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(c) Identification of studies. For each study of a type identified in paragraph (b) of this section, the applicant (or registrant in the case of information submitted under FIFRA sec. 3(c)(2)(B)) shall include the appropriate one of the following two statements, together with the signature of the authorized representative of the company, and the date of signature:

(1) “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.]”

[53 FR 15992, May 4, 1988, as amended at 58 FR 34203, June 23, 1993]

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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.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]

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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.

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(a) Rationale and policy. (1) The data requirements specified in this part as applicable to a category of products will not always be appropriate for every product in that category. Some products may have unusual physical, chemical, or biological properties or atypical use patterns which would make particular data requirements inappropriate, either because it would not be possible to generate the required data or because the data would not be useful in the Agency's evaluation of the risks or benefits of the product. The Agency will waive data requirements it finds are inappropriate, but will ensure that sufficient data are available to make the determinations required by the applicable statutory standards.

(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) Procedure for requesting waiver. (1) An applicant should discuss his plans to request a waiver with the EPA Product Manager responsible for his product before developing and submitting extensive support information for the request.

(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) Notification of waiver decision. The Agency will review each waiver request and inform the applicant in writing of its decision. In addition, for decisions that could apply to more than a specific product, the Agency may choose to send a notice to all registrants or to publish a notice in the Federal Register announcing its decision. An Agency decision denying a written request to waive a data requirement shall constitute final Agency action for purposes of FIFRA section 16(a).

(d) Availability of waiver decisions. Agency decisions under this section granting waiver requests will be available to the public at the OPP Regulatory Public Docket located as set forth in 40 CFR 150.17(c). Any person may obtain a copy of any waiver decision by written request in the manner set forth in 40 CFR part 2.

[49 FR 42881, Oct. 24, 1984, as amended at 69 FR 39864, July 1, 2004; 71 FR 35545, June 21, 2006]

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(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, product chemistry, and residue chemistry data.

(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).

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]

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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 vs. non-crop) and the corresponding data necessary to support registration under FIFRA. This information is present in each data requirement table. In addition, the Use Pattern Index (appendix A) is a comprehensive list of pesticide use patterns, cross-referenced to the general use patterns appearing in the tables; the index will further assist the reader in distinguishing agricultural versus non-agricultural uses of pesticides.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]

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(a) Minor use policy. A minor use of a pesticide is a use on a “minor crop” (a crop which is planted on a small total amount of acreage) or a use which is otherwise limited such that the potential market volume of the product for that use is inherently small. EPA's policy concerning data requirements for minor uses of pesticides includes the following elements:

(1) Since the market volume for a minor use of a pesticide is intrinsically low, and the risk associated with the use often is also correspondingly low, EPA will adjust the data requirements concerning the minor use appropriately.

(2) A new data requirement pertinent to both an unregistered minor use and a registered major use will not be applied to a minor use applicant until it is applied to the major use registrations.

(3) EPA will accept extrapolations and regional data to support establishment of individual minor use tolerances.

(4) Group tolerances will be established to assist applicants for registration of products for minor uses as described in 40 CFR 180.34.

(b) Advice on data requirements to support minor uses. Applicants for registration are advised to contact the appropriate EPA Product Manager of the Minor Use Officer for advice on developing data to support new applications for minor uses of pesticides.

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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) Biochemical pesticides. Biochemical pesticides include, but are not limited to, products such as semichemicals (e.g. insect pheromones), hormones (e.g., insect juvenile growth hormones), natural plant and insect regulators, and enzymes. When necessary the Agency will evaluate products on an individual basis to determine whether they are biochemical or conventional chemical pesticides.

(b) Microbial pesticides. (1) Microbial pesticides include microbial entities such as bacteria, fungi, viruses, and protozoans. The data requirements apply to all microbial pesticides, including those that are naturally-occurring as well as those that are genetically modified. Each “new” variety, subspecies, or strain of an already registered microbial pest control agent must be evaluated, and may be subject to additional data requirements.

(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.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]

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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) General policy. Any appropriate protocol may be used provided that it meets the purpose of the test standards specified in the guidelines and provides data of suitable quality and completeness as typified by the protocols cited in the guidelines. Applicants should use the test procedure which is most suitable for evaluation of the particular ingredient, mixture, or product. Accordingly, failure to follow a suggested protocol will not invalidate a test if another appropriate methodology is used.

(b) Organization for Economic Cooperation and Development (OECD) Protocols. Tests conducted in accordance with the requirements and recommendations of the applicable OECD protocols can be used to develop data necessary to meet the requirements specified in this part. Readers should note, however, that certain of the OECD recommended test standards, such as test duration and selection of test species, are less restrictive than those recommended by EPA. Therefore, when using the OECD protocols, care should be taken to observe the test standards in a manner such that the data generated by the study will satisfy the requirements of this part.

(c) Procedures for requesting advice on protocols. Normally, all contact between the Agency and applicants or registrants is handled by the assigned Product Manager in the Registration Division of the Office of Pesticide Programs. Accordingly, questions concerning protocols should be directed, preferably in writing, to the Product Manager responsible for the registration or application which would be affected.

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(a) General policy. The data routinely required by part 158 may not be sufficient to permit EPA to evaluate every pesticide product. If the information required under this part is not sufficient to evaluate the potential of the product to cause unreasonable adverse effects on man or the environment, additional data requirements will be imposed. However, EPA expects that the information required by this part will be adequate in most cases for an assessment of the properties of pesticide.

(b) Policy on test substance. In general, where the technical grade of the active ingredient is specified as the substance to be tested, tests may be performed using a technical grade which is substantially similar to the technical grade used in the product for which registration is sought. In addition to or in lieu of the testing required in subparts C and D of this part the Administrator will, on a case-by-case basis, require testing to be conducted with:

(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.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58 FR 34203, June 23, 1993]

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(a) General policy. The Agency will determine whether the data submitted to fulfill the data requirements specified in this part are acceptable. This determination will be based on the design and conduct of the experiment from which the data were derived, and an evaluation of whether the data fulfill the purpose(s) of the data requirement. In evaluating experimental design, the Agency will consider whether generally accepted methods were used, sufficient numbers of measurements were made to achieve statistical reliability, and sufficient controls were built into all phases of the experiment. The Agency will evaluate the conduct of each experiment in terms of whether the study was conducted in conformance with the design, good laboratory practices were observed, and results were reproducible. The Agency will not reject data merely because they were derived from studies which, when initiated were in accordance with an Agency-recommended protocol, even if the Agency subsequently recommends a different protocol, as long as the data fulfill the purposes of the requirements as described in this paragraph.

(b) Previously developed data. The Agency will consider that data developed prior to the effective date of this part would be satisfactory to support applications provided good laboratory practices were followed, the data meet the purposes of this part, and the data permit sound scientific judgments to be made. Such data will not be rejected merely because they were not developed in accordance with suggested protocols.

(c) Data developed in foreign countries. The Agency considers all applicable data developed from laboratory and field studies anywhere to be suitable to support pesticide registrations except for data from tests which involved field test sites or a test material, such as a native soil, plant, or animal, that is not characteristic of the United States. When studies at test sites or with materials of this type are anticipated, applicants should take steps to assure that United States materials are used or be prepared to supply data or information to demonstrate the lack of substantial or relevant differences between the selected material or test site and the United States material or test site. Once comparability has been established, the Agency will assess the acceptability of the data as described in paragraph (a) of this section.

(d) Data from monitoring studies. Certain data are developed to meet the monitoring requirements of FIFRA sections 5, 8 or 20. Applicants may wish to determine whether some of these data may meet the requirements of this part. In addition, data developed independently of FIFRA regulations or requirements may also satisfy data requirements in this part. Consultation with appropriate EPA Product Managers would be helpful if applicants are unsure about suitability of such data.

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(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 et seq.). Changes having a significant impact on the registration process, applicants, testers, or other parties, or on the outcome and evaluation of studies, will be made only after public notice and opportunity for comment. Until final rules reflecting a change have been promulgated, the Agency can implement changes in the data requirements on a case-by-case basis.

(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.

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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 as conditionally required for that product.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15993, May 4, 1988]

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(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.

[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]

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(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).

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]

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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:

[53 FR 15993, May 4, 1988]

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Source:  53 FR 15993, May 4, 1988, unless otherwise noted.

§ 158.150   General.

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(a) Applicability. This subpart describes the product chemistry data that are required to support the registration of each pesticide product. The information specified in this subpart must be submitted with each application for new or amended registration or for reregistration, if it has not been submitted previously or if the previously submitted information is not complete and accurate. References in this subpart to the “applicant” include the registrant if the information is required for a registered product.

(b) Purpose—(1) Product composition. (i) Data on product composition are needed to support the conclusions expressed in the statement of formula. These data include information on the starting materials, production or formulating process, possible formation of impurities, results of preliminary analysis of product samples, a description of analytical methods to identify and quantify ingredients and validation data for such methods. In addition, an applicant is required to certify the limits for ingredients of his product.

(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) Certified limits. Certified limits required by §158.175 are used in two ways. First, the Agency considers the certified limits in making the registration determination required by sections 3(c)(5), 3(c)(7) and 3(d) of the Act and making other regulatory decisions required by the Act. Second, the Agency may collect commercial samples of the registered products and analyze them for the active ingredient(s), inert ingredients, or impurities determined by the Agency to be toxicologically significant. If, upon analysis the composition of such a sample is found to differ from that certified, the results may be used by the Agency in regulatory actions under FIFRA sec. 12(a)(1)(C) and other pertinent sections.

(3) Nominal concentration. The nominal concentration required by §158.155 is the amount of active ingredient that is most likely to be present in the product when produced. Unlike the certified limits, which are the outer limits of the range of the product's ingredients and thus are present only in a small proportion of the products, the nominal concentration is the amount that typically is expected to result from the applicant's production or formulating process. The nominal concentration together with production process information is used to gauge the acceptability of the certified limits presented by the applicant. The nominal concentration is used by the Agency as the basis for enforceable certified limits if the applicant has chosen not to specify certified limits of his own (thereby agreeing to abide by the standard limits in §158.175).

(4) Physical and chemical characteristics. (i) Data on the physical and chemical characteristics of pesticide active ingredients and products are used to confirm or provide supportive information on their identity. Such data are also used in reviewing the production or formulating process used to produce the pesticide or product. For example, data that indicate significant changes in production or formulation might indicate the need for additional information on product composition.

(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.

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The following terms are defined for the purposes of this subpart:

(a) Active ingredient means any substance (or group of structurally similar substances, if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA sec. 2(a).

(b) End use product means a pesticide product whose labeling

(1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating or regulating growth of plants, and

(2) Does not state that the product may be used to manufacture or formulate other pesticide products.

(c) Formulation means

(1) The process of mixing, blending, or dilution of one or more active ingredients with one or more other active or inert ingredients, without an intended chemical reaction, to obtain a manufacturing use product or an end use product, or

(2) The repackaging of any registered product.

(d) Impurity means any substance (or group of structurally similar substances if specified by the Agency) in a pesticide product other than an active ingredient or an inert ingredient, including unreacted starting materials, side reaction products, contaminants, and degradation products.

(e) Impurity associated with an active ingredient means:

(1) Any impurity present in the technical grade of active ingredient; and

(2) Any impurity which forms in the pesticide product through reactions between the active ingredient and any other component of the product or packaging of the product.

(f) Inert ingredient means any substance (or group of structurally similar substances if designated by the Agency), other than an active ingredient, which is intentionally included in a pesticide product.

(g) Integrated system means a process for producing a pesticide product that:

(1) Contains any active ingredient derived from a source that is not an EPA-registered product; or

(2) 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) Manufacturing use product means any pesticide product other than an end use product. A product may consist of the technical grade of active ingredient only, or may contain inert ingredients, such as stabilizers or solvents.

(i) Nominal concentration means the amount of an ingredient which is expected to be present in a typical sample of a pesticide product at the time the product is produced, expressed as a percentage by weight.

(j) Starting material means a substance used to synthesize or purify a technical grade of active ingredient (or the practical equivalent of the technical grade ingredient if the technical grade cannot be isolated) by chemical reaction.

(k) Technical grade of active ingredient means a material containing an active ingredient:

(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).

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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) Active ingredient. The following information is required for each active ingredient in the product:

(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) Inert ingredients. The following information is required for each inert ingredient (if any) in the product:

(1) The chemical name of the ingredient according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names (if known). If the chemical identity or chemical composition of an ingredient is not known to the applicant because it is proprietary or trade secret information, the applicant must ensure that the supplier or producer of the ingredient submits to the Agency (or has on file with the Agency) information on the identity or chemical composition of the ingredient. Generally, it is not required that an applicant know the identity of each ingredient in a mixture that he uses in his product. However, in certain circumstances, the Agency may require that the applicant know the identity of a specific ingredient in such a mixture. If the Agency requires specific knowledge of an ingredient, it will notify the applicant in writing.

(2) The nominal concentration in the product.

(3) Upper and lower certified limits in accordance with §158.175.

(4) The purpose of the ingredient in the formulation.

(c) Impurities of toxicological significance associated with the active ingredient. For each impurity associated with the active ingredient that is determined to be toxicologically significant, the following information is required:

(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) Other impurities associated with the active ingredient. For each other impurity associated with an active ingredient that was found to be present in any sample at a level equal to or greater than 0.1 percent by weight of the technical grade active ingredient, the following information is required:

(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) Impurities associated with an inert ingredient. [Reserved]

(f) Ingredients that cannot be characterized. If the identity of any ingredient or impurity cannot be specified as a discrete chemical substance (such as mixtures that cannot be characterized or isomer mixtures), the applicant must provide sufficient information to enable EPA to identify its source and qualitative composition.

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The following information must be submitted on the materials used to produce the product:

(a) Products not produced by an integrated system. (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) Products produced by an integrated system. (1) The information required by paragraph (a)(1) of this section concerning each active ingredient that is derived from an EPA-registered product (if any).

(2) The following information concerning each active ingredient that is not derived from an EPA-registered product:

(i) The name and address of the producer of the ingredient (if different from the applicant).

(ii) Information on each starting material used to produce the active ingredient, as follows:

(A) Each brand name, trade name, or other commercial designation of the starting material.

(B) The name and address of the person who produces the starting material or, if that information is not known to the applicant, the name and address of each person who supplies the starting material.

(C) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and if requested by the Agency, chemical or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing it.

(3) The information required by paragraph (a)(2) of this section concerning each inert ingredient.

(c) Additional information. On a case-by-case basis, the Agency may require additional information on substances used in the production of the product.

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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.

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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.

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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) Technical grade active ingredients and products produced by an integrated system. (1) Each impurity associated with the active ingredient which was found to be present in any analysis of the product conducted by or for the applicant.

(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) Products not produced by an integrated system. Each impurity associated with the active ingredient which the applicant has reason to believe may be present in the product at any time before use at a level equal to or greater than 0.1 percent (1000 ppm) by weight of the product based on what he knows about the following:

(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) Expanded discussion. On a case-by-case basis, the Agency may require an expanded discussion of information of impurities:

(1) From other possible chemical reactions;

(2) Involving other ingredients; or

(3) At additional points in the production or formulation process.

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(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.

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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) Ingredients for which certified limits are required. Certified limits are required on the following ingredients of a pesticide product:

(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) EPA determination of certified limits for active and inert ingredients. (1) Unless the applicant proposes different limits as provided in paragraph (c) of this section, the upper and lower certified limits for active and inert ingredients will be determined by EPA. EPA will calculate the certified limits on the basis of the nominal concentration of the ingredient in the product, according to the table in paragraph (b)(2) of this section.

(2) Table of standard certified limits.

(c) Applicant proposed limits. (1) The applicant may propose a certified limit for an active or inert ingredient that differs from the standard certified limit calculated according to paragraph (b)(2) of this section.

(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) Special cases. If the Agency finds unacceptable any certified limit (either standard or applicant-proposed), the Agency will inform the applicant of its determination and will provide supporting reasons. EPA may also recommend alternative limits to the applicant. The Agency may require, on a case-by-case basis, any or all of the following:

(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) Certification statement. The applicant must certify the accuracy of the information presented, and that the certified limits of the ingredients will be maintained. The following statement, signed by the authorized representative of the company, is acceptable:

I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the description of the composition of [product name], EPA Reg. No. [insert registration number], refers to the composition set forth on the Statement of Formula and supporting materials. This description includes the representations that: (1) no ingredient will be present in the product in an amount greater than the upper certified limit or in an amount less than the lower certified limit (if required) specified for that ingredient in a currently approved Statement of Formula (or as calculated by the Agency); and (2) if the Agency requires that the source of supply of an ingredient be specified, that all quantities of such ingredient will be obtained from the source specified in the Statement of Formula.

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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.

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(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the physical and chemical characteristics data requirements and the substance to be tested.

[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]

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(a) General. The data requirements for registration are intended to generate data and information necessary to address concerns pertaining to the identity, composition, potential adverse effects and environmental fate of each pesticide.

(b) [Reserved]

(c) Residue chemistry. (1) Residue Chemistry Data are used by the Agency to estimate the exposure of the general population to pesticide residues in food and for setting and enforcing tolerances for pesticide residues in food or feed.

(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) Environmental fate—(1) General. The data generated by environmental fate studies are used to: assess the toxicity to man through exposure of humans to pesticide residues remaining after application, either upon reentering treated areas or from consuming inadvertently-contaminated food; assess the presence of widely distributed and persistent pesticides in the environment which may result in loss of usable land, surface water, ground water, and wildlife resources; and, assess the potential environmental exposure of other nontarget organisms, such as fish and wildlife, to pesticides. Another specific purpose of the environmental fate data requirements is to help applicants and the Agency estimate expected environmental concentrations of pesticides in specific habitats where threatened or endangered species or other wildlife populations at risk are found.

(2) Degradation studies. The data from hydrolysis and photolysis studies are used to determine the rate of pesticide degradation and to identify pesticides that may adversely affect nontarget organisms.

(3) Metabolism studies. Data generated from aerobic and anaerobic metabolism studies are used to determine the nature and availability of pesticides to rotational crops and to aid in the evaluation of the persistence of a pesticide.

(4) Mobility studies. These data requirements pertain to leaching, adsorption/desorption, and volatility of pesticides. They provide information on the mode of transport and eventual destination of the pesticide in the environment. This information is used to assess potential environmental hazards related to: contamination of human and animal food; loss of usable land and water resources to man through contamination of water (including ground water); and habitat loss of wildlife resulting from pesticide residue movement or transport in the environment.

(5) Dissipation studies. The data generated from dissipation studies are used to assess potential environmental hazards (under actual field use conditions) related to: reentry into treated areas; hazards from residues in rotational crop and other food sources; and the loss of land as well as surface and ground water resources.

(6) Accumulation studies. Accumulation studies indicate pesticide residue levels in food supplies that originate from wild sources or from rotational crops. Rotational crop studies are necessary to establish realistic crop rotation restrictions and to determine if tolerances may be needed for residues on rotational crops. Data from irrigated crop studies are used to determine the amount of pesticide residues that could be taken up by representative crops irrigated with water containing pesticide residues. These studies allow the Agency to establish label restrictions regarding application of pesticides on sites where the residues can be taken up by irrigated crops. These data also provide information that aids the Agency in establishing any corresponding tolerances that would be needed for residues on such crops. Data from pesticides accumulation studies in fish are used to establish label restrictions to prevent applications in certain sites so that there will be minimal residues entering edible fish or shell fish. These residue data are also used to determine if a tolerance or action level is needed for residues in aquatic animals eaten by humans.

(e) Hazard to humans and domestic animals. Data required to assess hazards to humans and domestic animals are derived from a variety of acute, subchronic and chronic toxicity tests, and tests to assess mutagenicity and pesticide metabolism.

(1) Acute studies. Determination of acute oral, dermal and inhalation toxicity is usually the initial step in the assessment and evaluation of the toxic characteristics of a pesticide. These data provide information on health hazards likely to arise soon after, and as a result of, short-term exposure. Data from acute studies serve as a basis for classification and precautionary labeling. For example, acute toxicity data are used to calculate farmworker reentry intervals and to develop precautionary label statements pertaining to protective clothing requirements for applicators. They also: provide information used in establishing the appropriate dose levels in subchronic and other studies; provide initial information on the mode of toxic action(s) of a substance; and determine the need for child resistant packaging. Information derived from primary eye and primary dermal irritation studies serves to identify possible hazards from exposure of the eyes, associated mucous membranes and skin.

(2) Subchronic studies. Subchronic tests provide information on health hazards that may arise from repeated exposures over a limited period of time. They provide information on target organs and accumulation potential. The resulting data are also useful in selecting dose levels for chronic studies and for establishing safety criteria for human exposure. These tests are not capable of detecting those effects that have a long latency period for expression (e.g., carcinogenicity).

(3) Chronic studies. Chronic toxicity (usually conducted by feeding the test substance to the test species) studies are intended to determine the effects of a substance in a mammalian species following prolonged and repeated exposure. Under the conditions of this test, effects which have a long latency period or are cumulative should be detected. The purpose of long-term oncogenicity studies is to observe test animals over most of their life span for the development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of administration.

(4) Teratogenicity and reproduction studies. The teratogenicity study is designed to determine the potential of the test substance to induce structural and/or other abnormalities to the fetus as the result of exposure of the mother during pregnancy. Two-generation reproduction testing is designed to provide information concerning the general effects of a test substance on gonadal function, estrus cycles, mating behavior, conception, parturition, lactation, weaning, and the growth and development of the offspring. The study may also provide information about the effects of the test substance on neonatal morbidity, mortality, and preliminary data on teratogenesis and serve as a guide for subsequent tests.

(5) Mutagenicity studies. For each test substance a battery of tests are required to assess potential to affect the mammalian cell's genetic components. The objectives underlying the selection of a battery of tests for mutagenicity assessment are:

(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) Metabolism studies. Data from studies on the absorption, distribution, excretion, and metabolism of a pesticide aid in the valuation of test results from other toxicity studies and in the extrapolation of data from animals to man. The main purpose of metabolism studies is to produce data which increase the Agency's understanding of the behavior of the chemical in its consideration of the human exposure anticipated from intended uses of the pesticide.

(f) Reentry Protection. Data required to assess hazard to farm employees resulting from reentry into areas treated with pesticides are derived from studies on toxicity, residue dissipation, and human exposure. Monitoring data generated during exposure studies are used to determine the quantity of pesticide to which people may be exposed after application and to develop reentry intervals.

(g) Pesticide Spray Drift Evaluation. Data required to evaluate pesticide spray drift are derived from studies of droplet size spectrum and spray drift field evaluations. These data contribute to development of the overall exposure estimate and along with data on toxicity for humans, fish and wildlife, or plants are used to assess the potential hazard of pesticides to these organisms. A purpose common to all these tests is to provide data which will be used to determine the need for (and appropriate wording for) precautionary labeling to minimize the potential adverse effect to nontarget organisms.

(h) Hazard to nontarget organisms—(1) General. The information required to assess hazards to nontarget organisms are derived from tests to determine pesticidal effects on birds, mammals, fish, terrestrial and aquatic invertebrates, and plants. These tests include short-term acute, subacute, reproduction, simulated field, and full field studies arranged in a hierarchial or tier system which progresses from the basic laboratory tests to the applied field tests. The results of each tier of tests must be evaluated to determine the potential of the pesticide to cause adverse effects, and to determine whether further testing is required. A purpose common to all data requirements is to provide data which determines the need for (and appropriate wording for) precautionary label statements to minimize the potential adverse effects to nontarget organisms.

(2) Short term studies. The short-term acute and subchronic laboratory studies provide basic toxicity information which serves as a starting point for the hazard assessment. These data are used: to establish acute toxicity levels of the active ingredient to the test organisms; to compare toxicity information with measured or estimated pesticide residues in the environment in order to assess potential impacts on fish, wildlife and other nontarget organisms; and to indicate whether further laboratory and/or field studies are needed.

(3) Long term and field studies. Additional studies (i.e., avian, fish, and invertebrate reproduction, lifecycle studies and plant field studies) may be required when basic data and environmental conditions suggest possible problems. Data from these studies are used to: estimate the potential for chronic effects, taking into account the measured or estimated residues in the environment; and to determine if additional field or laboratory data are necessary to further evaluate hazards. Simulated field and/or field data are used to examine acute and chronic adverse effects on captive or monitored fish and wildlife populations under natural or near-natural environments. Such studies are required only when predictions as to possible adverse effects in less extensive studies cannot be made, or when the potential for adverse effects is high.

(i) Product performance. Requirements to develop data on product performance provide a mechanism to ensure that pesticide products will control the pests listed on the label and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. Specific performance standards are used to validate the efficacy data in the public health areas, including disinfectants used to control microorganisms infectious to man in any area of the inanimate environment and those pesticides used to control vertebrates (such as rodents, birds, bats and skunks) that may directly or indirectly transmit diseases to humans.

[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993, May 4, 1988]

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(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the residue chemistry data requirements and the substances to be tested.

[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993, 15999, May 4, 1988; 58 FR 34203, June 23, 1993]

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(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the environmental fate data requirements and the substance to be tested.