CODE OF FEDERAL REGULATIONS40
CONTAINING
A CODIFICATION OF DOCUMENTS
OF GENERAL APPLICABILITY
AND FUTURE EFFECT
Published by
the Office of the Federal Register
National Archives and Records
Administration
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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows:
Title 1 through Title 16
Title 17 through Title 27
Title 28 through Title 41
Title 42 through Title 50
The appropriate revision date is printed on the cover of each volume.
The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510).
The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule.
To determine whether a Code volume has been amended since its revision date (in this case, July 1, 1999), consult the “List of CFR Sections Affected (LSA),” which is issued monthly, and the “Cumulative List of Parts Affected,” which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule.
Each volume of the Code contains amendments published in the Federal Register since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut-off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text.
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(b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process.
(c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51.
Properly approved incorporations by reference in this volume are listed in the Finding Aids at the end of this volume.
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Title 40—
Chapter I—Environmental Protection Agency appears in all twenty-four volumes. A Pesticide Tolerance Commodity/Chemical Index appears in parts 150-189. A Toxic Substances Chemical—CAS Number Index appears in parts 700-789 and part 790 to End. Redesignation Tables appear in the volumes containing parts 50-51, parts 150-189, and parts 700-789. Regulations issued by the Council on Environmental Quality appear in the volume containing part 790 to End. The OMB control numbers for title 40 appear in § 9.1 of this chapter.
For this volume, Melanie L. Marcec was Chief Editor. The Code of Federal Regulations publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.
(This book contains parts 150 to 189)
7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.
Part 152 sets forth procedures, requirements and criteria concerning the registration and reregistration of pesticide products under FIFRA sec. 3, and for associated regulatory activities affecting registration. These latter regulatory activities include data compensation and exclusive use (subpart E), and the classification of pesticide uses (subpart I).
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.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(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.
(l)
(m)
(n)
(1) Hospitals and nursing homes.
(2) Schools other than preschools and day care facilities.
(3) Museums and libraries.
(4) Sports facilities.
(5) Office buildings.
(o)
(p)
(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 or 409 of the Federal Food, Drug and Cosmetic Act;
(2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or
(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.
(q)
(r)
(s)
(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.
(t)
(u)
(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
(d) Any fungus, bacterium, virus, or other microorganisms, 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 sec. 201(g)(1)) and cosmetics (as defined in FFDCA sec. 201(i)).
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 product intended for use only for the control of fungi, bacteria, viruses, or other microorganisms in or on living man or animals, and labeled accordingly.
(b) A product intended for use only for control of internal invertebrate parasites or nematodes in living man or animals, and labeled accordingly.
(c) A product of any of the following types, intended only to aid the growth of desirable plants:
(1) A fertilizer product not containing a pesticide.
(2) 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.
(3) A plant inoculant product consisting of microorganisms applied to the plant or soil for the purpose of enhancing the availiability or uptake of plant nutrients through the root system.
(4) A soil amendment product containing a substance or substances added to the soil for the purpose of improving soil characteristics favorable for plant growth.
(d) 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, i.e., use for the purpose of preventing, destroying, repelling, or mitigating any pest or use as a plant regulator, defoliant, or desiccant. A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
(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) Eucaryotic microorganisms, including protozoa, algae and fungi;
(ii) Procaryotic microorganisms, including bacteria; and
(iii) Viruses.
(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 com-pound 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 pher-o-mone 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)
(1) The product, in the undiluted package concentration at which it is distributed or sold, meets the criteria of § 156.10(h)(1) 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.
(e)
(f)
(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.
(g)
(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
(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
(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 § 158.180 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 consolidate an amendment affecting a number of products into a single application.
(4) Permit an applicant to modify a registration by notification or non-notification in accordance with § 152.46.
(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 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 158.30 of this chapter, with respect to times for submission;
(ii) Section 158.32 of this chapter, with respect to format of submission;
(iii) Section 158.33 of this chapter, with respect to studies for which a claim of trade secret or confidential business information is made;
(iv) Section 158.34 of this chapter, with respect to flagging for potential adverse effects; and
(v) Section 160.12 of this chapter, if applicable, with respect to a statement of whether studies were conducted in accordance with the 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)
Applications and correspondence relating to registration should be mailed to the Registration Division (TS-767C), U.S. Environmental Protection Agency, Washington, DC 20460. Persons who wish to hand-deliver applications should contact the Registration Division to determine the location for delivery.
This subpart E (§§ 152.80 through 152.119)
(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 which is registered under FIFRA section 3;
(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:
(a)
(b)
(c)
(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.
(d)
(e)
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) FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or cite data pertaining to the safety of any ingredient (or mixture of ingredients) contained in his product that is derived solely from one or more EPA-registered products which the applicant purchases from another producer.
(b) If the product contains one or more ingredients eligible for the formulators' exemption, the applicant need not comply with the requirements of §§ 152.90 through 152.96 with respect to any data requirements pertaining to the safety of any such ingredient, provided that he submits to the Agency a certification statement containing the following information (a form for this purpose is available from the Agency):
(1) Identification of the applicant, and of the product by EPA registration number or file symbol;
(2) 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;
(3) A statement that the listed ingredients meet the requirements for the formulators' exemption;
(4) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula; and
(5) The name, title and signature of the applicant or his authorized representative and the date of signature.
(c) An applicant for amended registration is not required to submit a new formulators' exemption statement, if the current statement in Agency files is complete and accurate.
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)(D) 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 previously been submitted to the Agency. This section summarizes the procedures that an applicant must follow if he chooses the selective method of demonstrating compliance. Sections 152.91 through 152.96 contain specific procedures for citing or submitting a study or demonstrating a data gap.
(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. 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 should be cited in accordance with § 152.93.
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)(D);
(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)
(i) The study was originally submitted to the Agency on or before December 31, 1969; or
(ii) The study was originally submitted to the Agency on or before the date that is 15 years before the date of the application for which it is cited, and the study is not an exclusive use study, as defined in § 152.83(c).
(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)(D).
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)(D);
(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 re-quirement(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, if 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)(D) 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
(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)(D), 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)(D). 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
(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)(D)(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)(D), 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 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 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. If an applicant for amended registration submits only that portion of the labeling proposed for amendment, the Agency may review the entire label, as revised by the proposed changes, in deciding whether to approve the amendment. The Agency will not approve final printed labeling, but will selectively review it for compliance.
The Agency will complete its review of applications as expeditiously as possible. Applications involving new active ingredients, new uses, petitions for tolerance or exemptions, or consultation with other Federal agencies normally will take longer than applications for substantially similar products and uses.
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 by part 158 of this chapter for the product;
(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, sec. 409 or both; 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)(D)(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, he shall, in accordance with FIFRA sec. 6(a)(2), 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
(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 distributed and sold without the requirement of a new application for registration by that other person, if the parties submit to the Agency the documents listed in paragraphs (b) and (c) of this section, and receive Agency approval as described in paragraph (d) of this section.
(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 reg-is-tra-tion(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 sec. 3(c)(1)(D) 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 submit the information required by paragraph (c)(1) of this section. The Agency may deny registration or initiate cancellation proceedings if the registrant fails to comply within the timeframes established by the Agency in its notification.
(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
(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 sub-chron-ic 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 degradation products, in the diet of exposed birds at levels that equal or exceed one-fifth of the avian subacute dietary LC
(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 Washington, DC address set forth 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. Compounds which function simply to enhance or prolong the activity of an active ingredient by physical action, such as stickers and other adjuvants,
(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 are those listed in § 180.1001 (c) and (d) of this chapter. Upon written request additional dyes will be considered for inclusion in this listing.
15 U.S.C. 136a, d, and w.
(a)
(b)
(a) Except as otherwise defined in this section, terms defined in section 2 of FIFRA shall have the same definitions for purposes of this part.
(b) The term
(c) The term
(d) The term
(e) The term
(f) The term
(g) The term
(h)
(i) The term
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
(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 Program Management and Support Division, in Rm. 236, CM#2, 1921 Jefferson Davis Highway, Arlington, VA, from 8 a.m. to 4 p.m. Monday through Friday, excluding legal holidays.
(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 in the
(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 discretion, the Agency holds such meetings with any person outside of government concerning a use of a pesticide product, the Agency will prepare and file in the docket a memorandum of such meeting, meeting the requirements specified in § 154.15(b)(7).
(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
(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
(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. 136 through 136y.
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
(3) Any written material received by the Agency that is not marked as confidential will be deemed to be non-con-fi-den-tial, 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 which the notice indicated a Registration Standard was under development (within 10 working days after receipt by the Agency, or 15 working days if the submitter has asserted a confidential business information claim concerning the material).
(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
7 U.S.C. 136-136y.
(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) Warning or precautionary statements as prescribed in paragraph (h) of this section;
(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 statements such as “safe,” “nonpoisonous,” “noninjurious,” “harm-less” or “nontoxic to humans and pets” with or without such a qualifying phrase as “when used as directed”; and
(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, i.e., “1 pound 10 ounces” rather than “26 ounces.”
(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
(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)
(1)
(i)
(B)
(C)
(D)
(E)
(ii)
(iii)
(B)
(iv)
(2)
(i)
(B) The following table depicts typical precautionary statements. These statements must be modified or expanded to reflect specific hazards.
(ii)
(A) If a pesticide intended for outdoor use contains an active ingredient with
(B) If a pesticide intended for outdoor use contains an active ingredient with a fish acute LC
(C) If a pesticide intended for outdoor use contains an active ingredient with an avian acute oral LD
(D) If either accident history or field studies demonstrate that 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.
(E) For uses involving foliar application to agricultural crops, forests, or shade trees, or for mosquito abatement treatments, pesticides toxic to pollinating insects must bear appropriate label cautions.
(F) For all outdoor uses 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.”
(iii)
(B) A “total release fogger” is defined as a pesticide product in a pressurized container designed to automatically release the total contents in one operation, for the purpose of creating a permeating fog within a confined space to deliver the pesticide throughout the space.
(C)
This product contains a highly flammable ingredient. It may cause a fire or explosion if not used properly. Follow the “Directions for Use” on this label very carefully.
(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
(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 and disposal of the pesticide and its container, meeting the requirements of 40 CFR part 165. These instructions shall 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 § 162.10(h)(1)(iv))
(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 paragraph (h)(2)(iii)(B) of this section, 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. x 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 (i.e., refrigerators, thermostats, etc.). Call your gas utility or management company if you need assistance with your pilot lights.”
(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.
(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)
(2) No pesticide product bearing labeling amended and revised as required by this subpart shall be distributed or sold by a registrant prior to April 21, 1993.
(3) No product to which this subpart applies shall be distributed or sold without amended labeling by any registrant after April 21, 1994.
(4) No product to which this subpart applies shall be distributed or sold without amended labeling by any person after October 23, 1995.
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)
(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 § 156.10(h)(1). 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
(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:
(a)
(b)
(c)
(d)
(e)
(1) Directly 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 or around any preschool or day care facility.
(f)
(g)
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 or other members of the general public. 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.
(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 child-resistant packaging either for each unit package or for the outer retail container which contains the unit packages. Child-resistant packaging is not required for both the outer package and the unit packages unless the Agency determines, on a case-by-case basis, that it is necessary for risk reduction.
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 reg-istration, 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.
(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 §§ 158.100 and 158.101.
(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 § 158.35
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 158, 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 § 158.160.
(4)
(i) Product chemistry data, as required by subpart C of this part.
(ii) Product performance data, to the extent required by § 158.160.
(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 § 158.33;
(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 § 158.34(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 § 158.33 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 the confidential attachment, the submitter waives a claim of confidentiality for such information under FIFRA sec. 10(d)(1) (A), (B), or (C).
(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 (i.e., identified by number).
(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 § 158.34(c) when any criterion is met or exceeded.
(c)
(1) “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) “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.]”
Several provisions of this part provide EPA flexibility in requiring (or not requiring) data and information for the purposes specified in § 158.20(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 his product to resolve questions relating to the protocols or the data requirements before undertaking extensive testing under § 158.40.
(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 § 158.45.
(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 § 158.75.
(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 § 158.60.
(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 § 158.80.
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)
(a) FIFRA section 3(c)(2)(D) provides that an applicant for registration of an end-use pesticide product need not submit or cite any data that pertain to the safety of another registered pesticide product which is purchased by the applicant and used in the manufacture or formulation of the product for which registration is sought.
(b) This exemption applies only to data concerning safety of a product or its ingredients, not to efficacy data. Data concerning safety includes toxicity, metabolism, environmental fate,
(c) This exemption does not apply to data concerning the safety of the applicant's end-use product itself, unless the composition of the applicant's product and that of the purchased product are identical, i.e., data which this part indicates must be developed by tests using the end-use product for which registration is sought as the test substance. These requirements can be identified by the notation “EP*” in the “test substance” column of the tables in subparts C and D of this part and these are the minimum data requirements that the applicant described in paragraph (a) of this section (i.e., the “formulator”) must satisfy.
(d) The data to which this exemption applies usually will concern the safety of one or more of the end-use product's active ingredients, specifically, those active ingredients which are contained in the purchased product. These data requirements normally can be identified by the notations “TGAI” (technical grade of active ingredient), “PAI” (pure active ingredients), “PAIRA” (pure active ingredient, radiolabeled), or “TEP” (typical end-use product) in the “test substance” column of the tables in subparts C and D of this part.
(e) EPA interprets FIFRA section 3(c)(2)(D) as allowing an applicant to use the formulator's exemption with respect to a data requirement concerning the safety of an ingredient of his product only if:
(1) His application indicates that the ingredient's presence in his product is attributable solely to his purchase from another person of an identified, registered product containing that ingredient and his use of the purchased product in formulating his 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 with any use for which the applicant's product will be labeled; or
(3) The purchased end-use product is a registered end-use product labeled for each use for which the applicant's product will be labeled.
(f) Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve an application unless there is available to EPA for its review whatever data is necessary in order to make the required risk/benefit finding under FIFRA section 3(c)(5) or section 3(c)(7).
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
(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)
Biochemical and microbial pesticides are generally distinguished from conventional chemical pesticides by their unique modes of action, low use volume, target species specificity or natural occurrence. In addition, microbial pesticides are living entities capable of survival, growth reproduction and infection. Biochemical and microbial pesticides are subject to a different set of data requirements, as specified in §§ 158.165 and 158.170, respectively.
(a)
(b)
(2) Novel microbial pesticides (i.e., genetically modified or non-indigenous microbial pesticides) will be subject to additional data or information requirements on a case-by-case basis depending on the particular micro-organism, its parent microorganism, the proposed pesticide use pattern, and the manner and extent to which the organism has been genetically modified. Additional requirements may include information on the genetic engineering techniques used, the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene), information on the control region of the gene in question, a description of the “new” traits or characteristics that are intended to be expressed, tests to evaluate genetic stability and exchange, and/or selected Tier II environmental expression and toxicology tests.
(3) 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.
The Agency has published Pesticide Assessment Guidelines, as indicated in § 158.20(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 (§§ 158.150 through 158.740). These subparts describe the data requirements, including data tables for each subject area. The corresponding subdivisions in the Pesticide Assessment Guidelines are listed in § 158.108.
(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 and the substance to be tested in developing data to meet each requirement. The data EPA must have available to review the registration of a specific product consists of all the data designated as required for that product and all the applicable data designated
(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 § 158.45 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 § 158.45.
(c) For certain of the required or conditionally required data, the “R” or “CR” designations and are enclosed in brackets (i.e., [R], [CR]). The brackets designate those data that are required or conditionally required to support a product when an experimental use permit is being sought. In all other situations (i.e., other than support of an experimental use permit), the brackets have no meaning and the designations R and CR are equivalent to [R] and [CR], respectively.
(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 (i.e., MP or EP).
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 (703-487-4650). The following Subdivisions of the Pesticide Assessment Guidelines, referenced to the appropriate sections of this part, are currently available:
(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, this determination involves a comparison of the composition of an applicant's product with that of currently registered products.
(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 § 158.175.
(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 § 158.175.
(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
(2) The nominal concentration in the product.
(3) Upper and lower certified limits in accordance with § 158.175.
(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 § 158.175.
(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)
(1) For each active ingredient that is derived from an EPA-registered product:
(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
(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 § 158.165.
(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 158.162(b)(2), pertaining to characterization of the process.
(b) Section 158.162(b)(4), pertaining to ingredients used in the process.
(c) Section 158.162(b)(5), pertaining to process equipment.
(d) Section 158.162(b)(6), pertaining to the conditions of the process.
(e) Section 158.162(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 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 TGAI. 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 substance are intended.
(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)
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 §§ 158.120 through 153.170.
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. 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 part:
(1) Ten percent of the maximum contaminant level (MCL) established by EPA, or if no MCL has been established by EPA, 10 percent of the most recent draft or final long-term health advisory level (HAL) established by EPA, or if EPA has not published or proposed an MCL or HAL, the lowest detectable amount of the pesticide.
(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 as specified in either paragraph (a) or (b) of this section, and must meet the other requirements of this section:
(a) Be mailed by certified or registered mail to the following address, or such other address as the Agency may subsequently specify in writing:
(b) Be delivered in person or by courier service or by such other methods as the Agency deems appropriate to the following address, or to such other address as the Agency may subsequently specify in writing: Document Processing Desk—6(a)(2), Office of Pesticide Programs, Room 266A, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, Virginia 22202.
(c) 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).
(d) 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.
(e) 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).
(f) In reporting incidents, provide the data listed in § 159.184, to the extent such information is available.
(g) In submitting scientific studies, follow the procedures set forth in § 158.32 of this chapter.
(h) 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.
(i) 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 of this chapter regarding the identification and segregation of information claimed to be confidential.
(j) If a submission includes a study subject to the flagging requirements of § 158.34 of this chapter, comply with the requirements of that section, and, if the flagging statement is positive, identify it as 6(a)(2) information in the transmittal.
(k) 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 the Office of Pesticide Programs as required by 40 CFR 152.50(f)(3).
(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,
(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 (7 U.S.C. section 136(u)).
(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 exposure monitoring studies that indicate higher levels of risk or exposure than would be expected based on previously available reports, data, or exposure estimates. Such information must be submitted regardless of whether the registrant considers any observed correlation or association to be significant.
(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
(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 any conditions, resulting in degradation of less than 10 percent in a 30-day period.
(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 (i.e., crop, forest, orchard, home garden, ornamental, forage).
(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 minimally traumatic. The symptoms resolved rapidly and usually involve skin, eye or respiratory irritation.
(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
(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 that may pose a risk to human health, including any of the public health antimicrobials identified in part 158 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 159.188 if the registrant has been informed by EPA that such additional information has the potential to raise questions about the continued registration of a product or about the appropriate terms and conditions of registration of a product.
7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w; 21 U.S.C. 346a, 348, 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 (FIFRA), as amended (7 U.S.C. 136a, 136c, 136f, 136q and 136v(c)) and sections 408 and 409 of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a, 348).
(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.
(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 sponsor that refuses to permit inspection in accordance with this part. The determination that a study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to EPA.
(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
(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 interpretation, analysis, documentation, and reporting of results, and represents the single point of study control. The study director shall assure that:
(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
(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, photo-period) 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
(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
(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 the study and reasonably expected to be present in such feed, soil, or water are not present at levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data.
(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
(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
(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 his-to-pa-thol-ogy is required, records of gross findings for a specimen from post-mor-tem observations shall be available to a pathologist when examining that specimen his-to-path-o-log-ically.
(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, and shall be dated and signed or identified at the time of the change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.
(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 amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible. Modification of a final report to comply with the submission requirements of EPA does not constitute a correction, addition, or amendment to a final report.
(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
(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 length of time specified in paragraph (b) of this section.
(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. 136v, 136w.
(a)
(b)
Unless otherwise indicated, terms used in this subpart have the meanings set forth in FIFRA and in subpart A of this part. In addition, as used in this subpart, the following terms have the meanings set forth below:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(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,
(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 § 162.153(h).
(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
(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.
(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
(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
(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 be corrected in a reasonable time, then the Administrator will withdraw, in writing, the notice of intent to suspend.
(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)
(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 under the direct supervision of, an applicator certified under a plan approved by EPA in accordance with sec. 4 of FIFRA.
(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)
21 U.S.C. 346a.
Words in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand.
Unless the context otherwise requires, the following terms shall be construed, respectively, to mean:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
The Director is authorized to take such action as, in his discretion, may be necessary to carry out the provisions of sections 408(i) and 408(l) of the Act and the regulations in this part.
All requests for a certification shall be made in writing to the Director. Action upon such a request will not be undertaken unless (a) the person making the request has, pursuant to the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act, registered or submitted an application for the registration of an economic poison consisting of or containing the pesticide chemical for which the certification is sought and (b) the request is accompanied by a copy of the petition. The person requesting certification may at any time withdraw such request for certification.
In addition to the data required by section 408(d)(1) of the Act to be included in the petition, the request for certification should be supported by the following material, to the extent it is relied upon by the petitioner:
(a) A complete report of the results of any experimental work by the petitioner on the effectiveness of the pesticide chemical for the purposes intended;
(b) Data relating to the usefulness of the pesticide chemical obtained by other qualified investigators;
(c) Any other material which the petitioner believes will justify a finding of usefulness.
If the product for which a certification is sought is intended for both economic poison and noneconomic poison uses, any certification relative to the usefulness of such product will refer only to economic poison uses. No action will be taken with respect to the noneconomic poison uses of such product.
In determining whether a pesticide chemical is useful for the purposes for which a tolerance or exemption is sought, consideration will be given, among other things, to:
(a) The results of any experimental work by the petitioner on the effectiveness of the pesticide chemical for the purposes intended.
(b) Data relating to the usefulness of the pesticide chemical obtained by other qualified investigators.
(c) Reports of other experimental work before the Director in publications, the official files of the Agency, or otherwise.
(d) Opinions of experts qualified in the fields involved.
Usefulness of a pesticide chemical for the purposes intended will be determined upon the basis of its practical pesticidal, or biological, effectiveness. Pesticidal effectiveness may be established in terms of percentage reduction or control of pests or, when appropriate, increase in yield or quality of crop following application of the specified pesticide under the conditions prescribed, compared with the results from adequate controls. Consideration may also be given to other economic gain or practical benefit, including: Economy or ease of production, harvest, or storage of crop; flexibility as regards the time of planting or harvest, even at the possible sacrifice of yield; and general benefit to livestock, plants, or human welfare.
(a) If, upon the basis of the data before him, it appears to the Director that the pesticide chemical is not useful for the purpose or purposes for which a tolerance or exemption is sought, or is useful for only some of the purposes for which a tolerance or exemption is sought, the Director shall notify the person requesting the certification of his proposal to so certify. Notice of such proposed certification will be given by registered mail.
(b) Within one week after receipt of such notice of proposed certification the person requesting the certification may, by filing a request with the Director, (1) request that the certification be made on the basis of the proposed certification; (2) request a hearing on the proposed certification or the parts objected to; (3) request both such certification and such hearing; or (4) withdraw the request for certification as provided for in § 163.10.
In some cases it may be necessary for the Director to notify the petitioner of his proposal to certify that the pesticide chemical does not appear to be useful for some or all of the purposes for which a tolerance or exemption is sought only because the data submitted by the petitioner are not sufficiently clear or complete to justify a finding of usefulness. In such cases the petitioner may withdraw his request for certification pending its clarification or the obtaining of additional data, and no further action will be taken with respect to the making of the certification until the request for certification is resubmitted. Upon the resubmission of the request for certification, the time limitation within which final certification is required to be made will begin to run anew from the date of the resubmission.
(a) Since in most cases where a pesticide chemical may leave a residue in or on a raw agricultural commodity there can be no determination of the adequacy of the directions for use or the warning or caution statements appearing on the labeling of an economic poison until a tolerance or exemption has been established for the pesticide chemical which is, or is a part of, such economic poison, it will not ordinarily be possible to register the economic poison under the Federal Insecticide, Fungicide, and Rodenticide Act until such tolerance or exemption has been established.
(b) Factors other than pesticidal, or biological, effectiveness are considered in the granting of registration under the Federal Insecticide, Fungicide, and Rodenticide Act. Therefore, the criteria for registration are not all applied in considering the certification of usefulness, and the fact that such a certification has been made does not mean that the economic poison can be registered for the uses concerned.
(a) In forming an opinion whether the tolerance or exemption proposed by the petitioner reasonably reflects the amount of residue likely to result when the pesticide chemical is used in the
(1) Data furnished by the petitioner showing (i) the results of tests to ascertain the amount of residue remaining, including a description of the analytical methods used, and (ii) practicable methods for removing residue which exceeds any proposed tolerance;
(2) Reports of other experimental work before the Director in publications, the official files of the Agency, or otherwise;
(3) Opinions of experts qualified in the fields involved.
(b) If a tolerance proposed by the petitioner is reasonably to reflect the amount of residue likely to result when a pesticide chemical is used, it must be large enough to include all residue which is likely to result when the pesticide chemical is used in the manner proposed by the petitioner, but not larger than needed for this purpose. The tolerance proposed by the petitioner may take into account reduction of residue by washing, brushing, or other applicable method.
(c) If there is insufficient information before the Director to support an opinion as to whether the tolerance proposed by the petitioner reasonably reflects the amount of residue likely to result, the opinion will so state.
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 the Administrator, he shall, at the same time, file a statement of issues.
(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
(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)
(c) Ordinarily, the appeal from an accelerated decision will be decided on the basis of the submission of briefs, but the Environmental Appeals Board may allow additional briefs and oral argument.
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
(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 oppor-tunities. 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
(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. 136-136y.
(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 shall have the meanings established by the -Federal Insecticide, Fungicide, and Rodenticide Act. In addition, as used in
(a) The term
(b) The terms
(c) The term
(d) The term
(1) No effective pesticides are available under the Act that have labeled uses registered for control of the -pest under the conditions of the emer-gency; and
(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 a pest 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 en-viron-ment; 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).
(e) The term
(f) The term
(g) The term
(h) The term
(i) The term
(j) The term
(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 sale, ships, delivers for shipment, or receives and (having so received) delivers or offers to deliver any pesticide, to advertise the pesticide for any use authorized by an emergency exemption, except for advertisements that are placed in media that address only persons in the geographical area to which the exemption applies, state the name and address of one or more retail dealers where users may buy the pesticide, and contain a prominent notice of the limitations on use under the emergency exemption. EPA may withdraw an exemption if the use of the pesticide covered by the exemption is advertised unlawfully.
(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) The registration number and the name of the pesticide product if a specific product is requested; or the formulation(s) requested if a specific product is not desired; 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 total acreage or other appropriate unit proposed to be treated;
(v) The total amount of pesticide proposed to be used in terms of both active ingredient and product; and
(vi) All applicable restrictions and requirements concerning the proposed use and the qualifications of applicators using the pesticide.
(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
(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, which addresses all of the following:
(i) Historical net and gross revenues for the site;
(ii) The estimated net and gross revenues for the site without the use of the proposed pesticide; and
(iii) The estimated net and gross revenues for the site with use of the proposed pesticide.
(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 for a specific or public health exemption, if:
(i) An emergency exemption has been requested or granted for that use in any 3 previous years, 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
(7) 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 level of residues in or on all food resulting from the proposed use;
(3) The anticipated benefits to be derived from the proposed use; and
(4) The potential risks to the 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, unless the use is authorized in accordance with the provisions of §§ 164.130 through 164.133 of this chapter;
(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, -has not been submitted, rea-son-able progress towards registration has not been made.
(a)
(b)
(a)
(1)
(2)
(ii)
(b)
(c)
(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 emergency condition exists; and
(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.
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 active ingredient authorized for use, including, if available, the common name and the Chemical Abstracts Service (CAS) number;
(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 or the date on which use of the pesticide began;
(5) An estimate of the level of residues of the pesticide expected to result from use under the crisis exemption; and
(6) 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.
If a use authorized under a crisis exemption will result in residues of the pesticide chemical in or on food, the Agency will notify the authorizing agency, the Food and Drug Administration, U.S. Department of Health and Human Services and the Food Safety and Inspection Service, U.S. Department of Agriculture, as appropriate, of the level of residues expected to result and whether such residues pose an unacceptable risk to public health. This notice shall be provided as soon as the Agency makes its determination. Additionally, the Agency will ensure that
(a)
(1) The name of the State or Federal agency using a crisis exemption;
(2) The name of the active ingredient authorized for use, including, if available, the common name and the Chemical Abstracts Service (CAS) number;
(3) The site to be treated;
(4) The name, telephone number, and address of a person in the Agency who can provide further information; and
(5) Whether a specific, quarantine, or public health exemption has been requested.
(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 domestic, which produces a pesticidal product for use under an Experimental Use Permit, FIFRA section 18 Emergency Exemption or section 24(c) Special Local Needs registration, must be registered.
(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)
(b)
(1)
(i)
(ii)
(iii)
(A) A pesticide is considered registered for the purposes of the section 17(a)(1) requirement only when:
(
(
(
(
(
(
(
(iv)
(v)
(vi)
(vii)
(2)
(3)
(4)
(i)
(A) The warning and caution statements.
(B) Where required, the statement “Not Registered for Use in the United States of America.”
(C) The ingredient statement.
(D) Where required in accordance with paragraph (b)(1)(vii) of this section, the word “Poison” and the statement of practical treatment in case of poisoning.
(ii)
(c)
(1)
(2)
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
(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
(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. (Pesticide use patterns are listed in appendix A to 40 CFR part 158—Data Requirements for Registration: Use Pattern Index. The general pesticide use patterns are: terrestrial food crop and terrestrial nonfood 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 non-food 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 requirement to obtain a purchaser acknowledgement statement as a condition for export. In EPA's Policy Statement on Inert Ingredients in Pesticide Products, EPA included inert ingredients on List 4-a list of inert ingredients posing minimal hazard or risk-if the inert ingredients were generally regarded as innocuous. The provisions of this paragraph do not apply to those pesticide products intended for public health uses which are required or conditionally required to submit efficacy data pursuant to § 158.640 of this chapter. Any differences in formula or composition caused by adding a List 4 inert 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.
(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 § 180.1001, 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 chemicals exempted from the requirement of a tolerance (§ 180.1001) 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
(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
(iv) If known or reasonably ascertainable, the country or countries of final destination of the export shipment, i.e., where the exported pesticide is intended to be used, if different from the country of the foreign purchaser's address.
(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 take place until a signed purchaser acknowledgement statement was received. 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 following address:
(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 following address:
(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 following address:
(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 active ingredients used in producing a pesticide.
(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 cannot be sold in the United States under this Act.
(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
(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 at all reasonable times to have access to and copy all records showing the delivery or holding of such pesticide, device, or active ingredient used in producing a pesticide, including the quantity, the date of shipment and receipt, and the name and address of the consignor and consignee, and any guarantee received pursuant to section 12(b)(1) of the Act.
(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)
(b)
(1) Section 170.112(a) through (c)(3);
(2) Section 170.112(d)(1) through (d)(2)(ii);
(3) The requirement of § 170.112(c)(3) as referenced in § 170.112(d)(2)(iii);
(4) The requirement of § 170.112(c)(3) as referenced in § 170.112(e)(5);
(5) Section 170.120(a)(3); and
(6) Section 170.120(b)(3).
(c)
(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
(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 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.
(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.
(c)
(i) Section 170.130.
(ii) Section 170.150.
(iii) Section 170.160.
(2) Conditions of exemption. (i) Applies only when the persons are performing crop advising tasks in the treated area.
(ii) 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.
(iii) Before entering a treated area, the crop advisor must inform, through an established practice of communication, each person under his direct supervision of the active ingredient, 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 for early entry is provided to the worker. Such personal protective equipment
(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 pro-tection 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) Gloves shall be of the type specified by the product labeling. Gloves or glove linings made of leather, cotton, or other absorbent materials must not be worn for early-entry activities unless these materials are listed on the product labeling as acceptable for such use. If chemical-resistant gloves with sufficient durability and suppleness are not obtainable for tasks with roses or other plants with sharp thorns, leather gloves may be worn over chemical-resistant liners. However, once leather gloves have been worn for this use, thereafter they shall be worn only with chemical-resistant liners and they shall not be worn for any other use.
(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 with-out implementing, when appropriate, mea-sures 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 with the treated surfaces. The information should include the costs associated with early-entry, such as decontamination facilities, special information and training for the workers, heat stress avoidance procedures, and provision, inspection, cleaning, and maintenance of personal protective equipment. EPA will not grant exceptions where the costs of early entry equal or exceed the expected loss in value of crop yield or quality.
(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 for hand labor to harvest greenhouse-grown cut roses published in the
(ii) Exception to perform irrigation tasks under specified conditions published in the
(iii) Exceptions to perform limited contact tasks under specified conditions published in the
(iv) Exception for hand labor to harvest greenhouse-grown roses 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 1/4 mile of the treated area; 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 (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 black-and-white example of a warning sign meeting these requirements, other than the size requirements, follows:
(2) The standard sign shall be at least 14 inches by 16 inches with letters at least 1 inch in height. Farms and forests shall use the standard size sign unless a smaller sign is necessary because the treated area is too small to accommodate a sign of this size. In nurseries and greenhouses, the agricultural employer may, at any time, use a sign smaller than the standard size sign. Whenever a small sign is used on any establishment, there are specific posting distances depending on the size of the lettering and symbol on the sign. If a sign is used with DANGER and PELIGRO in letters at least
(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
(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 1/4 mile of) and that may be treated with a pesticide or that may be under a restricted-entry interval while the handler will be on the agricultural establishment:
(a) Specific location and description of any such areas; and
(b) Restrictions on entering those areas.
(a)
(2)
(3)
(ii)
(iii)
(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 (c)(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 1/4 mile from the nearest place of vehicular access:
(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) Conditions of exemption. (i) The certification or licensing program requires pesticide safety training that includes, at least, all the information in § 170.230(c)(4).
(ii) No entry into the treated area occurs until after application ends.
(iii) Applies only when performing crop advising tasks in the treated area.
(iv) The crop advisor must make specific determinations regarding 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.
(c)
(i) Section 170.230.
(ii) Section 170.232.
(iii) Section 170.240.
(iv) Section 170.250.
(v) Section 170.260.
(2) Conditions of exemption. (i) No entry into the treated area occurs until after application ends.
(ii) Applies only when the persons are performing crop advising tasks in the treated area.
(iii) 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.
(iv) Before entering a treated area, the 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
(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) Gloves shall be of the type specified by the product labeling. Gloves or glove linings made of leather, cotton, or other absorbent material shall not be worn for handling activities unless such materials are listed on the product labeling as acceptable for such use.
(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) away from pesticide storage and pesticide use areas where they may:
(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 pro-tective 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. 136b and 136w.
This section deals with the certification of applicators of restricted use pesticides.
(a)
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(b)
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(b)
(ii)
(2)
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(c)
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(d)
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(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.
(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
(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
(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,
(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
(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:
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(3)
(4)
7 U.S.C. 136c, 136w. Section 172.4 is also issued under 31 U.S.C. 9701.
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 phrase
(g) The term
(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. Subdivision I of the Pesticide Assessment Guidelines provides guidance on the procedures, data requirements, and general aspects pertaining to the issuance and use of EUPs. 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 Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, Telephone: (703-305-5447). 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 et seq.) as:
(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 phy-to-tox-i-city and other forms of tox-i-city or effects on non-tar-get 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 a regulation promulgated under section 409 of that Act; or
(ii) Submit a petition proposing establishment of a tolerance or an exemption from the requirement of a tolerance under section 408, or a regulation under section 409, of the Federal Food, Drug, and Cosmetic Act; or
(iii) Certify that the food or feed derived from the experimental program
(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 regarding entry of persons into treated areas; and
(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
(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, D.C. 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.
(a) Terms used in this subpart shall, with the exception of those terms defined below, have the meaning set forth in FIFRA and in § 172.1.
(1)
(2)
(b) [Reserved]
(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 State, as required by State law, to a permittee who already holds a valid Federal experimental use permit issued under subpart A for the same purpose, or who is not required to obtain a permit under this rule.
(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
(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 observe any activities conducted, as necessary to enforce compliance with State law, the terms of the permit, and this subpart;
(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 4 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, or a regulation established under section 409 of the 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, or a regulation established under section 409 of the 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 or food additive regulation upon which the permit is based
(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 initiating civil or criminal sanctions for violations of the permit conditions or other violations, as authorized by law.
(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) The continental United States, including Alaska, and the immediately adjoining countries (i.e., Canada and Mexico).
(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 (i.e., either by issuing or denying a permit or determining that a permit is unnecessary; or a permit is not pending with the USDA).
(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
(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.
(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 the notice by agreement. Any settlement agreement shall be in writing and signed by the parties and shall:
(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
(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 Agency action forty-five (45) days after its service upon the parties and without further proceedings unless (1) an appeal to the Administrator is taken from it by a party to the proceeding, or (2) the Administrator elects, sua sponte, to review the recommended decision.
(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.
21 U.S.C. 348, 371(a) 331(j); Reorg. Plan No. 3 of 1970.
(a) This part establishes procedures for the establishment, modification, or revocation by the Administrator of food additive regulations under section 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 348, for food additives which may result in pesticide residues in or on processed food or otherwise affect the characteristics of such food.
(b) Part 178 of this chapter contains procedures for filing objections and requests for hearings under FFDCA section 409(f) on food additive regulations or petition denials issued under this part. Part 179 of this chapter contains rules governing formal evidentiary hearings under FFDCA section 409(f).
(c) Part 180 of this chapter contains regulations establishing tolerances, or exemptions from the necessity for a tolerance, for pesticide residues on raw agricultural commodities under FFDCA section 408. If the use of a pesticide chemical in the production, storage, or transportation of a raw agricultural commodity (RAC) in conformity with such a tolerance or exemption results in the presence of a pesticide residue in or on processed food made from the RAC, FFDCA section 402(a)(2)(C) provides that such pesticide residue shall not be deemed unsafe for the purposes of FFDCA section 409 (despite the absence of a food additive regulation regarding such residue on the processed food) if the residue in or on the RAC has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the RAC. However, a food additive regulation would be required if the level of the pesticide residue in the processed food when ready to eat exceeded the level permitted in the “parent” RAC by the tolerance established under FFDCA section 408. In addition, if a pesticide residue in or on a processed food results from the application of a pesticide during or after processing, the food would be unsafe within the meaning of FFDCA section 409 unless a food additive regulation permitted that residue in or on the processed food.
For the purposes of this part:
(1) A pesticide chemical in or on a raw agricultural commodity.
(2) A pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity.
(3) A color additive.
(4) Any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to the FFDCA, the Poultry Products Inspection Act, or the Federal Meat Inspection Act.
(5) A new animal drug.
(6) A substance that is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.
(1) The particular food or classes of food in or on which a food additive may be used.
(2) The maximum quantity of the food additive which may be used in or on such food.
(3 The manner in which the food additive may be added to or used in or on such food.
(4) Directions or other labeling or packaging requirements for the food additive.
(1) The amount of a pesticide residue that legally may be present in or on a raw agricultural commodity under the terms of a tolerance under FFDCA section 408 or a processed food under the terms of a food additive regulation under FFDCA section 409. Tolerances are usually expressed in terms of parts of the pesticide residue per million parts of the food (ppm), by weight.
(2) [Reserved]
(a)
(b)
(c)
(d)
(e)
(f)
(2)
(3)
(a) After a preliminary review of the petition, the Administrator may notify the petitioner that the Agency has found the petition to be incomplete or deficient, i.e., that it does not comply with the requirements of § 177.102 or § 177.105, and that it will not be accepted for detailed review.
(b) A petitioner who receives a notice under paragraph (a) of this section may supplement the petition, in which case the Agency shall conduct a further preliminary review of the petition as supplemented and take action under paragraph (a) of this section or under § 177.86.
Unless the Administrator notifies the petitioner under § 177.84 that the petition is incomplete or deficient, the Administrator shall accept the petition for detailed review.
Within 30 days of acceptance of a petition for detailed review, the Administrator shall publish in the
After a notice of a petition has been published, the petitioner may submit additional information or data in support of the petition, or may amend the petition. Any such submission or amendment shall be accompanied by an informative summary of its contents that may be published in the
(a) The petitioner seeks to amend the petition by:
(1) Increasing a requested tolerance, by identifying any additional food additive or additional pesticide residues to which the requested food additive regulation would apply.
(2) Identifying any additional processed food to which the requested food additive regulation would apply.
(3) Changing the method for detecting or measuring pesticide residues to be used for enforcement purposes.
(b) The Administrator finds that publication of such a notice otherwise would be in the public interest.
A petitioner may withdraw a petition. The Agency may retain a copy of a withdrawn petition and any supporting data and information.
A petitioner may demand action on a petition if the Administrator has not acted on the petition within the timeframes in FFDCA section 409(c)(2).
A petition to establish a food additive regulation, or to modify a food additive regulation by increasing a tolerance for a pesticide residue in or on a processed food or by removing any other condition of use of a food additive, shall include the following data and information:
(a)(1) The name and composition of the food additive that is a subject of the petition, and the chemical composition of each component of the food additive.
(2) The name, chemical identity, and composition of each pesticide residue that is a subject of the petition.
(3) The identity of the processed food(s) in question.
(b) A statement of any conditions of use proposed for the food additive, including all directions, recommendations, and suggestions proposed regarding the use of the food additive, i.e., the amount, frequency, method, and time of application or other use, and a copy of its proposed labeling.
(c) Full reports of investigations made with respect to the toxicity of the food additive and of its safety for the proposed use, including full information as to the methods and controls used in conducting such investigations.
(d) The results of tests to determine the identity and amount of pesticide residues in or on the processed food resulting from the proposed use of the food additive, including a description of the analytical methods used, and a description of practicable methods for measuring such pesticide residues.
(e) Full reports of investigations made with respect to the toxicity of such pesticide residues, including full information as to the methods and controls used in conducting such investigations.
(f) All relevant data bearing on the physical or other technical effects such food additive is intended to produce, and the quantity of such food additive required to produce such effect.
(g) The terms of each food additive regulation proposed.
(h) Any other information relevant to the approval of the petition known to the petitioner that is unfavorable to the petition.
(i) A statement of why, in the petitioner's opinion, it would be reasonable for the Administrator to approve the petition, taking into account the terms of the FFDCA and FIFRA, this part, the petition, the data and information submitted or cited in support of the petition, and other information available to the Agency.
(j) An informative summary of the petition and of the data, information, and arguments submitted or cited in support of the petition, and a statement that the petitioner agrees that such summary or any information it contains may be published as a part of the notice to be furnished to the public under § 177.88 or as part of a proposal under § 177.130. The summary need not refer to any method or process that is entitled to protection as a trade secret under FFDCA section 301(j).
A petition to revoke a food additive regulation, or to modify such a regulation by decreasing a tolerance for a pesticide residue in or on a processed food or by adding a condition on the use of a food additive, shall include:
(a) The data and information required by § 177.102(a), (b), (g), (h), and (i).
(b) Such data and information of the types described in § 177.102(c), (d), (e), and (f) as the petitioner chooses to submit.
(c) Information showing what changes, if any, petitioner believes would have to be made in associated registrations of pesticides under
(a) The Administrator may require or occasion a petitioner to submit data or information other than that described by this part only if the Administrator finds such data or information to be necessary for the evaluation of the petition.
(b) The Administrator may waive a requirement imposed by this part for the submission of data or information if the Administrator finds such data or information to be unnecessary for the evaluation of the petition.
The Agency may require the petitioner to submit a sample of the food additive or pesticide residue that is a subject of the petition. The Agency shall specify in such request the quantity which it requires.
(a) After a petition has been accepted for detailed review, the Administrator shall review the petition, the accompanying data and information, and other pertinent data or information available to the Administrator.
(b) Upon completion of such review, the Administrator shall determine, in accordance with the Act, whether to issue an order that establishes, modifies, or revokes a food additive regulation (whether or not in accord with the action proposed by the petitioner), whether to issue an order denying the petition, or whether to publish a proposed food additive regulation and request public comment thereon under § 177.130.
(c) The Administrator shall publish in the
(a) The Administrator may publish in the
(b) The Administrator shall provide a period of not less than 30 days for persons to comment on the proposed regulation.
(c) After reviewing any timely comments made, the Administrator may by order establish, modify, or revoke a food additive regulation, or may by order decide that no final action on the proposal is warranted. Each such order and each such regulation shall be published in the
Any final regulation issued under § 177.125 or § 177.130 shall be effective on the date of publication in the
The FFDCA does not provide for judicial review of an order or regulation issued under this part or of a denial of a petition under this part. However, if an objection to such action is submitted to the Administrator in the manner prescribed by part 178 of this chapter, judicial review may be obtained of the Administrator's action on the objection. (See FFDCA sections 409(f) and (g).)
21 U.S.C. 346a, 348, 371(a); Reorg. Plan No. 3 of 1970.
For the purposes of this part:
(a) On or before the 30th 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 30th 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 (A-110), U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
(2) For personal delivery, the Office of the Hearing Clerk is located at: room M3708, Waterside Mall, 401 M St., SW., Washington, DC.
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 in question should be modified or revoked, the Administrator will by order publish appropriate rulemaking documents in the
(b) The Administrator will provide an opportunity for objections and requests for hearing on such rule 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, which must not be earlier than the 90th day after the order is
An order issued under § 178.37 is final agency action reviewable in the courts as provided by FFDCA sections 408(i) or 409(g)(1), as of the date of entry of the order, which shall be determined in accordance with §§ 23.10 and 23.11 of this chapter. The failure to file a petition for judicial review within the period ending on the 60th day after the date of the entry of the order constitutes a waiver under FFDCA section 408(i) or 409(g)(1) of the right to judicial review of the order and of any regulation promulgated by the order.
(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 § 177.125 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 § 177.130 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 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.
(5) 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.
(6) 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.
(7) All other documents or information submitted to the docket for the rulemaking in question.
(8) 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 record is specified in the order issued under § 178.37.
21 U.S.C. 346a, 348, 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 by this part or part 178 of this chapter shall be resolved by the Administrator or presiding officer, as appropriate.
(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 § 177.81 or § 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 177, 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) OPPTS, 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 OPPTS with respect to the hearing and in any pleading or oral argument before the Administrator. An employee or other representatives of OPPTS 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 OPPTS 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 OPPTS, 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 OPPTS. 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 OPPTS.
(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
(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) OPPTS 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 subpart. Any person whose participation is striken may obtain interlocutory review thereof by the Administrator.
(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, i.e., the testimony of the witnesses will not be taken anew except as the new presiding officer may order upon the request of a party where the credibility of a witness is of particular importance.
(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
(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 or taking testimony in a closed hearing.
(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 parts 177 or 180 of this chapter, that are relevant to the issues in the hearing.
(2) All documents in the files of OPPTS containing factual information or expert opinion, whether favorable or unfavorable to the position of OPPTS, which relate to the issues involved in the hearing. For purposes of this paragraph, “files” means the principal files in OPPTS 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 OPPTS 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 OPPTS 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 OPPTS 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 presiding officer may authorize submission of a reduced number of copies.
(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
(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 or 409 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 food additive regulation.
(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 order) before such exhibit is used in the cross-examination.
(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
(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
(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, which date must not be earlier than the 90th day after it is published unless the order contains findings as to the existence of emergency conditions that necessitate an earlier effective date.
(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 Administrator under paragraph (d) of this section.
(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 OPPTS, by the Pesticides and Toxic Substances Division of the Office of General Counsel, or by any other person who is a representative of OPPTS 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 or case to the Administrator when appropriate.
(a) The Administrator's final decision is final agency action reviewable in the courts as provided by FFDCA section 408(i) or 409(g)(1), as of the date of entry of the order, which shall be determined in accordance with §§ 23.10 and 23.11 of this chapter. The failure of a person to file a petition for judicial review within the period ending on the 60th day after the date of the entry of the order constitutes a waiver under FFDCA sections 408(i) or 409(g)(1) of the right to judicial review of the order and of any regulation promulgated by the order.
(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 § 177.125 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 § 177.130 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 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.
(5) 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.
(6) 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.
(7) All other documents or information submitted to the docket for the rulemaking in question under parts 177 or part 180 of this chapter.
(8) The Notice of Hearing published under § 179.20.
(9) All notices of participation filed under § 179.42.
(10) Any
(11) All submissions filed under § 179.80.
(12) 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.
An alphabetical listing of pesticide chemicals appears at the end of this table of contents.
21 U.S.C. 321(q), 346(a) and 374.
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) [Reserved]
(d)
(e) 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.
(f) Where raw agricultural commodities bearing residues that have been exempted from the requirement of a tolerance, or which are within a tolerance permitted under section 408 are used, the processed foods will not be considered unsafe within the meaning of section 406 if:
(1) The poisonous or deleterious pesticide residues have been removed to the extent possible in good manufacturing practice; and
(2) The concentration of the pesticide in the preserved or processed food when ready to eat is not greater than the tolerance permitted on the raw agricultural commodity.
(g) 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.
(h) 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 agricultural commodities listed in column B. However, a tolerance or exemption for a specific commodity in column B does not apply to the general category in column A.
(i) Unless otherwise specified, tolerances and exemptions established under the regulations in this part apply to residues from only preharvest application of the chemical.
(j) Unless otherwise specified in this paragraph or in tolerance regulations prescribed in this part for specific pesticide chemicals, the raw agricultural commodity to be examined for pesticide residues, shall consist of the whole raw agricultural commodity.
(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
(k) The term
(l) The term
(m) The term
(n) The term
(o) The term
(1) A pesticide chemical; or
(2) Any other added substance that is present on or in the commodity or food primarily as a result of the metabolism
For
(a) As a general rule, pesticide chemicals other than benzaldehyde (when used as a bee repellant in the harvesting of honey), ferrous sulfate, lime, lime-sulfur, potassium sorbate, sodium carbonate, sodium chloride, sodium hypochlorite, sulfur, and when used as plant desiccants, sodium metasilicate (not to exceed 4 percent by weight in aqueous solution) and when used as postharvest fungicide, citric acid, fumaric acid, oil of lemon, and oil of orange are not for the purposes of section 408(a) of the Act generally recognized as safe.
(b) Upon written request, the Registration Division will advise interested persons whether a pesticide chemical should be considered as poisonous or deleterious, or one not generally recognized by qualified experts, as safe.
(c) The training and experience necessary to qualify experts to evaluate the safety of pesticide chemicals for the purposes of section 408(a) of the Act are essentially the same as training and experience necessary to qualify experts to serve on advisory committees prescribed by section 408(g) of the Act. (See § 180.11.)
(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 per-mitted by the larger of the two tol-er-ances, 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 (chlorinated camphene containing 67-69 percent chlorine) on the same raw agricultural commodities, the total amount of such pesticides shall not yield more residue than that permitted by the larger of the two tolerances, calculated as a chlorinated terpene of molecular weight 396.6 containing 67 percent chlorine.
(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 α-naphthaleneacetamide and/or α-naphthaleneacetic acid in or on the same raw agricultural com-mod-i-ty, the total amount of such pesticides shall not yield more residue than -that permitted by the higher of the two tol-er-ances, calculated as -α-naphth-alen-e-acetic acid.
(8) Where tolerances are established for residues of
(9) 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.
(10) 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 me-tab-o-lites.
(11) Where a tolerance is established for triclopyr, chloropyrifos, and chlorpyrifos-methyl having the common metabolite 3,5,6-trichloro-2-py-rid-i-nol 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 me-tab-o-lites.
(12) 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.
(13) Where tolerances are established for residues of both 1-(4-chlor-o-phe-noxy)-3,3-di-methyl-1-(1
(14) 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:
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 impregnated with an insect repellent 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
(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 will be incurred, but there is a reasonable expectation of finite residues; or
(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 section 408(d) shall be submitted in duplicate to the Registration Division. 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 petitioner's mail address to which notice of objection under section 408(d)(5) may be sent.
(b) Petitions shall include the following data and be submitted in the following form:
The undersigned,
Attached hereto, in duplicate and constituting a part of this petition, are the following:
A. The name, chemical identity, and composition of the pesticide chemical. (If the pesticide chemical is an ingredient of an economic poison, the complete quantitative formula of the resulting economic poison should be submitted. The submission of this information does not restrict the application of any tolerance or exemption granted to the specific formula(s) submitted.)
B. The amount, frequency, and time of application of the pesticide chemical.
C. Full reports of investigations made with respect to the safety of the pesticide chemical. (These reports should include, where necessary, detailed data derived from appropriate animal or other biological experiments in which the methods used and the results obtained are clearly set forth.)
D. The results of tests on the amount of residue remaining, including a description of the analytical method used. (See § 180.34 for further information about residue tests.)
E. Practicable methods for removing residue that exceeds any proposed tolerance.
F. Proposed tolerances for the pesticida chemical if tolerances are proposed.
G. Reasonable grounds in support of the petition.
Enclosed is (money order, bank draft, or certified check) for $
Very truly yours,
This petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an authorized official.
The data specified under the several lettered headings 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.
The petition shall be submitted in duplicate. The petitioner shall show that he has registered or has submitted an application for the registration of an economic poison containing the pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act.
(c) Except as noted in paragraph (d) of this section, a petition shall not be accepted for filing if any of the data prescribed by 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.
(d) The Registration Division shall notify the petitioner within 15 days after its receipt of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. Copy of the notice shall be sent to the Registration Division, Environmental Protection Agency. If accepted, the date of notification becomes the date of filing for the purposes of section 408(d)(1). If petitioner desires, he may supplement a deficient petition after notification as to deficiencies. If the supplementary material or explanation of petition is deemed acceptable, petitioner shall be notified, and date of such notification becomes the date of filing. If the petitioner does not wish to supplement or
(e) The Registration Division may request a sample of the pesticide chemical at any time while a petition is under consideration. The Registration Division 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. The date used for computing the 90-day limit for the purposes of section 408(d)(2) shall be moved forward 1 day for each day in excess of 15 from the mailing date of the request taken by the petitioner to submit the sample. If the sample is not submitted within 180 days after mailing date of the request, the petition will be considered withdrawn without prejudice.
(f) The date of receipt from the Administration of certification as to usefulness shall be the date used for computing the 90-day limit for the purposes of section 408(d)(2).
(g) If the petition is not referred to an advisory committee, or upon receipt of the report of an advisory committee under § 180.12(c) if such a referral occurred, 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), or whether to publish a proposed tolerance regulation and request public comment thereon under § 180.29. The Administrator shall publish in the
In some cases the Registration Division or an advisory committee to which the petition has been referred 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. Upon refiling, the time limitation will begin to run anew from the date of refiling or the date of receipt of certification from the Administrator, whichever is later. A deposit for fees as specified in § 180.33 shall accompany the resubmission of the petition.
After a petition has been filed or referred to an advisory committee, the petitioner may submit additional information or data in support thereof, but in such cases the petition will be given a new filing date or a new initial date of consideration by the advisory committee, and the time limitation will begin to run anew.
(a) If within the prescribed period a person filing a petition requests that the petition be referred to an advisory committee, he shall make such request in writing to the Administrator and forward with such request an advance deposit for fees prescribed by § 180.33.
(b) If further advance deposits are not made upon request of the Administrator, as provided for in § 180.33, the request for referral of the petition to an advisory committee shall be considered withdrawn, and a tolerance shall be established within 90 days of the date on which the Administrator requested the further advance deposit.
(c) In case the Administrator on his own initiative deems it necessary to refer a petition to an advisory committee, he shall, in writing, so inform the person filing the petition.
(a) Whenever the referral of a petition or proposal to an advisory committee is requested or the Administrator otherwise deems such referral necessary, the Administrator will request the National Academy of Sciences, National Research Council, to select qualified experts, including at least one representative from land-grant colleges, willing to serve on the advisory committee. All such experts shall have had sufficient training and experience in biology, medicine, physiology, toxicology, pharmacology, veterinary medicine, or other appropriate science to evaluate the safety of pesticide chemicals. The Administrator will requet the National Academy of Sciences, when it furnishes the names of such experts, to supply a biographical sketch showing the background of their experience and their connection, if any, with academic and commercial institutions.
(b) Each advisory committee shall consist of not less than three experts, at least one of whom is a representative from a land-grant college. The Administrator may specify a larger number to serve. He shall appoint one member of the committee as chairman, and the chairman shall be the spokesman of the committee for receiving and forwarding reports and other functions of the committee.
(c) The Administrator shall appoint the experts so selected and fix their compensation at not to exceed the maximum permitted by other authority per day for each day or part thereof spent in committee meetings and in traveling to and from committee meetings held outside the city of their residence, plus necessary traveling and subsistence expenses while the experts are serving away from their places of residence. Subsistence expenses shall not exceed the maximum per diem permitted by other authority.
(a) The Administrator shall submit to the chairman of the committee the petition for tolerances, together with certification by the Administrator and such other relevant, reliable information as may be available. When the Administrator submits a proposal to an advisory committee, he shall inform the petitioner and furnish him with copies of material other than the petition and certification that is furnished the committee. The chairman of the committee shall acknowledge receipt of the information and readiness of the committee to act. The date of receipt of such information shall be considered the beginning of the period allowed for consideration by the committee. Copy of this acknowledgement shall be forwarded to the petitioner by the chairman of the committee.
(b) A secretariat to advisory committees will be established by the Administrator. The secretariat shall furnish members of the committee with copies of the proposal or petition, certification from the Administrator, and any data received by the chairman. If the chairman of the committee believes that a meeting of the committee is necessary before making a recommendation, he shall so advise the Administrator. Such meetings shall be held in Washington, DC, or such other
(c) As soon as practicable, but not later than 60 days after receipt of proposal or petition (unless the time has been extended as provided in paragraph (d) of this section), the chairman shall certify to the Administrator the report of the committee, including any minority report, and shall return the petition for tolerances and the certification. The report will include copies of all relevant material considered by the committee, except that in the case of scientific literature readily available in scientific libraries proper reference may be made to it instead of furnishing actual copies. The report of the advisory committee shall be available for inspection by any interested person after a tolerance or exemption resulting from the petition is published.
(d) If at any time within 60 days, the chairman believes that the advisory committee needs more time, he shall so inform the Administrator in writing, in which case he shall make the certification contemplated by section 408(d)(3) of the act within the additional 30 days.
(e) The date of receipt of the committee report will be the date for computing time for the Administrator to act for the purposes of both sections 408 (d)(3) and (e).
(f) The chairman of the committee, after consultation with the committee members, will inform the National Academy of Sciences of the committee's opinion as to the member who may best represent the committee at a hearing, if one occurs.
(g) More than one petition or proposal may be handled by a committee concurrently.
(h) Persons authorized under section 408(h) to discuss proposals or petitions with the committee shall notify the chairman and if practicable make appointments through him. The report of the committee shall show the names of persons other than committee members discussing proposals or petitions with the committee. Except for discussions with authorized persons the committee shall not disclose data originating with a petitioner prior to publication of a regulation.
(a) Upon the Administrator's own initiative, or at the written request of any interested person furnishing reasonable grounds therefor and such fees or deposits as are prescribed by § 180.33, the Administrator may propose, under sec. 408(e) of the Federal Food, Drug, and Cosmetic Act, 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. As used in the preceding sentence, “reasonable grounds” shall include a statement describing the nature of the requestor's interest in issuance of such a tolerance or exemption, and adequate data on subjects outlined in sec. 408(d)(1) (A) through (F) of the Federal Food, Drug, and Cosmetic Act. Any petition received by the Agency which requests establishment of a tolerance or exemption for pesticide residues in or on a raw agricultural commodity that result from any pesticide use not directly associated with producing, storing, or transporting that commodity, will be treated by the Agency as a request for issuance of the tolerance or exemption under sec. 408(e) of that Act. (As the Agency interprets that Act, the certification of usefulness which is a prerequisite of issuing a regulation under sec. 408(d) can only be made with respect to pesticides used to help produce, store, or transport the commodity for which the tolerance or exemption is sought.) Requests shall be submitted in duplicate to: Registration Division (TS-767), Environmental Protection Agency, Washington, DC 20460. If any part of the request or supporting data is in a language other than English, it must be accompanied by a
(b) The notice of the proposal shall show whether it is made on the initiative of the Administrator or at the request of an interested person, naming such person.
(c) If within 30 days after publication of the proposal a person who has registered, or who has submitted an application for registration of an economic poison under the Federal Insecticide, Fungicide, and Rodenticide Act containing the pesticide chemical named in the proposal, requests in writing that the proposal be referred to an advisory committee and makes advance deposit as provided by § 180.33, the Administrator shall appoint a committee as provided in § 180.11 and refer the proposal and relevant data to such committee. The Agency and the committee shall proceed as prescribed in section 408 and this part.
(d) If further advance deposits are not made upon request of the Administrator, as provided in § 180.33, the request for referral of the petition to an advisory committee shall be considered withdrawn, and a tolerance shall be established within 90 days from the date on which the Administrator requested the further advance deposit.
(e) The Administrator shall provide a period of not less than 30 days for persons to comment on the proposed regulation.
(f) 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
(g) Any final regulation issued under this section shall be effective on the date of publication in the
(h) In ruling on a request under paragraph (a) of this section, the Administrator may publish a
(i) When a request is denied under this section, the administrative record consists of:
(1) The request, including all data and information submitted in support of the request.
(2) Any
(3) Any comments submitted by members of the public in response to the
(4) If the request resulted in any other procedures, the order of the Administrator providing the procedures and the administrative record of the procedure provided.
(5) All other documents or information submitted to the record.
(6) The Administrator's order and decision on the request, including all information identified by the Administrator as part of the record.
(a) It is the Agency's view that the Act does not allow a person to obtain direct judicial review of a regulation issued under this part that establishes, amends, or revokes a tolerance regulation or a regulation exempting a pesticide chemical from the need for a tolerance. However, if an objection to such action is submitted to the Administrator in the manner prescribed by part 178 of this chapter, judicial review may be obtained of the Administrator's action on the objections (see sections 408(d)(5) and 408(i) of the Act).
(b) A decision under §§ 180.29 and 180.32 that a request does not warrant the issuance of a proposed regulation is final agency action. Although the Act makes no special provision for review of such final agency action, the action may be reviewable under other provisions of the United States Code (see e.g., 5 U.S.C. 701-706, 28 U.S.C. 1331).
(a) A temporary tolerance (or exemption from a tolerance) established under authority of section 408(j) of the act shall be deemed to be a tolerance (or exemption from the requirement of a tolerance) for the purposes of section 408(a) (1) or (2) of the act.
(b)(1) A request for a temporary tolerance or a temporary exemption from a tolerance by a person who has obtained an experimental permit for a pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act shall be accompanied by a copy of such experimental permit, such data as are available on subjects outlined in clauses (A), (B), (C), (D), (E), (F), and (G) of section 408(d)(1), and an advance deposit to cover fees as provided in § 180.33(d).
(2) Before an experimental permit has been obtained, the Pesticides Tolerance Division upon request of the Environmental Protection Agency or a person who proposes to apply for an experimental permit will consider available data and discuss its adequacy for the purpose of justifying a tolerance or exemption from a tolerance.
(c) A notice of the issuance of a temporary tolerance outlining any restrictions as to use of the chemical imposed under the experimental permit under the Federal Insecticide, Fungicide, and Rodenticide Act may be published in the
(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 when the Administrator concludes that the public health can be adequately protected during such marketing. A temporary tolerance or exemption from a tolerance may be revoked if the experimental permit is revoked, or may be revoked at any time if it develops that the application for a temporary tolerance contains a misstatement of a material fact or that new scientific data or experience with the pesticide chemical indicates that it may be hazardous to the public health.
(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 own initiative or on request from an interested person furnishing reasonable grounds therefor, may propose the issuance of a regulation amending or repealing a tolerance for a pesticide chemical on raw agricultural commodities or granting or repealing an exemption from tolerance for such chemical. Requests for such amendment or repeal shall be made in writing and accompanied by an advance deposit to cover fees as provided in § 180.33.
(b) 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
(c) The notice announcing the proposal to amend or repeal a regulation shall show whether the proposal was made on the initiative of the Administrator or at the request of an interested person, naming such person. From this point the proceedings shall be the same as prescribed by section 408(e), beginning with the second sentence of that paragraph, and the regulations applicable to section 408(d), (e), (f), and (g).
(d) In ruling on a request under paragraph (a) of this section, the Administrator may publish a
(e) When a request is denied under this section, the administrative record consist of:
(1) The request, including all data and information submitted in support of the request.
(2) Any
(3) Any comments submitted by members of the public in response to the
(4) If the request resulted in any other procedures, the order of the Administrator providing the procedures and the administrative record of the procedure provided.
(5) All other documents or information submitted to the record.
(6) The Administrator's order and decision on the request, including all information identified by the Administrator as part of the record.
(a) Each petition or request for the establishment of a new tolerance or a tolerance higher than already established, shall be accompanied by a fee of $68,025, plus $1,700 for each raw agricultural commodity in excess of nine for which the establishment of a tolerance is requested, except as provided in paragraphs (b), (d), and (h) of this section.
(b) Each petition or request 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 $15,550 plus $1,025 for each raw agricultural commodity for which a tolerance is requested.
(c) Each petition or request for an exemption from the requirement of a tolerance or repeal of an exemption shall be accompanied by a fee of $12,550.
(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 $27,175 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 $3,850.
(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 $13,525 plus $1,025 for each raw agricultural commodity on which the temporary tolerance is sought.
(f) Each petition or request for repeal of a tolerance shall be accompanied by a fee of $8,500. Such fee is not required when, in connection with the change sought under this paragraph, a petition or request is filed for the establishment
(g) If a petition or a request is not accepted for processing because it is technically incomplete, the fee, less $1,700 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 $1,700 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 or request 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.e., paragraphs (a) through (f) of this section, without a charge for each commodity where that would otherwise apply.
(i) Objections under section 408(d)(5) of the Act shall be accompanied by a filing fee of $3,400.
(j)(1) In the event of a referral of a petition or proposal under this section to an advisory committee, the costs shall be borne by the person who requests the referral of the data to the advisory committee.
(2) Costs of the advisory committee shall include compensation for experts as provided in § 180.11(c) and the expenses of the secretariat, including the costs of duplicating petitions and other related material referred to the committee.
(3) An advance deposit shall be made in the amount of $33,950 to cover the costs of the advisory committee. Further advance deposits of $33,950 each shall be made upon request of the Administrator when necessary to prevent arrears in the payment of such costs. Any deposits in excess of actual expenses will be refunded to the depositor.
(k) The person who files a petition for judicial review of an order under section 408(d)(5) or (e) 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.
(l) No fee under this section will be imposed on the Inter-Regional Research Project Number 4 (IR-4 Program).
(m) 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 in writing to the Environmental Protection Agency, Office of Pesticide Programs, Registration Division (7505C), Washington, DC 20460. A fee of $1,700 shall accompany every request for a waiver or refund, except that the fee under this sentence shall not be imposed on any person who has no financial interest in any action requested by such person under paragraphs (a) through (k) of this section. The fee for requesting a waiver or refund shall be refunded if the request is granted.
(n) 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 Environmental Protection Agency, Office of Pesticide Programs, Registration Division, (7504C) Washington, DC 20460. A petition will not be accepted for processing until the required fees have been submitted. A petition for which a waiver of fees has been requested will not be accepted for processing until the fee has been waived or,
(o) 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
(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 as related for the purpose of paragraph (d) of this section. This grouping of crops does not affect the certification of usefulness by the Administrator as contemplated by section 408(l) of the act.
(1) Apples, crabapples, pears, quinces.
(2) Avocados, papayas.
(3) Blackberries, boysenberries, dew-ber-ries, loganberries, raspberries.
(4) Blueberries, currants, gooseber-ries, 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(h) 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 that residues may concentrate in processed food and/or feed. Processing data will be required prior to establishment of a group tolerance, and food additive tolerances will not be granted on a group basis.
(g) If maximum residues (tolerances) for the representative crops vary by
(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) 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, cranberry, fig, globe artichoke, grape, hops, kiwifruit, mango, mushroom, okra, papaya, pawpaw, peanut, persimmon, pineapple, strawberry, 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 the group. If the group includes subgroups, each subgroup lists the subgroup name, the representative commodity or commodities, and the member commodities for the subgroup. Subgroups, which are a subset of their associated crop group, are established for some but not all crops groups.
(1)
(i)
(ii)
(iii)
(2)
(i)
(ii)
(3)
(i)
(ii)
(4)
(i)
(ii)
(iii)
(5)
(i)
(ii)
(iii)
(6)
(i)
(ii)
(iii)
(7)
(i)
(ii)
(iii)
(8)
(i)
(ii)
(9)
(i)
(ii)
(iii)
(10)
(i)
(ii)
(11)
(i)
(ii)
(12)
(i)
(ii)
(13)
(i)
(ii)
(iii)
(14)
(i)
(ii)
(15)
(i)
(ii)
(16)
(i)
(ii)
(17)
(i)
(ii)
(18)
(i)
(ii)
(19)
(i)
(ii)
(iii)
(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.
The following tolerances are established for residues of the herbicide sesone (sodium 2,4-di-chlor-o-phe-noxy-ethyl sul-fate) in or on the raw agricultural commodities indicated:
6 parts per million in or on potatoes, peanuts, peanut hay.
2 parts per million in or on asparagus, strawberries.
(a) Tolerances are established for residues of the fungicide captan (
(b) The following tolerances for residues of captan are established on an interim basis pending evaluation of captan under the Rebuttable Presumption Against Registration (RPAR) review on the transmission of residues to meat, milk, and eggs from feeding cattle or poultry with raw agricultural commodities or their byproducts when such commodities have been treated with captan:
(a)
(b)
(c)
(d)
(a)
(2) A food additive tolerance of 0.02 ppm is established for the combined residues of acephate (
(i) In or on all food items (other than those already covered by a higher tolerance as a result of use on growing crops) in food handling establishments.
(ii) The acephate may be present as a residue from applications of acephate 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 in accordance with the following prescribed conditions:
(A) 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 and served. Spray concentration shall be limited to a maximum of 1.0 percent active ingredient. For crack and crevice treatments, equipment capable of delivering a pin-stream of insecticide shall be used. For spot treatments, a coarse, low-pressure spray shall be used to avoid atomization or splashing of the spray. Contamination of food or food-contact surfaces shall be avoided.
(B) 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)
Tolerances are established for residues of the insecticide ethyl 4,4′-dichlorobenzilate (chlorobenzilate) in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)
(2) Malathion may be safely used in accordance with the following conditions:
(i) It is incorporated into paper trays in amounts not exceeding 100milligrams per square foot.
(ii) Treated paper trays are intended for use only in the drying of grapes (raisins).
(iii) Total residues of malathion resulting from drying of grapes on treated trays and from application to grapes before harvest shall not exceed 12 parts per million on processed ready-to-eat raisins.
(3) Residues of malathion in refined safflower oil from application to the growing safflower plant shall not exceed 0.6 parts per million.
(b)
(c)
(d)
Tolerances are established for residues of the insecticide allethrin (allyl homolog of cinerin I) as follows:
4 parts per million from postharvest use in or on the following raw agricultural commodities: Apples, blackberries, blueberries (huckleberries), boysenberries, cherries, crabapples, currants, dewberries, figs, gooseberries, grapes, guavas, loganberries, mangoes, muskmelons, oranges, peaches, pears, pineapples, plums (fresh prunes), raspberries, tomatoes.
2 parts per million from postharvest use in or on the following grains: Barley, corn, grain sorghum, milo, oats, rye, wheat.
(a)
(b)
(c)
(d)
Tolerances for residues of the fungicide ziram (zinc dimethyldithiocarba-mate), calculated as zinc ethyl-ene-bis-dith-i-o-car-ba-mate, in or on raw agricultural commodities are established as follows:
7
0.1 part per million in or on almonds, pecans.
Tolerances are established for negligible residues (N) of the herbicide S-ethyl dipropylthiocarbamate in or on the following raw agricultural commodities:
Tolerances are established for residues of the insecticide methoxychlor (2,2-bis (
100 parts per million in or on alfalfa, clover, cowpeas, grass for forage, peanut forage, soybean forage.
14
7 parts per million in or on sweet potatoes and yams from preharvest and postharvest application.
3 parts per million in or on the fat of meat from cattle, goats, hogs, horses, or sheep.
2 parts per million in or on the following grains from storage-bin treatment: Barley, corn, oats, rice, rye, sorghum grain, wheat.
1.25 parts per million in milk fat reflecting negligible residues in milk.
1 part per million in or on potatoes.
1 part per million in or on horseradish.
(a)
(2) Tolerances are established for residues of the insecticide
(b)
(c)
(d)
(a) Tolerances are established for residues of inorganic bromides (calculated as Br) in or on the following raw agricultural commodities which have been fumigated with the antimicrobial agent and insecticide methyl bromide after harvest (with the exception of strawberries):
(b) A tolerance with regional registration, as defined in § 180.1(n), is established for residues of inorganic bromides (calculated as Br) in or on the following raw agricultural commodity grown in soil fumigated with methyl bromide.
(a) Investigations by the Food and Drug Administration show that peanut
(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.
Tolerances are established for residues of the fungicide glyodin (2-heptadecyl-2-imidazoline acetate or 2-heptadecyl-2-imidazoline (base)) in or on the following raw agricultural commodities:
Tolerances are established for residues of the insecticide calcium cyanide, calculated as hydrogen cyanide, in or on raw agricultural commodities as follows:
25 parts per million, from postharvest application, in or on the grains: Barley, buckwheat, corn, oats, rice, rye, sorghum, and wheat.
5 parts per million in or on cucumbers, lettuce, radishes, and tomatoes.
Tolerances for residues of the insecticide piperonyl butoxide [(butyl carbityl) (6-propyl piperonyl)ether] are established in or on the following raw agricultural commodities:
Tolerances for residues of the insecticide pyrethrins (insecticidally active principles of
Tolerances are established for -combined residues of the fungicide
Tolerances for residues of the insecticide hydrogen cyanide from post-har-vest fum-i-ga-tion are established as follows:
250 parts per million in or on the following spices: Allspice, anise, basil, bay, black pepper, caraway, cassia, celery seed, chili, cinnamon, cloves, coriander, cumin, dill, ginger, mace, marjoram, nutmeg, oregano, paprika, poppy, red pepper, rosemary, sage, savory, thyme, tumeric, white pepper.
75 parts per million in or on barley, buckwheat, corn (including popcorn), milo (grain sorghum), oats, rice, rye, wheat.
50 parts per million in or on citrus fruits.
25 parts per million in or on almonds, beans (dried), cashews, cocoa beans, peanuts, peas (dried), pecans, sesame, walnuts.
Tolerances for residues of the fungicide thiram (tetramethyl thiuram disulfide) in or on raw agricultural commodities are established as follows:
7 parts per million in or on apples, celery, peaches, strawberries, tomatoes.
7 parts per million in or on bananas, (from preharvest and postharvest application) of which not more than 1 part per million shall be in the pulp after peel is removed and discarded.
0.5 part per million in or on onions (dry bulb).
Tolerances are established for residues of the insecticide lindane (gamma isomer of benzene hexachloride) in or on raw agricultural commodities as follows:
7 parts per million in or on the fat of meat from cattle, goats, horses, and sheep.
4 parts per million in or on the fat of meat from hogs.
3 parts per million in or on cucumbers, lettuce, melons, mushrooms, pumpkins, squash, summer squash, and tomatoes.
1 part per million in or on apples, apricots, asparagus, avocados, broccoli, brussels sprouts, cabbage, cauliflower, celery, cherries, collards, eggplants, grapes, guavas, kale, kohlrabi, mangoes, mustard greens, nectarines, okra, onions (dry bulb only), peaches, pears, peppers, pineapples, plums (fresh prunes), quinces, spinach, strawberries, and Swiss chard.
0.01 part per million (negligible residue) in or on pecans.
The tolerance for residues of the fungicide basic copper carbonate in or on pears from post-harvest use of the chemical is 3 parts per million of combined copper.
Tolerances are established for residues of the fungicide biphenyl (also known as diphenyl) from postharvest use on the following raw agricultural commodities:
(a)
(i) The tolerance on apricots also includes residues of 2,4-D (2,4-dichlorophenoxyacetic acid) from the preharvest application of 2,4-D dimethylamine salt to apricots.
(ii) The tolerance on citrus fruits also includes residues 2,4-D from the preharvest application of 2,4-D isopropyl ester and 2,4-D butoxyethyl ester and from the postharvest application of 2,4-D alkanolamine salts and 2,4-D isopropyl ester to citrus fruits.
(2) Tolerances are established for residues of 2,4-D at:
(i)
(A) The inorganic salts: Ammonium, lithium, potassium, and sodium.
(B) The amine salts: Alkanolamines of the ethanol and isopropanol series, alkyl (C-12), alkylk (C-13), alkyl (C-14), alkylamines derived from tall oil, amylamine, diethanolamine, di-ethyl-a-mine, di-iso-pro-pan-o-la-mine, di-methyl-a-mine, N,N-di-methyl-lin-oleyla-mine, N,N-di-methyl-oley-a-mine, eth-an-o-la-mine, ethyl-a-mine, hep-tyl-a-mine, is-o-pro-pa-nola-mine, iso-pro-pyla-mine, lin-oleyl-a-mine, methyl-a-mine, mor-pho-line, oc-tyl-a-mine, oleyl-a-mine, N-oleyl-1,3-pro-pyl-enedi-a-mine, pro-pyl-a-mine, tri-eth-anol-a-mine, tri-ethyl-a-mine, tri-iso-pro-pan-ol-a-mine, and tri-methy-a-mine.
(ii)
(3) Tolerances are established for negligible residues of 2,4-D from application of its dimethylamine salt to irrigation ditch banks in the Western United States in programs of the Bureau of Reclamation, U.S. Department of Interior; cooperating water user organizations; the Bureau of Sport Fisheries, U.S. Department of Interior; Agricultural Research Service, U.S. Department of Agriculture; and the Corps of Engineers, U.S. Department of Defense. Where tolerances are established at higher levels from other uses of 2,4-D on the following crops, the higher tolerance applies also to residues from the irrigation ditch bank use cited in this paragraph.
(4) A tolerance is established for residues of 2,4-D sodium salt and al-ka-nola-mine salts (of the eth-a-nol and iso-pro-panol series), calculated as 2,4-D (2,4-di-chlor-o-phen-oxy-ace-tic acid) as follows:
(5) A tolerance is established for residues of 2,4-D from application of its alkanolamine salts (of the ethanol and isopropanol series) as follows:
(6) Tolerances are established for residues of 2,4-D from application of its dimethylamine salt for water hyacinth control in ponds, lakes, reservoirs,
(7) [Reserved]
(8) Tolerances are established for residues of 2,4-dichlorophenoxyacetic acid (2,4-d) and/or its metabolite, 2,4-dichlorophenol (2,4-DCP) in food products of animal origin as follows.
(9) A tolerance is established for residues of 2,4-D from applications of its dimethylamine salt or its bu-toxy-eth-a-nol es-ter for Eu-ra-sian Water-mil-foil control in programs conducted by the Tennessee Valley Authority in dams and reservoirs of the TVA system as follows:
(10) A tolerance with regional registration as defined in § 180.1(n) is established for the residues of 2,4-D (2,4-dichlorophenoxyacetic acid). The tolerance includes residues from the application of 2,4-D and its N-oleyl-1,3-propylenediamine salt on the following raw agricultural commodity:
(11) A tolerance that expires on December 31, 2001 is established for residues of the herbicide 2,4-D (2,4-dichlorophenoxyacetic acid) resulting from the preplant use of 2,4-D ester or amine in or on the food commodity as follows:
(12) The following tolerances are established for residues of 2,4-D (2,4-dichloro-phenoxyacetic acid) in the following processed feeds. Such residues may be present therein only as a result of application to the growing crop of the herbicides identified in this section:
(i) 5 parts per million in sugarcane bagasse and sugarcane molasses.
(ii) 2 parts per million in the milled fractions derived from barley, oats, rye, and wheat to be ingested as animal feed or converted into animal feed.
(13) Tolerances are established for residues of the herbicide 2,4-D (2,4-dichlorophenoxyacetic acid) as follows:
(i) 5 ppm in sugarcane molasses, resulting from application of the herbicide to sugarcane fields.
(ii) 2 ppm in the milled fractions (except flour) derived from barley, oats, rye, and wheat to be ingested as food or to be converted to food. Such residues may be present therein only as a result of application to the growing crop of the herbicides identified in 40 CFR 180.142.
(iii) 0.1 ppm (negligible residue) in potable water. Such residues may be present therein only:
(A) As a result of the application of the dimethylamine salt of 2,4-D to irrigation ditch banks in the Western
(B) As a result of the application of the dimethylamine salt of 2,4-D for water hyacinth control in ponds, lakes, reservoirs, marshes, bayous, drainage ditches, canals, rivers and streams that are quiescent or slow moving in programs of the Corps of Engineers or other Federal, State, or local public agencies.
(C) As a result of application of its dimethylamine salt or is butoxy-ethanol ester for Eurasian watermilfoil control in programs conducted by the Tennessee Valley Authority in dams and reservoirs of the TVA system.
(b)
(c)
(d)
Tolerances are established for negligible residues of the insecticide di-pro-pyl iso-cinch-o-mer-onate, resulting from dermal application, in raw agricultural commodities as follows:
0.1 part per million in meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep.
0.004 part per million in milk.
Tolerances are established for combined residues of the pesticide cy-hex-a-tin (tri-cyc-lo-hex-yl-hy-droxy-stan-nane; CAS Reg. No. 13121-70-5) and its organ-otin me-tab-o-lites (calculated as cy-hex-a-tin) in or on the following raw agricultural commodities:
(a)
(2) Time-limited tolerances are established for residues of the insecticidal fluorine compounds cryolite and synthetic cryolite (sodium aluminum fluoride) in or on the commodities as follows:
(b)
(c)
(d)
(a) For the purposes of this section, the insecticide mineral oil is defined as the refined petroleum fraction having the following characteristics:
(1) Minimum flashpoint of 300 °F.
(2) Gravity of 27 to 34 by the American Petroleum Institute standard method.
(3) Pour point of 30 °F. maximum.
(4) Color 2 maximum by standards of the American Society for Testing Materials.
(5) Boiling point between 480 °F. and 960 °F.
(6) Viscosity at 100 °F. of 100 to 200 seconds Saybolt.
(7) Unsulfonated residue of 90 percent minimum.
(8) No sulfur compounds according to the United States Pharmacopeia test under Liquid Petrolatum.
(b) Tolerances of 200 parts per million for residues of mineral oil as specified in paragraph (a) of this section are established in or on the following grains from postharvest application: Shelled corn, grain sorghum.
(a) Tolerances are established for residues of the herbicide dalapon (2,2-dichloropropionic acid) resulting from application of dalapon sodium salt or sodium-magnesium salt mixtures in or on the following raw agricultural commodities.
(b) Tolerances are established for residues of dalapon (2,2-dichloropropionic acid) resulting from application of dalapon sodium-magnesium salt mixtures to irrigation ditch banks in the western United States in or on the following raw agricultural commodities. Where tolerances are established at higher levels from other uses of dalapon on the subject crops, the higher tolerance applies also to residues from the irrigation ditch bank use.
A tolerance of 50 parts per million is established for residues of the antimicrobial agent and insecticide ethylene oxide, when used as a postharvest fumigant in or on the following raw agricultural commodities: Black walnut meats, copra, whole spices.
A tolerance of 25 parts per million is established for residues of the fungicide sodium dimethyldithio-carbamate, calculated as zinc ethylene-bisdithiocarbamate, in or on melons.
(a)
(2) A regulation is established permitting the use of the insecticide diazinon (
(i) Application shall be limited solely to spot and/or crack and crevice treatment 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 where food and food products are held, processed, and served.
(A) Spray and dust concentrations shall be limited to a maximum of 1 percent and 2 percent, respectively, of active ingredient by weight. The spray concentration limit of 1 percent shall include, but not be limited to, encapsulated formulations of the additive utilizing the encapsulating polymer formed from the reaction of sebacoyl chloride, polymethylene polyphenyl-isocyanate, ethylenediamine and/or diethylenetriamine.
(B) Application to areas, surfaces, or utensils contacted by food, contamination of food and food contact surfaces, and the introduction of spray or dust into the air is to be avoided.
(C) For spot treatment, a coarse, low pressure spray shall be used. Application is limited to floor surfaces only and to 20 percent of the surface area. Any individual spot treatment shall not exceed 2 square feet.
(D) For crack and crevice treatment, equipment capable of delivering dust or a pin stream of spray directly into the cracks and crevices shall be used.
(ii) 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 regulation is established permitting the use of the insecticide diazinon (
(i) Application shall be limited solely to spot and/or crack and crevice treatment in animal feed handling establishments, including feed manufacturing and processing establishments such as stores, supermarkets, dairies, meat slaughtering and packing plants, and canneries, where feed and feed products are held, processed, and sold.
(A) Spray and dust concentrations shall be limited to a maximum of 1 percent and 2 percent, respectively, of active ingredient by weight. The spray concentration limit of 1 percent shall include, but not be limited to, encapsulated formulations of the additive utilizing the encapsulating polymer formed from the reaction of sebacoyl chloride, polymethylene polyphenylisocyanate, ethylene-diamine and/or diethylenetriamine.
(B) Application to areas, surfaces, or utensils contacted by feed, contamination of feed or feed contact surfaces, and the introduction of spray and dust into the air is to be avoided.
(C) For spot treatment, a coarse, low-pressure spray shall be used. Application is limited to floor surfaces only and to 20 percent of the surface area. Any individual spot treatment shall not exceed 2 square feet.
(D) For crack and crevice treatment, equipment capable of delivering dust or a pin stream directly into cracks and crevices shall be used.
(ii) To assure safe use of the insecticide, its label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and shall be used in accordance with that label and labeling.
(b)
(c)
(d)
(a) Tolerances for residues of the insecticide
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of the insecticide
A tolerance of 0.04 part per million (negligible residue) is established for residues of
(a) Tolerances are established for residues of the plant growth regulator 1-naphthaleneacetic acid in or on the following raw agricultural commodities:
(b) Tolerances are established for residues of the ethyl ester of 1-naphthaleneacetic acid in or on the following raw agricultural commodities:
Tolerances are established for residues of the insecticide methyl 3-[(dimethoxyphosphinyl)oxy]butenoate, alpha and beta isomers, in or on the following raw agricultural commodities:
A tolerance of 7 parts per million is established for residues of the fungicide manganous dimethyldithio-carbamate, calculated as zinc ethyl-ene-bis-di-thi-o-car-ba-mate, in or on apples.
(a)
(b)
(c)
(d)
Tolerances of 1 part per million are established for residues of the insecticide nicotine (3-1-methyl-2-pyrrolidyl) pyridine) in the raw agricultural commodities eggs and the meat, fat, and meat byproducts of poultry.
(a) Tolerances are established for residues of the insecticide carbaryl (1-naphthyl
(b) Tolerances are established for residues of the insecticide carbaryl (1-naphthyl
(c) A tolerance is established for residues of the insecticide carbaryl (1-naphthyl
(d) Tolerances are established for residues of the insecticide carbaryl (1-naphthyl
(e) Tolerances with regional registration are established for the insecticide carbaryl (1-napthyl
For
(a) Tolerances are established for residues of the fungicide dodine (
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of dodine in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) A food additive known as maleic hydrazide (1,2-dihydro-3,6-py-rid-a-zinedione) 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)
65 parts per million in or on peanut vine hay, sugarbeet tops.
25 parts per million in or on the straws of barley, oats, rye, wheat.
10 parts per million in or on crabapples, fennel, pears, quinces.
10 parts per million in or on the whole fruit of papayas, with no residue present in the edible pulp after the peel is removed and discarded.
7 parts per million in or on apples, cranberries, and grapes.
5 parts per million in or on celery; corn fodder and forage; and the grains of barley, oats, rye, and wheat.
4 parts per million in or on bananas, preharvest use only, of which not more than 0.5 part per million shall be in the pulp after peel is removed and discarded.
4 parts per million in or on cucumbers, melons, summer squash, and tomatoes.
2 parts per million in or on carrots, sugar beets.
0.5 part per million in or on popcorn grain, fresh corn including sweet corn (kernels plus cob with husk removed), cottonseed, kidney, liver, onions (dry bulb), and peanuts.
0.1 part per million (negligible residue) in or on asparagus.
0.1 part per million in or on corn grain (except popcorn grain).
(b)
(c)
(d)
(a)
(b)
(c)
(d)
A tolerance that expires on July 1, 1995, of 4 parts per million of combined As
(a)
(b)
(c)
(d)
Tolerances are established for the total residues of the insecticide en-do-sul-fan (6,7,8,9,10,10-hex-a-chloro-1,5,5a,6,9,9
(a)
(2) Tolerances for residues of
(i) 5 parts per million in dehydrated sugar beet pulp when present therein as a result of the application of the pesticide to the growing agricultural crop, provided that, if residues of demeton are also present, the total of both residues shall not exceed 5 parts per million.
(ii) 5 parts per million in pineapple bran when present therein as a result of the application of the insecticide in the production of pineapples.
(b)
(c)
(d)
(a) Tolerances are established for residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-meth-yl-urea) in or on the following raw agricultural commodities:
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of the herbicide linuron [3-(3,4-dichlorophenyl)-1-meth-oxy-1-meth-yl-urea] in or on the following raw agricultural commodity:
(a) Tolerances for combined residues of the herbicide dimethyl tet-ra-chlor-o-ter-eph-thal-ate and its me-tab-o-lites mon-o-meth-yl tet-ra-chlor-o-ter-e-phthal-ate and tet-ra-chlor-o-ter-e-phthal-ic acid (calculated as di-meth-yl tet-ra-chlor-o-ter-e-phthal-ate) are established in or on the following raw agricultural commodities:
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for the combined residues of dimethyl tetrachloroterephthalate and its metabolites, calculated as dimethyl tetrachloroterephthalate, in or on the following raw agricultural commodities:
Tolerances are established for residues of the insecticide coumaphos (
1 part per million in or on meat, fat, and meat byproducts of cattle, goats, hogs, horses, poultry, and sheep.
0.5 part per million in milk-fat reflecting negligible residues in milk.
0.1 part per million in eggs.
(a)
(b)
(c)
(d)
Tolerances are established for the fungicide folpet
Tolerances are established for residues of the insecticide dimethyl (2,2,2-trichloro-1-hydroxyethyl) phosphonate in or on the following raw agricultural commodities:
(a) Tolerances are established for residues of inorganic bromides (calculated as Br) in or on the following raw agricultural commodities grown in soil fumigated with combinations of chlor-o-pic-rin, meth-yl bro-mide, and pro-par-gyl bro-mide. No tolerances are established for chlor-o-pic-rin since it has been established that no residue of this substance remains in the raw agricultural commodity.
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of inorganic bromides (calculated as Br) in or on the following raw agricultural commodities grown in soil fumigated with combinations of chloropicrin, methyl bromide, and propargyl bromide:
(c) A tolerance with regional registration, as defined in § 180.1(n), is established for residues of inorganic bromides (calculated as Br) in or on the following raw agricultural commodity grown in soil fumigated with combinations of methyl bromide and chlor-o-pic-rin. No tolerance is established for chlor-o-pic-rin since it has been established that no residue of this substance remains in the raw agricultural commodity when formulations containing chlor-o-pic-rin at 2 percent or less are used.
(a)
(2) Unless otherwise specified, these tolerances prescribed in this section provide for residues from preharvest application only.
(b)
(c)
(d)
A tolerance of 8 parts per million is established for residues of sulfamate ion, expressed as sulfamic acid, from the postharvest application of the fungicide chlorosulfamic acid in or on asparagus, carrots, cauliflower, celery, potatoes, and radishes.
Tolerances are established for combined residues of the plant regulator
2 parts per million in or on mung bean sprouts to inhibit embryonic root development.
0.05 part per million in or on tomatoes.
(a) Tolerances are established for total residues of the insecticide di-meth-o-ate (
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for total residues of dimethoate including its oxygen analog in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established for negligible residues of the herbicide
(a)
(2) Tolerances are established for combined residues of the herbicide terbacil (3-
(b)
(c)
(d)
A tolerance of 0.1 part per million is established for residues of the herbicide bromacil (5-bromo-3-
(a)
(b)
(c)
(d)
Tolerances are established for residues of the herbicide
(a)
(2) Tolerances are established for the combined residues of the herbicide simazine (2-chloro-4,6-bis(ethylamino)-
(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)
Tolerances for combined negligible residues of the herbicide chloroxuron (3-[
(a) 0.15 part per million in or on soybeans and soybean forage.
(b) 0.1 part per million in or on carrots, celery, onions (dry bulb), and strawberries.
(a)
(b)
(c)
(d)
(a)
(2) A tolerance is established for combined residues of the herbicide atrazine (2-chloro-4-ethylamino-6-iso-pro-pyl-a-mino-
(b)
(c)
(d)
Tolerances are established for residues of the insecticide
(a)
(b)
(c)
(d)
(a) Tolerances are established for residues of the fumigant phosphine in or on the following raw agricultural commodities from postharvest treatment with aluminum phosphide:
(b) Tolerances are established for residues of the fumigant phosphine in or on all raw agricultural commodities at 0.01 ppm resulting from preharvest treatment of pest burrows in agricultural and noncropland areas with aluminum phosphide.
(a) Tolerances are established for residues of the plant growth regulator diquat [6,7-dihydrodipyrido (1,2-a:2′(a) Tolerancprime;,1′-c) pyrazinediium] derived from application of the dibromide salt and calculated as the cation in or on the following raw agricultural commodities:
(b) Tolerances are established for residues of the herbicide diquat (6,7-di-hy-dro-di-pyr-i-do (1,2-a:2′,1′-c) pyr-a-zi-ned-iium) (calculated as the cation) derived from the application of the di-bro-mide salt to ponds, lakes, reservoirs, marshes, drainage ditches, canals, streams, and rivers which are slow-moving or quies-cent in programs of the Corps 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 control of the user, in or on the following raw agricultural commodities:
(c)(1) Tolerances are established for the plant growth regulator diquat [6,7-
(2) There are no U.S. registrations as of December 6, 1995.
(a)
(2) Tolerances are established for the combined residues of the herbicide dicamba (3,6-dichloro-
(3) Tolerances are established for the combined residues of dicamba (3,6-dichloro
(b)
(c)
(d)
Tolerances are established for negligible residues of the herbicide
(a)
(b)
(c)
(d)
Tolerances are established for residues of the herbicide diphenamid (
(a)
(b)
(c)
(d)
Tolerances are established for the herbicide butylate in or on the raw agricultural commodities corn, field, grain; corn, pop, grain; corn, sweet (kernels, plus cob with husk removed); corn, field, fodder; corn, field, forage; corn, pop, forage; and corn, sweet, forage at 0.1 part per million.
(a)
(2) The tolerance of 0.1 part per million prescribed by 21 CFR 556.180 for negligible residues of 2,2-dichlorovinyl
(b)
(c)
(d)
Tolerances are established for residues of the fungicide triphenyltin hydroxide in or on raw agricultural commodities as follows:
Tolerances are established for negligible residues of the herbicide
Tolerances (expressed as phos-pha-mi-don) for residues of the in-sec-ti-cide phos-pha-mi-don (2-chloro-2-di-eth-yl-car-ba-moyl-1-meth-yl-vin-yl di-meth-yl phos-phate) including all of its related cho-lin-es-ter-ase-inhibiting compounds in or on raw agricultural commodities are established as follows:
1 part per million in or on apples.
Tolerances are established for the herbicide
Tolerances are established for negligible residues of the herbicide
(a)
(2) Tolerances are established for combined residues of thiabendazole and its metabolite 5-hydrox-ythiabendazole in the following raw agricultural commodities:
(b)
(c)
(d)
For
Tolerances are established for negligible residues (N) of the herbicide propazine (2-chloro-4,6-bis-(iso-pro-pyl-a-mino)-
A tolerance of 30 parts per million is established for residues of the fungicide basic zinc sulfate, calculated as elemental zinc, in or on the raw agricultural commodity peaches.
Tolerances of 0.25 part per million are established for residues of the fungicide streptomycin in or on the raw agricultural commodities celery, peppers, and tomatoes from treatment of the seedling plants before transplanting; potatoes from treatment of seed pieces; and pome fruits.
Tolerances are established for the combined residues of the herbicide alachlor (2-chloro-2′,6′-diethyl-
A tolerance of 0.2 part per million is established for residues of the herbicide metobromuron (
Tolerances are established for residues of the insecticide 2-chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl phosphate in or on raw agricultural commodities as follows:
110 parts per million in or on alfalfa and corn fodder and forage (including field corn, sweet corn, and popcorn).
10 parts per million in or on apples, cherries, corn grain, fresh corn including sweet corn (kernels plus cob with husk removed), cranberries, and pears.
5 parts per million in or on tomatoes.
1.5 parts per million in the fat of cattle and hogs.
0.75 part per million in the fat of poultry.
0.5 part per million in milk fat (reflecting negligible residues in whole milk) and in the fat of goats, horses, and sheep.
0.1 part per million in or on peaches.
0.1 part per million in eggs.
(a) Tolerances are established for residues of the insecticide methomyl (
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of methomyl in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
Tolerances are established for residues of the fungicide chloroneb (1,4-dichloro-2,5-dimethoxybenzene) and its metabolite 2,5-dichloro-4-meth-oxy-phe-nol (calculated as chlor-o-neb) in or on raw agricultural commodities as follows:
(a)
(b)
(c)
(d)
(a) Tolerances are established for residues of the pesticide propargite (2-(
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of propargite in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established for residues of the insecticide phosalone (
Tolerances are established for negligible residues (N) of the herbicide terbutryn (2-
Tolerances are established for residues of the herbicide chloramben (3-amino-2,5-dichlorobenzoic acid; CAS Reg. No. 133-90-4) in or on the following raw agricultural commodities:
Tolerances are established for residues of the fungicide captafol (
A time-limited tolerance, with an expiration date of January 1, 1998, is established for negligible residues of the herbicide barban (4-chloro-2-butynyl
Tolerances are established for combined residues of the insecticide and nematocide aldicarb (2-methyl-2-(meth-yl-thio)pro-pi-onal-de-hyde
Tolerances are established for residues of the defoliant
4 parts per million in or on cottonseed.
0.02 part per million (negligible residue) in meat, fat, and meat byproducts of cattle, goats, and sheep.
0.002 part per million (negligible residue) in milk.
(a)
(2) Tolerances are established for the combined residues of the herbicide propanil (3′,4′-dichloropropionanilide; CAS Reg. No. 709-98-8) and its metabolites (calculated as the parent compound) in or on the following processed feeds when present therein as a result of application of the herbicide to the growing crops:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) A tolerance of 8 parts per million is established for residues of the insecticide formetanate hydrochloride (
(b)
(c)
(d)
Tolerances are established for residues of the herbicide phenmedipham [methyl
Tolerances are established for negligible residues of the herbicide 2-chloro-
A tolerance of 0.1 part per million is established for negligible residues of the herbicide 2,3,6-trichloro-phen-yl-a-cet-ic acid in or on su-gar-cane, such residues resulting from application of its di-meth-yl-a-mine or sodium salts.
(a)
(b)
(c)
(d)
Tolerances are established for residues of the insecticide amitraz (
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a) A tolerance of 0.1 part per million is established for negligible residues of the fungicide pentachloronitrobenzene in or on the raw agricultural commodity cottonseed.
(b) Tolerances with regional registration (refer to § 180.1 (n)) are established for the combined residues of the fungicides pentachloronitrobenzene (PCNB) and its metabolites pen-ta-chlor-o-a-ni-line (PCA) and meth-yl pen-ta-chlor-o-phen-yl sul-fide (MPCPS) in or on the following raw agricultural commodities:
(a)
(2) Tolerances are established for residues of picloram [4-amino-3,5,6-trichloropicolinic acid] resulting from the application of the pesticide to growing crops in the following:
(3) Tolerances are established for residues of picloram [4-amino-3,5,6-trichloro-picolinic acid] resulting from the application of the pesticide to growing crops in the following:
(b)
(c)
(d)
(a)
(2) An interim tolerance of 0.2 parts per millino is established for residues of the herbicide endothall (7 - oxabicyclo[2.2.1] heptane-2,3-dicar-box-ylic acid) in potable water from use of its potassium, sodium, di-
(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 methidathion, its oxygen analog (S-[(5-meth-oxy-2-oxo-1,3,4-thi-a-dia-zol-3(2
(b)
(c)
(d)
Tolerances are established for residues of the insecticide dimethyl phosphate of 3-hydroxy-
(a) Tolerances are established for residues of the plant regulator ethephon [(2-chloroethyl) phosphonic acid] in or on raw agricultural commodities as follows:
(b) A tolerance with regional registration, as defined in § 180.1(n), of 0.1 part per million is established for residues of the plant regulator ethephon [(2-chloroethyl)phosphonic acid] in or on the raw agricultural commodity sugarcane.
(a)
(b)
(c)
(d)
Tolerances are established for the sum of the residues of the insecticide oxamyl (methyl N′-N′-dimethyl-N-[(meth-yl-car-ba-moyl)-oxy]-1-thio-oxa-mim-i-date) and its ox-ime met-a-bol-ite N′,N′-di-meth-yl-N-hy-droxy-1-thio-oxa-mim-i-date calculated as ox-a-myl in or on the following raw agricultural commodities:
For
(a) Tolerances are established for the combined residues of the herbicide oryzalin (3,5-dinitro-
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of oryzalin (3,5-dinitro-
Tolerances are established for negligible residues of an insecticide that is a mixture consisting of 3,4,5-tri-meth-yl-phen-yl meth-yl-car-ba-mate and 2,3,5-tri-meth-yl-phen-yl meth-yl-car-ba-mate is-o-mers, which are present in ratios varying between 4:1 and 3:1, respectively, in or on the raw agricultural commodities corn grain (including field corn and popcorn) and corn fodder and for-age at 0.1 part per million (such tolerance to cover the sum of the residues of both components).
Tolerances are established for residues of the herbicide 2-[[4-chloro-6-(ethylamino)-
Tolerances are established for combined negligible residues of the plant regulator
Tolerances are established for residues of the defoliant cacodylic acid (dimethylarsinic acid), expressed as As
2.8 parts per million in or on cottonseed.
1.4 parts per million in the kidney and liver of cattle.
0.7 part per million in meat, fat, and meat byproducts (except kidney and liver) of cattle.
A tolerance of 0.1 part per million is established for negligible residues of the bird repellent 4-aminopyridine in or on the raw agricultural commodities corn fodder and forage, corn grain (including popcorn grain), fresh corn (including sweet corn kernels plus cob with husks removed), and sunflower seeds.
(a)
(b)
(c)
(d)
(a) Tolerances are established for residues of the insecticide methamidophos (
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of methamidophos in or on the following raw agricultural commodities:
Tolerances are established for combined residues of the herbicide pyrazon (5-amino-4-chloro-2-phenyl-3(2
1 part per million in or on beet tops and sugar beet tops.
0.1 part per million (negligible residue) in or on beets and sugar beets.
0.01 part per million (negligible residue) in milk.
(a)
(b)
(c)
(d)
A tolerance of 0.1 part per million is established for negligible residues of the herbicide 4-(2-methyl-4-chlor-o-phe-noxy) bu-tyr-ic acid in or on the raw agricultural commodity peas.
While petitions for tolerances for negligible residues are pending and until action is completed on these petitions, interim tolerances are established for residues of the listed pesticide chemicals in or on the following raw agricultural commodities:
(a)
(2) Tolerances are established for residues of the herbicide bromoxynil (3,5-dibromo-4-hydroxybenzonitrile) 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 following commodities:
(b)
(c)
(d)
A tolerance of 0.1 part per million is established for negligible residues of the plant regulator 2-(
(a) Tolerances are established for negligible residues (
(b) Tolerances with regional registration are established for residues of the herbicide
(a)
(b)
(c)
(d)
Tolerances are established for the combined residues of the herbicide 4-(2,4-dichlorophenoxy) butyric acid and
(a)
(b)
(c)
(d)
Tolerances are established for residues of the pesticide oxytetracycline in or on the following raw agricultural commodities:
Tolerances are established for residues of the fungicide and insecticide 6-methyl-1,3-dithiolo [4,5-b] quinoxalin-2-one in or on raw agricultural commodities as follows:
(a) Tolerances are established for residues of the herbicide 2-methyl-4-chlorophenoxyacetic acid from application of the herbicide in the acid form or in the form of its sodium, ethanolamine, diethanolamine, triethanolamine, iso-pro-pa-nol-a-mine, di-iso-pro-pa-nol-a-mine, tri-iso-pro-pa-nol-a-mine, or di-meth-yl-a-mine salts or its iso-oc-tyl or bu-tox-y-eth-yl es-ters in or on raw agricultural commodities as follows:
(b) Tolerances are established for combined negligible residues (N) of the herbicide 2-methyl-4-chlor-o-phen-ox-y-ace-tic acid and its me-tab-o-lite 2-meth-yl-4-chlor-o-phen-ol in or on the following raw agricultural commodities:
(a)
0.1 part per million in or on apples and grapes.
(b)
(c)
(d)
(a) Tolerances are established for combined residues of the pesticide chlorpyrifos (
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for the combined residues of chlorpyrifos and its metabolite 3,5,6-trichloro-2-pyridinol in or on the following raw agricultural commodities:
(c) Tolerances are established for residues of the pesticide chlorpyrifos (
(d) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of the pesticide chlorpyrifos (
(e) Tolerances are established as follows for residues of the insecticide chlorpyrifos [
(f) A tolerance of 15 parts per million is established for residues of the pesticide chlorpyrifos [
(1) Such tolerance applies only to oats that were treated post-harvest with chlorpyrifos on or before June 15, 1994.
(2) Such tolerance applies only to oats to be used as animal feed or as a constituent of animal feed.
(3) Notwithstanding any other provision of law or regulation, this tolerance does not authorize the presence of residues of chlorpyrifos in any human food item made from such treated oats, other than residues resulting from the use of the oats for animal feed purposes.
(4) Such tolerance expires on December 31, 1996.
A tolerance of 0.02 part per million is established for negligible residues of the plant regulators 4,6-dinitro-
(a)
(2) Tolerances are established for combined residues of the herbicide ethofumesate (2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate; CAS Reg. No. 26225-79-6) and its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate, (both calculated as the parent compound) in or on the following processed feeds when present therein as a result of application of the herbicide to the growing crops:
(b)
(c)
(d)
(a)
0.2 part per million (negligible residue) in or on rice straw.
0.1 part per million in milk fat (reflecting negligible residues in milk).
0.01 part per million (negligible residue) in the meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep.
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the nematocide ethyl 3-methyl-4-(methylthio)phenyl (1-meth-yl-eth-yl)phos-phor-ami-date and its cho-lines-ter-ase-inhibiting me-tab-o-lites eth-yl 3-meth-yl-4-(meth-yl-sul-finyl)phen-yl (1-meth-yl-eth-yl)phos-phor-ami-date, eth-yl 3-meth-yl-4-(meth-yl-sul-fonyl)phen-yl (1-meth-yl-eth-yl)phos-phor-ami-date, eth-yl 3-meth-yl-4-(meth-yl-thio)phen-yl phos-phor-ami-date, eth-yl-4-(meth-yl-sul-finyl)phen-yl phos-phor-ami-date, and eth-yl 3-meth-yl-4-(meth-yl-sul-fonyl)phen-yl phos-phor-ami-date in or on the following raw agricultural meat commodities:
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a) Tolerances are established for combined residues of the insecticide terbufos (S-[[1,1-dimethyl)thio]methyl] O,O-diethyl phosphorodithioate and its cholinesterase-inhibiting metabolites in or on the following raw agricultural commodities.
(b) A time-limited tolerance to expire December 15, 1997 is established for combined residues of the insecticide/nematicide terbufos (
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established for residues of the insect growth regulator methoprene (isopropyl (E,E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate) in or on the following raw agricultural commodities:
A tolerance is established for negligible residues of the herbicide asulam (methyl sulfanilylcarbamate) in or on the raw agricultural commodity sugar-cane at 0.1 part per million.
(a)
(b)
(c)
(d)
(a) Tolerances are established for the combined residues of the insecticide hexakis[2-methyl-2-phenylpropyl] dis-tan-nox-ane and its or-gan-o-tin me-tab-o-lites calculated as hex-akis[2-meth-yl-2-phen-yl-pro-pyl] dis-tan-nox-ane in or on the following raw agricultural commodities:
(b) Tolerances with regional registration are established for residues of the insecticide hexakis [2-methyl-2-phen-yl-pro-pyl] dis-tan-nox-ane and its or-gan-o-tin me-tab-o-lites calculated as hex-a-kis [2-meth-yl-2-phen-yl-pro-pyl] dis-tan-nox-ane
Tolerances are established for residues of the herbicide fluchloralin [
(a)
(2) Tolerances are established for residues of glyphosate
(3) Tolerances are established for residues of glyphosate, (
(b)
(c)
(d)
For
Tolerances are established for residues of the insecticide n-octyl bi-cyclo-hep-tene-di-car-box-i-mide, resulting from dermal application, in raw agricultural commodities as follows:
(a)
(b)
(c)
(d)
For
Tolerances are established for residues of difenzoquat (1,2-dimethyl-3,5-diphenyl-1
(a)
(b)
(c)
(d)
Tolerances are established for residues of the fungicide thiophanate-methyl (dimethyl [(1,2-phenylene)-bis(iminocarbonothioyl)] bis[car-ba-mate]), its oxygen anal-o-gue di-methyl-4,4′-
A tolerance is established for residues of the fungicide 2,6-dimethyl-4-tridecylmorpholine in or on the following raw agricultural commodity:
(a) Tolerances are established for residues of the fumigant phosphine in or on the following raw agricultural commodities from postharvest treatment with magnesium phosphide:
(b) Tolerances are established for residues of the fumigant phosphine in or on all raw agricultural commodities at 0.01 ppm resulting from preharvest treatment of pest burrows in agricultural and noncropland areas with magnesium phosphide.
(a)
(2) Tolerances are established for residues of the insecticide diflubenzuron (N-[[4-chlorophenyl)amino]-carbonyl]-2,6-difluorobenzamide) and its metabolites 4-chlorophenylurea and 4-chloroaniline on rice grain at 0.02 ppm and rice straw at 0.8 ppm.
(b)
(c)
(d)
(a) Tolerances, to expire on November 15, 1997, are established for residues of the insecticide permethrin [(3-pheoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylate] in or on the following raw agricultural commodities:
(b) Tolerances are established for residues of the insecticide permethrin [(3-phenoxyphenyl)methyl 3-(2,2-di-chloro-ethenyl)-2,2-di-meth-yl-cyclo-pro-pane car-box-y-late] and the sum of its me-tab-o-lites 3-(2,2-di-chloro-ethenyl)-2,2-di-meth-yl-cyclo-pro-pane car-box-ylic acid (DCVA) and (3-phen-o-xy-phenyl)meth-a-nol (3-
(c) Tolerances are established for residues of permethrin and the sum total of its metabolites 3-(2,2-di-chloro-ethenyl)-2,2-di-methyl-cyclo-pro-pane car-box-y-lic acid (DCVA) and (3-phen-o-xy-phenyl(meth-a-nol (3-PBA) and 3-phen-o-xy-ben-zoic acid in or on the following animal commodities.
(d) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of permethrin [(3-phenoxyphenyl)methyl-3-(2,2-di-chloro-ethenyl)-2,2-di-methyl-cyclo-pro-pane car-box-y-late] and the sum of its me-tab-o-lites 3-(2,2-di-chloro-ethenyl(-2,2-di-methyl-cyclo-pro-pane car-box-y-lic acid (DCVA) and (3-phen-o-xy-phenyl)methanol (3-PBA) in or on the following raw agricultural commodities:
For
(a)
(2) A food additive tolerance of 0.05 parts per million is established for residues of the insecticide cyano(37phenoxy-phenyl)methyl-4-chloro-alpha-(1-methyl-ethyl)benzeneacetate and an isomer, (S)-cyano(3-phenoxy-phenyl)methyl-(S)-4-chloro-alpha-(1-methylethyl)-benzeneacetate, as follows:
(i) In or on all food item (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.
(ii) Application of cyano(3-phenoxy-phenyl)methyl-4-chloro-alpha-(1-methy-lethyl)benzeneacetate shall be limited to space treatment with a maximum of 0.5 fluid ounce of a 0.05-percent active ingredient solution per 1,000 cubic feet of space, or as a contact spray applied as a coarse wet spray at a maximum of 1 gallon of a 0.2-percent active ingredient solution per 1,000 square feet of surface. Food must be removed or covered during treatment. Spray should not be applied directly to surfaces or utensils that may come into contact with food. Food-contact surfaces and equipment should be thoroughly cleaned with an effective cleaning compound and rinsed with potable water before using.
(iii) Application of (S)-cyano(3-phenoxy-phenyl) methyl-(S)-4-chloro-alpha-(1-methy-lethyl)benzeneacetate shall be limited to space treatment with a maximum of 1.0 fluid ounce of a 0.25-percent active ingredient solution per 1,000 cubic feet of space, or as a contact spray applied as a coarse wet spray at a maximum of 1 gallon of a 0.05-percent active ingredient solution per 1,000 square feet of surface, or as a pressurized spot/crack and crevice spray of a 0.25-percent solution. Food must be removed or covered during treatment. Spray should not be applied directly to surfaces or utensils that may come into contact with food. Food-contact surfaces and equipment should be thoroughly cleaned with an effective cleaning compound and rinsed with potable water before using.
(iv) 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.
(3) A regulation is established permitting residues of the insecticide 4-cyano(3-phenoxy-phenyl)methyl 4-chloro-alpha-(1-methyl-ethyl)benzeneacetate in or on the following commodities:
(b)
(c)
(d)
For
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a) Tolerances are established for residues of the fungicide triforine (
(b) Tolerances with regional registration are established for residues of the fungicide triforine (
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established for residues of the herbicide tebuthiuron (
(a)
(b)
(c)
(d)
(a) Tolerances are established for combined residues of the herbicide hexazinone (3-cyclohexyl-6-(di-methyl-a-mi-no)-1-methyl-1, 3, 5-tri-a-zine-2,4(1
(b) A tolerance with regional registration, as defined in § 180.1(n) and which excludes use of hexazinone on sugarcane in Florida, is established for combined residues of the herbicide hexazinone (3-cyclohexyl-6-(dimethyamino)-1-methyl-1,3,5-triazine-2,4(1
A tolerance is established for the combined residues of the insecticide chlorthiophos, that is a mixture of
(a)
(2) Tolerances are established for the combined residues of iprodione [3-(3,5-dichlorophenyl)-
(b)
(c)
(d)
For
(a) Tolerances are established for the combined residues of the herbicide thiobencarb (
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of the herbicide thiobencarb (S-[(4-chloro-phenyl)methyl]di-ethyl-carbamothioate) and its chlorobenzyl and chlorophenyl moiety-containing metabolites in or on the following raw agricultural commodities:
Tolerances are established for the combined residues of the herbicide diethatyl-ethyl and its metabolites (free and bound) determinable as the
Tolerances are established for the combined residues of the defoliant thidiazuron (N-phenyl-N′-1,2,3-thia-di-a-zol-5-ylurea) and its aniline containing me-tab-o-lites in or on the following raw agricultural commodities:
Tolerances are established for combined residues of the insecticide profenofos [
(a) Tolerances are established for the combined residues of chlorsulfuron (2-chloro-
(b) Tolerances are established for residues of chlorsulfuron (2-chloro-
Tolerances are established for residues of the harvest growth regulant dimethipin (2,3-dihydro-5,6-dimethyl-1,4-dithiin 1,1,4,4-tetraoxide; CAS Reg. No. 55290-64-7) in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established for the combined residues of the insecticide pirimiphos-methyl,
(a)
(b)
(c)
(d)
(a) Tolerances are established for residues of the herbicide fluazifop-butyl (
(b) Tolerances with regional registration are established for residues of fluazifop-butyl (
(c) Tolerances are established for residues of the resolved isomer of fluazifop, (R)-2-[4-[[5-(tri-fluoro-meth-yl)-2-py-rid-i-nyl]oxy]phen-oxy]pro-pan-oic
(d) Tolerances with regional registration, see § 180.1(n), are established for residues of the resolved isomer of the herbicide flu-azifop, (R)-2-[4-[[5-(tri-fluoro-methyl)-2-py-rid-i-nyl]-oxy]phen-oxy] pro-pan-oic acid, both free and con-ju-gated and of flu-azifop-P-butyl, butyl[R]-2-[4-[[5-(tri-fluoro-methyl)-2-py-rid-i-nyl]oxy]phen-oxy] pro-pan-o-ate, all expressed as flu-azifop, in or on the raw agricultural commodities:
(a)
(b)
(c)
(d)
(a) Tolerances are established for the combined residues of the fungicide imazalil 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-1
(b) Tolerances are established for the combined residues of the fungicide imazalil 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-1
(a)
(2) Tolerances are established for residues of the cyromazine metabolite melamine (1,3,5-triazine-2,4,6-triamine) in or on the following food commodities:
(3) Tolerances are established for residues of the insecticide cyromazine (
(4) The additive cyromazine (
(i) It is used as a feed additive only in the 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.
(ii) It is used for control of flies in manure of treated chicken layer hens and chicken breeder hens.
(iii) 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) preslaughter interval.
(iv) To ensure safe use of the additive, the labeling of the pesticide formulation containing the feed additive shall conform to the labeling which is registered by the U.S. Environmental Protection Agency, and the additive shall be used in accordance with this registered labeling.
(v) Residues of cyromazine are not to exceed 5.0 parts per million (ppm) in poultry feed.
(b)
(c)
(d)
(a) Tolerances are established for residues of the fungicide aluminum tris (
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of the fungicide aluminum tris(
(c) Time-limited tolerances are established for residues of the fungicide aluminum tris (
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established 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 in or on the following raw agricultural commodities:
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the insecticide zeta-cypermethrin (
(b)
(c)
(d)
Tolerances are established for the combined residues of the insecticide chlorpyrifos-methyl [
(a) Tolerances are established for the combined residues (free and bound) of the herbicide fluridone (1-methyl-3-phenyl-5-[3-trifluoromethyl)phenyl]-4(1
(b) Tolerances are established for residues of the herbicide fluridone in the following raw agricultural commodities:
(c) Tolerances are established in the following irrigated crops and crop groupings for residues of the herbicide fluridone resulting from use of irrigation water containing residues of 0.15 ppm following applications on or around aquatic sites. Where tolerances are established at higher levels from other uses of fluridone on the following crops, the higher tolerance also applies to residues in the irrigated commodity. The tolerances follow:
(a)
(2) A tolerance is established for combined residues of the fungicide fenarimol [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] and its metabolites [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-1,4-dihydro-5-pyrimidinemethanol and 5-[(2-chlorophenyl) (4-chlorophenyl)methyl]-3,4-dihydro-4-pyrimidinol measured as the total of fenarimol and 5-[(2-chlorophenyl)-(4-chlorophenyl)methyl]pyrimidine (calculated as fenarimol)], in or on the following raw agricultural commodities:
(b)
(c)
(d)
(a)
(2) A food additive tolerance of 0.02 part per million is established for the combined residues of the insecticide tralomethrin ((
(i) In or on all food items (other than those covered by a higher tolerance as a result of use on growing crops) in food-handling establishments.
(ii) 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 in accordance with the following prescribed conditions:
(A) 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.
(B) To assure safe use of the insecticide, its label and labelling shall conform to that registered with the U.S. Environmental Protection Agency and shall be used in accordance with such label and labelling.
(3) A feed additive tolerance of 0.02 part per million is established for the combined residues of the insecticide tralomethrin ((
(i) In or on all feed items (other than those covered by a higher tolerance as a result of use on growing crops) in feed-handling establishments.
(ii) The insecticide may be present as a residue from application of tralomethrin in feed-handling establishments, including feed manufacturing and processing establishments in accordance with the following prescribed conditions:
(A) 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) To assure safe use of the insecticide, its label and labelling shall conform to that registered with the U.S. Environmental Protection Agency and shall be used in accordance with such label and labelling.
(b)
(c)
(d)
Tolerances are established for residues of the hybridizing agent potassium salt of fenridazon (1-(4-chlorophenyl)-1,4-dihydro-6-methyl-4-oxo-3-pyridazinecarboxylic acid, potassium salt; CAS Reg. No. 83588-43-6) in
Tolerances are established for residues of the herbicide 2-(3,5-di-chloro-phenyl)-2-(2,2,2-tri-chloroethyl)-oxirane in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
A tolerance is established for residues of the herbicide 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
(a) Tolerances are established for residues of the insecticide (alpha
(b) Tolerances with regional registration, as defined in § 180.1(n), are established for residues of the insecticide (alpha RS,2R)-fluvalinate[(RS)-alpha-cyano-3-phenoxybenzyl(R)-2-[2-chloro-4-(trifluoromethyl)anilino]-3-methylbutanoate in or on the following commodities:
(a) Tolerances are established for the combined residues of the herbicide metsulfuron methyl (methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino] -sulfonyl]benzoate) and its metabolite methyl 2-[[[[(4-methoxy-6-methyl-1-,3,5-triazin-2-yl)amino]carbonyl]amino] sulfonyl]-4-hydroxybenzoate in or on the following raw material agricultural commodities:
(b) 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:
A tolerance is established for the residues of the herbicide chlorimuron ethyl [ethyl 2-[[[[ (4-chloro-6-methoxypyrimidin-2yl) amino]carbonyl] amino]sulfonyl] benzoate] in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a) Tolerances are established for the combined residues of lactofen, 1-(carboethoxy)ethyl-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its associated metabolites containing the diphenyl ether linkage expressed as lactofen in or on the following raw agricultural commodities:
(b) A time-limited tolerance, that expired December 31, 1995, is renewed for 1 year and will now expire December 31, 1996, for residues of the herbicide lactofen, 1-(carboethoxy)ethyl-5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its metabolites containing the diphenyl ether linkage in or on the following raw agricultural commodity:
(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-phenoxy-phenyl)methyl-3-(2,2-dichloroethenyl)-2,2-di-methyl-cyclo-propane-carboxy-late; CAS Reg. No. 69359-37-5) in food commodities exposed to the insecticide during treatment of food-handling establishments where food and food products are held, processed, prepared, or served. Treatments may be made by general surface, spot, and/or crack and crevice applications.
(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-phen-oxy-phenyl)methyl-3-(2,2-dichloro-ethenyl)-2,2-dimethyl-cyclo-propane-carboxy-late; 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.
(b)
(c)
(d)
Tolerances are established for the combined residues of the herbicide methyl 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-
(a)
(2) A food additive tolerance of 0.01 part per million is established for residues of the insecticide [1
(i) In or on all food items (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.
(ii) Application shall be limited solely to spot and/or crack and crevice
(iii) For spot treatment, a coarse low-pressure spray shall be used. Limit individual spot treatments to an area no larger than 20 percent of the surface area. Any individual spot treatment shall not exceed 2 square feet.
(iv) For crack and crevice treatment, equipment capable of delivering a pin-stream of spray directly into the cracks and crevices shall be used.
(v) 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.
(3) A food additive tolerance is established for residues of the insecticide [1
(b)
(c)
(d)
Tolerances are established for residues of the herbicide thifensulfuron methyl (methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino] carbonyl] amino] sulfonyl]-2-thiophene carboxylate) in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of the herbicide quizalofop (2-[4-(6-chloroquinoxalin-2-yl oxy)phenoxy]propanoic acid), quizalop-ethyl (ethyl-2-[4-(6-chloroquinoxalin-2-yl oxy)phenoxy]propanoate), and quizalofop-methyl (methyl 2-[4-(6-chloroquinoxalin-2-yl-oxy)phenoxy]propanoate, all expressed as quizalofop ethyl, as follows:
(3) Tolerances are established for the combined residues of the herbicide quizalofop-p ethyl ester [ethyl (
(4) Time limited tolerances to expire on June 14, 1999 are established for the combined residues of the herbicide quizalofop-p ethyl ester (ethyl (
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
At 63 FR 49479, Sept. 16, 1998, § 180.443 was amended. At 64 FR 38308, July 16, 1999, the amendatory instruction was corrected, effective July 16, 1999.
A tolerance is established as follows for sulfite residues of the fungicide sulfur dioxide (determined as (SO
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for the combined residues of clofentezine and the 3-(2-chloro-4-hydroxyphenyl)-6-(2-
(b)
(c)
(d)
(a) Tolerances are established for residues of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
(b) Tolerances are established for the sum of the residues of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
(c) A tolerance is established for the sum of residues of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
(d) Tolerances with regional registration, as defined in § 180.1(n) of this chapter, are established for the sum of residues of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a) Tolerances are established for the combined residues of the fungicide
(b) Tolerances are established for the combined residues of the fungicide
(a) Tolerances are established for the residues of the herbicide tribenuron methyl (methyl-2-[[[[
(b) Tolerances with regional registration, as defined in § 180.1(n) are established for residues of the herbicide tribenuron methyl (methyl-2-[[[[
(a)
(b)
(c)
(d)
Tolerances are established for the residues of the herbicide nicosulfuron [3-pyridinecarboxamide, 2-((((4,6-di-meth-ox-y-pyr-i-midin-2-yl)a-mi-no-car-bon-yl)a-mi-no-sul-fon-yl))-N,N-di-methyl] in or on the following raw agricultural commodities:
A tolerance is established for the residues of the fungicide procymidone,
Tolerances are established for the combined residues of the fungicide oxadixyl [2-methoxy-N-(2-oxo-1,3-oxazolidin-3-yl)-acet-2′,6′-xylidide] and its desmethyl (M-3) metabolite (2-hydroxy-N-(2-oxo-1,3-oxazolidin-3-yl)-acet-2′,6′-xylidide), calculated as oxadixyl in or on the raw agricultural commodities cotton seed, peas, soybeans, sunflower seed and the crop groupings fruiting vegetables (except cucurbits) group, cucurbit vegetables group, leafy vegetables (except Brassica vegetables) group, Brassica (cole) leafy vegetables group, root and tuber vegetables group, cereal grains group (except wheat), grass forage, fodder and hay group, and nongrass animal feeds (forage, fodder, straw, and hay) group at 0.1 part per million.
A tolerance is established for the residues of the fungicide beta-([1,1′-biphenyl]-4-yloxy)-alpha-(1,1-dimethylethyl)-1
(a)
(2) Time-limited tolerances are established for the combined residues of clethodim ((E)-(
(3) Tolerances are established for the herbicide clethodim [(E)-(
(4) Food additive tolerances are established for the combined residues of the herbicide clethodim ((E)-(
(5) Tolerances are established for residues of the herbicide clethodim ((E)-(
(6) Tolerances are established for the herbicide clethodim [(E)-(
(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)
(2) A tolerance is established to permit residues of the herbicide 3,7-dichloro-8-quinoline carboxylic acid in or on the feed commodity rice bran at 15.0 ppm when present therein as a result of application of the herbicide to the growing crop.
(b)
(c)
(d)
Tolerances are established for residues of the herbicide dimethenamid, 1(
Tolerances, to expire on January 31, 1998, are established for residues of 4-(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane (CAS Reg. No. 71526-07-3) when used as an inert ingredient (safener) in pesticide formulations applied to corn fields before the corn plants emerge from the soil with a maximum use level of 0.4 pound per acre per year in or on the following raw agricultural commodities:
(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:
Tolerances are established for residues of the herbicide flumetsulam,
Time-limited tolerances, to expire December 31, 1998, are established for residues of
Tolerances are established for residues of acetochlor, 2-chloro-2′-methyl-6-ethyl-
Tolerances, to expire June 30, 1996, are established for residues of 3-dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine (CAS Reg. No. 121776-33-8) when used as an inert ingredient (safener) in pesticide formulations in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
(a)(1) Time-limited tolerances are established for residues of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-methylphosphinico-propionic acid, in or on the following raw agricultural commodities:
(2) Residues in these commodities not in excess of the established tolerances resulting from the uses described in paragraph (a)(1) of this section remaining after expiration of the time-limited tolerance will not be considered to be actionable if the herbicide is applied during the term of and in accordance with the provisions of paragraph (a)(1) of this section.
(b)(1) A tolerance, to expire on January 18, 2000, is established as follows for combined residues of glufosinate ammonium (monoammonium 2-amino-4-(hydroxymethylphosphinyl) butanoate) and its metabolite 3-methylphosphinicopropionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents.
(2) There are no U.S. registrations as of August 24, 1994, for bananas.
(c) Time-limited tolerances are established for residues of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-,monoammonium salt), and its metabolites 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid in or on the following raw agricultural commodities derived from transgenic corn and soybeans that are tolerant to the herbicide glufosinate ammonium, as provided below. These tolerances shall expire and be automatically revoked on July 13, l999.
(a)
(2) Tolerances are established for the combined residues of the fungicide, tebuconazole and its 1-(4-chlorophenyl)-4,4-dimethyl-3-(1
(b)
(2)
(c)
(d)
(a)
(b)
(c)
(d)
(a) Tolerances are established for the combined residues of the fungicide triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1
(b) Tolerances are established for the combined residues of the fungicide triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1
Tolerances are established for residues of the herbicide flumiclorac pentyl, pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)phenoxy]acetate, including all the metabolites of flumiclorac pentyl, in or on the raw agricultural commodities listed below. The tolerance level for each commodity is expressed in terms of the parent only which serves as an indicator of the use of flumiclorac pentyl on these raw agricultural commodities.
(a)
(b)
(c)
(d)
(a) General. (1) Tolerances are established for residues of the herbicide halosulfuron, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl) amino] carbonylaminosulfonyl-3-chloro-1-methyl-1
(2) Tolerances are established for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl) amino]carbonylaminosulfonyl-3-chloro-1-methyl-1
(b)
(c)
(d)
(a)
(2) Residues in these commodities not in excess of the established tolerance resulting from the uses described in paragraph (a)(1) of this section remaining after expiration of the time-limited tolerance will not be considered to be actionable if the fungicide is applied during the term of and in accordance with the provisions of the above regulation.
(b)
(c)
(d)
Tolerances that expire as indicated in the table below are established for residues of the herbicide prosulfuron 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea in or on the following raw agricultural commodities:
(a)
(b)
(c)
(d)
Time-limited tolerances are established for residues of the insecticide
(a)
(2)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
Tolerances are established permitting the residue of the insecticide phosphorothioic acid,
(a)
(2) Residues in these commodities not in excess of the established tolerance resulting from the use described in the following table remaining after expiration of the time-limited tolerance will not be considered to be actionable if the herbicide is applied during the term of and in accordance with the provisions of paragraph (a) of this section.
(b)
(c)
(d)
A tolerance is established for residues of the fungicide hexaconazole, [alpha-butyl-alpha-(2,4-dichlorophenyl)-1
(a)
(b)
(c)
(d)
Tolerance is established for residues of the herbicide; (=)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1
A time-limited tolerance to expire on May 20, 1998 is established for residues of the fumigant propylene oxide, in or on the following raw agricultural commodities.
Tolerances to expire as shown in the table below are established for residues of the herbicide, triflusulfuron methyl, methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-trifluorothoxy)-1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-methylbenzoate, in or on the raw agricultural commodities:
(a)
(b)
(c)
(d)
(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)
(a)
(b)
(a)
(b)
(c)
(d)
Tolerances are being established for residues of the herbicide imazapyr, [2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic acid], applied as the acid or ammonium salt, in or on the following raw agricultural commodities:
(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)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Tolerances are established for residues of the fungicide, azoxystrobin [methyl(
(3)
(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)
(e)
(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) It is used or intended for use in or on raisins and dried Zante currants as a bulk and package fumigant.
(2) It is used in accordance with directions registered with the U.S. Environmental Protection Agency, and so used that the total formic acid present free and combined, in the finished product shall not exceed 250 parts per million.
(3) To assure safe use of the additive, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency.
(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) Methyl bromide. Total residues of inorganic bromides (calculated as Br) from the use of this fumigant shall not exceed 125 parts per milion.
(2) Methyl bromide is used to fumigate corn grits and cracked rice in the production of fermented malt beverages.
(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 beverages, 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)
(1) The food additive is applied as a preharvest spray or dust on growing strawberries at a rate of not more than 1 pound per acre, calculated as metaldehyde, and applied not later than 14 days before first picking.
(2) A tolerance of zero is established for residues of metaldehyde on strawberries.
(3) To insure safe usage of the additive:
(i) The label of any market package of the additive shall bear, in addition to other information required by the act, the name of the additive.
(ii) The label of any prepared mix or concentrate shall indicate the percentage by weight of the additive.
(iii) The label shall bear adequate directions for use, in conformance with paragraph (a) of this section and may indicate that in the event the metaldehyde is removed by rain an additional application may be made provided such application is made not less than 14 days before first picking.
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Residues in these commodities not in excess of the established tolerance resulting from the use described in paragraph (a) of this section remaining after expiration of the time-limited tolerance will not be considered to be actionable if the herbicide is applied during the term of and in accordance with the provisions of the above regulation.
(b)
(c)
(d)
(2) Residues in these commodities not in excess of the established tolerance resulting from the use described in paragraph (d)(1) of this section remaining after expiration of the time-limited tolerance will not be considered to be actionable if the herbicide is applied during the term of and in accordance with the provisions of the above regulation.
(a)
(1) It is used in combination with the active ingredients d-limonene and dihydro-5-pentyl-2(3H)-furanone in insect-repellent tablecloths and in insect-repellent strips used in food- or feed-handling establishments.
(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.
(b)
(c)
(d)
(a)
(1) It is used in combination with the active ingredients d-limonene and dihydro-5-heptyl-2(3H)-furanone in insect-repellent tablecloths and in insect-repellent strips used in food- or feed-handling establishments.
(2) To assure safe use of the insecticide, its label and labeling shall conform to that registered by the U.S. Enviornmental Protection Agency, and it shall be used in accordance with such label and labeling.
(b)
(c)
(d)
(a)
(2) The insecticide 2,2-dimethyl-1,3-benzodioxol-4-ol 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.
(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) The following tolerances are established for residues of the insecticide
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
At 63 FR 71026, Dec. 23, 1998, § 180.536 was added, effective Dec. 23, 1999.
(a)
(2) Tolerances are established for combined residues of the herbicide isoxaflutole [5-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethyl benzoyl) isoxazole] and its metabolite 1-(2-methylsulfonyl-4-trifluoromethylphenyl)-2-cyano-3-cyclopropyl propan-1,3-dione (RPA 202248), calculated as the 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)
(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) 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.
(b) When applied to growing crops, in accordance with good agricultural practice, the following pesticide chemicals are exempt from the requirement of a tolerance:
(1) The following copper compounds: Bordeaux mixture, basic copper carbonate (malachite), copper-ethylenediamine complex, copper hydroxide, copper-lime mixtures, copper linoleate, copper oleate, copper oxychloride, copper octanoate, copper sulfate basic, copper sulfate pentahydrate, cupric oxide, cuprous oxide. These compounds are used primarily as fungicides.
(2)
(3) Petroleum oils.
(4) Piperonyl butoxide.
(5) [Reserved]
(6) Pyrethrum and pyrethrins.
(7) Rotenone or derris or cube roots.
(8) Sabadilla.
These pesticides are not exempted from the requirement of a tolerance when applied to a crop at the time of or after harvest.
(c) 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:
(d) 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:
(e) 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:
1. For
2. At 63 FR 69208, Dec. 16, 1998, § 180.1001(b)(1) was amended by adding “copper ammonium complex” immediately after “copper acetate”. However, “copper acetate” doesn't exist in this section in the 1999 edition of this volume.
The insecticide allethrin is exempted from the requirement of a tolerance for residues when used before harvest in the production of the following commodities:
The fungicide ammonia is exempted from the requirement of a tolerance when used after harvest on the raw agricultural commodities grapefruit, lemons, oranges, and corn grain for feed use only.
The insecticide chloropicrin is exempted from the requirement of a tolerance for residues when used as a fumigant after harvest for the following grains: Barley, buckwheat, corn (including popcorn), oats, rice, rye, grain sorghum, wheat.
(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
The fungicide, 1,1,1-trichloroethane is exempted from the requirement of a tolerance for residues when used in the postharvest fumigation of citrus fruits.
(a) Residues from the use of sulfur dioxide in liquid grain-fumigant formulations for marker or fire-retardant purposes at levels not exceeding 5 percent by weight of such formulations are exempted from the requirement of a tolerance in or on barley, buckwheat, corn, oats, popcorn, rice, rye, grain sorghum (milo), wheat.
(b) Residues of sulfur dioxide resulting from postharvest fungicidal use are exempted from the requirement of tolerances in or on corn for feed use only.
Pentane is exempted from the requirement of a tolerance for residues when used in accordance with good commercial practice as an adjuvant in liquid grain fumigants for the fumigation of the following grains: Barley, corn, oats, popcorn, rice, rye, sorghum (milo), wheat.
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.
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 raw agricultural commodities after harvest, and to animals.
Sulfuric acid is exempted from the requirement of a tolerance for residues when used in accordance with good agricultural practice as a herbicide in the production of garlic and onions and as a potato vine desiccant in the production of potatoes.
(a) Sodium chlorate is exempted from the requirement of a tolerance for residues in or on the following raw agricultural commodities when used as a defoliant, desiccant, or fungicide in accordance with good agricultural practice.
(b) A time-limited exemption from the requirement of a tolerance is established for residues of the defoliant/desiccant in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. The exemption will expire and is revoked on the date specified in the following table:
Copper is exempted from the requirement of a tolerance in meat, milk, poultry, eggs, fish, shellfish and irrigated crops when it results from the use of:
(a) 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.
(b) Basic copper carbonate (malachite) as an algicide or herbicide in impounded and stagnant bodies of water.
(c) Copper triethanolamine and copper monoethanolamine as an algicide or herbicide in fish hatcheries, lakes, ponds, and reservoirs.
(d) Cuprous oxide bearing antifouling coatings for control of algae or other organisms on submerged concrete or other (irrigation) structures.
The aqueous solution of hydriodic acid and elemental iodine, including one or both of the surfactants (a) pol-yoxypropylene-polyoxyethylene gly-col nomionic block polymers (minimum average molecular weight 1,900) and (b)
(a) Postharvest application of propionic 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, barley grain, Bermuda grass, bluegrass, brome grass, clover, corn grain, cowpea hay, fescue, lespedeza, lupines, oat grain, orchard grass, peanut hay, peavine hay, rye grass, sorghum grain, soybean hay, sudan grass, timothy, vetch, and wheat grain.
(b) Propionic acid is exempt from the requirement of a tolerance for residues in or on meat and meat byproducts of cattle, sheep, hogs, goats, horses, and poultry, milk, and eggs when applied as a bactericide/fungicide to livestock drinking water, poultry litter, and storage areas for silage and grain.
(c) Postharvest application of propionic acid when used as a fungicide is exempted from the requirement of a tolerance for residues in or on the following raw agricultural commodities: Cottonseed, peanuts, rice grain, and soybeans.
The insecticide paraformaldehyde is exempted from the requirement of a tolerance for residues in or on sugar beets (roots and tops) when applied to the soil not later than planting.
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
(a) The cross-linked nylon-type polymer formed by the reaction of a mixture of sebacoyl chloride and polymethylene polyphenylisocycanate with a mixture of ethylenediamine and diethylenetriamine is exempted from the requirement of a tolerance when used as an inert encapsulating material for formulations of methly parathion applied to growing alfalfa, apples, artichokes, barley, cabbage, cherries, corn (except popcorn), cotton, forage grasses, grapes, beans, (dry, lima, and snap), nectarines, oats, onions, (dry bulb), peaches, pears, peas, plums (fresh prunes), potatoes, rice, soybeans, tomatoes, and wheat.
(b) The cross-linked nylon-type polymer formed by the reaction of a mixture of sebacoyl chloride and polymethylene polyphenylisocyanate with a mixture of ethylenediamine and diethylenetriamine is exempted from the requirement of a tolerance when used as an inert encapsulating material for formulations of parathion applied to growing sorghum.
Formaldehyde is exempt from the requirement of a tolerance for residues in or on the grains of barley, corn, oats, sorghum, and wheat and the forages of alfalfa, Bermuda grass, bluegrass, brome grass, clover, cowpea hay, fescue, lespedeza, lupines, orchard grass, peanut hay, peavine hay, rye grass, soybean hay, sudan grass, timothy, and vetch from postharvest application of formaldehyde or a mixture of methylene bispropionate and oxy(bismethylene) bispropionate when used as a fungicide. These raw agricultural commodities are for use only as animal feeds.
Methoprene is exempt from the requirement of a tolerance in or on all raw agricultural commodities when used to control mosquito larvae including pastures, rice fields, vineyards, date palm orchards, nut orchards, berry orchards, and fruit orchards.
Pine oil is exempted from the requirement of a tolerance for residues in the raw agricultural commodities honey and beeswax, when present therein as a result of its use as a deodorant at no more than 12 percent in
The adhesive hydrogenated castor oil is exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity cottonseed when used as an inert adhesive for formulations of the attractant gossyplure (1:1 mixture of (
(a) Polybutenes are exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity cottonseed when used as a sticker agent for formulations of the attractant gossyplure (1:1 mixture of (
(b) Polybutenes are exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity artichokes when used as a sticker agent in multi-layered laminated controlled-release dispensers of (Z)-11-hexadecenal to disrupt the mating of the artichoke plume moth.
Polyoxymethylene copolymer, conforming to 21 CFR 177.2470, is exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity cottonseed when used as an inert controlled-release dispenser for formulations of the attractant gossyplure (1:1 mixture of (
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 (
Chlorotoluene, an isomeric mixture predominantly of ortho- and para-monochlorotoluene with up to 6 percent unreacted toluene and a boiling range of 110 degrees C to 162 degrees C, is exempted from the requirement of a tolerance when used as a solvent or cosolvent in pesticide formulations with the following restrictions:
(a) Not for use after edible parts of the plant begin to form.
(b) Do not graze livestock in treated areas within 48 hours after application.
(a) Residues of dimethylformamide are exempted from the requirement of a tolerance when used in accordance with good agricultural practices in formulations with the fungicide triforine (
(b) Dimethylformamide (DFM) is exempted from the requirement of a tolerance, when used by the U.S. Department of Interior, Fish and Wildlife Service, as a solvent for the lamprecide, sodium salt of alpha, alpha, alpha-trifluoro-4-nitro-meta-cresol, or 4-nitro-3-(trifluoromethyl)phenol in the Great Lakes.
The insecticide carbon dioxide is exempted from the requirement of a tolerance when used after harvest in modified atmospheres for stored insect control on raw agricultural 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 raw agricultural commodities.
The insecticide combustion product gas is exempted from the requirements of a tolerance when used after harvest in modified atmospheres for stored product insect control on all raw agricultural commodities (except fresh meat) with the following prescribed conditions.
(a) The insecticide is produced by the controlled combustion in air of butane, propane, or natural gas. The combustion equipment shall be provided with an absorption type filter capable of removing possible toxic impurities, through which all gas used in the treatment of food shall pass; and with suitable controls to insure that any combustion products failing to meet the specifications provided will be prevented from reaching the food being treated.
(b) The insecticide meets the following specifications:
(1) Carbon monoxide content not to exceed 4.5 percent by volume.
(2) It is used or intended for use to displace or remove oxygen in the storage of food, except fresh meat.
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
Polyamide polymer derived from sebacic acid, vegetable oil acids with or without dimerization, terephthalic acid and/or ethylenediamine is exempted from the requirement of a tolerance when used as an encapsulating medium for methoprene only.
(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 grapes 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, Bermuda grass hay, blue grass hay, brome grass hay, clover hay, corn grain, oat grain, orchard grass hay, sorghum grain, sudan grass hay, rye grass hay, and timothy hay.
(a) Polyvinyl chloride (film and resin) is exempt from the requirement of a tolerance for residues in or on cottonseed, when used as an inert controlled-release dispenser for formulations of the attractant gossyplure [(
(b) Polyvinyl chloride is exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity artichokes when used as inert multi-layered laminated controlled-release dispensers of (Z)-11-hexadecenal to disrupt the mating of the artichoke plume moth.
(a) Butyl benzyl phthalate is exempt from the requirement of a tolerance for residues in or cottonseed, when used as an inert plasticizer in the formulation of controlled-release laminated dispensers of the attractant gossyplure [(
(b) Butyl benzyl phthalate is exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity artichokes when used as an inert plasticizer in multi-layered laminated controlled-release dispensers of
An exemption from the requirement of a tolerance for the combined residues of the biological insecticide Kontrol H.V. when used on cotton to control the tobacco budworm.
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-
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 180.1001(d).
(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 crop group
Whole egg solids (of at least feed grade quality) are exempted from the requirement of a tolerance for residues when used as an animal repellent in or on almonds and applied to the growing crop in accordance with good agricultural practices.
(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 peaches, quinces, nectarines, and macadamia nuts 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
2,2-Dichloro-
The insecticide poly(oxy-1,2,-ethanediyl), alpha-isooctadecyl-omega-hydroxy (as Registry Number 52292-17-8) is exempted from the requirement of a tolerance for residues in or on fish, shellfish, irrigated crops, meat, milk, poultry, and eggs when used in accordance with good agricultural practice as a mosquito control agent in aquatic sites.
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-
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:
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-
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: cotton, soybeans, potatoes, sugarbeets, tomatoes, bell peppers, squash, strawberries, eggplants, cucumbers, carrots, radish, turnips, onions, peas, melons, grapes, walnuts, almond, 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 biofungicide
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 beeswax and honey 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 grapes 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 RAC's 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
Tetradecyl acrylate-acrylic acid copolymer, hexadecyl acrylate-acrylic acid copolymer, octadecyl acrylate-acrylic acid copolymer, docosyl methacrylate-acrylic acid copolymer, hexadecyl acrylate-butyl acrylate-acrylic acid copolymer, hexadecyl acrylate-dodecyl acrylate-acrylic acid copolymer, octadecyl methacrylate-butyl acrylate-acrylic acid copolymer, octadecyl methacrylate-hexyl acrylate-acrylic acid copolymer, octadecyl acrylate-dodecyl acrylate-acrylic acid copolymer, octadecyl methacrylate-dodecyl acrylate-acrylic acid copolymer, octadecyl methacrylate-dodecyl methacrylate-acrylic acid copolymer, and docosyl methacrylate-octadecyl methacrylate-acrylic acid copolymer, minimum number average molecular weight 3,000, are exempted from the requirement of a tolerance when used as inert ingredients (controlled-release agents) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, or animals.
The biological pesticides
The biological pesticide
An exemption from the requirement of a tolerance is established for the microbial pest control agent
(a) Application shall be limited solely to placement of attractant stations containing Metarhizium anisopliae strain ESF1.
(b) To ensure safe use of the microbial pest control agent, its label and labeling shall conform to that registered by the U.S. Environmental Protection Agency.
An exemption from the requirement of a tolerance is established for residues of the frost protectant urea in or on the following raw agricultural commodities when used before harvest in the production of: alfalfa, almonds, apples, apricots, artichokes, asparagus, avocados, beans, bell peppers, blackberries, blueberries, broccoli, brussels sprouts, boysenberries, caneberries, canola, cantaloupes, carrots, cauliflower, casaba, celery, cherries, chili peppers, chinese cabbage (bok choy, napa), cooking peppers, corn, cotton, crenshaw, cucumbers, figs, grapefruit, grapes, honeydew melon, hops, kiwifruit, kohlrabi, lemons, lentils, lettuce, limes, macadamia nuts, musk melon, nectarines, olives, onions, oranges, peaches, pears, peanuts, peas, persian melon, pistachios, plums, potatoes, pumpkin, prunes, radish, raspberries, rice, safflower, sorghum, spinach, spinach (New Zealand), squash (winter and summer), strawberries, sugar beets, sunflower, sweet pepper, table beets, tangerines, tomatoes, walnuts, watermelon, and zucchini.
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,
(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.
The biological pesticide
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 microbial pest control agent
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, i.e., placed in the field in easily perceived distinct locations in a manner that does not prevent later retrieval. This exemption does not apply to codlure applied in a broadcast manner either to a crop field plot or to individual plants.
(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 (i.e., in easily perceived distinct locations in a manner that
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) Cumulative yearly application cannot exceed 20 grams of each floral attractant/acre/application.
(b) [Reserved]
The biofungicide
An exemption from the requirement of a tolerance is established for residues of the biological pesticide
The biological fungicide
The plant pesticides watermelon mosaic virus-2 coat protein and zucchini
Methyl-1-alkylamido ethyl-2-alkyl-imidazolinium methyl sulfate, where the alkyl group (C
The neomycin phosphotransferase II (NPTII) and the genetic material necessary for the production of this protein are exempted from the requirement of a tolerance in or on all raw agricultural commodities when used as a plant-pesticide inert ingredient.
The biological nematicide
The biochemical sodium 5-nitroguaiacolate is exempted from the requirement of a tolerance when used as a plant regulator in end-use products at a concentration of 0.1% by weight and applied at an application rate of 20 grams of active ingredient per acre (20 g ai/A) or less per application, in or on the raw agricultural commodities cottonseed, cotton gin byproducts, rice, rice straw, soybeans, and soybean forage and hay.
The biochemical sodium
The biochemical sodium
An exemption from the requirement of a tolerance is established for residues of the plant growth regulator 1,4-
Methyl anthranilate, a biochemical pesticide, is exempt from the requirement of a tolerance when used in accordance with good agricultural practices on the following raw agricultural commodities: Blueberry, cherry, and grape.
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 plant growth regulator 6-benzyladenine is exempt from the requirement of a tolerance when used as a fruit-thinning agent at an application rate not to exceed 30 grams of active ingredient per acre (30 g ai/A) in or on apples.
Phosphinothricin Acetyltransferase (PAT) and the genetic material necessary for its production in all plants are exempt from the requirement of a tolerance when used as plant-pesticide
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 pertains to only 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.
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.
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 (Reg. No. 11688-8) is exempt from the requirement of a tolerance on all raw agricultural 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
Killed
(a) Meat meal, a sterilized food by-product, is exempt from the requirement of a tolerance on all raw agricultural commodities when used as an olfactory animal repellent.
(b) Red pepper (
(c) Corn gluten (CAS Reg. No. 66071-96-3) is exempt from the requirement of a tolerance on all food commodities when used as an herbicide in accordance with good agricultural practice.
(d) Any edible food commodity (except for peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat) used as a pesticide is exempted from the requirement of a tolerance when used in accordance with good agricultural practice in or on all food commodities. This exemption shall not apply to any edible food commodity that is adulterated under section 342 of Title 21 of the United States Code. The term edible food commodity means a food that is widely consumed for its nutrient properties. The term only applies to food in the form it is sold or distributed to the public for consumption.
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 dihydroazadirachtin is exempted from the requirement of a tolerance in or on all raw agricultural commodities when applied as an insect growth regulator and/or antifeedant at 20 gm or less per acre with the maximum number of seven applications per growing season on all raw agricultural commodities.
CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) and the genetic material necessary for its production in all plants are exempt from the requirement of a tolerance when used as plant pesticide inert ingredients in all raw agricultural commodities. “Genetic material necessary for its production” means the genetic material which comprise genetic material encoding the CP4 EPSPS and its regulatory regions. “Regulatory regions” are the genetic material that control the expression of the genetic material encoding the CP4 EPSPS, such as promoters, terminators, and enhancers.
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 beeswax 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). This temporary exemption from the requirement of a tolerance expires and is
(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 is established for residues of the microbial plant regulator
An exemption fron the requirement of a tolerance is established for residues of the biological plant pesticide Coat Protein of Potato Virus Y and the genetic material necessary for its production in or on all food commodities.
An exemption from the requirement of a tolerance is established for residues of the biological plant pesticide Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 gene) and the genetic material necessary for its production.
An exemption from the requirement of a tolerance is established for residues of the biological plant pesticide Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow Mosaic Virus and the genetic material necessary for its production in or on all food commodities.
An exemption from the requirement of a tolerance is established for residues of the biological plant pesticide Coat Protein of Papaya Ringspot Virus and the genetic material necessary for its production in or on all food commodities.
An exemption from the requirement of a tolerance is established for residues of the biological plant pesticide Coat Protein of Cucumber Mosaic Virus and the genetic material necessary for its production in or on all food commodities.
Gamma aminobutyric acid is exempt from the requirement of a tolerance on all food commodities when used as a plant growth enhancer 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.
Glyphosate Oxidoreductase [GOX or GOXv247] and the genetic material necessary for its production in all plants are exempt from the requirement of a tolerance when used as plant-pesticide inert ingredients in all plant RACs.
An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide, ferric phosphate (FePO
The plant-pesticide
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.
An exemption from the requirement of a tolerance is established for residues of the biochemical pesticide, canola oil, conforming to the following definition when used as an insecticide, in or on all food commodities: Canola oil, also known as low erucic rapeseed oil, is the full refined, bleached, and deodorized edible oil obtained from certain varieties of
Titanium dioxide 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.
An exemption from the requirement of a tolerance is established for residues of peroxyacetic acid up to 100 ppm in or on raw agricultural commodities, in processed commodities, when such residues result from the use of peroxyacetic acid as an antimicrobial agent on fruits, vegetables, tree nuts, cereal grains, herbs, and spices.
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 crops and postharvest potatoes when applied as an algaecide, fungicide and bactericide.
An exemption from the requirement of a tolerance is established for residues of the microbial pesticide,
The phospholipid biochemical Lyso-PE (lysophosphatidylethanolamine); is temporarily exempted from the requirement of a tolerance for residues when used on crops including: apples, citrus, cranberries, grapes, nectarines, peaches, pears, strawberries, and tomatoes. This temporary exemption from the requirement for a tolerance will permit the marketing of the food commodities in this paragraph when treated in accordance with the provisions of experimental use permit 70515-EUP-1, which is being issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the requirement of a tolerance expires and is revoked on June 1, 2001. This temporary exemption from the requirement of a tolerance may be revoked at any time if the experimental use permit is revoked or if any experience with or scientific data on this pesticide indicate that the tolerance is not safe.
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,
The biological pesticide Harpin is exempted from the requirement of a temporary tolerance when applied under the terms of Experimental Use Permit 69834-EUP-1, for the broad spectrum control of various bacterial, fungal, and viral plant diseases when used on
An exemption from the requirement of a tolerance is established for residues of the insecticide
21 U.S.C. 346(a) and 348.
The text of part 185 set forth below was transferred and recodified at 53 FR 24666, June 29, 1988. New part 185 formerly appeared in 21 CFR part 193. A Redesignation Table appears in the Finding Aids section of this volume.
(a) A regulation is established permitting the combined residues of the insecticide/nematocide aldicarb 2-methyl-2-(methylthio)propion-aldehyde
(b) [Reserved]
The food additive aluminum phosphide may be safely used in accordance with the following prescribed conditions:
(a) It is used to generate phosphine in the fumigation of processed foods.
(b) To assure safe use of the additive, it is used in compliance with label and labeling conforming to that registered with the U.S. Environmental Protection Agency. Labeling shall bear a warning to aerate the finished food for 48 hours before it is offered to the consumer. A further warning shall state that under no condition should the formulation containing aluminum phosphide be used so that it or its unreacted residues 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.
(c) Residues of phosphine in or on processed foods do not exceed 0.01 part per million.
Tolerances are established for combined residues of the herbicide 4-amino-6-(1,1-dimethylethyl)-3-(methyl-thio)--1,2,4-triazin-5(4
The food additive carbon dioxide may be safely used after harvest in modified atmospheres for stored product insect control on all processed agricultural commodities.
(a) Tolerances are established for the combined residues of the insecticide chlorpyrifos [
(b) The additive chlorpyrifos [
(1) 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.
(2) 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.
(3) Paint-on application for spot treatment shall be limited to a maximum of 2 percent of the active ingredient by weight.
(4) 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.
(5) 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.
(6) 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.
(c) A tolerance of 0.1 part per million is established for residues of chlorpyrifos, per se, in or on all food items (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.
(1) 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.
(2) Spray concentrations shall be limited to a maximum of 0.5 percent of the active ingredient by weight.
(3) 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.
(4) For spot treatment, an individual spot shall not exceed 2 square feet.
(5) 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.
(d) Tolerances are established for residues of the insecticide chlorpyrifos [
Tolerances are established for the combined residues of the insecticide chlorpyrifos-methyl (
The food additive combustion product gas may be safely used after harvest in modified atmospheres for stored product insect control on all processed agricultural commodities (except fresh meat) with the following prescribed conditions:
(a) The combustion product gas is produced by the controlled combustion in air of butane, propane, or natural gas. The combustion equipment shall be provided with an absorption type filter capable of removing possible toxic impurities through which all gas used in the treatment of food shall pass and with suitable controls to insure that any combustion products failing to meet the specifications provided will be prevented from reaching the food being treated.
(b) The insecticide meets the following specifications:
(1) Carbon monoxide content not to exceed 4.5 percent by volume.
(2) It is used or intended for use to displace or remove oxygen in the storage of food, except fresh meat.
A tolerance of 1 part per million is established in potable water for residues of copper resulting from the use of the algicides or herbicides basic copper carbonate (malachite), copper sulfate, copper monoethanolamine, and copper triethanolamine to control aquatic plants in reservoirs, lakes, ponds, irrigation ditches, and other potential sources of potable water.
Tolerances are established for combined residues of the insecticide cyhexatin (tri-cyclo-hexyl-hydroxystannane; CAS Reg. No. 13121-70-5) and its organotin metabolites (calculated as cyhexatin) in or on the following processed foods when present therein as a result of application of this insecticide to the growing crops:
A tolerance of 0.2 part per million is established for residues of the herbicide dalapon (2,2-dichloropropionic acid) in potable water when present therein as a result of the application of dalapon sodium-magnesium salt mixtures to irrigation ditch banks in the western United States.
The food additive 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 processing and food storage areas in accordance with the prescribed conditions:
(a) It is used or intended for use for control of insects in food processing and food storage areas:
(b) 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.
Tolerances are established for the combined residues of the herbicide dicamba (3,6-dichloro-
The food additive 2,2-dichlorovinyl dimethyl phosphate 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.
(a) A tolerance of 30 parts per million, of which no more than 15 parts per million is
(b) [Reserved]
(a) A tolerance of 0.01 ppm is established for residues of the herbicide diquat (6,7-dihydrodipyrido (1,2-a:2′,1′-c) pyrazidiinium) derived from application of the dibromide salt in potable water resulting from the application of the pesticide for control of aquatic weeds in ponds, lakes, reservoirs, marshes, bayous, drainage ditches, canals, streams, and rivers which are slow-moving or quiescent in programs of the Corps of Engineers or other Federal or State public agencies. These agencies or contractors or licensees under their direct control will make certain that the treated water will not be used for animal consumption, swimming, spraying, domestic purposes, or for irrigation for 14 days post-treatment or until approved analysis shows that the water does not contain more than 0.01 ppm of diquat (calculated as the cation) and that no treatment will be made where commercial processing of fish resulting in the production of fish protein concentrate or fish meal is practiced.
(b) A tolerance of 0.01 ppm is established for residues of the herbicide diquat (6,7-dihydrodipyrido (1,2-a:2′,1′-c) pyrazinediium) (calculated as the cation) derived from application of the dibromide salt in potable water resulting from the application of the pesticide in ponds, lakes, and drainage ditches where there is little or no outflow of water and which are totally under control of the user. The applicator will make certain that treated water will not be used for animal consumption, swimming, spraying, irrigation, or domestic purposes for 14 days post-treatment. For the purposes of this paragraph only (§ 185.2500(b)) these applications of diquat are not to be used in aquatic sites in Florida.
(c) A food additive regulation of 0.5 part per million is established for residues of diquat in processed potatoes (includes potato chips).
A tolerance of 24 parts per million is established for 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) and its metabolite endosulfan sulfate (6,7,8,9,10,10-hexa-chloro-1,5,5a,6,9,9a-hexa-hydro-6,9-methano-2,4,3-benzo-dioxathiepin-3,3-dioxide) in or on dried tea (reflecting less than 0.1 part per million residues in beverage tea) resulting from application of the insecticide to growing tea.
A food additive regulation is established permitting residues of the plant growth regulator ethephon [(2-chloroethyl) phosphonic acid] in or on the following food commodities:
Ethylene oxide may be safely used as a fumigant for the control of microorganisms and insect infestation in ground spices and other processed natural seasoning materials, except mixtures to which salt has been added, in accordance with the following prescribed conditions:
(a) Ethylene oxide, either alone or admixed with carbon dioxide or dichlorodifluoromethane, shall be used in amounts not to exceed that required to accomplish the intended technical effects. If used with dichlorodifluoromethane, the dichlorodifluoromethane shall conform with the requirements
(b) 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 or labeling.
(c) Residues of ethylene oxide in ground spices from both postharvest application to the raw agricultural commodity whole spices and application to the ground spices shall not exceed the established tolerance of 50 parts per million for residues in whole spices in 40 CFR 180.151.
Tolerances are established for the combined residues of the nematocide ethyl 3-methyl-4-(methylthio)phenyl (1-methylethyl)-phosphoramidate and its cho-lin-esterase-inhibiting metabolites ethyl 3-methyl-4-(methyl-sulfinyl)phenyl (1-methyl-ethyl)-phos-phoramidate and ethyl 3-methyl-4-(methyl-sulfonyl)-phenyl (1-methyl-ethyl) phos-phoramidate in or on the following food commodities:
A tolerance of 1 part per million is established for residues of the insecticide
Tolerances are established for residues of (
A regulation is established permitting the combined residues of the insecticide hexakis (2-methyl-2-phenyl-propyl) distannoxane and its organotin metabolites calculated as hexakis (2-methyl-2-phenyl-propyl) distannoxane in or on the following food items:
A food additive tolerance with regional registration, as defined in § 180.1(n) and which excludes use of hexazinone on sugarcane in Florida, is established for combined residues of the herbicide hexazinone (3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4(1
Tolerances are established for the combined residues of the fungicide imazalil 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-1
The food additive inorganic bromide may be present as a residue in certain processed foods in accordance with the following conditions:
(a) When the food additive is 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 40 CFR part 180, the total residues of inorganic bromides (calculated as Br) shall not exceed the following levels:
(b) [Reserved]
(c) When the food additive is present in fermented malt beverages in accordance with §§ 185.3480 and/or 21 CFR 172.730(a)(2) of this chapter, the amount shall not exceed 25 parts per million (calculated as Br).
(d)-(v) [Reserved]
(w) Where tolerances are established under sections 408 and 409 of the FFDCA on both the raw agricultural commodities and processed foods made therefrom, the total residues of inorganic bromides in or on the processed food shall not be greater than those designated in paragraphs (a) of this section, unless a higher level is established elsewhere in this part or in part 180.
The food additive d-limonene may be safely used in accordance with the following conditions:
(a) It is used with the active ingredients dihydro-5-pentyl-2(3H)-furanone and dihydro-5-heptyl-2(3H)-furanone in insect-repellent tablecloths and in insect-repellent strips used in food-handling establishments.
(b) 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.
The food additive magnesium phosphide may be safely used in accordance with the following prescribed conditions:
(a) It is used to generate phosphine in the fumigation of processed foods.
(b) To assure safe use of the additive, it is used in compliance with the label and labeling conforming to that registered with the U.S. Environmental Protection Agency. The labeling shall bear a warning to aerate the finished food for 48 hours before it is offered to the consumer. A further warning shall state that under no condition should the formulation containing magnesium phosphide be used so that it or its unreacted residues will come in contact with any processed food.
(c) Residues of phosphine in or on processed foods do not exceed 0.01 part per million.
(a) A regulation is established permitting the combined residues of the fungicide metalaxyl [
(b)
(c) [Reserved]
(d) A food additive regulation is established for residues of the fungicide metalaxyl, [N-(2,6-dimethylphenyl)-N-(methoxyacetyl)alanine methyl ester], and its metabolites containing the 2,6-dimethylaniline moiety, and N-(2-hydroxymethyl-6-methylphenyl)-N-(methoxyacetyl) alanine methyl ester, each expressed as metalaxyl, in or on the following processed foods when present therein as a result of application to growing hops:
A food additive regulation is established allowing the use of the microbial pest-control agent
(a)
(b) Application shall be limited solely to placement of attractant stations containing
(c) To ensure safe use of the microbial pest control agent, 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 food additive tolerance of 12 parts per million is established for residues of the insecticide methomyl (S-methyl-N-[(methyl-carbomyl) oxy]thio-acetimidate) in or on the processed commodity dried hops as a result of application to the growing hops. There are no United States registrations for use of methomyl on hops, as of February 14, 1990.
A tolerance of 10 parts per million is established for residues of isopropyl (E,E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate) in or on the food additive commodity cereal grain milled fractions (except flour and rice hulls).
The food additive nitrogen may be safely used after harvest in modified atmospheres for stored product insect control on all processed agricultural commodities.
The food additive
(a) It is used in combination with piperonyl butoxide and pyrethrins for insect control in food-processing and food-storage areas, provided that the food is removed or covered prior to such use.
(b) Residues in food resulting from the use described in paragraph (a) of this section shall not exceed 10 parts per million of
(c) 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.
The food additive paraformaldehyde may be safely used in accordance with the following prescribed conditions.
(a) It is used to control microbial or fungal growth in maple tree tapholes
(b) It is so used that the maple sirup produced from the sap of treated maple trees does not contain in excess of 2 parts per million of formaldehyde.
The food additive piperonyl butoxide may be safely used in accordance with the following prescribed conditions:
(a) It is used or intended for use in combination with pyrethrins for control of insects:
(1) 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.
(2) 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 dried foods.
(3) 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 dried foods that contain 4 percent fat or less.
(4) 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 prunes, raisins, and other dried fruits 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).
(5) In food processing and food storage areas:
(b) It is used or intended for use in combination with pyrethrins and
(c) A tolerance of 10 parts per million is established for residues of piperonyl butoxide in or on:
(1) Milled fractions derived from cereal grains when present therein as a result of its use in cereal grain mills and in storage areas for milled cereal grain products.
(2) Dried foods when present as a result of migration from its use on the outer ply of multiwall paper bags of 50 pounds or more capacity.
(3) Foods treated in accordance with § 178.3730.
(4) Dried foods 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.
(5) Foods treated in accordance with paragraph (a)(4) and (5) of this section.
(d) 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.
(e) Where tolerances are established under sections 408 and 409 of the Act on both raw agricultural commodities and
(a) Tolerances are established for the combined residues of the insecticide pirimiphos-methyl (
(b) A food additive tolerance of 8.0 parts per million is established for residues of the insecticide pirimiphos-methyl (0-[2-diethylamino-6-methyl-4-pyrimidinyl]0,0-dimethyl phos-phorothioate) and its metabolite 0-(2-ethyl-amino-6-methyl-py-rim-i-dine-4-yl)0,0-dimethyl-phosphoro-thioate and, in free and conjugated forms, the metabolites 2-diethyl-amino-6-methyl-py-rim-i-din-4-ol,2-ethyl-amino-6-methyl-py-rim-i-din-4-ol, and 2-amino-6-methyl-py-rim-i-din-4-ol in or on the processed commodity wheat flour as a result of application to stored wheat grain. There are no United States registrations for use of pirimiphos-methyl on wheat, as of June 12, 1990.
Tolerances are established for residues of the insecticide propargite (2-(
At 61 FR 12009, Mar. 22, 1996, in § 185.5000, the entries for “Figs, dried” and “Tea, dried” were removed from the table, effective May 21, 1996. At 61 FR 25154, May 20, 1996, those removals were stayed indefinitely, effective May 21, 1996.
A tolerance of 0.1 part per million is established for residues of the insecticide propetamphos ([(e)-]-methylethyl 3-[[(ethylamino) methoxyphosphinothioyl]oxy]-2-butenoate]) in food commodities exposed to the insecticide during treatment of food-handling establishments.
(a) Direct 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. Spray and dust concentrations shall be limited to a maximum of 1 percent active ingredient. For crack and crevice treatment, equipment capable of delivering a dust or a pin-stream of spray directly into cracks and crevices shall be used. For spot treatment, a coarse, low-pressure spray shall be used to avoid contamination of food or food-contact surfaces.
(b) To ensure 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.
The food additive propylene oxide may be safely used in or on foods in accordance with the following prescribed conditions:
(a) It is intended as a fumigant in or on bulk quantities of cocoa, gums, processed spices, and processed nutmeats (except peanuts) when such bulk foods are to be further processed into a final food form.
(b) It is applied in fumigation chambers not more than one time at a temperature not in excess of 125 °F. The maximum period of fumigation shall not exceed 4 hours for cocoa, processed nutmeats (except peanuts), and processed spices. For edible gums, the maximum duration shall be 24 hours.
(c) When used as described in paragraphs (a) and (b) of this section, residues shall not exceed the following limitations:
(d) When used as a mixture with carbon dioxide (92 parts of carbon dioxide to 8 parts of propylene oxide on a weight/weight basis), all commodities listed in paragraph (c) of this section may be processed not more than one time for a period not to exceed 48 hours and at a temperature not to exceed 125 °F.
(e) To assure safe use of the additive, the label and labeling of the pesticide formulation containing the food additive shall conform to the label an labeling registered by the U. S. Environmental Protection Agency.
The food additive pyrethrins may be safely used in accordance with the following prescribed conditions:
(a) It is used or intended for use in combination with piperonyl butoxide for control of insects:
(1) In cereal grain mills and in storage areas for milled cereal grain products, whereby the amount of pyrethrins is from 10 percent to 100 percent of the amount of piperonyl butoxide in the formulation.
(2) On the outer ply of multiwall paper bags of 50 pounds or more capacity in amounts not exceeding 6 milligrams per square foot, whereby the amount of pyrethrins is equal to 10 percent of the amount of piperonyl butoxide in the formulation. Such treated bags are to be used only for dried foods.
(3) On cotton bags of 50 pounds or more capacity in amounts not exceeding 5.5 milligrams per square foot of cloth, whereby the amount of pyrethrins is equal to 10 percent of the amount of piperonyl butoxide in the formulation. Such treated bags are constructed with waxed paper liners and are to be used only for dried foods that contain 4 percent fat or less.
(4) 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 10 milligrams of pyrethrins per square foot (107.6 milligrams per square meter). Such treated bags are to be used only for packaging prunes, raisins, and other dried fruits and are to have a maximum ratio of 0.31 milligram of pyrethrins per ounce of fruit (0.01 milligram of pyrethrins per gram of product).
(5) In food processing areas and food storage areas:
(b) It is used or intended for use in combination with piperonyl butoxide and
(c) A tolerance of one part per million is established for residues of pyrethrins in or on:
(1) Milled fractions derived from cereal grains when present as a result of its use in cereal grain mills and in storage areas for milled cereal grain products.
(2) Dried foods when present as the result of migration from its use on the outer ply of multiwall paper bags of 50 pounds or more capacity.
(3) Foods treated in accordance with § 185.4500.
(4) Dried foods 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.
(5) Foods treated in accordance with paragraphs (a)(4) and (a)(5) of this section.
(d) 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.
(e) Where tolerances are established under sections 408 and 409 of the Act on both raw agricultural commodities and processed foods made therefrom, 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.
A food additive regulation is established to permit residues of the fungicide triforine (
Tolerances are established for residues of a fungicide which is a coordination product of zinc ion and maneb (manganous ethylenebisdithiocarbamate) containing 20 percent manganese, 2.5 percent zinc, and 77.5 percent ethylenebisdithiocarbamate (the whole product calculated as zinc ethylenebisdithiocarbamate) in or on the following processed foods, when present therein as a result of the application of this fungicide to growing crops:
Malathion may be safely used for the control of insects during the drying of grapes (raisins) in compliance with § 185.3850 by incorporation into paper trays in amounts not exceeding 100 milligrams per square foot.
21 U.S.C. 342, 348, and 371.
The text of part 186 set forth below was transferred and recodified at 53 FR 24668, June 29, 1988. New part 186 formerly appeared in 21 CFR part 561. A Redesignation Table appears in the Finding Aids section of this volume.
Tolerances are established for combined residues of the insecticide and nematocide aldicarb (2-methyl-2-(methyl-thio)-pro-pionaldehyde
The food additive aluminum phosphide may be safely used in accordance with the following prescribed conditions:
(a) It is used to generate phosphine in the fumigation of animal feeds.
(b) To assure safe use of the additive, it is used in compliance with label and labeling conforming to that registered with the U.S. Environmental Protection Agency. Labeling shall bear a warning to aerate the finished feed for 48 hours before use.
(c) Residues of phosphine in or on animal feeds do not exceed 0.1 part per million.
A tolerance is established for residues of the insecticide carbaryl (1-napthyl
The additive 2-chloro-1-(2,4,5-tri-chlorophenyl)vinyl dimethyl phosphate may be safely used in accordance with the following prescribed conditions:
(a) It is used as a feed additive in the feed of beef, dairy cattle, and horses at a rate of 0.00015 pound (0.07 gram) and swine at the rate of 0.00011 pound (0.05 gram) per 100 pounds of body weight per day.
(b) It is used for control of fecal flies in manure of treated cattle, horses, and swine.
(c) To assure safe use of the additive, the label and labeling of the pesticide
(a) Tolerances are established for combined residues of the insecticide chlorpyrifos (
(b) [Reserved]
Tolerances are established for the combined residues of the insecticide chlorpyrifos-methyl (
Tolerances are established for combined residues of the insecticide cyhexatin (tri-cyclo-hexyl-hydroxystannane; CAS Reg. No. 13121-70-5) and its organotin metabolites (calculated as cyhexatin) in or on the following processed foods when present therein as a result of application of the insecticide to the growing crops:
A tolerance of 20 parts per million is established for residues of the herbicide dalapon (calculated as 2,2-dichloropropionic acid) in dehydrated citrus pulp for cattle feed, when present therein as a result of the application of dalapon sodium salt or dalapon sodium-magnesium salt mixtures during the growing of citrus fruit.
The feed additive 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 feed processing and feed storage areas in accordance with the prescribed conditions:
(a) It is used or intended for use for control of insects in feed processing and feed storage areas:
(b) 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) Tolerances are established for the combined residues of of the herbicide dicamba (3,6-dichloro-
(b) A tolerance is established for the combined residues of dicamba (3,6-dichloro-
A regulation is established permitting residues of the insecticide diflubenzuron (
A tolerance is established for residues of the harvest growth regulant dimethipin (2,3-dihydro-5,6-dimethyl-1,4-dithiin 1,1,4,4-tetraoxide; CAS Reg. No. 55290-64-7) in or on the following processed feeds when present therein as a result of application of the harvest growth regulant to the growing crops:
A tolerance of 5 parts per million is established for total residues of the insecticide dimethoate (
A feed additive regulation of 1.0 part per million (ppm) is established for residues of the desiccant diquat [6,7-dihydrodipyrido (1,2-a:2′,1′-c) pyr-azinediium] derived from application of the dibromide salt and calculated as the cation, in processed, dried potato waste.
(a) A feed additive regulation is established permitting residue of the plant growth regulator ethephon [(2-chloroethyl) phosphonic acid] in or on the following feed commodities.
(b) [Reserved]
Tolerances are established for the combined residues of the nematocide ethyl 3-methyl-4-(methylthio)phenyl (1-meth-yl-ethyl)-phos-phor-am-i-date and its cholin-esterase-in-hib-iting me-tab-o-lites ethyl 3-methyl-4-(methyl-sulfinyl)phenyl (1-meth-yl-ethyl)-phos-pho-ram-i-date and ethyl 3-methyl-4-(methyl-sulfonyl)phenyl (1-meth-yl-ethyl) phos-pho-ram-i-date in or on the following feed commodities:
Tolerances are established for residues of (
Tolerances are established for residues of the herbicide flumiclorac pentyl, pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)phenoxy]acetate, including all the metabolites of flumiclorac pentyl, in or on the feeds listed below. The tolerance level for each commodity is expressed in terms of the parent only which serves as an indicator of the use of flumiclorac pentyl on these feeds.
A regulation is established permitting residues of the insecticide (alpha
(a) Tolerances are established for combined residues of the insecticide hexakis (2-methyl-2-phenylpropyl)distannoxane and its organotin metabolites calculated as hexakis (2-methyl-2-phenylpropyl)distannoxane in the following processed feeds when present therein as a result of application of the insecticide to growing crops:
(b) Tolerances with regional registration, as defined in § 180.1(n) of this chapter, are established for residues of the pesticide hexakis in or on the following feed commodities:
A feed additive tolerance with regional registration, as defined in § 180.1(n) and which excludes use of hexazinone on sugarcane in Florida, is established for combined residues of the herbicide hexazinone (3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4(1
A tolerance is established for the combined residues of the fungicide imazalil 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-1
Tolerances are established for residues of inorganic bromides (calculated as Br) as follows:
(a) 400 parts per million for residues in or on dog food, resulting from fumigation with methyl bromide.
(b) 125 parts per million for residues in or on milled fractions for animal feed from barley, corn, grain sorghum (milo), oats, 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.
The feed additive d-limonene may be safely used in accordance with the following conditions:
(a) It is used with the active ingredients dihydro-5-pentyl-2(3H)-furanone and dihydro-5-heptyl-2(3H)-furanone in insect-repellent tablecloths and in insect-repellent strips used in feed-handling establishments.
(b) 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.
The feed additive magnesium phosphide may be safely used in accordance with the following prescribed conditions:
(a) It is used to generate phosphine in the fumigation of animal feeds.
(b) To assure safe use of the additive, it is used in compliance with the label and labeling conforming to that registered with the U.S. Environmental Protection Agency. The labeling shall bear a warning to aerate the finished feed for 48 hours before use. A further warning shall state that under no condition should the formulation containing magnesium phosphide be used so that it or its unreacted residues will come in contact with any processed feed.
(c) Residues of phosphine in or on animal feeds do not exceed 0.1 part per million.
Malathion (
(a) A tolerance of 50 parts per million is established for residues of malathion in dehydrated citrus 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 dried citrus pulp shall not exceed 50 parts per million.
(b) 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.
A feed additive regulation is established allowing the use of the microbial pest-control agent
(a)
(b) Application shall be limited solely to placement of attractant stations containing
(c) To ensure safe use of the microbial pest control agent, 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.
The feed additive methoprene (isopropyl (
(a) It is used as a feed additive in the form of mineral and/or protein blocks or other feed supplements in the feed of cattle at the rate of 22.7 to 45.4 milligrams per 100 pounds of body weight per month.
(b) It is used to prevent the breeding of hornflies in the manure of treated cattle.
(c) To ensure safe use of the additive, the label and labeling of the pesticide formulation containing this additive shall conform to the label and labeling registered by the U.S. Environmental Protection Agency.
(d) Tolerances are established for residues of the insect growth regulator methoprene (isopropyl (E,E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate) in or on the following feed additive commodities:
A tolerance of 6 parts per million is established for residues of the insecticide oxamyl (methyl
The food additive piperonyl butoxide may be safely used in accordance with the following prescribed conditions:
(a) It is used or intended for use in combination with pyrethrins for control of insects:
(1) On the outer ply of multiwall paper bags of 50 pounds or more capacity in amounts not exceeding 60 milligrams per square foot.
(2) 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 are to be used only for dried feeds that contain 4 percent fat or less.
(b) 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 dried feeds.
(c) A tolerance of 10 parts per million is established for residues of piperonyl butoxide when present as the result of migration:
(1) In or on dried feeds from its use on the outer ply of multiwall paper bags of 50 pounds or more capacity.
(2) In or on dried feeds that contain 4 percent fat, or less, from its use on cotton bags of 50 pounds or more capacity constructed with waxed paper liners.
(d) To assure safe use of the additive, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency.
(e) Where tolerances are established under sections 408 and 409 of the Act on both raw agricultural commodities and processed foods made therefrom, the total residues of piperonyl butoxide in
(a) Tolerances are established for the combined residues of the insecticide pirimiphos-methyl (
(b) [Reserved]
A regulation is established permitting residues of the insecticide profenofos [
(a) Tolerances are established for residues of the insecticide propargite (2-(
(b) [Reserved]
A tolerance of 0.1 part per million is established for residues of the insecticide propetamphos ([e)-]-methylethyl 3-[[(ethylamino) methoxyphosphinothioyl]oxy]-2-butenoate]) in animal feed exposed to the insecticide during treatment of animal feed-handling establishments.
(a) Direct application shall be limited solely to spot and/or crack and crevice treatment in feed-handling establishments where feed and feed products are held, processed, prepared, or sold. Spray and dust concentrations shall be limited to a maximum of 1 percent active ingredient. For crack and crevice treatment, equipment capable of delivering a dust or a pinstream of spray directly into cracks and crevices shall be used. For spot treatment, a coarse, low-pressure spray shall be used to avoid contamination of feed or feed-contact surfaces.
(b) To ensure 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.
The food additive pyrethrins may be safely used in accordance with the following prescribed conditions:
(a) It is used or intended for use in combination with piperonyl butoxide for control of insects:
(1) On the outer ply of multiwall paper bags of 50 pounds or more capacity in amounts not exceeding 6 milligrams per square foot.
(2) On cotton bags of 50 pounds or more capacity in amounts not exceeding 5.5 milligrams per square foot of cloth. Such treated bags are constructed with waxed paper liners and are to be used only for dried feeds that contain 4 percent fat or less.
(b) It is used in combination with piperonyl butoxide, whereby the amount of pyrethrins is equal to 10 percent of the amount of piperonyl butoxide in the formulation. Such treated bags are to be used only for dried feeds.
(c) A tolerance of 1 part per million is established for residues of pyrethrins when present as the result of migration:
(1) In or on dried feeds from its use on the outer ply of multiwall paper bags of 50 pounds or more capacity.
(2) In or on dried feeds that contain 4 percent fat, or less, from its use on cotton bags of 50 pounds or more capacity constructed with waxed paper liners.
(d) To assure safe use of the additive, its label and labeling shall conform to that registered with the U.S. Environmental Protection Agency.
(e) Where tolerances are established under sections 408 and 409 of the Act on both raw agricultural commodities and processed foods made therefrom, 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.
A regulation is established for the combined residues of the defoliant thidiazuron (
Tolerances are established for residues of the fungicide thiophanate-methyl (dimethyl [(1,2-phenylene)bis (iminocarbonothioyl)], bis [carbamate]), its oxygen analogue dimethyl-4,4′-
A tolerance of 6 parts per million is established for residues of the defoliant
Tolerances are established for the combined residues of the fungicide triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1
A feed additive regulation is established to permit residues of the fungicide triforine (
Tolerances are established for residues of a fungicide which is a coordination product of zinc ion and maneb (manganous ethylenebisdithiocarba- mate) containing 20 percent manganese, 2.5 percent zinc, and 77.5 percent ethylenebisdithiocarbamate (the whole product calculated as zinc ethylenebisdithiocarbamate) in or on the following processed feed, when present therein as a result of the application of this fungicide to growing crops: 20 parts per million in the milled feed fractions of barley, oats, rye, and wheat.
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
Pesticide Tolerance Commodity/Chemical Index
Crop Grouping Commodities Index
Redesignation Table
List of CFR Sections Affected
The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR Part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.
For the convenience of the user, the Office of Pesticide Programs, Office of Prevention, Pesticides and Toxic Substances, Environmental Protection Agency, has developed the following Pesticide Tolerance Commodity Index. This index indicates the name of the commodity, pesticide chemical, and allowable tolerances.
The EPA Pesticide Tolerance Index System (TISInfo) is available on EPA's World Wide Web site. The index was previously available through the Government Printing Office Federal Bulletin Board service. The index is only available by downloading the TISInfo file from EPA's web site at http://www.epa.gov/opprd001/tolerance/tisinfo/.
The following index is a finding aid to help the reader cross match the listing of commodities with the crop group numbers in the crop group tables appearing in § 180.41.
At 53 FR 24666, June 29, 1988, 21 CFR Parts 193 and 561 were redesignated and recodified into 40 CFR Parts 185 and 186. The following Redesignation Table shows the relationship of the CFR section numbers formerly under Parts 193 and 561 and those sections being redesignated into Parts 185 and 186.
All changes in this volume of the Code of Federal Regulations which were made by documents published in the Federal Register since January 1, 1986, are enumerated in the following list. Entries indicate the nature of the changes effected. Page numbers refer to Federal Register pages. The user should consult the entries for chapters and parts as well as sections for revisions.
Title 40 was established at 36 FR 12213, June 29, 1971. For the period before January 1, 1986, see the “List of CFR Sections Affected, 1964—1972 and 1973-1985” published in six separate volumes.