87 

Environmental Protection Agency Pt. 158 

Agency finally notifies the registrant 

of the requirement. 

(b) Contents of certification. The certification must contain the following 

information: 

(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. 

§ 157.36 Recordkeeping. 

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). 

[51 FR 21286, June 11, 1986; 51 FR 36692, Oct. 

15, 1986, as amended at 65 FR 39304, June 26, 

2000] 

PART 158—DATA REQUIREMENTS 

FOR PESTICIDES 

Subpart A—General Provisions 

Sec. 

158.1 Purpose and scope. 

158.3 Definitions. 

158.5 Applicability. 

158.30 Flexibility. 

158.32 Format of data submissions. 

158.33 Confidential data. 

158.34 Flagging of studies for potential adverse effects. 

158.45 Waivers. 

158.60 Minor use data policies. 

158.70 Satisfying data requirements. 

158.75 Requirements for additional data. 

158.80 Use of other data. 

Subpart B—How To Use Data Tables 

158.100 Pesticide use patterns. 

158.110 Required and conditionally required 

data. 


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Pt. 158 40 CFR Ch. I (7–1–15 Edition) 

158.120 Determining data requirements. 

158.130 Purposes of the registration data requirements. 

Subpart C—Experimental Use Permits 

158.200 Experimental use permit data requirements tables. 

158.210 Experimental use permit data requirements for product chemistry 

158.220 Experimental use permit data requirements for product performance. 

158.230 Experimental use permit data requirements for toxicology. 

158.240 Experimental use permit data requirements for ecological effects. 

158.243 Experimental use permit data requirements for terrestrial and aquatic 

nontarget organisms. 

158.250 Experimental use permit data requirements for human exposure. 

158.260 Experimental use permit data requirements for environmental fate. 

158.270 Experimental use permit data requirements for residue chemistry. 

158.280–158.290 [Reserved] 

Subpart D—Product Chemistry 

158.300 Definitions. 

158.310 Product chemistry data requirements table. 

158.320 Product identity and composition. 

158.325 Description of materials used to 

produce the product. 

158.330 Description of production process. 

158.335 Description of formulation process. 

158.340 Discussion of formation of impurities. 

158.345 Preliminary analysis. 

158.350 Certified limits. 

158.355 Enforcement analytical method. 

Subpart E—Product Performance 

158.400 Product performance data requirements. 

Subpart F—Toxicology 

158.500 Toxicology data requirements table. 

158.510 Tiered testing options for nonfood 

pesticides. 

Subpart G—Ecological Effects 

158.630 Terrestrial and aquatic nontarget 

organisms data requirements table. 

158.660 Nontarget plant protection data requirements table. 

Subparts H–J [Reserved] 

158.700–158.900 [Reserved] 

Subpart K—Human Exposure 

158.1000 Applicator exposure—general requirements. 

158.1010 Applicator exposure—criteria for 

testing. 

158.1020 Applicator exposure data requirements table. 

158.1050 Post-application exposure—general 

requirements. 

158.1060 Post-application exposure—criteria 

for testing. 

158.1070 Post-application exposure data requirements table. 

Subpart L—Spray Drift 

158.1100 Spray drift data requirements 

table. 

Subpart M [Reserved] 

158.1200–158.1299 [Reserved] 

Subpart N—Environmental Fate 

158.1300 Environmental fate data requirements table. 

Subpart O—Residue Chemistry 

158.1400 Definitions. 

158.1410 Residue chemistry data requirements table. 

Subparts P–T [Reserved] 

158.1500–158.1900 [Reserved] 

Subpart U—Biochemical Pesticides 

158.2000 Biochemical pesticides definition 

and applicability. 

158.2010 Biochemical pesticides data requirements. 

158.2030 Biochemical pesticides product 

chemistry data requirements table. 

158.2040 Biochemical pesticides residue data 

requirements table. 

158.2050 Biochemical pesticides human 

health assessment data requirements 

table. 

158.2060 Biochemical pesticides nontarget 

organisms and environmental fate data 

requirements table. 

158.2070 Biochemical pesticides product performance data requirements. 

158.2080 Experimental use permit data requirements—biochemical pesticides. 

158.2081 Experimental use permit biochemical pesticides product chemistry 

data requirements table. 

158.2082 Experimental use permit biochemical pesticides residue data requirements table. 

158.2083 Experimental use permit biochemical pesticides human health assessment data requirements table. 

158.2084 Experimental use permit biochemical pesticides nontarget organisms 

and environmental fate data requirements table. 


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Environmental Protection Agency § 158.3 

Subpart V— Microbial Pesticides 

158.2100 Microbial pesticides definition and 

applicability. 

158.2110 Microbial pesticides data requirements. 

158.2120 Microbial pesticides product analysis data requirements table. 

158.2130 Microbial pesticides residue data 

requirements table. 

158.2140 Microbial pesticides toxicology 

data requirements table. 

158.2150 Microbial pesticides nontarget organisms and environmental fate data requirements table. 

158.2160 Microbial pesticides product performance data requirements. 

158.2170 Experimental use permit data requirements—microbial pesticides. 

158.2171 Experimental use permit microbial 

pesticides product analysis data requirements table. 

158.2172 Experimental use permit microbial 

pesticides residue data requirements 

table. 

158.2173 Experimental use permit microbial 

pesticides toxicology data requirements 

table. 

158.2174 Experimental use permit microbial 

pesticides nontarget organisms and environmental fate data requirements table. 

Subpart W—Antimicrobial Pesticide Data 

Requirements 

158.2200 Applicability. 

158.2201 Antimicrobial use patterns. 

158.2203 Definitions. 

158.2204 Public health and nonpublic health 

claims. 

158.2210 Product chemistry. 

158.2220 Product performance. 

158.2230 Toxicology. 

158.2240 Nontarget organisms. 

158.2250 Nontarget plant protection. 

158.2260 Applicator exposure. 

158.2270 Post-application exposure. 

158.2280 Environmental fate. 

158.2290 Residue chemistry. 

Subpart X–Z [Reserved] 

158.2300–158.2500 [Reserved] 

AUTHORITY: 7 U.S.C. 136–136y; 21 U.S.C. 

346a. 

SOURCE: 72 FR 60957, Oct. 26, 2007, unless 

otherwise noted. 

Subpart A—General Provisions 

§ 158.1 Purpose and scope. 

(a) Purpose. The purpose of this part 

is to specify the kinds of data and information EPA requires in order to 

make regulatory judgments under 

FIFRA secs. 3, 4, and 5 about the risks 

and benefits of pesticide products. Further, this part specifies the data and 

information needed to determine the 

safety of pesticide chemical residues 

under FFDCA sec. 408. 

(b) Scope. (1) This part describes the 

minimum data and information EPA 

typically requires to support an application for pesticide registration or 

amendment; support the reregistration 

of a pesticide product; support the 

maintenance of a pesticide registration 

by means of the data call-in process, 

e.g., as used in the registration review 

program; or establish or maintain a 

tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. 

(2) This part establishes general policies and procedures associated with the 

submission of data in support of a pesticide regulatory action. 

(3) This part does not include study 

protocols, methodology, or standards 

for conducting or reporting test results; nor does this part describe how 

the Agency uses or evaluates the data 

and information in its risk assessment 

and risk management decisions, or the 

regulatory determinations that may be 

based upon the data. 

(c) Scope of individual subparts. (1) 

Conventional pesticides. Subparts A, B, 

C, D, F, G, K, L, N, and O apply to conventional pesticides. 

(2) Biochemical pesticides. Subparts A, 

B and U apply to biochemical pesticides. 

(3) Microbial pesticides. Subparts A, B 

and V apply to microbial pesticides. 

(4) Antimicrobial pesticides. Subparts 

A, B, C, D, and W of this part apply to 

antimicrobial pesticides. 

[72 FR 60957, Oct. 26, 2007, as amended at 78 

FR 26978, May 8, 2013] 

§ 158.3 Definitions. 

All terms defined in sec. 2 of the Federal Insecticide, Fungicide, and 

Rodenticide Act apply to this part and 

are used with the meaning given in the 

Act. Applicable terms from the Federal 

Food, Drug, and Cosmetic Act also 

apply to this part. Individual subparts 

may contain definitions that pertain 

solely to that subpart. The following 

additional terms apply to this part: 


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§ 158.5 40 CFR Ch. I (7–1–15 Edition) 

Applicant means any person or entity, including for the purposes of this 

part a registrant, who submits, or is required to submit, to the Agency any 

application, petition, or submission 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. Such submissions may include, 

but are not limited to, the following: 

(1) An application for registration or 

amended registration of a pesticide 

product under FIFRA sec. 3 or 24. 

(2) A submission of data required in 

conjunction with reregistration of a 

currently registered product under 

FIFRA sec. 4. 

(3) An application for an experimental use permit under FIFRA sec. 5. 

(4) A submission of data in response 

to a notice issued by EPA under FIFRA 

sec. 3(c)(2)(B). 

(5) A petition to establish or modify 

a tolerance or an exemption from the 

requirement of a tolerance for a pesticide chemical residue under FFDCA 

sec. 408. 

Registration includes a new registration, amended registration and reregistration, unless stated otherwise. 

§ 158.5 Applicability. 

(a) The requirements of this part 

apply to the following submissions: 

(1) An application for new or amended registration under FIFRA sec. 3 or 

24. 

(2) An application for experimental 

use permit under FIFRA sec. 5. 

(3) A submission of data or information to support the continuation of a 

registration under FIFRA sec. 3, 4, or 

24. 

(4) A petition to establish, modify or 

revoke a tolerance or exemption from a 

tolerance under FFDCA sec. 408. 

(b) The information specified in this 

part must be furnished with each submission described in paragraph (a) of 

this section if it has not been submitted previously, or if any previous 

submission is not accurate or complete. 

§ 158.30 Flexibility. 

(a) FIFRA provides EPA flexibility to 

require, or not require, data and information for the purposes of making regulatory judgments for pesticide products. EPA has the authority to establish or modify data needs for individual 

pesticide chemicals. The actual data 

required may be modified on an individual basis to fully characterize the 

use and properties, characteristics, or 

effects of specific pesticide products 

under review. The Agency encourages 

each applicant to consult with EPA to 

discuss the data requirements particular to its product prior to and during the registration process. 

(b) The Agency cautions applicants 

that the data routinely required in this 

part may not be sufficient to permit 

EPA to evaluate the potential of the 

product to cause unreasonable adverse 

effects to man or the environment. 

EPA may require the submission of additional data or information beyond 

that specified in this part if such data 

or information are needed to appropriately evaluate a pesticide product. 

(c) This part will be updated as needed to reflect evolving program needs 

and advances in science. 

§ 158.32 Format of data submissions. 

(a) General. (1) All data submitted 

under this part must be formatted in 

accordance with this section. 

(2) The requirements of this section 

do not apply to administrative materials accompanying a data submission, 

including forms, labeling, and correspondence. 

(b) Transmittal document. Each submission in support of a regulatory action must be accompanied by a transmittal document, which includes: 

(1) Identity of the submitter. 

(2) The transmittal date. 

(3) Identification of the regulatory 

action with which the submission is associated, e.g., the registration or petition number. 

(4) A list of the individual documents 

included in the submission. 

(c) Individual documents. Unless otherwise specified by the Agency, each 

submission must be in the form of individual documents or studies. Previously submitted documents should 

not be resubmitted unless specifically 

requested by the Agency, but should be 

cited with adequate information to 


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Environmental Protection Agency § 158.33 

identify the previously submitted document. Each study or document should 

include the following: 

(1) A title page including the following information: 

(i) The title of the study, including 

identification of the substance(s) tested and the test name or data requirement addressed. 

(ii) The author(s) of the study. 

(iii) The date the study was completed. 

(iv) If the study was performed in a 

laboratory, the name and address of 

the laboratory, project numbers or 

other identifying codes. 

(v) If the study is a commentary on 

or supplement to another previously 

submitted study, full identification of 

the other study with which it should be 

associated in review. 

(vi) If the study is a reprint of a published document, all relevant facts of 

publication, such as the journal title, 

volume, issue, inclusive page numbers, 

and date of publication. 

(2) The appropriate statement(s) regarding any data confidentiality 

claims as described in §158.33. 

(3) A statement of compliance or noncompliance with respect to Good Laboratory Practice Standards as required 

by 40 CFR 160.12, if applicable. 

(4) A complete and accurate English 

translation must be included for any 

information that is not in English. 

(5) A flagging statement as prescribed by §158.34, if applicable. 

§ 158.33 Confidential data. 

(a) Definitions. For the purposes of 

this section: 

(1) Registered or previously registered 

pesticide means any pesticide containing an active ingredient contained 

in a product that is, or has ever been, 

an active ingredient in a product registered under sec. 3 of FIFRA. A registered pesticide that is the subject of 

an application for a new use falls within the category of ‘‘registered or previously registered pesticide.’’ 

(2) Safety and efficacy information 

means information concerning the objectives, methodology, results, or significance of any test or experiment 

performed on or with a registered or 

previously registered pesticide or its 

separate ingredients, impurities, or 

degradation products, and any information concerning the effects of such pesticide on any organism or the behavior 

of such pesticide in the environment, 

including, but not limited to, data on 

safety to fish and wildlife, humans and 

other mammals, plants, animals, and 

soil, and studies on persistence, 

translocation and fate in the environment, and metabolism. 

(b) Applicability. (1) This section applies to information submitted pursuant to this part. It supplements the 

general confidentiality procedures in 40 

CFR part 2, subpart B, including 

FIFRA confidentiality procedures at 40 

CFR 2.307. To the extent that provisions in this section conflict with those 

in 40 CFR part 2, subpart B, the provisions in this section take precedence. 

The provisions of 40 CFR 2.308 do not 

apply to information to which this section applies. In addition to complying 

with the requirements of this section, 

any confidentiality claims for information subject to 40 CFR part 174 (plantincorporated protectants) must be substantiated at the time of submission as 

described in §174.9 of this chapter. 

(2) FFDCA sec. 408(i) protects confidential information submitted in connection with an application for a tolerance or exemption to the same extent 

as FIFRA sec. 10. References in this 

section to FIFRA sec. 10 are deemed to 

apply equally to information submitted 

pursuant to FFDCA sec. 408, pursuant 

to the authority in sec. 408(i). 

(c) Method of asserting business confidentiality claims—(1) Claim required. Information to which this section applies 

(and which is submitted on or after the 

effective date of this regulation) will 

be deemed as not subject to a confidentiality claim unless a claim for that information is made in accordance with 

the procedures specified in this paragraph. Information not subject to a 

confidentiality claim may be made 

available to the public without further 

notice, subject to the requirements of 

FIFRA sec. 10(g). 

(2) Statement required. Upon submission to EPA, each document must be 

accompanied by a signed and dated 

document containing either the statements in paragraph (c)(2)(i) or (ii) of 

this section. No claims or markings on 

the document or any attachments, 


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§ 158.33 40 CFR Ch. I (7–1–15 Edition) 

other than these statements and attachments submitted in accordance 

with paragraph (c)(3) of this section, 

will be recognized as asserting a claim 

of confidentiality. The format of data 

submissions is set forth in §158.32. 

(i) No claim of confidentiality. 

No claim of confidentiality, on any basis 

whatsoever, is made for any information 

contained in this document. I acknowledge 

that information not designated as within 

the scope of FIFRA sec. 10(d)(1)(A), (B), or 

(C) and which pertains to a registered or previously registered pesticide is not entitled to 

confidential treatment and may be released 

to the public, subject to the provisions regarding disclosure to multinational entities 

under FIFRA sec. 10(g). 

(ii) Claim of confidentiality. 

Information claimed as confidential has 

been removed to a confidential attachment. 

(3) Confidential attachment. (i) All information claimed as confidential must 

be submitted in a separate confidential 

attachment to the document and cross 

referenced to the specific location in 

the document from which it was removed. The confidential attachment 

must have its own title page and be 

paginated separately from the non-confidential document. 

(ii) All information in the confidential attachment that consists of (or 

whose disclosure would in turn disclose) manufacturing or quality control processes must be individually 

identified in the confidential attachment as a claim for information within 

the scope of FIFRA sec. 10(d)(1)(A). 

(iii) All information in the confidential attachment that consists of (or 

whose disclosure would in turn disclose) the details of any methods for 

testing, detecting, or measuring the 

quantity of any deliberately added 

inert ingredient of a pesticide, must be 

individually identified in the confidential attachment as a claim for information within the scope of FIFRA sec. 

10(d)(1)(B). 

(iv) All information in the confidential attachment that consists of (or 

whose disclosure would in turn disclose) the identity or percentage quantity of any deliberately added inert ingredient of a pesticide must be individually identified in the confidential attachment as a claim for information 

within the scope of FIFRA sec. 

10(d)(1)(C). 

(v) Information in the confidential 

attachment that is designated in accordance with paragraphs (c)(3)(ii) - 

(iv) of this section must be on a separate page from information that is not 

so designated. 

(4) Voluntary release of information to 

States and foreign governments. (i) Submitters are encouraged to include with 

the statement required under paragraph (c)(2) of this section an additional statement to allow EPA to share 

information with State and foreign 

governments. EPA will not consider 

such a statement to be a waiver of confidentiality or proprietary claims for 

the information. The statement is as 

follows: 

I authorize the Environmental Protection 

Agency to release any information contained 

in this document to State or foreign governments, without relinquishing proprietary 

rights or any confidentiality claims asserted 

above. 

(ii) Information designated as releasable to state or foreign governments in 

accordance with this section may be 

released to such a government without 

further notice to the submitter. EPA 

will inform the State or foreign government of any of the confidentiality 

claims associated with the information. 

(d) Release of information. (1) Safety 

and efficacy information that was submitted to EPA on or after May 4, 1988 

and that has not been designated by 

the submitter as FIFRA sec. 

10(d)(1)(A), (B), or (C) information in 

accordance with the applicable requirements of this section is not entitled to 

confidential treatment and may be disclosed to the public without further notice to the submitter, in accordance 

with paragraph (d)(2) of this section. 

Safety and efficacy information which 

has been designated by the submitter 

as FIFRA sec. 10(d)(1) (A), (B), or (C) 

information is entitled to confidential 

treatment only to the extent provided 

by FIFRA sec. 10(b), this section, and 

40 CFR 2.208. 

(2) Information that is not entitled to 

be protected as confidential in accordance with FIFRA sec. 10(b), this section and with EPA confidentiality regulations at 40 CFR part 2, subpart B, 


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Environmental Protection Agency § 158.34 

may be released to the public without 

the affirmation of non-multinational 

status provided under FIFRA sec. 10(g), 

provided that the information does not 

contain or consist of any complete unpublished report submitted to EPA, or 

excerpts or restatements of any such 

report which reveal the full methodology and complete results of the 

study, test, or experiment, and all explanatory information necessary to understand the methodology or interpret 

the results. 

§ 158.34 Flagging of studies for potential adverse effects. 

(a) Any applicant who submits a 

study of a type listed in paragraph (b) 

of this section must submit with the 

study a statement in accordance with 

paragraph (c) of this section. 

(b) The following table indicates the 

study types and the criteria to be applied to each. Column 1 lists the study 

types by name. Column 2 lists the associated Pesticide Assessment Guideline 

number. Column 3 lists the criteria applicable to each type of study. Column 

4 lists the reporting code to be included 

in the statement specified in paragraph 

(c) of this section when any criterion is 

met or exceeded. 

TABLE—FLAGGING CRITERIA

Study Type(s) Guideline No. Criteria: Treated animals show any of the following: Criteria No. 

Carcinogenicity or combined carcinogenicity/chronic feeding study 870.4200 

870.4300 

An incidence of neoplasms in males or females which 

increases with dose (positive trend p≤0.05); or 

1 

A statistically significant (pairwise p≤0.05) increase of 

any type of neoplasm in any test group, males or females at any dose level, compared to concurrent control animals of the same sex; or 

2 

An increase in any type of uncommon or rare neoplasms in any test group, males or females animals 

at any dose level, compared to concurrent controls of 

the same sex; or 

3 

A decrease in the time to development of any type of 

neoplasms in any test group, males or females at any 

dose level, compared to concurrent controls of the 

same sex. 

4 

Prenatal developmental toxicity 

Reproduction and fertility 

Developmental neurotoxicity 

870.3700 

870.3800 

870.6300 

When compared to concurrent controls, treated offspring show a dose-related increase in malformations, 

pre- or post-natal deaths, or persistent functional or 

behavioral changes on a litter basis in the absence of 

significant maternal toxicity at the same dose level. 

5 

Neurotoxicity 870.6100 

870.6200 

When compared to concurrent controls, treated animals 

show a statistically or biologically significant increase 

in neuropathological lesions or persistent functional or 

behavioral changes. 

6 

Chronic feeding 

Carcinogenicity 

Reproduction and fertility 

Prenatal developmental toxicity 

Developmental neurotoxicity 

Acute or 90–day neurotoxicity 

870.4100 

870.4200 

870.3800 

870.3700 

870.6300 

870.6200 

The no observed adverse effect level (NOAEL) from 

one of these studies is less than the NOAEL currently 

used by the Agency as the basis for either the acute 

or chronic reference dose. 

7 

(c) Identification of studies. For each 

study of a type identified in paragraph 

(b) of this section, the applicant 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) Study does not meet or exceed criteria. 

I have applied the criteria of 40 CFR 158.34 

for flagging studies for potential adverse effects to the results of the attached study. 

This study neither meets nor exceeds any of 

the applicable criteria. 


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§ 158.45 40 CFR Ch. I (7–1–15 Edition) 

(2) Study meets or exceeds criteria. 

I have applied the criteria of 40 CFR 158.34 

for flagging studies for potential adverse effects to the results of the attached study. 

This study meets or exceeds the criteria 

numbered [insert all applicable reporting 

codes]. 

§ 158.45 Waivers. 

(a) The data requirements specified 

in this part as applicable to a category 

of products will not always be appropriate for every product in that category. Some products may have unusual physical, chemical, or biological 

properties or atypical use patterns 

which would make particular data requirements inappropriate, either because it would not be possible to generate the required data or because the 

data would not be useful in the Agency’s evaluation of the risks or benefits 

of the product. The Agency will waive 

data requirements it finds are inappropriate, but will ensure that sufficient 

data are available to make the determinations required by the applicable 

statutory standards. 

(b)(1) Applicants are encouraged to 

discuss a data waiver request with the 

Agency before developing and submitting supporting data, information, or 

other materials. 

(2) All waiver requests must be submitted to the Agency in writing. The 

request must clearly identify the data 

requirement(s) for which a waiver is 

sought along with an explanation and 

supporting rationale why the applicant 

believes the data requirement should 

be waived. In addition, the applicant 

must describe any unsuccessful attempts to generate the required data, 

furnish any other information which 

the applicant(s) believe(s) would support the request, and when appropriate, 

suggest alternative means of obtaining 

data to address the concern which 

underlies the data requirement. 

(c) The Agency will review each 

waiver request and subsequently inform the applicant in writing of its decision. If the decision could apply to 

more than the requested product, the 

Agency, in its discretion, may choose 

to send a notice to all registrants or 

publish a notice in the FEDERAL REGISTER announcing the decision. An 

Agency decision denying a written request to waive a data requirement is a 

final Agency action. 

§ 158.60 Minor use data policies. 

FIFRA sec. 2(ll) defines the term 

‘‘minor use’’and FIFRA provides a 

number of statutory provisions concerning minor uses. In addition, EPA 

has established policies with respect to 

minor uses of pesticides, including, but 

not limited to, the following: 

(a) A new data requirement pertinent 

to both an unregistered minor use and 

a registered major use will not be applied to a minor use applicant until it 

is applied to the major use registration. 

(b) EPA will accept appropriate and 

adequate extrapolations and regional 

data to support establishment of individual minor use tolerances. 

§ 158.70 Satisfying data requirements. 

(a) General policy. The Agency will 

determine whether the data submitted 

or cited 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. 

(1) The provisions in this part 158 

should be read in conjunction with the 

provisions in §152.85 to claim eligibility for the formulators’ exemption. 

(2) [Reserved] 


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Environmental Protection Agency § 158.80 

(b) Good laboratory practices. Applicants must adhere to the good laboratory practice (GLP) standards described in 40 CFR part 160 when conducting studies. Applicants must also 

adhere to GLP standards when conducting a study in support of a waiver 

request of any data requirement which 

is within the scope of the GLP requirements. 

(c) Agency guidelines. EPA has published Test Guidelines that contain 

standards for conducting acceptable 

tests, guidance on the evaluation and 

reporting of data, definition of terms, 

and suggested study protocols. Copies 

of the Test Guidelines may be obtained 

by visiting the agency’s website at 

www.epa.gov/pesticides. 

(d) Study protocols—(1) General. Any 

appropriate protocol may be used to 

generate the data required by this part, 

provided that it meets the purpose of 

the test standards specified in the pesticide assessment 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. 

(2) Organization for Economic Co-Operation 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. 

Applicants 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 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. 

(e) Combining studies. Certain toxicology studies may be combined to satisfy data requirements. For example, 

carcinogenicity studies in rats may be 

combined with the rat chronic toxicity 

study. Combining appropriate studies 

may be expected to reduce usage of test 

animals as well as reduce the cost of 

studies. EPA encourages this practice 

by including standards for acceptable 

combined tests in the Pesticide Assessment Guidelines. Registrants and applicants are encouraged to consider 

combining other tests when practical 

and likely to produce scientifically acceptable results. Registrants and applicants, however, must consult with the 

EPA before initiating combined studies. 

§ 158.75 Requirements for additional 

data. 

The data routinely required by this 

part may not be sufficient to permit 

EPA to evaluate every pesticide product. If the information required under 

this part is not sufficient to evaluate 

the potential of the product to cause 

unreasonable adverse effects on man or 

the environment, additional data requirements will be imposed. However, 

EPA expects that the information required by this part will be adequate in 

most cases for an assessment of the 

properties and effects of the pesticide. 

§ 158.80 Use of other data. 

(a) Data developed in foreign countries. 

With certain exceptions, laboratory 

and field study data developed outside 

the United States may be submitted in 

support of a pesticide registration. 

Data generated in a foreign country 

which the Agency will not consider include, but are not limited to, 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. Applicants submitting foreign data must 

take steps to ensure that U.S. 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 U.S. material or 

test site. Once submitted, the Agency 

will determine whether or not the data 

meet the data requirements. 

(b) Data generated for other purposes. 

Data developed for purposes other than 

satisfaction of FIFRA data requirements, such as monitoring studies, 

may also satisfy data requirements in 


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§ 158.100 40 CFR Ch. I (7–1–15 Edition) 

this part. Consultation with the Agency should be arranged if applicants are 

unsure about suitability of such data. 

Subpart B—How To Use Data 

Tables 

§ 158.100 Pesticide use patterns. 

(a) General use patterns for conventional, biochemical, and microbial pesticides. There are six broad use categories used in the data tables. The six 

broad categories include terrestrial 

outdoor uses, aquatic outdoor uses, 

greenhouse uses, forestry uses, residential outdoor uses, and indoor uses of all 

types. The 6 broad use categories are 

further subdivided into 12 general use 

patterns which are the bases for data 

requirements established by use pattern. Within the data tables, general 

use patterns have been combined into 

single columns when the data requirements are the same for the combined 

uses. If there are no data requirements 

for a specific use, the column for that 

use is not included in the table. The 12 

general use pattern groups used in the 

data table in this part are: 

(1) Terrestrial food crop use. 

(2) Terrestrial feed crop use. 

(3) Terrestrial nonfood crop use. 

(4) Aquatic food crop use. 

(5) Aquatic nonfood use. 

(6) Greenhouse food crop use. 

(7) Greenhouse nonfood crop use. 

(8) Forestry use. 

(9) Residential outdoor use. 

(10) Residential indoor use. 

(11) Indoor food use. 

(12) Indoor nonfood use. 

(b) Pesticide use site index for conventional, biochemical, and microbial pesticides. The Pesticide Use Site Index for 

Conventional, Biochemical, and Microbial Pesticides is a comprehensive list 

of specific pesticide use sites. The 

index is alphabetized separately by site 

for all agricultural and all nonagricultural uses. The Pesticide Use 

Site Index associates each pesticide use 

site with one or more of the 12 general 

use patterns. It may be used in conjunction with the data tables to determine the applicability of data requirements to specific uses. The Pesticide 

Use Site Index for Conventional, Biochemical, and Microbial Pesticides will 

be updated periodically, and is available from the Agency or may be obtained from the Agency’s Web site at 

http://www.epa.gov/pesticides. 

(c) Antimicrobial pesticide use patterns. 

The general use patterns for antimicrobial pesticides are described in 

§158.2201. 

(d) Pesticide use site index for antimicrobial pesticides. The Pesticide Use 

Site Index for Antimicrobial Pesticides 

is a comprehensive list of specific antimicrobial use sites. The index is alphabetized by antimicrobial use sites, and 

associates each antimicrobial use site 

with one or more of the antimicrobial 

use patterns. It may be used in conjunction with the data tables to determine the applicability of data requirements to specific uses. The Pesticide 

Use Site Index for Antimicrobial Pesticides will be updated periodically, 

and is available from the Agency or 

may be obtained from the Agency’s 

Web site at http://www.epa.gov/pesticides. 

(e) Determination of use pattern. Applicants unsure of the correct use pattern 

for their particular product should consult the Agency. 

[72 FR 60957, Oct. 26, 2007, as amended at 78 

FR 26978, May 8, 2013] 

§ 158.110 Required and conditionally 

required data. 

The tables in this part use the 

descriptors R (required), CR (conditionally required), and NR (not required) as a general indication of the 

applicability of a data requirement. In 

all cases, the test notes referred to in 

the table must be consulted to determine the actual applicability of the 

data requirement. 

(a) EPA requires data designated as 

‘‘required’’(R) for products with a given 

use pattern in order to evaluate the 

risks or benefits of a product having 

that use pattern under any conditions 

established by the test notes. 

(b) Data designated as ‘‘conditionally 

required’’ (CR) for products with a 

given use pattern are required by EPA 

to evaluate the risks or benefits of a 

product having that use pattern if the 

product meets the conditions specified 

in the notes accompanying the requirement. The determination of whether 

the data must be submitted is based on 

the product’s use pattern, physical or 


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Environmental Protection Agency § 158.120 

chemical properties, expected exposure 

of nontarget organisms, and/or results 

of previous testing (for example, tier 

testing). Applicants must evaluate 

each applicable test note for the conditions and criteria to be considered in 

determining whether conditionally required data must be submitted. 

(c) Data not required for the Agency’s assessment of the risks and benefits of a particular use pattern are designated ‘‘not required’’ (NR) in data tables. 

§ 158.120 Determining data requirements. 

As with current practice, the actual 

data and studies required may be modified on an individual basis to fully 

characterize the use and properties of 

specific pesticide products under review. While EPA is attempting to assist the applicant in this subpart, it is 

important to emphasize that it is the 

applicant’s obligation under FIFRA to 

demonstrate that an individual product 

meets the standard under FIFRA and/ 

or FFDCA. Accordingly, applicants are 

encouraged to consult with the Agency 

on the appropriate data requirements 

as set forth here as they relate to their 

specific product prior to and during the 

registration process. 

(a) Finding the appropriate data table. 

(1) Pesticide data requirements for conventional chemical active ingredients 

and related substances are presented in 

subparts D, E, F, G, K, L, N, and O of 

this part in the form of a series of data 

tables, each addressing a particular scientific discipline or data topic. Data 

requirements for biochemical and microbial pest control agents are contained and are described separately 

within subparts U and V of this part, 

respectively. 

(2) Key to table notations. R = required data; CR = conditionally required data; NR = Not required; MP = 

manufacturing-use product; EP = enduse product; TEP = typical end-use 

product; TGAI = technical grade of the 

active ingredient; PAI = pure active ingredient; PAIRA = pure active ingredient, radiolabeled; Choice = choice of 

several test substances depending on 

studies required. 

(b) Identifying required studies. To determine the specific kinds of data needed to support the registration use of 

each pesticide product, the applicant 

may: 

(1) Refer to the applicable subpart(s) 

of this part. These subparts describe 

the data requirements including data 

tables for each subject area. 

(2) Select the general use pattern(s) 

that best cover the use pattern(s) specified on the pesticide product label as 

explained in §158.100. All applicable use 

patterns must be included. 

(3) Proceed down the appropriate general use pattern column in the table 

and note which tests are required (R), 

conditionally required (CR), or not required (NR). Required and conditionally required studies are described 

in §158.110. 

(4) Review the notes for each requirement to determine its applicability to 

the specific product proposed for registration. 

(5)(i) Proceed down the Test substance columns and determine the appropriate test substance needed for 

that study. If the data are intended to 

support a manufacturing-use product, 

use the MP column. If the data are intended to support an end-use product, 

use the EP column. 

(ii) The test substances columns 

specify which substance is to be used 

for testing. Applicants should note 

that the substance that must be used 

when performing the study may or may 

not be the product itself. For example, 

the data from a certain study may be 

required to support the registration of 

an end-use product, but the test substance column may state that the particular test shall be performed using 

the technical grade of the active ingredient(s) in the end-use product. 

(iii) Manufacturing-use products 

(MP) and end-use products (EP) containing a single active ingredient and 

no intentionally added inert ingredients are considered identical in composition to each other, and to the technical grade of the active ingredient 

(TGAI) from which they were derived. 

Therefore, the data from a test conducted using any one of these as the 

test substance is also suitable to meet 

the requirement (if any) for the same 

test to be conducted using either of the 

other substances. 


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§ 158.130 40 CFR Ch. I (7–1–15 Edition) 

(6) Refer to the Pesticide Assessment 

Guideline reference number for each 

study located in the first column. See 

§158.70(c) for information pertaining to 

the guidelines and how to obtain copies. 

§ 158.130 Purposes of the registration 

data requirements. 

(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) Product chemistry—(1) Product composition. Data on product composition 

are needed: 

(i) To support the conclusions expressed in the statement of formula; 

(ii) To compare to the composition of 

materials used in required testing 

under this part; and 

(iii) To determine whether a product 

is ‘‘identical or substantially similar’’to another product, a determination that involves the comparison of 

product composition. 

(2) Nominal concentration and certified 

limits. The nominal concentration of a 

product, defined as that concentration 

that is expected to be present in a 

product as a result of the production or 

formulation process, is used to gauge 

the acceptability of the certified limits, which define the outer limits of the 

range of the product’s ingredients. The 

certified limits are used to enforce the 

composition of the product and to ensure the accuracy of hazard assessments. 

(3) Physical and chemical characteristics. The physical and chemical characteristics of an active ingredient or 

product are used: 

(i) To confirm or provide supportive 

information on the identity and composition of the product; 

(ii) To assess the hazards of the ingredient or product; and 

(iii) To trigger or evaluate certain 

other studies required by this part. 

(c) Product performance. Requirements to develop data on product performance provide a mechanism to ensure that pesticide products will perform as intended 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. 

(d) Toxicology-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). 


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Environmental Protection Agency § 158.130 

(3) Chronic studies. Chronic toxicity 

studies (usually conducted by feeding 

the test substance to the test species) 

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 carcinogenicity 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) Developmental toxicity and reproduction studies. The developmental toxicity 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 

prenatal developmental toxicity and 

serve as a guide for subsequent tests. 

(5) Mutagenicity studies. For each test 

substance a battery of tests is required 

to assess the 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, carcinogenicity, and, possibly, 

other health effects. 

(6) Metabolism studies. Data from 

studies on the absorption, distribution, 

metabolism, and excretion 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 

increases the Agency’s understanding 

of the behavior of the chemical when 

considering the human exposure anticipated from intended uses of the pesticide. 

(e) Hazards to nontarget organisms—(1) 

General. The information required to 

assess hazards to nontarget organisms 

is derived from tests to determine pesticidal effects on birds, mammals, fish, 

terrestrial and aquatic invertebrates 

and plants. These tests include shortterm acute, subacute, reproduction, 

simulated field, and full field studies 

arranged in a hierarchical or tier system which progresses from the basic 

laboratory tests to the applied field 

tests. The results of each tier of testing 

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 determine 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, life cycle 

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 


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§ 158.130 40 CFR Ch. I (7–1–15 Edition) 

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. 

(f) Applicator and post-application exposure. Data are used to evaluate exposures to persons in occupational and 

non-occupational settings, including 

agricultural, residential, commercial, 

institutional and recreational sites. 

Data include oral, dermal and inhalation exposure data, post-application 

residue data, post-application monitoring data, use information, and 

human activity information. These 

data, together with toxicology data, 

are used to determine whether application or post-application risks are of 

concern, and, where appropriate, to develop post-application restrictions 

such as reentry restrictions. 

(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 the 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) 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 

inadvertantly-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 crops and other food sources; 

and the loss of land as well as surface 

and ground water resources. 

(i) 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 the pesticide application, and 

results of tests on the amount of residues remaining on or in the treated 

food or feed, are needed to support a 


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Environmental Protection Agency § 158.220 

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. 

(4) 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 pesticide 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 shellfish. These residue data 

are also used to determine if a tolerance or action level is needed for residues in aquatic animals eaten by humans. 

Subpart C—Experimental Use 

Permits 

§ 158.200 Experimental use permit 

data requirements tables. 

Sections 158.200 through 158.270 describe how to use these tables to determine the experimental use permit data 

requirements for a particular pesticide 

product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to 

the designated test are listed at the 

end of each table. Refer to 40 CFR part 

172 for further information on experimental use permits. 

§ 158.210 Experimental use permit 

data requirements for product 

chemistry. 

All product chemistry data, as described in §158.310, must be submitted 

to support a request for an experimental use permit. 

§ 158.220 Experimental use permit 

data requirements for product performance. 

All product performance data, as described in paragraph (c) of this section, 

must be submitted to support a request 

for an experimental use permit. 

(a) Use patterns. (1) The terrestrial 

use pattern includes products classified 

under the general use patterns of terrestrial food crop and terrestrial 

nonfood crop. The aquatic use pattern 

includes products classified under the 

general use patterns of aquatic food 

crop and aquatic nonfood crop. The 

greenhouse use pattern includes products classified under the general use 

patterns of greenhouse food crop and 

greenhouse nonfood crop. The indoor 

use pattern includes products classified 

under the general use patterns of indoor food and indoor nonfood use. 

(2) Data are also required for forestry 

and residential outdoor uses. 

(b) Key. CR=Conditionally required; 

NR=Not required; R=Required; 

MP=Manufacturing-use product; 

EP=End-use product; TEP=Typical 

end-use product. 

(c) Table. The following table shows 

the experimental use data requirements for product performance. The 

test notes are shown in paragraph (d) 

of this section. 


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§ 158.220 40 CFR Ch. I (7–1–15 Edition) 

TABLE—EXPERIMENTAL

USE PERMIT

DATA

REQUIREMENTS FOR PRODUCT PERFORMANCE

Guideline No. Data Requirement 

Use Pattern Test substance to 

support 

Test Note 

No. 

Terrestrial Aquatic Greenhouse 

Forestry 

Residential 

Outdoors Indoor MP EP Food Crop Nonfood Crop Food Crop Nonfood Crop Food Crop Nonfood Crop 

Efficacy of antimicrobial agents 

91–8 Products for treating water 

systems 

NR NR CR NR NR NR NR NR NR NR EP 1 

Efficacy of fungicides and nematicides 

93–16 Products for control of organisms producing mycotoxins CR NR CR NR CR NR NR NR NR NR EP 1 

Efficacy of vertebrate control agents 

96–5 Avian toxicants R R NR NR NR NR NR R R NR EP 1 96–6 Avian repellents R R NR NR NR NR NR R NR NR EP 1 96–7 Avian frightening agents R R NR NR NR NR NR R NR NR EP 1 96–9 Bat toxicants and repellents NR NR NR NR NR NR NR NR R NR EP 1 96–10 Commensal rodenticides R R NR NR NR NR NR R R TEP EP 1 96–12 Rodenticides on farm and 

rangelands 

R R NR NR NR NR NR R NR NR EP 1 

95–13 Rodent fumigants R R NR NR NR NR NR R R NR EP 1 95–16 Rodent reproductive inhibitors R R NR NR NR NR NR R R NR EP 1 95–17 Mammalian predacides R R NR NR NR NR NR R NR NR EP 1 


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Environmental Protection Agency § 158.230 

(d) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (c) of this 

section. 

1. The Agency has waived the requirement 

to submit efficacy data unless the pesticide 

product bears a claim to control pest microorganisms that pose a threat to human 

health and whose presence cannot readily be 

observed by the user including, but not limited to, microorganisms infectious to man in 

any area of the inanimate environment, or a 

claim to control vertebrates (such as rodents, birds, bats, canids, and skunks) that 

may directly or indirectly transmit diseases 

to humans. However each registrant must 

ensure through testing that his product is efficacious when used in accordance with label 

directions and commonly accepted pest control practices. The Agency reserves the right 

to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration. 

2. [Reserved] 

[72 FR 60957, Oct. 26, 2007, as amended at 73 

FR 75596, Dec. 12, 2008] 

§ 158.230 Experimental use permit 

data requirements for toxicology. 

All toxicology data, as described in 

paragraph (c) of this section, must be 

submitted to support a request for an 

experimental use permit. 

(a) Use patterns. (1) Food use patterns 

include products classified under the 

general use patterns of terrestrial food 

crop use, terrestrial feed crop use, 

aquatic food crop use, greenhouse food 

crop use, and indoor food use. 

(2) Nonfood use patterns include 

products classified under the general 

use patterns of terrestrial nonfood crop 

use, aquatic nonfood crop use, aquatic 

nonfood outdoor use, greenhouse 

nonfood crop use, forestry use, residential outdoor use, indoor nonfood use, 

and indoor residential use. 

(b) Key. CR=Conditionally required; 

NR=Not required; R=Required; 

EP=End-use product; 

MP=Manufacturing-use product; 

PAIRA=Pure active ingredient radiolabeled; TGAI=Technical grade of the 

active ingredient. 

(c) Table. The following table shows 

the experimental use data requirements for toxicology. The test notes 

are shown in paragraph (d) of this section. 

TABLE—EXPERIMENTAL USE PERMIT TOXICITY DATA REQUIREMENTS

Guideline Number Data Requirement 

Use Pattern Test substance to support Test Note No. Food Nonfood MP EP 

Acute Testing 

870.1100 Acute oral toxicity - rat R R MP and 

TGAI 

TGAI, EP 1 

870.1200 Acute dermal toxicity R R MP and 

TGAI 

TGAI, EP 1, 2 

870.1300 Acute inhalation toxicity - 

rat 

R R MP and 

TGAI 

TGAI and 

EP 

3 

870.2400 Primary eye irritation - 

rabbit 

R R MP TGAI and 

EP 

2 

870.2500 Primary dermal irritation R R MP TGAI and 

EP 

1, 2 

870.2600 Dermal sensitization R R MP TGAI and 

EP 

2, 4 

870.6100 Delayed neurotoxicity 

(acute) - hen 

CR CR TGAI TGAI 5 

Subchronic Testing 

870.3100 90–day Oral - rodent R NR TGAI TGAI -- 

870.3150 90–day Oral - non-rodent R NR TGAI TGAI -- 

Chronic Testing 


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§ 158.240 40 CFR Ch. I (7–1–15 Edition) 

TABLE—EXPERIMENTAL USE PERMIT TOXICITY DATA REQUIREMENTS—Continued 

Guideline Number Data Requirement 

Use Pattern Test substance to support Test Note 

No. Food Nonfood MP EP 

870.4100 Chronic oral - rodent R NR TGAI TGAI 6 

Developmental Toxicity and Reproduction 

870.3700 Prenatal Developmental 

toxicity - rat and rabbit, preferred 

R NR TGAI TGAI 7, 8 

870.3800 Reproduction R NR TGAI TGAI 6 

Mutagenicity Testing 

870.5100 Bacterial reverse mutation assay R NR TGAI TGAI 9 

870.5300 

870.5375 

In vitro mammalian cell 

assay 

R NR TGAI TGAI 9, 10 

870.5385 

870.5395 

In vivo cytogenetics R NR TGAI TGAI 9, 11 

(d) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (c) of this 

section. 

1. Not required if test material is a gas or 

a highly volatile liquid. 

2. Not required if test material is corrosive 

to skin or has a pH of less than 2 or greater 

than 11.5. 

3. Required if the product consists of, or 

under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or 

particulate). 

4. Required if repeated dermal exposure is 

likely to occur under conditions of use. 

5. Required if the test material is an 

organophosphorus substance, which includes 

uncharged organophosphorus esters, 

thioesters, or anhydrides of 

organophosphoric, organophosphonic, or 

organophosphoramidic acids, or of related 

phosphorothioic, phosponothioic, or 

phosphorothioamidic acids, or is structurally 

related to other substances that may cause 

the delayed neurotoxicity sometimes seen in 

this class of chemicals. 

6. These studies are seldom required to 

support EUPs. They may be required if the 

dietary exposure for these EUPs occupies a 

large part, e.g., greater than 50%, of the reference dose. 

7. The oral route, by oral intubation, is 

preferred unless the chemical or physical 

properties of the test substance or the pattern of exposure suggests a more appropriate 

route of exposure. 

8. May be combined with the 2–generation 

reproduction study in rodents by utilizing a 

second mating of the parental animals in either generation. 

9. At a minimum, an initial battery of mutagenicity tests with possible confirmatory 

testing is required. Other relevant mutagenicity tests that may have been performed, 

plus a complete reference list must also be 

submitted. 

10. Choice of assay using either: 

i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing 

assay conditions for small colony expression 

or detection; 

ii. Chinese hamster ovary (CHO) or Chinese 

hamster lung fibroblast (V79) cells, 

hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an 

appropriate in vitro test for clastogenicity; or 

iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene 

locus. 

11. The micronucleus rodent bone marrow 

assay is preferred; however, rodent bone 

marrow assays using metaphase analysis (aberrations) are acceptable. 

[72 FR 60957, Oct. 26, 2007, as amended at 73 

FR 75596, Dec. 12, 2008] 

§ 158.240 Experimental use permit 

data requirements for ecological effects. 

All data for terrestrial nontarget organisms and aquatic nontarget organisms as described in §158.243 must be 

submitted to support a request for an 

experimental use permit. No data for 

nontarget plant protection must be 

submitted to support a request for an 

experimental use permit. 


Lhorne on DSK5TPTVN1PROD with CFR
105 

Environmental Protection Agency § 158.243 

§ 158.243 Experimental use permit 

data requirements for terrestrial 

and aquatic nontarget organisms. 

All terrestrial and aquatic nontarget 

organism data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit. 

(a) Use patterns. (1) The terrestrial 

use pattern includes products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

and terrestrial nonfood crop. The 

aquatic use pattern includes products 

classified under the general use patterns of aquatic food crop and aquatic 

nonfood. The greenhouse use pattern 

includes products classified under the 

general use patterns of greenhouse food 

crop and greenhouse nonfood crop. The 

indoor use pattern includes products 

classified under the general use patterns of indoor food and indoor nonfood 

use. 

(2) Data are also required for the general use patterns of forestry and residential outdoor use. 

(b) Key. CR=Conditionally required; 

NR=Not required; R=Required; 

TEP=Typical end-use product; 

TGAI=Technical grade of the active ingredient; commas between the test substances (e.g. TGAI, TEP) indicate that 

data may be required on the TGAI or 

TEP depending on the conditions set 

forth in the test note. 

(c) Table. The following table shows 

the experimental use data requirements for terrestrial and aquatic nontarget organisms. The test notes are 

shown in paragraph (d) of this section. 

TABLE—EXPERIMENTAL USE PERMIT TERRESTRIAL AND AQUATIC NONTARGET ORGANISM DATA

REQUIREMENTS

Guideline No. Data Requirement 

Use Pattern 

Test 

substance 

Test 

Note 

No. Terrestrial Aquatic Forestry 

Residential 

Outdoor 

Greenhouse Indoor 

Avian and Mammalian Testing 

850.2100 Avian oral toxicity R R R R CR CR TGAI 1, 2, 3 

850.2200 Avian dietary toxicity R R R R NR NR TGAI 1, 4 

Aquatic Organisms Testing 

850.1075 Freshwater fish toxicity R R R NR NR NR TGAI, 

TEP 

1, 2, 5, 

6, 11 

850.1010 Acute toxicity freshwater 

invertebrates 

R R R NR NR NR TGAI, 

TEP 

1, 2, 6, 

7, 11 

850.1300 Aquatic invertebrate life 

cycle (freshwater) 

NR R R NR NR NR TGAI 1, 7, 8 

850.1400 Fish early-life stage 

(freshwater) 

NR R R NR NR NR TGAI 1, 8, 9 

Accumulation Study 

850.1730 Fish CR CR CR NR NR NR TGAI or 

PAIRA 

10 

Insect Pollinator Testing 

850.3020 Honeybee acute contact 

toxicity 

R R R NR NR NR TGAI 1 

(d) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (c) of this 

section. 

1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to, turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile 


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§ 158.250 40 CFR Ch. I (7–1–15 Edition) 

liquid, a highly reactive solid, or a highly 

corrosive material. 

2. For greenhouse and indoor end-use products, data using the TGAI are required to 

support manufacturing-use products to be reformulated into these same end-use products 

or to support end-use products when there is 

no registered manufacturing-use product. 

Avian acute oral data are not required for 

liquid formulations for greenhouse and indoor uses. The study is not required if there 

is no potential for environmental exposure. 

3. Data are required on one passerine species and either one waterfowl species or one 

upland game bird species for terrestrial, 

aquatic, forestry, and residential outdoor 

uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses. 

4. Data are required on waterfowl and upland game bird species. 

5. Data are required on one coldwater fish 

and one warmwater fish for terrestrial, 

aquatic, forestry, and residential outdoor 

uses. For indoor and greenhouse uses, testing 

with only one of either fish species is required. 

6. EP or TEP testing is required for any 

product which meets any of the following 

conditions: 

i. The end-use pesticide will be introduced 

directly into an aquatic environment (e.g., 

aquatic herbicides and mosquito larvicides) 

when used as directed. 

ii. The maximum expected environmental 

concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is ≥one-half the LC50 or EC50

of the TGAI when the EP is used as directed. 

iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active 

ingredient or to cause toxicity to aquatic organisms. 

7. Data are required on one freshwater 

aquatic invertebrate species. 

8. Data are generally not required for outdoor residential uses, other than turf, unless 

data indicate that pesticide residues from 

the proposed use(s) can potentially enter waterways. 

9. Data are required on one freshwater fish 

species. If the test species is different from 

the two species used for the freshwater fish 

acute toxicity tests, a 96 hour LC50 on that 

species must also be provided. 

10. Not required when: 

i. The octanol/water partition coefficients 

of the pesticide and its major degradates are 

<1,000; or 

ii. There are no potential exposures to fish 

and other nontarget aquatic organisms; or 

iii. The hydrolytic half-life is <5 days at pH 

5, 7 and 9. 

11. The freshwater fish test species for the 

TEP testing is the most sensitive of the species tested with the TGAI. A freshwater invertebrate must also be tested with the EP 

or TEP using the same species tested with 

the TGAI. 

[72 FR 60957, Oct. 26, 2007, as amended at 73 

FR 75596, Dec. 12, 2008] 

§ 158.250 Experimental use permit 

data requirements for human exposure. 

No data for applicator exposure and 

post-application exposure must be submitted to support a request for an experimental use permit. 

§ 158.260 Experimental use permit 

data requirements for environmental fate. 

All environmental fate data, as described in paragraph (c) of this section, 

must be submitted to support a request 

for an experimental use permit. 

(a) Use patterns. (1) The terrestrial 

use pattern includes products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

and terrestrial nonfood. The aquatic 

use pattern includes the general use 

patterns of aquatic food crop, aquatic 

nonfood residential, and aquatic 

nonfood outdoors. The greenhouse use 

pattern includes both food and nonfood 

uses. The indoor use pattern includes 

food, nonfood, and residential indoor 

uses. 

(2) Data are also required for the general use patterns of forestry use and 

residential outdoor use. 

(b) Key. CR=Conditionally required; 

NR=Not required; R=Required; 

PAIRA=Pure active ingredient radiolabeled; TGAI=Technical grade of the 

active ingredient. 

(c) Table. The following table shows 

the experimental use data requirements for environmental fate. The test 

notes are shown in paragraph (d) of 

this section. 


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Environmental Protection Agency § 158.300 

TABLE—EXPERIMENTAL USE PERMIT ENVIRONMENTAL FATE DATA REQUIREMENTS

Guideline No. Data Requirement 

Use Pattern 

Test 

substance 

Test Note 

No. Terrestrial Aquatic Greenhouse Indoors Forestry 

Residential 

Outdoors 

Degradation Study - Laboratory 

835.2120 Hydrolysis R R R NR R R TGAI 

or 

PAIRA 

1 

Metabolism Studies - Laboratory 

835.4100 Aerobic soil R CR NR NR R NR TGAI 

or 

PAIRA 

2 

835.4300 Aerobic aquatic NR R NR NR NR NR TGAI 

or 

PAIRA 

-- 

Mobility Study 

835.1230 

835.1240 

Leaching and adsorption/ 

desorption 

R NR NR NR R NR TGAI 

or 

PAIRA 

3 

(d) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (c) of this 

section. 

1. Study is required for indoor uses in cases 

where environmental exposure is likely to 

occur. Such sites include, but are not limited 

to, agricultural premises, in or around farm 

buildings, barnyards, and beehives. 

2. Required for aquatic uses for aquatic 

sites that are intermittently dry. Such sites 

include, but are not limited to cranberry 

bogs and rice paddies. 

3. Adsorption and desorption using a batch 

equilibrium method is preferred. However, in 

some cases, for example, where the pesticide 

degrades rapidly, soil column leaching with 

unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major 

transformation products. 

[72 FR 60957, Oct. 26, 2007, as amended at 73 

FR 75596, Dec. 12, 2008] 

§ 158.270 Experimental use permit 

data requirements for residue 

chemistry. 

All residue chemistry data, as described in §158.1410, are required for an 

experimental use permit for which a 

temporary tolerance under FFDCA section 408(r) is sought. Residue chemistry 

data are not required for an experimental use permit issued on a crop-destruct basis. 

§§ 158.280–158.290 [Reserved] 

Subpart D—Product Chemistry 

§ 158.300 Definitions. 

The following terms are defined for 

the purposes of this subpart: 

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, defoliant, 

or nitrogen stabilizer, within the 

meaning of FIFRA sec. 2(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, or as a nitrogen stabilizer, and 

(2) does not state that the product 

may be used to manufacture or formulate other pesticide products. 

Formulation means: 


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§ 158.310 40 CFR Ch. I (7–1–15 Edition) 

(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. 

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. 

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. 

Inert ingredient means any substance 

(or group of structurally similar substances if designated by the Agency), 

other than the active ingredient, which 

is intentionally included in a pesticide 

product. 

Integrated system means a process for 

producing a pesticide product that: 

(1) Contains any active ingredient derived from a source that is not an EPAregistered 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. 

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. 

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. 

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. 

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). 

§ 158.310 Product chemistry data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the product chemistry data 

requirements for a particular pesticide 

product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to 

the designated test are listed in paragraph (f) of the section. 

(b) Use patterns. Product chemistry 

data are required for all pesticide products and are not use-specific. 

(c) Test substance. Data requirements 

that list only the manufacturing-use 

product as the test substance apply to 

products containing solely the technical grade of the active ingredient and 

manufacturing-use products to which 

other ingredients have been intentionally added. 

(d) Key. R=Required; 

CR=Conditionally required; 

MP=Manufacturing-use product; 

NR=Not required; EP=End-use product; 

TGAI=Technical grade of the active ingredient; PAI=Pure active ingredient. 

(e) Table. The following table shows 

the data requirements for product 

chemistry. The table notes are shown 

in paragraph (f) of this section. 

PRODUCT CHEMISTRY DATA REQUIREMENTS

Guideline 

Number Data Requirement 

Use Pattern Test substance to support Test Note 

No. All MP EP 

Product Identity and Composition 


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Environmental Protection Agency § 158.310 

PRODUCT CHEMISTRY DATA REQUIREMENTS—Continued 

Guideline 

Number Data Requirement 

Use Pattern Test substance to support Test Note 

No. All MP EP 

830.1550 Product identity and composition R MP EP 1 

830.1600 Description of materials used to produce the 

product 

R MP EP 2 

830.1620 Description of production process R MP EP 3 

830.1650 Description of formulation process R MP EP 4 

830.1670 Discussion of formulation of impurities R MP, and possibly TGAI EP, and possibly TGAI 5 

830.1700 Preliminary analysis CR MP, and possibly TGAI EP, and possibly TGAI 6, 9, 10 

830.1750 Certified limits R MP EP 7 

830.1800 Enforcement analytical method R MP EP 8 

830.1900 Submittal of samples CR MP, PAI and 

TGAI 

EP, PAI, TGAI 9, 11 

Physical and Chemical Properties 

830.6302 Color R MP and TGAI EP 9 

830.6303 Physical state R MP and TGAI EP and TGAI 9 

830.6304 Odor R MP and TGAI EP 9 

830.6313 Stability to normal and elevated temperatures, metals, and metal ions R MP and TGAI EP 9, 12, 26 

830.6314 Oxidation/reduction: chemical incompatibility CR MP EP 13 

830.6315 Flammability CR MP EP 14 

830.6316 Explodability CR MP EP 15 

830.6317 Storage stability R MP EP 

830.6319 Miscibility CR MP EP 16 

830.6320 Corrosion characteristics R MP EP 

830.6321 Dielectric breakdown voltage CR NR EP 17 

830.7000 pH CR MP and TGAI EP and TGAI 9, 18 

830.7050 UV/visible light absorption R TGAI or PAI NR -- 

830.7100 Viscosity CR MP EP 19 

830.7200 Melting point/melting range R TGAI or PAI TGAI or PAI 9, 20 

830.7220 Boiling point/boiling range R TGAI or PAI TGAI or PA 9, 21 

830.7300 Density/relative density/bulk density R MP and TGAI EP and TGAI 9 

830.7370 Dissociation constants in water R TGAI or PAI TGAI or PAI 9, 22 

830.7520 Particle size, fiber length, and diameter distribution CR TGAI or PAI EP 23 

830.7550 

830.7560 

830.7570 

Partition coefficient (n-octanol/water) R TGAI or PAI TGAI or PAI 24 

830.7840 

830.7860 

Water solubility R TGAI or PAI TGAI or PAI 9 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.320 40 CFR Ch. I (7–1–15 Edition) 

PRODUCT CHEMISTRY DATA REQUIREMENTS—Continued 

Guideline 

Number Data Requirement 

Use Pattern Test substance to support Test Note 

No. All MP EP 

830.7950 Vapor pressure R TGAI or PAI TGAI or PAI 9, 25 

(f) Test notes. The following test notes 

are applicable to the product chemistry 

data requirements in the table to paragraph (e) of this section: 

1. Data must be provided in accordance 

with §158.320. 

2. Data must be provided in accordance 

with §158.325. 

3. Data must be provided in accordance 

with §158.330. 

4. Data must be provided in accordance 

with §158.335. 

5. Data must be provided in accordance 

with §158.340. 

6. Data must be provided in accordance 

with §158.345. 

7. Data must be provided in accordance 

with §158.350. 

8. Data must be provided in accordance 

with §158.355. 

9. If the TGAI cannot be isolated, data are 

required on the practical equivalent of the 

TGAI. 

10. Data are required if the product is produced by an integrated system. 

11. Basic manufacturers are required to 

provide the Agency with a sample of each 

TGAI used to formulate a product produced 

by an integrated system when the new TGAI 

is first used as a formulating ingredient in 

products registered under FIFRA. A sample 

of the active ingredient (PAI) suitable for 

use as an analytical standard is also required 

at this time. Samples of end-use products 

produced by an integrated system must be 

submitted on a case-by-case basis. 

12. Data on the stability to metals and 

metal ions are required only if the TGAI is 

expected to come into contact with either 

material. 

13. Required when the product contains an 

oxidizing or reducing agent. 

14. Required when the product contains 

combustible liquids. 

15. Required when the product is potentially explosive. 

16. Required when the product is an emulsifiable liquid and is to be diluted with petroleum solvent. 

17. Required when the EP is a liquid and is 

to be used around electrical equipment. 

18. Required when the test substance is 

soluble or dispersible in water. 

19. Required when the product is a liquid. 

20. Required when the TGAI is solid at 

room temperature. 

21. Required when the TGAI is liquid at 

room temperature. 

22. Required when the test substance contains an acid or base functionality (organic 

or inorganic) or an alcoholic functionality 

(organic). 

23. Required for water insoluble test substances (>10¥6 g/l) and fibrous test substances with diameter of ≥0.1 μm. 

24. Required if technical chemical is organic and non-polar. 

25. Not required for salts. 

26. Data on stability of the MP and TGAI 

to storage at normal temperatures are required. Data on the stability of the TGAI to 

high temperatures are required if the TGAI 

is expected to be subjected to temperatures 

>50 °C (122 °F) during production or storage. 

§ 158.320 Product identity and composition. 

Information on the composition of 

the pesticide product must be furnished. The information required by 

paragraphs (a), (b), and (f) of this section must be provided for each product. 

In addition, if the product is produced 

by an integrated system, the information on impurities required by paragraphs (c) and (d) of this section must 

be provided. 

(a) 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 §158.350. 

(2) If the source of any active ingredient in the product is not an EPA-registered product: 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.325 

(i) The chemical name according to 

Chemical Abstracts Society (CAS) nomenclature, the CAS Registry Number, 

and any common names. 

(ii) The molecular, structural, and 

empirical formulae and the molecular 

weight or weight range. 

(iii) The nominal concentration. 

(iv) Upper and lower certified limits 

of the active ingredient in accordance 

with §158.350. 

(v) The purpose of the ingredient in 

the formulation. 

(b) 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. 

(3) Upper and lower certified limits in 

accordance with §158.350. 

(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 by EPA 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 §158.350. 

(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 ≥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) The 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. 

§ 158.325 Description of materials used 

to produce the product. 

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, 

common name, or other commercial 

designation of the ingredient. 

(ii) All information that the applicant knows (or that is reasonably 

available to him) concerning the composition (and, if requested by the Agency, chemical and physical properties) 

of the ingredient, including a copy of 

technical specifications, data sheets, or 

other documents describing the ingredient. 

(iii) If requested by the Agency, the 

name and address of the producer of 

the ingredient or, if that information is 

not known to the applicant, the name 


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§ 158.330 40 CFR Ch. I (7–1–15 Edition) 

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 about each starting 

material used to produce the active ingredient, as follows: 

(A) Each brand name, trade name, or 

other commercial designation of the 

starting material. 

(B) The name and address of the person who produces the starting material 

or, if that information is not known to 

the applicant, the name and address of 

each person who supplies the starting 

material. 

(C) All information that the applicant knows (or that is reasonably 

available to him), concerning the composition (and if requested by the Agency, chemical or physical properties) of 

the starting material, including a copy 

of all technical specifications, data 

sheets, or other documents describing 

it. 

(3) The information required by paragraph (a)(2) of this section concerning 

each inert ingredient. 

(c) Additional information. On a caseby-case basis, the Agency may require 

additional information on substances 

used in the production of the product. 

§ 158.330 Description of production 

process. 

If the product is produced by an integrated system, the applicant must submit information on the production (reaction) processes used to produce the 

active ingredients in the product. The 

applicant must also submit information about the formulation process, in 

accordance with §158.335. 

(a) Information must be submitted 

for the current production process for 

each active ingredient that is not derived from an EPA-registered product. 

If the production process is not continuous (a single reaction process from 

starting materials to active ingredient), but is accomplished in stages or 

by different producers, the information 

must be provided for each such production process. 

(b) The following information must 

be provided for each process resulting 

in a separately isolated substance: 

(1) The name and address of the producer who uses the process, if not the 

same as the applicant. 

(2) A general characterization of the 

process (e.g., whether it is a batch or 

continuous process). 

(3) A flow chart of the chemical equations of each intended reaction occurring at each step of the process, and of 

the duration of each step and of the entire process. 

(4) The identity of the materials used 

to produce the product, their relative 

amounts, and the order in which they 

are added. 

(5) A description of the equipment 

used that may influence the composition of the substance produced. 

(6) A description of the conditions 

(e.g., temperature, pressure, pH, humidity) that are controlled during each 

step of the process to affect the composition of the substance produced, and 

the limits that are maintained. 

(7) A description of any purification 

procedures (including procedures to recover or recycle starting materials, 

intermediates or the substance produced). 

(8) A description of the procedures 

used to assure consistent composition 

of the substance produced, e.g., calibration of equipment, sampling regimens, 

analytical methods, and other quality 

control methods. 

§ 158.335 Description of formulation 

process. 

The applicant must provide information on the formulation process of the 

product (unless the product consists 

solely of a technical grade of active ingredient) as required by the following 

sections: 

(a) Section 158.330(b)(2), pertaining to 

characterization of the process. 

(b) Section 158.330(b)(4), pertaining to 

ingredients used in the process. 

(c) Section 158.330(b)(5), pertaining to 

process equipment. 


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Environmental Protection Agency § 158.340 

(d) Section 158.330(b)(6), pertaining to 

the conditions of the process. 

(e) Section 158.330(b)(8), pertaining to 

quality control measures. 

§ 158.340 Discussion of formation of 

impurities. 

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 

also 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 

registrant or applicant has reason to 

believe may be present in his product 

at any time before use at a level ≥0.1 

percent (1,000 ppm) by weight of the 

technical grade of the active ingredient, based on what he knows about 

the following: 

(i) The composition (or composition 

range) of each starting material used 

to produce his product. 

(ii) The impurities which the applicant knows are present (or believes are 

likely to be present) in the starting 

materials, and the known or presumed 

level (or range of levels) of these impurities. 

(iii) The intended reactions and side 

reactions which may occur in the production of the product, and the relative 

amounts of byproduct impurities produced by such reactions. 

(iv) The possible degradation of the 

ingredients in the product after its production but prior to its use. 

(v) Post-production reactions between the ingredients in the product. 

(vi) The possible migration of components of packaging materials into the 

pesticide. 

(vii) The possible carryover of contaminants from use of production 

equipment previously used to produce 

other products or substances. 

(viii) The process control, purification and quality control measures 

used to produce the product. 

(b) 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 ≥0.1 percent (1,000 

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 ingredient and the production equipment. 

(4) Post-production reactions between any of the product’s active ingredients and any other component of 

the product or its packaging. 

(5) Possible migration of packaging 

materials into the product. 

(6) Possible contaminants resulting 

from earlier use of equipment to 

produce other products. 

(c) Expanded discussion. On a case-bycase basis, the Agency may require an 

expanded discussion of information on 

impurities: 

(1) From other possible chemical reactions. 

(2) Involving other ingredients. 

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


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§ 158.345 40 CFR Ch. I (7–1–15 Edition) 

§ 158.345 Preliminary analysis. 

(a) If the product is produced by an 

integrated system, the applicant must 

provide a preliminary analysis of each 

technical grade of active ingredient 

contained in the product to identify all 

impurities present at 0. 1 percent or 

greater of the technical grade of the 

active ingredient. The preliminary 

analysis should be conducted at the 

point in the production process after 

which no further chemical reactions 

designed to produce or purify the substances are intended. 

(b) Based on the preliminary analysis, a statement of the composition of 

the technical grade of the active ingredient must be provided. If the technical 

grade of the active ingredient cannot 

be isolated, a statement of the composition of the practical equivalent of 

the technical grade of the active ingredient must be submitted. 

§ 158.350 Certified limits. 

The applicant must propose certified 

limits for the ingredients in the product. Certified limits become legally 

binding limits upon approval of the application. Certified limits will apply to 

the product from the date of production to date of use. If the product label 

bears a statement prohibiting use after 

a certain date, the certified limits will 

apply only until that date. 

(a) 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 standard 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. 

STANDARD CERTIFIED LIMITS

If the nominal concentration (N) for the ingredient and 

percentage by weight for the ingredient is: 

The certified limits for that ingredient will be as follows: 

Upper Limit Lower Limit 

N ≤1.0% N + 10%N N - 10%N 

1.0% ≤N ≤20.0% N + 5%N N - 5%N 

20.0% ≤N ≤100.0% N + 3%N N - 3%N 

(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 applicants must propose a certified limit. The standard 

certified limits may not be used for 

such substances. 

(3) Certified limits should: 

(i) Be based on a consideration of the 

variability of the concentration of the 

ingredient in the product when good 

manufacturing practices and normal 

quality control procedures are used. 

(ii) Allow for all sources of variability likely to be encountered in the 

production process. 

(iii) Take into account the stability 

of the ingredient in the product and 

the possible formation of impurities 

between production and sale or distribution. 

(4) The applicant may include an explanation of the basis of his proposed 


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Environmental Protection Agency § 158.400 

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 registrant or 

applicant of its determination and will 

provide supporting reasons. The Agency 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 [insert 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. 

§ 158.355 Enforcement analytical method. 

An analytical method suitable for enforcement purposes must be provided 

for each active ingredient in the product and for each other ingredient or 

impurity that the Agency determines 

to be toxicologically significant. 

Subpart E—Product Performance 

§ 158.400 Product performance data 

requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the product performance 

data requirements for a particular pesticide product. Notes that apply to an 

individual test, including specific conditions, qualifications, or exceptions to 

the designated test are listed in paragraph (e) of this section. 

(b) Use patterns. The terrestrial use 

pattern includes products classified 

under the general use patterns of terrestrial food crop and terrestrial 

nonfood crop. The aquatic use pattern 

includes products classified under the 

general use patterns of aquatic food 

crop and aquatic nonfood. The greenhouse use pattern includes products 

classified under the general use patterns of greenhouse food crop and 

greenhouse nonfood crop. Data are also 

required for the general use patterns of 

forestry use, residential outdoor use, 

and indoor use, which includes both 

food and nonfood uses. 

(c) Key. CR=Conditionally required; 

NR=Not required; R=Required; 

EP=End-use product; 

MP=Manufacturing-use product; 

TEP=Typical end-use product. 

(d) Table. The following table lists 

the data requirements that pertain to 

product performance. The table notes 

are shown in paragraph (e) of this section. 


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§ 158.400 40 CFR Ch. I (7–1–15 Edition) 

TABLE—PRODUCT PERFORMANCE

DATA

REQUIREMENTS

Guideline Number Data Requirement 

Use Pattern Test substance to 

support 

Test Note 

No. 

Terrestrial Aquatic Greenhouse Forestry Resi- dential Outdoor Indoor MP EP Food Crop Nonfood Crop Food Nonfood Food Crop Nonfood Crop 

810.2700 Products with prion-related 

claims 

NR NR NR NR NR NR NR NR R NR EP 1 

Efficacy of fungicides and nematicides 

93–16 Products for control of organisms producing mycotoxins CR NR CR NR CR NR NR NR NR NR EP 1 

Efficacy of vertebrate control agents 

96–5 Avian toxicants R R NR NR NR NR NR R R NR EP 1 96–6 Avian repellents R R NR NR NR NR NR R NR NR EP 1 96–7 Avian frightening agents R R NR NR NR NR NR R NR NR EP 1 96–9 Bat toxicants and repellents NR NR NR NR NR NR NR NR R NR EP 1 96–10 Commensal rodenticides R R NR NR NR NR NR R R TEP EP 1 96–12 Rodenticides on farm and 

rangelands 

R R NR NR NR NR NR R NR NR EP 1 

95–13 Rodent fumigants R R NR NR NR NR NR R R NR EP 1 95–16 Rodent reproductive inhibitors R R NR NR NR NR NR R R NR EP 1 95–17 Mammalian predacides R R NR NR NR NR NR R NR NR EP 1 


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Environmental Protection Agency § 158.500 

(e) Test notes. The following notes 

appy to the data requirements table in 

paragraph (d) of this section. 

1. The Agency has waived the requirement 

to submit product performance data unless 

the pesticide product bears a claim to control pest microorganisms that pose a threat 

to human health and whose presence cannot 

readily be observed by the user including, 

but not limited to, microorganisms infectious to man in any area of the inanimate 

environment, or a claim to control 

vertebrates (such as rodents, birds, bats, 

canids, and skunks) that may directly or indirectly transmit diseases to humans. However each registrant must ensure through 

testing that his product is efficacious when 

used in accordance with label directions and 

commonly accepted pest control practices. 

The Agency reserves the right to require, on 

a case-by-case basis, submission of product 

performance data for any pesticide product 

registered or proposed for registration. 

2. [Reserved] 

[72 FR 60957, Oct. 26, 2007, as amended at 78 

FR 13507, Feb. 28, 2013; 78 FR 26978, May 8, 

2013] 

Subpart F—Toxicology 

§ 158.500 Toxicology data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use the data 

table in paragraph (d) of this section to 

determine the toxicology data requirements for a particular pesticide product. Notes that apply to an individual 

test and include specific conditions, 

qualifications, or exceptions to the designated test in the table are listed in 

paragraph (e) of this section. 

(b) Use patterns. (1) Food use patterns 

include products classified under the 

general use patterns of terrestrial food 

crop use, terrestrial feed crop use, 

aquatic food crop use, greenhouse food 

crop use, and indoor food use. 

(2) Nonfood use patterns include 

products classified under the general 

use patterns of terrestrial nonfood crop 

use, aquatic nonfood use, greenhouse 

nonfood crop use, forestry use, residential outdoor use, and indoor nonfood 

use. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; 

TGAI=Technical grade of the active ingredient; PAI=Pure active ingredient; 

PAIRA=Pure active ingredient radiolabeled; Choice=Choice of several test 

substances depending on study required. 

(d) Table. The following table lists 

the toxicology data requirements. The 

table notes are shown in paragraph (e) 

of this section. 

TABLE—TOXICOLOGY DATA REQUIREMENTS

Guideline 

Number Data Requirements 

Use Pattern Test substance to support Test Note 

No. Food Nonfood MP EP 

Acute Testing 

870.1100 Acute oral toxicity - rat R R TGAI and 

MP 

TGAI, EP, 

and 

possibly 

diluted 

EP 

1, 2 

870.1200 Acute dermal toxicity R R TGAI and 

MP 

TGAI, EP 1, 2, 3 

870.1300 Acute inhalation toxicity - rat R R TGAI and 

MP 

TGAI and 

EP 

4 

870.2400 Primary eye irritation - rabbit R R TGAI and 

MP 

TGAI and 

EP 

3 

870.2500 Primary dermal irritation R R TGAI and 

MP 

TGAI and 

EP 

1, 3 

870.2600 Dermal sensitization R R TGAI and 

MP 

TGAI and 

EP 

3, 5 

870.6100 Delayed neurotoxicity (acute) - hen CR CR TGAI TGAI 6 


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§ 158.500 40 CFR Ch. I (7–1–15 Edition) 

TABLE—TOXICOLOGY DATA REQUIREMENTS—Continued 

Guideline 

Number Data Requirements 

Use Pattern Test substance to support Test Note 

No. Food Nonfood MP EP 

870.6200 Acute neurotoxicity - rat R R TGAI TGAI 7 

Subchronic Testing 

870.3100 90–day Oral - rodent R CR TGAI TGAI 8, 9 

870.3150 90–day Oral - non-rodent R CR TGAI TGAI 36 

870.3200 21/28–day Dermal R NR TGAI TGAI and 

EP 

10, 11 

870.3250 90–day Dermal CR R TGAI TGAI and 

EP 

11, 12 

870.3465 90–day Inhalation - rat CR CR TGAI TGAI 13, 14 

870.6100 28–day Delayed neurotoxicity-hen CR CR TGAI TGAI 6, 15 

870.6200 90–day Neurotoxicity - rat R R TGAI TGAI 7, 16 

Chronic Testing 

870.4100 Chronic oral - rodent R CR TGAI TGAI 17, 18, 19 

870.4200 Carcinogenicity - two rodent species - rat 

and mouse preferred 

R CR TGAI TGAI 9, 17, 18, 

19, 20, 

21 

Developmental Toxicity and Reproduction 

870.3700 Prenatal Developmental toxicity - rat and 

rabbit, preferred 

R R TGAI TGAI 22, 23, 24, 

25, 26 

870.3800 Reproduction and fertility effects R R TGAI TGAI 26, 27, 29 

870.6300 Developmental neurotoxicity CR CR TGAI TGAI 27, 28, 29 

Mutagenicity Testing 

870.5100 Bacterial reverse mutation assay R R TGAI TGAI 30 

870.5300 

870.5375 

In vitro mammalian cell assay R R TGAI TGAI 30, 31 

870.5385 

870.5395 

In vivo cytogenetics R R TGAI TGAI 30, 32 

Special Testing 

870.7485 Metabolism and pharmacokinetics R CR PAI or 

PAIRA 

PAI or 

PAIRA 

33 

870.7200 Companion animal safety CR CR NR TGAI or 

EP 

34 

870.7600 Dermal penetration CR CR Choice Choice 35 

870.7800 Immunotoxicity R R TGAI TGAI 

(e) Test notes. The following test 

notes apply to the requirements in the 

table to paragraph (d) of this section: 

1. Not required if test material is a gas or 

a highly volatile liquid. 

2. Diluted EP testing is required to support 

the end product registration if results using 

the EP meet the criteria for restricted use 

classification under §152.170(b) or special review consideration under §154.7(a)(1). 

3. Not required if the test material is corrosive to skin or has a pH of less than 2 or 

greater than 11.5. 


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Environmental Protection Agency § 158.500 

4. Required if the product consists of, or 

under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or 

particulate). 

5. Required if repeated dermal exposure is 

likely to occur under conditions of use. 

6. Required if the test material is an 

organophosphorus substance, which includes 

uncharged organophosphorus esters; 

thioesters or anhydrides of 

organophosphoric, organophosphonic, or 

organophosphoramidic acids; or of related 

phosphorothioic, phosponothioic, or 

phosphorothioamidic acids; or is structurally 

related to other substances that may cause 

the delayed neurotoxicity sometimes seen in 

this class of chemicals. 

7. As determined by the Agency, additional 

measurements may also be required, such as 

cholinesterase activity for certain pesticides, e.g., organophosphates and some 

carbamates. The route of exposure must correspond with the primary route of exposure. 

8. Required for nonfood use pesticides if 

oral exposure could occur. 

9. The 90–day study is required in the rat 

for hazard characterization (possibly endpoint selection) and dose-setting for the 

chronic/carcinogenicity study. It is not required in the mouse, but the Agency would 

strongly encourage the registrant to conduct 

a 90–day range finding for the purposes of 

dose selection for the mouse carcinogenicity 

study to achieve adequate dosing and an acceptable study. The registrant is also encouraged to consult with the Agency on the 

results of the 90–day mouse study prior to 

conducting the carcinogenicity study. 

10. Required for agricultural uses or if repeated human dermal exposure may occur. 

Not required if an acceptable 90–day dermal 

toxicity study is performed and submitted. 

11. EP testing is required if the product, or 

any component of it, may increase dermal 

absorption of the active ingredient(s) as determined by testing using the TGAI, or increase toxic or pharmacologic effects. 

12. Required for food uses if either of the 

following criteria is met: 

(i) The use pattern is such that the dermal 

route would be the primary route of exposure; or 

(ii) The active ingredient is known or expected to be metabolized differently by the 

dermal route of exposure than by the oral 

route, and a metabolite is the toxic moiety. 

13. Required if there is the likelihood of 

significant repeated inhalation exposure to 

the pesticide as a gas, vapor, or aerosol. 

14. Based on estimates of the magnitude 

and duration of human exposure, studies of 

shorter duration, e.g., 21- or 28-days, may be 

sufficient to satisfy this requirement. Registrants should consult with the Agency to 

determine whether studies of shorter duration would meet this requirement. 

15. Required if results of acute 

neurotoxicity study indicate significant statistical or biological effects, or if other 

available data indicate the potential for this 

type of delayed neurotoxicity, as determined 

by the Agency. 

16. All 90–day subchronic studies in rats 

can be designed to simultaneously fulfill the 

requirements of the 90–day neurotoxicity 

study using separate groups of animals for 

testing. Although the subchronic guidelines 

include the measurement of neurological 

endpoints, they do not meet the requirement 

of the 90–day neurotoxicity study. 

17. Required if either of the following are 

met: 

(i) The use of the pesticide is likely to result in repeated human exposure over a considerable portion of the human lifespan, as 

determined by the Agency; 

(ii) The use requires a tolerance or an exemption from the requirement of a tolerance. 

18. Based on the results of the acute and 

subchronic neurotoxicity studies, or other 

available data, a combined chronic toxicity 

and neurotoxicity study may be required. 

19. Studies which are designed to simultaneously fulfill the requirements of both the 

chronic oral and carcinogenicity studies (i.e., 

a combined study) may be conducted. Minimum acceptable study durations are: 

(i) Chronic rodent feeding study (food use) 

- 24 months. 

(ii) Chronic rodent feeding study (nonfood 

use) - 12 months. 

(iii) Mouse carcinogenicity study - 18 

months. 

(iv) Rat carcinogenicity study - 24 months. 

20. Required if any of the following, as determined by the Agency, are met: 

(i) The use of the pesticide is likely to result in significant human exposure over a 

considerable portion of the human life span 

which is significant in terms of either frequency, duration, or magnitude of exposure; 

(ii) The use requires a tolerance or an exemption from the requirement of a tolerance; or 

(iii) The active ingredient, metabolite, 

degradate, or impurity (a) is structurally related to a recognized carcinogen, (b) causes 

mutagenic effects as demonstrated by in 

vitro or in vivo testing, or (c) produces a morphologic effect in any organ (e.g., 

hyperplasia, metaplasia) in subchronic studies that may lead to a neoplastic change. 

21. If this study is modified or waived, a 

subchronic 90–day oral study conducted in 

the same species may be required. 

22. Testing in two species is required for all 

uses. 

23. The oral route, by oral intubation, is 

preferred unless the chemical or physical 

properties of the test substance or the pattern of exposure suggests a more appropriate 

route of exposure. 


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§ 158.510 40 CFR Ch. I (7–1–15 Edition) 

24. Additional testing by other routes may 

be required if the pesticide is determined to 

be a prenatal developmental toxicant after 

oral dosing. 

25. May be combined with the 2–generation 

reproduction study in rodents by utilizing a 

second mating of the parental animals in either generation. 

26. Required to support products intended 

for food uses and to support products intended for nonfood uses if use of the product 

is likely to result in significant human exposure over a portion of the human life span in 

terms of frequency, magnitude or duration of 

exposure. 

27. An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, 

pharmacokinetic, or mechanistic data) to determine whether a standard guideline study, 

an enhanced guideline study, or an alternative study should be conducted to assess 

potential hazard to the developing animal, or 

in some cases to support a waiver for such 

testing. Registrants should submit any alternative proposed testing protocols and supporting scientific rationale to the Agency 

prior to study initiation. 

28. Study required using a weight-of-evidence approach considering: 

(i) The pesticide causes treatment-related 

neurological effects in adult animal studies 

(i.e., clinical signs of neurotoxicity, 

neuropathology, functional or behavioral effects). 

(ii) The pesticide causes treatment-related 

neurological effects in developing animals, 

following pre- and postnatal exposure (i.e., 

nervous system malformations or neuropathy, brain weight changes in offspring, 

functional or behavioral changes in the offspring). 

(iii) The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological 

studies. 

(iv) The pesticide evokes a mechanism that 

is associated with adverse effects on the development of the nervous system (e.g., SAR 

relationship to known neurotoxicants, altered neuroreceptor or neurotransmitter responses). 

29. The use of a combined study that utilizes the 2–generation reproduction study in 

rodents as a basic protocol for the addition 

of other endpoints or functional assessments 

in the immature animal is encouraged. 

30. At a minimum, an initial battery of 

mutagenicity tests with possible confirmatory testing is required. Other relevant mutagenicity tests that may have been performed, plus a complete reference list must 

also be submitted. 

31. Choice of assay using either: 

(i) Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing 

assay conditions for small colony expression 

or detection; 

(ii) Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, 

hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an 

appropriate in vitro test for clastogenicity; or 

(iii) CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene 

locus. 

32. The micronucleus rodent bone marrow 

assay is preferred; however, rodent bone 

marrow assays using metaphase analysis (aberrations) are acceptable. 

33. Required when chronic or carcinogenicity studies are required. May be required if significant adverse effects are seen 

in available toxicology studies and these effects can be further elucidated by metabolism studies. 

34. May be required if the product’s use 

will result in exposure to domestic animals 

through, but not limited to, direct application. 

35. A risk assessment assuming that dermal absorption is equal to oral absorption 

must be performed to determine if the study 

is required, and to identify the doses and duration of exposure for which dermal absorption is to be quantified. 

36. A 1–year non-rodent study (i.e., 1–year 

dog study) would be required if the Agency 

finds that a pesticide chemical is highly bioaccumulating and is eliminated so slowly 

that it does not achieve steady state or sufficient tissue concentrations to elicit an effect 

during a 90–day study. EPA would require 

the appropriate tier II metabolism and pharmacokinetic studies to evaluate more precisely bioavailability, half-life, and steady 

state to determine if a longer duration dog 

toxicity study is needed. 

§ 158.510 Tiered testing options for 

nonfood pesticides. 

For nonfood use pesticides only, applicants have two options for generating and submitting required toxicology (§158.500) and human exposure 

(§158.1020, §158.1070, and §158.1410) studies. Applicants are to select one of the 

following: 

(a) Acute, subchronic, chronic, and 

other toxicological studies on the active ingredient must be submitted together. The specific makeup of the set 

of toxicology study requirements is 

based on the anticipated exposure to 

the pesticide as determined by the 

Agency. If hazards are identified based 

upon review of these studies, specific 

exposure data will be required to evaluate risk. 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.630 

(b) Certain toxicological and exposure studies must be submitted simultaneously with the toxicology data 

submitted in a tiered system. Exposure 

data must be submitted along with 

first tier toxicology data. The requirement for additional second and third 

level toxicology testing will be determined by the Agency based on the results of the first tiered studies. 

(1) The required first-tier toxicology 

studies consist of: 

(i) Battery of acute studies. 

(ii) A subchronic 90–day dermal study 

or a subchronic 90–day inhalation 

study. 

(iii) An acute and subchronic 

neurotoxicity screening battery in the 

rat. 

(iv) Prenatal developmental toxicity 

studies in both the rat and rabbit. 

(v) Reproduction and fertility studies 

in rats. 

(vi) Battery of mutagenicity studies. 

(vii) Immunotoxicity study. 

(2) The conditionally required second-tier studies include: 

(i) Subchronic 90–day feeding studies 

in both the rodent and nonrodent. 

(ii) Dermal penetration study. 

(3) The conditionally required thirdtier studies include: 

(i) Chronic feeding studies in the rodent. 

(ii) Carcinogenicity. 

(iii) Metabolism study. 

(iv) Additional mutagenicity testing. 

Subpart G— Ecological Effects 

§ 158.630 Terrestrial and aquatic nontarget organisms data requirements 

table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the terrestrial and aquatic 

nontarget data requirements for a particular pesticide product. Notes that 

apply to an individual test including 

specific conditions, qualifications, or 

exceptions to the designated test are 

listed in paragraph (e) of this section. 

(b) Use patterns. (1) The terrestrial 

use pattern includes products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

and terrestrial nonfood crop. The 

aquatic use pattern includes products 

classified under the general use patterns of aquatic food crop and aquatic 

nonfood use patterns. The greenhouse 

use pattern includes products classified 

under the general use patterns of 

greenhouse food crop and greenhouse 

nonfood crop. The indoor use pattern 

includes products classified under the 

general use patterns of indoor food and 

indoor nonfood use. 

(2) Data are also required for the general use patterns of forestry and residential outdoor use. 

(3) In general, for all outdoor enduses, including turf, the following studies are required: Two avian oral LD50, 

two avian dietary LC50, two avian reproduction studies, two freshwater fish 

LC50, one freshwater invertebrate EC50, 

one honeybee acute contact LD50, one 

freshwater fish early-life stage, one 

freshwater invertebrate life cycle, and 

three estuarine acute LC50/EC50 studies 

-- fish, mollusk and invertebrate. All 

other outdoor residential uses, i.e., gardens and ornamental will not usually 

require the freshwater fish early-life 

stage, the freshwater invertebrate lifecycle, and the acute estuarine tests. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; TGAI=Technical grade of the 

active ingredient; TEP=Typical enduse product; PAI=Pure active ingredient; EP=end-use product. Commas 

between the test substances (i.e., TGAI, 

TEP) indicate that data may be required on the TGAI or the TEP depending on the conditions set forth in the 

test note. 

(d) Table. The following table shows 

the data requirements for nontarget 

terrestrial and aquatic organism. The 

table notes are shown in paragraph (e) 

of this section. 


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§ 158.630 40 CFR Ch. I (7–1–15 Edition) 

TERRESTRIAL AND AQUATIC NONTARGET ORGANISM DATA REQUIREMENTS

Guideline Number Data Require- ment 

Use Pattern Test 

substance 

Test Terres- Note No. trial Aquatic Forestry 

Residential Outdoor 

Greenhouse Indoor 

Avian and Mammalian Testing 

850.2100 Avian oral toxicity R R R R CR CR TGAI 1, 2, 3 

850.2200 Avian dietary toxicity R R R R NR NR TGAI 1, 4 

850.2400 Wild mammal 

toxicity 

CR CR CR CR NR NR TGAI 5 

850.2300 Avian reproduction R R R R NR NR TGAI 1, 4 

850.2500 Simulated or actual field testing 

CR CR CR CR NR NR TEP 6, 7 

Aquatic Organisms Testing 

850.1075 Freshwater fish 

toxicity 

R R R R CR CR TGAI, 

TEP 

1, 2, 8, 

9, 26 

850.1010 Acute toxicity 

freshwater invertebrates 

R R R R CR CR TGAI, 

TEP 

1, 2, 9, 

10, 26 

850.1025 

850.1035 

850.1045 

850.1055 

850.1075 

Acute toxicity estuarine and 

marine organisms 

R R R R NR NR TGAI, 

TEP 

1, 9, 11, 

12, 26 

850.1300 Aquatic invertebrate life cycle 

(freshwater) 

R R R R NR NR TGAI 1, 10, 12 

850.1350 Aquatic invertebrate life cycle 

(saltwater) 

CR CR CR CR NR NR TGAI 12, 14, 

15 

850.1400 Fish early-life 

stage (freshwater) 

R R R R NR NR TGAI 1, 12, 13 

850.1400 Fish early-life 

stage (saltwater) 

CR CR CR CR NR NR TGAI 12, 15, 

16 

850.1500 Fish life cycle CR CR CR CR NR NR TGAI 17, 18 

850.1710 

850.1730 

850.1850 

Aquatic organisms bioavailability, biomagnification, 

toxicity 

CR CR CR CR NR NR TGAI, 

PAI, 

degradate 

19 

850.1950 Simulated or actual field testing for aquatic 

organisms 

CR CR CR CR NR NR TEP 7, 20 

Sediment Testing 

850.1735 Whole sediment: 

acute freshwater invertebrates 

CR CR CR CR NR NR TGAI 21 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.630 

TERRESTRIAL AND AQUATIC NONTARGET ORGANISM DATA REQUIREMENTS—Continued 

Guideline Number Data Requirement 

Use Pattern 

Test 

substance 

Test 

Terres- Note No. 

trial Aquatic Forestry 

Residential Outdoor 

Greenhouse Indoor 

850.1740 Whole sediment: 

acute marine 

invertebrates 

CR CR CR CR NR NR TGAI 21, 23 

Whole sediment: 

chronic invertebrates freshwater and marine 

CR CR CR CR NR NR TGAI 22, 23 

Insect Pollinator Testing 

850.3020 Honeybee acute 

contact toxicity 

R CR R R NR NR TGAI 1 

850.3030 Honey bee toxicity of residues on foliage 

CR CR CR CR NR NR TEP 24 

850.3040 Field testing for 

pollinators 

CR CR CR CR NR NR TEP 25 

(e) Test notes. The following test 

notes apply to terrestrial and aquatic 

nontarget organisms data requirements in the table to paragraph (d) of 

this section: 

1. Data using the TGAI are required to support all outdoor end-use product uses including, but not limited to turf. Data are generally not required to support end-use products in the form of a gas, a highly volatile 

liquid, a highly reactive solid, or a highly 

corrosive material. 

2. For greenhouse and indoor end-use products, data using the TGAI are required to 

support manufacturing-use products to be reformulated into these same end-use products 

or to support end-use products when there is 

no registered manufacturing-use product. 

Avian acute oral data are not required for 

liquid formulations for greenhouse and indoor uses. The study is not required if there 

is no potential for environmental exposure. 

3. Data are required on one passerine species and either one waterfowl species or one 

upland game bird species for terrestrial, 

aquatic, forestry, and residential outdoor 

uses. Data are preferred on waterfowl or upland game bird species for indoor and greenhouse uses. 

4. Data are required on waterfowl and upland game bird species. 

5. Tests are required based on the results of 

lower tier toxicology studies, such as the 

acute and subacute testing, intended use pattern, and environmental fate characteristics 

that indicate potential exposure. 

6. Higher tier testing may be required for a 

specific use pattern when a refined risk assessment indicates a concern based on laboratory toxicity endpoints and refined exposure assessments. 

7. Environmental chemistry methods used 

to generate data associated with this study 

must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available 

as addenda to the guideline for this test requirement. 

8. Data are required on one coldwater fish 

and one warmwater fish for terrestrial, 

aquatic, forestry, and residential outdoor 

uses. For indoor and greenhouse uses, testing 

with only one of either fish species is required. 

9. EP or TEP testing is required for any 

product which meets any of the following 

conditions: 

i. The end-use pesticide will be introduced 

directly into an aquatic environment (e.g., 

aquatic herbicides and mosquito larvicides) 

when used as directed. 

ii. The maximum expected environmental 

concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic environment is ≥one-half the LC50 or EC50

of the TGAI when the EP is used as directed. 

iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active 

ingredient or to cause toxicity to aquatic organisms. 

10. Data are required on one freshwater 

aquatic invertebrate species. 

11. Data are required on one estuarine/marine mollusk, one estuarine/marine invertebrate and one estuarine/marine fish species. 


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§ 158.630 40 CFR Ch. I (7–1–15 Edition) 

12. Data are generally not required for outdoor residential uses, other than turf, unless 

data indicate that pesticide residues from 

the proposed use(s) can potentially enter waterways. 

13. Data are required on one freshwater 

fish species. If the test species is different 

from the two species used for the freshwater 

fish acute toxicity tests, a 96–hour LC50 on 

that species must also be provided. 

14. Data are required on one estuarine/marine invertebrate species. 

15. Data are required on estuarine/marine 

species if the product meets any of the following conditions: 

i. Intended for direct application to the estuarine or marine environment. 

ii. Expected to enter this environment in 

significant concentrations because of its expected use or mobility patterns. 

iii. If the acute LC50 or EC50 <1 milligram/ 

liter (mg/l). 

iv. If the estimated environmental concentration (EEC) in water is ≥0.01 of the 

acute EC50 or LC50 or if any of the following 

conditions exist: 

A. Studies of other organisms indicate the 

reproductive physiology of fish and/or invertebrates may be affected. 

B. Physicochemical properties indicate 

bioaccumulation of the pesticide. 

C. The pesticide is persistent in water (e.g., 

half-life in water >4 days). 

16. Data are required on one estuarine/marine fish species. 

17. Data are required on estuarine/marine 

species if the product is intended for direct 

application to the estuarine or marine environment, or the product is expected to enter 

this environment in significant concentrations because of its expected use or mobility 

patterns. 

18. Data are required on freshwater species 

if the end-use product is intended to be applied directly to water, or is expected to be 

transported to water from the intended use 

site, and when any of the following conditions apply: 

i. If the estimated environmental concentration (EEC) is ≥0.1 of the no-observedeffect level in the fish early-life stage or invertebrate life cycle test; 

ii. If studies of other organisms indicate 

that the reproductive physiology of fish may 

be affected. 

19. Not required when: 

i. The octanol/water partition coefficients 

of the pesticide and its major degradates are 

<1,000; or 

ii. There are no potential exposures to fish 

and other nontarget aquatic organisms; or 

iii. The hydrolytic half-life is <5 days at pH 

5, 7 and 9. 

20. Data are required based on the results 

of lower tier studies such as acute and chronic aquatic organism testing, intended use 

pattern, and environmental fate characteristics that indicate significant potential exposure. 

21. Data are required if: 

i. The half-life of the pesticide in the sediment is ≤10 days in either the aerobic soil or 

aquatic metabolism studies and if any of the 

following conditions exist: 

A. The soil partition coefficient (Kd) is ≥50. 

B. The log Kow is ≥3. 

C. The Koc ≥1,000. 

ii. Registrants must consult with the 

Agency on appropriate test protocols prior 

to designing the study. 

22. Data are required if: 

i. The estimated environmental concentration (EEC) in sediment is >0.1 of the acute 

LC50/EC50 values and 

ii. The half-life of the pesticide in the sediment is >10 days in either the aerobic soil or 

aquatic metabolism studies and if any of the 

following conditions exist: 

A. The soil partition coefficient (Kd) is ≥50. 

B. The log Kow is ≥3. 

C. The Koc ≥1,000. 

iii. Registrants must consult with the 

Agency on appropriate test protocols prior 

to designing the study. 

23. Sediment testing with estuarine/marine 

test species is required if the product is intended for direct application to the estuarine 

or marine environment or the product is expected to enter this environment in concentrations which the Agency believes to be 

significant, either by runoff or erosion, because of its expected use or mobility pattern. 

24. Data are required only when the formulation contains one or more active ingredients having an acute LD50 of <11 micrograms 

per bee as determined in the honey bee acute 

contact study and the use pattern(s) indicate(s) that honey bees may be exposed to 

the pesticide. 

25. Required if any of the following conditions are met: 

i. Data from other sources (Experimental 

Use Permit program, university research, 

registrant submittals, etc.) indicate potential adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.); 

ii. Data from residual toxicity studies indicate extended residual toxicity. 

iii. Data derived from studies with terrestrial arthropods other than bees indicate potential chronic, reproductive or behavioral 

effects. 

26. The freshwater fish test species for the 

TEP testing is the most sensitive of the species tested with the TGAI. Freshwater invertebrate and acute estuarine and marine organisms must also be tested with the EP or 

TEP using the same species tested with the 

TGAI. 


Lhorne on DSK5TPTVN1PROD with CFR
125 

Environmental Protection Agency § 158.660 

§ 158.660 Nontarget plant protection 

data requirements table. 

(a) General. Sections 158.100 

through158.130 describe how to use this 

table to determine the nontarget plant 

data requirements for a particular pesticide product. Notes that apply to an 

individual test and include specific 

conditions, qualifications, or exceptions to the designated test are listed 

in paragraph (e) of this section. 

(b) Use patterns. (1) The terrestrial 

use pattern includes products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

and terrestrial nonfood. The aquatic 

use pattern includes only the general 

use patterns of aquatic food crops and 

aquatic nonfood. 

(2) Data are also required for the general use patterns of forestry use and 

residential outdoor use. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; TGAI=Technical grade of the 

active ingredient; TEP=Typical enduse product. 

(d) Table. The following table shows 

the nontarget plant protection data requirements. The table notes are shown 

in paragraph (e) of this section. 

TABLE—NONTARGET PLANT PROTECTION DATA REQUIREMENTS

Guideline Number Data Requirement 

Use Pattern 

Test substance Test Note No. Terrestrial Aquatic 

Forestry and 

Residential 

Outdoor 

Nontarget Area Phytotoxicity - Tier I 

850.4100 Seedling emergence R R R TEP 1, 2, 7 

850.4150 Vegetative vigor R R R TEP 1, 2, 3, 7 

850.4400 

850.5400 

Aquatic plant growth 

(algal and aquatic vascular plant toxicity) 

R R R TEP or 

TGAI 

1, 2, 7 

Nontarget Area Phytotoxicity - Tier II 

850.4100 Seedling emergence CR CR CR TEP 1, 4, 5, 7 

850.4150 Vegetative vigor CR CR CR TEP 1, 3, 4, 5, 7 

850.4400 

850.5400 

Aquatic plant growth 

(algal and aquatic vascular plant toxicity) 

CR CR CR TEP or 

TGAI 

1, 4, 6, 7 

Nontarget Area Phytotoxicity - Tier III 

850.4300 Terrestrial field CR CR CR TEP 1, 7, 8, 10 

850.4450 Aquatic field CR CR CR TEP 1, 7, 8, 10 

Target Area Phytotoxicity 

850.4025 Target area phytotoxicity CR CR CR TEP 1, 7, 9, 10 

(e) Test notes. The following test 

notes apply to the table in paragraph 

(d) of this section. 

1. Not required for contained pesticide 

treatments such as bait boxes and 

pheromone traps unless adverse effects reports are received by the Agency. 

2. Not required for known phytotoxicants. 

3. Generally not required for granular formulations. May be requested on a case-bycase basis. 

4. Required for known phytotoxicants such 

as herbicides, desiccants and defoliants. 

5. Required if a tested terrestrial species 

exhibits a 25 percent or greater detrimental 

effect in the Tier I study. When Tier II testing is required, the test species should be the 

species that showed detrimental effects in 

the Tier I testing. 

6. Required if the tested aquatic species exhibits a 50 percent or greater detrimental effect in the Tier I study. When Tier II testing 

is required, the test species should be the 


Lhorne on DSK5TPTVN1PROD with CFR
126 

§§ 158.700–158.900 40 CFR Ch. I (7–1–15 Edition) 

species that showed detrimental effects in 

the tier I testing. 

7. Not required for aquatic residential uses. 

8. Environmental chemistry methods used 

to generate data must include the results of 

a successful confirmatory method trial by an 

independent laboratory. 

9. Tests are required on a case-by-case 

basis based on the results of lower tier 

phytotoxicity studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure. 

10. Registrants must consult with the 

Agency on appropriate test protocols prior 

to designing the study. 

Subparts H–J [Reserved] 

§§ 158.700–158.900 [Reserved] 

Subpart K—Human Exposure 

§ 158.1000 Applicator exposure—general requirements. 

(a) If EPA determines that industrial 

standards, such as the workplace 

standards set by the Occupational 

Safety and Health Administration 

(OSHA), provide adequate protection 

from risk under FIFRA for a particular 

pesticide use pattern, exposure data 

may not be required for that use pattern. Applicants should consult with 

the Agency on appropriate testing 

prior to the initiation of studies. 

(b) The Agency may accept surrogate 

exposure data estimations from other 

sources to satisfy applicator exposure 

data requirements if the data meet the 

basic quality assurance, quality control, good laboratory practice, and 

other scientific requirements set by 

EPA. In order to be acceptable, the 

Agency must find that the surrogate 

exposure data estimations have adequate information to address applicator exposure data requirements and 

contain adequate replicates of acceptable quality data to reflect the specific 

use prescribed on the label and the applicator activity of concern, including 

formulation type, application methods 

and rates, type of activity, and other 

pertinent information. The Agency will 

consider using such surrogate data for 

evaluating human exposure on a caseby-case basis. 

§ 158.1010 Applicator exposure—criteria for testing. 

Applicator exposure data described in 

paragraph (d) of this section are required based on toxicity and exposure 

criteria. Data are required if a product 

meets, as determined by the Agency, at 

least one of the toxicity criteria in 

paragraph (a) of this section and either 

or both of the exposure criteria in 

paragraph (b) of this section. 

(a) Toxicity criteria. (1) Evidence of 

potentially significant adverse effects 

have been observed in any applicable 

toxicity study. 

(2) Scientifically sound epidemiological or poisoning incident data indicate 

that adverse health effects may have 

resulted from handling of the pesticide. 

(b) Exposure criteria. (1) Dermal exposure may occur during the prescribed 

use. 

(2) Respiratory exposure may occur 

during the prescribed use. 

§ 158.1020 Applicator exposure data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the applicator exposure data 

requirements for a particular pesticide 

product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to 

the designated test are listed in paragraph (e) of this section. 

(b) Use patterns. (1) Occupational use 

patterns include products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

terrestrial nonfood crop, aquatic food, 

aquatic nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor 

food use, and indoor nonfood use. Occupational use patterns also include commercial (‘‘for hire’’) applications to 

residential outdoor and indoor sites. 

(2) Residential use patterns include 

residential outdoor use and residential 

indoor use. These use patterns are limited to nonoccupational, i.e., nonprofessional, pesticide applications. 

(c) Key. R=Required; 

CR=Conditionally required; 

TEP=Typical end-use product. 

(d) Table. The data requirements listed pertain to pesticide products that 

meet the testing criteria outlined in 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.1060 

§158.1010. The table notes are shown in 

paragraph (e) of this section. 

TABLE—APPLICATOR EXPOSURE DATA REQUIREMENTS

Guideline 

Number Data requirement 

Use pattern Test substance Test Note No. Occupational Residential 

875.1100 Dermal outdoor exposure R R TEP 1, 2, 3 

875.1200 Dermal indoor exposure R R TEP 1, 2, 4 

875.1300 Inhalation outdoor exposure R R TEP 1, 2, 3 

875.1400 Inhalation indoor exposure R R TEP 1, 2, 4 

875.1500 Biological monitoring CR CR TEP 1, 2 

875.1600 Data reporting and calculations R R TEP 5 

875.1700 Product use information R R TEP -- 

(e) Test notes. The following notes 

apply to the data requirements in the 

table to paragraph (d) of this section: 

1. Protocols must be submitted for approval prior to the initiation of the study. 

Details for developing protocols are available from the Agency. 

2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal 

and inhalation exposure data, provided the 

human pharmacokinetics of the pesticide 

and/or metabolite/analog compounds (i.e., 

whichever method is selected as an indicator 

of body burden or internal dose) allow for the 

back calculation to actual dose. 

3. Data are required if the product is applied outdoors. 

4. Data are required if the product is applied indoors. 

5. Data reporting and calculations are required when handler exposure data are submitted. 

§ 158.1050 Post-application exposure— 

general requirements. 

(a) If EPA determines that industrial 

standards, such as the workplace 

standards set by the Occupational 

Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants 

should consult with the Agency on appropriate testing before the initiation 

of studies. 

(b) The Agency may accept surrogate 

exposure data from other sources to 

satisfy post-application exposure data 

requirements if the data meet the basic 

quality assurance, quality control, 

good laboratory practice, and other scientific needs of EPA. In order to be acceptable, among other things, the 

Agency must find that the surrogate 

exposure data have adequate information to address post-application exposure data requirements and contain 

adequate replicates of acceptable quality data to reflect the specific use prescribed on the label and the post-application activity of concern, including 

formulation type, application methods 

and rates, type of activity, and other 

pertinent information. The Agency will 

consider using such surrogate data for 

evaluating human exposure on a caseby-case basis. 

§ 158.1060 Post-application exposure— 

criteria for testing. 

Exposure data described in 

§158.1070(d) are required based upon 

toxicity and exposure criteria. Data 

are required if a product meets, as determined by the Agency, either or both 

of the toxicity criteria in paragraph (a) 

of this section and either or both of the 

exposure criteria in paragraph (b) of 

this section. 

(a) Toxicity criteria. (1) Evidence of 

potentially significant adverse health 

effects have been observed in any applicable toxicity study. 

(2) Scientifically sound epidemiological or poisoning incident data indicate 

that adverse health effects may have 

resulted from post-application exposure to the pesticide. 

(b) Exposure criteria. The need for 

data from potential exposure resulting 


Lhorne on DSK5TPTVN1PROD with CFR
128 

§ 158.1070 40 CFR Ch. I (7–1–15 Edition) 

from situations not covered by this 

paragraph should be discussed with the 

Agency. 

(1) For outdoor uses. (i) Occupational 

human post-application exposure to 

pesticide residues on plants or in soil 

could occur as the result of cultivation, 

pruning, harvesting, mowing or other 

work-related activity. Such uses include agricultural food, feed, and fiber 

commodities, forest trees, ornamental 

plants, and turf grass. 

(ii) Residential human post-application exposure to pesticide residues on 

plants or in soil could occur. Such uses 

may include turf grass, fruits, vegetables, and ornamentals grown at sites, 

including, but not limited to, homes, 

parks, and recreation areas. 

(2) For indoor uses. (i) Occupational 

human post-application exposure to 

pesticide residues could occur following the application of the pesticide 

to indoor spaces or surfaces at agricultural or commercial sites, such as, but 

not limited to, agricultural animal facilities and industrial or manufacturing facilities. 

(ii) Residential human post-application exposure to pesticide residues 

could occur following the application 

of the pesticide to indoor spaces or surfaces at residential sites, such as, but 

not limited to homes, daycare centers, 

hospitals, schools, and other public 

buildings. 

§ 158.1070 Post-application exposure 

data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the post-application data requirements for a particular pesticide 

product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to 

the designated test are listed in paragraph (e) of this section. 

(b) Use patterns. (1) Occupational use 

patterns include products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

terrestrial nonfood use, aquatic food, 

aquatic nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor 

food, and indoor nonfood. Occupational 

use patterns also include commercial 

(‘‘for hire’’) applications to residential 

outdoor and indoor sites. 

(2) Residential use patterns include 

residential outdoor use and indoor residential use. These use patterns are limited to nonoccupational, i.e., nonprofessional, pesticide applications. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; TEP=Typical end-use product. 

(d) Table. The data requirements listed in the following table pertain to pesticide products that meet the testing 

criteria outlined in §158.1060. The table 

notes are shown in paragraph (e) of this 

section. 

TABLE—POST-APPLICATION EXPOSURE DATA REQUIREMENTS

Guideline 

Number Data Requirement 

Use Pattern Test Substance Test Note No. 

Occupational Residential 

875.2100 Dislodgeable foliar residue and turf transferable residues R R TEP 1, 2, 3, 4, 5 

875.2200 Soil residue dissipation R CR TEP 1, 2, 6, 7 

875.2300 Indoor surface residue dissipation R R TEP 1, 2, 8, 9 

875.2400 Dermal exposure R R TEP 1, 2, 10, 11, 

12 

875.2500 Inhalation exposure R R TEP 1, 10, 11, 12 

875.2600 Biological monitoring CR CR TEP 1, 12, 13 

875.2700 Product use information R R TEP -- 

875.2800 Description of human activity R R TEP -- 

875.2900 Data reporting and calculations R R TEP 14 

875.3000 Nondietary ingestion exposure NR R TEP 1, 11, 15 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.1100 

(e) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (d) of this 

section: 

1. Protocols must be submitted for approval prior to the initiation of the study. 

Details for developing protocols are available from the Agency. 

2. Bridging applicable residue dissipation 

data to dermal exposure data is required. 

3. Turf grass transferable residue dissipation data are required when pesticides are 

applied to turf grass. Dislodgeable foliar residue dissipation data are required when pesticides are applied to the foliage of plants 

other than turf grass. 

4. Data are required for occupational sites 

if (i) there are uses on turf grass or other 

plant foliage, and (ii) the human activity 

data indicate that workers are likely to have 

post-application dermal contact with treated 

foliage while participating in typical activities. 

5. Data are required for residential sites if 

there are uses on turf grass or other plant foliage. 

6. Data are required for occupational sites, 

if (i) there are outdoor or greenhouse uses to 

or around soil or other planting media, and 

(ii) the human activity data indicate that 

workers are likely to have post-application 

dermal contact with treated soil or planting 

media while participating in typical activities. 

7. Data are required for residential sites if 

the pesticide is applied to or around soil or 

other planting media both outdoors and indoors, e.g., residential greenhouse or houseplant uses. 

8. Data are required for occupational sites 

if the pesticide is applied to or around on 

non-plant surfaces, e.g., flooring or 

countertops, and if the human activity data 

indicate that workers are likely to have 

post-application dermal contact with treated 

indoor surfaces while participating in typical activities. 

9. Data are required for residential sites if 

the pesticide is applied to or around nonplant surfaces, e.g., flooring and countertops. 

10. Data are required for occupational sites 

if the human activity data indicate that 

workers are likely to have post-application 

exposures while participating in typical activities. 

11. Data are required for residential sites if 

post-application exposures are likely. 

12. Biological monitoring data may be submitted in addition to, or in lieu of, dermal 

and inhalation exposure data provided the 

human pharmocokinetics of the pesticide 

and/or metabolite/analog compounds (i.e., 

whichever method is selected as an indicator 

of body burden or internal dose) allow for a 

back-calculation to the total internal dose. 

13. Data are required when passive dosimetry techniques are not applicable for a particular exposure scenario, such as a swimmer 

exposure to pesticides. 

14. Data reporting and calculations are required when any post-application exposure 

monitoring data are submitted. 

15. The selection of a sampling method will 

depend on the nondietary pathway(s) of interest. Data must be generated to consider 

all potential pathways of nondietary ingestion exposure that are applicable (e.g., soil 

ingestion, hand-to-mouth transfer, and object-to-mouth transfer of surface residues). 

Subpart L—Spray Drift 

§ 158.1100 Spray drift data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the spray drift data requirements for a particular pesticide product. Notes that apply to an individual 

test, including specific conditions, 

qualifications, or exceptions to the designated test are listed in paragraph (e) 

of this section. 

(b) Use patterns. The terrestrial use 

pattern includes products classified 

under the general use patterns of terrestrial food crop and terrestrial 

nonfood crop. The aquatic use pattern 

includes products classified under the 

general use patterns of aquatic food 

crop and aquatic nonfood. The greenhouse use pattern includes products 

classified under the general use patterns of greenhouse food crop and 

greenhouse nonfood crop. Data are also 

required for the general use patterns of 

forestry use, residential outdoor use, 

and indoor use. 

(c) Key. CR=Conditionally required; 

NR=Not required; TEP=Typical enduse product; MP=Manufacturing use 

product; EP=End-use product. 

(d) Table. The following table lists 

the data requirements that pertain to 

spray drift. The table notes are shown 

in paragraph (e) of this section. 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.1100 40 CFR Ch. I (7–1–15 Edition) 

TABLE—SPRAY

DRIFT

DATA

REQUIREMENTS

Guideline Number Data Requirement 

Use Pattern Test substance 

Test Note 

No. 

Terrestrial Aquatic Greenhouse Forestry Resi- dential Outdoor Indoor MP EP Food Crop Nonfood Crop Food Nonfood Food Crop Nonfood Crop 

201–1 Droplet size spectrum CR CR CR CR NR NR CR NR NR TEP TEP 1 202–1 Droplet size spectrum CR CR CR CR NR NR CR NR NR TEP TEP 1 


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Environmental Protection Agency § 158.1300 

(e) Test notes. The following notes 

apply to the requirements in the table 

to paragraph (d) of this section: 

1. This study is required when aerial applications (rotary and fixed winged) and mist 

blower or other methods of ground application are proposed and it is estimated that 

the detrimental effect level of those nontarget organisms expected to be present would 

be exceeded. The nontarget organisms include humans, domestic animals, fish and 

wildlife, and nontarget plants. 

2. [Reserved] 

Subpart M [Reserved] 

§§ 158.1200–158.1299 [Reserved] 

Subpart N—Environmental Fate 

§ 158.1300 Environmental fate data requirements table. 

(a) General. All environmental fate 

data, as described in paragraph (c) of 

this section, must be submitted to support a request for registration. 

(b) Use patterns. (1) The terrestrial 

use pattern includes products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

and terrestrial nonfood. The aquatic 

use pattern includes the general use 

patterns of aquatic food crop, and 

aquatic nonfood. The greenhouse use 

pattern includes both food and nonfood 

uses. The indoor use pattern includes 

food, nonfood, and residential indoor 

uses. 

(2) Data are also required for the general use patterns of forestry use and 

residential outdoor use. 

(c) Key. CR=Conditionally required; 

NR=Not required; R=Required; 

PAIRA=Pure active ingredient radiolabeled; TGAI=Technical grade of the 

active ingredient; TEP=Typical enduse product. 

(d) Table. The following table shows 

the data requirements for environmental fate. The test notes are shown 

in paragraph (e) of this section. 

TABLE—ENVIRONMENTAL FATE DATA REQUIREMENTS

Guideline Number Data Requirement 

Use Pattern 

Test 

substance 

Test 

Terres- Note No. 

trial Aquatic Greenhouse Indoor Forestry 

Residential Outdoor 

Degradation Studies - Laboratory 

835.2120 Hydrolysis R R R CR R R TGAI or 

PAIRA 

1 

835.2240 Photodegradation 

in water 

R R NR NR R NR TGAI or 

PAIRA 

2 

835.2410 Photodegradation 

on soil 

R NR NR NR R NR TGAI or 

PAIRA 

3 

835.2370 Photodegradation 

in air 

CR NR CR NR CR CR TGAI or 

PAIRA 

4 

Metabolism Studies - Laboratory 

835.4100 Aerobic soil R CR R NR R R TGAI or 

PAIRA 

5 

835.4200 Anaerobic soil R NR NR NR NR NR TGAI or 

PAIRA 

-- 

835.4300 Aerobic aquatic R R NR NR R NR TGAI or 

PAIRA 

-- 

835.4400 Anaerobic aquatic R R NR NR R NR TGAI or 

PAIRA 

-- 

Mobility Studies 

835.1230 

835.1240 

Leaching and adsorption/ 

desorption 

R R R NR R R TGAI or 

PAIRA 

6 


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§ 158.1300 40 CFR Ch. I (7–1–15 Edition) 

TABLE—ENVIRONMENTAL FATE DATA REQUIREMENTS—Continued 

Guideline Number Data Requirement 

Use Pattern 

Test 

substance 

Test 

Terres- Note No. 

trial Aquatic Greenhouse Indoor Forestry 

Residential Outdoor 

835.1410 Volatility - laboratory CR NR CR NR NR NR TEP 4 

835.8100 Volatility - field CR NR CR NR NR NR TEP -- 

Dissipation Studies - Field 

835.6100 Terrestrial R CR NR NR CR R TEP 5, 7, 12 

835.6200 Aquatic (sediment) CR R NR NR NR NR TEP 7, 8 

835.6300 Forestry NR NR NR NR CR NR TEP 7, 9, 12 

835.6400 Combination and 

tank mixes 

CR CR NR NR NR NR TEP 10 

Ground Water Monitoring 

835.7100 Ground water 

monitoring 

CR NR NR NR CR CR TEP 7, 9, 11 

(e) Test notes. The following test 

notes apply to the requirements in the 

table to paragraph (d) of this section: 

1. Study is required for indoor uses in cases 

where environmental exposure is likely to 

occur. Such sites include, but are not limited 

to, agricultural premises, in or around farm 

buildings, barnyards, and beehives. 

2. Not required when the electronic absorption spectra, measured at pHs 5, 7, and 9, of 

the chemical and its hydrolytic products, if 

any, show no absorption or tailing between 

290 and 800 nm. 

3. Not required when the chemical is to be 

applied only by soil injection or is incorporated in the soil. 

4. Requirement based on use patterns and 

other pertinent factors including, but not 

limited to, the Henry’s Law Constant of the 

chemical. In view of methodological difficulties with the study of photodegradation in 

air, prior consultation with the Agency regarding the protocol is recommended before 

the test is performed. 

5. Required for aquatic food and nonfood 

crop uses for aquatic sites that are intermittently dry. Such sites include, but are not 

limited to, cranberry bogs and rice paddies. 

6. Adsorption and desorption using a batch 

equilibrium method is preferred. However in 

some cases, for example, where the pesticide 

degrades rapidly, soil column leaching with 

unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major 

transformation products. 

7. Environmental chemistry methods used 

to generate data associated with this study 

must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available 

as addenda to the guideline for this test requirement. 

8. Requirement for terrestrial uses is based 

on potential for aquatic exposure and if pesticide residues have the potential for persistence, mobility, nontarget aquatic toxicity or 

bioaccumulation. Not required for aquatic 

residential uses. Field testing under the terrestrial field dissipation requirement may be 

more appropriate for some aquatic food 

crops, such as rice and cranberry uses, that 

are managed to have a dry-land period for 

production. The registrant is encouraged to 

consult with the Agency on protocols. 

9. Agency approval of a protocol is necessary prior to initiation of the study. 

10. This study may be triggered if there is 

specific evidence that the presence of one 

pesticide can affect the dissipation characteristics of another pesticide when applied 

simultaneously or serially. 

11. Required if the weight-of-evidence indicates that the pesticide and/or its degradates 

is likely to leach to ground water, taking 

into account other factors such as the toxicity of the chemicals(s), available monitoring data, and the vulnerability of ground 

water resources in the pesticide use area. 

12. If the terrestrial dissipation study cannot assess all of the major routes of dissipation, the forestry study will be required. 


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Environmental Protection Agency § 158.1410 

Subpart O—Residue Chemistry 

§ 158.1400 Definitions. 

The following terms are defined for 

the purposes of this subpart: 

Livestock, for the purposes of this section, includes all domestic animals 

that are bred for human consumption, 

including, but not limited to, cattle, 

swine, sheep, and poultry. 

Plant or animal metabolite means a 

pesticide chemical residue that is the 

result of biological breakdown of the 

parent pesticide within the plant or 

animal. 

Residue of concern means the parent 

pesticidal compound and its metabolites, degradates, and impurities of toxicological concern. 

Tolerance, for the purposes of this 

section, includes the establishment of a 

new tolerance or tolerance exemption, 

or amended tolerance or tolerance exemption. 

§ 158.1410 Residue chemistry data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the residue chemistry data 

requirements for a particular pesticide 

product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to 

the designated test are listed in paragraph (e) of this section. 

(b) Use patterns. (1) Data are required 

or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops 

are grown. Food use patterns include 

products classified under the general 

use patterns of terrestrial food crop 

use, terrestrial feed crop use, aquatic 

food crop use, greenhouse food crop 

use, and indoor food use. 

(2) Data may be required for nonfood 

uses if pesticide residues may occur in 

food or feed as a result of the use. Data 

requirements for these nonfood uses 

will be determined on a case-by-case 

basis. For example, most products used 

in or near kitchens require residue 

data for risk assessment purposes even 

though tolerances may not be necessary in all cases. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; TGAI=Technical grade of the 

active ingredient; PAI=Pure active ingredient; PAIRA=Pure active ingredient radio-labeled; Residue of 

concern= the active ingredient and its 

metabolites, degradates, and impurities of toxicological concern; 

TEP=Typical end-use product. 

(d) Table. The following table list the 

data requirements for residue chemistry related to food uses. The table 

notes are shown in paragraph (e) of this 

section. 

TABLE—RESIDUE CHEMISTRY DATA REQUIREMENTS FOR FOOD USES

Guideline Number Data Requirement 

Use Pattern 

Test substance 

Test 

Note 

No. 

Terrestrial 

Food or 

Feed 

Aquatic 

Food 

Greenhouse 

Food 

Indoor 

Food 

Residential 

Outdoor 

Supporting Information 

860.1100 Chemical identity R R R R R TGAI -- 

860.1200 Directions for use R R R R R -- -- 

860.1550 Proposed tolerance R R R CR NR -- 1 

860.1560 Reasonable grounds in 

support of petition 

R R R CR NR -- 1 

860.1650 Submittal of analytical reference standards R R R CR NR PAI and 

residue 

of concern 

1, 2, 25 

Nature of the residue 

860.1300 Nature of the residue in 

plants 

R R R CR CR PAIRA 3, 4, 25 


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§ 158.1410 40 CFR Ch. I (7–1–15 Edition) 

TABLE—RESIDUE CHEMISTRY DATA REQUIREMENTS FOR FOOD USES—Continued 

Guideline Number Data Requirement 

Use Pattern 

Test substance 

Test 

Note 

No. 

Terrestrial 

Food or 

Feed 

Aquatic 

Food 

Greenhouse 

Food 

Indoor 

Food 

Residential 

Outdoor 

860.1300 Nature of the residue in 

livestock 

CR CR CR CR NR PAIRA or 

radiolabeled plant 

metabolite 

1, 6, 25 

860.1850 Confined rotational crops CR CR NR NR NR PAIRA 7 

Analytical methods 

860.1340 Residue analytical methods R R R CR CR Residue 

of concern 

1, 3, 8, 

9, 10, 

25 

860.1360 Multiresidue method R R R CR NR Residue 

of concern 

1, 11, 

25 

Magnitude of the residue 

860.1380 Storage stability R R R CR CR TEP or 

residue 

of concern 

1, 3, 

10, 12, 

25 

860.1500 Crop field trials R R R CR CR TEP 3, 10, 

14, 24, 

25 

860.1520 Processed food or feed CR CR CR CR NR TEP 1, 15, 

25 

860.1480 Meat/milk/poultry/eggs CR CR CR CR NR TGAI or 

plant metabolite 

1, 16, 

17, 18, 

25 

860.1400 Potable water NR R NR NR NR TEP 19, 25 

860.1400 Fish NR R NR NR NR TEP 5, 25 

860.1400 Irrigated crops NR CR NR NR NR TEP 20, 25 

860.1460 Food handling NR NR NR CR NR TEP 1, 21, 

25 

860.1540 Anticipated residues CR CR CR CR NR Residue 

of concern 

1, 13, 

22, 26 

860.1900 Field rotational crops CR CR NR NR NR TEP 23, 25 

(e) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (d) of this 

section. 

1. Required if indoor use could result in 

pesticide residues in or on food or feed. 

2. Material safety data sheets must accompany standards as specified by OSHA in 29 

CFR 1910.1200. 

3. Required for residential outdoor uses on 

food crops if the corresponding agricultural 

use is not approved or the residential use is 

expected to produce higher residues based on 

the label directions. 

4. Required for indoor uses where the pesticide is applied directly to food, in order to 

determine metabolites and/or degradates. 

Not required when only indirect contact 

with food would occur (e.g., crack and crevice treatments). 

5. Data for fish are required for all pesticides applied directly to water inhabited, 

or which will be inhabited, by fish that may 

be caught or harvested for human consumption. 


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Environmental Protection Agency §§ 158.1500–158.1900 

6. Required when a pesticide is to be applied directly to livestock, to livestock 

premises, to livestock drinking water, or to 

crops used for livestock feed. If results from 

the plant metabolism study show differing 

metabolites in plants from those found in 

animals, an additional livestock metabolism 

study involving dosing with the plant metabolite(s) may also be required. 

7. Required when the Agency determines 

that it is reasonably foreseeable that a food 

or feed crop could be subsequently planted 

on the site of pesticide application after harvest or failure of the treated crop. Typically 

not required for pesticide uses in permanent 

food crops (e.g., various tree crops, vines) or 

semi-permanent crops (e.g., asparagus, pineapples). 

8. A residue analytical method suitable for 

enforcement purposes is required whenever a 

numeric tolerance (including temporary and 

time-limited tolerances) is proposed. 

9. New analytical methods to be used for 

enforcement purposes must include results 

from an independent laboratory validation. 

10. A residue method, storage stability 

data, and crop field trials are required for 

the nonfood crop tobacco (green, freshly harvested). Depending on the level of residues 

found on the green tobacco, additional data 

may be required on cured/dried tobacco and 

pyrolysis products. 

11. Data are required to determine whether 

FDA/USDA multiresidue methodology would 

detect and identify the pesticides and any 

metabolites. 

12. Data are required for any magnitude of 

the residue study unless analytical samples 

are stored frozen for 30 days or less, and the 

active ingredient is not known to be volatile 

or labile. 

13. Studies using single serving samples of 

a raw agricultural commodity may be needed for acutely toxic pesticides and/or their 

metabolites. These residue studies must be 

conducted using a statistical design accepted 

by the Agency. 

14. Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal waxes or 

stored grain fumigants). 

15. Data on the nature and level of residues 

in processed food/feed are required if residues 

could potentially concentrate on processing 

thus requiring the establishment of a separate tolerance higher than that of the raw 

agricultural commodity. 

16. Required when the pesticide use is a direct application to livestock. 

17. Data are required if pesticide residues 

are present in or on livestock feed items or 

intentionally added to drinking water. These 

studies, however, may not be required in 

cases where the livestock metabolism studies indicate negligible transfer of the pesticide’s residues of concern to tissues, milk, 

and eggs at the maximum expected exposure 

level for the animals. 

18. If results from the plant metabolism 

study show differing metabolites in plants 

from those found in animals, an additional 

livestock feeding study involving dosing 

with the plant metabolite(s) may also be required. 

19. Data are required whenever a pesticide 

may be applied directly to water, unless it 

can be demonstrated that the treated water 

would not be available for human or livestock consumption. 

20. Data are required when a pesticide is to 

be applied directly to water that could be 

used for irrigation or to irrigation facilities 

such as irrigation ditches. 

21. Data are required whenever a pesticide 

may be used in a food handling or feed handling establishment. 

22. Required when residues at the tolerance 

level may result in a risk of concern. These 

data may include washing, cooking, processing or degradation studies as well as market basket surveys for a more precise residue 

determination. 

23. Typically required if pesticide residues 

of concern greater than 0.01 ppm are found in 

crops at the appropriate plant back intervals 

(taking into account plant back restrictions 

on product labels) in the confined rotational 

crop study. If residues of concern in the confined study are greater than 0.01 ppm but less 

than the limit of quantitation of the analytical method to be used on field trial samples, 

the Agency will consider not requiring, on a 

case-by-case basis, the limited field trials. If 

there are particular toxicological concerns 

with the parent pesticide or any metabolites, 

limited field studies may be needed if such 

residues are identified at levels below 0.01 

ppm in the confined study. 

24. Crop field trials are required to establish tolerances on rotational crops when 

quantifiable residues of concern are observed 

in the field rotational crops study. 

25. Not required for an exemption from a 

tolerance provided that dietary exposure estimates are not needed due to low toxicity or 

that theoretical estimates of exposure are 

adequate to assess dietary risk. 

26. Not required for an exemption from a 

tolerance. 

Subparts P–T [Reserved] 

§§ 158.1500–158.1900 [Reserved] 

Subpart U—Biochemical 

Pesticides 

SOURCE: 72 FR 61002, Oct. 26, 2007, unless 

otherwise noted. 


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§ 158.2000 40 CFR Ch. I (7–1–15 Edition) 

§ 158.2000 Biochemical pesticides definition and applicability. 

This subpart applies to all biochemical pesticides as defined in paragraphs (a), (b), and (c) of this section. 

(a) Definitions. The following terms 

are defined for the purposes of subpart 

U of this part. 

(1) A biochemical pesticide is a pesticide that: 

(i) Is a naturally-occurring substance 

or structurally-similar and functionally identical to a naturally-occurring 

substance; 

(ii) Has a history of exposure to humans and the environment demonstrating minimal toxicity, or in the 

case of a synthetically-derived biochemical pesticides, is equivalent to a 

naturally-occurring substance that has 

such a history; and 

(iii) Has a non-toxic mode of action 

to the target pest(s). 

(2) A Pheromone is a compound produced by a living organism or is a synthetically derived substance that is 

structurally similar and functionally 

identical to a naturally-occurring 

pheromone, which, alone or in combination with other such compounds, 

modifies the behavior of other individuals of the same species. 

(i) An Arthropod Pheromone is a 

pheromone produced by a member of 

the taxonomic phylum Arthropoda. 

(ii) A Lepidopteran Pheromone is an 

arthropod pheromone produced by a 

member of the insect order Lepidoptera. 

(iii) A Straight Chain Lepidopteran 

Pheromone is a lepidopteran pheromone 

consisting of an unbranched aliphatic 

chain (between 9 and 18 carbons) ending 

in an alcohol, aldehyde, or acetate 

functional group and containing up to 

three double bonds in the aliphatic 

backbone. 

(b) Examples. Biochemical pesticides 

include, but are not limited to: 

(1) Semiochemicals (insect 

pheromones and kairomones), 

(2) Natural plant and insect regulators, 

(3) Naturally-occurring repellents 

and attractants, and 

(4) Enzymes. 

(c) Applicability. The Agency may review, on a case-by-case basis, naturally-occurring pesticides that do not 

clearly meet the definition of a biochemical pesticide in an effort to ensure, to the greatest extent possible, 

that only the minimum testing sufficient to make scientifically sound regulatory decisions would be conducted. 

The Agency will review applications 

for registration of naturally-occurring 

pesticides to determine whether to review the pesticide under this subpart 

U. 

§ 158.2010 Biochemical pesticides data 

requirements. 

(a) Sections 158.2030 through 158.2070 

identify the data requirements that are 

required to support registration of biochemical pesticides. Sections 158.2080 

through 158.2084 identify the data requirements that are required to support Experimental Use Permits (EUPs). 

Variations in the test conditions are 

identified within the test notes. Definitions that apply to all biochemical 

data requirements can be found in 

§158.2000. 

(b) Each data table includes ‘‘use patterns’’ under which the individual data 

are required, with variations including 

food and nonfood uses for terrestrial 

and aquatic applications, greenhouse, 

indoor, forestry, and residential outdoor applications under certain circumstances. 

(c) The categories for each data requirement are ‘‘R’’, which stands for 

required, and ‘‘CR’’ which stands for 

conditionally required. Generally, ‘‘R’’ 

indicates that the data are more likely 

required than for those data requirements with ‘‘CR.’’ However, in each 

case, the regulatory text preceding the 

data table and the test notes following 

the data table must be used to determine whether the data requirement 

must be satisfied. 

(d) Each table identifies the test substance that is required to be tested to 

satisfy the data requirement. Test substances may include: technical grade 

active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use product 

(TEP), residue of concern, and pure active ingredient (PAI) or all of the above 

(All). Commas between the test substances (i.e., TGAI, EP) indicate that 

data may be required on the TGAI or 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.2030 

EP or both depending on the conditions 

set forth in the test note. 

(e) The data requirements are organized into a tier-testing system with 

specified additional studies at higher 

tiers being required if warranted by adverse effects observed in lower tier 

studies. The lower tier studies are a 

subset of those required for conventional pesticides, and the studies overall are generally selected from those 

required for conventional pesticides. 

(f) Two sets of guideline numbers are 

provided for some of the environmental 

fate data requirements. For ease of understanding, the current guidelines will 

be used as an interim measure until 

the new guidelines (in parentheses) are 

finalized. 

§ 158.2030 Biochemical pesticides 

product chemistry data requirements table. 

(a) General. (1) Sections 158.100 

through 158.130 describe how to use this 

table to determine the product chemistry data requirements for a particular pesticide product. Notes that 

apply to an individual test and include 

specific conditions, qualifications, or 

exceptions to the designated test are 

listed in paragraph (e) of the section. 

(2) Definitions in §158.300 apply to 

data requirements in this section. 

(b) Use patterns. Product chemistry 

data are required for all pesticide products and are not use specific. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; Residue 

of concern=the active ingredient and 

its metabolites, degradates, and impurities of toxicological concern; All=All 

of the above. 

(d) Table. The following table shows 

the data requirements for biochemical 

pesticides product chemistry. The test 

notes are shown in paragraph (e) of this 

section. 

TABLE—BIOCHEMICAL PESTICIDES PRODUCT CHEMISTRY DATA REQUIREMENTS

Guideline Number Data Requirement All Use 

Patterns 

Test Substance 

Test Notes 

MP EP 

Product Identity and Composition 

880.1100 Product identity and composition R TGAI, 

MP 

TGAI, 

EP 

1, 2 

880.1200 Description of starting materials, production and formulation process R TGAI, 

MP 

TGAI, 

EP 

2, 3 

880.1400 Discussion of formation of impurities R TGAI 

and MP 

TGAI 

and EP 

4 

Analysis and Certified Limits 

830.1700 Preliminary analysis CR TGAI 

and MP 

TGAI 

and EP 

5, 8 

830.1750 Certified limits R MP EP 6 

830.1800 Enforcement analytical method R MP EP 7 

Physical and Chemical Characteristics 

830.6302 Color R TGAI TGAI 8 

830.6303 Physical state R TGAI 

and MP 

TGAI 

and EP 

8 

830.6304 Odor R TGAI TGAI 8 

830.6313 Stability to normal and elevated temperatures, metals and metal ions R TGAI TGAI 8, 17 

830.6315 Flammability CR MP EP 9 

830.6317 Storage stability R MP EP -- 


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§ 158.2040 40 CFR Ch. I (7–1–15 Edition) 

TABLE—BIOCHEMICAL PESTICIDES PRODUCT CHEMISTRY DATA REQUIREMENTS—Continued 

Guideline Number Data Requirement All Use 

Patterns 

Test Substance 

Test Notes 

MP EP 

830.6319 Miscibility CR MP EP 10 

830.6320 Corrosion characteristics R MP EP -- 

830.7000 pH CR TGAI 

and MP 

TGAI 

and EP 

8, 11 

830.7050 UV/Visible light absorption R TGAI TGAI -- 

830.7100 Viscosity CR MP EP 12 

830.7200 Melting point/melting range CR TGAI TGAI 8, 13 

830.7220 Boiling point/boiling range CR TGAI TGAI 8, 14 

830.7300 Density/relative density/bulk density R TGAI 

and MP 

TGAI 

and EP 

8, 18 

830.7520 Particle size, fiber length, and diameter distribution CR TGAI TGAI 8, 15 

830.7550 

830.7560 

830.7570 

Partition coefficient (n-Octanol /Water) CR TGAI TGAI 16 

830.7840 Water solubility R TGAI TGAI 8 

830.7950 Vapor pressure R TGAI TGAI 8, 19 

(e) Test notes. The following test 

notes are applicable to the data requirements for biochemical pesticides 

product chemistry and are referenced 

in the last column of the table in paragraph (d) of this section. 

1. Data must be provided in accordance 

with §158.320. 

2. If the MP and EP are produced by an integrated formulation system (non-registered 

source), these data are also required on 

TGAI. 

3. Data must be provided in accordance 

with §§158.325, 158.330, and §158.335. 

4. Data must be provided in accordance 

with §158.340. 

5. Data must be provided in accordance 

with §158.345. Also, required to support the 

registration of each manufacturing-use product (including registered TGAIs) and end-use 

products produced by an integrated formulation system. Data on other end-use products 

would be required on a case-by-case basis. 

6. Data must be provided in accordance 

with §158.350. 

7. Data must be provided in accordance 

with §158.355. 

8. If the TGAI cannot be isolated, data are 

required on the practical equivalent of the 

TGAI. EP testing may also be appropriate. 

9. Required if the product contains combustible liquids. 

10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents. 

11. Required if the test substance is soluble 

or dispersible in water. 

12. Required if the product is a liquid. 

13. Required when the technical chemical 

is a solid at room temperature. 

14. Required when the technical chemical 

is a liquid at room temperature. 

15. Required for water insoluble test substances (>10¥6g/l) and fibrous test substances 

with diameter ≥0.1 μm. 

16. Required for organic chemicals unless 

they dissociate in water or are partially or 

completely soluble in water. 

17. Data on the stability to metals and 

metal ions is required only if the active ingredient is expected to come in contact with 

either material during storage. 

18. True density or specific density are required for all test substances. Data on bulk 

density is required for MPs or EPs that are 

solid at room temperature. 

19. Not required for salts. 

§ 158.2040 Biochemical pesticides residue data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the biochemical pesticides 

residue data requirements for a particular pesticide product and the substance that needs to be tested. These 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.2040 

data requirements apply to all biochemical pesticides, i.e., naturally occurring insect repellents and 

attractants, semiochemicals (e.g., insect pheromones), natural and plant 

growth regulators. Notes that apply to 

an individual test and include specific 

conditions, qualifications, or exceptions to the designated test are listed 

in paragraph (e) of this section. 

(b) Use patterns. (1) Data are required 

or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops 

are grown. Food use patterns include 

products classified under the general 

use patterns of terrestrial food crop 

use, terrestrial feed crop use, aquatic 

food crop use, greenhouse food crop 

use, and indoor food use. Data are also 

conditionally required for aquatic 

nonfood use if there is direct application to water that could subsequently 

result in exposure to food. 

(2) Data are conditionally required 

for nonfood uses if pesticide residues 

may occur in food or feed as a result of 

the use. Data requirements for these 

nonfood uses would be determined on a 

case-by-case basis. For example, most 

products used in or near kitchens require residue data for risk assessment 

purposes even though tolerances may 

not be necessary in all cases. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing end-use 

product; EP=End-use product; 

TEP=Typical end-use product; 

TGAI=Technical grade of the active ingredient; Residue of concern=the active 

ingredient and its metabolites, 

degradates, and impurities of toxicological concern; All=All of the above. 

Specific conditions, qualifications, or 

exceptions to the designated test procedures appear in paragraph (e) of this 

section, and apply to the individual 

tests in the following table: 

(d) Data requirements table. The following table shows the data requirements for biochemical pesticides residue. The test notes are shown in paragraph (e) of this section. 

TABLE—BIOCHEMICAL RESIDUE DATA REQUIREMENTS FOR SPECIFIC USES

Guideline 

Number Data Requirement 

Use Patterns 

Test Substance Test 

Notes 

Terrestrial Aquatic Greenhouse 

Food 

Indoor 

Food Food/ 

Feed Food 

Supporting Information 

860.1100 Chemical identity CR CR CR CR TGAI 1, 2, 4 

860.1200 Directions for use CR CR CR CR -- 1, 3, 4 

Nature of the Residue 

860.1300 Nature of the residue in plants CR CR CR CR TGAI 1, 4, 5, 6 

860.1300 Nature of the residue in livestock CR CR CR CR TGAI or 

plant metabolite 

1, 7, 8, 

10, 13 

860.1340 Residue analytical method CR CR R CR Residue of 

concern 

4, 9, 10 

860.1360 Multiresidue method CR CR R CR Residue of 

concern 

10, 11 

Magnitude of the Residue 

860.1400 Potable water NR CR NR NR TGAI 1, 12 

860.1400 Fish NR CR NR NR TGAI 1, 13 

860.1400 Irrigated crops NR CR NR NR TGAI 1, 14 

860.1460 Food handling NR NR NR CR TGAI 1, 15 


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§ 158.2040 40 CFR Ch. I (7–1–15 Edition) 

TABLE—BIOCHEMICAL RESIDUE DATA REQUIREMENTS FOR SPECIFIC USES—Continued 

Guideline 

Number Data Requirement 

Use Patterns 

Test Substance Test 

Notes 

Terrestrial Aquatic Greenhouse 

Food 

Indoor 

Food Food/ 

Feed Food 

860.1480 Meat/milk/poultry/eggs CR CR CR CR TGAI or 

plant metabolites 

1, 7, 8, 10 

860.1500 Crop field trials CR CR CR CR TEP 1, 3, 4 

860.1520 Processed food/feed CR CR CR CR TEP 1, 16 

860.1540 Anticipated residues CR CR CR CR Residue of 

concern 

1, 10, 17 

860.1550 Proposed tolerances CR CR CR CR -- 1, 18 

860.1560 Reasonable grounds in support of the 

petition 

CR CR CR CR -- 1, 10 

860.1650 Submittal of analytical reference 

standards 

CR CR CR CR TGAI and 

residue of 

concern 

10, 19 

(e) Test notes. The following test 

notes are applicable to the data requirements for biochemical pesticides 

product chemistry and are in the last 

column of the table contained in paragraph (d) of this section. 

1. Residue chemistry data requirements 

apply to biochemical pesticide products 

when Tier II or Tier III toxicology data are 

required, as specified for biochemical agents 

in the biochemical human health assessment 

data requirements, §158.2050. 

2. The same chemical identity data are required for biochemical product chemistry 

data requirements, §158.2030, with an emphasis on impurities. 

3. Required information includes crops to 

be treated, rate of application, number and 

timing of applications, preharvest intervals, 

and relevant restrictions. 

4. Required for residential outdoor uses on 

food crops if the corresponding agricultural 

use is not approved or the residential use is 

expected to produce higher residues based on 

the label directions. 

5. Required unless it is an arthropod 

pheromone applied at a rate less than or 

equal to 150 grams active ingredient per acre. 

6. Required for indoor uses where the pesticide is applied directly to food, in order to 

determine metabolites and/or degradates. 

Not required when only indirect contact 

with food would occur (e.g., crack and crevice treatments). 

7. Required when a pesticide is to be applied directly to livestock, to livestock 

premises, to livestock drinking water, or to 

crops used for livestock feed. 

8. If results from the plant metabolism 

study show differing metabolites in plants 

from those found in animals, an additional 

livestock metabolism study involving dosing 

with the plant metabolite(s) may also be required. 

9. A residue analytical method suitable for 

enforcement of tolerances is required whenever a numeric tolerance (including temporary and time-limited tolerances) is proposed. 

10. Required if indoor use could result in 

pesticide residues in or on food or feed. 

11. Data are required to determine whether 

FDA/USDA multiresidue methodology would 

detect and identify the pesticides and any 

metabolites. 

12. Data are required whenever a pesticide 

may be applied directly to water, unless it 

can be demonstrated that the treated water 

would not be available for human or livestock consumption. 

13. Data on fish are required for all pesticides applied directly to water inhabited, 

or which will be inhabited by fish that may 

be caught or harvested for human consumption. 

14. Data are required when a pesticide is to 

be applied directly to water that could be 

used for irrigation or to irrigation facilities 

such as irrigation ditches. 

15. Data are required whenever a pesticide 

may be used in food/feed handling establishments. 

16. Data on the nature and level of residue 

in processed food/feed are required when 

detectible residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher 


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Environmental Protection Agency § 158.2050 

than that of the raw agricultural commodity. 

17. Required when residues at the tolerance 

level may result in risk of concern. These 

data may include washing, cooking, processing, or degradation studies as well as market basket surveys for a more precise residue 

determination. 

18. The proposed tolerance must reflect the 

maximum residue likely to occur in crops, in 

meat, milk, poultry, or eggs. 

19. Required when a residue analytical 

method is required. 

§ 158.2050 Biochemical pesticides 

human health assessment data requirements table. 

(a) General. (1) Sections 158.100 

through 158.130 describe how to use this 

table to determine the biochemical 

human health assessment data requirements for a particular biochemical pesticide product. 

(2) The data in this section are not 

required for straight chain 

lepidopteran pheromones when applied 

up to a maximum use rate of 150 grams 

active ingredient/acre/year. 

(b) Use patterns. (1) Food use patterns, in general, include products classified under the following general uses: 

terrestrial food crop use; terrestrial 

feed crop use; aquatic food crop use; 

greenhouse food crop use. 

(2) Nonfood use patterns include 

products classified under the general 

use patterns of terrestrial nonfood crop 

use; aquatic nonfood residential use; 

aquatic nonfood outdoor use; aquatic 

nonfood industrial use; greenhouse 

nonfood crop use; forestry use; residential outdoor use; residential indoor use; 

indoor food use; indoor nonfood use; indoor medical use. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; Residue 

of concern=the active ingredient and 

its metabolites, degradates, and impurities of toxicological concern; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to 

the individual tests in the following 

table: 

(d) Table. The following table shows 

the data requirements for biochemical 

pesticides human health assessment. 

The test notes are shown in paragraph 

(e) of this section. 

TABLE—BIOCHEMICAL PESTICIDES HUMAN HEALTH ASSESSMENT DATA REQUIREMENTS

Guideline Number Data Requirement 

Use Patterns Test Substance 

Test Notes 

Food Nonfood MP EP 

Tier I 

Acute Testing 

870.1100 Acute oral toxicity - rat R R TGAI 

and MP 

TGAI and 

EP 

1 

870.1200 Acute dermal toxicity R R TGAI 

and MP 

TGAI and 

EP 

1, 2 

870.1300 Acute inhalation toxicity - rat R R TGAI 

and MP 

TGAI and 

EP 

3 

870.2400 Primary eye irritation - rabbit R R TGAI 

and MP 

TGAI and 

EP 

2 

870.2500 Primary dermal irritation R R TGAI 

and MP 

TGAI and 

EP 

1, 2 

870.2600 Dermal sensitization R R TGAI 

and MP 

TGAI and 

EP 

2, 4 

none Hypersensitivity incidents R R All All 5 

Subchronic Testing 

870.3100 90-day oral (one species) R CR TGAI TGAI 6 


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§ 158.2050 40 CFR Ch. I (7–1–15 Edition) 

TABLE—BIOCHEMICAL PESTICIDES HUMAN HEALTH ASSESSMENT DATA REQUIREMENTS—Continued 

Guideline Number Data Requirement 

Use Patterns Test Substance 

Test Notes 

Food Nonfood MP EP 

870.3250 90-day dermal - rat CR CR TGAI TGAI 7 

870.3465 90-day inhalation - rat CR CR TGAI TGAI 8 

Developmental Toxicity 

870.3700 Prenatal developmental - rat preferably R CR TGAI TGAI 9 

Mutagenicity Testing 

870.5100 Bacterial reverse mutation test R CR TGAI TGAI 10 

870.5300 

870.5375 

In vitro mammalian cell assay R CR TGAI TGAI 10, 11 

Tier II 

Mutagenicity Testing (In vivo cytogenetics) 

870.5385 

870.5895 

In vivo Mammalian Cytogenetics CR CR TGAI TGAI 13 

Developmental Toxicity 

870.3700 Prenatal developmental CR CR TGAI TGAI 9 

Special Tests 

880.3550 Immunotoxicity CR CR TGAI TGAI 12, 13 

Applicator/User Exposure 

875.1100 Dermal outdoor exposure CR CR TGAI TGAI 15 

875.1200 Dermal indoor exposure CR CR TGAI TGAI 15 

875.1300 Inhalation outdoor exposure CR CR TGAI TGAI 15 

875.1400 Inhalation indoor exposure CR CR TGAI TGAI 15 

875.1500 Biological monitoring CR CR TGAI TGAI 15 

Tier III 

Chronic Testing/Special Testing 

880.3800 Immune response CR CR TGAI TGAI 14 

870.3800 Reproduction and fertility effects CR CR TGAI TGAI 16 

870.4100 Chronic oral - rodent and nonrodent CR CR TGAI TGAI 17 

870.4200 Carcinogenicity - two species - rat and 

mouse preferred 

CR CR TGAI TGAI 18 

870.5380 Mammalian spermatogonial chromosome 

aberration test 

CR CR TGAI TGAI 19 

Special Testing 

870.7200 Companion animal safety CR CR NR TGAI or EP 20 

(e) Test notes. The following test 

notes are applicable to the data requirements for biochemical pesticides 

human health assessment as referenced 

in the last column of the table in paragraph (d) of this section. 

1. Required unless the test material is a 

gas or highly volatile (vapor pressure 

>10¥4torr (mm/Hg)). 


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Environmental Protection Agency § 158.2050 

2. Required unless the test material is corrosive to skin or has pH <2 or >11.5. 

3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain 

lepidopteran pheromone. 

4. Required if repeated contact with human 

skin is likely to occur under conditions of 

use. 

5. Hypersensitivity incidents must be reported as adverse effects data. 

6. Required for non-food uses that are likely to result in repeated oral exposure to humans. 

7. Required to support uses involving purposeful application to the human skin or 

which would result in comparable prolonged 

human exposure to the product (e.g., insect 

repellents) and if any of the following criteria are met: 

i. Data from a 90–day oral study are not required. 

ii. The active ingredient is known or expected to be metabolized differently by the 

dermal route of exposure than by the oral 

route and the metabolite is of toxicological 

concern. 

iii. The use pattern is such that the dermal 

route would be the primary route of exposure. 

8. Required if there is a likelihood of significant levels of repeated inhalation exposure to the pesticide as a gas, vapor, or aerosol. 

9. Required if the use of the product under 

widespread and commonly recognized practice may reasonably be expected to result in 

significant exposure to female humans (e.g., 

occupational exposure or repeated application of insect repellents directly to the skin). 

Tier II data is required on a different test 

species from Tier I data when developmental 

effects are observed in the first study and information on species-to-species extrapolation is needed. 

10. Required to support nonfood uses if either: 

i. The use is likely to result in significant 

human exposure; or 

ii. The active ingredient (or its metabolites) is structurally related to a known 

mutagen or belongs to any chemical class of 

compounds containing a known mutagen. 

Additional mutagenicity tests that may 

have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the 

available evidence. 

11. Choice of assay using either: 

i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing 

assay conditions for small colony expression 

or detection; 

ii. Chinese hamster ovary (CHO) or Chinese 

hamster lung fibroblast (V79) cells, 

hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an 

appropriate in vitro test for clastogenicity; or 

iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene 

locus. 

12. Required if there are effects on hematology, clinical chemistry, lymphoid organ 

weights, and histopathology are observed in 

the 90–day studies. 

13. The micronucleus rodent bone marrow 

assay is preferred; however, rodent bone 

marrow assays using metaphase analysis (aberrations) are acceptable. 

14. Required if adverse effects are observed 

in the Tier II immunotoxicity study. The 

protocol for evaluating adverse effects to the 

immune response should be developed after 

evaluating the effects noted in the 

immunotoxicity study. 

15. These data are required when the data 

used for the human health assessment indicates that the biochemical may pose a potential hazard to the applicator/user. 

16. Required if there is evidence of: 

i. Endocrinological effects from the subchronic toxicity studies. 

ii. Developmental effects in the prenatal 

developmental toxicity study(s), or 

iii. Genotoxicity to mammals based on results from the mutagenicity tests. 

The use of a combined study that utilizes the 

two-generation reproduction study in rodents (guideline 870.3800) as a basic protocol 

for the addition of other endpoints or functional assessments in the immature animal 

is encouraged. 

17. Required if the potential for adverse 

chronic effects is indicated based on any of 

the following: 

i. The subchronic effect level established in 

the following Tier I studies: 90–day oral toxicity study, 90–day dermal toxicity study, or 

90–day inhalation toxicity study. 

ii. The pesticide use pattern (e.g., rate, frequency, and site of application). 

iii. The frequency and level of repeated 

human exposure that is expected. 

18. Required if the product meets either of 

the following criteria: 

i. The active ingredient (or any of its metabolites, degradation products, or impurities) produce(s) in Tier I subchronic studies a 

morphologic effect (e.g., hyperplasia or 

metaplasia) in any organ that potentially 

could lead to neoplastic change. 

ii. Adverse cellular effects suggesting carcinogenic potential are observed in Tier II 

immunotoxicity and Tier III immune response study or in Tier II mammalian mutagenicity assays. 

In addition, a 90–day range finding study in 

both rats and mice is required to determine 

the dose levels if carcinogenicity studies are 

required. If the mouse carcinogenicity study 

is not required, the 90–day mouse subchronic 

study is likewise not required. 


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§ 158.2060 40 CFR Ch. I (7–1–15 Edition) 

19. Required if results from lower tiered 

mutation or reproductive studies indicate 

there is potential for chromosomal aberration to occur. 

20. May be required if the product’s use 

will result in exposure to domestic animals 

through, but not limited to, direct application or consumption of treated feed. 

§ 158.2060 Biochemical pesticides nontarget organisms and environmental fate data requirements 

table. 

(a) General. (1) Sections 158.100 

through 158.130 describe how to use this 

table to determine the terrestrial and 

aquatic nontarget organisms and fate 

data requirements for a particular biochemical pesticide product. Notes that 

apply to an individual test including 

specific conditions, qualifications, or 

exceptions to the designated test are 

listed in paragraph (e) of this section. 

In general, for all outdoor end-use 

products including turf, the following 

studies are required: one avian acute 

oral, one avian dietary, one acute 

freshwater fish, one acute freshwater 

invertebrate study, plant toxicity testing, and a honeybee acute contact 

study. 

(2) The data in this section are not 

required for arthropod pheromones 

when applied at up to a maximum use 

rate of 150 grams active ingredient/ 

acre/year except when the product is 

expected to be available to avian species (i.e., granular formulation). 

(b) Use patterns. The terrestrial use 

pattern includes products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

and terrestrial nonfood/nonfeed crop. 

The greenhouse use pattern includes 

products classified under the general 

use patterns of greenhouse food crop 

and greenhouse nonfood crop. The indoor use pattern includes products 

classified under the general use patterns of indoor food and nonfood use. 

The remaining terrestrial uses include: 

forestry and residential outdoor use. 

Data are also required for the general 

use patterns of aquatic food and 

nonfood crop use. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; Residue 

of concern=the active ingredient and 

its metabolites, degradates, and impurities of toxicological concern; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to 

the individual tests in the following 

table: 

(d) Table. The following table shows 

the data requirements for biochemical 

pesticides nontarget organisms and environmental fate. The test notes are 

shown in paragraph (e) of this section. 

TABLE—BIOCHEMICAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA

REQUIREMENTS

Guideline Number Data Requirement 

Use Patterns 

Test 

Substance Test Notes 

Terrestrial Aquatic Greenhouse Forestry, 

Residential 

Outdoor 

Indoor 

Food/ 

Feed/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

Tier I 

Avian Testing 

850.2100 Avian acute oral toxicity R R CR R CR TGAI, 

EP 

1, 2, 3, 4 

850.2200 Avian dietary toxicity R R CR R CR TGAI, 

EP 

1, 2, 3, 4 

Aquatic Organism Testing 

850.1075 Fish acute toxicity, freshwater R R CR R CR TGAI, 

EP 

2, 3, 4, 5 


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Environmental Protection Agency § 158.2060 

TABLE—BIOCHEMICAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA

REQUIREMENTS—Continued 

Guideline Number Data Requirement 

Use Patterns 

Test 

Substance Test Notes 

Terrestrial Aquatic Greenhouse Forestry, 

Residential 

Outdoor 

Indoor 

Food/ 

Feed/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

850.1010 Aquatic invertebrate acute 

toxicity, freshwater 

R R CR R CR TGAI, 

EP 

2, 3, 5 

Nontarget Plant Testing 

850.4100 Terrestrial Plant Toxicity, 

Seedling emergence 

R R NR R NR TGAI, 

EP 

5 

850.4150 Terrestrial Plant Toxicity, 

Vegetative vigor 

R R NR R NR TGAI, 

EP 

5 

Insect Testing 

880.4350 Nontarget Insect Testing R R R R NR TGAI 14 

Tier II 

Environmental Fate Testing 

163-1 

(835.1230) 

Sediment and soil adsorption/desorption for parent and degradates 

CR CR CR CR NR TGAI 6 

163-1 

(835.1240) 

Soil column leaching CR CR CR CR NR TGAI 6 

163-2 

(835.1410) 

Laboratory volatilization 

from soil 

CR NR CR CR NR TEP 7 

161-1 

(835.2120) 

Hydrolysis CR CR CR CR NR TGAI 6 

161-1 

(835.4100) 

Aerobic soil metabolism CR NR CR CR NR TGAI 6 

161-2 

(835.2240) 

Photodegradation in water CR CR CR CR NR TGAI 6 

161-3 

(835.2410) 

Photodegradation on soil CR NR CR CR NR TGAI 6 

162-2 

(835.4200) 

Anaerobic soil metabolism CR NR NR NR NR TGAI 6 

162-4 

(835.4300) 

Aerobic aquatic metabolism CR CR CR CR NR TGAI 6 

162-3 

(835.4400) 

Anaerobic aquatic metabolism CR CR NR NR NR TGAI 6 

880.4425 Dispenser - water leaching CR NR CR CR NR EP 8 

Nontarget Plant 

850.4225 Seedling emergence R R NR R NR TGAI 9 

850.4250 Vegetative vigor R R NR R NR TGAI 9 

Tier III 

Aquatic Fauna Chronic, Life Cycle, and Field Studies 

850.1300 

850.1400 

850.1500 

Freshwater fish/invertebrate testing CR CR NR CR NR TGAI 10 


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§ 158.2060 40 CFR Ch. I (7–1–15 Edition) 

TABLE—BIOCHEMICAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA

REQUIREMENTS—Continued 

Guideline Number Data Requirement 

Use Patterns 

Test 

Substance Test Notes 

Terrestrial Aquatic Greenhouse Forestry, 

Residential 

Outdoor 

Indoor 

Food/ 

Feed/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

850.1025 

850.1035 

850.1045 

850.1055 

850.1350 

850.1400 

850.1500 

Marine/Estuarine fish/invertebrate animal testing 

CR CR NR CR NR TGAI 10 

850.1950 Aquatic field fish/invertebrate testing CR CR NR CR NR EP 10 

Terrestrial Wildlife 

850.2300 Avian Reproduction CR CR NR CR NR TGAI 11 

850.2400 Wild mammal acute toxicity CR CR NR CR NR TGAI 11 

850.2500 Terrestrial field testing CR CR NR CR NR EP 11 

Beneficial Insects 

850.3040 Field testing for Pollinators CR CR NR CR NR TEP 12 

Nontarget Plants 

850.4225 

850.4250 

850.4300 

850.4450 

Nontarget plant CR CR NR CR NR TGAI 13 

(e) Test notes. The following test 

notes are applicable to the data requirements for biochemical pesticides 

nontarget organisms and environmental fate as referenced in the last 

column of the table contained in paragraph (d) of this section. 

1. Required for the EP when any end-use 

formulation may contain other ingredients 

that may be toxic to nontarget organisms or 

to support arthropod pheromones that would 

be available to avian wildlife, (e.g., a granular product). 

2. Tests for pesticides intended solely for 

indoor application would be required on a 

case-by-case basis, depending on use pattern, 

physical/chemical properties, production volume, and other pertinent factors. 

3. Not required for any use groups if the 

pesticide is highly volatile (estimated volatility >5 ×10¥5atm m3/mol). 

4. Preferred test species are Upland game, 

waterfowl, or passerine for avian acute oral 

toxicity studies; Upland game and waterfowl 

for avian dietary studies; and coldwater fish 

species for acute freshwater fish studies. 

5. Required for the EP when the end-use 

formulation may contain other ingredients 

that may be toxic to nontarget organisms. 

6. Required on a case-by-case basis when 

results from Tier I studies indicate adverse 

effects. 

7. Required when results of any one or 

more of the nontarget organism studies in 

Tier I indicate potential adverse effects on 

nontarget organisms and the pesticide is to 

be applied on land. In view of methdological 

difficulties with the study of 

photodegradation in air, prior consultation 

with the Agency regarding the protocol is 

recommended before the test is performed. 

8. Required when results of any one or 

more of the nontarget organism studies in 

Tier I indicate potential adverse effects on 

nontarget organisms and the pesticide is to 

be applied in a passive dispenser. 

9. Required to support registration of 

known phytotoxicants, i.e., herbicides, 

desiccants, defoliants, and plant growth regulators. 

10. Required if environmental fate characteristics indicate that the estimated environmental concentration of the pesticide in 

the aquatic environment is >0.01 of any EC50


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Environmental Protection Agency § 158.2081 

or LC50 determined in the aquatic nontarget 

organism testing. 

11. Required if either of the following criteria are met: 

i. Environmental fate characteristics indicate that the estimated concentration of the 

pesticide in the terrestrial environment is 

>0.20 the avian dietary LC50 or equal to >0.20 

the avian oral single dose LD50 (converted to 

ppm). 

ii. The pesticide or any of its metabolites 

or degradation products are stable in the environment to the extent that potentially 

toxic amounts may persist in the avian or 

mammalian feed. 

12. Required when results of Tier I nontarget organism studies indicate potential adverse effects on nontarget insects and results 

of Tier II tests indicate exposure of nontarget insects. Additional insect species may 

have to be tested if necessary to address 

issues raised by use patterns and potential 

exposure of important nontarget insect species, (e.g., threatened or endangered species). 

13. Required if the product is expected to 

be transported from the site of application 

by air, soil, or water. The extent of movement would be determined by the results of 

the Tier II environmental fate studies. 

14. Required depending on pesticide mode 

of action, method and timing of application, 

and results of any available efficacy data. 

Typically the honeybee acute toxicity guideline (guideline 850.3020) satisfies this requirement, however, additional nontarget insect 

species may have to be tested if necessary to 

address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., endangered species.) 

§ 158.2070 Biochemical pesticides 

product performance data requirements. 

Product performance data must be 

developed for all biochemical pesticides. However, the Agency typically 

does not require applicants to submit 

such efficacy data unless the pesticide 

product bears a claim to control public 

health pests, such as pest microorganisms infectious to man in any area of 

the inanimate environment or a claim 

to control vertebrates (including but 

not limited to: rodents, birds, bats, 

canids, and skunks) or invertebrates 

(including but not limited to: mosquitoes and ticks) that may directly or indirectly transmit diseases to humans. 

However, each registrant must ensure 

through testing that his products are 

efficacious when used in accordance 

with label directions and commonly accepted pest control practices. The 

Agency reserves the right to require, 

on a case-by-case basis, submission of 

efficacy data for any pesticide product 

registered or proposed for registration. 

§ 158.2080 Experimental use permit 

data requirements—biochemical 

pesticides. 

(a) Sections 158.2081 through 158.2084 

describe the experimental use permit 

(EUP) data requirements for biochemical pesticides. Variations in the 

test conditions are identified within 

the test notes. Definitions that apply 

to all biochemical data requirements 

can be found in §158.2000. 

(b) For general information on the 

data requirement tables, see 

§158.2010(b)-(f). 

§ 158.2081 Experimental use permit 

biochemical pesticides product 

chemistry data requirements table. 

(a) General. (1) Sections 158.100 

through 158.130 describe how to use this 

table to determine the product chemistry data requirements for a particular biochemical pesticide product. 

Notes that apply to an individual test 

and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) 

of the section. 

(2) Depending on the results of the required product chemistry studies, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed. 

(b) Use patterns. Product chemistry 

data are required for all pesticide products and are not use specific. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; Residue 

of concern=the active ingredient and 

its metabolites, degradates, and impurities of toxicological concern; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to 

the individual tests in the following 

table: 

(d) Table. The following table shows 

the data requirements for experimental 


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§ 158.2081 40 CFR Ch. I (7–1–15 Edition) 

use permit biochemical pesticides product chemistry. The test notes are 

shown in paragraph (e) of this section. 

TABLE—EUP BIOCHEMICAL PESTICIDES PRODUCT CHEMISTRY DATA REQUIREMENTS

Guideline Num- ber Data Requirement All Use Pat- terns 

Test Substance Test Notes MP EP 

Product Identity and Composition 

880.1100 Product identity and composition R TGAI, MP TGAI, EP 1, 2 

880.1200 Description of starting materials, production 

and formulation process 

R TGAI, MP TGAI, EP 2, 3 

880.1400 Discussion of formation of impurities R TGAI and MP TGAI and EP 4 

Analysis and Certified Limits 

830.1700 Preliminary analysis CR TGAI and MP TGAI and EP 5, 8 

830.1750 Certified limits R MP EP 6 

830.1800 Enforcement analytical method R MP EP 7 

Physical and Chemical Characteristics 

830.6302 Color R TGAI TGAI 8 

830.6303 Physical state R TGAI and MP TGAI and EP 8 

830.6304 Odor R TGAI TGAI 8 

830.6313 Stability to normal and elevated temperatures, metals and metal ions R TGAI TGAI 8, 17 

830.6315 Flammability CR MP EP 9 

830.6317 Storage stability R MP EP -- 

830.6319 Miscibility CR MP EP 10 

830.6320 Corrosion characteristics R MP EP -- 

830.7000 pH CR TGAI and MP TGAI and EP 8, 11 

830.7050 UV/Visible light absorption R TGAI TGAI -- 

830.7100 Viscosity CR MP EP 12 

830.7200 Melting point/melting range CR TGAI TGAI 8, 13 

830.7220 Boiling point/boiling range CR TGAI TGAI 8, 14 

830.7300 Density/relative density/bulk density R TGAI and MP TGAI and EP 8, 18 

830.7520 Particle size, fiber length, and diameter 

distribution 

CR TGAI TGAI 8, 15 

830.7550 

830.7560 

830.7570 

Partition coefficient (n-Octanol /Water) CR TGAI TGAI 16 

830.7840 Water solubility R TGAI TGAI 8 

830.7950 Vapor pressure R TGAI TGAI 8, 19 

(e) Test notes. The following test 

notes are applicable to the data requirements for experimental use permit biochemical pesticides product 

chemistry and are referenced in the 

last column of the table in paragraph 

(d) of this section. 


Lhorne on DSK5TPTVN1PROD with CFR
149 

Environmental Protection Agency § 158.2082 

1. Data must be provided in accordance 

with §158.320. 

2. If the MP and EP are produced by an integrated formulation system (non-registered 

source), these data are also required on 

TGAI. 

3. Data must be provided in accordance 

with §158.325, §158.330, and §158.335. 

4. Data must be provided in accordance 

with §158.340. 

5. Data must be provided in accordance 

with §158.345. Also, required to support the 

registration of each manufacturing-use product (including registered TGAIs) and end-use 

products produced by an integrated formulation system. Data on other end-use products 

would be required on a case-by-case basis. 

For pesticides in the production stage, a preliminary product analytical method and data 

would suffice to support an experimental use 

permit. 

6. Data must be provided in accordance 

with §158.350. 

7. Data must be provided in accordance 

with §158.355. 

8. If the TGAI cannot be isolated, data are 

required on the practical equivalent of the 

TGAI. EP testing may also be appropriate. 

9. Required if the product contains combustible liquids. 

10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents. 

11. Required if the test substance is soluble 

or dispersible in water. 

12. Required if the product is a liquid. 

13. Required when the technical chemical 

is a solid at room temperature. 

14. Required when the technical chemical 

is a liquid at room temperature. 

15. Required for water insoluble test substances (>10¥6g/l) and fibrous test substances 

with diameter ≥0.1 μm. 

16. Required for organic chemicals unless 

they dissociate in water or are partially or 

completely soluble in water. 

17. Data on the stability to metals and 

metal ions is required only if the active ingredient is expected to come in contact with 

either material during storage. 

18. True density or specific density are required for all test substances. Data on bulk 

density is required for MPs or EPs that are 

solid at room temperature. 

19. Not required for salts. 

§ 158.2082 Experimental use permit 

biochemical pesticides residue data 

requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the biochemical pesticides 

residue data requirements for a particular pesticide product and the substance that needs to be tested. These 

data requirements apply to all biochemical pesticides, i.e., naturally occurring insect repellents and 

attractants, semiochemicals (e.g., insect pheromones), natural and plant 

growth regulators. Notes that apply to 

an individual test and include specific 

conditions, qualifications, or exceptions to the designated test are listed 

in paragraph (e) of this section. 

(b) Use patterns. (1) Data are required 

or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops 

are grown. Food use patterns include 

products classified under the general 

use patterns of terrestrial food crop 

use, terrestrial feed crop use, aquatic 

food crop use, greenhouse food crop 

use, and indoor food use. Data are also 

conditionally required for aquatic 

nonfood use if there is direct application to water that could subsequently 

result in exposure to food. 

(2) Data are conditionally required 

for nonfood uses if pesticide residues 

may occur in food or feed as a result of 

the use. Data requirements for these 

nonfood uses would be determined on a 

case-by-case basis. For example, most 

products used in or near kitchens require residue data for risk assessment 

purposes even though tolerances may 

not be necessary in all cases. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing end-use 

product; EP=End-use product; 

TEP=Typical end-use product; 

TGAI=Technical grade of the active ingredient; Residue of concern=the active 

ingredient and its metabolites, 

degradates,and impurities of toxicological concern. All=All of the above. 

Specific conditions, qualifications, or 

exceptions to the designated test procedures appear in paragraph (e) of this 

section, and apply to the individual 

tests in the following table: 

(d) Data table. The following table 

shows the data requirements for biochemical pesticides residue. The test 

notes are shown in paragraph (e) of this 

section. 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.2082 40 CFR Ch. I (7–1–15 Edition) 

TABLE—EUP BIOCHEMICAL PESTICIDES RESIDUE DATA REQUIREMENTS

Guideline Number Data Requirement 

Use Patterns 

Test Substance Test Notes Terrestrial Aquatic Greenhouse 

Food 

Indoor Food Food/ 

Feed Food 

Supporting Information 

860.1100 Chemical identity CR CR CR CR TGAI 1, 2, 4 

860.1200 Directions for use CR CR CR CR -- 1, 3, 4 

Nature of Residue 

860.1300 Nature of the residue in 

plants 

CR CR CR CR TGAI 1, 4, 5, 6 

860.1300 Nature of the residue in 

livestock 

CR CR CR CR TGAI or plant 

metabolite 

1, 7, 8, 9, 

13 

Magnitude of the Residue 

860.1400 Potable water NR CR NR NR TGAI 1, 11 

860.1400 Fish NR CR NR NR TGAI 1, 12 

860.1400 Irrigated crops NR CR NR NR TGAI 1, 13 

860.1460 Food handling NR NR NR CR TGAI 1, 14 

860.1480 Meat/milk/poultry/eggs CR CR CR CR TGAI or plant 

metabolites 

1, 7, 8, 9 

860.1500 Crop field trials CR CR CR CR TEP 1, 3, 4 

860.1520 Processed food/feed CR CR CR CR TEP 1, 15 

860.1540 Anticipated residues CR CR CR CR Residue of 

concern 

1, 9, 16 

860.1550 Proposed tolerances CR CR CR CR -- 1, 17 

860.1560 Reasonable grounds in 

support of the petition 

CR CR CR CR -- 1, 9 

860.1650 Submittal of analytical 

reference standards 

CR CR CR CR TGAI and 

residue of 

concern 

9, 18 

(e) Test notes. The following test 

notes are applicable to the data requirements for biochemical pesticides 

product chemistry and are referenced 

referenced in the last column of the 

table contained in paragraph (d) of this 

section. 

1. Residue chemistry data requirements 

apply to biochemical pesticide products 

when Tier II or Tier III toxicology data are 

required, as specified for biochemical agents 

in the biochemical human health assessment 

data requirements, §158.2050. 

2. The same chemical identity data are required for biochemical product chemistry 

data requirements,§158.2030 with an emphasis on impurities. 

3. Required information includes crops to 

be treated, rate of application, number and 

timing of applications, preharvest intervals, 

and relevant restrictions. 

4. Required for residential outdoor uses on 

food crops if the corresponding agricultural 

use is not approved or the residential use is 

expected to produce higher residues based on 

the label directions. 

5. Required unless it is an arthropod 

pheromone applied at a rate less than or 

equal to 150 grams active ingredient per acre. 

6. Required for indoor uses where the pesticide is applied directly to food, in order to 

determine metabolites and/or degradates. 

Not required when only indirect contact 

with food would occur (e.g., crack and crevice treatments). 

7. Required when a pesticide is to be applied directly to livestock, to livestock 

premises, to livestock drinking water, or to 

crops used for livestock feed. If results from 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.2083 

the plant metabolism study show differing 

metabolites in plants form those found in 

animals, an additional livestock metabolism 

study involving dosing with the plant metabolite(s) may also be required. 

8. Livestock feeding studies are required 

whenever a pesticide residue is present in 

livestock feed or when direct application to 

livestock uses occurs. 

9. Required if indoor use could result in 

pesticide residues in or on food or feed. 

10. Data are required to determine whether 

FDA/USDA multiresidue methodology would 

detect and identify the pesticides and any 

metabolites. 

11. Data are required whenever a pesticide 

may be applied directly to water, unless it 

can be demonstrated that the treated water 

would not be available for human or livestock consumption. 

12. Data on fish are required for all pesticides applied directly to water inhabited, 

or which will be inhabited, by fish that may 

be caught or harvested for human consumption. 

13. Data are required when a pesticide is to 

be applied directly to water that could be 

used for irrigation or to irrigation facilities 

such as irrigation ditches. 

14. Data are required whenever a pesticide 

may be used in food/feed handling establishments. 

15. Data on the nature and level of residue 

in processed food/feed are required when 

detectible residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher 

than that of the raw agricultural commodity. 

16 Anticipated residue data are required 

when the assumption of tolerance level residues would result in predicted exposure at an 

unsafe level of exposure. Data, using single 

serving samples of a raw agricultural commodity, on the level or residue in food as 

consumed would be used to obtain a more 

precise estimate of potential dietary exposure. These data may also include washing, 

cooking, processing or degradation studies as 

well as market basket surveys for a more 

precise residue determination. 

17. The proposed tolerance must reflect the 

maximum residue likely to occur in crops, in 

meat, milk, poultry, or eggs. 

18. Required when a residue analytical 

method is required. 

§ 158.2083 Experimental use permit 

biochemical pesticides human 

health assessment data requirements table. 

(a) General. (1) Sections 158.100 

through 158.130 describe how to use this 

table to determine the human health 

assessment data requirements for a 

particular biochemical pesticide product. 

(2) The data in this section are not 

required for straight chain 

lepidopteran pheromones when applied 

up to a maximum use rate of 150 grams 

active ingredient/acre/year. 

(b) Use patterns. (1) Food use patterns, in general, include products classified under the following general uses: 

terrestrial food crop use; terrestrial 

feed crop use; aquatic food crop use; 

greenhouse food crop use. 

(2) Nonfood use patterns include 

products classified under the general 

use patterns of terrestrial nonfood crop 

use; aquatic nonfood residential use; 

aquatic nonfood outdoor use; aquatic 

nonfood industrial use; greenhouse 

nonfood crop use; forestry use; residential outdoor use; residential indoor use; 

indoor food use; indoor nonfood use; indoor medical use. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; Residue 

of concern=the active ingredient and 

its metabolites, degradates, and impurities of toxicological concern; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to 

the individual tests in the following 

table: 

(d) Table. The following table shows 

the data requirements for experimental 

use permit biochemical pesticides 

human health assessment. The test 

notes are shown in paragraph (e) of this 

section. 

TABLE—EUP BIOCHEMICAL PESTICIDES HUMAN HEALTH ASSESSMENT DATA REQUIREMENTS

Guideline Number Data Requirement 

Use Patterns Test Substance Test Notes Food Nonfood MP EP 

Tier I 


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§ 158.2083 40 CFR Ch. I (7–1–15 Edition) 

TABLE—EUP BIOCHEMICAL PESTICIDES HUMAN HEALTH ASSESSMENT DATA REQUIREMENTS— 

Continued 

Guideline Number Data Requirement 

Use Patterns Test Substance 

Test Notes 

Food Nonfood MP EP 

Acute Testing 

870.1100 Acute oral toxicity - rat R R TGAI 

and MP 

TGAI and EP 1 

870.1200 Acute dermal toxicity R R TGAI 

and MP 

TGAI and EP 1, 2 

870.1300 Acute inhalation toxicity - rat R R TGAI 

and MP 

TGAI and EP 3 

870.2400 Primary eye irritation - rabbit R R TGAI 

and MP 

TGAI and EP 2 

870.2500 Primary dermal irritation R R TGAI 

and MP 

TGAI and EP 1, 2 

none Hypersensitivity incidents R R All All 4 

Subchronic Testing 

870.3100 90-day oral (one species) R NR TGAI TGAI -- 

Developmental Toxicity 

870.3700 Prenatal developmental - rat preferably R CR TGAI TGAI 5 

Mutagenicity Testing 

870.5100 Bacterial reverse mutation test R CR TGAI TGAI 6 

870.5300 In vivo mammalian cell assay R CR TGAI TGAI 6, 7 

Tier II 

Developmental Toxicity 

870.3700 Prenatal developmental CR CR TGAI TGAI 5 

(e) Test notes. The following test 

notes are applicable to the data requirements for experimental use permit biochemical pesticides human 

health assessment as referenced in the 

last column of the table in paragraph 

(d) of this section. 

1. Required unless the test material is a 

gas or highly volatile (vapor pressure 

>10¥4torr (mm/Hg)). 

2. Required unless the test material is corrosive to skin or has pH <2 or >11.5. 

3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain 

lepidopteran pheromone. 

4. Hypersensitivity incidents must be reported as adverse effects data. 

5. Required if the use of the product under 

widespread and commonly recognized practice may reasonably be expected to result in 

significant exposure to female humans (e.g., 

occupational exposure or repeated application of insect repellents directly to the skin). 

Tier II data is required on a different test 

species from Tier I data when developmental 

effects are observed in the first study and information on species-to-species extrapolation is needed. 

6. Required to support nonfood uses if either: 

i. The use is likely to result in significant 

human exposure; or 

ii. The active ingredient (or its metabolites) is structurally related to a known 

mutagen or belongs to any chemical class of 

compounds containing a known mutagen. 

Additional mutagenicity tests that may 

have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the 

available evidence. 

7. Choice of assay using either: 

i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing 


Lhorne on DSK5TPTVN1PROD with CFR
153 

Environmental Protection Agency § 158.2084 

assay conditions for small colony expression 

or detection; 

ii. Chinese hamster ovary (CHO) or Chinese 

hamster lung fibroblast (V79) cells, 

hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an 

appropriate in vivo test for clastogenicity; or 

iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene 

locus. 

§ 158.2084 Experimental use permit 

biochemical pesticides nontarget 

organisms and environmental fate 

data requirements table. 

(a) General. (1) Sections 158.100 

through 158.130 describe how to use this 

table to determine the terrestrial and 

aquatic nontarget organisms and fate 

data requirements for a particular biochemical pesticide product. Notes that 

apply to an individual test including 

specific conditions, qualifications, or 

exceptions to the designated test are 

listed in paragraph (e) of this section. 

In general, for all outdoor end-use 

products including turf, the following 

studies are required: one avian acute 

oral, one avian dietary, one acute 

freshwater fish, and one acute freshwater invertebrate study. 

(2) The data in this section are not 

required for arthropod pheromones 

when applied at up to a maximum use 

rate of 150 grams active ingredient/ 

acre/year except when the product is 

expected to be available to avian species (i.e., granular formulation). 

(b) Use patterns. The terrestrial use 

pattern includes products classified 

under the general use patterns of terrestrial food crop, terrestrial feed crop, 

and terrestrial nonfood/nonfeed crop. 

The greenhouse use pattern includes 

products classified under the general 

use patterns of greenhouse food crop 

and greenhouse nonfood crop. The indoor use pattern includes products 

classified under the general use patterns of indoor food and nonfood use. 

The remaining terrestrial uses include 

forestry and residential outdoor use. 

Data are also required for the general 

use patterns of aquatic food and 

nonfood crop use. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; Residue 

of concern=the active ingredient and 

its metabolites, degradates, and impurities of toxicological concern; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to 

the individual tests in the following 

table: 

(d) Table. The following table shows 

the data requirements for experimental 

use permit biochemical pesticides nontarget organisms and environmental 

fate. The test notes are shown in paragraph (e) of this section. 

TABLE—EUP BIOCHEMICAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA

REQUIREMENTS

Guideline Number Data Requirement 

Use Patterns 

Test 

Substance Test Notes 

Terrestrial Aquatic Greenhouse Forestry, 

Residential 

Outdoor 

Indoor 

Food/ 

Feed/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

Tier I 

Avian Testing 

850.2100 Avian acute oral 

toxicity 

R R NR R NR TGAI, 

EP 

1, 2, 3 

850.2200 Avian dietary toxicity R R NR R NR TGAI, 

EP 

1, 2, 3 

Aquatic Organism Testing 

850.1075 Fish acute toxicity, 

freshwater 

R R NR R NR TGAI, 

EP 

2, 3, 4 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.2100 40 CFR Ch. I (7–1–15 Edition) 

TABLE—EUP BIOCHEMICAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA

REQUIREMENTS—Continued 

Guideline Number Data Requirement 

Use Patterns 

Test 

Substance Test Notes 

Terrestrial Aquatic Greenhouse Forestry, 

Residential 

Outdoor 

Indoor 

Food/ 

Feed/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

Food/ 

Nonfood 

850.1010 Aquatic invertebrate 

acute toxicity, 

freshwater 

R R NR R NR TGAI, 

EP 

2, 4 

(e) Test notes. The following test 

notes are applicable to the data requirements for experimental use permit biochemical pesticides nontarget 

organisms and environmental fate as 

referenced in the last column of the 

table contained in paragraph (d) of this 

section. 

1. Required for the EP when any end-use 

formulation may contain other ingredients 

that may be toxic to nontarget organisms or 

to support arthropod pheromones that would 

be available to avian wildlife, (e.g., a granular product). 

2. Not required for any use groups if the 

pesticide is highly volatile (estimated volatility >5×10¥5atm m3/mol). 

3. Preferred test species are: upland game, 

waterfowl, or passerine for avian acute oral 

toxicity studies; upland game or waterfowl 

for avian dietary studies; and coldwater fish 

for acute freshwater fish studies. 

4. Required for the EP when the end-use 

formulation may contain other ingredients 

that may be toxic to nontarget organisms. 

Subpart V—Microbial Pesticides 

SOURCE: 72 FR 61002, Oct. 26, 2007, unless 

otherwise noted. 

§ 158.2100 Microbial pesticides definition and applicability. 

(a) This subpart applies to all living 

or dead microbial pesticides as described in paragraphs (b) and (c) of this 

section. 

(b) Definition. Microbial pesticide is a 

microbial agent intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as 

a plant regulator, defoliant, or desiccant, that: 

(1) Is a eucaryotic microorganism including, but not limited to, protozoa, 

algae, and fungi; 

(2) Is a procaryotic microorganism, 

including, but not limited to, 

Eubacteria and Archaebacteria; or 

(3) Is a parasitically replicating microscopic element, including, but not 

limited to, viruses. 

(c) Applicability. (1) This subpart applies to microbial pesticides as specified in paragraphs (c)(2), (c)(3), and 

(c)(4) of this section. 

(2) Each new isolate of a microbial 

pesticide is a new active ingredient and 

must be registered independently of 

any similarly designated and already 

registered microbial pesticide active 

ingredient. Each new isolate for which 

registration is sought must have a 

unique identifier following the taxonomic name of the microorganism, and 

the registration application must be 

supported by data required in this subpart. This does not preclude the possibility of using data from another isolate, provided sufficient similarity is 

established, to support registration. 

(3) Genetically modified microbial 

pesticides may be subject to additional 

data or information requirements on a 

case-by-case basis depending on the 

particular microbial agent and/or its 

parental strains, the proposed pesticide 

use pattern, and the manner and extent 

to which the organism has been genetically modified. 

(4) Pest control organisms such as insect predators, nematodes, and macroscopic parasites are exempt from the 

requirements of FIFRA as authorized 

by section 25(b) of FIFRA and specified 

in §152.20 (a) of this chapter. 

[72 FR 61002, Oct. 26, 2007, as amended at 77 

FR 52612, Aug. 30, 2012] 


Lhorne on DSK5TPTVN1PROD with CFR
155 

Environmental Protection Agency § 158.2120 

§ 158.2110 Microbial pesticides data requirements. 

(a) For all microbial pesticides. (1) The 

following §158.2120 through §158.2150 

identify the data requirements that are 

required to support registration of microbial pesticides. The variations in 

the test conditions are identified within the test notes. 

(2) Each data table includes ‘‘use patterns’’ under which the individual data 

are required, with variations including 

all use patterns, food and nonfood uses 

for terrestrial and aquatic applications, greenhouse, indoor, forestry, and 

residential outdoor applications under 

certain circumstances. 

(3) The categories for each data requirement are ‘‘R,’’ which stands for 

required, and ‘‘CR’’ which stands for 

conditionally required. If a bracket appears around the ‘‘R’’ or ‘‘CR,’’ the 

data are required for both the registration and experimental use permit requests. Generally, ‘‘R’’ indicates that 

the data are more likely required than 

for those data requirements with 

‘‘CR.’’ However, in each case, the regulatory text preceding the data table 

and the test notes following the data 

table must be used to determine whether the data requirement must be satisfied. 

(4) Each table identifies the test substance that is required to be tested to 

satisfy the data requirement. Test substances may include: technical grade 

active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use product 

(TEP), residue of concern, and pure active ingredient (PAI) or all of the above 

(All). Commas between the test substances (i.e., TGAI, EP) indicate that 

data may be required on the TGAI or 

EP or both depending on the conditions 

set forth in the test note. Data requirements which list two test substances 

(i.e., TGAI and EP) indicate that both 

are required to be tested. Data requirements that list only MP as the test 

substance apply to products containing 

solely the technical grade of the active 

ingredient and manufacturing-use 

products to which other ingredients 

have been intentionally added. Data requirements listing the EP as the test 

substance apply to any EP with an ingredient in the end-use formulation 

other than the active ingredient that is 

expected to enhance the toxicity of the 

product. 

(b) Additional data requirements for genetically modified microbial pesticides. 

Additional requirements for genetically modified microbial pesticides 

may include but are not limited to: 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 

selected Tier II environmental expression and toxicology tests. 

§ 158.2120 Microbial pesticides product 

analysis data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the product analysis data requirements and the substance to be 

tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to 

the designated test are identified in 

paragraph (d) of this section. 

(b) Key. R = Required; CR = Conditionally required; NR = Not required; 

MP = Manufacturing-use product; EP = 

End-use product; TEP = Typical enduse product; TGAI = Technical grade of 

the active ingredient; All = All of the 

above. 

(c) Table. The table in this paragraph 

shows the data requirements for microbial pesticides product analysis. The 

test notes are shown in paragraph (d) 

of this section. 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.2130 40 CFR Ch. I (7–1–15 Edition) 

TABLE—MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS

Test guideline No. Data requirement All use 

patterns 

Test substance Test 

notes MP EP 

Product Chemistry and Composition 

885.1100 ............. Product identity ................................... R MP ........................ EP.

885.1200 ............. Manufacturing process ....................... R TGAI and MP ....... TGAI and EP.

885.1250 ............. Deposition of a sample in a nationally 

recognized culture collection.

R TGAI ..................... TGAI ..................... 1 

885.1300 ............. Discussion of formation of unintentional ingredients.R TGAI and MP ....... TGAI and EP.

Analysis and Certified Limits 

885.1400 ............. Analysis of samples ............................ R TGAI and MP ....... TGAI and EP ........ 2 

885.1500 ............. Certification of limits ........................... R MP ........................ EP.

Physical and Chemical Characteristics 

830.6302 ............. Color ................................................... R TGAI ..................... TGAI.

830.6303 ............. Physical state ..................................... R TGAI ..................... TGAI.

830.6304 ............. Odor .................................................... R TGAI ..................... TGAI.

830.6313 ............. Stability to normal and elevated temperatures, metals, and metal ions.R TGAI ..................... TGAI.

830.6317 ............. Storage stability .................................. R TGAI and MP ....... TGAI and EP.

830.6319 ............. Miscibility ............................................ R MP ........................ EP ........................ 3 

830.6320 ............. Corrosion characteristics .................... R MP ........................ EP ........................ 4 

830.7000 ............. pH ....................................................... R TGAI ..................... TGAI.

830.7100 ............. Viscosity .............................................. R MP ........................ EP ........................ 5 

830.7300 ............. Density/relative density/bulk density 

(specific gravity).

R TGAI ..................... TGAI ..................... ............

(d) Test notes. The following test 

notes are applicable to the data requirements for microbial pesticides 

product analysis as referenced in the 

last column of the table contained in 

paragraph (c) of this section. 

1. Required for each isolate of a microbial 

pesticide. Isolates must be deposited with an 

agreement to ensure that the sample will be 

maintained and will not be discarded for the 

duration of the associated registration(s). 

2. Required to support registration of each 

manufacturing-use product and end-use product. This analysis must be conducted at the 

point in the production process after which 

there would be no potential for microbial 

contamination or microbial regrowth. For 

full registration, generally an analysis of 

samples is a compilation of batches, over a 

period of time, depending on the frequency of 

manufacturing. 

3. Only required for emulsifiable liquid 

forms of microbial pesticides. 

4. Required when microbial pesticides are 

packaged in metal, plastic, or paper containers. 

5. Only required for liquid forms of microbial pesticides. 

[72 FR 61002, Oct. 26, 2007, as amended at 77 

FR 52612, Aug. 30, 2012] 

§ 158.2130 Microbial pesticides residue 

data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the residue chemistry data 

requirements and the substance to be 

tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated 

test appear in paragraph (d) of this section, and the procedures appear in 

paragraph (e) of this section. 

(b) Key. R=required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to 

the individual tests in the following 

table: 

(c) Table. The following table shows 

the data requirements for microbial 

pesticides residue. The test notes are 

shown in paragraph (d) of this section. 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.2140 

TABLE—MICROBIAL PESTICIDES RESIDUE DATA REQUIREMENTS

Guideline Number Data Requirement All Use Patterns 

Test Substance 

Data to Support 

MP or EP 

Test Notes 

885.2100 Chemical Identity CR EP 1 

885.2200 Nature of the Residue in plants CR EP 1 

885.2250 Nature of the Residue in animals CR EP 1 

885.2300 Analytical methods - plants CR TGAI 1 

885.2350 Analytical methods - animals CR TGAI 1 

885.2400 Storage Stability CR EP 1 

885.2500 Magnitude of residue in plants CR EP 1 

885.2550 Magnitude of residues in meat, milk, poultry, eggs CR EP 1 

885.2600 Magnitude of residues in potable water, fish, and 

irrigated crops 

CR EP 1 

(d) Test notes. The following test note 

is applicable to the data requirements 

for microbial pesticides residue as referenced in the last column of the table 

contained in paragraph (c) of this section. 

1. Required when the results of testing: 

i. Indicate the potential to cause adverse 

human health effects or the product characterization indicates the microbial pesticide 

has a significant potential to produce a 

mammalian toxin; and 

ii. The use pattern is such that residues 

may be present in or on food or feed crops. 

§ 158.2140 Microbial pesticides toxicology data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the toxicology data requirements for a particular pesticide product. Notes that apply to an individual 

test and include specific conditions, 

qualifications, or exceptions to the designated test are listed in paragraph (d) 

of this section. 

(b) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to 

the individual tests in the following 

table: 

(c) Table. The following table shows 

the data requirements for microbial 

pesticides toxicology. The test notes 

are shown in paragraph (d) of this section. 

TABLE—MICROBIAL PESTICIDES TOXICOLOGY

DATA REQUIREMENTS

Guideline 

Number Data Requirement 

All 

Use 

Patterns 

Test 

Substance 

Test 

Notes 

Tier I 

885.3050 Acute oral toxicity/ 

pathogenicity 

R TGAI 1 

885.3150 Acute pulmonary toxicity/pathogenicity R TGAI -- 

885.3200 Acute injection toxicity/ 

pathogenicity/(intravenous) 

Acute injection toxicity/ 

pathogenicity/ 

(intraperitoneal) 

R TGAI 2 

885.3400 Hypersensitivity incidents R All 3 

885.3500 Cell culture R TGAI 4 

870.1100 Acute oral toxicity R MP , 

EP 

1, 5 

870.1200 Acute dermal toxicity R MP , 

EP 

5 

870.1300 Acute inhalation toxicity R MP , 

EP 

5, 6 

870.2400 Acute eye irritation R MP , 

EP 

5 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.2140 40 CFR Ch. I (7–1–15 Edition) 

TABLE—MICROBIAL PESTICIDES TOXICOLOGY

DATA REQUIREMENTS—Continued 

Guideline 

Number Data Requirement 

All 

Use 

Patterns 

Test 

Substance 

Test 

Notes 

870.2500 Primary dermal irritation R MP , 

EP 

5 

Tier II 

885.3550 Acute toxicology CR TGAI 7 

885.3600 Subchronic toxicity/ 

pathogenicity 

CR TGAI 8 

Tier III 

885.3650 Reproductive fertility 

effects 

CR TGAI 9, 13 

870.4200 Carcinogenicity CR TGAI 10, 13 

870.7800 Immunotoxicity CR TGAI 11, 13 

885.3000 Infectivity/pathogenicity analysis CR TGAI 12, 13 

(d) Test notes. The following test 

notes are applicable to the data requirements for microbial pesticides 

toxicology as referenced in the last column of the table contained in paragraph (c) of this section: 

1. The acute oral toxicity/pathogenicity 

study is required to support the TGAI. However, it can be combined with the unit dose 

portion of the acute oral toxicity study, with 

an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in 

a single study, if the new protocol is designed to address the endpoints of concern. 

2. Data not required for products whose active ingredient is a virus. For test materials 

whose size or consistency may prevent use of 

an intravenous injection, the intraperitoneal 

injection procedure may be employed. 

3. Hypersensitivity incidents, including 

immediate type and delayed-type reactions 

of humans or domestic animals, occur during 

the testing or production of the TGAI, MP, 

or EP, or are otherwise known to the applicant must be reported if they occur. 

4. Data must be submitted only for products whose active ingredient is a virus. 

5. The 870 series studies for the MP and EP 

are intended to provide data on the acute 

toxicity of the product. Waivers for any or 

all of these studies may be granted when the 

applicant can demonstrate that the combination of inert ingredients is not likely to pose 

any significant human health risks. Where 

appropriate, the limit dose approach to testing is recommended. 

6. Required when the product consists of, 

or under conditions of use would result in, an 

inhalable material (e.g., gas, volatile substances, or aerosol particulate). 

7. Data required when significant toxicity, 

in the absence of pathogenicity and significant infectivity, is observed in acute oral, injection, or pulmonary studies (Tier I). 

Route(s) of exposure correspond to route(s) 

where toxicity was observed in Tier I studies. The toxic component of the TGAI is to 

be tested. 

8. Data required when significant infectivity and/or unusual persistence is observed 

in the absence of pathogenicity or toxicity in 

Tier I studies. Routes of exposure (oral and/ 

or pulmonary) correspond to routes in Tier I 

studies where adverse effects were noted. 

Data may also be required to evaluate adverse effects due to microbial contaminants 

or to toxic byproducts. 

9. Data are required when one or more of 

the following criteria are met: 

i. Significant infectivity of the microbial 

pest control agent (MPCA) was observed in 

test animals in the Tier II subchronic study 

and in which no significant signs of toxicity 

or pathogenicity were observed. 

ii. The microbial pesticide is a virus which 

can persist or replicate in mammalian cell 

culture lines. 

iii. The microbial pesticide is not amenable to thorough taxonomic classification, 

and is related to organisms known to be 

parasitic for mammalian cells. 

iv. The microbial pesticide preparation is 

not well purified, and may contain contaminants which are parasitic for mammals. 

10. Data may be required for products 

known to contain or suspected to contain 

carcinogenic viruses or for microbial components that are identified as having significant toxicity in Tier II testing. 

11. Data may be required for products 

known to contain or suspected to contain viruses that can interact in an adverse manner 

with components of the mammalian immune 

system. 

12. An analysis of human infectivity/pathogenicity potential using scientific literature, 

genomic analysis, and/or actual specific cell 

culture/animal data may be required for 

products known to contain or suspected of 

containing intracellular parasites of mammalian cells for products that exhibit pathogenic characteristics in Tier I and/or Tier II, 

for products which are closely related to 

known human pathogens based on the product analysis data, or for known human 

pathogens that have been ‘‘disarmed’’ or rendered non-pathogenic for humans. 

13. Test standards may have to be modified 

depending on the characteristics of the 

microorganism. Requirements may vary for 

these studies depending on the active ingredient being tested. Consultation with the 

Agency is advised before performing these 

Tier III studies. 


Lhorne on DSK5TPTVN1PROD with CFR
159 

Environmental Protection Agency § 158.2150 

§ 158.2150 Microbial pesticides nontarget organisms and environmental 

fate data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the terrestrial and aquatic 

nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an 

individual test including specific conditions, qualifications, or exceptions to 

the designated test are listed in paragraph (e) of this section. 

(b) Use patterns. Aquatic uses include: 

food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, NonFood, Forestry, Residential outdoor, 

greenhouse (food and food), Indoor 

(food and nonfood), and Industrial. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to 

the individual tests in the following 

table: 

(d) Table. The following table shows 

the data requirements for microbial 

pesticides nontarget organisms and environmental fate. The test notes are 

shown in paragraph (e) of this section. 

TABLE—MICROBIAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA

REQUIREMENTS

Guideline 

Number Data Requirement 

Use Patterns 

Test 

Substance 

Test 

Notes Aquatic 

Terrestrial 

Food/ 

Feed Nonfood 

Food/ 

Feed/ 

Nonfood 

Forestry 

Resi 

dential 

Greenhouse Indoor Industrial 

Outdoor Food/ 

Nonfood Food/ Nonfood 

Tier I 

885.4050 Avian oral toxicity R R R R R CR CR CR TGAI 1, 2 

885.4100 Avian inhalation toxicity/pathogenicity CR CR CR CR CR CR CR CR TGAI 1, 2, 

3 

885.4150 Wild mammal toxicity/ 

pathogenicity 

CR CR CR CR CR NR NR CR TGAI 1, 4 

885.4200 Freshwater fish 

toxicity/ pathogenicity 

R R R R CR CR CR CR TGAI 

or 

TEP 

1, 2, 

5 

885.4240 Freshwater invertebrate toxicity/pathogenicity 

R R R R CR CR CR CR TGAI 

or 

TEP 

1, 2, 

5 

885.4280 Estuarine/Marine fish 

testing 

Estuarine and marine 

invertebrate testing 

CR CR CR CR CR NR NR CR TGAI 1, 6 

885.4300 Nontarget plant 

testing 

CR CR CR R CR NR CR CR TEP 1, 7 

885.4340 Nontarget insect testing R R R R R CR NR CR TGAI 1, 8 

885.4380 Honey bee testing R R R R R CR NR CR TGAI 1 

Tier II 

885.5200 Terrestrial environmental expression 

tests 

CR CR CR CR CR NR NR CR TGAI 

or 

TEP 

9 


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§ 158.2150 40 CFR Ch. I (7–1–15 Edition) 

TABLE—MICROBIAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA

REQUIREMENTS—Continued 

Guideline 

Number Data Requirement 

Use Patterns 

Test 

Substance 

Test 

Notes 

Aquatic 

Terrestrial 

Food/ 

Feed Nonfood 

Food/ 

Feed/ 

Nonfood 

Forestry 

Resi 

dential 

Greenhouse Indoor Industrial 

Outdoor Food/ 

Nonfood 

Food/ 

Nonfood 

885.5300 Freshwater environmental expression 

tests 

CR CR CR CR CR NR NR CR TGAI 

or 

TEP 

10 

885.5400 Marine or estuarine 

environmental expression tests 

CR CR CR CR CR NR NR CR TGAI 

or 

TEP 

11, 

12 

Tier III 

885.4600 Avian chronic pathogenicity and reproduction test 

CR CR CR CR CR NR NR CR TGAI 12, 

13 

885.4650 Aquatic invertebrate 

range testing 

CR CR CR CR CR NR NR CR TGAI 12, 

14 

885.4700 Fish life cycle studies CR CR CR CR CR NR NR CR TGAI 12, 

14 

885.4750 Aquatic ecosystem test CR CR CR CR CR NR NR CR TGAI 15 

Tier IV 

850.2500 

850.1950 

Field testing for terrestrial wildlife and Field 

testing for aquatic 

organisms 

CR CR CR CR CR NR NR CR TGAI 

or 

TEP 

11, 

16 

850.2500 Simulated or actual 

field tests (birds, 

mammals) 

CR CR CR CR CR NR NR CR TEP 16, 

17, 

20 

850.1950 Simulated or actual 

field test (aquatic organisms) 

CR CR CR CR CR NR NR CR TEP 16, 

18, 

19, 

20 

850.2500 Simulated or actual 

field tests (insect 

predators, parasites) 

CR CR CR CR CR NR NR CR TEP 16, 

18, 

19, 

20 

850.3040 Simulated or actual 

field tests (insect 

pollinators) 

CR CR CR CR CR NR NR CR TEP 16, 

18, 

19, 

20 

850.4300 Simulated or actual 

field tests (plants) 

CR CR CR CR CR NR NR CR TEP 16, 

18, 

19, 

20 

(e) Test notes. The following test 

notes are applicable to the data requirements for microbial pesticides 

nontarget organism and environmental 

fate as referenced in the last column of 

the table contained in paragraph (d) of 

this section. 

1. Tests for pesticides intended solely for 

indoor application would be required on a 


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Environmental Protection Agency § 158.2150 

case-by-case basis, depending on use pattern, 

production volume, and other pertinent factors. 

2. The preferred species for the avian oral 

study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and 

the avian chronic toxicity/pathogenicity 

study is the upland game. There is also the 

option to test the passerine if there is a concern. The coldwater fish is preferred for 

freshwater fish testing. However, two species 

(coldwater and warmwater fish species are 

the preferred species) must be tested for uses 

involving direct freshwater exposure. Freshwater invertebrate testing is also required. 

3. Data required when the nature of the microbial pesticide and/or its toxins indicates 

potential pathogenicity to birds. 

4. Required on a case-by-case basis if results of tests required by §158.2140 are inadequate or inappropriate for assessment of 

hazards to wild mammals. 

5. Required when there will be significant 

exposure to aquatic organisms (fish and invertebrates). 

6. Required if the product is intended for 

direct application into the estuarine or marine environment or expected to enter this 

environment in significant concentrations 

because of expected use or mobility pattern. 

7. Required if the microbial pesticide is 

taxonomically related to a known plant 

pathogen. 

8. Data are not required unless an active 

microbial ingredient controls the target insect pest by a mechanism of infectivity; i.e., 

may create an epizootic condition in nontarget insects. 

9. Required if toxic or pathogenic effects 

are observed in one or more of the following 

tests for microbial pesticides: 

i. Avian acute oral or avian inhalation 

studies. 

ii. Wild mammal studies. 

iii. Nontarget plant studies (terrestrial). 

iv. Honey bee studies. 

v. Nontarget insect studies. 

10. Required when toxic or pathogenic effects are observed in any of the following 

Tier I tests for microbial pest control agents: 

i. Freshwater fish studies. 

ii. Freshwater invertebrate studies. 

iii. Nontarget plant studies (aquatic). 

11. Required if product is applied on land or 

in fresh water or marine/estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests for 

microbial pesticides: 

i. Estuarine and marine animal toxicity 

and pathogenicity. 

ii. Plant studies - estuarine or marine species. 

12. An appropriate dose-response toxicity 

test is required when toxic effects on nontarget terrestrial wildlife or aquatic organisms 

(including plants) are reported in one or 

more Tier I tests and results of Tier II tests 

indicate exposure of the microbial agent to 

the affected nontarget terrestrial wildlife or 

aquatic organisms. The protocols for these 

tests may have to be modified in accordance 

with results from the nontarget organism 

and environmental expression studies. 

13. Required when one or more of the following are present: 

i. Pathogenic effects are observed in Tier I 

avian studies. 

ii. Tier II environmental expression testing 

indicate that long-term exposure of terrestrial animals is likely. 

14. Required when product is intended for 

use in water or expected to be transported to 

water from the intended use site, and when 

pathogenicity or infectivity was observed in 

Tier I aquatic studies. 

15. Required if, after an analysis of the microbial pesticide’s ability to survive and 

multiply in the environment and what ecological habitat it would occupy, the intended 

use patterns, and the results of previous nontarget organisms and environmental expression tests, it is determined that use of the 

microbial agent may result in adverse effects 

on the nontarget organisms in aquatic environments. Testing is to determine if applications of the microbial pest control would be 

expected to disrupt the balance of populations in the target ecosystem. 

16. Tier IV studies may be conducted as a 

condition of registration as post-registration 

monitoring if the potential for unreasonable 

adverse effects appears to be minimal during 

that period of use due to implementation of 

mitigation measures. 

17. Required when both of the following 

conditions occur: 

i. Pathogenic effects observed at actual or 

expected field residue exposure levels are reported in Tier III; and 

ii. The Agency determines that quarantine 

methods would not prevent the microbial 

pesticide from contaminating areas adjacent 

to the test area. 

18. Short term simulated or actual field 

studies are required when it is determined 

that the product is likely to cause adverse 

short-term or acute effects, based on consideration of available laboratory data, use patterns, and exposure rates. 

19. Data from a long-term simulated field 

test (e.g., where reproduction and growth of 

confined populations are observed) and/or an 

actual field test (e.g., where reproduction 

and growth of natural populations are observed) are required if laboratory data indicate that adverse long-term, cumulative, or 

life-cycle effects may result from intended 

use. 

20. Since test standards would be developed 

on a case-by-case basis, consultation with 

the Agency and development of a protocol is 

advised before performing these Tier IV 

studies. 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.2160 40 CFR Ch. I (7–1–15 Edition) 

§ 158.2160 Microbial pesticides product 

performance data requirements. 

Product performance data must be 

developed for all microbial pesticides. 

However, the Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim 

to control public health pests, such as 

pest microorganisms infectious to man 

in any area of the inanimate environment or a claim to control vertebrates 

(including but not limited to: rodents, 

birds, bats, canids, and skunks) or invertebrates (including but not limited 

to: mosquitoes and ticks) that may directly or indirectly transmit diseases 

to humans. However, each registrant 

must ensure through testing that his 

products are efficacious when used in 

accordance with label directions and 

commonly accepted pest control practices. The Agency reserves the right to 

require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed 

for registration. 

§ 158.2170 Experimental use permit 

data requirements—microbial pesticides. 

(a) For all microbial pesticides. (1) The 

following §158.2171 through §158.2174 

identify the data requirements that are 

required to support experimental use 

permits for microbial pesticides. The 

variations in the test conditions are 

identified within the test notes. 

(2) For general information on the 

data requirement tables, see 

§158.2110(a)(2)-(4). 

(b) Additional data requirements for genetically modified microbial pesticides. 

Additional requirements for genetically modified microbial pesticides 

may include but are not limited to: 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 

selected Tier II environmental expression and toxicology tests. 

§ 158.2171 Experimental use permit 

microbial pesticides product analysis data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the product analysis data requirements and the substance to be 

tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to 

the designated test are identified in 

paragraph (d) of this section. 

(b) Key. R = Required; CR = Conditionally required; NR = Not required; 

MP = Manufacturing-use product; EP = 

End-use product; TEP = Typical enduse product; TGAI = Technical grade of 

the active ingredient; All = All of the 

above. 

(c) Table. The table in this paragraph 

shows the data requirements for experimental use permit microbial pesticides product analysis. The test notes 

are shown in paragraph (d) of this section. 

TABLE—EUP MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS

Test guideline No. Data requirement All use patterns 

Test substance Test 

notes MP EP 

Product Chemistry and Composition 

885.1100 ............. Product identity ................................... R MP ........................ EP.

885.1200 ............. Manufacturing process ....................... R TGAI and MP ....... TGAI and EP ........ 1, 2 

885.1250 ............. Deposition of a sample in a nationally 

recognized culture collection.

R TGAI ..................... TGAI ..................... 3 

885.1300 ............. Discussion of formation of unintentional ingredients.R TGAI and MP ....... TGAI and EP ........ 2 

Analysis and Certified Limits 

885.1400 ............. Analysis of samples ............................ R TGAI and MP ....... TGAI and EP ........ 2, 4 

885.1500 ............. Certification of limits ........................... R MP ........................ EP.


Lhorne on DSK5TPTVN1PROD with CFR
163 

Environmental Protection Agency § 158.2172 

TABLE—EUP MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS—Continued 

Test guideline No. Data requirement All use patterns 

Test substance Test 

notes MP EP 

Physical and Chemical Characteristics 

830.6302 ............. Color ................................................... R TGAI ..................... TGAI.

830.6303 ............. Physical state ..................................... R TGAI ..................... TGAI.

830.6304 ............. Odor .................................................... R TGAI ..................... TGAI.

830.6313 ............. Stability to normal and elevated temperatures, metals, and metal ions.R TGAI ..................... TGAI.

830.6317 ............. Storage stability .................................. R TGAI and MP ....... TGAI and EP.

830.6319 ............. Miscibility ............................................ R MP ........................ EP ........................ 5 

830.6320 ............. Corrosion characteristics .................... R MP ........................ EP ........................ 6 

830.7000 ............. pH ....................................................... R TGAI ..................... TGAI.

830.7100 ............. Viscosity .............................................. R MP ........................ EP ........................ 7 

830.7300 ............. Density/relative density/bulk density 

(specific gravity).

R TGAI ..................... TGAI ..................... ............

(d) Test notes. The following test 

notes are applicable to the data requirements for experimental use permit microbial pesticides product analysis as referenced in the last column of 

the table contained in paragraph (c) of 

this section. 

1. If an experimental use permit is being 

sought, and if the pesticide is not already 

under full-scale production, a schematic diagram and/or description of the manufacturing process suffices. 

2. If an experimental use permit is being 

sought, and if the product is not already 

under full-scale production, a discussion of 

unintentional ingredients is required to be 

submitted to the extent this information is 

available. 

3. Required for each isolate of a microbial 

pesticide. Isolates must be deposited with an 

agreement to ensure that the sample will be 

maintained and will not be discarded for the 

duration of the associated experimental use 

permit(s). 

4. Required to support registration of each 

manufacturing-use product and end-use product. This analysis must be conducted at the 

point in the production process after which 

there would be no potential for microbial 

contamination or microbial regrowth. For 

pesticides in the production stage, a preliminary product analytical method and data 

would suffice to support an experimental use 

permit. For full registration, generally an 

analysis of samples is a compilation of 

batches, over a period of time, depending on 

the frequency of manufacturing. 

5. Only required for emulsifiable liquid 

forms of microbial pesticides. 

6. Required when microbial pesticides are 

packaged in metal, plastic, or paper containers. 

7. Only required for liquid forms of microbial pesticides. 

[72 FR 61002, Oct. 26, 2007, as amended at 77 

FR 52613, Aug. 30, 2012] 

§ 158.2172 Experimental use permit 

microbial pesticides residue data 

requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the residue chemistry data 

requirements and the substance to be 

tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated 

test appear in (d) of this section, and 

the procedures appear in paragraph (e) 

of this section. 

(b) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to 

the individual tests in the following 

table: 

(c) Table. The following table shows 

the data requirements for experimental 

use permit microbial pesticides residue. The test notes are shown in paragraph (d) of this section. 


Lhorne on DSK5TPTVN1PROD with CFR
164 

§ 158.2173 40 CFR Ch. I (7–1–15 Edition) 

TABLE—EUP MICROBIAL PESTICIDES RESIDUE

DATA REQUIREMENTS

Guideline 

Number Data Requirement 

All 

Use 

Patterns 

Test 

Substance 

Data to 

Support 

MP or 

EP 

Test 

Notes 

885.2100 Chemical Identity CR EP 1 

885.2200 Nature of the Residue 

in plants 

CR EP 1 

885.2250 Nature of the Residue 

in animals 

CR EP 1 

885.2300 Analytical methods - 

plants 

CR TGAI 1 

885.2350 Analytical methodsanimals CR TGAI 1 

885.2400 Storage Stability CR EP 1 

885.2500 Magnitude of residue 

in plants 

CR EP 1 

885.2550 Magnitude of residues 

in meat, milk, poultry, eggs 

CR EP 1 

885.2600 Magnitude of residues 

in potable water, 

fish, and irrigated 

crops 

CR EP 1 

(d) Test notes. The following test note 

is applicable to the data requirements 

for experimental use permit microbial 

pesticides residue as referenced in the 

last column of the table contained in 

paragraph (c) of this section. 

1. Required when the results of testing: 

i. Indicate the potential to cause adverse 

human health effects or the product characterization indicates the microbial pesticide 

has a significant potential to produce a 

mammalian toxin; and 

ii. The use pattern is such that residues 

may be present in or on food or feed crops. 

§ 158.2173 Experimental use permit 

microbial pesticides toxicology data 

requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the toxicology data requirements for a particular microbial pesticide product. Notes that apply to an 

individual test and include specific 

conditions, qualifications, or exceptions to the designated test are listed 

in paragraph (d) of this section. 

(b) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to 

the individual tests in the following 

table: 

(c) Table. The following table shows 

the data requirements for microbial 

pesticide toxicology. The test notes are 

shown in paragraph (d) of this section. 

TABLE—EUP MICROBIAL PESTICIDES

TOXICOLOGY DATA REQUIREMENTS

Guideline 

Number Data Requirement 

All 

Use 

Patterns 

Test 

Substance 

Test 

Notes 

885.3050 Acute oral toxicity/ 

pathogenicity 

R TGAI 1 

885.3150 Acute pulmonary toxicity/pathogenicity R TGAI -- 

885.3200 Acute injection toxicity/pathogenicity/ 

(intravenous) 

Acute injection toxicity/pathogenicity/ 

(intraperitoneal) 

R TGAI 2 

885.3400 Hypersensitivity incidents R All 3 

885.3500 Cell culture R TGAI 4 

870.1100 Acute oral toxicity R MP, EP 1, 5 

870.1200 Acute dermal toxicity R MP, EP 5 

870.1300 Acute inhalation toxicity R MP, EP 5, 6 

870.2400 Acute eye irritation R MP, EP 5 

870.2500 Primary dermal irritation CR MP, EP 5 

(d) Test notes. The following test 

notes are applicable to the data requirements for experimental use permit microbial pesticides toxicology as 

referenced in the last column of the 

table contained in paragraph (c) of this 

section: 

1. The acute oral toxicity/pathogenicity 

study is required to support the TGAI. However, it can be combined with the unit dose 

portion of the acute oral toxicity study, with 

an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in 

a single study, if the new protocol is designed to address the endpoints of concern. 


Lhorne on DSK5TPTVN1PROD with CFR
165 

Environmental Protection Agency § 158.2174 

2. Data not required for products whose active ingredient is a virus. For test materials 

whose size or consistency may prevent use of 

an intravenous injection, the intraperitoneal 

injection procedure may be employed. 

3. Hypersensitivity incidents, including 

immediate type and delayed type reactions 

of humans or domestic animals occur during 

the testing or production of the TGAI, MP, 

or EP, or are otherwise known to the applicant must be reported if they occur. 

4. Data must be submitted only for products whose active ingredient is a virus. 

5. The 870 series studies for the MP and EP 

are intended to provide data on the acute 

toxicity of the product. Waivers for any or 

all of these studies may be granted when the 

applicant can demonstrate that the combination of inert ingredients is not likely to pose 

any significant human health risks. Where 

appropriate, the limit dose approach to testing is recommended. 

6. Required when the product consists of, 

or under conditions of use that would result 

in an inhalable material (e.g., gas, volatile 

substances, or aerosol particulate). 

§ 158.2174 Experimental use permit 

microbial pesticides nontarget organisms and environmental fate 

data requirements table. 

(a) General. Sections 158.100 through 

158.130 describe how to use this table to 

determine the terrestrial and aquatic 

nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an 

individual test including specific conditions, qualifications, or exceptions to 

the designated test are listed in paragraph (e) of this section. 

(b) Use patterns. Aquatic uses include: 

food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, NonFood, Forestry, Residential outdoor, 

greenhouse (food and food), Indoor 

(food and nonfood), and Industrial. 

(c) Key. R=Required; 

CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 

end-use product; TGAI=Technical 

grade of the active ingredient; All=All 

of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to 

the individual tests in the following 

table: 

(d) Table. The following table shows 

the data requirements for experimental 

use permit microbial pesticides nontarget organisms and environmental fate. 

The test notes are shown in paragraph 

(e) of this section. 

TABLE—EUP MICROBIAL PESTICIDES NONTARGET ORGANISMS AND ENVIRONMENTAL FATE DATA

REQUIREMENTS

Guideline 

Number Data Requirement 

Use Patterns 

Test 

Substance 

Test 

Notes 

Aquatic 

Terrestrial 

Food/ 

Feed Nonfood 

Food/ 

Feed/ 

Nonfood 

Forestry 

Resi 

dential 

Greenhouse Indoor Industrial 

Outdoor Food/ 

Nonfood 

Food/ 

Nonfood 

885.4050 Avian oral 

toxicity 

NR R R R R NR NR NR TGAI 1, 2 

885.4200 Freshwater fish toxicity/pathogenicity NR R R R NR NR NR NR TGAI 1, 2, 

3 

885.4240 Freshwater invertebrate toxicity/pathogenicity 

NR R R R NR NR NR NR TGAI 1, 2, 

3 

885.4300 Nontarget plant 

testing 

NR NR NR R NR NR NR NR TEP 1, 4 

885.4340 Nontarget insect testing R R R R NR NR NR NR TGAI 1, 5 

885.4380 Honey bee testing R R R R NR NR NR NR TGAI 1 


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§ 158.2200 40 CFR Ch. I (7–1–15 Edition) 

(e) Test notes. The following test 

notes are applicable to the data requirements for microbial pesticides 

nontarget organism and environmental 

fate as referenced in the last column of 

the table contained in paragraph (d) of 

this section. 

1. Tests for pesticides intended solely for 

indoor application would be required on a 

case-by-case basis, depending on use pattern, 

production volume, and other pertinent factors. Tests to support EUP’s are based on the 

application timing and acreage. 

2. The preferred species for the avian oral 

study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and 

the avian chronic toxicity/pathogenicity 

study is the upland game. There is also the 

option to test a passerine species if there is 

a concern. The coldwater fish is preferred for 

freshwater fish testing. However, two species 

(coldwater and warmwater fish are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrates are preferred for invertebrate testing. 

3. Required when there will be significant 

exposure to aquatic organisms (fish and invertebrates). 

4. Required if the microbial pesticide is 

taxonomically related to a known plant 

pathogen. 

5. Data are not required unless an active 

microbial ingredient controls the target insect pest by a mechanism of infectivity; i.e., 

may create an epizootic condition in nontarget insects. 

Subpart W—Antimicrobial 

Pesticide Data Requirements 

SOURCE: 78 FR 26978, May 8, 2013, unless 

otherwise noted. 

§ 158.2200 Applicability. 

Part 158, subpart W establishes data 

requirements for any pesticide product 

that is: 

(a) A pesticide that is intended for 

use as an ‘‘antimicrobial pesticide’’ 

within the meaning of FIFRA sec. 

2(mm)(1)(A), regardless of whether it 

also meets the criterion of FIFRA sec. 

2(mm)(1)(B). That criterion excludes 

from the definition any antimicrobial 

product that is intended for a food-use 

requiring a tolerance or exemption 

under FFDCA sec. 408 or a food additive regulation or clearance under 

FFDCA sec. 409. EPA will apply this 

subpart to all products intended for an 

antimicrobial use, purpose or function; 

the exclusion in FIFRA sec. 

2(mm)(1)(B) does not exclude products 

from the data requirements of this subpart. 

(b) A product that bears both antimicrobial and non-antimicrobial uses 

or claims. Such a product is subject to 

the data requirements for pesticides in 

subparts C through O, and U or V of 

this part with respect to its non-antimicrobial uses and claims, and to the 

requirements of this subpart with respect to its antimicrobial uses and 

claims. 

(c) A wood preservative, including a 

product that is intended to prevent 

wood degradation problems due to 

fungal rot or decay, sapstain, or molds. 

(d) An antifoulant, including a product that is intended to kill or repel organisms that can attach to underwater 

surfaces, such as boat bottoms. 

§ 158.2201 Antimicrobial use patterns. 

(a) Antimicrobial use patterns. The 12 

general use patterns used in the data 

tables in this subpart are: 

(1) Agricultural premises and equipment. 

(2) Food-handling/storage establishments, premises and equipment. 

(3) Commercial, institutional and industrial premises and equipment. 

(4) Residential and public access 

premises. 

(5) Medical premises and equipment. 

(6) Human drinking water systems. 

(7) Materials preservatives. 

(8) Industrial processes and water 

systems. 

(9) Antifoulant paints and coatings. 

(10) Wood preservatives. 

(11) Swimming pools. 

(12) Aquatic areas. 

(b) Use site index. The Pesticide Use 

Site Index for Antimicrobial Pesticides 

is a comprehensive list of specific antimicrobial use sites. The Index associates antimicrobial use sites with one or 

more of the 12 antimicrobial use patterns. It is to be used in conjunction 

with the data tables in this subpart to 

determine the applicability of data requirements to specific uses. The Antimicrobial Pesticide Use Site Index, 

which will be updated periodically, is 

available from the Agency or may be 


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Environmental Protection Agency § 158.2204 

obtained from the Agency’s Web site at 

http://www.epa.gov/pesticides. 

§ 158.2203 Definitions. 

The following terms are defined for 

the purposes of this subpart: 

Disinfectant means a substance, or 

mixture of substances, that destroys or 

irreversibly inactivates bacteria, fungi 

and viruses, but not necessarily bacterial spores, in the inanimate environment. 

Fungicide means a substance, or mixture of substances, that destroys fungi 

(including yeasts) and fungal spores 

pathogenic to man or other animals in 

the inanimate environment. 

Microbiological water purifier means 

any unit, water treatment product or 

system that removes, kills or inactivates all types of disease-causing 

microorganisms from the water, including bacteria, viruses and protozoan 

cysts, so as to render the treated water 

safe for drinking. 

Sanitizer means a substance, or mixture of substances, that reduces the 

bacteria population in the inanimate 

environment by significant numbers, 

but does not destroy or eliminate all 

bacteria. Sanitizers meeting Public 

Health Ordinances are generally used 

on food contact surfaces and are 

termed sanitizing rinses. 

Sterilant means a substance, or mixture of substances, that destroys or 

eliminates all forms of microbial life in 

the inanimate environment, including 

all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and 

viruses. 

Tuberculocide means a substance, or 

mixture of substances, that destroys or 

irreversibly inactivates tubercle bacilli 

in the inanimate environment. 

Virucide means a substance, or mixture of substances, that destroys or irreversibly inactivates viruses in the inanimate environment. 

§ 158.2204 Public health and nonpublic 

health claims. 

(a) Public health claim. An antimicrobial pesticide is considered to 

make a public health claim if the pesticide product bears a claim to control 

pest microorganisms that pose a threat 

to human health, and whose presence 

cannot readily be observed by the user, 

including but not limited to, microorganisms infectious to man in any 

area of the inanimate environment. A 

product makes a public health claim if 

one or more of the following apply: 

(1) A claim is made for control of specific microorganisms that are directly 

or indirectly infectious or pathogenic 

to man (or both man and animals). Examples of specific microorganisms include, but are not limited to: 

Mycobacterium tuberculosis, 

Pseudomonas aeruginosa, Escherichia coli 

(E. coli), human immunodeficiency virus 

(HIV), Streptococcus, and Staphylococcus 

aureus. Claims for control of microorganisms infectious or pathogenic 

only to animals (such as canine distemper virus or hog cholera virus) are 

not considered public health claims. 

(2) A claim is made for the pesticide 

product as a sterilant, disinfectant, 

virucide, sanitizer, or tuberculocide 

against microorganisms that are infectious or pathogenic to man. 

(3) A claim is made for the pesticide 

product as a fungicide against fungi infectious or pathogenic to man, or the 

product does not clearly state that it is 

intended for use only against nonpublic 

health fungi. 

(4) A claim is made for the pesticide 

product as a microbiological water purifier or microbial purification system. 

(5) A non-specific claim is made that 

the pesticide product will beneficially 

impact or affect public health at the 

site of use or in the environment in 

which it is applied, and: 

(i) The pesticide product contains one 

or more ingredients that, under the criteria in 40 CFR 153.125(a), is an active 

ingredient with respect to a public 

health microorganism and there is no 

other functional purpose for the ingredient in the product; or 

(ii) The pesticide product is similar 

in composition to a registered pesticide 

product that makes antimicrobial public health claims. 

(b) Nonpublic health claim. An antimicrobial pesticide is considered to 

make a nonpublic health claim if the 

pesticide product bears a claim to control microorganisms of economic or 

aesthetic significance, where the presence of the microorganism would not 

normally lead to infection or disease in 

humans. Examples of nonpublic health 


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§ 158.2210 40 CFR Ch. I (7–1–15 Edition) 

claims include, but are not limited to: 

Algaecides, slimicides, preservatives 

and products for which a pesticidal 

claim with respect to odor sources is 

made. 

§ 158.2210 Product chemistry. 

The product chemistry data requirements of subpart D of this part apply 

to antimicrobial products covered by 

this subpart. 

§ 158.2220 Product performance. 

(a) General—(1) Product performance 

requirement for all antimicrobial pesticides. Each applicant must ensure 

through testing that his product is efficacious when used in accordance with 

label directions and commonly accepted pest control practices. The Agency 

may require, on a case-by-case basis, 

submission of product performance 

data for any pesticide product registered or proposed for registration or 

amendment. 

(2) Product performance data for each 

product that bears a public health claim. 

Each product that bears a public 

health claim, as described in 

§158.2204(a), must be supported by product performance data, as listed in the 

table in paragraph (c) of this section. 

Product performance data must be submitted with any application for registration or amended registration. 

(3) Product performance data for each 

product that bears a nonpublic health 

claim. Each product that bears a nonpublic health claim, as described in 

§158.2204(b), must be supported by product performance data. Each registrant 

must ensure through testing that his 

product is efficacious when used in accordance with label directions and 

commonly accepted practices. The 

Agency reserves the right to require, 

on a case-by-case basis, submission of 

product performance data for any pesticide product registered or proposed 

for registration or amendment. 

(4) Determination of data requirements. 

Subpart B of this part and §158.2201 describe how to use the table in paragraph (c) of this section to determine 

the product performance data requirements for antimicrobial pesticide products. 

(b) Key. R = Required; EP = End-use 

product. 

(c) Antimicrobial product performance 

data requirements table. The following 

table shows the data requirements for 

antimicrobial product performance. 

TABLE—ANTIMICROBIAL PRODUCT PERFORMANCE DATA REQUIREMENTS

Guideline No. Data requirement All use patterns Test substance 

810.2100 ................ Sterilants—Efficacy Data Recommendations ....... R ...................................... EP 

810.2200 ................ Disinfectants for Use on Hard Surfaces—Efficacy 

Data Recommendations.

R ...................................... EP 

810.2300 ................ Sanitizers for Use on Hard Surfaces—Efficacy 

Data Recommendations.

R ...................................... EP 

810.2400 ................ Disinfectants and Sanitizers for Use on Fabrics 

and Textiles—Efficacy Data Recommendations.

R ...................................... EP 

810.2500 ................ Air Sanitizers—Efficacy Data Recommendations R ...................................... EP 

810.2600 ................ Disinfectants for Use in Water—Efficacy Data 

Recommendations.

R ...................................... EP 

§ 158.2230 Toxicology. 

(a) General. Subpart B of this part 

and §158.2201 describe how to use the 

table in paragraph (g) of this section to 

determine the toxicology data requirements for an antimicrobial pesticide 

product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions are 

listed in paragraph (h) of this section. 

(b) Uses. The applicant for registration must first determine whether the 

use is likely to result in pesticide residues in food or water and therefore 

consult the ‘‘Food Use’’ columns of the 

table in paragraph (g) of this section. 

Generally, if the residues of the antimicrobial result from an application to 

a surface or if incorporated into a material that may come into contact with 

food or feed, and residues may be expected to transfer to such food or feed, 

then the ‘‘Indirect Food Uses’’ columns 

is to be consulted. 


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Environmental Protection Agency § 158.2230 

(c) Tiering of data requirements. Applicants for registration of antimicrobials 

may perform tests in a tiered fashion. 

After the initially required tests are 

conducted, additional testing may be 

required if results of the initial tests 

trigger the need for additional data. 

Conditions that trigger the need for additional data are given in the test 

notes in paragraph (h) of this section. 

(d) 200 parts per billion (ppb). The 200 

ppb level was originally used by the 

Food and Drug Administration with respect to the concentration of residues 

in or on food for tiering of data requirements for indirect food use 

biocides. The Agency has also adopted 

this same residue level for determining 

toxicology data requirements for indirect food uses of antimicrobial pesticides. The 200 ppb level is the concentration of antimicrobial residues in 

or on the food item. 

(e) Use of OSHA standards. If EPA determines that industrial standards, 

such as the workplace standards set by 

the Occupational Safety and Health 

Administration (OSHA standards), provide adequate protection for a particular pesticide or a particular use 

pattern, additional toxicity data may 

not be required for that pesticide or 

the use pattern. 

(f) Key. R = Required; CR = Conditionally required; NR = Not required; 

MP = Manufacturing-use product; EP = 

End-use product; TGAI = Technical 

grade of the active ingredient; TEP = 

Typical end-use product; PAI = Pure 

active ingredient; PAIRA = Pure active 

ingredient, radiolabeled; Choice = 

choice of several test substances depending on studies required. 

(g) Antimicrobial toxicology data requirements table. The following table 

shows the data requirements for toxicology. The test notes applicable to the 

data requirements in this table appear 

in paragraph (h) of this section. 


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§ 158.2230 40 CFR Ch. I (7–1–15 Edition) 

TABLE—ANTIMICROBIAL

TOXICOLOGY

DATA

REQUIREMENTS

Guideline 

No. 

Data 

requirement 

Food uses Nonfood uses Test substance 

Test note No. 

Direct food uses Indirect food uses (>200 ppb) Indirect food uses 

(≤200 ppb) 

Swimming pools, 

aquatic areas, 

wood preservatives, metal working fluids All other nonfood uses MP EP 

Acute Testing 

870.1100 ........ Acute oral toxicity— 

rat.

R ......................... R ......................... R ......................... R ......................... R ......................... MP and 

TGAI.

EP and TGAI 1, 2 

870.1200 ........ Acute dermal toxicity R ......................... R ......................... R ......................... R ......................... R ......................... MP and 

TGAI.

EP and TGAI 1, 2, 3 

870.1300 ........ Acute inhalation toxicity—rat. R ......................... R ......................... R ......................... R ......................... R ......................... MP and TGAI. EP and TGAI 2, 4 870.2400 ........ Primary eye irritation—rabbit. R ......................... R ......................... R ......................... R ......................... R ......................... MP and TGAI. EP and TGAI 1, 2, 3 870.2500 ........ Primary dermal irritation. R ......................... R ......................... R ......................... R ......................... R ......................... MP and TGAI. EP and TGAI 1, 2, 3 870.2600 ........ Dermal sensitization R ......................... R ......................... R ......................... R ......................... R ......................... MP and 

TGAI.

EP and TGAI 1, 2, 3, 5 

870.2600 ........ Acute 

neurotoxicity—rat.

R ......................... R ......................... CR ...................... R ......................... CR ...................... TGAI ............ TGAI ............ 6, 11 

Subchronic Testing 

870.3100 ........ 90-Day oral toxicity—rodent. R ......................... R ......................... R ......................... R ......................... CR ...................... TGAI ............ TGAI ............ 8, 9, 15, 38 870.3150 ........ 90-Day oral toxicity—nonrodent. R ......................... R ......................... CR ...................... R ......................... CR ...................... TGAI ............ TGAI ............ 10, 15 870.3200 ........ 21/28-Day dermal 

toxicity.

CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ EP and TGAI 12, 13 

870.3250 ........ 90-Day dermal toxicity. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ EP and TGAI 7, 13, 14, 15 870.3465 ........ 90-Day inhalation 

toxicity—rat.

CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 7, 15, 16, 17 

870.6200 ........ 90-Day 

neurotoxicity—rat.

R ......................... R ......................... CR ...................... R ......................... CR ...................... TGAI ............ TGAI ............ 6, 8 

Chronic Testing 

870.4100 ........ Chronic oral toxicity—rodent. R ......................... R ......................... CR ...................... R ......................... CR ...................... TGAI ............ TGAI ............ 18, 19, 20 870.4200 ........ Carcinogenicity— 

two rodent species—rat and mouse preferred.

R ......................... R ......................... CR ...................... R ......................... CR ...................... TGAI ............ TGAI ............ 19, 21, 22 


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Environmental Protection Agency § 158.2230 Developmental Toxicity and Reproduction 870.3700 ........ Prenatal develop- mental toxicity— rat and rabbit pre- ferred. R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 23, 24, 25, 26 870.3800 ........ Reproduction and fertility effects. R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 26, 27, 28, 29 870.6300 ........ Developmental neurotoxicity. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 28, 29, 30 Mutagenicity 870.5100 ........ Reverse mutation assay. R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 31, 32 870.5300 ........ 870.5375 ........ In vitro mammalian gene mutation. R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 31, 33 870.5385 ........ 870.5395 ........ In vivo cytogenetics R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 31, 34 Special Testing 870.7485 ........ Metabolism and pharmacokinetics. R ......................... R ......................... CR ...................... R ......................... CR ...................... PAI or PAIRA. PAI or PAIRA. 35, 39 870.7200 ........ Companion animal safety. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... NR ............... Choice ......... 36 870.7600 ........ Dermal penetration CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... Choice ......... Choice ......... 3, 37 870.7800 ........ Immunotoxicity ........ R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 8 


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§ 158.2230 40 CFR Ch. I (7–1–15 Edition) 

(h) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (g) of this 

section: 

1. Not required if test material is a 

gas or highly volatile liquid. 

2. The six end-use product (EP) acute 

toxicity studies are required using the 

product as formulated for sale and distribution. In addition, if the EP label 

has directions for diluting the product, 

then, the applicant may also need to 

conduct certain of the acute toxicity 

studies using the highest concentration 

labeled for dilution (i.e., the least diluted product). The end-use dilution 

testing is in addition to the testing 

conducted on the EP. 

3. Not required if test material is corrosive to skin or has pH less than 2 or 

greater than 11.5. 

4. Data are required when the product consists of, or under conditions of 

use will result in, a respirable material 

(e.g., gas, vapor, aerosol or particulates). 

5. Data are required if repeated dermal exposure is likely to occur under 

conditions of use. 

6. For indirect food uses ≤200 ppb, and 

all other nonfood uses, data are required if the neurotoxicity screen in 

the 90-day oral rodent study or other 

data indicate neurotoxicity. 

7. The 90-day dermal toxicity study 

and/or 90-day inhalation toxicity study 

are required if the Agency determines 

that dermal and/or inhalation exposure 

is the primary route of exposure. 

8. All 90-day subchronic studies in 

the rodent can be designed to simultaneously fulfill the requirements of the 

90-day neurotoxicity and/or 

immunotoxicity studies by adding separate groups of animals for testing of 

neurotoxicity and/or immunotoxicity 

parameters. 

9. The 90-day study is required in the 

rodent for hazard characterization 

(possibly endpoint selection) and dosesetting for the chronic/carcinogenicity 

study. It is not required in the mouse, 

but the Agency would encourage the 

applicant to conduct a 90-day range 

finding study for the purposes of dose 

selection for the mouse carcinogenicity 

study to achieve adequate dosing and 

an acceptable study. 

10. A 1-year non-rodent study (i.e., 1- 

year dog study) may be required if the 

Agency finds that a pesticide chemical 

is highly bioaccumulative and slowly 

eliminated. EPA may also require the 

appropriate metabolism and pharmacokinetic studies to evaluate more precisely bioavailability, half life, and 

steady state to determine if a longer 

duration dog toxicity study is needed. 

11. Although the subchronic toxicity 

testing guidelines include measurement of neurological endpoints, such 

screens do not meet the requirement of 

the 90-day neurotoxicity study. For 

nonfood uses, if the 90-day study does 

not include a neurotoxicity screen, 

then the acute neurotoxicity study will 

be required. 

12. Data are required if all of the following criteria are met: 

i. The intended use of the antimicrobial pesticide product is expected 

to result in repeated dermal human exposure to the product. 

ii. Data from a 90-day dermal toxicity study are not available. 

iii. The 90-day dermal toxicity study 

has not been triggered. 

13. EP testing is required if the product or any component of the product 

may increase dermal absorption of the 

active ingredient(s) or increases its 

toxic or pharmacologic effects, as determined by testing using the TGAI or 

based on available information about 

the toxic effects of the product or its 

components. 

14. Data are required if the active ingredient in the product is known or expected to be metabolized differently by 

the dermal route of exposure than by 

the oral route, and a metabolite of the 

active ingredient is the toxic moiety. 

15. A 90-day oral toxicity test is not 

required for heating, ventilation, air 

conditioning, and refrigeration systems 

(collectively referred to as HVAC&R). 

Instead, two 90-day toxicity tests, one 

by the dermal route and one by the inhalation route are required. 

16. Data are required if there is the 

likelihood of significant repeated inhalation exposure to the pesticide as a 

gas, vapor, or aerosol. 

17. Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, e.g., 


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Environmental Protection Agency § 158.2230 

21- or 28-days, may be sufficient to satisfy this requirement. The prime consideration in determining the appropriateness of a shorter duration study 

is the likely period of time for which 

humans will be exposed. 

18. Based on the positive results of 

the acute or 90-day neurotoxicity studies, or on other data indicating 

neurotoxicity, a chronic neurotoxicity 

study (i.e., a chronic study with additional neurotoxicity evaluations) may 

be required to provide information 

about potential neurotoxic effects from 

long-term exposures. 

19. Studies which are designed to simultaneously fulfill the requirements 

of both the chronic oral and carcinogenicity studies (i.e., a combined study) 

may be conducted. 

20. For indirect food uses ≤200 ppb, 

and all other nonfood uses, data are required if either of the following criteria are met: 

i. The use of the pesticide is likely to 

result in repeated human exposure over 

a considerable portion of the human 

lifespan; or 

ii. The use requires that a tolerance, 

tolerance exemption, or food additive 

regulation or clearance be established. 

21. For indirect food uses ≤200 ppb, 

and all other nonfood uses, data are required if any of the following criteria, 

are met: 

i. The use of the pesticide is likely to 

result in significant human exposure 

over a considerable portion of the 

human life span which is significant in 

terms of frequency, time, duration, 

and/or magnitude of exposure. 

ii. The use requires that a tolerance, 

tolerance exemption, or food additive 

regulation or clearance be established. 

iii. The active ingredient, metabolite, degradate, or impurity: 

A. Is structurally related to a recognized carcinogen; 

B. Causes mutagenic effects as demonstrated by in vitro or in vivo testing; 

or 

C. Produces a morphologic effect in 

any organ (e.g., hyperplasia, 

metaplasia) in subchronic studies that 

may lead to a neoplastic change. 

22. If the requirement for a carcinogenicity study in any species is modified or waived for any reason, then a 

subchronic 90-day oral study in the 

same species may be required. 

23. Testing in two species is required 

for all uses. 

24. The oral route, by oral intubation, 

is preferred, unless the chemical or 

physical properties of the test substance, or the pattern of human exposure, suggest a more appropriate route 

of exposure. 

25. Additional testing by other routes 

of exposure may be required if the pesticide is determined to be a prenatal 

developmental toxicant after oral dosing. 

26. The developmental toxicity study 

in rodents may be combined with the 

two-generation reproduction study in 

rodents by using a second mating of 

the parental animals in either generation. Protocols must be approved by 

the Agency prior to the initiation of 

the study. 

27. A two-generation reproduction 

study is required. 

28. An information-based approach to 

testing is preferred, which utilizes the 

best available knowledge on the chemical (hazard, pharmacokinetic, or 

mechanistic data) to determine whether a standard guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing 

animal. Applicants must submit any 

alternative proposed testing protocols 

and supporting scientific rationale to 

the Agency. Protocols must be approved by the Agency prior to the initiation of the study. 

29. The use of a combined two-generation reproduction/developmental 

neurotoxicity study that utilizes the 

two-generation reproduction study in 

rodents as a basic protocol for the addition of other endpoints or functional 

assessments in the immature animal is 

encouraged. 

30. A DNT study is required using a 

weight-of-evidence approach when: 

i. The pesticide causes treatment-related neurological effects in adult animal studies (i.e., clinical signs of 

neurotoxicity, neuropathology, functional or behavioral effects). 

ii. The pesticide causes treatment-related neurological effects in developing 

animals, following pre- or post-natal 


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§ 158.2240 40 CFR Ch. I (7–1–15 Edition) 

exposure (i.e., nervous system malformations or neuropathy, brain 

weight changes in offspring, functional 

or behavioral changes in the offspring). 

iii. The pesticide elicits a causative 

association between exposures and adverse neurological effects in human epidemiological studies. 

iv. The pesticide evokes a mechanism 

that is associated with adverse effects 

on the development of the nervous system (i.e., structure-activity-relationship (SAR) to known neurotoxicants, 

altered neuroreceptor or 

neurotransmitter responses). 

31. To facilitate the weight-of-evidence determination for the pesticide’s 

mutagenicity, in addition to those specifically listed in this table, the Agency requires submission of other mutagenicity test results that may have 

been performed. A reference list of all 

studies and papers known to the applicant concerning the mutagenicity of 

the test chemical must be submitted 

with the required studies. 

32. Due to the nature of 

antimicrobials, if testing with bacterial strains has not been conducted, 

then testing using a mammalian cell 

assay such as the mouse lymphoma TK 

±assay is preferred. If reverse mutation 

assay testing with bacterial strains has 

already been conducted, and the testing was conducted at levels that did 

not cause toxicity to the bacterial 

strains tested, then the applicant may 

submit the study to fulfill this data requirement. 

33. For the in vitro mammalian gene 

mutation study, there is a choice of assays using either mouse lymphoma 

L5178Y cell thymidine kinase (tk) gene 

locus, maximizing assay conditions for 

small colony expression and detection; 

Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (v79) cells, 

hypoxanthine-guanine phosphoribosyl 

transferase (hgprt) gene locus, accompanied by an appropriate in vitro test 

for clastogenicity; or CHO cells strains 

AS52, xanthine-guanine phosphoribosyl 

transferase (xprt) gene locus. 

34. There is a choice of assays, but 

the micronucleus rodent bone marrow 

assay is preferred; the rodent bone 

marrow assays using metaphase analysis (aberrations) are acceptable. 

35. Data are required when chronic 

toxicity or carcinogenicity studies are 

also required. 

36. Data is required if the product 

label directs that it be applied to domestic animals, such as cats, dogs, cattle, pigs, and horses. 

37. In the absence of dermal absorption data or a repeated dose dermal 

toxicity study, the assumption of 100 

percent dermal absorption would be 

used in a risk assessment to determine 

if a dermal penetration study is required, and to identify the doses and 

duration of exposure for which dermal 

absorption is to be quantified. 

38. Required for nonfood uses, if oral 

exposure could occur. 

39. Data may be required if significant adverse effects are seen in available toxicology studies and these effects can be further elucidated by metabolism and pharmacokinetics studies. 

§ 158.2240 Nontarget organisms. 

(a) General. Subpart B of this part 

and §158.2201 describe how to use the 

table in paragraph (c) of this section to 

determine the terrestrial and aquatic 

nontarget organisms data requirements for a particular antimicrobial 

pesticide product. Notes that apply to 

an individual test, including specific 

conditions, qualifications, or exceptions are listed in paragraph (d) of this 

section. 

(1) Terrestrial and aquatic nontarget 

organism data are required to support 

the registration of most end-use and 

manufacturing-use antimicrobial products. 

(2) Data are generally not required to 

support end-use products of a gas, highly volatile liquid, highly reactive solid, 

or a highly corrosive material. 

(3) Data on transformation/degradation products or leachate residues of 

the parent compound are also required 

to support registration, if the transformation/degradation/degradation 

products or leachate residues meet one 

of the following criteria: 

(i) More toxic, persistent, or bioaccumulative than the parent; 

(ii) Have been shown to cause adverse 

effects in mammalian or aquatic reproductive studies; or 


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Environmental Protection Agency § 158.2240 

(iii) The moiety of concern (i.e., functional group in the parent chemical 

molecule that imparts adverse effects) 

remains intact. 

(4) If an antimicrobial may be applied 

to a field crop, horticultural crop, or 

turf, then the data requirements in 

§158.630 apply. 

(5) For the purpose of determining 

data requirements, the all other use 

patterns category includes the following use patterns: 

(i) Agricultural premises and equipment. 

(ii) Food-handling/storage establishments, premises, and equipment. 

(iii) Commercial, institutional and 

industrial premises and equipment. 

(iv) Residential and public access 

premises. 

(v) Medical premises and equipment. 

(vi) Human drinking water systems. 

(vii) Materials preservatives. 

(viii) Swimming pools. 

(b) Key. MP = Manufacturing use 

product; EP = End-use product; R = Required; CR = Conditionally required; 

NR = Not required; TGAI = Technical 

grade of the active ingredient; TEP = 

Typical end-use product; PAIRA = Pure 

active ingredient radiolabeled; a.i. = 

active ingredient. 

(c) Antimicrobial nontarget organism 

data requirements table. The following 

table shows the data requirements for 

nontarget organisms. The test notes 

appear in paragraph (d) of this section. 


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§ 158.2240 40 CFR Ch. I (7–1–15 Edition) 

TABLE—ANTIMICROBIAL

NONTARGET

ORGANISM

DATA

REQUIREMENTS

Guideline No. Data requirement 

Use pattern Test substance 

Test note No. Industrial 

processes and 

water systems 

Antifoulant coatings and paints Wood preservatives Aquatic areas All other use pat- terns category MP EP 

Tier One Testing 

850.2100 ........ Acute avian oral toxicity. R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 1 850.1010 ........ Acute freshwater invertebrates toxicity. R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 2 850.1075 ........ Acute freshwater 

fish toxicity.

R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 3 

Higher Tier Testing 

Avian Testing 850.2200 ........ Avian dietary toxicity CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 4 850.2300 ........ Avian reproduction .. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 1, 6 

Aquatic Organisms Testing 

850.1010 ........ Acute freshwater invertebrates toxicity. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... ..................... TEP ............. 2, 5, 7 850.1075 ........ Acute freshwater 

fish toxicity.

CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... ..................... TEP ............. 3, 5, 7 

850.1025 ........ Acute estuarine and 

marine organisms toxicity.

CR ...................... R ......................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 8, 9 

850.1035 850.1045 850.1055 ........ Acute estuarine and 

marine organisms toxicity.

CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... ..................... TEP ............. 5, 7, 8 

850.1075 850.1400 ........ Fish early-life stage R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 10 850.1300 ........ Aquatic invertebrate 

life-cycle.

R ......................... R ......................... R ......................... R ......................... R ......................... TGAI ............ TGAI ............ 10 

850.1350 850.1500 ........ Fish life-cycle .......... CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 11, 12 850.1710 ........ Aquatic organisms, 

bioavailability, biomagnification, toxicity tests.

CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI, PAI, 

degradate.

TGAI, PAI, 

degradate.

13 

850.1730 


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Environmental Protection Agency § 158.2240 850.1850 850.1950 ........ Simulated or actual field testing for aquatic organisms. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TEP ............. TEP ............. 14, 15, 16 Sediment Testing 850.1735 ........ Whole sediment; acute freshwater invertebrates. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 15, 17 850.1740 ........ Whole sediment; acute marine in- vertebrates. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 15, 17, 19 None .............. Whole sediment; chronic inverte- brates fresh-water and marine. CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI ............ TGAI ............ 15, 18, 19 Insect Pollinator Testing 850.3020 ........ Honeybee acute contact. NR ...................... NR ...................... R ......................... NR ...................... CR ...................... TGAI ............ TGAI ............ 20 850.3030 ........ Toxicity of residues to honeybees. NR ...................... NR ...................... R ......................... NR ...................... CR ...................... TGAI ............ TEP or treat- ed wood. 20, 21 


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§ 158.2240 40 CFR Ch. I (7–1–15 Edition) 

(d) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (c) of this 

section: 

1. For industrial processes and water 

systems, antifoulant paints and coatings, wood preservatives, and aquatic 

areas, data are required for two avian 

species: one waterfowl species and one 

upland game bird species. For the all 

other use patterns category (as specified in §158.2240(a)(5)), data are required 

for one avian species. 

2. Data are required on one freshwater aquatic invertebrate species. 

3. For the industrial processes and 

water systems, antifoulant paints and 

coatings, wood preservatives, and 

aquatic use pattern areas, data are required on two species of fish, one cold 

water species and one warm water species. For the all other use patterns category (as specified in §158.2240(a)(5)), 

data are required on one species of fish, 

either one cold water species or one 

warm water species. Testing on a second species is required if the active ingredient or principal transformation 

products are stable in the environment 

and the LC50 in the first species is less 

than or equal to 1 ppm or 1 mg/L. 

4. Data are required on one avian species, either one waterfowl species or 

one upland game bird species, if the 

avian acute oral LD50 (TGAI testing) is 

less than or equal to 100 mg/a.i./kg and 

a.i. residues or its principal transformation products are likely to occur 

in avian feed items. Data on the second 

species are required if the avian dietary LC50 in the first species tested is 

less than or equal to 500 ppm a.i. in the 

diet. 

5. If TEP testing cannot be conducted 

due to the physical characteristics of 

the test substance (for example, a 

paint), then the applicant should request a waiver. 

6. Data are required if one or more of 

the following criteria are met: 

i. Birds may be subjected to repeated 

or continued exposure to the pesticide 

or any of its transformation products, 

especially preceding or during the 

breeding season. 

ii. The pesticide or any of its major 

metabolites or degradation products 

are stable in the environment to the 

extent that a potentially toxic amount 

may persist in avian feed. 

iii. The pesticide or any of its major 

metabolites or degradation products 

are stored or accumulated in plant or 

animal tissues, as indicated by the octanol/water partition coefficient (Kow is 

greater than or equal to 1,000), accumulation studies, metabolic release and 

retention studies, or as indicated by 

structural similarity to known bioaccumulative chemicals. 

iv. Any other information, such as 

that derived from mammalian reproduction studies, indicates that reproduction in terrestrial vertebrates may 

be adversely affected by the anticipated use of the pesticide product. 

7. TEP testing is required for any 

product which meets one or more of 

the following conditions: 

i. When based on deterministic modeling results: If the Estimated Environmental Concentration (EEC) in the 

aquatic environment is equal to or 

greater than one-half the LC50/EC50 of 

the TGAI. 

ii. When based on probabilistic modeling results: If the estimated 10th percentile 7Q10 Surface Water Concentration exceeds the acute concentration of 

concern (i.e., one-half the LC50/EC50). 

iii. If an ingredient in the end-use 

product other than the active ingredient is expected to enhance the toxicity of the active ingredient or to 

cause toxicity to aquatic organisms. 

iv. The end-use antimicrobial product 

will be applied directly into an aquatic 

environment. 

8. Data are required on one estuarine/ 

marine mollusk, one other estuarine/ 

marine invertebrate, and one estuarine/ 

marine fish species. 

9. For the all other use patterns category (as specified in §158.2240(a)(5)), 

industrial processes and water systems, 

wood preservatives, and aquatic areas, 

data are required if the pesticide residues from the parent compound and/or 

transformation products are likely to 

enter the estuarine/marine environment. 

10. Testing must be conducted with 

the most sensitive organism (either 

freshwater or estuarine/marine 

vertebrates, or freshwater or estuarine/ 

marine invertebrates), as determined 

from the results of the acute toxicity 


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Environmental Protection Agency § 158.2250 

tests (acute EC50 freshwater invertebrates; acute LC50/EC50 estuarine and 

marine organisms; acute freshwater 

fish LC50). 

11. Data are required on estuarine/ 

marine species if the product is intended for direct application to the estuarine or marine environment, or the 

product is expected to enter this environment in significant concentrations 

because of its expected use or mobility 

patterns. 

12. Data are required on freshwater 

species if the end-use product is intended to be applied directly to water, 

or is expected to be transported to 

water from the intended use site, and 

when one or more of the following conditions apply: 

i. When based on deterministic modeling results: If the Estimated Environmental Concentration (EEC) in water 

is equal to or greater than 0.1 of the 

no-observed-adverse-effect concentration or no-observed-adverse-effect level 

(NOAEC/NOAEL) in the fish early-life 

stage or invertebrate life cycle tests. 

ii. When based on probabilistic modeling results: If the estimated 10th percentile 7Q10 Surface Water Concentration based on probabilistic modeling 

exceeds for 20 days or more the chronic 

concentration of concern (i.e., onetenth the NOAEC or NOAEL) determined in the fish early-life stage or invertebrate life cycle tests. 

iii. If studies of other organisms indicate that the reproductive physiology 

of fish may be affected. 

13. Not required when: 

i. The octanol/water partition coefficients of the pesticide and its major 

degradates are less than 1,000; 

ii. There are no potential exposures 

to fish and other nontarget aquatic organisms; or 

iii. The hydrolytic half-life is less 

than 5 days at pH 5, 7, and 9. 

14. Environmental chemistry methods used to generate data associated 

with this study must include results of 

a successful confirmatory method trial 

by an independent laboratory. Test 

standards and procedures for independent laboratory validation are 

available as addenda to the guideline 

for this test requirement. 

15. Protocols must be approved by 

the Agency prior to the initiation of 

the study. 

16. Data are required if the intended 

use pattern, and the physical/chemical 

properties and environmental fate 

characteristics of the antimicrobial indicate significant potential exposure, 

and, based on the results of the acute 

and chronic aquatic organism testing, 

significant impairment of nontarget 

aquatic organisms could result. 

17. Data are required if the half-life 

of the pesticide in the sediment is 

equal to or less than 10 days in either 

the aerobic soil or aquatic metabolism 

studies, and if one or more of the following conditions are met: 

i. The soil partition coefficient (Kd) is 

equal to or greater than 50 L/kg. 

ii. The log Kow is equal to or greater 

than 3. 

iii. The Koc is equal to or greater 

than 1,000. 

18. Data are required if the EEC in 

sediment is greater than 0.1 of the 

acute LC50/EC50 values and if one or 

more of the following conditions are 

met: 

i. The soil partition coefficient (Kd) is 

equal to or greater than 50 L/kg. 

ii. The log Kow is equal to or greater 

than 3. 

iii. The Koc is equal to or greater 

than 1,000. 

19. Sediment testing with estuarine/ 

marine test species is required if the 

product is intended for direct application to the estuarine or marine environment or the product is expected to 

enter this environment in significant 

concentrations either by runoff or erosion, because of its expected use or mobility pattern. 

20. For the all other use patterns category (as specified in §158.2240(a)(5)), 

data are required only for beehive applications when the beehive (empty or 

occupied) may be treated. 

21. A study similar to ‘‘Honey Bee 

Toxicity of Residues on Foliage’’ is required using treated wood instead of 

the foliage. Protocols must be approved 

by the Agency prior to the initiation of 

the study. 

§ 158.2250 Nontarget plant protection. 

(a) Subpart B of this part and 

§158.2201 describe how to use the table 


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§ 158.2250 40 CFR Ch. I (7–1–15 Edition) 

in paragraph (f) of this section to determine the nontarget plant protection 

data requirements for a particular 

antimicrobial pesticide product. Notes 

that apply to an individual test including specific conditions, qualifications, 

or exceptions are listed in paragraph 

(g) of this section. 

(b) Data on transformation/degradation products or leachate residues of 

the parent compound are also required 

to support registration, if the transformation/degradation products or 

leachate residues meet one of the following criteria: 

(1) More toxic, persistent, or bioaccumulative than the parent; 

(2) Have been shown to cause adverse 

effects in mammalian or aquatic reproductive studies; or 

(3) The moiety of concern (i.e., functional group in the parent chemical 

molecule that imparts adverse effects) 

remains intact. 

(c) For the purpose of determining 

data requirements, the all other use 

patterns category includes the following use patterns: 

(1) Agricultural premises and equipment. 

(2) Food-handling/storage establishments, premises, and equipment. 

(3) Commercial, institutional and industrial premises and equipment. 

(4) Residential and public access 

premises. 

(5) Medical premises and equipment. 

(6) Human drinking water systems. 

(7) Materials preservatives. 

(8) Swimming pools. 

(d) If an antimicrobial may be applied to a field crop, horticultural crop, 

or turf, then the data requirements in 

§158.660 apply. 

(e) Key. MP = Manufacturing use 

product; EP = End-use product; R = Required; CR = Conditionally required; 

NR = Not required; TGAI = Technical 

grade of the active ingredient; TEP = 

Typical end-use product. 

(f) Nontarget plant protection data requirements table. The following table 

shows the data requirements for nontarget plant protection. The test notes 

appear in paragraph (g) of this section. 


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Environmental Protection Agency § 158.2250 

TABLE—NONTARGET PLANT PROTECTION

DATA

REQUIREMENTS

Guideline No. Data requirement 

Use pattern Test substance 

Test note No. Industrial processes and water 

systems 

Antifoulant coatings and paints Wood preserva- tives Aquatic areas All other use pat- terns category MP EP 

850.4225 ........ Seedling emergence, Tier II— 

dose response.

CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TEP ............. TEP ............. 1, 2 

850.4250 ........ Vegetative vigor, 

Tier II—dose response.

CR ...................... NR ...................... CR ...................... CR ...................... CR ...................... TEP ............. TEP ............. 1, 3 

850.4400 ........ Aquatic plant growth 

(aquatic vascular plant) Tier II— dose response.

R ......................... R ......................... R ......................... R ......................... CR ...................... TGAI, TEP ... TGAI, TEP ... 4, 10 

850.5400 ........ Aquatic plant growth 

(algal) Tier II (dose response).

R ......................... R ......................... R ......................... R ......................... R ......................... TGAI, TEP ... TGAI, TEP ... 4, 5, 6 

850.4300 ........ Terrestrial field ........ CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TEP ............. TEP ............. 7, 8, 9 850.4450 ........ Aquatic field ............ CR ...................... CR ...................... CR ...................... CR ...................... CR ...................... TEP ............. TEP ............. 7, 8, 9 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.2260 40 CFR Ch. I (7–1–15 Edition) 

(g) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (f) of this section: 

1. Data on only one plant species 

(rice, Oryza sativa) are required. 

2. Data are required if the risk 

quotient from any aquatic plant 

growth Tier II study exceeds a level of 

concern for aquatic plants. 

3. Not required when: 

i. There are no potential exposures to 

plants; 

ii. The hydrolytic half-life is less 

than 5 days at pH 5, 7, and 9; or 

iii. The results of a biodegradation 

study indicate that the active ingredient or principal degradation products 

are not biodegradable in 28 days, i.e., 

the biodegradation curve has not 

reached a plateau for at least three determinations within the 28 days. 

4. For TEP testing, data are required 

for the applicant’s end-use product if 

an ingredient in the end-use product, 

other than the active ingredient, is expected to enhance the toxicity of the 

active ingredient. 

5. One Tier II (dose response) study, 

conducted with Selenastrum 

capricornutum, is required for the all 

other use patterns category (as specified in §158.2250(c)). If the results of 

this study exhibit detrimental effects 

(EC50 less than 1.0 ppm or mg/L), then 

additional Tier II (dose response) studies are required on three species 

(Anabaena flos-aquae, Navicula 

pelliculosa, and Skeletonema costatum). 

6. For industrial processes and water 

systems, antifoulant coatings and 

paints, wood preservatives, and aquatic 

areas, Tier II (dose response) studies 

are required on four species (Anabaena 

flos-aquae, Navicula pelliculosa, 

Skeletonema costatum, and Selenastrum 

capricornutum). 

7. Environmental chemistry methods 

used to generate data must include the 

results of a successful confirmatory 

method trial by an independent laboratory. 

8. Tests are required on a case-bycase basis based on the results of lower 

tier plant protection studies, adverse 

incident reports, intended use pattern, 

and environmental fate characteristics 

that indicate potential exposure. 

9. Protocols must be approved by the 

Agency prior to the initiation of the 

study. 

10. For the all other use patterns category (as specified in §158.2250(c)), data 

are required if the aquatic (algal) plant 

growth Tier II study demonstrates detrimental effects at less than 1.0 ppm or 

mg/L. 

§ 158.2260 Applicator exposure. 

(a) General. Subpart B of this part 

and §158.2201 describe how to use the 

table in paragraph (d) of this section to 

determine the applicator exposure data 

requirements for antimicrobial pesticide products. Notes that apply to an 

individual test including specific conditions, qualifications, or exceptions are 

listed in paragraph (e) of this section. 

(1) The Agency may accept surrogate 

exposure data estimations and/or modeling estimations from other sources to 

satisfy exposure data requirements. 

The surrogate data must meet the 

basic quality assurance, quality control, good laboratory practice, and 

other scientific requirements set by 

EPA. To be acceptable, the Agency 

must find that the surrogate exposure 

data estimations have adequate information to address the applicable exposure data requirements and contain 

adequate monitoring events of acceptable quality. The data must reflect the 

specific use prescribed on the label and 

the activity of concern, including formulation type, application methods 

and rates, type of activity, and other 

pertinent information. 

(2) Occupational uses include not 

only handlers, mixers, loaders, and applicators, but also commercial applications to residential sites. Residential 

uses are limited to non-occupational, 

i.e., non-professional, antimicrobial applications. Both occupational and residential applicator data may be required for the same product. 

(b) Criteria for testing. Applicator exposure data described in the table to 

paragraph (d) of this section are required based on toxicity and exposure 

criteria. Data are required if at least 

one of the toxicity criteria in paragraph (b)(1) of this section, and at least 

one of the exposure criteria in paragraph (b)(2) of this section are met. 


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Environmental Protection Agency § 158.2270 

(1) Toxicity criteria. (i) Evidence of potentially significant adverse effects 

have been observed in any applicable 

toxicity studies. 

(ii) Scientifically sound epidemiological or poisoning incident data with a 

clear cause-effect relationship indicating that adverse health effects may 

have resulted from exposure to the pesticide. 

(2) Exposure criteria. (i) Dermal exposure may occur during product use. 

(ii) Respiratory exposure may occur 

during product use. 

(c) Key. R = Required; CR = Conditionally required; TEP = Typical enduse product. 

(d) Antimicrobial applicator exposure 

data requirements table. The following 

table shows the data requirements for 

applicator exposure. The test notes appear in paragraph (e) of this section. 

TABLE—ANTIMICROBIAL APPLICATOR EXPOSURE DATA REQUIREMENTS

Guideline No. Data requirements 

Use sites Test substance 

Test note No. Occupational Residential 

875.1100 Dermal exposure .................................... R ......................... R ......................... TEP .................... 1, 2, 3, 4 

875.1200 

875.1300 Inhalation exposure ................................ R ......................... R ......................... TEP .................... 1, 2, 3, 4 

875.1400 

875.1500 Biological monitoring .............................. CR ...................... CR ...................... TEP .................... 1, 2, 3 

875.1600 Data reporting and calculations ............. R ......................... R ......................... TEP .................... 5 

875.1700 Product use information ......................... R ......................... R ......................... TEP .................... ....................

(e) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (d) of this 

section: 

1. Prior to initiation of the study, 

protocols involving intentional exposure of human subjects must be submitted for review by EPA and then the 

Human Studies Review Board (HSRB) 

according to 40 CFR 26.1125. Examples 

of proposed human study research can 

be found in various reviews provided by 

the Human Studies Review Board 

(http://www.epa.gov/osa/hsrb/index.htm). 

2. Biological monitoring data may be 

submitted in addition to, or in lieu of, 

dermal and inhalation passive dosimetry exposure data, provided the 

human pharmacokinetics of the pesticide or metabolite/analog compounds 

(i.e., whichever method is selected as 

an indicator of body burden or internal 

dose) allow for the back calculation to 

the total internal dose. 

3. For products with both indoor and 

outdoor uses, and similar conditions of 

use, data are generally required for the 

indoor applications only. However, 

data for outdoor uses are required if 

the Agency expects outdoor uses to result in greater exposure than indoor 

uses (e.g., higher use rates and application frequency, or longer exposure duration, or application methods/equipment create potential for increased 

dermal or inhalation exposure in outdoor versus indoor use sites). In certain 

cases, when a pesticide may be used 

both indoors and outdoors under dissimilar conditions of use, the Agency 

may require submission of applicator 

exposure data for both use patterns. 

4. EPA will consider waiving this 

data requirement for antimicrobials 

applied via closed loading systems if 

the antimicrobial has a low vapor pressure. 

5. Data reporting and calculations 

are required only if handler exposure 

data are required. 

§ 158.2270 Post-application exposure. 

(a) General. Subpart B of this part 

and §158.2201 describe how to use the 

table in paragraph (d) of this section to 

determine the post-application exposure data requirements for antimicrobial pesticide products. The data 

generated during these studies are used 

to determine the quantity of pesticide 

to which people may be exposed after 

application. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions to 

the designated test, are listed in paragraph (e) of this section. 


Lhorne on DSK5TPTVN1PROD with CFR
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§ 158.2270 40 CFR Ch. I (7–1–15 Edition) 

(1) Post-application exposure data 

are required when certain toxicity criteria are met and the human activities 

associated with the pesticide’s use pattern can lead to potential adverse exposures. 

(2) The Agency may accept surrogate 

exposure data estimations and/or modeling estimations from other sources to 

satisfy exposure data requirements. 

The surrogate data must meet the 

basic quality assurance, quality control, good laboratory practice, and 

other scientific requirements set by 

EPA. To be acceptable, the Agency 

must find that the surrogate exposure 

data estimations have adequate information to address the applicable exposure data requirements and contain 

adequate monitoring events of acceptable quality. The data must reflect the 

specific use prescribed on the label and 

the activity of concern, including formulation type, application methods 

and rates, type of activity, and other 

pertinent information. 

(b) Criteria for testing. Post-application exposure data described in the 

table to paragraph (d) of this section 

are required based on toxicity and exposure criteria. Data are required if at 

least one of the toxicity criteria in 

paragraph (b)(1) of this section, and at 

least one of the exposure criteria in 

paragraph (b)(2) of this section are met. 

(1) Toxicity criteria. (i) Evidence of potentially significant adverse effects 

have been observed in any applicable 

toxicity studies. 

(ii) Scientifically sound epidemiological or poisoning incident data with a 

clear cause-effect relationship indicating that adverse health effects may 

have resulted from exposure to the pesticide. 

(2) Exposure criteria—(i) Outdoor uses. 

(A) Occupational human post-application or bystander exposure to residues 

of antimicrobial pesticides could occur 

as the result of, but is not limited to, 

worker reentry into treatment sites, 

clean-up and equipment maintenance 

tasks, handling wood preservativetreated wood, or other work-related activity. 

(B) Residential human post-application or bystander exposure to residues 

of antimicrobial pesticides could occur 

following the application of antimicrobial pesticides to outdoor areas 

and spaces at residential sites, such as, 

but not limited to homes, daycare centers, and other public buildings. 

(ii) Indoor uses. (A) Occupational 

human post-application or bystander 

exposure to pesticide residues could 

occur following the application of the 

antimicrobial pesticide to indoor 

spaces or surfaces. 

(B) Residential human post-application or bystander exposure to pesticide 

residues could occur following the application of the antimicrobial pesticide 

to indoor spaces or surfaces at residential sites, such as, but not limited to 

homes, daycare centers, hospitals, 

schools, and other public buildings. 

(c) Key. R = Required; CR = Conditionally required; NR = Not required; 

TEP = Typical end-use product. 

(d) Antimicrobial post-application exposure data requirements table. The following table shows the data requirements for post-application exposure. 

The test notes appear in paragraph (e) 

of this section. 

TABLE—ANTIMICROBIAL POST-APPLICATION EXPOSURE DATA REQUIREMENTS

Guideline No. Data requirement 

Use sites Test substance 

Test note No. Occupational Residential 

875.2200 Soil residue dissipation .......................... CR ...................... CR ...................... TEP .................... 2, 3 

875.2300 Indoor surface residue dissipation ......... CR ...................... R ......................... TEP .................... 3, 4, 5, 6 

875.2400 Dermal exposure .................................... CR ...................... CR ...................... TEP .................... 1, 7, 8 

875.2500 Inhalation exposure ................................ CR ...................... CR ...................... TEP .................... 1,7, 8, 9 

875.2600 Biological monitoring .............................. CR ...................... CR ...................... TEP .................... 1, 8 

875.2700 Product use information ......................... R ......................... R ......................... TEP.

875.2800 Description of human activity ................. R ......................... R ......................... TEP.

875.2900 Data reporting and calculations ............. R ......................... R ......................... TEP .................... 10 

(e) Test notes. The following test 

notes apply to the data requirements 

in the table to paragraph (d) of this 

section: 


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Environmental Protection Agency § 158.2280 

1. Prior to initiation of the study, 

protocols involving intentional exposure of human subjects must be submitted for review by EPA and then the 

Human Studies Review Board (HSRB) 

according to 40 CFR 26.1125. Examples 

of proposed human study research can 

be found in various reviews provided by 

the Human Studies Review Board 

(HSRB) (http://www.epa.gov/osa/hsrb/ 

index.htm). 

2. For residential wood preservative 

uses, data may be required if soil has 

the potential to be an important exposure pathway, and soil is in contact 

with or adjacent to treated wood, including but not limited to decks, play 

sets, and gazebos, 

3. Protocols must be approved by the 

Agency prior to the initiation of the 

study. 

4. For wood preservatives, data are 

required for treated wood surfaces 

where post-application contact with 

treated wood is anticipated. 

5. For occupational uses, data are required if the pesticide may be applied 

to or around surfaces, and if the human 

activity data indicate that workers are 

likely to have post-application dermal 

contact with treated surfaces while 

participating in typical activities. 

6. Data are required for residential 

use sites, schools, and daycare institutions. This includes but is not limited 

to the following: Residential and public 

access premises; material preservatives 

(including those used in residential 

products, including but not limited to 

clothing and plastic toys) and wood 

preservatives (when contact with treated wood is likely to occur). 

7. Data are required for occupational 

and residential uses if the human activity data indicate the potential for 

post-application dermal and/or inhalation exposures while participating in 

typical activities and no acceptable 

modeling options are available. 

8. Biological monitoring data may be 

submitted in addition to, or in lieu of, 

dermal and inhalation passive dosimetry exposure data provided the human 

pharmacokinetics of the pesticide or 

metabolite/analog compounds (i.e., 

whichever method is selected as an indicator of body burden or internal 

dose) allow for a back-calculation to 

the total internal dose. 

9. Data are required for occupational 

and residential uses if there is the potential for bystander exposure and the 

pesticide use could result in respirable 

and/or inhalable material (e.g., gas, 

vapor, aerosol, or particulates). 

10. Data reporting and calculations 

are required only if post-application 

exposure data are required. 

§ 158.2280 Environmental fate. 

(a) General. Subpart B of this part 

and §158.2201 describe how to use the 

table in paragraph (c) of this section to 

determine the environmental fate data 

requirements for antimicrobial pesticide products. Notes that apply to an 

individual test including specific conditions, qualifications, or exceptions are 

listed in paragraph (d) of this section. 

(1) Environmental fate data are required to support the registrations of 

all end-use and manufacturing-use 

antimicrobial products. 

(2) Data on transformation/degradation products or leachate residues of 

the parent compound are also required 

to support registration, if the transformation/degradation products or 

leachate residues meet one of the following criteria: 

(i) More toxic, persistent, or bioaccumulative than the parent; 

(ii) Have been shown to cause adverse 

effects in mammalian or aquatic reproductive studies; or 

(iii) The moiety of concern (i.e., functional group in the parent chemical 

molecule that imparts adverse effects) 

remains intact. 

(3) For the purpose of determining 

data requirements, the all other use 

patterns category includes the following use patterns: 

(i) Agricultural premises and equipment. 

(ii) Food-handling/storage establishments, premises, and equipment. 

(iii) Commercial, institutional and 

industrial premises and equipment. 

(iv) Residential and public access 

premises. 

(v) Medical premises and equipment. 

(vi) Human drinking water systems. 

(vii) Materials preservatives. 

(viii) Swimming pools. 

(b) Key. MP = Manufacturing use 

product; EP = End-use product; R = Required; CR = Conditionally required; 


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§ 158.2280 40 CFR Ch. I (7–1–15 Edition) 

NR = Not required; TGAI = Technical 

grade of the active ingredient; TEP = 

Typical end-use product; PAIRA = Pure 

active ingredient radiolabeled; ROC = 

residue of concern. 

(c) Antimicrobial environmental fate 

data requirements table. The following 

table shows the data requirements for 

environmental fate. The test notes appear in paragraph (d) of this section. 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.2280 

TABLE—ANTIMICROBIAL ENVIRONMENTAL FATE

DATA

REQUIREMENTS

Guideline No. Data requirement 

Use pattern Test substance 

Test note No. Industrial 

processes and 

water systems 

Antifoulant coatings and paints Wood preservatives Aquatic areas All other use pat- terns category MP EP 

Degradation Studies—Laboratory 

835.2120 ........ Hydrolysis ................... R ......................... R ......................... R ........................ R ........................ R ........................ TGAI or 

PAIRA.

TGAI or 

PAIRA.

1 

835.2240 ........ Photodegradation in 

water.

R ......................... R ......................... R ........................ R ........................ R ........................ TGAI or 

PAIRA.

TGAI or 

PAIRA.

2 

835.2410 ........ Photodegradation in 

soil.

NR ...................... NR ...................... R ........................ NR ..................... NR ..................... TGAI or 

PAIRA.

TGAI or 

PAIRA.

10 

Toxicity and Fate in Wastewater Systems 

850.6800 ........ Activated Sludge, 

Respiration Inhibition Test.

R ......................... R ......................... R ........................ NR ..................... R ........................ TGAI ............ TGAI ............ 21 

OECD 209.

835.1110 ........ Activated Sludge 

Sorption Isotherm.

CR ...................... CR ...................... CR ..................... NR ..................... CR ..................... TGAI ............ TGAI ............ 19, 20 

835.3110 ........ Ready 

Biodegradability.

CR ...................... CR ...................... CR ..................... NR ..................... CR ..................... TGAI ............ TGAI ............ 3, 4, 18 

835.3220 ........ Porous Pot Study ....... CR ...................... CR ...................... CR ..................... NR ..................... CR ..................... TGAI ............ TGAI ............ 3, 18 835.3280 ........ Simulation Tests to 

Assess the Biodegradability of Chemicals Discharged in Wastewater.

CR ...................... CR ...................... CR ..................... NR ..................... CR ..................... TGAI ............ TGAI ............ 3, 18 

835.3240 ........ Simulation Test—Aerobic Sewage Treatment: A. Activated 

Sludge Units.

CR ...................... CR ...................... CR ..................... NR ..................... CR ..................... TGAI ............ TGAI ............ 3, 18 

Mobility Studies 

835.1230 ........ Leaching and adsorption/de-sorption. R ......................... R ......................... R ........................ R ........................ CR ..................... TGAI or PAIRA. TGAI or PAIRA. 5, 6 835.1240 

Metabolism Studies—Laboratory 

835.4100 ........ Aerobic soil metabolism. CR ...................... NR ...................... R ........................ CR ..................... CR ..................... TGAI or PAIRA. TGAI or PAIRA. 7, 8, 9 835.4200 ........ Anaerobic soil metabolism. NR ...................... NR ...................... R ........................ NR ..................... CR ..................... TGAI or PAIRA. TGAI or PAIRA. 5, 8 


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§ 158.2280 40 CFR Ch. I (7–1–15 Edition) 

TABLE—ANTIMICROBIAL ENVIRONMENTAL FATE

DATA

REQUIREMENTS—Continued 

Guideline No. Data requirement 

Use pattern Test substance 

Test note No. Industrial 

processes and 

water systems 

Antifoulant coatings and paints Wood preservatives Aquatic areas All other use pat- terns category MP EP 

835.4300 ........ Aerobic aquatic metabolism. R ......................... R ......................... R ........................ R ........................ CR ..................... TGAI or PAIRA. TGAI or PAIRA. 5, 8 835.4400 ........ Anaerobic aquatic metabolism. R ......................... R ......................... R ........................ R ........................ CR ..................... TGAI or PAIRA. TGAI or PAIRA. 5, 8 

Dissipation Studies—Field 

835.6200 ........ Aquatic (sediment) ..... CR ...................... R ......................... CR ..................... R ........................ CR ..................... TEP ............. TEP ............. 11, 12, 13 

Ground and Surface Water Monitoring 

None ............... Monitoring of representative U.S. 

waters.

CR ...................... CR ...................... CR ..................... CR ..................... CR ..................... ROC ............ ROC ............ 11, 14, 17 

Special Studies 

None ............... Special leaching ......... NR ...................... R ......................... R ........................ NR ..................... NR ..................... TGAI ............ TEP ............. 15, 16 


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Environmental Protection Agency § 158.2280 

(d) Test notes. The following test 

notes apply to the data requirements 

in the table in paragraph (c) of this section: 

1. For testing antifoulant paints and 

coatings, testing is to be performed 

separately with both sterile buffered 

distilled water and sterile synthetic 

seawater at pHs 5, 7, and 9. 

2. Not required if: 

i. The electronic absorption spectra, 

measured at pHs 5, 7 and 9, of the 

chemical and its hydrolytic products, if 

any, show no absorption or tailing between 290 and 800 nm, inclusive; or 

ii. The results of the hydrolysis study 

at all three pHs (5, 7, and 9) demonstrates a half-life of less than 30 

days. 

3. The results of the activated sludge, 

respiration inhibition (ASRI) test determine which of the following tests 

are required: Ready biodegradability, 

porous pot, the biodegradation in activated sludge study as described in the 

‘‘Simulation Tests to Assess the 

Biodegradability of Chemicals Discharged in Wastewater,’’ or simulation 

test—aerobic sewage treatment: A. activated sludge units. 

i. If the ASRI test EC50 is equal to or 

less than 20 mg/L, then the applicant 

must choose either to: 

A. Conduct the biodegradation in activated sludge study as described in the 

‘‘Simulation Tests to Assess the 

Biodegradability of Chemicals Discharged in Wastewater’’; 

B. Conduct the porous pot test; or 

C. Conduct the simulation test—aerobic sewage treatment: A. activated 

sludge units. 

ii. If the ASRI test EC50 is greater 

than 20 mg/L, then the applicant must 

choose either to: 

A. Conduct a ready biodegradability 

study; or 

B. Conduct one of the following studies: The biodegradation in activated 

sludge study as described in the ‘‘Simulation Tests to Assess the 

Biodegradability of Chemicals Discharged in Wastewater,’’ the porous 

pot test, or the simulation test—aerobic sewage treatment: A. activated 

sludge units. 

4. Pass criteria for the ready 

biodegradability study are: 70 percent 

removal of dissolved organic carbon 

(DOC) and 60 percent removal of theoretical oxygen demand (ThOD) or theoretical carbon dioxide (ThCO2) production for respirometric methods. These 

pass levels must be reached in a 10-day 

window within the 28-day period of the 

test. If the antimicrobial passes the 

ready biodegradability study, then no 

further testing is required. If the antimicrobial fails the ready 

biodegradability study, then the applicant must conduct one of the following 

studies: The biodegradation in activated sludge study as described in the 

‘‘Simulation Tests to Assess the 

Biodegradability of Chemicals Discharged in Wastewater,’’ the porous 

pot test, or the simulation test—aerobic sewage treatment: A. activated 

sludge units. 

5. For the all other use patterns category (as specified in §158.2280(a)(3)), 

data are required based on a weight-ofevidence evaluation of the results of 

the hydrolysis, photodegradation in 

water, activated sludge sorption isotherm, biodegradability, and activated 

sludge, respiration inhibition tests. 

6. Adsorption and desorption using a 

batch equilibrium method is preferred. 

In some cases, as when the antimicrobial pesticide degrades rapidly, 

soil column leaching with unaged or 

aged columns may be more appropriate 

to fully characterize the potential mobility of the parent compound and 

major transformation products. 

7. For industrial processes and water 

systems, aquatic areas, and the all 

other use patterns category (as specified in §158.2280(a)(3)), data are required 

based on a weight-of-evidence evaluation of the results of the hydrolysis, 

photodegradation in water, activated 

sludge sorption isotherm, 

biodegradability, and activated sludge, 

respiration inhibition tests. 

8. The environmental media (soil, 

water, hydrosoil, and biota) to be utilized in these studies must be collected 

from areas representative of potential 

use sites. 

9. For industrial processes and water 

systems, and aquatic areas, data are 

required for use sites that are intermittently dry. 

10. Data are not required if the antimicrobial is an inorganic substance or 

a metal salt; or if the standardized soil 


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§ 158.2290 40 CFR Ch. I (7–1–15 Edition) 

profiles demonstrate that the antimicrobial is likely to readily degrade 

either microbially or via redox reactions (chemically) and no transformation/degradate/leachate products 

of concern (as described under 

§158.2280(a)(2)) are produced. 

11. Analytical methods used to generate data associated with this study 

must include results of a successful 

confirmatory method trial by an independent laboratory. 

12. Protocols must be approved by 

the Agency prior to the initiation of 

the study. 

13. For industrial processes and water 

systems, wood preservatives, and the 

all other use patterns category (as 

specified in §158.2280(a)(3)), data are required based on the potential for 

aquatic exposure and if the weight-ofevidence indicates that the active ingredient or principal transformation 

products are likely to have the potential for persistence, mobility, nontarget aquatic toxicity, or bioaccumulation. 

14. Data are required if the weight-ofevidence indicates that the active ingredient or principal transformation 

products are likely to occur in nontarget freshwater, estuarine, or marine 

waters such that human or environmental exposures are likely to occur. 

In making that determination, the 

Agency takes into account other factors such as the toxicity of the chemical(s), available monitoring data and 

the vulnerability of the freshwater, estuarine, or marine water resources in 

the antimicrobial use area. 

15. For wood preservatives, an aquatic leaching study is required. A soil 

leaching study is required if human or 

environmental exposures are likely to 

occur from leachates that contain the 

active ingredient or principal transformation products from wood treated 

with a preservative product. Protocols 

must be approved by the Agency prior 

to the initiation of the study. 

16. For antifoulant paints and coatings, a leaching study is required. Protocols must be approved by the Agency 

prior to the initiation of the study. 

17. Protocols, which include the residues of concern (such as parent, 

degradate/transformation product, and/ 

or leachate residues) that would be 

monitored, must be approved by the 

Agency prior to the initiation of the 

study. 

18. A biodegradation study is not required if the antimicrobial meets one 

or more of the following criteria: 

i. Classified as a metal, 

ii. Relatively volatile, but not hydrophobic, 

iii. Highly reactive, 

iv. Both the parent and all transformation/degradate products (as described under §158.2280(a)(2)) have halflives of less than 3 hours, 

v. None of the registered or proposed 

product uses would result in transport 

of the parent and its transformation/ 

degradate products (as described under 

§158.2280(a)(2)) to a wastewater treatment plant. 

19. The activated sludge sorption isotherm test is not required if the antimicrobial is: 

i. Relatively volatile, but not hydrophobic; 

ii. Highly reactive; or 

iii. The log Kow is less than 3.0. 

20. If the criteria of test note 19 of 

this paragraph are not met, then the 

activated sludge sorption isotherm test 

is required if one or more of the following criteria are also met: 

i. The antimicrobial is a metal, 

ii. The log Kow is greater than or 

equal to 3.0, 

iii. The antimicrobial is positively 

charged or polycationic, 

iv. The EC50 in the activated sludge, 

respiration inhibition test is less than 

or equal to 20 mg/L, 

v. The EC50 in the activated sludge, 

respiration inhibition test is greater 

than 20 mg/L, and the antimicrobial 

fails the ready biodegradability study. 

21. The activated sludge respiration 

inhibition study is not required if none 

of the registered or proposed product 

uses would result in transport of the 

parent and its transformation/ 

degradate products (as described under 

§158.2280(a)(2)) to a wastewater treatment plant. 

§ 158.2290 Residue chemistry. 

(a) General. Subpart B of this part 

and §158.2201 describe how to use the 

table in paragraph (h) of this section to 

determine the residue chemistry data 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.2290 

requirements for antimicrobial pesticide products. Notes that apply to an 

individual test including specific conditions, qualifications, or exceptions are 

listed in paragraph (i) of this section. 

(b) Residue chemistry data are required for: 

(1) Antimicrobial end-use products 

with uses that may result in residues 

in or on food, including but not limited 

to: 

(i) Products that require a tolerance, 

tolerance exemption, or food additive 

regulation or clearance. 

(ii) Products that may be used to 

treat livestock or poultry drinking 

water, for food egg washing, or for fruit 

and vegetable rinses. 

(iii) Products that may be applied to 

a surface or incorporated into a material that may contact food or feed. 

Data are required regardless of whether 

the antimicrobial is applied or impregnated for the purpose of imparting 

antimicrobial protection to external 

surfaces of the substance or article, or 

for the purpose of protecting the substance or article itself. 

(iv) Products that may be applied to 

water that have the potential to result 

in residues in potable water, or in 

water used for livestock and poultry 

drinking water, irrigation of crops, or 

water containing fish that may be used 

for human food. 

(v) Wood preservative or antifoulant 

products intended for treating submerged materials that may result in 

food contact (e.g., lobster pots, fish 

cages on fish farms). 

(2) Each manufacturing-use product 

bearing directions for formulation into 

an end-use product bearing uses described in paragraph (b)(1) of this section. 

(c) Residue chemistry data are not 

required under paragraph (b) of this 

section if no adverse effects (no toxicity endpoints) are associated with dietary exposure to the active ingredient 

or if theoretical (high-end) dietary exposure estimates combined with the 

applicable toxicity endpoint result in 

acute and chronic dietary risks that 

are below the Agency levels of concern. 

(d) For purposes of this section, Magnitude of the Residue Studies include 

the following: Food-handling, migration studies, potable water, fish, irrigated crops, meat/milk/poultry/eggs, 

crop field trails, processed food or feed, 

and anticipated residues. 

(e) If the antimicrobial chemical may 

be applied to a field crop, then the residue chemistry data requirements of 

§158.1410 apply. 

(f) The following term is defined for 

the purposes of this section:Residue of 

concern means the parent pesticidal 

compound and its metabolites, 

degradates, and impurities of toxicological concern. 

(g) Key. R = Required; CR = Conditionally required; NR = Not required; 

TGAI = Technical grade of the active 

ingredient; TEP = Typical end-use 

product; PAI = Pure active ingredient; 

PAIRA = Pure active ingredient 

radiolabeled; ROC = Residue of concern. 

(h) Antimicrobial residue chemistry data 

requirements table. The following table 

shows the data requirements for residue chemistry. The test notes appear 

in paragraph (i) of this section. 


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§ 158.2290 40 CFR Ch. I (7–1–15 Edition) 

TABLE—ANTIMICROBIAL

RESIDUE

CHEMISTRY

DATA

REQUIREMENTS

Guideline No. Data requirement 

Uses 

Test 

substance 

Test note 

No. Agricultural 

premise Indirect food Direct food Aquatic 

Supporting Information 

860.1100 ........ Chemical identity ........................................................... R ......................... R ......................... R ......................... R ......................... TGAI.860.1200 ........ Directions for use .......................................................... R ......................... R ......................... R ......................... R ......................... .860.1550 ........ Proposed tolerance/tolerance exemption ...................... R ......................... R ......................... R ......................... R ......................... ............................. 1 860.1560 ........ Reasonable grounds in support of petition ................... R ......................... R ......................... R ......................... R ......................... ............................. 1 860.1650 ........ Submittal of analytical reference standards .................. R ......................... R ......................... R ......................... R ......................... PAI/ROC ............. 2 

Food-Contact Surfaces or Impregnated Materials 

860.1460 ........ Food-handling ................................................................ CR ...................... CR ...................... CR ...................... CR ...................... TEP ..................... 3 None .............. Nature of residue on surfaces ....................................... CR ...................... CR ...................... CR ...................... CR ...................... PAIRA or TGAI ... 4 None .............. Migration studies ........................................................... CR ...................... CR ...................... CR ...................... CR ...................... TEP ..................... 5 860.1340 ........ Residue analytical method for data collection .............. CR ...................... CR ...................... CR ...................... CR ...................... ROC .................... 6 860.1380 ........ Storage stability ............................................................. R ......................... R ......................... R ......................... R ......................... TEP or ROC ....... 7 

Higher tiered 

860.1300 ........ Nature of the residue in plants ...................................... CR ...................... CR ...................... CR ...................... CR ...................... PAIRA ................. 8 860.1300 ........ Nature of the residue in livestock .................................. CR ...................... CR ...................... CR ...................... CR ...................... PAIRA ................. 9 860.1340 ........ Residue analytical methods for tolerance/tolerance exemption enforcement. CR ...................... CR ...................... CR ...................... CR ...................... ROC .................... 10 860.1360 ........ Multiresidue method testing .......................................... CR ...................... CR ...................... CR ...................... CR ...................... ROC .................... 11 860.1400 ........ Potable water ................................................................. CR ...................... CR ...................... CR ...................... CR ...................... TEP ..................... 12 860.1400 ........ Fish ................................................................................ CR ...................... CR ...................... CR ...................... CR ...................... TEP ..................... 13 860.1400 ........ Irrigated crops ................................................................ CR ...................... CR ...................... CR ...................... CR ...................... TEP ..................... 14 860.1480 ........ Meat/milk/poultry/eggs ................................................... CR ...................... CR ...................... CR ...................... CR ...................... TGAI or ROC ...... 15 860.1500 ........ Crop field trials .............................................................. CR ...................... CR ...................... CR ...................... CR ...................... TEP ..................... 16 860.1520 ........ Processed food or feed ................................................. CR ...................... CR ...................... CR ...................... CR ...................... TEP ..................... 17 None .............. Anticipated residues ...................................................... CR ...................... CR ...................... CR ...................... CR ...................... ROC .................... 18 


Lhorne on DSK5TPTVN1PROD with CFR
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Environmental Protection Agency § 158.2290 

(i) Test notes. The following test notes 

apply to the data requirements in the 

table to paragraph (h) of this section: 

1. A petition proposing a numerical 

tolerance or a tolerance exemption is 

required for any food or feed use subject to section 408 of FFDCA if the use 

is not covered by an existing tolerance 

or tolerance exemption. If the use is 

subject to FFDCA section 409, the applicant must identify to EPA an applicable section 409 food additive regulation or clearance, or submit a copy of 

a petition to FDA requesting a section 

409 food additive regulation or clearance for the food or feed use. 

2. An analytical reference standard is 

required for any food or feed use requiring a numeric tolerance or exemption. Material safety data sheets as 

specified by the Occupational Safety 

and Health Administration in 29 CFR 

1910.1200 must accompany analytical 

standards. 

3. Data are required if a pesticide 

may be used in a food-handling establishment unless data including, but not 

limited to, theoretical (high-end) estimates, radiolabeled laboratory data, or 

the nature of the residue on surfaces 

study show that residues will not occur 

in food or feed. 

4. If an antimicrobial pesticide may 

be applied to a food-contact surface or 

impregnated into a food-contact material and if theoretical (high-end) estimates of exposure exceed EPA’s risk 

level of concern, then the nature of the 

residue on surfaces study is required. 

Protocols must be approved by the 

Agency prior to the initiation of the 

study. 

5. Based on the results of the nature 

of the residue on surfaces study, if residues of concern are identified, then the 

migration study will be required. Protocols must be approved by the Agency 

prior to the initiation of the study. 

6. If a magnitude of the residue 

study, as specified in §158.2290(d), is required, then a residue analytical method suitable for collecting data is also 

required. The method must be capable 

of determining all residues of concern, 

to permit calculation of dietary risk or 

to establish a tolerance or tolerance 

exemption. 

7. If a magnitude of the residue 

study, as specified in §158.2290(d), is required, then storage stability data are 

also required, unless analytical samples are stored for 30 days or less. If, 

during hazard characterization, a residue has been identified as ‘‘of concern’’ and is known to be volatile or labile, then storage stability data are required regardless of sample storage 

time. 

8. If crop plants or metabolically active raw agricultural commodities of 

food crops may be directly or indirectly exposed to an antimicrobial, 

plant metabolism studies are required 

to determine the transformation products that may enter the human diet. 

Such exposure could include, but is not 

limited to: 

i. Treatment of storage or shipping 

containers, 

ii. Postharvest fruit and vegetable 

treatment prior to shipping or storage, 

iii. Use of antimicrobial-treated 

water for irrigation, and 

iv. Any direct food contact use. 

9. If livestock may be exposed to an 

antimicrobial, then hen and ruminant 

metabolism studies are required to determine the identities of residues of 

concern that may enter the human diet 

from consumption of livestock commodities. Livestock may be exposed 

via the oral, dermal, or inhalation 

route following treatment or contamination of sites including, but not limited to, livestock premises, feed, and 

drinking water. Shell eggs and other 

metabolically active livestock products may also be treated. If livestock 

may be exposed to one or more residues 

of concern differing from those found 

in animals, then one or more additional livestock metabolism studies involving dosing with these residues may 

be required. 

10. If there is a numerical tolerance 

or tolerance exemption level to enforce, then a residue analytical method 

suitable for enforcement purposes is required. The method must be supported 

by an independent laboratory validation. 

11. If there is a numerical tolerance 

or tolerance exemption level to enforce, then testing is required to determine whether the Food and Drug Administration/United States Department of Agriculture multiresidue 

methodology would detect and identify 


Lhorne on DSK5TPTVN1PROD with CFR
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§§ 158.2300–158.2500 40 CFR Ch. I (7–1–15 Edition) 

the antimicrobial and its residues of 

concern, as part of programs to monitor pesticides in the U.S. food supply. 

12. Data are required if an antimicrobial may be applied directly to 

water or if there is the potential that 

the antimicrobial-treated water could 

be used directly for drinking water purposes by humans or animals or that 

contaminated water could run-off, 

leach, or be discharged from treated 

sites or materials and make its way 

into potable water. 

13. Data are required if an antimicrobial may be applied directly to 

water inhabited by fish or that will be 

inhabited by fish or if contaminated 

water could run-off, leach, or be discharged from treated sites or materials 

and make its way into bodies of water 

containing fish that may be used for 

human consumption. 

14. Data are required if an antimicrobial may be applied directly to 

water used for irrigation of food crops 

or such that contaminated water could 

run-off, leach, or be discharged from 

treated sites or materials to make its 

way into water used for irrigation of 

food crops. 

15. If the antimicrobial may be applied directly to livestock, metabolically-active livestock commodities 

(e.g., eggs), livestock feed or drinking 

water, or livestock premises, or a livestock metabolism study indicates that 

residues of the antimicrobial may result in livestock commodities, studies 

are required to determine the magnitude of the residues of concern in fat, 

meat, meat by-products, milk, poultry, 

and eggs that may be consumed by humans. These studies, however, may not 

be required in cases where the livestock metabolism studies indicate that 

transfer of pesticide residues of concern to tissues, milk, and eggs is not 

expected to occur at the maximum expected exposure level for the animals. 

16. If food crops or raw agricultural 

commodities of food crops may be exposed to an antimicrobial, then residue 

studies are required to determine the 

magnitude of the residues of concern 

that may enter the human diet. Such 

exposures include, but are not limited 

to, postharvest fruit and vegetable 

treatments and application of antimicrobial chemicals to field crops, 

mushroom houses, empty or occupied 

beehives, or wood used to construct 

beehives. 

17. Data on the nature and magnitude 

of residues in processed food or feed are 

required if antimicrobial residues could 

potentially concentrate on processing. 

If so, the establishment of a separate 

tolerance higher than that in the raw 

agricultural commodity may be required. 

18. Data are required when dietary 

exposure values at the tolerance level 

or screening-level (high-end) result in 

estimates of dietary or aggregate risk 

that meet or exceed the Agency’s level 

of concern. These data may include, 

but are not limited to, washing, cooking, processing, or degradation studies 

as well as market basket surveys for a 

more realistic residue determination. 

Protocols must be approved by the 

Agency prior to the initiation of the 

study. 

Subparts X–Z [Reserved] 

§§ 158.2300–158.2500 [Reserved] 

PART 159—STATEMENTS OF 

POLICIES AND INTERPRETATIONS 

Subparts A–C [Reserved] 

Subpart D—Reporting Requirements for 

Risk/Benefit Information 

Sec. 

159.152 What the law requires of registrants. 

159.153 Definitions. 

159.155 When information must be submitted. 

159.156 How information must be submitted. 

159.158 What information must be submitted. 

159.159 Information obtained before promulgation of the rule. 

159.160 Obligations of former registrants. 

159.165 Toxicological and ecological studies. 

159.167 Discontinued studies. 

159.170 Human epidemiological and exposure studies. 

159.178 Information on pesticides in or on 

food, feed, or water. 

159.179 Metabolites, degradates, contaminants, and impurities. 

159.184 Toxic or adverse effect incident reports. 

159.188 Failure of performance information. 

159.195 Reporting of other information. 

AUTHORITY: 7 U.S.C. 136–136y. 


Lhorne on DSK5TPTVN1PROD with CFR