Remain posted throughout the application and any restricted-entry interval.
(iii) Be removed within 3 days after the end of the application and any restricted-entry interval and before agricultural-worker entry is permitted, other than entry permitted by § 170.112.
(7) The signs shall remain visible and legible during the time they are posted.
(8) When several contiguous areas are to be treated with pesticides on a rotating or sequential basis, the entire area may be posted. Worker entry, other than entry permitted by § 170.112, is prohibited for the entire area while the signs are posted.
(d)
(1) The location and description of the treated area.
(2) The time during which entry is restricted.
(3) Instructions not to enter the treated area until the restricted-entry interval has expired.
When workers are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the agricultural employer shall display, in accordance with this section, specific information about the pesticide.
(a)
(b)
(2) The information shall be posted before the application takes place, if workers will be on the establishment during application. Otherwise, the information shall be posted at the beginning of any worker's first work period.
(3) The information shall continue to be displayed for at least 30 days after the end of the restricted-entry interval (or, if there is no restricted-entry interval, for at least 30 days after the end of the application) or at least until workers are no longer on the establishment, whichever is earlier.
(c)
(1) The location and description of the treated area.
(2) The product name, EPA registration number, and active ingredient(s) of the pesticide.
(3) The time and date the pesticide is to be applied.
(4) The restricted-entry interval for the pesticide.
Whenever handlers who are employed by a commercial pesticide handling establishment will be performing pesticide handling tasks on an agricultural establishment, the agricultural employer shall provide to the handler employer, or assure that the handler employer is aware of, the following information concerning any areas on the agricultural establishment that the handler may be in (or may walk within
(a) Specific location and description of any such areas; and
(b) Restrictions on entering those areas.
(a)
(2)
(3)
(ii)
(b)
(1) A worker who is currently certified as an applicator of restricted-use
(2) A worker who satisfies the training requirements of part 171 of this chapter.
(3) A worker who satisfies the handler training requirements of § 170.230(c).
(4) A worker who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, provided that a requirement for such certification or licensing is pesticide safety training that includes all the information set out in § 170.230(c)(4).
(c)
(1) Pesticides may be on or in plants, soil, irrigation water, or drifting from nearby applications.
(2) Prevent pesticides from entering your body by:
(i) Following directions and/or signs about keeping out of treated or restricted areas.
(ii) Washing before eating, drinking, using chewing gum or tobacco, or using the toilet.
(iii) Wearing work clothing that protects the body from pesticide residues.
(iv) Washing/showering with soap and water, shampoo hair, and put on clean clothes after work.
(v) Washing work clothes separately from other clothes before wearing them again.
(vi) Washing immediately in the nearest clean water if pesticides are spilled or sprayed on the body. As soon as possible, shower, shampoo, and change into clean clothes.
(3) Further training will be provided within 5 days.
(d)
(2) The person who conducts the training shall meet at least one of the following criteria:
(i) Be currently certified as an applicator of restricted-use pesticides under part 171 of this chapter; or
(ii) Be currently designated as a trainer of certified applicators or pesticide handlers by a State, Federal, or Tribal agency having jurisdiction; or
(iii) Have completed a pesticide safety train-the-trainer program approved by a State, Federal, or Tribal agency having jurisdiction; or
(iv) Satisfy the training requirements in part 171 of this chapter or in § 170.230(c).
(3) Any person who issues an EPA-approved Worker Protection Standard worker training certificate must assure that the worker who receives the training certificate has been trained in accordance with paragraph (d)(4) of this section.
(4) The training materials shall convey, at a minimum, the following information:
(i) Where and in what form pesticides may be encountered during work activities.
(ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.
(iii) Routes through which pesticides can enter the body.
(iv) Signs and symptoms of common types of pesticide poisoning.
(v) Emergency first aid for pesticide injuries or poisonings.
(vi) How to obtain emergency medical care.
(vii) Routine and emergency decontamination procedures, including emergency eyeflushing techniques.
(viii) Hazards from chemigation and drift.
(ix) Hazards from pesticide residues on clothing.
(x) Warnings about taking pesticides or pesticide containers home.
(xi) Requirements of this subpart designed to reduce the risks of illness or injury resulting from workers' occupational exposure to pesticides, including application and entry restrictions, the design of the warning sign, posting of
(e)
(2) If the agricultural employer is aware or has reason to know that an EPA-approved Worker Protection Standard worker training certificate has not been issued in accordance with this section, or has not been issued to the worker bearing the certificate, or the training was completed more than 5 years before the beginning of the current month, a worker's possession of that certificate does not meet the requirements of paragraph (a) of this section.
(a)
(b)
(1) Help keep pesticides from entering your body. At a minimum, the following points shall be conveyed:
(i) Avoid getting on your skin or into your body any pesticides that may be on plants and soil, in irrigation water, or drifting from nearby applications.
(ii) Wash before eating, drinking, using chewing gum or tobacco, or using the toilet.
(iii) Wear work clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and socks, and a hat or scarf).
(iv) Wash/shower with soap and water, shampoo hair, and put on clean clothes after work.
(v) Wash work clothes separately from other clothes before wearing them again.
(vi) Wash immediately in the nearest clean water if pesticides are spilled or sprayed on the body. As soon as possible, shower, shampoo, and change into clean clothes.
(vii) Follow directions about keeping out of treated or restricted areas.
(2) There are Federal rules to protect workers and handlers, including a requirement for safety training.
(c)
(2) The agricultural employer shall inform workers promptly of any change to the information on emergency medical care facilities.
(d)
(2) The information shall be displayed in a location in or near the forest in a place where it can be readily seen and read by workers and where workers are likely to congregate or pass by, such as at a decontamination site or an equipment storage site.
(e)
(f)
(a)(1)
(i) Any worker on the agricultural establishment is performing an activity in the area where a pesticide was applied or a restricted-entry interval (REI) was in effect within the last 30 days, and;
(ii) The worker contacts anything that has been treated with the pesticide, including, but not limited to
(2)
(b)
(2) When water stored in a tank is to be used for mixing pesticides, it shall not be used for decontamination or eyeflushing, unless the tank is equipped with properly functioning valves or other mechanisms that prevent movement of pesticides into the tank.
(3) The agricultural employer shall provide soap and single-use towels in quantities sufficient to meet worker's needs.
(4) To provide for emergency eyeflushing, the agricultural employer shall assure that at least 1 pint of water is immediately available to each worker who is performing early-entry activities permitted by § 170.112 and for which the pesticide labeling requires protective eyewear. The eyeflush water shall be carried by the early-entry worker, or shall be on the vehicle the early-entry worker is using, or shall be otherwise immediately accessible.
(c)
(2) For worker activities performed more than
(i) The soap, single-use towels, and water may be at the nearest place of vehicular access.
(ii) The agricultural employer may permit workers to use clean water from springs, streams, lakes, or other sources for decontamination at the remote work site, if such water is more accessible than the water located at the nearest place of vehicular access.
(3) The decontamination supplies shall not be maintained in an area being treated with pesticides.
(4) The decontamination supplies shall not be maintained in an area that is under a restricted-entry interval, unless the workers for whom the supplies are provided are performing early-entry activities permitted by § 170.112 and involving contact with treated surfaces and the decontamination supplies would otherwise not be reasonably accessible to those workers.
(d)
If there is reason to believe that a person who is or has been employed on an agricultural establishment to perform tasks related to the production of agricultural plants has been poisoned or injured by exposure to pesticides used on the agricultural establishment, including, but not limited to, exposures from application, splash, spill, drift, or pesticide residues, the agricultural employer shall:
(a) Make available to that person prompt transportation from the agricultural establishment, including any labor camp on the agricultural establishment, to an appropriate emergency medical facility.
(b) Provide to that person or to treating medical personnel, promptly upon
(1) Product name, EPA registration number, and active ingredients of any product to which that person might have been exposed.
(2) Antidote, first aid, and other medical information from the product labeling.
(3) The circumstances of application or use of the pesticide on the agricultural establishment.
(4) The circumstances of exposure of that person to the pesticide.
Except as provided by §§ 170.203 and 170.204, this subpart applies when any pesticide is handled for use on an agricultural establishment.
(a) For mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored by governmental entities.
(b) On livestock or other animals, or in or about animal premises.
(c) On plants grown for other than commercial or research purposes, which may include plants in habitations, home fruit and vegetable gardens, and home greenhouses.
(d) On plants that are in ornamental gardens, parks, and public or private lawns and grounds and that are intended only for aesthetic purposes or climatic modification.
(e) In a manner not directly related to the production of agricultural plants, including, but not limited to, structural pest control, control of vegetation along rights-of-way and in other noncrop areas, and pasture and rangeland use.
(f) For control of vertebrate pests.
(g) As attractants or repellents in traps.
(h) On the harvested portions of agricultural plants or on harvested timber.
(i) For research uses of unregistered pesticides.
The handlers listed in this section are exempt from the specified provisions of this subpart.
(a)
(i) Section 170.210(b) and (c).
(ii) Section 170.222.
(iii) Section 170.230.
(iv) Section 170.232.
(v) Section 170.234.
(vi) Section 170.235.
(vii) Section 170.240(e) through (g).
(viii) Section 170.250.
(ix) Section 170.260.
(2) The owner of the agricultural establishment must provide the protections listed in paragraphs (a)(1) (i) through (ix) of this section to other handlers and other persons who are not members of his immediate family.
(b)
(i) Section 170.232.
(ii) Section 170.240.
(iii) Section 170.250.
(iv) Section 170.260.
(2)
(ii) No entry into the treated area occurs until after application ends.
(iii) Applies only when performing crop advising tasks in the treated area.
(iv) The crop advisor must make specific determinations regarding the appropriate PPE, appropriate decontamination supplies, and how to conduct the tasks safely. The crop advisor must convey this information to each person under his direct supervision in a language that the person understands.
(v) Before entering a treated area, the certified or licensed crop advisor must inform, through an established practice of communication, each person under his direct supervision of the pesticide products and active ingredient(s) applied, method of application, time of application, the restricted entry interval, which tasks to undertake, and how to contact the crop advisor.
(a)
(b)
(c)
(1) That any handler who handles a fumigant in a greenhouse, including a handler who enters the greenhouse before the acceptable inhalation exposure level or ventilation criteria have been met to monitor air levels or to initiate ventilation, maintains continuous visual or voice contact with another handler.
(2) That the other handler has immediate access to the personal protective equipment required by the fumigant labeling for handlers in the event entry into the fumigated greenhouse becomes necessary for rescue.
When handlers (except those employed by a commercial pesticide handling establishment) are on an agricultural establishment and, within the last 30 days, a pesticide covered by this subpart has been applied on the establishment or a restricted-entry interval has been in effect, the handler employer shall display, in accordance with this section, specific information about the pesticide.
(a)
(b)
(2) The information shall be posted before the application takes place, if handlers (except those employed by a commercial pesticide handling establishment) will be on the establishment during application. Otherwise, the information shall be posted at the beginning of any such handler's first work period.
(3) The information shall continue to be displayed for at least 30 days after the end of the restricted-entry interval (or, if there is no restricted-entry interval, for at least 30 days after the end of the application) or at least until the handlers are no longer on the establishment, whichever is earlier.
(c)
(1) The location and description of the treated area.
(2) The product name, EPA registration number, and active ingredient(s) of the pesticide.
(3) The time and date the pesticide is to be applied.
(4) The restricted-entry interval for the pesticide.
Before the application of any pesticide on or in an agricultural establishment, the handler employer shall provide the following information to any agricultural employer for the establishment or shall assure that any agricultural employer is aware of:
(a) Specific location and description of the treated area.
(b) Time and date of application.
(c) Product name, EPA registration number, and active ingredient(s).
(d) Restricted-entry interval.
(e) Whether posting and oral notification are required.
(f) Any other product-specific requirements on the product labeling concerning protection of workers or other persons during or after application.
(a)
(b)
(1) A handler who is currently certified as an applicator of restricted-use pesticides under part 171 of this chapter.
(2) A handler who satisfies the training requirements of part 171 of this chapter.
(3) A handler who is certified or licensed as a crop advisor by a program acknowledged as appropriate in writing by EPA or a State or Tribal lead agency for pesticide enforcement, provided that a requirement for such certification or licensing is pesticide safety training that includes all the information set out in § 170.230(c)(4).
(c)
(2) The person who conducts the training shall meet at least one of the following criteria:
(i) Be currently certified as an applicator of restricted-use pesticides under part 171 of this chapter; or
(ii) Be currently designated as a trainer of certified applicators or pesticide handlers by a State, Federal, or Tribal agency having jurisdiction; or
(iii) Have completed a pesticide safety train-the-trainer program approved by a State, Federal, or Tribal agency having jurisdiction.
(3) Any person who issues an EPA-approved Worker Protection Standard handler training certificate must assure that the handler who receives the training certificate has been trained in accordance with paragraph (c)(4) of this section.
(4) The pesticide safety training materials must convey, at a minimum, the following information:
(i) Format and meaning of information contained on pesticide labels and in labeling, including safety information such as precautionary statements about human health hazards.
(ii) Hazards of pesticides resulting from toxicity and exposure, including acute and chronic effects, delayed effects, and sensitization.
(iii) Routes by which pesticides can enter the body.
(iv) Signs and symptoms of common types of pesticide poisoning.
(v) Emergency first aid for pesticide injuries or poisonings.
(vi) How to obtain emergency medical care.
(vii) Routine and emergency decontamination procedures.
(viii) Need for and appropriate use of personal protective equipment.
(ix) Prevention, recognition, and first aid treatment of heat-related illness.
(x) Safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup.
(xi) Environmental concerns such as drift, runoff, and wildlife hazards.
(xii) Warnings about taking pesticides or pesticide containers home.
(xiii) Requirements of this subpart that must be followed by handler employers for the protection of handlers and other persons, including the prohibition against applying pesticides in a manner that will cause contact with workers or other persons, the requirement to use personal protective equipment, the provisions for training and decontamination, and the protection against retaliatory acts.
(d)
(2) If the handler employer is aware or has reason to know that an EPA-approved Worker Protection Standard handler training certificate has not been issued in accordance with this section, or has not been issued to the handler bearing the certificate, or the handler training was completed more than 5 years before the beginning of the current month, a handler's possession of that certificate does not meet the requirements of paragraph (a) of this section.
(a)
(2) The handler employer shall assure that the handler has access to the product labeling information during handling activities.
(b)
(1) Specific location and description of any such areas; and
(2) Restrictions on entering those areas.
(a) The handler employer shall assure that before the handler uses any equipment for mixing, loading, transferring, or applying pesticides, the handler is instructed in the safe operation of such equipment, including, when relevant, chemigation safety requirements and drift avoidance.
(b) The handler employer shall assure that, before each day of use, equipment used for mixing, loading, transferring, or applying pesticides is inspected for leaks, clogging, and worn or damaged parts, and any damaged equipment is repaired or is replaced.
(c) Before allowing any person to repair, clean, or adjust equipment that has been used to mix, load, transfer, or apply pesticides, the handler employer shall assure that pesticide residues have been removed from the equipment, unless the person doing the cleaning, repairing, or adjusting is a handler employed by the agricultural or commercial pesticide handling establishment. If pesticide residue removal is not feasible, the handler employer shall assure that the person who repairs, cleans, or adjusts such equipment is informed:
(1) That such equipment may be contaminated with pesticides.
(2) Of the potentially harmful effects of exposure to pesticides.
(3) Of the correct way to handle such equipment.
(a)
(b)
(1) Help keep pesticides from entering your body. At a minimum, the following points shall be conveyed:
(i) Avoid getting on your skin or into your body any pesticides that may be on plants and soil, in irrigation water, or drifting from nearby applications.
(ii) Wash before eating, drinking, using chewing gum or tobacco, or using the toilet.
(iii) Wear work clothing that protects the body from pesticide residues (long-sleeved shirts, long pants, shoes and socks, and a hat or scarf).
(iv) Wash/shower with soap and water, shampoo hair, and put on clean clothes after work.
(v) Wash work clothes separately from other clothes before wearing them again.
(vi) Wash immediately in the nearest clean water if pesticides are spilled or sprayed on the body. As soon as possible, shower, shampoo, and change into clean clothes.
(vii) Follow directions about keeping out of treated or restricted areas.
(2) There are Federal rules to protect workers and handlers including a requirement for safety training.
(c)
(2) The handler employer shall inform handlers promptly of any change to the information on emergency medical care facilities.
(d)
(2) The information shall be displayed in a location in or near the forest in a place where it can be readily seen and read by handlers and where handlers are likely to congregate or pass by, such as at a decontamination site or an equipment storage site.
(e)
(f)
(a)
(b)
(2) Long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes, socks, and other items of work clothing are not considered personal protective equipment for the purposes of this section and are not subject to the requirements of this section, although pesticide labeling may require that such work clothing be worn during some activities.
(c)
(1) When “chemical-resistant” personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of the pesticide being used through the material during use.
(2) When “waterproof” personal protective equipment is specified by the product labeling, it shall be made of material that allows no measurable movement of water or aqueous solutions through the material during use.
(3) When a “chemical-resistant suit” is specified by the product labeling, it shall be a loose-fitting, one- or two-piece chemical-resistant garment that covers, at a minimum, the entire body except head, hands, and feet.
(4) When “coveralls” are specified by the product labeling, they shall be a loose-fitting, one- or two-piece garment, such as a cotton or cotton and polyester coverall, that covers, at a minimum, the entire body except head, hands, and feet. The pesticide product labeling may specify that the coveralls be worn over another layer of clothing.
(5)(i) Gloves shall be of the type specified on the pesticide product labeling. Gloves made of leather, cotton, or other absorbent materials may not be worn while mixing, loading, applying, or otherwise handling pesticides, unless gloves made of these materials are listed as acceptable for such use on the product labeling.
(ii) Separable glove liners may be worn beneath chemical-resistant gloves, unless the pesticide product labeling specifically prohibits their use. Separable glove liners are defined as separate glove-like hand coverings, made of lightweight material, with or without fingers. Work gloves made from lightweight cotton or poly-type material are considered to be glove liners if worn beneath chemical-resistant gloves. Separable glove liners may not extend outside the chemical-resistant gloves under which they are worn. Chemical-resistant gloves with non-separable absorbent lining materials are prohibited.
(iii) If used, separable glove liners must be discarded immediately after a total of no more than 10 hours of use or within 24 hours of when first put on, whichever comes first. The liners must be replaced immediately if directly contacted by pesticide. Used glove liners shall not be reused. Contaminated liners must be disposed of in accordance with any Federal, State, or local regulations.
(6) When “chemical-resistant footwear” is specified by the product labeling, one of the following types of footwear must be worn:
(i) Chemical-resistant shoes.
(ii) Chemical-resistant boots.
(iii) Chemical-resistant shoe coverings worn over shoes or boots.
(7) When “protective eyewear” is specified by the product labeling, one of the following types of eyewear must be worn:
(i) Goggles.
(ii) Face shield.
(iii) Safety glasses with front, brow, and temple protection.
(iv) Full-face respirator.
(8) When a “chemical-resistant apron” is specified by the product labeling, an apron that covers the front of the body from mid-chest to the knees shall be worn.
(9) When a respirator is specified by the product labeling, it shall be appropriate for the pesticide product used and for the activity to be performed. The handler employer shall assure that the respirator fits correctly.
(10) When “chemical-resistant headgear” is specified by the product labeling, it shall be either a chemical resistant hood or a chemical-resistant hat with a wide brim.
(d)
(ii) A chemical-resistant suit may be substituted for “coveralls” and a chemical-resistant apron.
(2)
(3)
(4)
(i) Persons using a closed system to mix or load pesticides with a signal word of DANGER or WARNING may substitute a long-sleeved shirt, long pants, shoes, socks, chemical-resistant apron, and any protective gloves specified on the labeling for handlers for the labeling-specified personal protective equipment.
(ii) Persons using a closed system to mix or load pesticides other than those in paragraph (d)(4)(i) of this section or to perform other handling tasks may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment.
(iii) Persons using a closed system that operates under pressure shall wear protective eyewear.
(iv) Persons using a closed system shall have all labeling-specified personal protective equipment immediately available for use in an emergency.
(5)
(i) Persons occupying an enclosed cab may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If a respiratory protection device is specified on the pesticide product labeling for the handling activity, it must be worn.
(ii) Persons occupying an enclosed cab that has a properly functioning ventilation system which is used and maintained in accordance with the manufacturer's written operating instructions and which is declared in writing by the manufacturer or by a governmental agency to provide respiratory protection equivalent to or greater than a dust/mist filtering respirator may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If a respiratory protection device other than a dust/mist-filtering respirator is specified on the pesticide product labeling, it must be worn.
(iii) Persons occupying an enclosed cab that has a properly functioning ventilation system which is used and maintained in accordance with the manufacturer's written operating instructions and which is declared in writing by the manufacturer or by a governmental agency to provide respiratory protection equivalent to or greater than the vapor- or gas-removing respirator specified on pesticide product labeling may substitute a long-sleeved shirt, long pants, shoes, and socks for the labeling-specified personal protective equipment. If an air-supplying respirator or a self-contained breathing apparatus (SCBA) is specified on the pesticide product labeling, it must be worn.
(iv) Persons occupying an enclosed cab shall have all labeling-specified personal protective equipment immediately available and stored in a chemical-resistant container, such as a plastic bag. They shall wear such personal protective equipment if it is necessary to exit the cab and contact pesticide-treated surfaces in the treated area. Once personal protective equipment is worn in the treated area, it must be removed before reentering the cab.
(6)
(ii)
(iii)
(7)
(i) Application has been completed for at least 4 hours.
(ii) Any inhalation exposure level listed in the labeling has been reached or any ventilation criteria established by § 170.110(c)(3) or in the labeling have been met.
(e)
(2) The handler employer shall assure that, before each day of use, all personal protective equipment is inspected for leaks, holes, tears, or worn places, and any damaged equipment is repaired or discarded.
(f)
(2) If any personal protective equipment cannot be cleaned properly, the handler employer shall dispose of the personal protective equipment in accordance with any applicable Federal, State, and local regulations. Coveralls or other absorbent materials that have been drenched or heavily contaminated with an undiluted pesticide that has the signal word DANGER or WARNING on the label shall be not be reused.
(3) The handler employer shall assure that contaminated personal protective equipment is kept separately and washed separately from any other clothing or laundry.
(4) The handler employer shall assure that all clean personal protective equipment shall be either dried thoroughly before being stored or shall be put in a well ventilated place to dry.
(5) The handler employer shall assure that all personal protective equipment is stored separately from personal clothing and apart from pesticide-contaminated areas.
(6) The handler employer shall assure that when dust/mist filtering respirators are used, the filters shall be replaced:
(i) When breathing resistance becomes excessive.
(ii) When the filter element has physical damage or tears.
(iii) According to manufacturer's recommendations or pesticide product labeling, whichever is more frequent.
(iv) In the absence of any other instructions or indications of service life, at the end of each day's work period.
(7) The handler employer shall assure that when gas- or vapor-removing respirators are used, the gas- or vapor-removing canisters or cartridges shall be replaced:
(i) At the first indication of odor, taste, or irritation.
(ii) According to manufacturer's recommendations or pesticide product labeling, whichever is more frequent.
(iii) In the absence of any other instructions or indications of service life, at the end of each day's work period.
(8) The handler employer shall inform any person who cleans or launders personal protective equipment:
(i) That such equipment may be contaminated with pesticides.
(ii) Of the potentially harmful effects of exposure to pesticides.
(iii) Of the correct way(s) to clean personal protective equipment and to protect themselves when handling such equipment.
(9) The handler employer shall assure that handlers have a clean place(s)
(i) Store personal clothing not in use.
(ii) Put on personal protective equipment at the start of any exposure period.
(iii) Remove personal protective equipment at the end of any exposure period.
(10) The handler employer shall not allow or direct any handler to wear home or to take home personal protective equipment contaminated with pesticides.
(g)
(a)
(b)
(2) When water stored in a tank is to be used for mixing pesticides, it shall not be used for decontamination or eye flushing, unless the tank is equipped with properly functioning valves or other mechanisms that prevent movement of pesticides into the tank.
(3) The handler employer shall provide soap and single-use towels in quantities sufficient to meet handlers' needs.
(4) The handler employer shall provide one clean change of clothing, such as coveralls, for use in an emergency.
(c)
(1)
(2)
(3)
(i) The soap, single-use towels, clean change of clothing, and water may be at the nearest place of vehicular access.
(ii) The handler employer may permit handlers to use clean water from springs, streams, lakes, or other sources for decontamination at the remote work site, if such water is more accessible than the water located at the nearest place of vehicular access.
(4)
(i) The decontamination supplies are in the area where the handler is performing handling activities;
(ii) The soap, single-use towels, and clean change of clothing are in enclosed containers; and
(iii) The water is running tap water or is enclosed in a container.
(d)
(e)
If there is reason to believe that a person who is or has been employed by an agricultural establishment or commercial pesticide handling establishment to perform pesticide handling tasks has been poisoned or injured by exposure to pesticides as a result of that employment, including, but not limited to, exposures from handling tasks or from application, splash, spill, drift, or pesticide residues, the handler employer shall:
(a) Make available to that person prompt transportation from the place of employment or the handling site to an appropriate emergency medical facility.
(b) Provide to that person or to treating medical personnel, promptly upon request, any obtainable information on:
(1) Product name, EPA registration number, and active ingredients of any product to which that person might have been exposed.
(2) Antidote, first aid, and other medical information from the product labeling.
(3) The circumstances of handling of the pesticide.
(4) The circumstances of exposure of that person to the pesticide.
7 U.S.C. 136i and 136w.
This section deals with the certification of applicators of restricted use pesticides.
(a) Terms used in this subpart have the same meaning as in the Act. In addition, the following definitions are applicable to all aspects of the certification of pesticide applicator program in this part:
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(b)
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(a)
(b)
(ii)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(c)
(a)
(b)
(i)
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(ii)
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(4)
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(6)
(7)
(8)
(9)
(10)
(d)
(e)
(2) Doctors of Medicine and Doctors of Veterinary Medicine applying pesticides as drugs or medication during the course of their normal practice.
(a) Competence in the use and handling of pesticides by a private applicator will be determined by procedures set forth below. State standards must conform and be at least equal to those prescribed herein. As a minimum requirement for certification, a private applicator must show that he possesses a practical knowledge of the pest problems and pest control practices associated with his agricultural operations; proper storage, use, handling and disposal of the pesticides and containers; and his related legal responsibility. This practical knowledge includes ability to:
(1) Recognize common pests to be controlled and damage caused by them.
(2) Read and understand the label and labeling information—including the common name of pesticides he applied; pest(s) to be controlled, timing and methods of application; safety precautions; any pre-harvest or re-entry restrictions; and any specific disposal procedures.
(3) Apply pesticides in accordance with label instructions and warnings, including the ability to prepare the proper concentration of pesticide to be used under particular circumstances taking into account such factors as area to be covered, speed at which application equipment will be driven, and the quantity dispersed in a given period of operation.
(4) Recognize local environmental situations that must be considered during application to avoid contamination.
(5) Recognize poisoning symptoms and procedures to follow in case of a pesticide accident.
(b) Such competence of each private applicator shall be verified by the responsible State agency through the administration of a private applicator certification system which ensures that the private applicator is competent, based upon the standards set forth above, to use the restricted use pesticides under limitations of applicable State and Federal laws and regulations. A certification system shall employ a written or oral testing procedure, or such other equivalent system as may be approved as part of a State plan.
(1) In any case where a person, at the time of testing for certification, is unable to read a label, the responsible State agency may employ a testing procedure, previously approved by the Administrator, which can adequately assess the competence of such person with regard to all of the above standards. Certification must be related and limited to the use and handling of each individual pesticide for which he desires certification at any time. Therefore, the applicator will be authorized to use only the pesticide(s) for which he has demonstrated competence. A specific procedure is required for § 171.5(a)(2) relating to label comprehension, with testing designed to assure his knowledge of the following:
(i) Understanding of the label and labeling information including those items indicated in that subsection.
(ii) Sources of advice and guidance necessary for the safe and proper use of each pesticide related to his certification.
(2) [Reserved]
(a) Certified applicators whose activities indicate a supervisory role must demonstrate a practical knowledge of Federal and State supervisory requirements, including labeling, regarding the application of restricted use pesticides by noncertified applicators.
(b) [Reserved]
If any State, at any time, desires to certify applicators of restricted use pesticides, the Governor of that State shall submit a State plan for that purpose. The Administrator shall approve the plan submitted by any State, or any modification thereof, if the plan in his judgment—
(a) Designates a State agency as the agency responsible for administering the plan throughout the State. Since several other agencies or organizations may also be involved in administering portions of the State plan, all of these shall be identified in the State plan, particularly any other agencies or organizations responsible for certifying
(b) Contains satisfactory assurances that such lead agency has or will have the legal authority and qualified personnel necessary to carry out the plan:
(1) Satisfactory assurances that the lead agency or other cooperating agencies have the legal authority necessary to carry out the plans should be in the form of an opinion of the Attorney General or the legal counsel of the lead agency. In addition:
(i) The lead agency should submit a copy of each appropriate State law and regulation.
(ii) In those States where any requisite legal authorities are pending enactment and/or promulgation, the Governor (or Chief Executive) may request that a State plan be approved contingent upon the enactment and/or promulgation of such authorities. Plans approved on a contingency basis will be subject to such reasonable terms and conditions, concerning the duration of the contingency approval and other matters, as the Administrator may impose. During the period of the contingency approval, the State will have an approved certification program and may proceed to certify applicators, who will then be permitted to use or supervise the use of pesticides classified for restricted use under FIFRA, as amended.
(iii) The State plan should indicate by citations to specific laws (whether enacted or pending enactment) and/or regulations (whether promulgated or pending promulgation) that the State has legal authorities as follows:
(A) Provisions for and listing of the acts which constitute grounds for denying, suspending, and revoking certification of applicators, and for assessing criminal and/or civil penalties. Such grounds should include, at a minimum, misuse of a pesticide and falsification of any records required to be maintained by the certified applicator.
(B) Provisions for reviewing an applicator's certification to determine whether suspension or revocation of the certification is appropriate in the event of criminal conviction under section 14(b) of the amended FIFRA, a final order imposing civil penalty under section 14(a) of the amended FIFRA, or conclusion of a State enforcement action.
(C) Provisions for right-of-entry by consent or warrant by appropriate State officials at reasonable times for sampling, inspection, and observation purposes.
(D) Provisions making it unlawful for persons other than certified applicators or persons working under their direct supervision to use restricted use pesticides.
(E) Provisions requiring certified commercial applicators to keep and maintain for the period of at least two years routine operational records containing information on kinds, amounts, uses, dates, and places of application of restricted use pesticides; and for ensuring that such records will be available to appropriate State officials.
(2) Satisfactory assurances that the lead agency and any cooperating organizations have qualified personnel necessary to carry out the plan will be demonstrated by including the numbers, job titles and job functions of persons so employed.
(c) Gives satisfactory assurances that the State will devote adequate funds to the administration of the plan.
(d) Provides that the State agency will make reports to the Administrator in a manner and containing information that the Administrator may from time to time require, including:
(1) An annual report to be submitted by the lead agency, at a time to be specified by the State, to include the following information:
(i) Total number of applicators, private and commercial, by category, currently certified; and number of applicators, private and commercial, by category, certified during the last reporting period.
(ii) Any changes in commercial applicator subcategories.
(iii) A summary of enforcement activities related to use of restricted use pesticides during the last reporting period.
(iv) Any significant proposed changes in required standards of competency.
(v) Proposed changes in plans and procedures for enforcement activities related to use of restricted use pesticides for the next reporting period.
(vi) Any other proposed changes from the State plan that would significantly affect the State certification program.
(2) Other reports as may be required by the Administrator shall be submitted from time to time to meet specific needs.
(e) Contains satisfactory assurances that the State standards for the certification of applicators of pesticides conform to those standards prescribed by the Administrator under §§ 171.1 through 171.6. Such assurances should consist of:
(1) A detailed description of the State's plan for certifying applicators and a discussion of any special situations, problems, and needs together with an explanation of how the State intends to handle them. The State plan should include the following elements as a minimum:
(i) For commercial applicators:
(A) A list and description of categories and subcategories to be used in the State, such categories to be consistent with those defined in § 171.3.
(B) An estimate of the number of commercial applicators by category expected to be certified by the State.
(C) The standards of competency elaborated by the State. These shall conform and be at least equal to those prescribed in § 171.4 for the various categories of applicators utilized by the State. The standards shall also cover each of the points listed in the general standards in § 171.4(b) and the points covered in the appropriate specific standards set forth in § 171.4(c).
(D) For each category and subcategory listed under § 171.7(e)(1)(i)(A), either submission of examinations or a description of the types and contents of examinations (e.g., multiple choice, true-false) and submission of sample examination questions; and a description of any performance testing used to determine competency of applicators.
(ii) For private applicators:
(A) An estimate of the number of private applicators expected to be certified by the State.
(B) The standards of competency elaborated by the State. These shall conform and be at least equal to those prescribed in § 171.5(a), including the five requirements listed in § 171.5(a) (1) through (5).
(C) Types and contents of examinations and/or submission of detailed description of methods other than examination used to determine competency of private applicators.
(D) A description of any special procedure of testing that a State develops to determine the competency of a private applicator who is unable to read the label as prescribed in § 171.5(b)(1).
(2) A provision for issuance by the State of appropriate credentials or documents verifying certification of applicators.
(3) If appropriate, a description of any existing State licensing, certification or authorization programs for private applicators or for one or more categories of commercial applicators may be included. If these programs are determined by EPA to meet standards of competency prescribed by §§ 171.1 through 171.6, States may certify applicators so licensed, certified or authorized without any additional demonstration of competency provided:
(i) The commercial applicators who were licensed, certified, or authorized have demonstrated their competency based on written examinations and, as appropriate, performance testing, conforming to the standards set forth in § 171.4, and
(ii) The private applicators who were licensed, certified, or authorized have demonstrated their competency by written or oral testing procedures or other acceptable equivalent system, conforming to the standards set forth in § 171.5.
(4) A statement that the State accepts Federal employees qualified under the Government Agency Plan (GAP) as fully meeting the requirements for certification by that State; or a description of any additional requirements these employees must meet to apply restricted use pesticides in that State. Any such additional requirements shall be consistent with and shall not exceed standards established for other comparable applicators in that State.
(i) Until such time as the GAP has been fully developed and approved by EPA, this statement (§ 171.7(e)(4)) is not required. However, within 60 days after final approval of the GAP, the State should forward such a statement for inclusion in its State plan.
(5) A description of any cooperative agreements a State has made with any Indian Governing Body to certify or assist in the certification of applicators not subject to State jurisdiction. (§ 171.10).
(6) A description of any arrangements that a State has made or plans to make relating to reciprocity with other States or jurisdictions for the acceptance of certified applicators from those States or jurisdictions. However, those arrangements should meet these conditions:
(i) The State according reciprocity should provide for issuance of an appropriate document verifying certification based upon the certifying document issued by the other States or jurisdictions.
(ii) The State according reciprocity should have enforcement procedures that cover out-of-State applicators determined to be competent and certified within the State or jurisdiction.
(iii) The detailed State or jurisdiction standards of competency, for each category identified in the reciprocity arrangement should be sufficiently comparable to justify waiving an additional determination of competency by the State granting reciprocity.
(f) In responding to the preceding requirements, a State may describe in its State plan other regulatory activities implemented under State laws or regulations which will contribute to the desired control of the use of restricted use pesticides by certified applicators. Such other regulatory activities, if described, will be considered by the Administrator in evaluating whether or not a State's certified applicator program satisfies the requirements of § 171.7 (a) through (e).
(a) Any State certification program approved under § 171.7 shall be maintained in accordance with the State plan approved under that section. Accordingly, the State plan should include:
(1) Provisions to assure that certified applicators comply with standards for the use of restricted use pesticides and carry out their responsibility to provide adequate supervision of noncertified applicators.
(2) Provisions to ensure that certified applicators continue to meet the requirements of changing technology and to assure a continuing level of competency and ability to use pesticides safely and properly.
(b) An approved State plan and the certification program carried out under such plan may not be substantially modified without the prior approval of the Administrator. A proposed change may be submitted for approval at any time but all applicable requirements prescribed by these Regulations must be satisfied for the modification to be eligible for approval by the Administrator.
(c) Whenever the Administrator determines that a State is not administering the certification program in accordance with the State plan approved under § 171.7, he shall so notify the State and provide for a hearing at the request of the State and, if appropriate corrective action is not taken within a reasonable time, not to exceed ninety days, the Administrator shall withdraw approval of the plan.
This section is included to provide for certain Federal employees including those whose duties may require
(a) Sections 171.1 through 171.8 will, with the necessary changes, apply to the Government Agency Plan (GAP) for determining and attesting to the competency of Federal employees to use or supervise the use of restricted use pesticides.
(b) Federal employees qualified under the GAP shall:
(1) Be prepared to present the Federal form issued to them attesting to their competency to appropriate State officials.
(2) Fulfill any additional requirements States may have enumerated in their State plans as provided for under § 171.7(e)(4).
(c) The employing Federal agency shall ensure that certified employees using or supervising the use of restricted use pesticides within a Federal facility are subject to the same or equivalent provisions prescribed under § 171.7(b)(1)(iii) (A)-(E).
This section applies to applicators on Indian Reservations.
(a) On Indian Reservations
(1) If the Indian Governing Body decides to utilize the State certification program, it should enter into a cooperative agreement with the State. This agreement should include matters concerning funding and proper authority for enforcement purposes. Such agreement and any amendments thereto shall be incorporated in the State plan, and forwarded to the Administrator for approval or disapproval.
(2) If the Indian Governing Body decides to develop its own certification plan, it shall be based on either Federal standards (§§ 171.1 through 171.8) or State standards for certification which have been accepted by EPA. Such a plan shall be submitted through the United States Department of the Interior to the EPA Administrator for approval.
(b) On Indian Reservations where the State has assumed jurisdiction under other Federal laws, anyone using or supervising the use of restricted use pesticides shall be certified under the appropriate State certification plan.
(c) Non-Indians applying restricted use pesticides on Indian Reservations not subject to State jurisdiction shall be certified either under a State certification plan accepted by the Indian Governing Body or under the Indian Reservation certification plan.
(d) Nothing in this section is intended either to confer or deny jurisdiction to the States over Indian Reservations not already conferred or denied under other laws or treaties.
(a)
(b)
(c)
(2)
(3)
(4)
(5)
(6)
(7)
(A) Name and address of the person for whom the pesticide was applied;
(B) Location of the pesticide application;
(C) Target pest(s);
(D) Specific crop or commodity, as appropriate, and site, to which the pesticide was applied;
(E) Year, month, day, and time of application;
(F) Trade name and EPA registration number of the pesticide applied;
(G) Amount of the pesticide applied and percentage of active ingredient per unit of the pesticide used; and
(H) Type and amount of the pesticide disposed of, method of disposal, date(s) of disposal, and location of the disposal site.
(ii)
(d)
(i)
(ii)
(iii)
(iv)
(2)
(3)
(e)
(f)
(i) Used any registered pesticide in a manner inconsistent with its labeling;
(ii) Made available for use, or used, any registered pesticide classified for restricted use other than in accordance with section 3(d) of the amended FIFRA and any regulations promulgated thereunder;
(iii) Refused to keep and maintain any records required pursuant to this section;
(iv) Made false or fraudulent records, invoices or reports;
(v) Failed to comply with any limitations or restrictions on or in a duly issued certificate; or,
(vi) Violated any provision of the amended FIFRA and the regulations promulgated thereunder.
(2) If the Administrator decides to deny, revoke, or modify a certificate, he or she will:
(i) Notify the applicant or certificate holder of:
(A) The ground(s) upon which the denial, revocation or modification is based;
(B) The time period during which the denial, revocation or modification is effective, whether permanent or otherwise;
(C) The conditions, if any, under which the individual may become certified or recertified; and,
(D) Any additional conditions the Administrator may impose.
(ii) Provide the applicant or certificate holder an opportunity to request a hearing prior to final Agency action to deny, revoke or modify the certificate.
(3) If a hearing is requested by an applicant or certificate holder pursuant to paragraph (f)(2)(ii) of this section, the Administrator will:
(i) Notify the affected applicant or certificate holder of those assertions of law and fact upon which the action to deny, revoke or modify the certificate is based;
(ii) Provide the affected applicant or certificate holder an opportunity to offer written statements of facts, explanations, comments, and arguments relevant to the proposed action;
(iii) Provide the affected applicant or certificate holder such other procedural opportunities as the Administrator may deem appropriate to ensure a fair and impartial hearing; and
(iv) Appoint an attorney in the Agency as Presiding Officer to conduct the hearing. No person shall serve as Presiding Officer if he or she has had any prior connection with the specific case.
(4) The Presiding Officer appointed pursuant to paragraph (f)(3)(iv) of this section shall:
(i) Conduct a fair, orderly, and impartial hearing, without unnecessary delay;
(ii) Consider all relevant evidence, explanation, comment, and argument submitted pursuant to paragraphs (f)(3)(ii) and (iii) of this section; and,
(iii) Promptly notify the affected applicant or certificate holder of his or her decision and order. Such an order is a final Agency action subject to judicial review in accordance with Section 16 of the amended FIFRA.
(5) If the Administrator decides to suspend all or part of a certificate, he or she will:
(i) First determine that the public health, interest or welfare warrants immediate action to suspend the certificate;
(ii) Notify the certificate holder of the ground(s) upon which the suspension action is based;
(iii) Notify the certificate holder of the time period during which the suspension is effective; and,
(iv) Notify the certificate holder of his or her intent to revoke or modify the certificate, as appropriate, in accord with paragraph (f)(2) of this section. If such revocation or modification notice has not previously been issued, it will be issued at the same time the suspension notice is issued.
(6) In cases where the act constituting grounds for suspension, revocation, or modification of a certificate is neither willful nor contrary to the public interest, health, or safety, the affected certificate holder may have additional procedural rights under 5 U.S.C. 558(c).
(7) Any notice, decision, or order issued by the Administrator under paragraph (f) of this section, and any documents filed by an applicant or certificate holder in a hearing under paragraph (f) of this section, shall be available to the public except as otherwise provided by section 10 of the amended FIFRA or by part 2 of this title. Any such hearing at which oral testimony is presented shall be open to the public, except that the Presiding Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidentiality under section 10 of the amended FIFRA or under part 2 of this title.
(g)
(i) Report to the Environmental Protection Agency (EPA) the business name by which the restricted use pesticide retail dealer operates, and the name and business address of each of his dealerships. For dealers or dealerships in Nebraska this initial report must be submitted to EPA, Region VII, 324 E. 11th Street, Kansas City, MO 64106. For dealers or dealerships in Colorado this initial report must be submitted to EPA, Region VIII, 1860 Lincoln Street, Denver, Colorado 80295. This report shall be submitted to the appropriate EPA regional office no later than 60 days after the date the person first becomes a restricted use pesticide retail dealer, or within 60 days after the publication of the effective date of this final rule, whichever date is later.
(ii) Submit revisions to the initial report to the appropriate EPA regional office listed above reflecting any name changes, additions or deletions of dealerships. Revisions shall be submitted to EPA within 10 days of the occurrence of such change, addition or deletion.
(2)
(i)
(A) Name and address of the residence or principal place of business of each person to whom the pesticide was made available for use.
(B) The certification number on the document evidencing that person's certification, the State (or other governmental unit) that issued the doucment, the expiration date of the certification, and the categories in which the applicator is certified, if appropriate.
(C) The product name, EPA registration number, and the State special local need registration number, granted under section 24(c) of the FIFRA (if any) on the label of the pesticide.
(D) The quantity of the pesticide made available for use in the transaction.
(E) The date of the transaction.
(ii)
(A) The name and address of the residence or principal place of business of the uncertified person to whom the restricted use pesticide is made available for use by a certified applicator.
(B) The name and address of the residence or principal place of business of the certified applicator who will use the restricted use pesticide.
(C) The certified applicator's certification number, the State (or other governmental unit) that issued his certification document, the expiration date of the certification, and the categories in which the applicator is certified, if appropriate.
(D) The product name, EPA registration number, and the State special local need registration number, granted under section 24(c) of the FIFRA (if any) on the label of the pesticide.
(E) The quantity of the pesticide made available for use in the transaction.
(F) The date of the transaction.
(G) At the time of each transaction, EPA recommends that the dealer obtain the information required in paragraph (g)(2)(ii) (A) through (C) of this section and assure himself that the restricted use pesticide is made available for use by a certified applicator by examining one of the following sets of documents:
(
(
(
(3)
(4)
7 U.S.C. 136c, 136w. Section 172.4 is also issued under 31 U.S.C. 9701.
Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply:
(a) Pursuant to section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 983), and except as herein provided by § 172.3, any person wishing to accumulate information necessary to register under section 3 of the Act and the regulations thereunder (1) a pesticide not registered with this Agency or (2) a registered pesticide for a use not previously approved in the registration of the pesticide may apply to the Administrator at any time for an experimental use permit.
(b) Pesticides under experimental use permits may not be sold or distributed other than through participants and, if sold or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of the experimental use permit.
(a) An experimental use permit (EUP) is generally required for testing of any unregistered pesticide or any registered pesticide being tested for an unregistered use. However, as described in paragraph (b) of this section, certain of such tests are presumed not to involve unreasonable adverse effects and, therefore, do not require an EUP.
(b) Except as provided in subpart C of this part or as specifically determined by the Environmental Protection Agency (EPA), it may be presumed that EUPs are not required when:
(1) The experimental use of the pesticide is limited to:
(i) Laboratory or greenhouse tests,
(ii) Limited replicated field trials as described in paragraph (c) of this section to confirm such tests, or
(iii) Other tests as described in paragraph (c) of this section whose purpose is only to assess the pesticide's potential efficacy, toxicity, or other properties.
(2) The producer, applicator, or any other person conducting the test does not expect to receive any benefit in pest control from the pesticide's use.
(c) For purposes of paragraphs (b)(1)(ii) and (b)(1)(iii) of this section, the following types of experimental tests are presumed not to need an EUP:
(1) A small-scale test involving use of a particular pesticide that is conducted on a cumulative total of no more than 10 acres of land per pest, except that:
(i) When testing for more than one target pest occurs at the same time and in the same locality, the 10 acre limitation shall encompass all of the target pests.
(ii) Any food or feed crops involved in, or affected by, such tests (including, but not limited to, crops subsequently grown on such land which may reasonably be expected to contain residues of the tested pesticides) shall be destroyed or consumed only by experimental animals unless an appropriate tolerance or exemption from a tolerance has been established under the Federal Food, Drug, and Cosmetic Act (FFDCA) for residues of the pesticide.
(2) A small-scale test involving the use of a particular pesticide that is conducted on a cumulative total of no more than 1 surface acre of water per pest, except that:
(i) When the testing for more than one target pest occurs at the same time and in the same locality, the 1 acre limitation shall encompass all of the target pests.
(ii) Waters which are involved in or affected by such tests are not used for irrigation purposes, drinking water supplies, or body contact recreational activities.
(iii) Testing shall not be conducted in any waters which contain or affect fish, shellfish, plants, or animals taken for recreational or commercial purposes and used for food or feed, unless an appropriate tolerance or exemption from a tolerance has been established under the FFDCA for residues of the pesticide.
(3) Animal treatment tests involving the use of a particular pesticide that are conducted only on experimental animals which will not be used for food or feed, unless an appropriate tolerance or an exemption from a tolerance has been established for animal products and byproducts under the FFDCA for residues of the pesticide.
(d) The examples in paragraphs (c)(1), (c)(2), and (c)(3) of this section are not all-inclusive and do not preclude testing in larger areas or larger numbers of units if the intended use meets the criteria of paragraph (a) of this section. However, tests which do not come within the examples in paragraphs (c)(1), (c)(2), and (c)(3) of this section, absent a specific determination by EPA to the contrary, require an EUP. Persons intending to conduct tests who are uncertain whether the testing may be conducted without a permit may submit a request for determination to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). Such a request shall include the information listed in § 172.4(b)(1)(ii) and (b)(1)(iii) and in the case of an unregistered product, the information in § 172.4(b)(3)(i).
(e) Notwithstanding paragraphs (b) through (d) of this section, EPA may, on a case-by-case basis, require that certain testing of a particular pesticide or class of pesticides be carried out under an EUP, if it is determined that such EPA oversight is warranted. If EPA determines that an EUP is required, it will notify the developer of the pesticide of the need for an EUP and provide opportunity for comment or objections before imposing the requirement.
(f) No EUP is required for a substance or mixture of substances being put through tests for the sole purpose of gathering data required for approval of such substance or mixture under the FFDCA (21 U.S.C. 301
(1) A “new drug” (21 U.S.C. sec. 321(p) and sec. 355).
(2) A “new animal drug” (21 U.S.C. sec. 321(w) and sec. 360(b)), or
(3) An “animal feed” (21 U.S.C. sec. 321 (x)) containing a “new animal drug” (21 U.S.C. sec. 360(b)).
(g) Paragraph (f) of this section shall not apply when a purpose of such test is to accumulate information necessary to register a pesticide under section 3 of the Act.
(a)
(b)
(ii) The registration number of the product, if registered;
(iii) The purpose or objectives of the proposed testing; a description in detail of the proposed testing program including test parameters; a designation of the pest organism(s) involved; the amount of pesticide product proposed for use; the crops, fauna, flora, sites, modes, dosage rates, and situation of application on or in which the pesticide is to be used; the States in which the proposed program will be conducted; the number of acres, number of structural sites, or number of animals by State to be treated or included in the area of experimental use; the proposed dates or period(s) during which the testing program is to be conducted; and the manner in which supervision of the program will be accomplished;
(iv) The name, street address, telephone number, and qualifications of all participants in the program (whether or not in the employ of the applicant). A permit must be amended to add or change participants;
(v) The name and street address of all cooperators, if available at the time an application is submitted or as soon thereafter as available;
(vi) A description and the specific results of any appropriate prior testing of the product conducted by the applicant to determine toxicity and effects in or on target organisms at the site of application; and to determine phytotoxicity and other forms of toxicity or effects on nontarget plants, animals, and insects at or near the site of application; and to determine adverse effects on the environment;
(vii) The proposed method of storage and disposition of any unused experimental use pesticide and its containers; and
(viii) Such other additional pertinent information as the Administrator may require.
(2)
(i) Submit evidence that a tolerance or exemption from the requirement of a tolerance has been established for residues of the pesticide in or on such food or feed under section 408 of the Federal Food, Drug, and Cosmetic Act; or
(ii) Submit a petition proposing establishment of a tolerance or an exemption from the requirement of a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act; or
(iii) Certify that the food or feed derived from the experimental program will be destroyed or fed only to experimental animals for testing purposes, or otherwise disposed of in a manner which will not endanger man or the environment. The method of such destruction or disposition shall be provided in the application for the permit.
(3)
(ii) Chemical and physical properties of each active ingredient of the formulation to be tested, including, but not limited to, the manufacturing or laboratory processes and analytical methods suitable for determining the active ingredients in the formulation;
(iii) Appropriate date, if available, on the rate of decline of residues on the treated crop or environmental site or other information for determination
(iv) Results of toxicity tests and other data relevant to the product's potential for causing injury to the users or other persons who may be exposed, including any available epidemiological information as to man.
(c)
(a)
(b)
(c)
(d)
(e)
(a)
(1) The prominent statement, “For Experimental Use Only”;
(2) The Experimental Use Permit number;
(3) The statement, “Not for sale to any person other than a participant or cooperator of the EPA-approved Experimental Use Program”;
(4) The name, brand, or trademark;
(5) The name and address of the permittee, producer, or registrant;
(6) The net contents;
(7) An ingredient statement;
(8) Warning or caution statements;
(9) Any appropriate limitations on entry of persons into treated areas;
(10) The establishment registration number, except in those cases where application of the pesticide is made solely by the producer; and
(11) The directions for use, except that the Administrator may approve the use of the experimental program as labeling provided that such program is to be distributed with the product.
(b)
Technical materials may be imported without registration in sufficient quantities to formulate a pesticide for which an Experimental Use Permit has been requested if the application for such permit states that such importation will occur.
(a) The permittee shall supervise the test program and evaluate the results of testing at each site of application. It will further be the responsibility of the permittee to report immediately to the Administrator, or to any person designated by him, any adverse effects from use of, or exposure to, the pesticide.
(b) The permittee shall submit the following reports to the Registration Division during the experimental program.
(1) [Reserved]
(2) A final report shall be submitted within 180 days after the expiration of the permit, unless a request for extension of time is approved, and shall include:
(i) All data gathered during the testing program; field notes need not be submitted but must be maintained and submitted upon request;
(ii) A description of the disposition of any pesticide containers and any unused pesticides including amounts disposed of and the method and site of disposition; and
(iii) The method of disposition of affected food and/or feed.
(c) In addition to the reporting requirements provided for elsewhere in this part, in the case of any meat-producing animals or birds that receive a direct treatment or application of any experimental use pesticide, the name and location of the packing plant where the animals will be processed shall be sent to the U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Washington, DC 20250, at least 10 days before the animals are to be shipped for slaughter. This requirement may be waived, on request, by the USDA. These provisions do not exempt treated food-producing animals and their products from compliance with other applicable inspection requirements.
(d) Failure to submit required reports may constitute grounds for revocation of the permit.
(e) For the purpose of supervising the use of experimental use pesticides, the Agency may require the permittee or any participant to give reasonable advance notification of the intended dates, times, and sites on which such experimental use pesticide will be applied.
(f) The permittee or participants in the experimental use program will permit any authorized representative of the Agency, upon presentation of official identification, entry, at any reasonable time, to any premises involved in the testing program to inspect and to determine whether there has been compliance with the terms and conditions of the permit.
Applications for renewal of experimental use permits and temporary tolerances, to provide for additional testing, shall be submitted prior to expiration of the permit. Requirements for renewals are the same as for applications under § 172.4, except that information previously submitted may be incorporated by reference.
(a)
(b)
(c)
(a)
(1) The active ingredients,
(2) Use pattern(s),
(3) Quantity of pesticide,
(4) Total acreage,
(5) Location of area of application,
(6) A statement soliciting comments from any interested persons regarding the application.
(b)
(c)
(1) The active ingredients,
(2) Use pattern(s),
(3) Quantity of pesticide,
(4) Total acreage,
(5) Location of area of application,
(6) A statement indicating where the experimental use permit is available for public inspection.
This subpart sets forth regulations governing State issuance of experimental use permits pursuant to section 5(f) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA). It also sets forth regulations governing authorization by the Administrator of State experimental use permit programs.
Terms used in this subpart shall have the meaning set forth in FIFRA and in § 172.1.
(a) Experimental use permits are not required under this rule in those situations described in § 172.3 of subpart A pertaining to Federal experimental use permits.
(b) Subpart B is not applicable to experimental use permits issued by a
(c) Pesticide products used under experimental use permits may not be sold or distributed other than through participants, and, if sold or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of the experimental use permit.
(d) Establishments in which pesticide products under State experimental use permits are produced shall be registered as required by 40 CFR 167.2(a) and producers of such products shall maintain books and records as required by 40 CFR 169.2.
(e) Pesticide products and their containers used under this rule must also be packaged, stored, transported, used, and disposed of in accordance with all applicable Federal laws and regulations, including the Resource Conservation and Recovery Act of 1976 as amended (Pub. L. 94-580; 90 Stat. 2795; 42 U.S.C. 6901
(a)
(2) A State shall request authorization to issue experimental use permits by having the Governor or Chief Executive Officer or his designated agent submit a State plan in writing to the Administrator.
(b)
(1) A designation of the State agency responsible for the administration of the State experimental use permit program.
(2) An opinion of the State attorney general or the legal counsel of the designated State agency that the State has the requisite legal authorities as set forth in paragraph (c)(1)(i) of this section, accompanied by copies of the applicable State laws and regulations.
(3) A description of procedures that the designated State agency will follow:
(i) To review experimental use permit applications, to ensure that experimental use permits will be issued in accordance with the terms and conditions of the authorization, FIFRA, and this subpart; and
(ii) To supervise use pursuant to the permits, and to ensure that permits are used in accordance with their terms and conditions, FIFRA, and this subpart.
(c)
(i) Has adequate legal authority under State law to implement the plan, including authority:
(A) To issue experimental use permits, subject to limitations necessary for the protection of public health and the environment;
(B) To supervise the use of a pesticide pursuant to an experimental use permit, as provided in § 172.25(c);
(C) To deny an experimental use permit if it determines that a permit is not justified, or that the issuance of the permit would cause unreasonable adverse effects on the environment;
(D) To amend or revoke an experimental use permit, if the designated State agency finds that:
(
(
(
(E) To enter, by consent or by warrant or by other legal means, in connection with an experimental use permit, a permittee's or cooperator's premises at reasonable times in order to sample or inspect any pesticides used or property treated, to inspect any equipment or records kept, or to
(F) To comply in all other respects with the requirements of this subpart, including labeling requirements; and
(ii) Utilizes procedures for the review of each permit which are adequate to ensure that the State program will be administered in accordance with the purposes of FIFRA and this subpart.
(2) After receiving a State plan, EPA shall publish a
(d)
(2) The Administrator may at any time revoke the authorization of a State to issue experimental use permits if he determines that the designated State agency has not complied with the requirements of this subpart or with the terms and conditions of such authorization. State experimental use permits issued prior to the revocation of authority shall remain valid until they expire or until three years from the date of revocation of the State's authority, whichever comes first, unless sooner revoked by EPA under § 172.26(c) of this subpart.
(3) Notices of approval, rejection, and revocation shall be published in the
(4) Prior to rejecting or revoking authorization, the Administrator shall notify the State in writing of his intention to take such action, along with the basis for such action, and shall afford the State the opportunity for a hearing, and time to take corrective action.
(a)
(b)
(1) To any person for the purpose of gathering the data necessary to support the State registration of a pesticide to meet special local needs under section 24(c), FIFRA.
(2) To any agricultural research agency or educational institution conducting work within the State for the purpose of experimentation:
(i) Which is done within the State; and
(ii) Which is not directly intended to result in the registration of a specific pesticide product.
(3) For use of a restricted use pesticide only if the pesticide is to be used by, or under the direct supervision of, an applicator certified in accordance with section 11 of FIFRA.
(c)
(2) A State may not issue an experimental use permit under § 172.24(b)(1) or § 172.24(b)(2) for any of the following:
(i) A product containing an active or inert ingredient not contained in any EPA-registered product;
(ii) A product containing an active or inert ingredient which is currently subject to an EPA cancellation or suspension of registration order, or which is currently subject to an EPA notice of intent to suspend or cancel registration because of human health, environmental or efficacy considerations; except that the State may issue a permit for such a product for a purpose or in a formulation—
(A) Which was not specifically considered in, or which is not subject to, such suspension or cancellation proceedings, after consultation with appropriate EPA officials; or
(B) Which was specifically considered during such proceedings but not suspended, cancelled, or subjected to a notice of intent to suspend or cancel;
(iii) A use of a product which has been the subject of a notice of denial of registration published in the
(iv) A use of a product which may involve use in or on food or feed other than as authorized under § 172.24(d),
(3) A State may not issue an experimental use permit for use of a pesticide product in an area or in an amount in excess of that necessary to accomplish the purposes for which the permit was issued under paragraph (b) of this section.
(d)
(1) Submit evidence that:
(i) A tolerance or exemption from the requirement of a tolerance has been established for residues of the pesticide in or on such food or feed under section 408 of the Federal Food, Drug and Cosmetic Act; and
(ii) The proposed program would not reasonably be expected to result in residues of the pesticide in or on such food or feed in excess of that authorized under section 408 of the Federal Food, Drug and Cosmetic Act; and
(iii) All inert ingredients in the pesticide are exempted from the requirement of a tolerance under the appropriate section of 40 CFR part 180, subpart D; or
(2) Certify that the food or feed derived from the experimental program will be destroyed or fed only to experimental animals for testing purposes, or otherwise disposed of in a manner which will not endanger man or the environment. The method of destruction or disposal shall be described in the application for the permit.
(a)
(b)
(c)
(2) The designated State agency may permit an EPA or State registered pesticide to be used under an experimental use permit with supplemental labeling as approved by the State agency. In exercising this discretion, the designated State agency shall ensure that the supplemental labeling and the registered label together satisfy the requirements of § 172.6(a).
(d)
(e)
(f)
(2) During the course of the program, the designated State agency shall require the permittee to submit such reports (both special and periodic) as are necessary to supervise effectively the progress of the program to prevent unreasonable adverse effects on man or the environment. The designated State agency shall also require the permittee to submit a final report at the conclusion of the program. Where applicable, such reports shall also be made available to the U.S. Department of Agriculture, Food Service and Quality Service (FSQS), as required by § 172.8(c).
(g)
(1) Disposed of in accordance with a disposal plan approved as part of the experimental program; or
(2) Returned to the permittee for storage or disposal in accordance with the requirements of RCRA and rules there under; or
(3) If the product is currently registered, used in accordance with the registered label.
(a)
(2) Within 10 days after amendment or revocation of an experimental use permit by a State, the designated State agency shall notify the appropriate EPA Regional Office in writing of the amendment or revocation. The notice shall include a brief explanation of the reason for the amendment or revocation. If amendments to permits include changes in the approved labeling, the designated State agency shall also forward a copy of the amended labeling.
(3) EPA shall give notice in the
(b)
(1) An annual report covering the number of permits issued, the names and addresses of permittees, the names of the products covered by permits, and the State permit numbers issued;
(2) Reports, as requested by EPA, containing any information that EPA may determine necessary to ensure that a State has acted in compliance with provisions of FIFRA and this subpart; and
(3) Reports of any serious adverse effect(s), as soon thereafter as possible, from use of, or exposure to, a pesticide used pursuant to an experimental use permit.
(c)
(i) That its terms and conditions are being violated;
(ii) That its terms and conditions are inadequate to avoid unreasonable adverse effects on the environment;
(iii) That new evidence demonstrates that any tolerance upon which the permit is based will be inadequate to protect the public health, or that any exemption from the requirement for a tolerance is no longer appropriate; or
(iv) That a failure by the permittee to meet any other provisions of FIFRA or this subpart has occurred.
(2) The Administrator shall, prior to revoking a State experimental use permit, consult with the State agency which issued the permit, except in cases where continued use of the pesticide under the permit would create an imminent hazard to man or the environment.
(3) The Administrator shall notify the designated State agency, in writing, of the revocation, and the State agency shall notify the permittee, also in writing, of the revocation.
(4) The permittee shall notify all participants of the revocation within 10 days after he receives notice of revocation.
(5) The revocation of a permit shall not preclude the Administrator from
(6) If a permittee wishes to contest the revocation of a State experimental use permit, he shall, within 30 days after receipt of notice of such revocation, file with the Administrator a written request for an opportunity to confer with the Administrator or his designee. The revocation of the permit shall remain effective pending the outcome of any conference requested under this paragraph.
(7) If a permittee requests a conference under paragraph (c)(6) of this section, the Administrator shall provide the permittee:
(i) With information as to the time, place and nature of the conference, and of the matters of fact and law asserted by the Agency as grounds for the revocation action;
(ii) An opportunity to offer a written statement of facts, explanations, and arguments relevant to the revocation action;
(iii) All other procedural opportunities to which the permittee may be entitled by law.
(8) The Administrator shall notify the affected permittee and State Agency, in writing, of his final decision on the revocation matter as expeditiously as possible and shall attempt to do so within 30 days after the conclusion of a conference conducted under paragraph (c)(7). The Administrator shall also provide the permittee and the State agency with a written statement of the reasons for his decision, which shall take into account the evidence presented pursuant to paragraph (c)(7)(ii) of this section.
(9) A decision to revoke a permit under paragraph (c)(8) of this section is a final Agency action subject to judicial review as provided by law.
Terms used in this subpart shall, with the exception of those defined below, have the meaning set forth in the Act and in § 172.1.
(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.
(1) The continental United States, including Alaska, and the immediately adjoining countries (
(2) The Hawaiian Islands.
(3) The Caribbean Islands including Puerto Rico and the U.S. Virgin Islands.
(a)
(1) Small-scale tests that involve an intentional environmental introduction of that microbial pesticide.
(2) Small-scale tests performed in a facility without adequate containment and inactivation controls as provided in paragraph (e) of this section.
(b)
(c)
(1) Microbial pesticides whose pesticidal properties have been imparted or enhanced by the introduction of genetic material that has been deliberately modified.
(2) Nonindigenous microbial pesticides that have not been acted upon by the U.S. Department of Agriculture (
(d)
(i) Microbial pesticides resulting from deletions or rearrangements within a single genome that are brought about by the introduction of genetic material that has been deliberately modified.
(ii) [Reserved]
(2) Testing conducted in a facility with adequate containment and inactivation controls, as provided in paragraph (e) of this section, does not require a Notification.
(e)
(i) Factors relevant to the microbial pesticide's ability to survive in the environment.
(ii) Potential routes of release in air, solids, and liquids; in or on waste materials and equipment; in or on people (including maintenance and custodial personnel); and in or on other organisms such as insects and rodents.
(iii) Procedures for transfer of materials between facilities.
(iv) Plans for routine or emergency clean-up and test termination.
(2) For purposes of paragraph (e)(1) of this section, EPA will presume that compliance with the containment provisions of the National Institutes of Health (NIH) “Guidelines for Research Involving Recombinant DNA Molecules” (51 FR 16958, May 7, 1986) constitutes selection and use of adequate containment and inactivation controls.
(3) The selection of containment and inactivation controls shall be approved by an authorized official of the organization that is conducting the test prior to commencement of the test.
(4) Records shall be developed and maintained describing the selection and use of the containment and inactivation controls, including contingency plans for emergency clean-up and test termination, that will be used during the test. These records shall be available for inspection at the test facility. In addition, these records shall be submitted to EPA at EPA's request and within the time frame specified in EPA's request.
(5) Subsequent to any EPA review of the containment/inactivation controls selected under paragraph (e)(1) of this section, changes to the controls necessary to prevent unreasonable adverse effects must be made upon EPA request. Failure to comply with EPA's request shall result in automatic revocation of the exemption from the requirement to submit a Notification.
(a)
(b)
(c)
(1) Each Notification must be accompanied by a transmittal document that clearly identifies the EPA action supported as a Biotechnology Notification Review.
(2) Five copies of each Notification must be submitted to EPA.
(3) Any claims of confidentiality for information submitted in the Notification must be made as described in paragraph (d) of this section.
(d)
(1) 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 will be considered a waiver of confidentiality for the information submitted, and the information may be made available to the public, subject to section 10(g) of the Act, with no further notice to the submitter.
(2) Of the five copies of the Notification required by paragraph (c) of this section, four copies must be complete with the information that is claimed confidential clearly marked in the manner described in § 2.203(b) of this chapter. All information claimed as confidential must be deleted from the fifth copy, but it must be otherwise complete. The first page of the fifth copy must be marked “Contains no information claimed as confidential.” EPA may include the fifth copy in a public file without further notice. EPA will consider incomplete a Notification containing information claimed as CBI that is not submitted in accordance with this paragraph and will suspend the review period on the Notification until such procedures are followed.
(3) 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 should refer to § 2.204(e)(4) of this chapter for points to address in the substantiation. If such comments are themselves claimed confidential and are marked confidential when submitted to EPA, they will be treated as such in accordance with § 2.205(c) of this chapter. EPA will consider incomplete all Notifications containing information claimed as CBI that are not accompanied by substantiation, and will suspend the review period on such Notifications until the required substantiation is provided.
(4) EPA will disclose information that is subject to a claim of confidentiality asserted under this section only to the extent and by means of the procedures set forth in section 10 of the Act, in this subpart, and in part 2 of this chapter.
This section identifies the data and information to be included in each Notification. When specific information is not submitted, an explanation of why it is not practical or necessary to provide the information is to be provided.
(a) The identity of the microorganism which constitutes the microbial pesticide including:
(1) Summary of data supporting the taxonomic designation and its interpretation.
(2) Means and limit of detection using sensitive and specific methods (e.g., note the use of any markers that are used to distinguish the introduced population from native microorganisms). Introduction into the microbial pesticide of a unique genetic marker is encouraged.
(b) Description of the natural habitat of the parental strain of the microbial pesticide including information on:
(1) Physical and chemical features important to growth and survival of the parental strain.
(2) Biological features of the parental strain that would have an impact on the microbial pesticide (e.g., presence of phages that infect the microorganism).
(3) Competitors.
(c) Information on the host range of the microbial pesticide, if any, with an assessment of infectivity and pathogenicity to nontarget organisms.
(d) Information on survival and the ability of the microbial pesticide to increase in numbers (biomass) in the environment (e.g., in the environment into which the microbial pesticide will be introduced, and in substantially different environments that may be in the immediate vicinity). These data may be derived from the scientific literature or from tests conducted in a laboratory or other containment facility.
(e) The identity of possible transmission vectors (e.g., insects).
(f) Data on relative environmental competitiveness compared to the parental strain of the microbial pesticide.
(g) Description of the methods used to genetically modify the microbial pesticide.
(h) The identity and location of the gene segments that have been rearranged or inserted/deleted (host source, nature, and, for example, base sequence data, or restriction enzyme map of the genes).
(i) Information on the control region of the genes, and a description of the new traits or characteristics that are expressed.
(j) Data on potential for genetic transfer and exchange with other organisms and on genetic stability of any inserted sequences in the microbial pesticide.
(k) A description of the proposed testing program including:
(1) The purpose or objectives of the proposed testing.
(2) Designation of the pest organisms involved (common and scientific names).
(3) The States in which the proposed program will be conducted.
(4) The exact location of the test sites (including proximity to residences and human activities, surface water, etc.).
(5) The crops, fauna, flora, geographical description of sites, modes, dosage rates, frequency, and situation of application on or in which the pesticide is to be used.
(6) The total amount of pesticide product proposed for use in the testing.
(7) The method of application.
(8) A comparison of the natural habitat of the microbial pesticide with the proposed test site.
(9) The number of acres, structural sites, or animals/plants by State, to be treated or included in the area of experimental use.
(10) Procedures to be used to protect the test area from intrusion by unauthorized individuals.
(11) The proposed dates or periods during which the testing program is to be conducted, and the manner in which supervision of the program will be accomplished.
(12) Description of procedures for monitoring the microbial pesticide within and adjacent to the test site during the test.
(13) The method of sanitation or disposal of plants, animals, soils, farm tools, machinery etc., that will be exposed to the microbial pesticide during or after the test.
(14) Means of evaluating potential adverse effects and methods of controlling the microbial pesticide if detected beyond the test area.
(l) A statement of composition for the formulation to be tested, giving:
(1) The name and percentage by weight (or other suitable units) of each ingredient, active and inert.
(2) Production methods.
(3) Extraneous microorganisms present as contaminants.
(4) Amount and potency of any toxin present.
(5) Where applicable, the number of viable microorganisms per unit weight or volume of the product or other appropriate system for designating the quantity of active ingredient.
(m) Any additional factual information regarding the potential for unreasonable adverse effects on the environment.
(a) EPA will review and evaluate each Notification as expeditiously as possible and will make a determination no later than 90 days after receipt of the complete Notification; however, under no circumstances shall the proposed test proceed until the submitter has received notice from EPA of its approval of such test.
(b) For each Notification, EPA may make the following determinations:
(1) Require additional information from the submitter to assess the proposed test adequately.
(2) Approve the proposed test.
(3) Approve the proposed test provided that the submitter makes certain modifications to the test proposal.
(4) Require an EUP for the test.
(5) Disapprove the proposed test because of the potential for unreasonable adverse effects. Such disapproval by EPA shall be considered the equivalent of denial of an EUP and the remedies for such denial provided by § 172.10 are available to the submitter.
(c) If the proposed test is approved by EPA, then the submitter shall perform the test in the same manner described in the Notification, subject to any requirements imposed under paragraph (b)(3) of this section.
(a)
(b)
(2)
(3)
(i) Name and address of petitioner and name, address, and telephone number of a person who may be contacted for further information.
(ii) Description of the exemption requested, including the specific microbial pesticide or class of microbial pesticides to be tested under the petition for exemption.
(iii) Basis for the petitioner's contention that the specific microbial pesticide or class of microbial pesticides meet the criteria of § 172.3 for small-scale tests of pesticides that do not require an EUP.
(iv) Discussion of the extent to which the microbial pesticide or class of microbial pesticides covered by the petition differ from microbial pesticides that are already registered or subject to an EUP under the Act.
(4)
(i) Grant the petition and publish a notice of proposed rulemaking in the
(ii) Grant the petition and publish a notice of proposed rulemaking in the
(iii) Deny the petition and provide the petitioner with a written explanation of EPA's decision.
(5)
(6)
Any person using a microbial pesticide in small-scale testing covered by this subpart who obtains information regarding potential unreasonable adverse effects on health or the environment must within 30 days of receipt of such information submit the information to EPA, unless the person has actual knowledge that EPA has been adequately informed of such information. The requirement to submit information applies both to those microbial pesticides subject to the notification requirements under § 172.45(c) and those that are exempt under § 172.45(d).
(a)
(b)
(1) Such use would create an imminent threat of substantial harm to health or the environment that is prohibited under paragraph (a) of this section; or
(2) The terms or conditions on which approval of the testing was granted under this subpart C are violated.
7 U.S.C. 136w and 136w-2.
These procedures govern any proceeding to rescind a State's primary enforcement responsibility for pesticide use violations conducted under section 27(b) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA), 7 U.S.C. 136
For purposes of this part:
(a)
(b)
(c)
(d)
(e)
(a) Whenever the Administrator determines that a State having primary enforcement responsibility for pesticide use violations is not carrying out such responsibility, or cannot carry out such responsibility due to the lack of adequate legal authority, the Administrator shall notify the State in writing of his intent to rescind its primary enforcement responsibility, in whole or in part, by serving upon the State a notice of intent to rescind.
(b) The notice of intent to rescind shall:
(1) Specify those aspects of the State's pesticide use enforcement program determined to be inadequate;
(2) Specify the facts which underlie the findings contained in the rescission notice;
(3) Have attached thereto copies of any relevant documents discoverable under the Federal Rules of Civil Procedure and the Freedom of Information Act which contain data relied upon by the Administrator in making his decision to issue the notice;
(4) Have attached thereto a copy of this part; and
(5) Be sent to the State by certified mail, return receipt requested.
(c) The State may respond in writing to the findings specified in the notice of intent to rescind.
(a) After receipt of a notice of intent to rescind, the State may request that an informal conference be held between appropriate State and EPA officials to discuss the findings made in the notice of intent to rescind. The informal conference shall then be held in the State. If the Administrator finds, on the basis of information submitted by the State at the conference, that the deficiencies specified in the notice did not exist or were corrected by the State, the Administrator shall issue an order withdrawing the notice of intent to rescind and terminating the rescission proceeding.
(b) At any time after receipt of a notice of intent to rescind and before the issuance of a final order, the State and EPA may resolve the issues raised in
(1) Detail the deficiencies found in the State program;
(2) Specify the steps the State has taken or will take to remedy the deficiencies; and
(3) Set forth a precise schedule for each remedial action yet to be initiated.
(c) If a written agreement is signed by the parties, the Administrator shall issue an order withdrawing the notice of intent to rescind and terminating the rescission proceeding. If the State does not comply with the terms of the settlement agreement, the Administrator may reissue the notice of intent to rescind.
A State may request a hearing before a Presiding Officer not later than sixty (60) days after receipt of a notice of intent to rescind.
(a) If the Administrator has not issued an order terminating the rescission proceeding within sixty (60) days after service of the notice of intent to rescind upon the State, the Administrator shall publish the notice of intent to rescind in the
(b) Concurrently with the publication of the notice of intent to rescind, the Administrator shall schedule a hearing in the State if one has been requested by the State. The date, time, and location of the hearing shall be published in the
(c) If a hearing is requested and the Administrator has not issued an order terminating the rescission proceeding, the Administrator shall provide for a hearing as scheduled. Representatives of the State, EPA, and the public may present evidence at the hearing. The Administrator shall appoint a Presiding Officer who shall preside over the hearing and make a recommended decision regarding the adequacy of the State's pesticide use enforcement program. The Administrator, after consultation with the State, may prescribe additional procedures governing the conduct of the hearing.
(d) If a termination order is issued or the hearing is rescheduled after the notice of intent to rescind is published in the
(a) The Presiding Officer shall:
(1) Conduct a fair and impartial hearing, without unnecessary delay;
(2) Ensure that the facts are fully elicited; and
(3) Consider all evidence, comment, and argument which is submitted by persons who will be affected by the outcome of the proceeding and which is not irrelevant, immaterial, unduly repetitious, or otherwise unreliable or of little probative value. The Presiding Officer may require any prospective witness to make available, in advance of the hearing, a brief summary of his or her testimony.
(b) If, following the close of the hearing, the Presiding Officer finds that the State has corrected, or has agreed in writing to correct, the deficiencies specified in the notice of intent to rescind or has shown that such deficiencies do not exist, the Presiding Officer shall issue a decision recommending that the notice of intent to rescind be withdrawn and that the rescission proceeding be terminated.
(c) If, following the close of the hearing, the Presiding Officer finds that the State has not corrected the deficiencies in its program, the Presiding Officer shall issue a decision recommending that the State's primary enforcement responsibility for pesticide use violations be rescinded in whole or in part.
(d) The recommended decision of the Presiding Officer shall become final
(a) If the State does not request a hearing within the sixty-day time period and the Administrator has not issued an order withdrawing the notice of intent to rescind, the Administrator shall issue a final order as soon as practicable after the time for public comment on the notice of intent to rescind has elapsed. The final order shall either withdraw the notice of intent to rescind and terminate the proceeding or rescind, in whole or in part, the State's primary enforcement responsibility for pesticide use violations.
(b) If a hearing has been held and the Presiding Officer has made a recommended decision, then either the Office of Enforcement or the State may appeal the recommended decision to the Administrator or the Administrator may elect to review the recommended decision on his own initiative.
(c) After an appeal or sua sponte review the Administrator shall issue a final order terminating the rescission proceeding or rescinding, in whole or in part, the State's primary enforcement responsibility for pesticide use violations.
(d) In no event may the Administrator issue his final decision sooner than ninety (90) days after service of the notice of intent to rescind on a State.
(e) Any final order, or a recommended decision which becomes a final order under § 173.7(c), shall be published in the
The State may appeal an order rescinding, in whole or in part, its primary enforcement responsibility for pesticide use violations to the appropriate federal court pursuant to section 16 of FIFRA.
7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.
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
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.
(1) In seed plants, reproduction by apomixis, or
(2) In other plants, reproduction by fragmentation, or division of the somatic body.
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
(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.
A plant-incorporated protectant is exempt from the requirements of FIFRA, other than the requirements of § 174.71, if it meets all of the following criteria:
(a) The plant-incorporated protectant meets the 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 plant-incorporated protectant are either exempted from the requirement of a tolerance under FFDCA (as amended, 21 U.S.C. 321
(c) Any inert ingredient that is part of the plant-incorporated protectant is on the list codified at § 174.705. Plant-incorporated protectants that are not exempt from the requirements of FIFRA under this subpart are subject to all the requirements of FIFRA.
A plant-incorporated protectant 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.
(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).
This subpart lists the tolerances and exemptions from the requirement of a tolerance for residues of plant-incorporated protectants in or on food commodities.
Residues of
(a) Residues of
(b) A time-limited exemption from the requirement of a tolerance is established for residues of
Residues of
Residues of
Residues of
Residues of nucleic acids that are part of a plant-incorporated protectant are exempt from the requirement of a tolerance.
Residues of a pesticidal substance that is part of a plant-incorporated protectant from a sexually compatible plant 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 residues of the pesticidal substance are not present in food from the plant at levels that are injurious or deleterious to human health.
Residues of
Residues of
Residues of
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.
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.
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.
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.
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.
The plant-incorporated protectant
Residues of
Residues of
Residues of
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.
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.
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.
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.
Residues of
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.
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.
Residues of
Residues of
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.
Residues of
Residues of
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.
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.
21 U.S.C. 346a and 371.
This part describes the procedures and criteria under which EPA will establish time-limited tolerances and exemptions from the requirement of a tolerance for pesticide chemical residues associated with use of pesticides under emergency or crisis exemptions under FIFRA section 18. This part applies only to tolerances issued on the initiative of EPA as the result of the issuance of an emergency exemption or the declaration of a crisis exemption. This part does not cover time-limited tolerances in any other circumstances.
The terms have the same meaning as in the Federal Insecticide, Fungicide, and Rodenticide Act section 2, and in the Federal Food, Drug, and Cosmetic Act section 201 and § 166.3 of this chapter. In addition, the following terms are defined for the purposes of this part.
EPA will establish a time-limited tolerance for pesticide chemical residues in or on raw or processed food or feed resulting from the use of a pesticide chemical, if EPA authorizes an emergency exemption or a crisis exemption. EPA will consider establishing such a tolerance only if an applicant acting under authority of FIFRA section 18 either has requested an emergency exemption, has stated its intention to issue a crisis exemption, or has issued a crisis exemption for a use that may result, directly or indirectly, in pesticide chemical residues in food or feed.
(a) EPA will establish a time-limited tolerance only if EPA can determine that the tolerance is safe, that is, there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. EPA will base its determination upon data submitted by the applicant and other readily available data. If, taking into account the limited duration and emergency nature of a section 18 application, and based on the available data the Agency cannot conclude that there is a reasonable certainty that no harm will result from the use proposed by the applicant or granted pursuant to a crisis exemption, EPA will not establish a tolerance.
(b) Data and other relevant information to support the establishment of a time-limited tolerance may be submitted by the applicant, or by any other person, in support of the time-limited tolerance. The applicant may also cite relevant data previously submitted to the Agency.
(a) If EPA issues an emergency exemption or crisis exemption under FIFRA section 18, and EPA concludes that the tolerance for residues resulting from use of the pesticide under the exemption will be safe, then EPA will establish the tolerance by publishing an amendment to 40 CFR part 180 in the
(b) A tolerance under this part may be established without prior publication of a proposed tolerance or comment period.
(a) Tolerances issued under this part will become effective upon publication
(b) Unless extended, tolerances will automatically expire and be revoked, without further action by EPA, at the time set out in the final rule published in
(c) The Administrator may revoke a tolerance at any time if the Administrator determines that the tolerance is no longer safe.
If additional emergency or crisis exemptions are authorized that would extend use beyond the date originally authorized, or if EPA determines that the duration of a time-limited tolerance is insufficient to allow treated commodities to clear the channels of trade, EPA may modify the time-limited tolerance by publication of a final rule in the
The establishment of a tolerance under this part does not alter the requirement that any applicant comply with procedures established in part 166 of this chapter for emergency exemptions of FIFRA.
21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.
For the purposes of this part:
(a) On or before the 60th day after the date of publication in the
(b) A person may include with any such objection a written request for an evidentiary hearing on such objection in accordance with § 178.27
(c) A person who submits objections need not request a hearing. For instance, if the person's objections are of a purely legal or policy nature, a hearing request would be inappropriate; the purpose of an evidentiary hearing is to resolve factual disputes. The Administrator will rule on the objections, whether or not a hearing is requested.
(d) As a matter of discretion, the Administrator may order a hearing on an objection even though no person has requested a hearing.
(a) To be considered by the Administrator, an objection must:
(1) Be in writing.
(2) Specify with particularity the provision(s) of the order, regulation, or denial objected to, the basis for the objection(s), and the relief sought.
(3) Be signed by the objector.
(4) State the objector's name and mailing address.
(5) Be accompanied by the fee prescribed by § 180.33(i) of this chapter, if the objection is to an order or regulation issued under part 180 of this chapter.
(6) Be submitted to the hearing clerk.
(7) Be received by the Hearing Clerk not later than the close of business of the 60th day following the date of the publication in the
(b) Submissions to the hearing clerk shall be made as follows:
(1) Mailed submissions should be addressed to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
(2) For hand/courier delivery the Office of the Hearing Clerk is located at Suite 350, 1099 14
To be considered by the Administrator, a request for an evidentiary hearing must meet the criteria in § 178.32, and must:
(a) Be submitted as a part of, and specifically request an evidentiary hearing on an objection that complies with the requirements of § 178.25.
(b) Include a statement of the factual issue(s) on which a hearing is requested and the requestor's contentions on each such issue.
(c) Include a copy of any report, article, survey, or other written document (or the pertinent pages thereof) upon which the objector relies to justify an evidentiary hearing, unless the document is an EPA document that is routinely available to any member of the public.
(d) Include a summary of any evidence not described in paragraph (a)(3) of this section upon which the objector relies to justify an evidentiary hearing.
(e) Include a discussion of the relationship between the factual issues and the relief requested by the objection.
The Administrator will respond to objections, and to requests for a hearing on such objections, as set forth in this section.
(a)
(1) The objection is found not to conform to § 178.25.
(2) The action requested by the objection is inconsistent with any provision of FFDCA.
(3) The action requested by the objection is inconsistent with any generic, e.g., non-chemical specific, interpretation of a provision of FFDCA in any regulation in this chapter (the proper procedure in such a case is for the person to petition for an amendment of the regulation involved).
(b)
(c)
(d)
(e)
(a) In the case of each request for an evidentiary hearing that was not denied under § 178.30(a) or (b), the Administrator will determine whether such a hearing on one or more of the objections is justified, and will publish in the
(b) A request for an evidentiary hearing will be granted if the Administrator determines that the material submitted shows the following:
(1) There is a genuine and substantial issue of fact for resolution at a hearing. An evidentiary hearing will not be granted on issues of policy or law.
(2) There is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary. An evidentiary hearing will not be granted on the basis of mere allegations, denials, or general descriptions of positions and contentions, nor if the Administrator concludes that the data and information submitted, even if accurate, would be insufficient to justify the factual determination urged.
(3) Resolution of the factual issue(s) in the manner sought by the person requesting the hearing would be adequate to justify the action requested. An evidentiary hearing will not be granted on factual issues that are not determinative with respect to the action requested. For example, a hearing will not be granted if the Administrator concludes that the action would be the same even if the factual issue were resolved in the manner sought.
(c) Where appropriate, the Administrator will make rulings on any issues raised by an objection which are necessary for resolution prior to determining whether a request for an evidentiary hearing should be granted.
(a) If the Administrator determines upon review of an objection or request for hearing that the regulation or prior order in question should be modified or
(b) The Administrator will provide an opportunity for objections and requests for hearing on such order to the extent required by law. Such objections to the modification or revocation of the regulation, and requests for a hearing on such objections, may be submitted under §§ 178.20 through 178.27.
(c) Objections and requests for hearing that are not affected by the modification or revocation will remain on file and be acted upon in accordance with this part.
(a) The Administrator will publish in the
(1) A hearing was not requested.
(2) A hearing was requested, but denied.
(b) Each order published under paragraph (a) of this section must state the reasons for the Administrator's determination. If the order denies a request for a hearing on the objection, the order also must state the reason for that denial (e.g., why the request for a hearing did not conform to § 178.27, or why the request was denied under § 178.32).
(c) Each order published under paragraph (a) of this section must state its effective date.
An order issued under § 178.37 is final agency action reviewable in the courts as provided by FFDCA section 408(h), as of the date of publication of the order in the
(a) For purposes of judicial review, the record of an administrative proceeding that culminates in an order under § 178.37 consists of:
(1) The objection ruled on (and any request for hearing that was included with the objection).
(2) Any order issued under § 180.7(g) of this chapter to which the objection related, and:
(i) Any regulation or petition denial that was the subject of that order.
(ii) The petition to which such order responded.
(iii) Any amendment or supplement of the petition.
(iv) The data and information submitted in support of the petition.
(v) The notice of filing of the petition.
(3) Any order issued under § 180.29(f) of this chapter to which the objection related, the regulation that was the subject of that order, and each related Notice of Proposed Rulemaking.
(4) Any comments submitted by members of the public in response to the Notice of Filing or Notice of Proposed Rulemaking, any data or information submitted as part of the comments, the Administrator's response to comments and the documents or information relied on by the Administrator in issuing the regulation or order.
(5) All other documents or information submitted to the docket for the rulemaking in question.
(6) The order issued under § 178.37.
(b) The record will be closed as of the date of the Administrator's decision unless another date for closing of the
21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.
Questions regarding procedural matters arising under this part or part 178 of this chapter that are not addressed
(a) If the Administrator determines under § 178.32 of this chapter that a hearing is justified on any issue, the Administrator will file with the hearing clerk and publish in the
(1) The docket number for the hearing.
(2) Each order, regulation, or petition denial that is the subject of the hearing, and a statement specifying any part of any such regulation or order that has been stayed in the Administrator's discretion.
(3) The identity of each person whose request for a hearing has been granted, and of any other person whose petition under § 180.7 of this chapter occasioned the order that the hearing concerns.
(4) A statement of the issues of fact on which a hearing has been found to be justified.
(5) A statement of the objections whose resolution depends on the resolution of those issues of fact.
(6) A statement that the presiding officer will be designated by the Chief Administrative Law Judge.
(7) The time within which notices of participation should be filed under § 179.42.
(8) The date, time, and place of the preliminary conference, or a statement that the date, time, and place will be announced in a later notice, and the place of the hearing.
(9) The time within which parties must submit written information and views under § 179.83.
(10) Designations with respect to separation of functions published under § 179.24(b)(2).
(b) The statement of the issues of fact on which a hearing has been justified determines the scope of the hearing and the matters on which evidence may be introduced. The issues may be revised by the presiding officer. A party may obtain interlocutory review by the Administrator of a decision by the presiding officer to revise the issues to include an issue on which the Administrator has not granted a request for a hearing or to eliminate an issue on which a request for a hearing has been granted.
(c) A hearing is deemed to begin on the date of publication of the Notice of Hearing.
(a) Any person may meet or correspond with any officer or employee of the Agency concerning a matter under parts 178 or 180 of this chapter prior to publication of a Notice of Hearing under § 179.20.
(b) Upon publication of a Notice of Hearing, the following separation of function rules apply:
(1) OCSPP, as a party to the hearing, is responsible for presentation of its position at the hearing and in any pleading or oral argument before the Administrator. The Pesticides and Toxic Substances Division of the Office of General Counsel shall advise and represent OCSPP with respect to the hearing and in any pleading or oral argument before the Administrator. An employee or other representatives of OCSPP may not participate in or advise the Administrator or any of his representatives on any decision under this part, other than as witness or counsel in public proceedings, except as provided by paragraph (b)(2) of this section. There is to be no other communication between representatives of OCSPP and the presiding officer or any representative of the Office of the Administrator concerning the merits of the hearing until after issuance of the decision of the Administrator.
(2) The Administrator may designate persons who otherwise would be regarded as representatives of OCSPP, to serve as representatives of the Office of the Administrator on matters pertaining to the hearing, and may also designate persons who otherwise would be regarded as representatives of the Office of the Administrator to serve as representatives of OCSPP. Such designations will be included in the Notice of Hearing published under§ 179.20.
(3) The Office of the Administrator is responsible for the final decision of the matter, with the advice and participation of anyone in the Agency other than representatives of OCSPP.
(c) Between the date of publication of the Notice of Hearing and the date of the Administrator's final decision on the matter, communication concerning the matter involved in the hearing will be restricted as follows:
(1) No person outside the Agency may have an ex parte communication with the presiding officer or any representative of the Office of the Administrator concerning the merits of the hearing. Neither the presiding officer nor any representative of the Office of the Administrator may have any ex parte communication with a person outside the Agency concerning the merits of the hearing.
(2) A written communication contrary to this section must be immediately served on all other participants and filed with the hearing clerk by the presiding officer at the hearing, or by the Administrator, depending on who received the communication. An oral communication contrary to this section must be immediately recorded in a written memorandum and similarly served on all other parties and filed with the hearing clerk. A person, including a representative of a party in the hearing, who is involved in an oral communication contrary to this section, must, to the extent necessary to determine the substance of the communication, be made available for cross-examination during the hearing with respect to the substance of that communication. Rebuttal testimony pertinent to a written or oral communication contrary to this section will be permitted.
(d) The prohibitions specified in paragraph (c) of this section also apply to a person who, in advance of the publication of a Notice of Hearing, knows that the notice has been signed. The prohibitions become applicable to such a person as of the time the knowledge is acquired.
(e) The making of a communication contrary to this section may, consistent with the interests of justice and the policies underlying the FFDCA, result in a decision adverse to the person knowingly making or causing the making of the communication.
(a) OCSPP shall be a party to a hearing under this part. Any other person may participate as a party in such a hearing to the extent specified by this section.
(b) A person desiring to participate in a hearing must file with the hearing clerk within 30 days after publication of the Notice of Hearing under § 179.20, a Notice of Participation in the following form:
(c) An amendment to a Notice of Participation must be filed with the hearing clerk and served on all parties.
(d) No person may participate in a hearing who has not filed a written Notice of Participation or whose participation has been stricken under paragraph (f) of this section.
(e) The presiding officer may permit the late filing of a Notice of Participation upon a showing of good cause. Arrangements and agreements previously made in the proceeding shall apply to any party admitted late.
(f) The presiding officer may strike the participation of a person for failure to comply with any requirement of this
(a) A party to a hearing may appear in person or by counsel or other representative in the hearing.
(b) The presiding officer may strike a person's right to appear in the hearing for violation of the rules of conduct in § l79.50.
The parties and their representatives must conduct themselves with dignity and observe the same standards of practice and ethics that would be required of parties in a judicial proceeding. Disrespectful, disorderly, or contumacious language or conduct, refusal to comply with directions, use of dilatory tactics, or refusal to adhere to reasonable standards of orderly and ethical conduct during any hearing constitute grounds for immediate exclusion from the proceeding by the presiding officer.
The presiding officer in a hearing will be an administrative law judge qualified under 5 U.S.C. 3l05 and designated by the Agency's chief administrative law judge.
The presiding officer shall conduct the hearing in a fair and impartial manner subject to the precepts of the Administrative Procedure Act. The presiding officer has all powers necessary to conduct a fair, expeditious, and orderly hearing, including the power to:
(a) Specify and change the date, time, and place for conferences, and issue and modify a schedule for the hearing.
(b) Establish an orderly manner for developing evidentiary facts at preliminary conferences under § 179.87, for making rulings on oral testimony and cross-examination under § 179.93, and for making other similar evidentiary rulings in accord with these regulations.
(c) Prepare statements of the areas of factual disagreement among the participants.
(d) Hold conferences to settle, simplify, or determine the issues in a hearing or to consider other matters that may expedite the hearing.
(e) Administer oaths and affirmations.
(f) Control the course of the hearing and the conduct of the participants.
(g) Examine witnesses and strike their testimony if they fail to respond fully to proper questions.
(h) Rule on, admit, exclude, or limit evidence.
(i) Set the time for filing pleadings.
(j) Rule on motions and other procedural matters.
(k) Rule on motions for summary decision under § l79.90.
(l) Conduct the hearing in stages if the number of parties is large or the issues are numerous and complex.
(m) Strike the participation of any person under § l79.42(f), or exclude any person from the hearing under § l79.50, or take other reasonable disciplinary action.
(n) Take any other action for the fair, expeditious, and orderly conduct of the hearing that is not in conflict with law or these rules.
(a) A deciding official in a hearing under this part (including, e.g., the Administrator, judicial officer, or presiding officer) shall not decide any matter in connection with which he or she has a financial interest in any of the parties, or a relationship that would make it otherwise inappropriate for him or her to act.
(b) A party may request that a deciding official disqualify himself/herself and withdraw from the proceeding. The party may obtain interlocutory review by the Administrator of a denial of such a request made to any deciding official other than the Administrator.
(c) A deciding official who is aware of grounds for disqualification shall withdraw from the proceeding.
If the presiding officer is unable to act for any reason, his or her powers with respect to the hearing will be assigned by the Chief Administrative Law Judge to another presiding officer. The substitution will not affect the hearing,
(a) All documents required or authorized to be filed by a party to a hearing under this part regarding any matter to be decided by the presiding officer, the judicial officer, or the Administrator shall be filed in triplicate with the hearing clerk, in the manner specified by § 178.25(b) of this chapter. Each filing shall prominently note the docket number. To determine compliance with deadlines in a hearing, a document is considered filed on the date it is actually received by the hearing clerk. When this part allows a response by a party to a submission and prescribes a period of time for the filing of the response, an additional 3 days are allowed for the filing of the response if the submission is served by mail.
(b) Each notice, order, decision, or other document issued under this part by the presiding officer, the judicial officer, or the Administrator shall be filed with the hearing clerk. The hearing clerk shall immediately serve all parties with a copy of such order, decision, or other document.
(c) At the same time that a party files any document with the hearing clerk, the party shall serve a copy thereof on each other party, unless the presiding officer specifies otherwise. Each filing shall be accompanied by a certificate of service, or a statement that service is not required. Service on a party is accomplished by mailing a submission to the address shown in the Notice of Participation or by personal delivery.
(d) The presiding officer may grant an extension of time for the filing of any pleading, document, or motion (1) Upon timely motion by a party, for good cause shown, and after consideration of prejudice to other parties, or (2) upon the presiding officer's own motion.
(e) A motion by a party for an extension may only be made after serving a copy of the motion on all other parties, unless the movant can show good cause why doing so is impracticable. The motion shall be filed in advance of the date on which the pleading, document, or motion is due to be filed, unless the failure of the party to make a timely motion for an extension was the result of excusable neglect.
(a) All orders, decisions, pleadings, transcripts, exhibits, and other docket entries shall become part of the official docket and shall be retained by the hearing clerk. Except as otherwise provided by paragraph (b) of this section or part 2 of this chapter, all documents that are a part of the official docket shall be made available to the public for reasonable inspection during Agency business hours. Copies of such documents may be obtained by members of the public as provided in part 2 of this chapter.
(b) Whenever any information or data are required to be produced or examined in a hearing and any party makes a business confidentiality claim regarding such information under part 2 of this chapter, the availability of such information to the other parties or to the public shall be determined by EPA in accordance with part 2 of this chapter, including specifically the procedures and principles set forth in § 2.30l(g)(3) and (g)(4) of this chapter. The presiding officer shall make the determinations with respect to the matters referred to in § 2.301(g)(3) and (g)(4) to the extent provided, and shall take such steps as are necessary for the protection of information entitled to confidential treatment or otherwise exempt from public disclosure, including issuance of protective orders to parties
(a) Within 60 days of the publication of the Notice of Hearing under § l79.20, or, if no party will be prejudiced, within another period set by the presiding officer, the Assistant Administrator shall file with the hearing clerk, in accordance with § 179.80, the following documents numbered and organized in the manner prescribed by the presiding officer:
(1) The portions of the administrative record of the proceeding developed under part 178 of this chapter, and under part 180 of this chapter, that are relevant to the issues in the hearing.
(2) All documents in the files of OCSPP containing factual information or expert opinion, whether favorable or unfavorable to the position of OCSPP, which relate to the issues involved in the hearing. For purposes of this paragraph, “files” means the principal files in OCSPP in which documents relating to each of the issues in the hearing are ordinarily kept. Documents that are internal memoranda reflecting the deliberative process, or are attorney work product, or were prepared specifically for use in connection with the hearing, are not required to be submitted.
(3) All other documentary data and information upon which OCSPP plans to rely upon in the hearing.
(4) A narrative position statement on the factual issues in the Notice of Hearing and the nature of the supporting evidence that OCSPP intends to introduce.
(5) A signed statement that, to the best knowledge and belief of the Assistant Administrator, the submission complies with this section.
(b) Within 70 days of the publication of the Notice of Hearing or, if no party will be prejudiced, within another period of time set by the presiding officer, each party other than OCSPP shall submit to the hearing clerk in accordance with § 179.80 the following documents, numbered and organized in the manner prescribed by the presiding officer:
(1) Any objections that the administrative record filed under paragraph (a)(l) of this section is incomplete.
(2) All documents (other than those filed under paragraph (a) of this section) in the party's files containing factual information or expert opinion, whether favorable or unfavorable to the party's position, that relates to the issues involved in the hearing. For purposes of this paragraph, “files” means the party's principal files in which documents relating to each of the issues in the hearing are ordinarily kept. Documents that are attorney work product, or were prepared specifically for use in connection with the hearing, are not required to be submitted.
(3) All other documentary data and information the party plans to rely upon in the hearing.
(4) A narrative position statement on the factual issues in the Notice of Hearing and the nature of the supporting evidence the party intends to introduce.
(5) A signed statement that, to the best knowledge and belief of the party, the submission complies with this section.
(c) Submissions required by paragraphs (a) and (b) of this section may be supplemented later in the proceeding, with the approval of the presiding officer, upon a showing that the material contained in the supplement was not reasonably known by or available to the party when the submission was made or that the relevance of the material contained in the supplement could not reasonably have been foreseen.
(d) If a party fails to comply substantially and in good faith with this section, the presiding officer may infer that such failure was for the purpose of withholding information that is unfavorable to the party's position, and may make such further adverse inferences and findings with respect to such failure as are warranted.
(e) Parties may reference each other's submissions. To reduce duplicative submissions, parties are encouraged to exchange and consolidate lists of documentary evidence. If a particular document is bulky or in limited supply and cannot reasonably be reproduced, and it constitutes relevant evidence, the
(f) The presiding officer will rule on questions relating to this section.
The presiding officer will conduct one or more preliminary conferences for the following purposes:
(a) To determine the areas of factual disagreement to be considered at the hearing.
(b) To establish any necessary procedural rules to control the course of the hearing and the schedule for the hearing.
(c) To group parties with substantially similar interests, for purposes of presenting evidence, making objections, cross-examination, and presenting oral argument.
(d) To obtain stipulations and admissions of facts.
(e) To take other action that may expedite the hearing.
A preliminary conference will commence at the date, time, and place announced in the Notice of Hearing, or as otherwise specified by the Administrator or presiding officer in a subsequent notice. The preliminary conference may not commence until after expiration of the time for filing notices of participation under § 179.42. The presiding officer may specify that two or more such conferences shall be held.
Parties in a hearing must appear at the preliminary conference(s) prepared to present a position on the matters specified in § 179.85. A preliminary conference may be held by telephone, or other electronic means, if appropriate.
(a) To expedite the hearing, parties are encouraged to prepare in advance for the conference. Parties should cooperate with each other and should request information and begin preparation of testimony at the earliest possible time. Failure of a party to appear at the preliminary conference or to raise matters that could reasonably be anticipated and resolved at that time will not delay the progress of the hearing, and constitutes a waiver of the rights of the party regarding such matters as objections to the agreements reached, actions taken, or rulings issued. Such failure to appear may also be grounds for striking the party's participation under § 179.42(f).
(b) Each party shall bring to the preliminary conference the following specific information, which will be filed with the hearing clerk under § 179.80:
(1) Any additional information to supplement the submission which may have been filed under § 179.83, and/or which may be filed if approved under § 179.83(c).
(2) A list setting forth each person who has been identified as a witness whose oral or written testimony will be offered by the party at the hearing, with a full curriculum vitae for each and a summary of the expected testimony (including a list of the principal exhibits on which the witness will rely) or a statement as to when such a summary will be furnished. A party may amend its witness and document list to add, delete, or substitute witnesses or documents.
(c) The presiding officer may hold preliminary conferences off the record in an effort to reach agreement on disputed factual or procedural questions.
(d) The presiding officer shall issue and file under § 179.80 a written order reciting the actions taken at each preliminary conference and setting forth the schedule for the hearing. The order will control the subsequent course of the hearing unless modified by the presiding officer for good cause.
A motion, unless made in the course of a preliminary conference or a transcribed oral hearing before the presiding officer, must be filed in the manner prescribed by § 179.80 and include a draft order. A response may be filed within 10 days of service of a motion. The moving party has no right to reply, except as permitted by the presiding officer. The presiding officer shall rule upon the motion.
(a) After the hearing commences, a party may file a written motion, with or without supporting affidavits or brief, for a summary decision on any issue in the hearing. Any other party may, within 10 days after service of the motion, which time may be extended for an additional 10 days for good cause shown, serve opposing affidavits or brief or countermove for summary decision. The presiding officer may set the matter for argument and call for the submission of briefs if not submitted by the parties.
(b) The presiding officer will grant the motion if the objections, requests for hearing, other pleadings, affidavits, and other material filed in connection with the hearing, or matters officially noticed, show that there is no genuine disagreement as to any material fact bearing on the issue and that a party is entitled to summary decision.
(c) Affidavits should set forth facts that would be admissible in evidence and show affirmatively that the affiant is competent to testify to the matters stated. When a properly supported motion for summary decision is made, a party opposing the motion may not rest upon mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses must demonstrate specifically that there is a genuine issue of material fact for the hearing.
(d) Should it appear from the affidavits of a party opposing the motion that for sound reasons stated, facts essential to justify the opposition cannot be presented by affidavit, the presiding officer may deny the motion for summary decision, order a continuance to permit affidavits or additional evidence to be obtained, or issue other just order.
(e) If a summary decision is not rendered upon all issues or for all the relief asked, and evidentiary facts need to be developed, the presiding officer will issue an order specifying the facts that appear without substantial controversy and directing further evidentiary proceedings. The facts so specified will be deemed established.
(f) A party may obtain interlocutory review by the Administrator of a summary decision of the presiding officer.
(a) The party whose request for an evidentiary hearing was granted has the burden of going forward in the hearing with evidence as to the issues relevant to that request for a hearing.
(b) The party or parties who contend that a regulation satisfies the criteria of section 408 of the FFDCA has the burden of persuasion in the hearing on that issue, whether the proceeding concerns the establishment, modification, or revocation of a tolerance or exemption from the requirement for a tolerance.
(a) The presiding officer will conduct such proceedings as are necessary for the taking of oral direct testimony and for the conduct of oral examination of witnesses by the parties. The presiding officer shall limit oral examination to prevent irrelevant, immaterial or unduly repetitious examination.
(b) Direct testimony shall be submitted in writing, except that the presiding officer may order direct testimony to be presented orally in those unusual cases where the memory or demeanor of the witness is of importance. Written direct testimony shall be in the form of a verified statement of fact or opinion prepared by the witness, in narrative form or in question-and-answer form. Written direct testimony may incorporate exhibits. Such a verified statement or exhibit may not be admitted into evidence sooner than 14 days (or such other reasonable period as the presiding officer may order) after the witness has delivered to the presiding officer and each party a copy of the statement or exhibit. The admissibility of the evidence contained in such a statement is subject to the same rules as if such testimony had been given orally.
(c) Oral cross-examination of witnesses will be permitted. Each exhibit that a party intends to rely upon in cross-examining a witness shall be furnished to the other parties not later than 3 days (or such other reasonable period as the presiding officer may
(d) Witnesses shall give testimony under oath or affirmation.
(a) The hearing clerk shall make arrangements to have all oral testimony stenographically reported or recorded and transcribed, with evidence that is admitted in the form of written testimony or exhibits attached or incorporated as appropriate.
(b) Unless the presiding officer orders otherwise, parties shall have 15 days from the date that the transcript of particular oral testimony first becomes available to propose corrections in the transcript of that testimony. Corrections are permitted only for transcription errors. The presiding officer shall promptly order justified corrections.
(c) As soon as practicable after the taking of the last evidence, the presiding officer shall certify:
(1) That the original transcript is a true transcript of the oral testimony offered or received at the hearing, except in such particulars as the presiding officer specifies.
(2) That the written testimony and exhibits accompanying the transcript are all the written testimony and exhibits introduced at the hearing, with such exceptions as the presiding officer specifies.
(3) The transcript with attached or incorporated material, as so certified by the presiding officer, shall be submitted to and filed by the hearing clerk under § 179.80.
(d) Copies of the transcript shall be available to the public in accordance with § 179.81; parties may make special arrangements through the hearing clerk to obtain copies on an ongoing, expedited basis.
(a) Written material identified as direct testimony or as an evidentiary exhibit and offered by a party in a hearing, and oral testimony, whether on direct or on cross-examination, is admissible as evidence unless the presiding officer excludes it (on objection of a party or on the presiding officer's own initiative) because it is irrelevant, immaterial, or unduly repetitive, or because its exclusion is necessary to enforce a specific requirement of this part relating to the admissibility of evidence.
(b) If a party objects to the admission or rejection of any evidence or to the limitation of the scope of any examination or cross-examination, the party shall state briefly the grounds for such objection. The transcript shall include any argument or debate thereon, unless the presiding officer, with the consent of all the parties, orders that such argument not be transcribed. The ruling and the reasons given therefor by the presiding officer on any objection shall be a part of the transcript. An automatic exception to that ruling will follow.
(c) Whenever evidence is deemed inadmissible, the party offering such evidence may make an offer of proof, which shall be included in the transcript. The offer of proof for excluded oral testimony shall consist of a brief statement describing the nature of the evidence excluded. If the evidence consists of a document or exhibit, it shall be inserted in the record in total. If the Administrator in reviewing the record under § 179.112 decides that the presiding officer's ruling in excluding the evidence was erroneous and prejudicial, the hearing may be reopened to permit the taking of such evidence, or, where appropriate, the Administrator may evaluate the evidence and proceed to a final decision.
(d) Official notice may be taken of Agency proceedings, any matter that might be judicially noticed by the courts of the United States, or any other fact within the knowledge and experience of the Agency as an expert agency. Any party shall be given adequate opportunity to show that such facts are erroneously noticed by presenting evidence to the contrary.
The presiding officer may schedule and hold conferences as needed to monitor the progress of the hearing, narrow and simplify the issues, and consider and rule on motions, requests, or other matters concerning the development of the evidence.
(a) Promptly after the taking of evidence is completed, the presiding officer will announce a schedule for the filing of briefs. Briefs must include a statement of position on each issue, with specific and complete citations to the evidence and points of law relied on. Briefs must contain proposed findings of fact and conclusions of law.
(b) The presiding officer may, as a matter of discretion, permit oral argument after the briefs are filed.
(a) Except as provided in paragraph (b) of this section and in §§ 179.20(b), 179.42(f), 179.75(b), and 179.90(f), rulings of the presiding officer may not be appealed to the Administrator before the Administrator's consideration of the entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory appeal to the Administrator if the presiding officer certifies on the record or by document submitted under § 179.80 that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any party or substantial harm to the public interest. When an order or ruling is not certified by the presiding officer, it shall be reviewed by the Administrator only upon appeal from the initial decision except when the Administrator determines upon the request of a party and in exceptional circumstances, that delaying review would be deleterious to vital public or private interests. Except in extraordinary circumstances, proceedings will not be stayed pending an interlocutory appeal. Where a stay is granted, a stay of more than 30 days must be approved by the Administrator.
(c) Ordinarily, the interlocutory appeal will be decided on the basis of the submission made to the presiding officer, but the Administrator may allow further briefs and oral arguments. Any oral argument will be transcribed and the transcript will be prepared and certified in the same manner as provided in § 179.94.
(a) After the filing of briefs and any oral argument, the presiding officer shall prepare and file an initial decision on the issues of fact in the hearing and the objections relating to those issues.
(b) The initial decision must be based on a fair evaluation of the entire record, and must contain:
(1)(i) A conclusion that no change is warranted in the order or regulation to which objection was taken; or
(ii) A conclusion that changes in the order or regulation are warranted, the language of the order or regulation as changed, and an effective date for the order or regulation as changed.
(2) Findings of fact supported by reliable, probative and substantial evidence that has been found admissible by the presiding officer, and adequate citations to the record supporting those findings.
(3) Conclusions on legal and policy issues, if such conclusions are necessary to resolve the objections.
(4) A discussion of the reasons for the findings and conclusions, including a discussion of the significant contentions made by any party.
(c) Except as otherwise provided by order of the Administrator filed in accordance with § 179.80, after the initial decision is filed, the presiding officer has no further jurisdiction over the matter and any motions or requests filed with the hearing clerk will be decided by the Administrator.
(d) The initial decision becomes the final decision of the Administrator by operation of law unless a party files exceptions with the hearing clerk under § 179.107 or the Administrator files a notice of review under § 179.110.
(a) A party may appeal an initial decision to the Administrator by filing exceptions with the hearing clerk, and serving them on the other parties, within the period specified in the initial decision. The period may not exceed 30 days, unless extended by the
(b) Exceptions must specifically identify alleged errors in the findings of fact or conclusions of law or policy in the initial decision and, if errors in the findings of fact are alleged, must provide supporting citations to evidence of record. Oral argument before the Administrator may be requested in the exceptions.
(c) Any reply to the exceptions is to be filed and served within the timeperiod specified in the initial decision. The timeperiod may not exceed 30 days after the end of the period (including any extensions) for filing exceptions, unless extended by the Administrator under paragraph (d) of this section.
(d) The Administrator may extend the time for filing exceptions or replies to exceptions for good cause shown.
(e) If the Administrator decides to hear oral argument, the parties will be informed of the date, time, and place; the amount of time allotted to each party, and the issues to be addressed.
Within 10 days following the expiration of the time for filing exceptions (including any extensions), the Administrator may file with the hearing clerk, and serve on the parties, a notice of the Administrator's determination to review the initial decision. The Administrator may invite the parties to file briefs or present oral argument on the matter. The time for filing briefs or presenting oral argument will be specified in that or a later notice.
(a) On appeal from or review of the initial decision, the Administrator shall have the same powers as did the presiding officer in making the initial decision. On the Administrator's own initiative or on motion, the Administrator may remand the matter to the presiding officer for any further action necessary for a proper decision.
(b) The scope of the issues on appeal to, or on review by the Administrator is the same as the scope of the issues before the presiding officer, unless the Administrator specifies otherwise.
(c) After the filing of briefs and any oral argument, the Administrator will issue a final decision on the issues of fact in the hearing and the objections related to those issues. A final decision must contain the elements required for an initial decision by § 179.105(b).
(d) The Administrator may adopt the initial decision as the final decision.
(e) The Administrator's decision, or a summary of the decision and a notice of its availability, will be published in the
A party may file a motion requesting the Administrator to reconsider a final decision under this part. Any such motion must be filed within 10 days after service of the final decision, and must set forth the matters claimed to have been erroneously decided and the nature of the alleged errors. Such a motion shall not stay the effective date of the final decision unless specifically so ordered by the Administrator.
(a) One or more judicial officers may be designated by the Administrator. A judicial officer shall be an attorney who is a permanent or temporary employee of the Agency or of another Federal agency. A judicial officer may perform other duties. A judicial officer who performs any duty under this part may not be employed by OCSPP, by the Pesticides and Toxic Substances Division of the Office of General Counsel, or by any other person who is a representative of OCSPP in the hearing. A person may not be designated as a judicial officer in a hearing if he or she performed any prosecutorial or investigative functions in connection with that hearing or any other factually related hearing.
(b) The Administrator may delegate to the judicial officer all or part of the Administrator's authority to act in a given proceeding under this part. Such a delegation does not prevent the judicial officer from referring any motion
(a) The Administrator's final decision is final agency action reviewable in the courts as provided by FFDCA section 408(h), as of the date of publication of the order in the
(b) The record for judicial review of a final decision under this part consists of the record described in § 179.130.
(a) For purposes of judicial review, the record of a hearing that culminates in a final decision of the Administrator under § 179.105(d) or § 179.112(c) ruling on an objection shall consist of:
(1) The objection ruled on (and any request for hearing that was included with the objection).
(2) Any order issued under § 180.7(g) of this chapter to which the objection related, and:
(i) The regulation or petition denial that was the subject of that order.
(ii) The petition to which such order responded.
(iii) Any amendment or supplement of the petition.
(iv) The data and information submitted in support of the petition.
(v) The notice of filing of the petition.
(3) Any order issued under § 180.29(f) of this chapter to which the objection related, the regulation that was the subject of that order, and each related Notice of Proposed Rulemaking.
(4) The comments submitted by members of the public in response to the Notice of Filing or Notice of Proposed Rulemaking, and the information submitted as part of the comments, the Administrator's response to comments and the documents or information relied on by the Administrator in issuing the regulation or order.
(5) All other documents or information submitted to the docket for the rulemaking in question under parts 177 or part 180 of this chapter.
(6) The Notice of Hearing published under § 179.20.
(7) All notices of participation filed under § 179.42.
(8) Any
(9) All submissions filed under § 179.80.
(10) Any document of which official notice was taken under § 179.95.
(b) The record of the administrative proceeding is closed:
(1) With respect to the taking of evidence, when specified by the presiding officer.
(2) With respect to pleadings, at the time specified in § 179.98(a) for the filing of briefs.
(c) The presiding officer may reopen the record to receive further evidence at any time before the filing of the initial decision.
21 U.S.C. 321(q), 346a and 371.
Nomenclature changes to part 180 appear at 62 FR 66023, Dec. 17, 1997.
The items in this glossary were compiled as an aid to the users of the Code of Federal Regulations. Inclusion or exclusion from this glossary has no legal significance.
(a)
(b)
(c)
(d) Raw agricultural commodities include, among other things, fresh fruits, whether or not they have been washed and colored or otherwise treated in their unpeeled natural form; vegetables in their raw or natural state, whether or not they have been stripped of their outer leaves, waxed, prepared into fresh green salads, etc.; grains, nuts, eggs, raw milk, meats, and similar agricultural produce. It does not include foods that have been processed, fabricated, or manufactured by cooking, freezing, dehydrating, or milling.
(e) Where a raw agricultural commodity bearing a pesticide chemical residue that has been exempted from the requirement of a tolerance, or which is within a tolerance permitted under FFDCA section 408, is used in preparing a processed food, the processed food will not be considered unsafe within the meaning of FFDCA sections 402 and 408(a), despite the lack of a tolerance or exemption for the pesticide chemical residue in the processed food, if:
(1) The pesticide chemical has been used in or on the raw agricultural commodity in conformity with a tolerance under this section;
(2) The pesticide chemical residue has been removed to the extent possible in good manufacturing practice; and
(3) The concentration of the pesticide chemical residue in the processed food is not greater than the tolerance prescribed for the pesticide chemical residue on the raw agricultural commodity.
(f) For the purpose of computing fees as required by § 180.33, each group of related crops listed in § 180.34(e) and each crop group or subgroup listed in § 180.41 is counted as a single raw agricultural commodity in a petition or request for tolerances or exemption from the requirement of a tolerance.
(g) Tolerances and exemptions established for pesticide chemicals in or on the general category of raw agricultural commodities listed in column A apply to the corresponding specific raw
(h) Unless otherwise specified in this paragraph or in tolerance regulations prescribed in this part for specific pesticide chemicals, the raw agricultural commodity or processed food to be examined for pesticide residues, shall consist of the whole raw agricultural commodity or processed food.
(1) The raw agricultural commodity bananas, when examined for pesticide residues, shall not include any crown tissue or stalk.
(2) Shell shall be removed and discarded from nuts before examination for pesticide residues.
(3) Caps (hulls) shall be removed and discarded from strawberries before examination for pesticide residues.
(4) Stems shall be removed and discarded from melons before examination for pesticide residues.
(5) Roots, stems, and outer sheaths (or husks) shall be removed and discarded from garlic bulbs and dry bulb onions, and only the garlic cloves and onion bulbs shall be examined for pesticide residues.
(6) Where a tolerance is established on a root vegetable including tops and/or with tops, and the tops and the roots are marketed together, they shall be analyzed separately and neither the pesticide residue on the roots nor the pesticide residue on the tops shall exceed the tolerance level, except that in the case of carrots, parsnips, and rutabagas, the tops shall be removed and discarded before analyzing roots for pesticide residues.
(7) The crowns (leaves at the top of the fruit) shall be removed and discarded from pineapples before examination for pesticide residues.
(8) The term
(9) The term
(10) For processed foods consisting primarily of one ingredient and sold in a form requiring further preparation prior to consumption (e.g., fruit juice concentrates, dehydrated vegetables, and powdered potatoes), the processed food to be examined for residues shall be the whole processed commodity after compensating for or reconstituting to the commodity's normal moisture content, unless a tolerance for the concentrated or dehydrated food form is included in this part. If there exists a tolerance for a specific pesticide on the processed food in its concentrated or dehydrated food form, for the purpose of determining whether the food is in compliance with that tolerance, the processed food to be examined for residues shall be the whole processed commodity on an “as is” basis.
(i) The term
(j) The term
(k) The term
(l) The term
(m) The term
(n) The term
(1) Any raw agricultural commodity (food or feed) as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act (FFDCA); and
(2) Any processed food or feed as defined in section 201(gg) of the FFDCA.
For
(a) Pesticide chemicals that cause related pharmacological effects will be regarded, in the absence of evidence to the contrary, as having an additive deleterious action. (For example, many pesticide chemicals within each of the following groups have related pharmacological effects: Chlorinated organic pesticides, arsenic-containing chemicals, metallic dithiocarbamates, cholinesterase-inhibiting pesticides.)
(b) Tolerances established for such related pesticide chemicals may limit the amount of a common component (such as As
(c)(1) Where tolerances for inorganic bromide in or on the same raw agricultural commodity are set in two or more sections in this part (example: §§ 180.123 and 180.199), the overall quantity of inorganic bromide to be tolerated from use of the same pesticide in different modes of application or from two or more pesticide chemicals for which tolerances are established is the highest of the separate applicable tolerances. For example, where the bromide tolerance on asparagus from methyl bromide commodity fumigation is 100 parts per million (40 CFR 180.123) and on asparagus from methyl bromide soil treatment is 300 parts per million (40 CFR 180.199), the overall inorganic bromide tolerance for asparagus grown on methyl bromide-treated soil and also fumigated with methyl bromide after harvest is 300 parts per million.
(2) Where tolerances are established in terms of inorganic bromide residues only from use of organic bromide fumigants on raw agricutural commodities, such tolerances are sufficient to protect the public health, and no additional concurrent tolerances for the organic pesticide chemicals from such use are necessary. This conclusion is based on evidence of the dissipation of the organic pesticide or its conversion to inorganic bromide residues in the food when ready to eat.
(d)(1) Where tolerances are established for both calcium cyanide and hydrogen cyanide on the same raw agricultural commodity, the total amount of such pesticides shall not yield more residue than that permitted by the larger of the two tolerances, calculated as hydrogen cyanide.
(2) Where tolerances are established for residues of both
(3) Where tolerances are established for both terpene polychlorinates (chlorinated mixture of camphene, pinene, and related terpenes, containing 65-66 percent chlorine) and toxaphene
(4) Where a tolerance is established for more than one pesticide containing arsenic found in, or on a raw agricultural commodity, the total amount of such pesticide shall not exceed the highest established tolerance calculated as As
(5) Where tolerances are established for more than one member of the class of dithiocarbamates listed in paragraph (e)(3) of this section on the same raw agricultural commodity, the total residue of such pesticides shall not exceed that permitted by the highest tolerance established for any one member of the class, calculated as zinc ethylenebisdithiocarbamate.
(6) Where tolerances are established for residues of both
(7) Where tolerances are established for residues of
(8) Where a tolerance is established for more than one pesticide having the metabolites 1-(3,4-dichlorophenyl)-3-methylurea (DCPMU) and 3,4-dichlorophenylurea (DCPU) found in or on a raw agricultural commodity, the total amount of such residues shall not exceed the highest established tolerance for a pesticide having these metabolites.
(9) Where a tolerance is established for more than one pesticide having as metabolites compounds containing the benzimidazole moiety found in or on a raw agricultural commodity, the total amount of such residues shall not exceed the highest established tolerance for a pesticide having these metabolites.
(10) Where a tolerance is established for triclopyr, chloropyrifos, and chlorpyrifos-methyl having the common metabolite 3,5,6-trichloro-2-pyridinol on the same raw agricultural commodity, the total amount of such residues shall not exceed the highest established tolerance for any of the pesticides having the metabolites.
(11) Where tolerances are established for more than one pesticide having the metabolite 3,5,6-trichloro-2-pyridinol found in or on the raw agricultural commodity, the total amount of such residues shall not exceed the highest established tolerance for a pesticide having this metabolite.
(12) Where tolerances are established for residues of methomyl, resulting from the use of thiodicarb and/or methomyl on the same raw agricultural commodity, the total amount of methomyl shall not yield more residue than that permitted by the higher of the two tolerances.
(e) Except as noted in paragraphs (e)(1) and (2) of this section, where residues from two or more chemicals in the same class are present in or on a raw agricultural commodity the tolerance for the total of such residues shall be the same as that for the chemical having the lowest numerical tolerance in this class, unless a higher tolerance level is specifically provided for the combined residues by a regulation in this part.
(1) Where residues from two or more chemicals in the same class are present in or on a raw agricultural commodity and there are available methods that permit quantitative determination of each residue, the quantity of combined residues that are within the tolerance may be determined as follows:
(i) Determine the quantity of each residue present.
(ii) Divide the quantity of each residue by the tolerance that would apply if it occurred alone, and multiply by 100 to determine the percentage of the permitted amount of residue present.
(iii) Add the percentages so obtained for all residues present.
(iv) The sum of the percentages shall not exceed 100 percent.
(2) Where residues from two or more chemicals in the same class are present in or on a raw agricultural commodity and there are available methods that permit quantitative determinations of one or more, but not all, of the residues, the amounts of such residues as may be determinable shall be deducted from the total amount of residues present and the remainder shall have the same tolerance as that for the chemical having the lowest numerical tolerance in that class. The quantity of combined residues that are within the tolerance may be determined as follows:
(i) Determine the quantity of each determinable residue present.
(ii) Deduct the amounts of such residues from the total amount of residues present and consider the remainder to have the same tolerance as that for the chemical having the lowest numerical tolerance in that class.
(iii) Divide the quantity of each determinable residue by the tolerance that would apply if it occurred alone and the quantity of the remaining residue by the tolerance for the chemical having the lowest numerical tolerance in that class and multiply by 100 to determine the percentage of the permitted amount of residue present.
(iv) Add the percentages so obtained for all residues present.
(v) The sum of the percentages shall not exceed 100 percent.
(3) The following pesticides are members of the class of dithiocarbamates:
(4) The following are members of the class of chlorinated organic pesticides:
(5) The following are members of the class of cholinesterase-inhibiting pesticides:
(6) The following pesticides are members of the class of dinitrophenols:
For
The substances listed in this section are excepted from the definitions of “pesticide chemical” and “pesticide chemical residue” under FFDCA section 201(q)(3) and are therefore exempt from regulation under FFDCA section 402(a)(2)(B) and 408. These substances are subject to regulation by the Food and Drug Administration as food additives under FFDCA section 409.
(a) Inert ingredients in food packaging treated with a pesticide, when such inert ingredients are the components of the food packaging material (e.g. paper and paperboard, coatings, adhesives, and polymers).
(b) [Reserved]
A zero tolerance means that no amount of the pesticide chemical may remain on the raw agricultural commodity when it is offered for shipment. A zero tolerance for a pesticide chemical in or on a raw agricultural commodity may be established because, among other reasons:
(a) A safe level of the pesticide chemical in the diet of two different species of warm-blooded animals has not been reliably determined.
(b) The chemical is carcinogenic to or has other alarming physiological effects upon one or more of the species of the test animals used, when fed in the diet of such animals.
(c) The pesticide chemical is toxic, but is normally used at times when, or in such manner that, fruit, vegetables, or other raw agricultural commodities will not bear or contain it.
(d) All residue of the pesticide chemical is normally removed through good agricultural practice such as washing or brushing or through weathering or other changes in the chemical itself, prior to introduction of the raw agricultural commodity into interstate commerce.
(a) When establishing tolerances for pesticide residues in or on raw agricultural commodities, consideration is always given to possible residues of those pesticide chemicals or their conversion products entering the diet of man through the ingestion of milk, eggs, meat, and/or poultry produced by animals fed agricultural products bearing such pesticide residues. In each instance an evaluation of all available data will result in a conclusion either:
(1) That finite residues will actually be incurred in these foods from feed use of the raw agricultural commodity including its byproducts; or
(2) That it is not possible to establish with certainty whether finite residues
(3) That it is not possible to establish with certainty whether finite residues will be incurred, but there is no reasonable expectation of finite residues.
(b) When the data show that finite residues will actually be incurred in milk, eggs, meat, and/or poultry, a tolerance will be established on the raw agricultural commodity used as feed provided that tolerances can be established at the same time, on the basis of the toxicological and other data available, for the finite residues incurred in milk, eggs, meat, and/or poultry. When it is not possible to determine with certainty whether finite residues will be incurred in milk, eggs, meat, and/or poultry but there is a reasonable expectation of finite residues in light of data reflecting exaggerated pesticides levels in feeding studies, a tolerance will be established on the raw agricultural commodity provided that appropriate tolerances can be established at the same time, on the basis of the toxicological and other data available, for the finite residues likely to be incurred in these foods through the feed use of the raw agricultural commodity or its byproducts. When it is not possible to determine with certainty whether finite residues will be incurred in milk, eggs, meat, and/or poultry but there is no reasonable expectation of finite residues in light of data such as those reflecting exaggerated pesticide levels in feeding studies and those elucidating the biochemistry of the pesticide chemical in the animal, a tolerance may be established on the raw agricultural commodity without the necessity of a tolerance on food products derived from the animal.
(c) The principles outlined in paragraphs (a) and (b) of this section will also be followed with respect to tolerances for residues which will actually be incurred or are reasonably to be expected in milk, eggs, meat, and/or poultry by the use of pesticides directly on the animal or administered purposely in the feed or drinking water.
(d) Tolerances contemplated by paragraphs (a) and (b) of this section will in addition to toxicological considerations be conditioned on the availability of a practicable analytical method to determine the pesticide residue; that is, the method must be sensitive and reliable at the tolerance level or in special cases at a higher level where such level is deemed satisfactory and safe in light of the toxicity of the pesticide residue and of the unlikelihood of such residue exceeding the tolerance. The analytical methods to be used for enforcement purposes will be those set forth in the “Pesticide Analytical Manual” (see § 180.101(c)). The sensitivities of these methods are expressed in that manual.
(a) Petitions to be filed with the Agency under the provisions of FFDCA section 408(d) shall be submitted in duplicate. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall be accompanied by an advance deposit for fees described in § 180.33. The petition shall state the petitioner's mail address to which notice of objection under FFDCA section 408(g)(2) may be sent. The petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an authorized official.
(b) Petitions shall include the following information:
(1) An informative summary of the petition and of the data, information, and arguments submitted or cited in support of the petition. Both a paper and electronic copy of the summary should be submitted. The electronic copy should be formatted according to the Office of Pesticide Programs' current standard for electronic data submission as specified at
(2) A statement that the petitioner agrees that such summary or any information it contains may be published as a part of the notice of filing of the petition to be published under FFDCA
(3) The name, chemical identity, and composition of the pesticide chemical residue and of the pesticide chemical that produces the residue.
(4) Data showing the recommended amount, frequency, method, and time of application of the pesticide chemical.
(5) Full reports of tests and investigations made with respect to the safety of the pesticide chemical, including full information as to the methods and controls used in conducting those tests and investigations.
(6) Full reports of tests and investigations made with respect to the nature and amount of the pesticide chemical residue that is likely to remain in or on the food, including a description of the analytical methods used. (See § 180.34 for further information about residue tests.)
(7) Proposed tolerances for the pesticide chemical residue if tolerances are proposed.
(8) Practicable methods for removing any amount of the residue that would exceed any proposed tolerance.
(9) A practical method for detecting and measuring the levels of the pesticide chemical residue in or on the food, or for exemptions, a statement why such a method is not needed.
(10) If the petition relates to a tolerance for a processed food, reports of investigations conducted using the processing method(s) used to produce that food.
(11) Such information as the Administrator may require to make the determination under FFDCA section 408(b)(2)(C).
(12) Such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.
(13) Information regarding exposure to the pesticide chemical residue due to any tolerance or exemption already granted for such residue.
(14) Information concerning any maximum residue level established by the Codex Alimentarius Commission for the pesticide chemical residue addressed in the petition. If a Codex maximum residue level has been established for the pesticide chemical residue and the petitioner does not propose that this level be adopted, a statement explaining the reasons for this departure from the Codex level.
(15) Such other data and information as the Administrator requires by regulation to support the petition.
(16) Reasonable grounds in support of the petition.
(c) The data specified under paragraphs (b)(1) through (b)(16) of this section should be on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by reference to the earlier one.
(d) Except as noted in paragraph (e) of this section, a petition shall not be accepted for filing if any of the data prescribed by FFDCA section 408(d) are lacking or are not set forth so as to be readily understood. The availability to the public of information provided to, or otherwise obtained by, the Agency under this part shall be governed by part 2 of this chapter. The Administrator shall make the full text of the summary referenced in paragraph (b)(1) of this section available to the public in the public docket at
(e) The Administrator shall notify the petitioner within 15 days after its receipt of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. If petitioner desires, the petitioner may supplement a deficient petition after notification as to deficiencies. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified.
(f) A notice of the filing of a petition for a pesticide chemical residue tolerance that the Administrator determines has met the requirements of paragraph (b) of this section shall be published in the
(g) The Administrator may request a sample of the pesticide chemical at any time while a petition is under consideration. The Administrator shall specify in its request for a sample of the pesticide chemical, a quantity which it deems adequate to permit tests of analytical methods used to determine residues of the pesticide chemical and of methods proposed by the petitioner for removing any residues of the chemical that exceed the tolerance proposed.
(h) The Administrator shall determine, in accordance with the Act, whether to issue an order that establishes, modifies, or revokes a tolerance regulation (whether or not in accord with the action proposed by the petitioner), whether to publish a proposed tolerance regulation and request public comment thereon under § 180.29, or whether to deny the petition. The Administrator shall publish in the
In some cases the Administrator will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a tolerance or the tolerance requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal may be without prejudice to a future filing. A deposit for fees as specified in § 180.33 shall accompany the resubmission of the petition.
After a petition has been filed, the petitioner may submit additional information or data in support thereof, but in such cases the petition will be given a new filing date.
(a) Upon the Administrator's own initiative, the Administrator may propose, under FFDCA section 408(e), the issuance of a regulation establishing a tolerance for a pesticide chemical or exempting it from the necessity of a tolerance, or a regulation modifying or revoking an existing tolerance or exemption.
(b) The Administrator shall provide a period of not less than 60 days for persons to comment on the proposed regulation, except that a shorter period for comment may be provided if the Administrator for good cause finds that it would be in the public interest to do so and states the reasons for the finding in the notice of proposed rulemaking.
(c) After reviewing any timely comments received, the Administrator may by order establish, modify, or revoke a tolerance regulation, which order and regulation shall be published in the
(d) Any final regulation issued under this section shall be effective on the date of publication in the
(a) Under FFDCA section 408(h), judicial review is available in the United States Courts of Appeal as to the following actions:
(1) Regulations establishing general procedures and requirements under FFDCA section 408(e)(1)(C).
(2) Orders issued under FFDCA section 408(f)(1)(C) requiring the submission of data.
(3) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to establishment, modification, or revocation of a tolerance or exemption under FFDCA section 408(d)(4), or any regulation that is the subject of such an order. The underlying action here is Agency disposition of a petition seeking the establishment, modification, or revocation of a tolerance or exemption.
(4) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to the denial of a petition under FFDCA section 408(d)(4).
(5) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to the establishment, modification, suspension, or revocation of a tolerance or exemption under FFDCA section 408(e)(1)(A) or (e)(1)(B). The underlying action here is the establishment, modification, suspension, or revocation of a tolerance or exemption upon the initiative of EPA including EPA actions pursuant to FFDCA sections 408(b)(2)(B)(v), 408(b)(2)(E)(ii), 408(d)(4)(C)(ii), 408(l)(4), and 408(q)(1).
(6) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to the revocation or modification of a tolerance or exemption under FFDCA section 408(f)(2) for noncompliance with requirements for the submission of data.
(7) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to rules issued under FFDCA sections 408(n)(3) and 408(d) or (e) regarding determinations pertaining to State authority to establish regulatory limits on pesticide chemical residues.
(8) Orders issued under FFDCA section 408(g)(2)(C) ruling on objections to orders issued under FFDCA section 408(n)(5)(C) authorizing States to establish regulatory limits not identical to certain tolerances or exemptions.
(b) Any issue as to which review is or was obtainable under paragraph (a) of this section shall not be the subject of judicial review under any other provision of law. In part, this means that, for the Agency actions subject to the objection procedure in FFDCA section 408(g)(2), judicial review is not available unless an adversely affected party exhausts these objection procedures, and any petition procedures preliminary thereto.
(a) A temporary tolerance (or exemption from a tolerance) established under the authority of FFDCA section 408(r) shall be deemed to be a tolerance (or exemption from the requirement of a tolerance) for the purposes of FFDCA section 408(a)(1) or (a)(2) and for the purposes of § 180.30.
(b) A request for a temporary tolerance or a temporary exemption from a tolerance by a person who has obtained or is seeking an experimental permit for a pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act shall be accompanied by such data as are available on subjects outlined in § 180.7(b) and an advance deposit to cover fees as provided in § 180.33.
(c) To obtain a temporary tolerance, a requestor must comply with the petition procedures specified in FFDCA section 408(d) and § 180.7 except as provided in this section.
(d) A temporary tolerance or exemption from a tolerance may be issued for a period designed to allow the orderly marketing of the raw agricultural commodities produced while testing a pesticide chemical under an experimental permit issued under authority of the Federal Insecticide, Fungicide, and Rodenticide Act if the Administrator concludes that the safety standard in
(e) Conditions under which a temporary tolerance is established shall include:
(1) A limitation on the amount of the chemical to be used on the designated crops permitted under the experimental permit.
(2) A limitation for the use of the chemical on the designated crops to bona fide experimental use by qualified persons as indicated in the experimental permit.
(3) A requirement that the person or firm which obtains the experimental permit for which the temporary tolerance is established will immediately inform the Environmental Protection Agency of any reports on findings from the experimental use that have a bearing on safety.
(4) A requirement that the person or firm which obtained the experimental permit for which the temporary tolerance is established will keep records of production, distribution, and performance for a period of 2 years and, on request, at any reasonable time, make these records available to any authorized officer or employee of the Environmental Protection Agency.
(a) The Administrator on his/her own initiative may propose the issuance of a regulation modifying or revoking a tolerance for a pesticide chemical residue on raw agricultural commodities or processed foods or modifying or revoking an exemption from tolerance for such residue.
(b) Any person may file with the Administrator a petition proposing the issuance of a regulation modifying or revoking a tolerance or exemption from a tolerance for a pesticide chemical residue. The petition shall furnish reasonable grounds for the action sought. Reasonable grounds shall include an explanation showing wherein the person has a substantial interest in such tolerance or exemption from tolerance and an assertion of facts (supported by data if available) showing that new uses for the pesticide chemical have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the application of the tolerance or exemption from tolerance may justify its modification or revocation. Evidence that a person has registered or has submitted an application for the registration of a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act will be regarded as evidence that the person has a substantial interest in a tolerance or exemption from the requirement of a tolerance for a pesticide chemical that consists in whole or in part of the pesticide. New data should be furnished in the form specified in § 180.7(b) for submitting petitions, as applicable.
(c) The procedures for completing action on an Administrator initiated proposal or a petition shall be those specified in §§ 180.29 and 180.7, as applicable.
(a) Each petition for the establishment of a new tolerance or a tolerance higher than already established, shall be accompanied by a fee of $80,950, plus $2,025 for each raw agricultural commodity more than nine on which the establishment of a tolerance is requested, except as provided in paragraphs (b), (d), and (h) of this section.
(b) Each petition for the establishment of a tolerance at a lower numerical level or levels than a tolerance already established for the same pesticide chemical, or for the establishment of a tolerance on additional raw agricultural commodities at the same numerical level as a tolerance already established for the same pesticide chemical, shall be accompanied by a fee of $18,500 plus $1,225 for each raw
(c) Each petition for an exemption from the requirement of a tolerance or repeal of an exemption shall be accompanied by a fee of $14,925.
(d) Each petition or request for a temporary tolerance or a temporary exemption from the requirement of a tolerance shall be accompanied by a fee of $32,325 except as provided in paragraph (e) of this section. A petition or request to renew or extend such temporary tolerance or temporary exemption shall be accompanied by a fee of $4,600.
(e) A petition or request for a temporary tolerance for a pesticide chemical which has a tolerance for other uses at the same numerical level or a higher numerical level shall be accompanied by a fee of $16,075, plus $1,225 for each raw agricultural commodity on which the temporary tolerance is sought.
(f) Each petition for revocation of a tolerance shall be accompanied by a fee of $10,125. Such fee is not required when, in connection with the change sought under this paragraph, a petition is filed for the establishment of new tolerances to take the place of those sought to be revoked and a fee is paid as required by paragraph (a) of this section.
(g) If a petition or a request is not accepted for processing because it is technically incomplete, the fee, less $2,025 for handling and initial review, shall be returned. If a petition is withdrawn by the petitioner after initial processing, but before significant Agency scientific review has begun, the fee, less $2,025 for handling and initial review, shall be returned. If an unacceptable or withdrawn petition is resubmitted, it shall be accompanied by the fee that would be required if it were being submitted for the first time.
(h) Each petition for a crop group tolerance, regardless of the number of raw agricultural commodities involved, shall be accompanied by a fee equal to the fee required by the analogous category for a single tolerance that is not a crop group tolerance,
(i) Objections under section 408(d)(5) of the Act shall be accompanied by a filing fee of $4,050.
(j) The person who files a petition for judicial review of an order under section 408(h) of the Act shall pay the costs of preparing the record on which the order is based unless the person has no financial interest in the petition for judicial review.
(k) No fee under this section will be imposed on the Interregional Research Project Number 4 (IR-4 Program).
(l) The Administrator may waive or refund part or all of any fee imposed by this section if the Administrator determines in his or her sole discretion that such a waiver or refund will promote the public interest or that payment of the fee would work an unreasonable hardship on the person on whom the fee is imposed. A request for waiver or refund of a fee shall 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). A fee of $2,025 shall accompany every request for a waiver or refund, as specified in paragraph (m) of this section, except that the fee under this paragraph shall not be imposed on any person who has no financial interest in any action requested by such person under paragraphs (a) through (j) of this section. The fee for requesting a waiver or refund shall be refunded if the request is granted.
(m) All deposits and fees required by the regulations in this part shall be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency. All deposits and fees shall be forwarded to the Environmental Protection Agency, Headquarters Accounting Operations Branch, Office of Pesticide Programs (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. The payments should be specifically labeled “Tolerance Petition Fees” and should be accompanied only by a copy of the letter or petition requesting the tolerance. The actual letter or petition, along with supporting data, shall be forwarded within 30 days of payment to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). A petition will not be
(n) This fee schedule will be changed annually by the same percentage as the percent change in the Federal General Schedule (GS) pay scale. In addition, processing costs and fees will periodically be reviewed and changes will be made to the schedule as necessary. When automatic adjustments are made based on the GS pay scale, the new fee schedule will be published in the
(o) No fee required by this section shall be levied during the period beginning on October 1, 2003, and ending September 30, 2008.
(a) Data in a petition on the amount of residue remaining in or on a raw agricultural commodity should establish the residue that may remain when the pesticide chemical is applied according to directions registered under the Federal Insecticide, Fungicide, and Rodenticide Act, or according to directions contained in an application for registration. These data should establish the residues that may remain under conditions most likely to result in high residues on the commodity.
(b) The petition should establish the reliability of the residue data reported in it. Sufficient information should be submitted about the analytical method to permit competent analysts to apply it successfully.
(c) If the pesticide chemical is absorbed into a living plant or animal when applied (is systemic), residue data may be needed on each plant or animal on which a tolerance or exemption is requested.
(d) If the pesticide chemical is not absorbed into the living plant or animal when applied (is not systemic), it may be possible to make a reliable estimate of the residues to be expected on each commodity in a group of related commodities on the basis of less data than would be required for each commodity in the group, considered separately.
(e) Each of the following groups of crops lists raw agricultural commodities that are considered to be related for the purpose of paragraph (d) of this section. Commodities not listed in this paragraph are not considered to be related for the purpose of paragraph (d) of this section.
(1) Apples, crabapples, pears, quinces.
(2) Avocados, papayas.
(3) Blackberries, boysenberries, dewberries, loganberries, raspberries.
(4) Blueberries, currants, gooseberries, huckleberries.
(5) Cherries, plums, prunes.
(6) Oranges, citrus citron, grapefruit, kumquats, lemons, limes, tangelos, tangerines.
(7) Mangoes, persimmons.
(8) Peaches, apricots, nectarines.
(9) Beans, peas, soybeans (each in dry form).
(10) Beans, peas, soybeans (each in succulent form).
(11) Broccoli, brussels sprouts, cauliflower, kohlrabi.
(12) Cantaloups, honeydew melons, muskmelons, pumpkins, watermelons, winter squash.
(13) Carrots, garden beets, sugar beets, horseradish, parsnips, radishes, rutabagas, salsify roots, turnips.
(14) Celery, fennel.
(15) Cucumbers, summer squash.
(16) Lettuce, endive (escarole), Chinese cabbage, salsify tops.
(17) Onions, garlic, leeks, shallots (green, or in dry bulb form).
(18) Potatoes, Jerusalem-artichokes, sweetpotatoes, yams.
(19) Spinach, beet tops, collards, dandelion, kale, mustard greens, parsley, Swiss chard, turnip tops, watercress.
(20) Tomatoes, eggplants, peppers, pimentos.
(21) Pecans, almonds, brazil nuts, bush nuts, butternuts, chestnuts, filberts, hazelnuts, hickory nuts, walnuts.
(22) Field corn, popcorn, sweet corn (each in grain form).
(23) Milo, sorghum (each in grain form).
(24) Wheat, barley, oats, rice, rye (each in grain form).
(25) Alfalfa, Bermuda grass, bluegrass, brome grass, clovers, cowpea hay, fescue, lespedeza, lupines, orchard grass, peanut hay, peavine hay, rye grass, soybean hay, sudan grass, timothy, and vetch.
(26) Corn forage, sorghum forage.
(27) Sugarcane, cane sorghum.
Experiments have shown that certain cholinesterase-inhibiting pesticides when fed together to test animals are more toxic than the sum of their individual toxicities when fed separately. One substance potentiates the toxicity of the other. Important toxicological interactions also have been observed between pesticides and other substances. Wherever there is reason to believe that a pesticide chemical for which a tolerance is proposed may interact with other pesticide chemicals or other substances to which man is exposed, it may be necessary to require special experimental data regarding potentiation capacities to evaluate the safety of the proposed tolerance. This necessarily will be determined on a case-by-case basis.
(a) Group or subgroup tolerances may be established as a result of:
(1) A petition from a person who has submitted an application for the registration of a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act.
(2) On the initiative of the Administrator.
(3) A petition by an interested person.
(b) The tables in § 180.41 are to be used in conjunction with this section for the establishment of crop group tolerances. Each table in § 180.41 lists a group of raw agricultural commodities that are considered to be related for the purposes of this section. Refer also to § 180.1(g) for a listing of commodities for which established tolerances may be applied to certain other related and similar commodities.
(c) When there is an established or proposed tolerance for all of the representative commodities for a specific group or subgroup of related commodities, a tolerance may be established for all commodities in the associated group or subgroup. Tolerances may be established for a crop group or, alternatively, tolerances may be established for one or more of the subgroups of a crop group.
(d) The representative crops are given as an indication of the minimum residue chemistry data base acceptable to the Agency for the purposes of establishing a group tolerance. The Agency may, at its discretion, allow group tolerances when data on suitable substitutes for the representative crops are available (e.g., limes instead of lemons).
(e) Since a group tolerance reflects maximum residues likely to occur on all individual crops within a group, the proposed or registered patterns of use for all crops in the group or subgroup must be similar before a group tolerance is established. The pattern of use consists of the amount of pesticide applied, the number of times applied, the timing of the first application, the interval between applications, and the interval between the last application and harvest. The pattern of use will also include the type of application; for example, soil or foliar application, or application by ground or aerial equipment.
(f) When the crop grouping contains commodities or byproducts that are utilized for animal feed, any needed tolerance or exemption from a tolerance for the pesticide in meat, milk, poultry and/or eggs must be established before a tolerance will be granted for the group as a whole. The representative crops include all crops in the group that could be processed such
(g) If maximum residues (tolerances) for the representative crops vary by more than a factor of 5 from the maximum value observed for any crop in the group, a group or subgroup tolerance will ordinarily not be established. In this case individual crop tolerances, rather than group tolerances, will normally be established.
(h) Alternatively, a commodity with a residue level significantly higher or lower than the other commodities in a group may be excluded from the group tolerance (e.g., cereal grains, except corn). In this case an individual tolerance at the appropriate level for the unique commodity would be established, if necessary. The alternative approach of excluding a commodity with a significantly higher or lower residue level will not be used to establish a tolerance for a commodity subgroup. Most subgroups have only two representative commodities; to exclude one such commodity and its related residue data would likely provide insufficient residue information to support the remainder of the subgroup. Residue data from crops additional to those representative crops in a grouping may be required for systemic pesticides.
(i) The commodities included in the groups will be updated periodically either at the initiative of the Agency or at the request of an interested party. Persons interested in updating this section should contact the Registration Division of the Office of Pesticide Programs.
(j) When EPA amends a crop group in a manner that expands or contracts the commodities that are covered by the group, EPA will initially retain the pre-existing as well as the revised crop group in the CFR. The revised crop group will have the same number as the pre-existing crop group; however, the revised crop group number will be followed by a hyphen and the final two digits of the year in which it was established (e.g., if Crop Group 1 is amended in 2007, the revised group will be designated as Crop Group 1-07). If the pre-existing crop group had crop subgroups, these subgroups will be numbered in a similar fashion in the revised crop group. The name of the revised crop group will not be changed from the pre-existing crop group unless the revision so changes the composition of the crop group that the pre-existing name is no longer accurate. Once a revised crop group is established, EPA will no longer establish tolerances under the pre-existing crop group. At appropriate times, EPA will amend tolerances for crop groups that have been superseded by revised crop groups to conform the pre-existing crop group to the revised crop group. Once all of the tolerances for the pre-existing crop group have been updated, the pre-existing crop group will be removed from the CFR.
(k) Establishment of a tolerance does not substitute for the additional need to register the pesticide under a companion law, the Federal Insecticide, Fungicide, and Rodenticide Act. The Registration Division of the Office of Pesticide Programs should be contacted concerning procedures for registration of new uses of a pesticide.
(a) The tables in this section are to be used in conjunction with § 180.40 to establish crop group tolerances.
(b) Commodities not listed are not considered as included in the groups for the purposes of this paragraph, and individual tolerances must be established. Miscellaneous commodities intentionally not included in any group include asparagus, avocado, banana, fig, globe artichoke, hops, mango, papaya, pawpaw, peanut, persimmon, pineapple, water chestnut, and watercress.
(c) Each group is identified by a group name and consists of a list of representative commodities followed by a list of all commodity members for
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Nomenclature changes to subpart C appear at 67 FR 41803-41808, June 19, 2002; 67 FR 42393-42397, June 21, 2002; 68 FR 39430-39435, July 1, 2003; 71 FR 74804-74812, Dec. 13, 2006; 72 FR 53137-53151, Sept. 18, 2007; 72 FR 61536, Oct. 31, 2007; 73 FR 60155-60157, Oct. 10, 2008; 75 FR 56014, Sept. 15, 2010; and 76 FR 34885, June 15, 2011.
(a) The tolerances established for pesticide chemicals in this subpart C apply to residues resulting from their application prior to harvest or slaughter, unless otherwise stated. Tolerances are expressed in terms of parts by weight of the pesticide chemical per one million parts by weight of the raw agricultural commodity.
(b) The poisonous and deleterious substances for which tolerances are established by the regulations in this subpart C are named by their common names wherever practicable, otherwise by their chemical names.
(c) The analytical methods to be used for determining whether pesticide residues, including negligible residues, in or on raw agricultural commodities are in compliance with the tolerances established in this part 180 are identified among the methods contained or referenced in the Food and Drug Administration's “Pesticide Analytical Manual” which is available from the Food and Drug Administration, Department of Health, Education, and Welfare, 200 C Street SW., Washington, DC 20204.
(a)(1)
(2) Tolerances are established for the combined residues of the fungicide,
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) A tolerance of 0.02 ppm is established for residues of acephate,
(3) Tolerances are established for residues of methamidophos,
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the insecticide malathion (
(3) Tolerances are established for residues of the insecticide malathion (
(4) Malathion may be safely used in accordance with the following conditions:
(i) It is incorporated into paper trays in amounts not exceeding 100 milligrams per square foot.
(ii) Treated paper trays are intended for use only in the drying of grape (raisins).
(iii) Total residues of malathion resulting from drying of grape on treated trays and from application to grape before harvest shall not exceed 12 parts per million on processed ready-to-eat raisins.
(5) Residues of malathion in safflower, refined oil from application to the growing safflower plant shall not exceed 0.6 parts per million.
(6) Malathion may be safely used for the control of insects during the drying of grape (raisins) in compliance with paragraph (a)(4) of this section by incorporation into paper trays in amounts not exceeding 100 milligrams per square foot.
(7) Malathion (
(i) A tolerance of 50 parts per million is established for residues of malathion in citrus, dried pulp for cattle feed, when present as the result of the application of the pesticide to bagged citrus pulp during storage. Whether or not tolerances for residues of malathion on the fresh fruit have been established under section 408 of the Act, the total residue of malathion in the citrus, dried pulp shall not exceed 50 parts per million.
(ii) A tolerance of 10 parts per million is established for malathion in nonmedicated cattle feed concentrate blocks resulting from its application as a pesticide to paper used in packaging the nonmedicated cattle feed concentrate blocks.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
(a)
(2) Inorganic bromide may be present as a residue in certain processed food in accordance with the following conditions:
(i) When inorganic bromide residues are present as a result of fumigation of the processed food with methyl bromide or from such fumigation in addition to the authorized use of methyl bromide on the source raw agricultural commodity, as provided for in this part, the total residues of inorganic bromides (calculated as Br) shall not exceed the following levels:
(A) 400 parts per million in or on egg, dried and herb, processed and spice.
(B) 325 parts per million in or on cheese, parmesan and cheese, roquefort cheese.
(C) 250 parts per million in or on tomato, concentrated products and fig, dried fruit.
(D) 125 parts per million in or on processed food other than those listed above.
(ii) When inorganic bromide residues are present in malt beverage, fermented in accordance with 21 CFR 172.730(a)(2), the amount shall not exceed 25 parts per million (calculated as Br).
(iii) Where tolerances are established on both the raw agricultural commodities and processed food made therefrom, the total residues of inorganic bromides in or on the processed food shall not be greater than those designated in paragraph (a)(2) of this section, unless a higher level is established elsewhere in this part.
(3) Tolerances are established for residues of inorganic bromides (calculated as Br) as follows:
(i) 400 parts per million for residues in or on dog food, resulting from fumigation with methyl bromide.
(ii) 125 parts per million for residues in or on processed commodities for animal feedstuffs from barley, corn, grain sorghum, oat, rice, rye and wheat, resulting directly from fumigation with methyl bromide or from carryover and concentration of residues of inorganic bromides from fumigation of the grains with methyl bromide.
(b)
(c)
(d)
(a) Investigations by the Food and Drug Administration show that peanut hay and peanut shells have been used as feed for meat and dairy animals. While many growers now harvest peanuts with combines and leave the hay on the ground to be incorporated into the soil, some growers follow the practice of curing peanuts on the vines in a stack and save the hay for animal feed. Peanut shells or hulls have been used to a minor extent as roughage for cattle feed. It has been established that the feeding to cattle of peanut hay and peanut hulls containing residues of inorganic bromides will contribute considerable residues of inorganic bromides to the meat and milk.
(b) There are no tolerances for inorganic bromides in meat and milk to cover residues from use of such peanut hulls as animal feed. Peanut hulls containing residues of inorganic bromides from the use of methyl bromide are unsuitable as an ingredient in the feed of meat and dairy animals and should not be represented, sold, or used for that purpose.
(a)
(b)
(c)
(d)
(a)
(2) Piperonyl butoxide may be safely used in accordance with the following prescribed conditions:
(i) It is used or intended for use in combination with pyrethrins for control of insects:
(A) In cereal grain mills and in storage areas for milled cereal grain products, whereby the amount of piperonyl butoxide is at least equal to but not more than 10 times the amount of pyrethrins in the formulation.
(B) On the outer ply of multiwall paper bags of 50 pounds or more capacity in amounts not exceeding 60 milligrams per square foot, whereby the amount of piperonyl butoxide is equal to 10 times the amount of pyrethrins in the formulation. Such treated bags are to be used only for food, dried.
(C) On cotton bags of 50 pounds or more capacity in amounts not exceeding 55 milligrams per square foot of cloth, whereby the amount of piperonyl butoxide is equal to 10 times the amount of pyrethrins in the formulation. Such treated bags are constructed with waxed paper liners and are to be used only for food, dried that contain 4 percent fat or less.
(D) In two-ply bags consisting of cellophane/polyolefin sheets bound together by an adhesive layer when it is incorporated in the adhesive. The treated sheets shall contain not more than 50 milligrams of piperonyl butoxide per square foot (538 milligrams per square meter). Such treated bags are to be used only for packaging plum, prune, dried; grape, raisin; and other fruit, dried and are to have a maximum ratio of 3.12 milligrams of piperonyl butoxide per ounce of fruit (0.10 milligram of piperonyl butoxide per gram of product).
(E) In food processing and food storage areas: Provided, That the food is removed or covered prior to such use.
(ii) It is used or intended for use in combination with pyrethrins and N-octylbicycloheptene dicarboximide for insect control in accordance with 21 CFR 178.3730.
(iii) A tolerance of 10 parts per million is established for residues of piperonyl butoxide in or on:
(A) Grain, cereal, milled fractions when present therein as a result of its use in cereal grain mills and in storage areas for milled cereal grain products.
(B) Food, dried when present as a result of migration from its use on the outer ply of multiwall paper bags of 50 pounds or more capacity.
(C) Food treated in accordance with 21 CFR 178.3730.
(D) Food, dried that contain 4 percent fat, or less, when present as a result of migration from its use on the cloth of cotton bags of 50 pounds or more capacity constructed with waxed paper liners.
(E) Food treated in accordance with paragraph (a)(2)(i)(D) and (E) of this section.
(iv) To assure safe use of the pesticide, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(v) Where tolerances are established on both raw agricultural commodities and processed food made therefrom, the total residues of piperonyl butoxide in or on the processed food shall not be greater than that permitted by the larger of the two tolerances.
(3) Piperonyl butoxide may be safely used in accordance with the following prescribed conditions:
(i) It is used or intended for use in combination with pyrethrins for control of insects:
(A) On the outer ply of multiwall paper bags of 50 pounds or more capacity in amounts not exceeding 60 milligrams per square foot.
(B) On cotton bags of 50 pounds or more capacity in amounts not exceeding 55 milligrams per square foot of cloth. Such treated bags are constructed with waxed paper liners and
(ii) It is used in combination with pyrethrins, whereby the amount of piperonyl butoxide is equal to 10 times the amount of pyrethrins in the formulation. Such treated bags are to be used only for feed, dried.
(iii) A tolerance of 10 parts per million is established for residues of piperonyl butoxide when present as the result of migration:
(A) In or on feed, dried from its use on the outer ply of multiwall paper bags of 50 pounds or more capacity.
(B) In or on feed, dried that contain 4 percent fat, or less, from its use on cotton bags of 50 pounds or more capacity constructed with waxed paper liners.
(iv) To assure safe use of the pesticide, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency.
(v) Where tolerances are established on both the raw agricultural commodities and food, processed made therefrom, the total residues of piperonyl butoxide in or on the processed food shall not be greater than that permitted by the larger of the two tolerances.
(b)
(c)
(d)
(a)
(2) A tolerance of 1.0 ppm is established for residues of the insecticide pyrethrins in or on milled fractions derived from grain, cereal when present as a result of its use in cereal grain mills and in storage areas for milled cereal grain products.
(3) A tolerance of 1.0 ppm is established for residues of the insecticide pyrethrins in or on all food items in food handling establishments where food and food products are held, processed, prepared and/or served. Food must be removed or covered prior to use.
(4) Where tolerances are established on both the raw agricultural commodities and processed foods made there-from, the total residues of pyrethrins in or on the processed food shall not be greater than that permitted by the larger of the two tolerances.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of fluoride in or on the following commodities from the postharvest fumigation with sulfuryl fluoride for the control of insects:
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the ethylene oxide reaction product, 2-chloroethanol, commonly referred to as ethylene chlorohydrin, when ethylene oxide is used as a postharvest fumigant in or on food commodities as follows:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
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(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the insecticide dicofol, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only the sum of p,p-dicofol, 4-chloro-α-(4-chlorophenyl)-α-(trichloromethyl)benzenemethanol, its isomer o,p-dicofol, 2-chloro-α-(4-chlorophenyl)-α-(trichloromethyl)benzenemethanol, and its metabolites 4-chloro-α-(4-chlorophenyl)-α-(dichloromethyl)benzenemethanol and 2-chloro-α-(4-chlorophenyl)-α-(dichloromethyl)benzenemethanol, calculated as the stoichiometric equivalent of p,p-dicofol, 4-chloro-α-(4-chlorophenyl)-α-(trichloromethyl)benzenemethanol, in or on the commodity.
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the insecticide carbaryl, 1-naphthyl
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) A food additive known as maleic hydrazide (1,2-dihydro-3,6-pyridazinedione) may be present in potato, chips when used in accordance with the following conditions:
(i) The food additive is present as a result of the application of a pesticide formulation containing maleic hydrazide to the growing potato plant in accordance with directions registered by the U.S. Environmental Protection Agency.
(ii) The label of the pesticide formulation containing the food additive conforms to labeling registered by the U.S. Environmental Protection Agency.
(iii) The food additive is present in an amount not to exceed 160 parts per million by weight of the finished food.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the plant regulator and herbicide chlorpropham (isopropyl m-chlorocarbanilate (CIPC) and its metabolite 4-hydroxychlorpropham-O-sulfonic acid (4-HSA) in or on the following food commodities:
(b)
(c)
(d)
(a)(1)
(2) A tolerance is established for the combined residues of the insecticide endosulfan, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2, 4,3-benzodioxathiepin-3-oxide (alpha and beta isomers), and its metabolite endosulfan sulfate, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2, 4,3-benzodioxathiepin-3,3-dioxide in or on the commodity in the following table:
(b)
(c) Tolerances with regional registrations. (1) Tolerances with regional registration, as defined in § 180.1(l), are established for residues of the insecticide endosulfan, including its metabolites and degradates, in or on the commodities in the table in this paragraph, when endosulfan is used in the state of Florida. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only the sum of endosulfan, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin 3-oxide (alpha and beta isomers), and its metabolite endosulfan sulfate, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3,3-dioxide, calculated as the stoichiometric equivalent of endosulfan, in or on the commodity.
(2) Tolerances with regional registrations. Tolerances with regional registration, as defined in § 180.1(l), are established for residues of the insecticide endosulfan, including its metabolites and degradates, in or on the commodities in the table in this paragraph, when endosulfan is used in the United States (except Florida). Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only the sum of endosulfan, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin 3-oxide (alpha and beta isomers), and its metabolite endosulfan sulfate, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3,3-dioxide, calculated as the stoichiometric equivalent of endosulfan, in or on the commodity.
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) A tolerance of 0.5 part per million is established for the pesticide naled in or on all raw agricultural commodities, except those otherwise listed in this section, from use of the pesticide for area pest (mosquito and fly) control.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fumigant in or on all RACs resulting from preharvest treatment of pest burrows in agricultural and non-crop land areas.
(3) Residues resulting from fumigation of processed food:
(4)
(5) To assure safe use of this pesticide, it must be used in compliance with the labeling conforming to that registered by the U.S. Environmental Protection Agency (EPA) under FIFRA. Labeling shall bear a restriction to aerate the finished food/feed for 48 hours before it is offered to the consumer, unless EPA specifically determines that a different time period is appropriate. Where appropriate, a warning shall state that under no condition should any formulation containing aluminum or magnesium phosphide be used so that it will come in contact with any processed food, except processed brewer's rice, malt, and corn grits stored in breweries for use in the manufacture of beer.
(b)
(c)
(d)
(a)
(2)(i) Tolerances are established for residues of the herbicide diquat (6,7 dihydrodipyrido(1,2-a:2'1'-c)pyrazinediium) (calculated as the cation) derived from the application of the dibromide salt to ponds, lakes, reservoirs, marshes, drainage ditches, canals, streams, and rivers which are slow-moving or quiescent in programs of the Corp of Engineers or other Federal or State public agencies and to ponds, lakes and drainage ditches only where there is little or no outflow of water and which are totally under the
(ii) Where tolerances are established at higher levels from other uses of diquat on the subject crops, the higher tolerances applies also to residues of the aquatic uses cited in this paragraph.
(3) Tolerances are established for the plant growth regulator diquat (6,7 dihydrodipyrido(1,2-a:2'1'-c)pyrazinediium) derived from application of the dibromide salt and calculated as the cation in or on the following food commodites:
(4) A tolerance of 0.5 part per million is established for residues of diquat in potato, granules/flakes and potato, chips.
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels is to be determined by measuring only the residues of dicamba (3,6-dichloro-o-anisic acid) and its metabolite, 3,6-
(3) Tolerances are established for residues of the herbicide dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels is to be determined by measuring only the residues of dicamba, 3,6-dichloro-o-anisic acid, and its metabolites, 3,6-dichloro-5-hydroxy-
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the herbicide fluometuron,
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) The tolerance of 0.1 part per million prescribed by 21 CFR 556.180 for negligible residues of 2,2-dichlorovinyl dimethyl phosphate in hog, fat; hog, meat; hog, meat byproducts; and hog, skin covers both its use as an anthelmintic in swine feed and as an insecticide applied directly to swine.
(3) Dichlorvos may be present as a residue from application as an insecticide on packaged or bagged nonperishable processed food (see: 21 CFR 170.3(j)) in an amount in such food not in excess of 0.5 part per million (ppm). To assure safe use of the insecticide, its label and labeling shall conform to the label and labeling registered by the U.S. Environmental Protection Agency, and the usage employed shall conform with such label or labeling.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolites 5-hydroxythiabendazole (free and conjugated) and benzimidazole in or on the following food commodities:
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide streptomycin from treatment of seedling plants before transplanting in or on the following food commodities:
(3) Tolerances are established for residues of the fungicide streptomycin
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the metabolite 4-hydroxy-2,5,6-trichloroisophthalonitrile in or on the following food commodities.
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) An interim tolerance of 0.2 parts per million is established for residues of the herbicide endothall (7 - oxabicyclo[2.2.1] heptane-2,3-dicarboxylic acid) in water, potable from use of its potassium, sodium, di-
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c) Tolerances with regional registrations. Tolerances with regional registration, as defined in § 180.1(l), are established for residues of the insecticide methidathion, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only methidathion,
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues, free and conjugated, of the herbicide MCPB, 4-(4-chloro-2-methylphenoxy)butanoic acid, and its metabolite MCPA, (4-chloro-2-methylphenoxy)acetic acid, in or on the following food commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide bromoxynil, 3,5-dibromo-4-hydroxybenzonitrile, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels is to be determined by measuring only bromoxynil and its metabolite, 3,5-dibromo-4-hydroxybenzoic acid (DBHA), resulting from application of its octanoic and/or heptanoic acid ester, in or on the commodities.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate) and its cholinesterase-inhibiting metabolites in or on the following food commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide MCPA ((4-chloro-2-methylphenoxy)acetic acid) resulting from the direct application of MCPA or its sodium or dimethylamine salts, or its 2-ethylhexyl ester in or on the following food commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Chlorpyrifos [
(i) Application shall be limited solely to spot and/or crack and crevice treatment in food handling establishments where food and food products are held, processed, prepared or served. Contamination of food or food contact surfaces shall be avoided. Food must be removed or covered during treatment.
(ii) Spray concentration for spot treatment shall be limited to a maximum of 0.5 percent of the active ingredient by weight. A course, low-pressure spray shall be used to avoid atomization or splashing of the spray.
(iii) Paint-on application for spot treatment shall be limited to a maximum of 2 percent of the active ingredient by weight.
(iv) Crack and crevice treatment shall be limited to a maximum of 2 percent of the active ingredient by weight. Equipment capable of delivering a pin-stream of insecticide shall be used.
(v) Application via adhesive strips shall contain a maximum of 10% by weight of the controlled-release product in food-handling establishments where food and food products are held, processed, prepared, or served. A maximum of 36 strips (or 5.15 grams of chlorpyrifos) is to be used per 100 square feet of floor space. The strips are not to be placed in exposed areas where direct contact with food, utensils, and food-contact surfaces would be likely to occur.
(vi) To assure safe use of the insecticide, its label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(3) A tolerance of 0.1 part per million is established for residues of chlorpyrifos, per se, in or on food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food service establishments where food and food products are prepared and served, as a result of the application of chlorpyrifos in microencapsulated form.
(i) Application of a microencapsulated product shall be limited solely to spot and/or crack and crevice treatment in food handling establishments where food and food products are prepared and served. All treatments shall be applied in such a manner as to avoid contamination of food or food contact surfaces.
(ii) Spray concentrations shall be limited to a maximum of 0.5 percent of the active ingredient by weight.
(iii) For crack and crevice treatment, equipment capable of delivering a pin stream of spray directly into cracks and crevices or capable of applying small amounts of insecticide into cracks and crevices shall be used.
(iv) For spot treatment, an individual spot shall not exceed 2 square feet.
(v) To assure safe use of the insecticide, its label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the herbicide bentazon (3-isopropyl-1
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(2) Tolerances are established for residues of the miticide/acaricide fenbutatin-oxide, including its metabolites and degradates, in or on the animal commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only the sum of fenbutatin-oxide, hexakis (2-methyl-2-phenylpropyl) distannoxane, and its organotin metabolites, dihydroxybis(2-methyl-2-phenylpropyl) stannane and 2-methyl-2-phenylpropylstannoic acid, calculated as the stoichiometric equivalent of fenbutatin-oxide, in or on the commodity.
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of glyphosate, including its metabolites and degradates, in or on the commodities listed below resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate. Compliance with the following tolerance levels is to be determined by measuring only glyphosate (
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of S-metolachlor, including its metabolites and degradates, in or on the commodity(s), as defined. Compliance with the tolerance levels specified in the following table below is to be determined by measuring only the sum of free and bound S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, its R-enantiomer, and its metabolites, determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, calculated as the stoichiometric equivalent of S-metolachlor, in or on the commodity.
(b)
(c)
(2) Tolerances with regional registration are established for residues of S-metolachlor, including its metabolites and degradates, in or on the commodities identified in the following table below. Compliance with the tolerance levels specified in the following table below is to be determined by measuring only the sum of free and bound S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, its R-enantiomer, and its metabolites, determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, calculated as the stoichiometric equivalent of S-metolachlor, in or on the commodity.
(d)
(2) Tolerances for are established for the indirect or inadvertent residues of S-metolachlor, including its metabolites and degradates, in or on the commodities identified in the following table below. Compliance with the tolerance levels specified in the following table below is to be determined by measuring only the sum of free and bound S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, its R-enantiomer, and its metabolites, determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, calculated as the stoichiometric equivalent of S-metolachlor, in or on the commodity.
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for combined residues of the insecticide diflubenzuron and its metabolites 4-chlorophenlyurea and 4-chloroaniline in or on the following food commodities:
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the plant growth regulator mepiquat chloride (N,N-dimethylpiperidinium chloride) in or on the following commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the herbicide
(3) A tolerance is established for the combined residues of the herbicide tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N'-dimethylurea) and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)urea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N'-hydroxymethyl-N-methylurea, and N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N'-hydroxymethyl-N-methylurea in or on the following raw agricultural commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide hexazinone, 3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4-(1
(3) A tolerance is established for residues of the herbicide hexazinone, 3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4-(1
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of iprodione [3-(3,5-dichlorophenyl)-
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of chlorsulfuron (2-chloro-
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(2) Tolerances are established for the combined residues of the fungicide imazalil, 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-1
(b)
(c)
(d)
(a)
(2) A tolerance of 5.0 parts per million is established for residues of the insecticide cyromazine, including its metabolites and degradates, in or on poultry feed when used as a feed additive only in feed for chicken layer hens and chicken breeder hens at the rate of not more than 0.01 pound of cyromazine per ton of poultry feed for control of flies in manure of treated chicken layer hens and chicken breeder hens, provided the feeding of cyromazine-treated feed must stop at least 3 days (72 hours) before slaughter. If the feed is formulated by any person other than the end user, the formulator must inform the end user, in writing, of the 3-day (72 hours) pre-slaughter interval. Compliance with the tolerance level specified in this paragraph is to be determined by measuring only cyromazine,
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances for the combined residues of the herbicide triclopyr ((3,5,6-trichloro-2-pyridinyl)oxy) acetic acid and its metabolite 3,5,6-trichloro-2-pyridinol (TCP), as a result of the application/use of butoxyethyl ester of triclopyr or the triethylamine salt of triclopyr, are established in or on the following raw agricultural commodities:
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of zeta-cypermethrin, (
(3) Tolerances are established for residues of the insecticide, alpha-cypermethrin, (
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the insecticide chlorpyrifos-methyl (
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide fluridone, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) A tolerance of 0.02 part per million with an expiration/revocation date of July 9, 2013 is established for residues of the insecticide tralomethrin, including its metabolites and degradates, in or on food commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food-handling establishments. Compliance with the tolerance level specified in this paragraph is to be determined by measuring only the sum of tralomethrin, (S)-cyano(3-phenoxyphenyl)methyl (1R,3S)-2,2-dimethyl-3-(1,2,2,2-tetrabromoethyl)cyclopropanecarboxylate, and its metabolites (S)-cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate and (S)-cyano(3-phenoxyphenyl)methyl (1S,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate, calculated as the stoichiometric equivalent of tralomethrin, in or on the commodity.
(i) The insecticide may be present as a residue from application of tralomethrin in food-handling establishments, including food service, manufacturing, and processing establishments, such as restaurants, cafeterias, supermarkets, bakeries, breweries, dairies, meat slaughtering and packing plants, and canneries.
(ii) The application shall be made in accordance with the following prescribed conditions: Application shall be limited to a general surface and spot and/or crack and crevice treatment in food-handling establishments where food and food products are held, processed, prepared, and served. General surface application may be used only when the facility is not in operation provided exposed food has been covered or removed from the area being treated. All food-contact surfaces and equipment must be thoroughly cleaned after general surface applications. Spot and/or crack and crevice application may be used while the facility is in operation provided exposed food is covered or removed from the area being treated prior to application. Spray concentration shall be limited to a maximum of 0.06 percent active ingredient. Contamination of food and food-contact surfaces shall be avoided.
(3) A tolerance of 0.02 part per million with an expiration/revocation date of July 9, 2013 is established for residues of the insecticide tralomethrin, including its metabolites and degradates, in or on feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in feed-handling establishments. Compliance with the tolerance level specified in this paragraph is to be determined by measuring only the sum of tralomethrin, (S)-cyano(3-phenoxyphenyl)methyl (1R,3S)-2,2-dimethyl-3-(1,2,2,2-tetrabromoethyl)cyclopropanecarboxylate, and its metabolites (S)-cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate and (S)-cyano(3-phenoxyphenyl)methyl (1S,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate, calculated as the stoichiometric equivalent of tralomethrin, in or on the commodity.
(i) The insecticide may be present as a residue from application of tralomethrin in feed-handling establishments, including feed manufacturing and processing establishments.
(ii) The application shall be made in accordance with the following prescribed conditions: Application shall be limited to a general surface and spot and/or crack and crevice treatment in feed-handling establishments where feed and feed products are held or processed. General surface application may be used only when the facility is not in operation provided exposed feed has been covered or removed from the area being treated. All feed-contact surfaces and equipment must be thoroughly cleaned after general surface applications. Spot and/or crack and crevice application may be used while the facility is in operation provided exposed feed is covered or removed from the area being treated prior to application. Spray concentration shall be limited to a maximum of 0.06 percent active ingredient. Contamination of feed and feed-contact surfaces shall be avoided.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
A tolerance is established for residues of the herbicide 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of metsulfuron methyl (methyl-2[[[[(4-methoxy- 6-methyl-1,3,5-triazin-2- yl)amino]carbonyl]amino] sulfonyl] benzoate) in or on the following raw agricultural commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) A tolerance of 0.05 ppm is established for residues of the insecticide deltamethrin (1
(i) In or on all food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments.
(ii) The insecticide may be present as a residue from application of deltamethrin in food handling establishments, including food service, manufacturing and processing establishments, such as restaurants, cafeterias, supermarkets, bakeries, breweries, dairies, meat slaughtering and packing plants, and canneries, feed handling establishments including feed manufacturing and processing establishments, in accordance with the following prescribed conditions:
(A) Application shall be limited to general surface and spot and/or crack and crevice treatment in food/feed handling establishments where food/feed and food/feed products are held, processed, prepared and served. General surface application may be used only when the facility is not in operation provided exposed food/feed has been covered or removed from the area being treated. Spot and/or crack and crevice application may be used while the facility is in operation provided exposed food/feed is covered or removed from the area being treated prior to application. Spray concentration shall be limited to a maximum of 0.06 percent active ingredient. Contamination of food/feed or food/feed contact surfaces shall be avoided.
(B) To assure safe use of the insecticide, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency and shall be used in accordance with such label and labeling.
(b)
(c)
(d)
(a)
(2) A tolerance of 0.05 ppm is established for residues of the insecticide cyfluthrin (cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate;
(i) General surface treatments shall be limited to a maximum of 3.8 grams of active ingredient per 1,000 square feet, applying to walls, floors, and ceilings with a low-pressure system. Cover or remove all food processing and/or handling equipment during application. Do not apply directly to food products. Reapplications may be made at 10-day intervals.
(ii) Crack and crevice or spot treatments shall be limited to a maximum of 0.1 percent of the active ingredient weight, applied with a low-pressure system with a pinpoint or variable-pattern nozzle. Dust formulation shall be limited to a maximum of 0.1 percent of the active ingredient by weight, applied using a hand duster, power duster, or other equipment capable of applying dust insecticide directly into voids and cracks and crevices. Dust applications should be made in a manner to avoid deposits on exposed surfaces or introducing the material into the air. Cover exposed food or remove food from premises. Do not apply directly to food. Reapplications may be made at 10-day intervals.
(iii) To ensure safe use of the insecticide, its label and labeling shall conform to that registered by the Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(3) A tolerance of 0.05 part per million is established for residues of the insecticide cyfluthrin (cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate; CAS Reg. No. 68359-37-5) in feed commodities exposed to the insecticide during treatment of feed-handling establishments where feed and feed products are held, processed, prepared, or served. Treatments may be made by general surface, spot, and/or crack and crevice applications.
(i) General surface tratments shall be limited to a maximum of 3.8 grams of active ingredient per 1,000 square feet, applying to walls, floors, and ceilings with a low-pressure system. Cover or remove all feed processing and/or handling equipment during application. Do not apply directly to feed products. Reapplications may be made at 10-day intervals.
(ii) Crack and crevice or spot treatments shall be limited to a maximum of 0.1 percent of the active ingredient by weight, applied with a low-pressure system with a pinpoint or variable-pattern nozzle. Dust formulation shall be limited to a maximum of 0.1 percent of the active ingredient by weight, applied using a hand duster, power duster, or other equipment capable of applying dust insecticide directly into voids and cracks and crevices. Dust applications should be made in a manner to avoid deposits on exposed surfaces or introducing the material into the air. Cover exposed feed or remove feed from premises. Do not apply directly to feed. Reapplications may be made at 10-day intervals.
(iii) To ensure safe use of the insecticide, its label and labeling shall conform to that registered by EPA, and it shall be used in accordance with such label and labeling.
(4) Tolerances are established for residues of the isomer, beta-cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-cyclopropanecarboxylate [mixture comprising the enantiomeric pair (
(b)
(c)
(d)
For
Tolerances are established for the combined residues of the herbicide methyl 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-
(a)
(2) Tolerances
(3) A tolerance of 0.01 part per million is established for residues of the insecticide lamba-cyhalothrin and an isomer gamma-cyhalothrin in or on all food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food-handling establishments where food products are held, processed, or prepared.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide quizalofop ethyl,
(b)
(c)
(d)
(a)
(2) A tolerance of 0.05 ppm is established for residues of the insecticide bifenthrin, (2-methyl[1,1′-biphenyl]-3-yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropane-carboxylate, as follows:
(i) In or on all food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments.
(ii) The insecticide may be present as a residue from application of bifenthrin in food handling establishments, including food service, manufacturing and processing establishments, such as restaurants, cafeterias, supermarkets, bakeries, breweries, dairies, meat slaughtering and packing plants, and canneries, feed handling establishments including feed manufacturing and processing establishments, in accordance with the following prescribed conditions:
(A) Application shall be limited to general surface and spot and/or crack and crevice treatment in food/feed handling establishments where food/feed and food/feed products are held, processed, prepared and served. General surface application may be used only when the facility is not in operation provided exposed food/feed has been covered or removed from the area being treated. Spot and/or crack and crevice application may be used while the facility is in operation provided exposed food/feed is covered or removed from the area being treated prior to application. Spray concentration shall be limited to a maximum of 0.06 percent active ingredient. Contamination of food/feed or food/feed contact surfaces shall be avoided.
(B) To assure safe use of the insecticide, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency and shall be used in accordance with such label and labeling.
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the insecticide clofentezine, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only the sum of clofentezine, 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine, and its metabolite, 3-(2-chloro-4-hydroxyphenyl)-6-(2-chlorophenyl)-1,2,4,5-tetrazine, calculated as the stoichiometric equivalent of clofentezine, in or on commodity.
(b)
(c)
(d)
(a)
(2) Tolerances are established for the sum of the residues of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo- 1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid; its metabolite CL 288511, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(1-hydroxyethyl)-3-pyridine carboxylic acid; and its metabolite CL 182704, 5-[1-(beta-D-glucopyranosyloxy)ethyl]-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic acid, applied as its acid or ammonium salt, in or on the following commodities:
(3) A tolerance is established for the sum of residues of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo- 1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid, and its metabolite CL 288511, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5- oxo-1H-imidazol-2-yl]-5-(1-hydroxyethyl)-3-pyridine carboxylic acid, applied as its acid or ammonium salt, in or on the following commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
A tolerance is established for the residues of the fungicide procymidone,
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
A tolerance is established for the residues of the nematicide/insecticide cadusafos,
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established for the nematicide, insecticide, and fungicide carbon disulfide, from the application of sodium tetrathiocarbonate, in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide tebuconazole, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of tebuconazole (alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1
(b)
(c)
(d)
For
(a)
(2) Tolerances are established for residues of difenoconazole, including its metabolites and degradates, in the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring the sum of difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1
(b)
(c)
(d)
For
(a)
(2) Tolerances are established for residues of the fungicide triflumizole, including its metabolites and degradates, in or on the commodities of animal origin listed in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the parent compound triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only halosulfuron-methyl.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the insecticide tebufenozide, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only the sum of tebufenozide, 3,5-dimethylbenzoic acid 1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, and its metabolites, 3,5-dimethylbenzoic acid 1-(1,1-dimethylethyl)-2-((4-carboxymethyl)benzoyl)hydrazide, 3-hydroxymethyl-5-methylbenzoic acid 1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, stearic acid conjugate of 3-hydroxymethyl-5-methylbenzoic acid 1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, and 3-hydroxymethyl-5-methylbenzoic acid 1-(1,1-dimethylethyl)-2-(4-(1-hydroxyethyl)benzoyl)hydrazide, calculated as the stoichiometric equivalent of tebufenozide, in or on the commodity.
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(2) A tolerance is established for the combined residues of the free and conjugated forms of the fungicide cyproconazole, including its metabolites and degradates, in or on the commodity in the table below. Compliance with the tolerance level specified below is to be determined by measuring only the sum of cyproconazole (α-(4-chlorophenyl)-α-(1-cyclopropylethyl)-1
(3) Tolerances are established for the combined residues of the free and conjugated forms of the fungicide cyproconazole, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance level specified below is to be determined by measuring only the sum of cyproconazole (α-(4-chlorophenyl)-α-(1-cyclopropylethyl)-1
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are also established for the combined residues of the herbicide imazapic, (±)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the reaction product, propylene chlorohydrin, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only the sum of propylene chlorohydrin (1-chloro-2-propanol), and its isomer 2-chloro-1-propanol, calculated as the stoichiometric equivalent of propylene chlorohydrin (1-chloro-2-propanol), that results from the use of propylene oxide as a postharvest fumigant, in or on the commodity.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established for combined residues of the herbicide thiazopyr (3-pyridinecaroxylic acid, 2-(difluoromethyl)-5-(4,5-dihydro-2-thiazolyl)-4-(2-methylpropyl)-6-(trifluoromethyl)-, methyl ester) and its metabolites determined as 2-(difluoromethyl)-6-(trifluoromethyl)-3,4,5-pyridinetricarboxylic acid, all expressed as the parent equivalents in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)(1)
(2) Tolerances are established for the combined residues of the free and conjugated forms of sulfentrazone, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of sulfentrazone (
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(1) Application shall be limited to spot, crack and crevice, perimeter and ultra low volume (ULV) fogging treatment in food storage or food-handling establishments, including warehouses, food service, manufacturing, and processing establishments such as restaurants, cafeterias, supermarkets, bakeries, breweries, dairies, meat slaughtering and packing plants, and canneries where food and food products are held, processed, and served: Provided that the food is removed or covered prior to such use, and food-processing surfaces are covered during treatment or thoroughly cleaned before using, or in the case of point-source device treatments, devices must not come into direct contact with food preparation surfaces and must be in a minimum distance of 3 feet from exposed foods.
(2) To assure safe use of the insect growth regulator, the label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for emamectin, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of emamectin (MAB
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide, azoxystrobin, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the table is to be determined by measuring only azoxystrobin, [methyl(
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(2) A tolerance of 0.10 parts per million is established for all food commodities as a result of the proposed use of NYLAR in food handling establishments where food and food products are held, prepared, processed or served. Application is limited to space, general surface, spot, and/or crack and crevice treatment in food handling establishments where food and food products are held, processed, prepared and served. Space and general surface application may be used only when the facility is not in operation provided exposed food is covered or removed from the area being treated prior to application. Spot, and/or crack and crevice treatment may be used while the facility is in operation provided exposed food is covered or removed from the area being treated prior to application. Food contact surfaces should be thoroughly washed with an effective cleaning compound and rinced with potable water after use of the product. To assure safe use of this additive, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency, and shall be used in accordance with such label and labeling.
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(2) A tolerance of 0.01 parts per million is established for residues of chlorfenapyr in or on all food commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling areas where food/feed products are prepared, held, processed, or served and in accordance with the following prescribed conditions:
(i) Application shall be no greater than a 0.5% active ingredient solution for spot crack and crevice use in food/feed handling establishments, where food and food products are held, processed, prepared and/or served.
(ii) Application may only be undertaken when the facility is not in operation, and provided exposed food has been covered, or removed from the area being treated prior to application.
(iii) Food contact surfaces and equipment should be throughly washed with an effective cleaning compound, and rinsed with potable water after each use of the product.
(iv) Contamination of food or food contact surfaces shall be avoided. Application excludes any direct application to any food, food packaging, or any food contact surfaces.
(v) To assure safe use, the label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide pyrimethanil, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of pyrimethanil and its metabolite 4-[4,6-dimethyl-2-pyrimidinyl)amino]phenol, calculated as the stoichiometric equivalent of pyrimethanil.
(3) Tolerances are established for residues of the fungicide pyrimethanil, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of pyrimethanil and its metabolite 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol, calculated as the stoichiometric equivalent of pyrimethanil.
(b)
(c)
(d)
(a)
(1) The food additives are present as a result of treating water aboard ships with a polybrominated ion-exchange resin (as a source of bromine) under the supervision of trained personnel.
(2) Residual bromine levels are controlled to not exceed 1.0 part per million (ppm) in the final treated water. Control is effected using calibrated recirculating or proportioning bromine feeder equipment and periodic checks of residual bromine using a bromine test kit. To assure safe use of the additives, the label and labeling of the disinfectant formulation containing the food additives shall conform to the label and labeling registered by the U.S. Environmental Protection Agency.
(3) No tolerance is established for bromide ion levels.
(b)
(c)
(d)
(a)
(1) The fumigants consist of methyl bromide.
(2) To assure safe use of the fumigant, its label and labeling shall conform to the label and labeling registered by the U.S. Environmental Protection Agency.
(3) Residues of inorganic bromides (calculated as Br) in milled fractions derived from cereal grain from all fumigation sources, including fumigation of grain-mill machinery, shall not exceed 125 parts per million.
(b)
(c)
(d)
(a)
(1)
(2) Methyl bromide is used to fumigate corn grits and cracked rice in the production of fermented malt beverage.
(3) To assure safe use of the fumigant, its label and labeling shall conform to the label and labeling registered by the U.S. Environmental Protection Agency, and the usage employed should conform with such label or labeling.
(4) The total residue of inorganic bromides in fermented malt beverage, resulting from the use of corn grits and cracked rice fumigated with the fumigant described in paragraph (a)(2) of this section plus additional residues of inorganic bromides that may be present from uses in accordance with other regulations in this chapter promulgated under section 408 and/or 409 of the Act, does not exceed 25 parts per million bromide (calculated as Br).
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) The insecticide 2,2-dimethyl-1,3-benzodioxol-4-yl methylcarbamate may be safely used in spot and/or crack and crevice treatments in food handling establishments, including food service, manufacturing and processing establishments, such as restaurants, cafeterias, supermarkets, bakeries, breweries, dairies, meat slaughtering and packing plants, and canneries until the tolerance expiration/revocation date of April 26, 2005.
(3) To ensure safe use of the additive, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency and it shall be used in accordance with such label and labeling.
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide cyprodinil, including its metabolites and degradates, in the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of cyprodinil 4-cyclopropyl-6-methyl-
(b)
(c)
(d)
For
(a)
(2) A tolerance of 0.05 ppm on raw agricultural food commodities (other than those food commodities already covered by a higher tolerance as a result of use on growing crops) is established for the combined residues of the insecticide esfenvalerate, (
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) To assure safe use of the insect repellent, its label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of methoxyfenozide [3-methoxy-2-methylbenzoic acid 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl)
(b)
(c)
(d)
(2) Tolerances are established for the indirect or inadvertent residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the raw agricultural commodities in the following table, when present therein as a result of the application of methoxyfenozide to growing crops as listed in paragraph (a) of this section. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of methoxyfenozide [3-methoxy-2-methylbenzoic acid, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide] and the following metabolites (all calculated as the stoichiometric equivalent of methoxyfenozide): free phenol of methoxyfenozide [3,5-dimethylbenzoic acid N-tert-butyl-N′-(3-hydroxy-2-methylbenzoyl) hydrazide], the glucose conjugate of the phenol [3,5-dimethyl benzoic acid N-tert-butyl-N′-[3 (β-D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide] and the malonylglycosyl conjugate of the phenol [3,5-dimethyl benzoic acid N-tert-butyl-N′-[3 (β-D-6-malonyl-glucopyranosyl-1-oxy)-2-methylbenzoyl]-hydrazide].
(a)
(2) In or on food commodities in food handling establishments where food and food products are held, processed, prepared and/or served.
(3) Application shall be limited to space, general surface, and spot and/or crack and crevice treatment in food handling establishments where food and food products are held, processed, prepared and/or served. General surface or space spray applications may be used only when the facility is not in operation provided exposed food has been covered or removed from the area being treated prior to application. Spot and/or crack and crevice application may be used while the facility is in operation provided exposed food is covered or removed from the area being treated prior to application. Spray concentrate shall be limited to a maximum of 2.0% active ingredient. Contamination of food or food contact surfaces shall be avoided. Food contact surfaces and equipment should be throughly washed with an effective cleaning compound and rinsed with potable water after use of the product.
(4) To assure safe use of the additive, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) A tolerance is established for the combined residues of the herbicide fluthiacet-methyland its acid metabolite: acetic acid, [[2-chloro-4-fluoro-5-[tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-α]pyridazin-1-ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-α]pyridazin-1-ylidene)amino]phenyl]thio]- , in or on the following food commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established in or on the following commodities for the residues of the metabolite (
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of acibenzolar-
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of indoxacarb, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of indoxacarb, (S)-methyl-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-phenyl]amino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3
(c)
(d)
(a)
(b)
(c)
(d)
For
(a)
(2) Tolerances are established for residues of the insecticide fenpyroximate, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified in the table is to be determined by measuring only the sum of fenpyroximate, (
(3) Tolerances are established for residues of the insecticide fenpyroximate, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified in the table is to be determined by measuring only the sum of fenpyroximate, (
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of zoxamide and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) in or on the following commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Time-limited tolerances are established for residues of the plant growth regulator forchlorfenuron;
(b)
(c)
(d)
(a)
(2) Tolerances are established for the residues of isoxadifen-ethyl (3-isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, ethyl ester (CAS No. 164520-33-0)), and its metabolites 4,5-dihydro-5,5-diphenyl-3-isoxazolecarboxylic acid and β-hydroxy-β-benzenepropanenitrile when used as an inert ingredient (safener) in or on the following raw agricultural commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of bifenazate (1-methylethyl 2-(4-methoxy[1,1′-biphenyl]-3-yl) hydrazinecarboxylate) including its metabolites and degradates, in or on the commodities listed in the following table. Compliance with the tolerance levels specified are to be determined by measuring only the sum of bifenazate and its metabolites diazinecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate); 1,1′-biphenyl, 4-ol; and 1,1′-biphenyl, 4-oxysulfonic acid (expressed as 1,1′-biphenyl, 4-ol) in or on the following food commodities:
(b)
(c)
(d)
For
(a)
(2) Tolerances are established for residues of tepraloxydim, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the combined residues of tepraloxydim (2-[1-[[[(2
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of fluazinam, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only fluazinam and its metabolite AMGT (3-[[4-amino-3-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]amino]-2-nitro-6-(trifluoromethyl) phenyl]thio]-2-(beta-D-glucopyranosyloxy) propionic acid).
(3) Tolerances are established for residues of fluazinam (3-chloro-
(b)
(c)
(d)
(a)(1)
(2) To assure safe use of this pesticide commodities treated with sulfuryl fluoride must be aerated for at least 24 hours prior to entering commerce.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the insecticide acetamiprid (1
(3) A tolerances of 0.01 ppm is established for residues of the insecticide acetamiprid, including its metabolites and degradates, in or on all food/feed items (other than those covered by a higher tolerance in paragraph (a)(1) or (a)(2) of this section as a result of the use on growing crops) as a result of the application of acetamiprid in food/feed handling establishments. Compliance with the 0.01 ppm tolerance level is to be determined by measuring only acetamiprid (1
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide fenamidone, including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels is to be determined by measuring fenamidone (4H-Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3 (phenylamino)-,(S)-), and its metabolite RPA 717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl), in or on the commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for combined residues of the fungicide pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound, in or on the following raw agricultural commodities.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Time-limited tolerances are established for residues of the insecticide clothianidin, including its metabolites and degradates. Compliance with the tolerance levels specified below is to be determined by measuring only clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on the following raw agricultural commodity:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide boscalid, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of boscalid, 3-pyridinecarboxamide, 2-chloro-
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide butafenacil, (1,1-dimethyl-2-oxo-2-(2-propenyloxy)ethyl 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester], and its metabolite, S-3153 acid-4-OH; [2-chloro-4-hydroxy-5-[5-methyl-6- oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-acetic acid, free and conjugated, in or on the following commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide propoxycarbazone methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate in/on the following raw agricultural commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of dinotefuran, (
(3) A tolerance of 0.01 parts per million is established for residues of the insecticide dinotefuran, (
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
(f)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and its metabolites containing the 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one and 4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one moieties, calculated as the stoichiometric equivalent of spiromesifen, in the following livestock commodities:
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate) and its free enol metabolite BAJ 2510 (3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one) in or on the following livestock commodities:
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of fluoxastrobin, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, and its phenoxy-hydroxypyrimidine, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol, calculated as the stoichiometric equivalent of fluoxastrobin.
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only aminopyralid.
(b)
(c)
(d)
(a)
(2) For the combined residues of pinoxaden, 8-(2,6-diethyl-4-methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites M2, 8-(2,6-diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5]oxadiazepine-7,9-dione, and free and conjugated forms of M4, 8-(2,6-diethyl-4-hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-7,9-dione, calculated as pinoxaden, in/on the following commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the residues of the insecticide flonicamid, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of flonicamid,
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established for the residues of the fungicide fenpropimorph (rel-(2R,6S)-4-[3-[4-(1,1-dimethylethyl)phenyl]-2-methylpropyl]-2,6-dimethylmorpholine) in or on the following commodity:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thion, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only prothioconazole and its metabolites prothioconazole-desthio, or α-(1-chlorocyclopropyl)-α-[(2-chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol, and conjugates that can be converted to these two compounds by acid hydrolysis, calculated as parent in or on the commodity.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide tembotrione, including its metabolites and degradates, in or on the commodities listed in the table to this paragraph. Compliance with the tolerance levels specified below is to be determined by measuring only tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-1,3-
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of flubendiamide, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified in the table is to be determined by measuring only flubendiamide
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are also established for residues of the insecticide spirotetramat, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spirotetramat (
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide safener cyprosulfamide,
(b)
(c)
(d)
(a)
(2) Tolerances are established for combined residues of thiencarbazone-methyl and its metabolite BYH 18636-MMT [5-methoxy-4-methyl-2,4-dihydro-3
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of saflufenacil, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of penthiopyrad, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of penthiopyrad (
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the herbicide pyroxasulfone, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of pyroxasulfone, 3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1
(3) Tolerances are established for residues of the herbicide pyroxasulfone, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of pyroxasulfone, 3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide fluopyram,
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
An exemption from a tolerance shall be granted when it appears that the total quantity of the pesticide chemical in or on all raw agricultural commodities for which it is useful under conditions of use currently prevailing or proposed will involve no hazard to the public health.
(a) When applied to growing crops, in accordance with good agricultural practice, the following pesticide chemicals are exempt from the requirement of a tolerance:
(1) Petroleum oils.
(2) Piperonyl butoxide.
(3) Pyrethrins.
(4) Sabadilla.
(b) When applied to growing crops, in accordance with good agricultural practice, the pesticides rotenone or derris or cube roots are exempt from the requirement of a tolerance. There are no U.S. registrations for use of rotenone, derris, or cube roots on food commodities as of March 23, 2011.
(c) These pesticides are not exempted from the requirement of a tolerance when applied to a crop at the time of or after harvest.
Residues of the following materials are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest:
For
The following materials are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops only:
For
The following materials are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to animals:
For
Residues of the following chemical substances are exempted from the requirement of a tolerance when used in accordance with good manufacturing practice as ingredients in an antimicrobial pesticide formulation, provided that the substance is applied on a semi-permanent or permanent food-contact surface (other than being applied on food packaging) with adequate draining before contact with food.
(a) The following chemical substances when used as ingredients in an antimicrobial pesticide formulation may be applied to: Food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils.
(b) The following chemical substances when used as ingredients in an antimicrobial pesticide formulation may be applied to: Dairy processing equipment, and food-processing equipment and utensils.
(c) The following chemical substances when used as ingredients in an antimicrobial pesticide formulation may be applied to: Food-processing equipment and utensils.
Unless specifically excluded, residues resulting from the use of the following substances as either an inert or an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide chemicals, are exempted from the requirement of a tolerance under FFDCA section 408, if such use is in accordance with good agricultural or manufacturing practices.
(a)
(1) Included within the term commonly consumed food commodities are:
(i) Sugars such as sucrose, lactose, dextrose and fructose, and invert sugar and syrup.
(ii) Spices such as cinnamon, cloves, and red pepper.
(iii) Herbs such as basil, anise, or fenugreek.
(2) Excluded from the term commonly consumed food commodities are:
(i) Any food commodity that is adulterated under 21 U.S.C. 342.
(ii) Both the raw and processed forms of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat.
(iii) Alcoholic beverages.
(iv) Dietary supplements.
(b)
(1) The hulls and shells of the commodities specified in paragraph (a)(2)(ii) of this section, and cocoa bean.
(2) Bird feed such as canary seed.
(3) Any feed component of a medicated feed meeting the definition of an animal feed item.
(c)
(1) Included within the term edible fats and oils are oils (such as soybean oil) that are derived from the commodities specified in paragraph (a)(2)(ii) of this section when such oils are highly refined via a solvent extraction procedure.
(2) Excluded from the term edible fats and oils are plant oils used in the pesticide chemical formulation specifically to impart their characteristic fragrance and/or flavoring.
(d) [Reserved]
(e)
For
Residues resulting from the use of the following substances, that meet the definition of a polymer and the criteria specified for defining a low-risk polymer in 40 CFR 723.250, as an inert ingredient in a pesticide chemical formulation, including antimicrobial pesticide chemical formulations, are exempted from the requirement of a tolerance under FFDCA section 408, if such use is in accordance with good agricultural or manufacturing practices.
For
(a) For the purposes of this section the microbial insecticide for which exemption from the requirement of a tolerance is being established shall have the following specifications:
(1) The microorganism shall be an authentic strain of
(2) Spore preparations of
(3) Each lot of spore preparation, prior to the addition of other materials, shall be tested by subcutaneous injection of at least 1 million spores into each of five laboratory test mice weighing 17 grams to 23 grams. Such test shall show no evidence of infection or injury in the test animals when observed for 7 days following injection.
(4) Spore preparations shall be free of the
(b) Exemption from the requirement of a tolerance is established for residues of the microbial insecticide
Ethylene is exempted from the requirement of a tolerance for residues when:
(a) For all food commodities, it is used as a plant regulator on plants, seeds, or cuttings and on all food commodities after harvest and when applied in accordance with good agricultural practices.
(b) Injected into the soil to cause premature germination of witchweed in bean (lima and string), cabbage, cantaloupe, collard, corn, cotton, cucumber, eggplant, okra, onion, pasture grass, pea (field and sweet), peanut, pepper, potato, sweet potato, sorghum, soybean, squash, tomato, turnip, and watermelon fields as part of the U.S. Department of Agriculture witchweed control program.
(a) Diatomaceous earth is exempted from the requirement of a tolerance for residues when used in accordance with good agricultural practice in pesticide formulations applied to growing crops, to food commodities after harvest, and to animals.
(b) Diatomaceous earth may be safely used in accordance with the following conditions. Application shall be limited solely to spot and/or crack and crevice treatments in food or feed processing and food or feed storage areas in accordane with the precribed conditions:
(1) It is used or intended for use for control of insects in food or feed processing and food or feed storage areas:
(2) To assure safe use of the insecticide, its label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.
(a) Residues of sulfuric acid are exempted from the requirement of a tolerance when used in accordance with good agricultural practice when used as a herbicide in the production of garlic and onions, and as a potato vine dessicant in the production of potatoes.
(b) Residues of sulfuric acid are exempted from the requirement of a tolerance in cattle, meat; goat, meat; hog, meat; horse, meat; sheep, meat; poultry, fat; poultry, meat; poultry, meat, byproducts; egg; milk; fish, shellfish, and irrigated crops when it results from the use of sulfuric acid as an inert ingredient in a pesticide product used in irrigation conveyance systems and lakes, ponds, reservoirs, or bodies of water in which fish or shellfish are cultivated. The sulfuric acid is not to exceed 10% of the pesticide formulation (non-aerosol formulations only).
Sodium chlorate is exempted from the requirement of a tolerance for residues when used as a defoliant or desiccant in accordance with good agricultural practice on the following crops:
(a) Copper is exempted from the requirement of a tolerance in cattle, meat; goat, meat; hog, meat; horse, meat; sheep, meat; milk, poultry, fat; poultry, meat; poultry, meat byproducts; egg, fish, shellfish, and irrigated crops when it results from the use of:
(1) Copper sulfate as an algicide or herbicide in irrigation conveyance systems and lakes, ponds, reservoirs, or bodies of water in which fish or shellfish are cultivated.
(2) Basic copper carbonate (malachite) as an algicide or herbicide in impounded and stagnant bodies of water
(3) Copper triethanolamine and copper monoethanolamine as an algicide or herbicide in fish hatcheries, lakes, ponds, and reservoirs
(4) Cuprous oxide bearing antifouling coatings for control of algae or other coatings for control of algae or other organisms on submerged concrete or other (irrigation) structures.
(b) The following copper compounds are exempt from the requirement of a tolerance when applied (primarily) as a fungicide to growing crops using good agricultural practices:
(c) Copper sulfate pentahydrate (CAS Reg. No. 7758-99-8) is exempt from the requirement of a tolerance when applied as a fungicide to growing crops or to raw agricultural commodities after harvest, and as a bactericide/fungicide in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses and poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding.
(d) Copper (II) hydroxide (CAS Reg. No. 20427-59-2) is exempt from the requirement of a tolerance when applied to growing crops or to raw agricultural commodities as an inert ingredient (for pH control) in pesticide products.
The aqueous solution of hydriodic acid and elemental iodine, including one or both of the surfactants (a) polyoxypropylene-polyoxyethylene glycol nomionic block polymers (minimum average molecular weight 1,900) and (b) α-(p- nonylphenyl)-
(a) Postharvest application of propanoic acid or a mixture of methylene bispropionate and oxy(bismethylene) bisproprionate when used as a fungicide is exempted from the requirement of a tolerance for residues in or on the following raw agricultural commodities: Alfalfa, forage; alfalfa, hay; alfalfa, seed; barley, grain; Bermudagrass, forage; Bermudagrass, hay; bluegrass, forage; bluegrass, hay; bromegrass, forage; bromegrass, hay; clover, forage; clover, hay; corn, field, grain; corn, pop, grain; cowpea, hay; fescue, forage; fescue, hay; lespedeza, forage; lespedeza, hay; lupin; oat, grain; orchardgrass, forage; orchardgrass, hay; peanut, hay; pea, field, hay; ryegrass, Italian, hay; sorghum, grain, grain; soybean, hay; sudangrass, forage; sudangrass, hay; timothy, forage; timothy, hay; vetch, forage; vetch, hay; and wheat, grain.
(b) Propanoic acid is exempt from the requirement of a tolerance for residues
(c) Preharvest and postharvest application of propanoic acid (CAS Reg. No. 79-09-4), propanioc acid, calcium salt (CAS Reg. No. 4075-81-4), and propanioc sodium salt (CAS Reg. No. 137-40-6) are exempted from the requirement of a tolerance on all crops when used as either an active or inert ingredient in accordance with good agricultural practice in pesticide formulations applied to growing crops, to raw agricultural commodities before and after harvest and to animals.
Xylene is exempted from the requirement of a tolerance when used as an aquatic herbicide applied to irrigation conveyance systems in accordance with the following conditions:
(a) It is to be used only in programs of the Bureau of Reclamation, U.S. Department of Interior, and cooperating water user organizations.
(b) It is to be applied as an emulsion at an initial concentration not to exceed 750 parts per million.
(c) It is not to be applied when there is any likelihood that the irrigation water will be used as a source of raw water for a potable water system or where return flows of such treated irrigation water into receiving rivers and streams would contain residues of xylene in excess of 10 parts per million.
(d) Xylene to be used as an aquatic herbicide shall meet the requirement limiting the presence of a polynuclear aromatic hydrocarbons as listed in 21 CFR 172.250.
(a) For the purposes of this section, the viral insecticide must be produced with an unaltered and unadulterated inoculum of the single-embedded
(b) Each lot of active ingredient of the viral insecticide shall have the following specifications:
(1) The level of extraneous bacterial contamination of the final unformulated viral insecticide should not exceed 10
(2) Human pathogens, e.g., Salmonella, Shigella, or Vibrio, must be absent.
(3) Safety to mice as determined by an intraperitoneal injection study must be demonstrated.
(4) Identity of the viral product, as determined by the most sensitive and standardized analytical technique, e.g., restriction endonuclease and/or SDS-PAGE analysis, must be demonstrated.
(c) Exemptions from the requirement of a tolerance are established for the residues of the microbial insecticide
Methoprene is exempt from the requirement of a tolerance in or on all food commodities when used to control insect larvae.
(a) Polybutenes are exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity cotton, undelinted seed when used as a sticker agent for formulations of the attractant gossyplure (1:1
(b) Polybutenes are exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity artichoke when used as a sticker agent in multi-layered laminted controlled-release dispensers of (Z)-11-hexaadecenal to disrupt the mating of the artichoke plume moth.
Ethylene glycol as a component of pesticide formulations is exempt from the requirement of a tolerance when used in foliar applications to peanut plants.
The insecticide
The pheromone gossyplure, a 1:1 mixture of (
The insecticide carbon dioxide is exempted from the requirement of a tolerance when used after harvest in modified atmospheres for stored insect control on food commodities.
The insecticide nitrogen is exempted from the requirements of a tolerance when used after harvest in modified atmospheres for stored product insect control on all food commodities.
2,2,5-trimethyl-3-dichloroacetyl-1,3-oxazolidine is exempted from the requirement of a tolerance when used as an inert ingredient in formulations of the herbicides
(a) Calcium hypochlorite is exempted from the requirement of a tolerance when used preharvest or postharvest in solution on all raw agricultural commodities.
(b) Calcium hypochlorite is exempted from the requirement of a tolerance in or on grape when used as a fumigant postharvest by means of a chlorine generator pad.
Boiled linseed oil (containing no more than 0.33 percent manganese naphthenate and no more than 0.33 percent cobalt naphthenate) is exempt from the requirement of a tolerance when used as a coating agent for
Sodium diacetate, when used postharvest as a fungicide, is exempt from the requirement of a tolerance for residues in or on alfalfa, hay; Bermudagrass, hay; bluegrass, hay; bromegrass, hay; clover,hay; corm, field, grain; corn, pop, grain; oat, grain; orchardgrass, hay; sorghum, grain, grain; sudangrass, hay; ryegrass, Italian, hay; timothy, hay.
An exemption from the requirement of a tolerance is established for combined residues of both components of the tomato pinworm insect pheromone (
(a) Application shall be limited solely to point source dispensers or point source chopped fibers containing the tomato pinworm insect pheromone.
(b) Cumulative yearly application cannot exceed 200 grams of tomato pinworm pheromone per acre.
The inert ingredient, 2-amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-alpha)pyrimidin-5-one is exempted from the requirement of a tolerance when used as an emetic at not more than 0.3 percent in formulations of paraquat dichloride. Further restrictions on this exemption are that this ingredient may not be advertised as an emetic and the paraquat product may not be promoted in any way because of the inclusion of this inert ingredient.
The insect attractant methyl eugenol and the insecticide malathion are exempt from the requirement of tolerances on all raw agricultural commodities when used in combination in Oriental fruit fly eradication programs under the authority of the U.S. Department of Agriculture, in accordance with the following directions and specifications:
(a) The combination shall be at the ratio of three parts methyl eugenol to one part technical malathion (3:1).
(b) This combination is to be impregnated on a carrier (cigarette filter tips (cellulose acetate); cotton strings; fiberboard squares) or mixed with a jel cleared under 40 CFR 180.920 or 180.950.
(c) The maximum actual dosage per application per acre shall be 28.35 grams (one ounce avoirdupois) methyl eugenol and 9.45 grams (one-third (0.33) ounce avoirdupois) technical malathion.
C
An exemption from the requirement of a tolerance is established for residues of the biological insecticide (pheromone) (
Sodium chlorite is exempted from the requirement of a tolerance for residues when used in accordance with good agricultural practice as a seed-soak treatment in the growing of the raw agricultural commodities vegetable, brassica, leafy, group 5 and radish, roots and radish, tops.
(a)
(1) Use in pesticide products intended to treat seeds.
(2) Use in nursery and greenhouse operations, as defined in 40 CFR 170.3, which includes seeding, potting and transplanting activities.
(3) Pre-plant and at-transplant applications.
(4) Incorporation into seedling and planting beds.
(5) Applications to cuttings and bare roots.
(6) Applications to the field that occur after the harvested crop has been removed.
(7) Soil-directed applications around and adjacent to all plants.
(8) Applications to rangelands, which is land, mostly grasslands, whose plants can provide food (
(9) Use in chemigation and irrigation systems (via flood, drip, or furrow application with no overhead spray applications).
(10) Application as part of a dry fertilizer on which an active ingredient is impregnated.
(11) Aerial and ground applications that occur when no above-ground harvestable food commodities are present (usually pre-bloom).
(12) Application as part of an animal feed-through product.
(13) Applications as gel and solid (non-liquid/non-spray) crack and crevice treatments that place the gel or bait directly into or on top of the cracks and crevices via a mechanism such as a syringe.
(14) Applications to the same crop from which the food commodity is derived, whether the plant fraction(s) intended for harvest are present or not, e.g., applications of peanut meal when applied to peanut plants.
(b)
(a) An exemption from the requirement of a tolerance is established for residues of the biological plant growth regulator poly-
(b) An exemption from the requirement of a tolerance is established for residues of the biological plant growth regulator poly-D-glucosamine when used as a pesticide in the production any raw agricultural commodity.
The oriental fruit moth pheromone (Isomate-M) (Z-8-dodecen-l-yl acetate, E-8-dodecen-l-yl acetate, Z-8-dodecen-l-ol) is exempt from the requirement of a tolerance in or on all the raw agricultural commodities (food and feed) including, peach; quince; nectarine; and nut, macadamia when used in orchards with encapsulated polyethylene tubing to control oriental fruit moth.
F.D.&C. Blue No. 1 is exempted from the requirement of a tolerance when used as an aquatic plant control agent.
An exemption from the requirement of a tolerance is established for residues of the mycoherbicide
(a) For the purposes of this section the microbial insecticide for which exemption from the requirement of a tolerance is being established shall have the following specifications:
(1) The microorganism shall be an authentic strain of
(2) Spore preparations of
(3) Each lot of spore preparation, prior to the addition of other materials, shall be tested by subcutaneous injection of at least 1 million spores into each of five laboratory test mice weighing 17 grams to 23 grams. Such test shall show no evidence of infection of injury in the test animals when observed for 7 days following injection.
(b) Exemption from the requirement of a tolerance is established for residues of the microbial insecticide
An exemption from the requirement of a tolerance is established for residues of the plant volatiles cyclic decadiene, cyclic decene, cyclic pentadecatriene, and decatriene and the pheromone Z-2-isopropenyl-1-methylcyclobutaneethanol; Z-3,3-dimethyl-Δ1,β-cyclohexaneethanol; Z-3,3-dimethyl-Δ1,α-cyclohexaneethanal; E-3,3-dimethyl-Δ1,α-cyclohexaneethanal combination when applied to cotton in hollow synthetic fibers.
Dimethyl sulfoxide (DMSO) [CAS Registry Number 67-68-5] is exempted from the requirement of a tolerance when used as an inert solvent or cosolvent in formulations with the following pesticides when used in accordance with good agricultural practices in or on the following raw agricultural commodities:
(a) Carbaryl (1-naphthyl methyl-carbamate)
(b)
Monocarbamide dihydrogen sulfate is exempted from the requirement of a tolerance when used as a herbicide or desiccant in or on all raw agricultural commodities.
The insect pheromone containing the active ingredients 3,7,11-trimethyl-1,6,10-dodecatriene-1-ol and 3,7,11-trimethyl-2,6,10-dodecatriene-3-ol is exempted from the requirement of a tolerance in or on all raw agricultural commodities.
An exemption from the requirement of a tolerance is established for residues of the biorational nematicide sesame stalk in or on the following raw agricultural commodities: Almond; almond, hulls; cotton, undelinted seed; cotton, gin byproducts; soybean, seed; soybean, forage; soybean, hay; aspirated grain fractions; potato; beet, sugar, roots; beet, sugar, tops; tomato; pepper, bell; squash; strawberry; eggplant; cucumber; carrot, roots; radish, roots; radish, top; turnip, roots; turnip, tops; onion; pea, dry; pea, succulent; melon; grape; walnut; orange; grapefruit; mulberry; peach; apple; apricot; blackberry; loganberry; pecan; cherry; plum, and cranberry.
An exemption from the requirement of a tolerance is established for residues of the biochemical nematicide poly-
Lactic acid (2-hydroxypropanoic acid) is exempted from the requirement of a tolerance when used as a plant growth regulator in or on all raw agricultural commodities.
Aluminum isopropoxide (CAS Reg. No. 555-31-7) and aluminum secondary butoxide (CAS Reg. No. 2269-22-9) are exempted from the requirement of a tolerance when used in accordance with good agricultural practices as stabilizers in formulations of the insecticide amitraz [
An exemption from the requirement of a tolerance is established for residues of the pesticidal chemical menthol in or on honey and honeycomb when used in accordance with good agricultural practice in over-wintering bee hives.
Chlorine gas is exempted from the requirement of a tolerance when used preharvest or postharvest in solution on all raw agricultural commodities.
The grape berry moth pheromone (GBM-ROPE) containing the active ingredients (Z)-9-dedecenyl acetate and (Z)-11-tetradecenyl acetate is exempt from the requirement of a tolerance in or on the raw agricultural commodity grape when used in orchards with encapsulated polyethylene tubing to control grape berry moth.
An exemption from the requirement of a tolerance is established for residues of gibberellins [gibberellic acids (GA3 and GA4 + GA7), and sodium or potassium gibberellate] in or on all food commodities when used as plant regulators on plants, seeds, or cuttings and on all food commodities after harvest in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of the biofungicide
Parasitic (parasitoid) and predatory insects are exempted from the requirement of a tolerance for residues when they are used in accordance with good agricultural and pest control practices to control insect pests of stored raw whole grains such as corn, small grains, rice, soybeans, peanuts, and other legumes either bulk or warehoused in bags. For the purposes of this rule, the parasites (parasitoids) and predators are considered to be species of Hymenoptera in the genera
An exemption from the requirement of a tolerance is established for residues of the biofungicide
The codling moth pheromone (Isomate-C) E,E-8,10-dodecenyl alcohol, dodecanol, tetradecanol is exempt from the requirements of a tolerance in or on all raw agricultural commodities when formulated in polyethylene pheromone dispensers for use in orchards with encapsulated polyethylene tubing to control codling moth.
The delta endotoxin of
The delta endotoxin of
An exemption from the requirement of a tolerance is established for the residues of 3-carbamyl-2,4,5-trichlorobenzoic acid in or on all raw agricultural commodities which occur from the direct application of chlorothalonil to crops in § 180.275 (a) and (b) and/or as an inadvertent residue resulting from the soil metabolism of chlorothalonil when applied to crops in § 180.275 (a) and (b), and subsequent uptake by rotated crops when used according to approved agricultural practices.
The biofungicide
The biological pesticides
An exemption from the requirement of a tolerance is established for the microbial pest control agent
An exemption from the requirement of a tolerance is established for the biochemical azadirachtin, which is isolated from the berries of the Neem tree (
The biological pesticide
An exemption from the requirement of a tolerance is established for residues of the pesticidal chemical boric acid and its salts, borax (sodium borate decahydrate), disodium octaborate tetrahydrate, boric oxide (boric anhydride), sodium borate and sodium metaborate, in or on raw agricultural commodities when used as an active ingredient in insecticides, herbicides, or fungicides preharvest or postharvest in accordance with good agricultural practices.
(a) All inert ingredients of semiochemical dispenser products formulated with, and/or contained in, dispensers made of polymeric matrix materials (including the monomers, plasticizers, dispersing agents, antioxidants, UV protectants, stabilizers, and other inert ingredients) are exempted from the requirement of a tolerance when used as carriers in pesticide formulations for application to growing crops only. These dispensers shall conform to the following specifications:
(1) Exposure must be limited to inadvertent physical contact only. The design of the dispenser must be such as to preclude any contamination by its components of the raw agricultural commodity (RAC) or processed foods/feeds derived from the commodity by virtue of its proximity to the RAC or as a result of its physical size.
(2) The dispensers must be applied discretely. This exemption does not apply to components of semiochemical formulations applied in a broadcast manner either to a crop field plot or to individual plants.
(b) A semiochemical dispenser is a single enclosed or semi-enclosed unit that releases semiochemical(s) into the surrounding atmosphere via volatilization and is applied in a manner to provide discrete application of the semiochemical(s) into the environment.
(c) Semiochemicals are chemicals that are emitted by plants or animals and modify the behavior of receiving organisms. These chemicals must be naturally occurring or substantially identical to naturally occurring semiochemicals.
Arthropod pheromones, as described in § 152.25(b) of this chapter, when used in retrievably sized polymeric matrix dispensers are exempt from the requirement of a tolerance in or on all raw agricultural commodities when applied to growing crops only at a rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for the insect pheromone codlure, (E,E)-8,10-dodecadien-1-ol, on all raw agricultural commodities in accordance with the following prescribed conditions:
(a) Application shall be limited solely to codlure dispensers that conform to the following specifications:
(1) Commodity exposure must be limited to inadvertent physical contact. The design of the dispenser must be such as to preclude any exposure of its components to the raw agricultural commodity (RAC) or processed foods/feeds derived from the commodity due to its proximity to the RAC or as a result of its physical size. Dispensers must be of such size and construction that they are readily recognized post-application.
(2) The dispensers must be applied discretely,
(b) A codlure dispenser is a single enclosed or semi-enclosed unit that releases codlure into the surrounding atmosphere via volatilization and is applied in a manner to provide discrete application (
Residues of the biochemical pesticide plant floral volatile attractant compounds: cinnamaldehyde, cinnamyl alcohol, 4-methoxy cinnamaldehyde, 3-phenyl propanol, 4-methoxy phenethyl alcohol, indole, and 1,2,4-trimethoxybenzene are exempt from the requirement of a tolerance in or on the following raw agricultural commodities: the following field crops—alfalfa, clover, cotton, dandelion, peanuts (including hay), rice, sorghum (milo), soybeans, sunflower, sweet potatoes, and wheat; the following vegetable crops—asparagus, beans (including forage hay), beets, carrots, celery, cole crops (cabbage, broccoli, brussels sprouts, cauliflower), collards (kale, mustard greens, turnip greens, kohlrabi), corn, fresh (field, sweet, pop, seed), corn fodder and forage, chinese cabbage, cowpeas, cucurbitis (cucumbers, squash, pumpkin), egg plant, endive (escarole), horseradish (radish, rutabagas, turnip roots), leafy greens (spinach, swiss chard), lettuce (head leaf), okra, parsley, parsnip, peas, peas with pods, peppers, potatoes, sugar beets, tomatoes; the following tree fruit, berry and nut crops—almonds, apples, apricots, berries (blackberry, boysenberry, dewberry, loganberry, raspberry), blueberry, cherry, citrus (grapefruit, kumquat, lemon, lime, orange, tangelo, and tangerine) cranberry, grapes, melons, (watermelon, honeydew, crenshaw, cantaloupe, casaba, persian), nectarines, pears, pecans, peaches, and strawberry as dispersed from the end-use product Corn Rootworm Bait ®, a pesticidal bait, in accordance with the prescribed conditions in paragraph (a) of this section.
(a) Cumulative yearly application cannot exceed 20 grams of each floral attractant/acre/application.
(b) [Reserved]
An exemption from the requirement of a tolerance is established for residues of the biofungicide
The biological fungicide
The biological nematicide
The biochemical sodium 5-nitroguiacolate is exempted from the requirement of a tolerance when used as a plant growth regulator in end-use products at a concentration of 0.1% by weight and applied at an application rate of 20 g of a.i. per acre or less per application, in or on all food commodities.
The biochemical sodium
The biochemical sodium
An exemption from the requirement of a tolerance is established for the residues of the plant growth regulator, 1,4-dimethylnaphthalene (1,4-DMN), when applied postharvest to all sprouting root, tuber, and bulb crops in accordance with good agricultural practices.
Residues of methyl anthranilate, a biochemical pesticide, are exempt from the requirement of a tolerance in or on all food commodities, when used in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of the microbial pest control agent Occlusion Bodies of the Granulosis Virus of
The microbial pest control agent inclusion bodies of the multi-nuclear polyhedrosis virus of
The biochemical plant regulator 6-benzyladenine (6-BA) is exempt from the requirement of a tolerance in or on apple and pear when applied at a rate of ≤182 grams of active ingredient per acre per season, and in or on pistachio when applied at a rate of ≤60 grams of active ingredient per acre per season.
Lepidopteran pheromones that are naturally occurring compounds, or identical or substantially similar synthetic compounds, designated by an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol, aldehyde or acetate functional group and containing up to 3 double bonds in the aliphatic backbone, are exempt from the requirement of a tolerance in or on all raw agricultural commodities. This exemption only pertains to those situations when the pheromone is: Applied to growing crops at a rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices; and applied as a post-harvest treatment to stored food commodities at a rate not to exceed 3.5 grams active ingredient/1,000 ft
CryIA(c) and CryIC derived delta-endotoxins of
Cinnamaldehyde (3-phenyl-2-propenal) is exempted from the requirement of a tolerance in or on all food commodities, when used as a fungicide, insecticide, and algaecide in accordance with good agricultual practices.
An exemption from the requirement of a tolerance is established for residues of cytokinins (specifically: aqueous extract of seaweed meal and kinetin) in or on all food commodities when used as plant regulators on plants, seeds, or cuttings and on all food commodities after harvest in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of auxins (specifically: indole-3-acetic acid and indole-3-butyric acid) in or on all food commodities when used as plant regulators on plants, seeds, or cuttings and on all food commodities after harvest in accordance with good agricultural practices.
(a) An exemption from the requirement of a tolerance is established for residues of pelargonic acid in or on all food commodities when used as a plant regulator on plants, seeds, or cuttings and on all food commodities after harvest in accordance with good agricultural practices.
(b) Pelargonic acid when used as an herbicide is exempt from the requirement of a tolerance on all plant food commodities provided that:
(1) Applications are not made directly to the food commodity except when used as a harvest aid or desiccant to: any root and tuber vegetable, bulb vegetable or cotton.
(2) When pelargonic acid is used as a harvest aid or desiccant, applications must be made no later than 24 hours prior to harvest.
(c) An exemption from the requirement of a tolerance is established for residues of pelargonic acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of pelargonic acid as an antimicrobial treatment in solutions containing a diluted end-use concentration of pelargonic acid up to 170 ppm per application on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants.
The insecticide and spray tank adjuvant jojoba oil is exempted from the requirement of a tolerance in or on all raw agricultural commodities when applied at the rate of 1.0% or less of the final spray in accordance with good agricultural practices, provided the jojoba oil does not contain simmondsin, simmondsin-2-ferulate, and related conjugated organonitriles including demethyl simmondsin and didemethylsimmondsin.
Clarified hydrophobic extract of neem oil is exempt from the requirement of a tolerance on all food commodities when used as a botanical fungicide/insecticide/miticide.
(a) Acrylate polymers and copolymers are exempt from the requirement of a tolerance when used as inert ingredients in pesticidal formulations applied to growing, raw agricultural commodities. This tolerance exemption covers the acrylate polymers/copolymers that are intrinsically safe and already listed in TSCA inventory or will meet the polymer tolerance exemption from requirements of premanufacturing notification under 40 CFR 723.250. Polymers exempted can be used as dispensers, resins, fibers, and beads, as long as the fibers, beads and resins particle sizes are greater than 10 microns and insoluble in water. This exemption pertains to the acrylate polymers/copolymers used as inert ingredients for sprayable and dispenser pesticide formulations that are applied on food crops. Any acrylate polymers/copolymers used for encapsulating material must be cleared as an inert ingredient when used in pesticide formulation applied on food crops.
(b) For the purposes of this exemption, acrylate polymers/copolymers used as inert ingredients in an end-use formulation must meet the definition for a polymer as given in 40 CFR 723.250(b), are not automatically excluded by 40 723.250(d), and meet the tolerance exemption criteria in 40 CFR 723.250(e)(1), 40 CFR 723.250 (e)(2) or 40 CFR 723.250(e)(3). Therefore, acrylate polymers and copolymers that are already listed in the TSCA inventory or will meet the polymer tolerance exemption under 40 CFR 723.250 as amended on March 29, 1995 are covered by this exemption.
Killed
Capsaicin is exempt from the requirement of a tolerance in or on all food commodities when used in accordance with approved label rates and good agricultural practice.
The insecticide and repellent Allyl isothiocyanate is exempt from the requirement of a tolerance for residues when used as a component of food grade oil of mustard, in or on all raw agricultural commodities, when applied according to approved labeling.
The biochemical pesticide sodium bicarbonate is exempted from the requirement of a tolerance in or on all raw agricultural commodities when applied as a fungicide or post-harvest fungicide in accordance with good agricultural practices.
The biochemical pesticide potassium bicarbonate is exempted from the requirement of a tolerance in or on all raw agricultural commodities when applied as a fungicide or post-harvest fungicide in accordance with good agricultural practices.
The pesticide formic acid is exempted from the requirement of a tolerance in or on honey and honeycomb when used to control tracheal mites and suppress varroa mites in bee colonies, and applied in accordance with label use directions.
The biochemical pesticide plant extract derived from
(a) The biochemical pesticide kaolin is temporarily exempted from the requirement of a tolerance for residues of the insecticide Kaolin, when used on crops (apples, apricots, bananas, beans, cane berries, citrus fruits, corn, cotton, cranberries, cucurbits, grapes, melons, nuts, ornamentals, peaches, peanuts, pears, peppers, plums, potatoes, seed crops, small grains, soybeans, strawberries, sugar beets, and tomatoes) to control certain insect, fungus, and bacterial damage to plants. This temporary exemption from the requirement of a tolerance will permit the marketing of the food commodities in this paragraph when treated in accordance with the provisions of experimental use permit 70060-EUP-1, which is being issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136).
(b) Kaolin is exempted from the requirement of a tolerance for residues when used on or in food commodities to aid in the control of insects, fungi, and bacteria (food/feed use).
An exemption from the requirement of a tolerance for residues of the
L-glutamic acid is exempt from the requirement of a tolerance on all food commodities when used in accordance with good agricultural practices.
Gamma aminobutyric acid is exempt from the requirement of a tolerance on all food commodities when used in accordance with good agricultural practices.
The biochemical pesticide methyl salicylate is exempt from the requirement of a tolerance for residues in or on food or feed when used as an insect repellant in food packaging and animal feed packaging at an application rate that does not exceed 0.2 mg of methyl salicylate per square inch of packaging materials.
An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide, ferric phosphate (FePO
Potassium dihydrogen phosphate is exempted from the requirement of a tolerance in or on all food commodities when applied as a fungicide in accordance with good agricultural practices.
Titanium dioxide (CAS Reg. No. 13463-67-7) is exempted from the requirement of a tolerance for residues in or on growing crops, when used as an inert ingredient (UV protectant) in microencapsulated formulations of the insecticide lambda cyhalothrin at no more than 3.0% by weight of the formulation and as an inert ingredient (UV-stabilizer) at no more than 5% in pesticide formulations containing the active ingredient napropamide.
(a) An exemption from the requirement of a tolerance is established for residues of peroxyacetic acid in or on all food commodities, when such residues result from the use of peroxyacetic acid as an antimicrobial treatment in solutions containing a diluted end use concentration of peroxyacetic acid up to 100 ppm per application on fruits, vegetables, tree nuts, cereal grains, herbs, and spices.
(b) An exemption from the requirement of a tolerance is established for residues of peroxyacetic acid, in or on all food commodities when used in
(c) An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide peroxyacetic acid and its metabolites and degradates, including hydrogen peroxide and acetic acid, in or on all food commodities, when used in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of hydrogen peroxide in or on all food commodities at the rate of ≤ 1% hydrogen peroxide per application on growing and postharvest crops.
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide,
An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide lysophosphatidylethanolamine in or on all food commodities.
A temporary exemption from the requirement of a tolerance is established for residues of the microbial pesticide,
An exemption from the requirement of a tolerance is established for residues of the microbial pesticides,
An exemption from the requirement of a tolerance is established for residues of individual harpin proteins that meet specified physiochemical and toxicological criteria when used as biochemical pesticides on all food commodities to enhance plant growth, quality and yield, to improve overall plant health, and to aid in pest management. The physiochemical and toxicological criteria identifying harpin proteins are as follows:
(a) Consists of a protein less than 100 kD in size, that is acidic (pI<7.0), glycine rich (>10%), and contains no more than one cystine residue.
(b) The source(s) of genetic material encoding the protein are bacterial plant pathogens not known to be mammalian pathogens.
(c) Elicits the hypersensitive response (HR) which is characterized as rapid, localized cell death in plant tissue after infiltration of harpin into the intercellular spaces of plant leaves.
(d) Possesses a common secondary structure consisting of α and β units that form an HR domain.
(e) Is heat stable (retains HR activity when heated to 65 °C for 20 minutes).
(f) Is readily degraded by a proteinase representative of environmental conditions (no protein fragments >3.5 kD after 15 minutes degradation with Subtilisin A).
(g) Exhibits a rat acute oral toxicity (LD
An exemption from the requirement of a tolerance is established for residues of the insecticide
(a) An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
(b) An exemption from the requirement of a tolerance is established for residues of
(c) An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of the following substances when used as inert ingredients (surfactants) at levels not to exceed 10% in pesticide formulations containing glyphosate:
An exemption from the requirement of a tolerance is established for residues of the microbial pesticides
An exemption from the requirement of a tolerance is established for residues of phosphorous acid and its ammonium, sodium, and potassium salts in or on all food commodities when used as an agricultural fungicide and in or on potatoes when applied as a post-harvest treatment at 35,600 ppm or less phosphorous acid.
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide Indian Meal Moth Granulosis Virus when used in or on all food commodities.
The pesticide foramsulfuron is exempted from the requirement of a tolerance in corn, field, grain/corn, field, forage/ corn, field, stover/corn, pop, grain/corn, pop, forage/corn, pop, stover; corn, sweet, forage; corn, sweet, kernel plus cob with husks removed; corn, sweet, stover when applied as a herbicide in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of the 1-Methylcyclopropene in or on fruits and vegetables when:
(a) Used as a post harvest plant growth regulator,
(b) Applied or used outdoors for pre-harvest treatments.
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of sucrose octanoate esters [(α-D-glucopyranosyl-β-D-fructofuranosyl-octanoate), mono-, di-, and triesters of sucrose octanoate] in or on all food commodities when used in accordance with good agricultural practices.
The herbicide imazamox, (±) 2, -[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(methoxymethyl)-3-pyridinecarboxylic acid, is exempt from the requirement of a tolerance on all food commodities when applied as a herbicide in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
An exemption from the requirement of a tolerance is established for residues of decanoic acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of decanoic acid as
A temporary exemption from the requirement of a tolerance is established for residues of the microbial pesticide
An exemption from the requirement of a tolerance is established for residues of diallyl sulfides when used in/on garlic, leeks, onions, and shallots.
An exemption from the requirement of a tolerance is established for residues of ferrous sulfate.
An exemption from the requirement of a tolerance is established for residues of lime.
An exemption from the requirement of a tolerance is established for residues of lime-sulfur.
An exemption from the requirement of a tolerance is established for residues of potassium sorbate.
An exemption from the requirement of a tolerance is established for residues of sodium carbonate.
An exemption from the requirement of a tolerance is established for residues of sodium hypochlorite.
An exemption from the requirement of a tolerance is established for residues of sulfur.
(a) An exemption from the requirement of a tolerance is established for residues of sodium metasilicate in or on all food commodities when used in accordance with approved label rates and good agricultural practices as a plant desiccant, so long as the sodium metasilicate does not exceed 4% by weight in aqueous solution.
(b) An exemption from the requirement of a tolerance is established for residues of sodium metasilicate in or on all food commodities when used in accordance with approved label rates and good agricultural practices as an insecticide and fungicide, so long as the sodium metasilicate does not exceed 2.41% by weight in aqueous solution.
(a) Time-limited exemptions from the requirement of a tolerance are established for residues of thymol on honey and honeycomb in connection with use of the pesticide under section 18 emergency exemptions granted by the EPA. These time-limited exemptions from the requirement of a tolerance for residues of thymol will expire and are revoked on June 30, 2007.
(b) An exemption from the requirement of a tolerance for residues of the thymol (as present in thyme oil) in or on food commodities when applied/used in/on public eating places, dairy processing equipment, and/or food processing equipment and utensils.
Time-limited exemptions from the requirement of a tolerance are established for residues of eucalyptus oil on honey and honeycomb in connection with use of the pesticide under section 18 emergency exemptions granted by the EPA. These time-limited exemptions from the requirement of a tolerance for residues of eucalyptus oil will expire and are revoked on June 30, 2007.
An exemption from the requirement of a tolerance for residues of the
An exemption from the requirement of tolerance is established for residues of ammonium bicarbonate used in or on all food commodities when used in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of rhamnolipid biosurfactant when used in accordance with good agricultural practices as a fungicide in or on all food commodities.
This regulation establishes an exemption from the requirement of a tolerance for residues of the biochemical pesticide Yeast Extract Hydrolysate from
An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide citronellol in or on all food commodities.
The C8, C10, and C12 straight-chain fatty acid monoesters of glycerol (glycerol monocaprylate, glycerol monocaprate, and glycerol monolaurate) and propylene glycol (propylene glycol monocaprylate, propylene glycol monocaprate, and propylene glycol monolaurate) are exempt from the requirement of a tolerance in or on all food commodities when used in accordance with approved label rates and good agricultural practice.
An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide geraniol in or on all food commodities.
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
(a) An exemption from the requirement of a tolerance is established for residues of
(b) An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
(a) An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide acetic acid when used as a preservative on post-harvest agricultural commodities intended for animal feed, including Alfalfa, seed; alfalfa, hay; barley, grain; bermudagrass, hay; bluegrass, hay; bromegrass, hay; clover, hay; corn, field, grain; corn, pop, grain; cowpea, hay; fescue, hay; lespedeza, hay; lupin; oat, grain; orchardgrass, hay; peanut, hay; timothy, hay; vetch, hay; and wheat, grain, or commodities described as grain or hay.
(b) An exemption from the requirement of a tolerance is established for residues of acetic acid in or on all food crops resulting from unintentional spray and drift to non-target vegetation including non-food, food and feed crops when used as a non-selective contact herbicide spray.
Residues of the biochemical pesticide
An exemption from the requirement of a tolerance is established on all food/feed commodities, for residues of
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of sorbitol octanoate in or on all food commodities when used in accordance with label directions.
Tetrahydrofurfuryl alcohol (THFA, CAS Reg. No. 97-99-4) is exempt from the requirement of a tolerance in or on all raw agricultural commodities when used in accordance with good agricultural practices as an inert ingredient applied only:
(a) For use as a seed treatment.
(b) For applications prior to planting and at the time of planting.
(c) For use on cotton.
(d) For use in herbicides with one application to wheat and barley prior to the pre-boot stage, and two applications to canola and soybeans pre-bloom.
(e) For use in herbicides with two applications to field corn up to 24 inches tall (V 5 stage).
An exemption from the requirement of a tolerance is established for residues of
Potassium silicate is exempt from the requirement of a tolerance in or on all food commodities so long as the potassium silicate is not applied at rates exceeding 1% by weight in aqueous solution and when used in accordance with good agricultural practices.
Isophorone (CAS Reg. No. 78-59-1) is exempt from the requirement of a tolerance when used as an inert ingredient in pesticide formulations applied to beets, ginseng, rice, spinach, sugar beets, and Swiss chard.
An exemption from the requirement of tolerance is established for residues
An exemption from the requirement of a tolerance is established for residues of
Residues of
Tris (2-ethylhexyl) phosphate (TEHP, CAS Reg. No. 78-42-2) is exempt from the requirement of a tolerance for residues in grain, aspirated fractions; barley, grain, barley, hay, barley, straw; wheat, grain; wheat, forage; wheat, hay; wheat, straw when used under the following conditions:
(a) The use is in accordance with good agricultural practices;
(b) Tris (2-ethylhexyl) phosphate is used as an inert ingredient in pesticide formulations with the active ingredients pinoxaden, clodinafop-propargyl, and tralkoxydium;
(c) Tris (2-ethylhexyl) phosphate is applied no more than twice per season; and
(d) The applications occur no later than the pre-boot stage (prior to formation of edible grain).
An exemption from the requirement of tolerance is established on all food/feed commodities, for residues of
A temporary exemption from the requirement of a tolerance is established for residues of tobacco mild green mosaic tobamovirus in or on all grass, forage and grass, hay.
Dibasic esters (CAS Reg. No. 95481-62-2) is exempted from the requirement of a tolerance for residues when used as an inert ingredient (solvent and/or anti-freeze) at 10% W/W or less in microencapsulated pesticide formulations with the active ingredient cyfluthrin.
Residues of the biochemical pesticide
An exemption from the requirement of a tolerance for residues of the ZYMV-WK strain in or on all raw cucurbit when applied/used in accordance with label directions.
Poly(hexamethylenebiguanide) hydrochloride (PHMB)(CAS Reg. No. 32289-58-0) is exempt from the requirement of a tolerance for residues of the antimicrobial in or on all food commodities when the residues are the result of the lawful application of a food contact surface sanitizer containing PHMB at 550 parts per million (ppm).
An exemption from the requirement of a tolerance is established for residues of S-Abscisic Acid in or on all food commodities when applied or used preharvest as a plant regulator.
An exemption from the requirement of a tolerance is established in/on all food/feed commodities, for residues of
An exemption from the requirement of a tolerance is established for residues of (Z)-7,8-epoxy-2-methyloctadecane on all food and feed crops that occur when it is used to treat trees, shrubs, and pastures and such use results in unintentional spray and drift to non-target vegetation including non-food, food, and feed crops. This active ingredient is also known as Disparlure.
Ammonium salts of C
An exemption from the requirement of a tolerance is established for the residues of polyoxin D zinc salt in or on all food commodities when applied as a fungicide and used in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for the residues of Extract of
An exemption from the requirement of a tolerance is established for residues of poly(oxy-1,2-ethanediyl), α-[2,4,6-tris(1-phenylethyl)phenyl]-ω-hydroxy-, (CAS Reg. No. 70559-25-0) and poly(oxy-1,2-ethanediyl), α-[tris(1-phenylethyl)phenyl]-ω-hydroxy-, (CAS Reg. No. 99734-09-5) on citrus crops, group 10, when used as inert ingredients under the following conditions:
(a) They are applied post-harvest;
(b) They are used as inert ingredients in pesticide formulations with azoxystrobin and fludioxonil; and
(c) They constitute no more than 10.0% of the formulated pesticide product.
An exemption from the requirement of a tolerance is established for the residues of the microbial pesticide,
An exemption from the requirement of a tolerance is established for residues of
Residues of the biochemical pesticide cold pressed neem oil are exempt from the requirement of a tolerance in or on all food commodities.
An exemption from the requirement of a tolerance is established in/on all food commodities for residues of
An exemption from the requirement of a tolerance is established for residues of laminarin in or on all food commodities when laminarin is applied preharvest.
An exemption from the requirement of a tolerance is established for the residues of the biochemical pesticide Terpene Constituents α-terpinene, d-limonene and p-cymene, of the Extract of Chenopodium
An exemption from the requirement of a tolerance is established for the residues of homobrassinolide in or on all food commodities when applied/used as a plant growth regulator in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of
A temporary exemption from the requirement of a tolerance is established for residues of prohydrojasmon, propyl-3-oxo-2-pentylcyclo-pentylacetate, when used as a plant growth regulator on red apples varieties and grapes pre-harvest, in accordance with good agricultural practices and the terms of Experimental Use Permit No. 62097-EUP-1, and will expire on August 1, 2014.
An exemption from the requirement of a tolerance is established for residues of potassium hypochlorite in or on all commodities.
A temporary exemption from the requirement of a tolerance is established for residues of lytic bacteriophages that are specific to
An exemption from the requirement of a tolerance is established for residues of sodium ferric EDTA in or on all food commodities when applied as a molluscicide and used in accordance with good agricultural practices.
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of lytic bacteriophage of Clavibacter michiganensis subspecies
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide,
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of the microbial pesticides,
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of killed, nonviable
An exemption from the requirement of a tolerance is established for residues of natamycin in or on mushrooms when applied as a fungistat to prevent the germination of fungal spores on mushrooms produced in enclosed mushroom production facilities.
An exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of Didecyl dimethyl ammonium chloride in or on broccoli resulting from the use of Didecyl dimethyl ammonium chloride as a seed treatment at a treatment concentration of 1200 ppm prior to planting by immersion.
An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide, 3-decen-2-one, in or on potatoes when applied as a potato sprout inhibitor and used in accordance with label directions and good agricultural practices.
An exemption from the requirement of a tolerance is established for the residues of Banda de
An exemption from the requirement of a tolerance is established for residues of methyl jasmonate in or on all food commodities when methyl jasmonate is applied pre-harvest.
An exemption from the requirement of a tolerance is established for residues of
This subpart sets forth the pesticide chemicals for use in agricultural or other food-related settings for which neither a tolerance nor an exemption is deemed to be needed by EPA.
(a) Food uses are the uses of a pesticide chemical that are likely to yield residues in food or feed crops, meat, milk, poultry or egg.
(b) Non-food uses are those uses that are not likely to yield residues in food or feed crops, meat, milk, poultry or egg.
The following pesticide chemical uses on food or feed, or food or feed crops, do not need a tolerance or exemption from the requirement of a tolerance, and may be registered under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136
The following pesticide chemical uses do not need a tolerance or exemption from the requirement of a tolerance based on EPA's determination that they are not likely to result in residues in or on food.