40 C.F.R. §§ 152.85–152.96

§152.85. Formulators' exemption.

40 C.F.R. § 152.85

(a)

Statutory provision. FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or cite data pertaining to any pesticide contained in his product that is derived solely from one or more EPA-registered products which the applicant purchases from another person. This provision is commonly referred to as the formulators' exemption.

(b)

Applicability of the formulators' exemption.

(1)

The formulators' exemption applies only to data concerning the purchased product or its ingredients. These data may include, but are not limited to, product chemistry, toxicology, residue chemistry, exposure, environmental fate, and ecological effects.

(2)

The data to which the formulators' exemption applies usually will concern the safety of one or more of the product's active ingredients, specifically, those active ingredients which are contained in the purchased product. In general, data for which the required test substance is the technical grade of the active ingredient, the pure active ingredient, the radiolabeled pure active ingredient, or a typical end-use product are eligible for the formulators' exemption.

(3)

The formulators' exemption generally does not apply to data on the applicant's product itself, including the safety or efficacy of the product, unless the composition of the product is identical to the purchased product. In general, data for which the required test substance is the product proposed for registration are not eligible for the formulators' exemption.

(c)

Limitation of the formulators' exemption. EPA interprets FIFRA section 3(c)(2)(D) as allowing an applicant to use the formulators' exemption with respect to data concerning an ingredient of his product only if:

(1)

The application indicates that the ingredient's presence in the product is attributable solely to the purchase from another person of an identified, registered product containing that ingredient and the use of the purchased product in formulating the product; and

(2)

The purchased product is a registered manufacturing-use product whose label does not prohibit its use for making an end-use product labeled for any use for which the applicant's product will be labeled; or

(3)

The purchased product is a registered end-use product labeled for each use for which the applicant's product will be labeled.

(d)

Claiming eligibility for the exemption.

(1)

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 requirement pertaining to 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):

(i)

Identification of the applicant, and of the product by EPA registration number or file symbol.

(ii)

Identification of each ingredient in the pesticide that is eligible for the formulators' exemption, and the EPA registration number of the product that is the source of that ingredient.

(iii)

A statement that the listed ingredients meet the requirements for the formulators' exemption.

(iv)

A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula.

(v)

The name, title and signature of the applicant or his authorized representative and the date of signature.

(2)

An applicant for amended registration is not required to submit a new formulators' exemption statement, if the current statement in Agency files is complete and accurate.

(e)

Approval of registration. Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve an application unless there are available to EPA for its review all data that are necessary to make the required risk/benefit finding under FIFRA section 3(c)(5) or section 3(c)(7).

Notes, amendments, and revision history

Amendments

[72 FR 61027, Oct. 26, 2007]

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Amendments

[72 FR 61027, Oct. 26, 2007]

§152.86. The cite-all method.

40 C.F.R. § 152.86

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)

Exclusive use studies. The applicant must certify to the Agency that he has obtained, from each person listed on the Data Submitters List as an exclusive use data submitter for the chemical in question, a written authorization that contains at least the following information:

(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)

Other studies. The applicant must certify to the Agency that, with respect to each other person on the Data Submitters List for the chemical in question:

(1)

He has obtained from that person a written authorization that contains the information required by paragraphs (a) (1) through (3) of this section; or

(2)

He has furnished to that person—

(i)

A notification of his intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;

(ii)

An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F) for any data on which the application relies;

(iii)

An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of any study; and

(iv)

The applicant's name, address, and contact information, including telephone number and email address.

(c)

General offer to pay statement. The applicant must submit to the Agency the following general offer to pay statement:

(d)

Acknowledgement of reliance on data. Each application filed under this section shall include an acknowledgement that for purposes of FIFRA section 3(c)(1)(F) the application relies on the following data:

(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.

Notes, amendments, and revision history

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

§152.90. The selective method.

40 C.F.R. § 152.90

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 claiming a data gap.

(a)

List of data requirements.

(1)

Each applicant must submit a list of the data requirements that would apply to his pesticide, its active ingredients, and its use patterns, if the product were being proposed for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(5) for the first time.

(2)

The applicant must list the applicable requirements, as prescribed by part 158 of this chapter, as applicable. All required (R) studies, and any studies that could be conditionally required (CR) based upon composition, use pattern, or the results of required studies, are to be listed. The applicant need not list data requirements pertaining to any ingredient which qualifies for the formulators' exemption.

(b)

Methods of demonstrating compliance. The applicant must state for each data requirement on the list required by paragraph (a) of this section which of the following methods of compliance with the requirement he is using, and shall provide the supporting documentation specified in the referenced section.

(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)

Claim of data gap. Refer to § 152.96.

Notes, amendments, and revision history

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]

§152.91. Waiver of a data requirement.

40 C.F.R. § 152.91

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)

Request for an extension of an existing waiver. An applicant may claim that a waiver previously granted by the Agency also applies to a data requirement for the product. To document this claim, the applicant must provide a reference to the Agency record that describes the previously granted waiver, such as an Agency list of waivers or an applicable Reregistration Eligibility Decision (RED) document or registration review decision document, and explain why that waiver should apply to the product.

(b)

Request for a new waiver. An applicant who requests a waiver to satisfy a data requirement must submit the information specified in 40 CFR 158.45 or 40 CFR 161.45.

(c)

Effect of denial of waiver request. A decision by the Agency to deny a written request for a new waiver or an extension of an existing waiver is a final Agency action. Following denial, the applicant must choose another method of satisfying the data requirement.

Notes, amendments, and revision history

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79 FR 6825, Feb. 5, 2014]

§152.92. Submission of a new valid study.

40 C.F.R. § 152.92

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.

Notes, amendments, and revision history

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

§152.93. Citation of a previously submitted valid study.

40 C.F.R. § 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)

Study originally submitted by the applicant. If the applicant certifies that he is the original data submitter, no documentation other than the citation is necessary.

(b)

Study previously submitted by another person. If the applicant is not the original data submitter, the applicant may cite the study only in accordance with paragraphs (b) (1) through (3) of this section.

(1)

Citation with authorization of original data submitter. The applicant may cite any valid study for which he has obtained the written authorization of the original data submitter. The applicant must obtain written authorization to cite any study that is an exclusive use study. The applicant must certify that he has obtained from the original data submitter a written authorization that contains at least the following information:

(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)

Citation with offer to pay compensation to the original data submitter. The applicant may cite any valid study that is not subject to the exclusive use provisions of FIFRA section 3(c)(1)(F)(i) without written authorization from the original data submitter if the applicant certifies to the Agency that he has furnished to the original data submitter:

(i)

A notification of the applicant's intent to apply for registration, including the proposed product name and a list of the product's active ingredients;

(ii)

Identification of the specific data requirement involved and of the study for which the offer to pay is made (by title, EPA Accession Number or Master Record Identification Number, and date of submission, if possible);

(iii)

An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);

(iv)

An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of the study; and

(v)

The applicant's name, address, and contact information, including a telephone number and email address.

(3)

Citation without authorization or offer to pay. The applicant may cite any valid study without written authorization from, or offer to pay to, the original data submitter if 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).

Notes, amendments, and revision history

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

§152.94. Citation of a public literature study or study generated at government expense.

40 C.F.R. § 152.94

(a)

An applicant may demonstrate compliance for a data requirement by citing, and submitting to the Agency, one of the following:

(1)

A valid study from the public literature.

(2)

A valid study generated by, or at the expense of, any government (Federal, State, or local) agency.

(b)

In no circumstances does submission of a public literature study or government-generated study confer any rights on the data submitter to exclusive use of data or compensation under FIFRA section 3(c)(1)(F).

Notes, amendments, and revision history

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

§152.95. Citation of all studies in the Agency's files pertinent to a specific data requirement.

40 C.F.R. § 152.95

An applicant normally may demonstrate compliance for a data requirement by citation of all studies in the Agency's files pertinent to that data requirement. The applicant who selects this cite-all option must submit to the Agency:

(a)

A general offer to pay statement having the same wording as that specified in § 152.86(c) except that the offer to pay may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected;

(b)

A certification that—

(1)

For each person who is included on the Data Submitters List as an original data submitter of exclusive use data for the active ingredient in question, the applicant has obtained a written authorization containing the information required by § 152.86(a) for the use the any exclusive use study that would be pertinent to the applicant's product; and

(2)

For each person included on the current Data Submitters List as an original data submitter of data that are not exclusive use for the active ingredient in question, the applicant has furnished:

(i)

A notification of the applicant's intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;

(ii)

Identification of the specific data requirement(s) for which the offer to pay for data is being made;

(iii)

An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F);

(iv)

An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for use of any study; and

(v)

The applicant's name, address, and contact information, including a telephone number and email address.

(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.

Notes, amendments, and revision history

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Amendments

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008; 79 FR 6825, Feb. 5, 2014]

§152.96. Claim of data gap.

40 C.F.R. § 152.96

(a)

When a data gap may be claimed. Except as provided in paragraph (b) of this section, an applicant may defer his obligation to satisfy an applicable data requirement until the Agency requires the data if no other person has previously submitted to the Agency a valid study that would satisfy the data requirement in question.

(b)

When a data gap may not be claimed—

(1)

Product containing a new active ingredient. An applicant for registration of a product containing a new active ingredient may not defer his obligation by claiming a data gap unless he can demonstrate to the Agency's satisfaction that the data requirement was imposed so recently that insufficient time has elapsed for the study to have been completed and that, in the public interest, the product should be registered during the limited period of time required to complete the study. Refer to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(7)(C).

(2)

Product not containing a new active ingredient. An applicant for registration of a product under FIFRA sections 3(c)(7)(A) or (B) (a product not containing a new active ingredient) may not defer his obligation by claiming a data gap if the data are:

(i)

Data needed to determine whether the product is identical or substantially similar to another currently registered product or differs only in ways that would substantially increase the risk of unreasonable adverse effects on the environment.

(ii)

Efficacy data specific to the product, if required to be submitted to the Agency.

(iii)

If a new use is proposed for a product that is identical or substantially similar to an existing product, data to demonstrate whether the new use would substantially increase the risk of unreasonable adverse effects on the environment.

(c)

Approval of application with a data gap claim.

(1)

In accordance with § 152.115(a), any registration that is approved based upon a data gap claim shall be conditioned on the submission of the data no later than the time that the data are required to be submitted for similar products already registered.

(2)

Notwithstanding paragraph (c)(1) of this section, the Agency will not approve an application if it determines that the data for which a data gap claim has been made are needed to determine if the product meets the requirements of FIFRA sections 3(c)(5) or (7).

Notes, amendments, and revision history

Amendments

[79 FR 6826, Feb. 5, 2014]

Source

Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.

Authority

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701.

Amendments

[79 FR 6826, Feb. 5, 2014]