40 CFR 158.34 - Flagging of studies for potential adverse effects. | Title 40 - Protection of Environment | Code of Federal Regulations

§ 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	870.4200870.4300	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 toxicityReproduction and fertility Developmental neurotoxicity	870.3700870.3800 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	870.6100870.6200	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 feedingCarcinogenicity Reproduction and fertility Prenatal developmental toxicity Developmental neurotoxicity Acute or 90-day neurotoxicity	870.4100870.4200 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.

(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].

Title 40 published on 2012-07-01

The following are only the Rules published in the Federal Register after the published date of Title 40.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2013-05-08; vol. 78 # 89 - Wednesday, May 8, 2013

78 FR 26936 - Data Requirements for Antimicrobial Pesticides

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-10162
RIN	2070-AD30
	EPA-HQ-OPP-2008-0110
	FRL-8886-5

ENVIRONMENTAL PROTECTION AGENCY

Final rule.

This final rule is effective July 8, 2013.

40 CFR Parts 158 and 161

Summary

EPA is revising the data requirements for antimicrobial pesticide products to reflect current scientific and regulatory practice, and to provide the regulated community with clearer and transparent information about the data needed to support pesticide registration decisions for antimicrobial products. The updated data requirements also serve to further enhance EPA's ability to make regulatory decisions about the human health, and environmental fate and effects of antimicrobial pesticide products. These revisions are also expected to help protect human health and the environment by providing an up-to-date scientific framework for identifying and assessing the risks of antimicrobial pesticides sold or distributed in the United States.

2013-02-28; vol. 78 # 40 - Thursday, February 28, 2013

78 FR 13501 - Declaration of Prion as a Pest Under FIFRA; Related Amendments; and Availability of Final Test Guidelines

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-04613
RIN	2070-AJ26
	EPA-HQ-OPP-2010-0427
	FRL-9372-7

ENVIRONMENTAL PROTECTION AGENCY

Final rule.

This final rule is effective April 29, 2013.

40 CFR Parts 152, 158 and 161

Summary

With this final rule EPA declares a prion ( i.e., proteinaceous infectious particle) to be a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and amends the regulations to expressly include prion within the regulatory definition of pest. This final rule also amends existing pesticide product performance data requirements to clarify that efficacy data are required for pesticide products with prion-related claims. In addition, EPA is announcing the availability of final test guidelines on generating the product performance data for prion-related pesticide products.

2012-08-30; vol. 77 # 169 - Thursday, August 30, 2012

77 FR 52610 - Pesticides; Microbial Pesticide Definitions and Applicability; Clarification and Availability of Test Guideline

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-21430
RIN	2070-AJ80
	EPA-HQ-OPP-2010-0670
	FRL-9338-9

ENVIRONMENTAL PROTECTION AGENCY

Final rule.

This final rule is effective October 29, 2012.

40 CFR Part 158

Summary

This final rule clarifies the distinction between “isolates” and “strains,” and clarifies the requirements applicable to new isolates, which are considered to be new active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additional revisions to regulatory text include several minor corrections to words and references. Finally, EPA is announcing the availability of a final microbial pesticide test guideline that further explains the existing data requirement to deposit a sample in a nationally recognized culture collection. Collectively, the final rule clarifications and revisions, as well as the final microbial pesticide test guideline, are expected to enhance the ability of industry to efficiently manage its microbial pesticide registration submissions.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

USC : Title 7 - AGRICULTURE

§ 136 - Definitions

§ 136a - Registration of pesticides

7 USC § 136a–1 - Reregistration of registered pesticides

§ 136b - Transferred

§ 136c - Experimental use permits

§ 136d - Administrative review; suspension

§ 136e - Registration of establishments

§ 136f - Books and records

§ 136g - Inspection of establishments, etc.

§ 136h - Protection of trade secrets and other information

§ 136i - Use of restricted use pesticides; applicators

7 USC § 136i–1 - Pesticide recordkeeping

7 USC § 136i–2 - Collection of pesticide use information

§ 136j - Unlawful acts

§ 136k - Stop sale, use, removal, and seizure

7 USC § -

§ 136m - Indemnities

§ 136n - Administrative procedure; judicial review

7 USC § -

§ 136p - Exemption of Federal and State agencies

§ 136q - Storage, disposal, transportation, and recall

§ 136r - Research and monitoring

7 USC § 136r–1 - Integrated Pest Management

§ 136s - Solicitation of comments; notice of public hearings

§ 136t - Delegation and cooperation

§ 136u - State cooperation, aid, and training

§ 136v - Authority of States

§ 136w - Authority of Administrator

7 USC § 136w–1 - State primary enforcement responsibility

7 USC § 136w–2 - Failure by the State to assure enforcement of State pesticide use regulations

7 USC § 136w–3 - Identification of pests; cooperation with Department of Agriculture’s program

7 USC § 136w–4 - Omitted

7 USC § 136w–5 - Minimum requirements for training of maintenance applicators and service technicians

7 USC § 136w–6 - Environmental Protection Agency minor use program

7 USC § 136w–7 - Department of Agriculture minor use program

7 USC § 136w–8 - Pesticide registration service fees

§ 136x - Severability

§ 136y - Authorization of appropriations

USC : Title 21 - FOOD AND DRUGS

§ 346a - Tolerances and exemptions for pesticide chemical residues

Title 40 published on 2012-07-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 40 CFR 158 after this date.

2013-05-08; vol. 78 # 89 - Wednesday, May 8, 2013

78 FR 26936 - Data Requirements for Antimicrobial Pesticides

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-10162
RIN	2070-AD30
	EPA-HQ-OPP-2008-0110
	FRL-8886-5

ENVIRONMENTAL PROTECTION AGENCY

Final rule.

This final rule is effective July 8, 2013.

40 CFR Parts 158 and 161

Summary

EPA is revising the data requirements for antimicrobial pesticide products to reflect current scientific and regulatory practice, and to provide the regulated community with clearer and transparent information about the data needed to support pesticide registration decisions for antimicrobial products. The updated data requirements also serve to further enhance EPA's ability to make regulatory decisions about the human health, and environmental fate and effects of antimicrobial pesticide products. These revisions are also expected to help protect human health and the environment by providing an up-to-date scientific framework for identifying and assessing the risks of antimicrobial pesticides sold or distributed in the United States.

2013-02-28; vol. 78 # 40 - Thursday, February 28, 2013

78 FR 13501 - Declaration of Prion as a Pest Under FIFRA; Related Amendments; and Availability of Final Test Guidelines

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-04613
RIN	2070-AJ26
	EPA-HQ-OPP-2010-0427
	FRL-9372-7

ENVIRONMENTAL PROTECTION AGENCY

Final rule.

This final rule is effective April 29, 2013.

40 CFR Parts 152, 158 and 161

Summary

With this final rule EPA declares a prion ( i.e., proteinaceous infectious particle) to be a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and amends the regulations to expressly include prion within the regulatory definition of pest. This final rule also amends existing pesticide product performance data requirements to clarify that efficacy data are required for pesticide products with prion-related claims. In addition, EPA is announcing the availability of final test guidelines on generating the product performance data for prion-related pesticide products.

2012-08-30; vol. 77 # 169 - Thursday, August 30, 2012

77 FR 52610 - Pesticides; Microbial Pesticide Definitions and Applicability; Clarification and Availability of Test Guideline

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-21430
RIN	2070-AJ80
	EPA-HQ-OPP-2010-0670
	FRL-9338-9

ENVIRONMENTAL PROTECTION AGENCY

Final rule.

This final rule is effective October 29, 2012.

40 CFR Part 158

Summary

This final rule clarifies the distinction between “isolates” and “strains,” and clarifies the requirements applicable to new isolates, which are considered to be new active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additional revisions to regulatory text include several minor corrections to words and references. Finally, EPA is announcing the availability of a final microbial pesticide test guideline that further explains the existing data requirement to deposit a sample in a nationally recognized culture collection. Collectively, the final rule clarifications and revisions, as well as the final microbial pesticide test guideline, are expected to enhance the ability of industry to efficiently manage its microbial pesticide registration submissions.

2012-08-08; vol. 77 # 153 - Wednesday, August 8, 2012

77 FR 47351 - Notification of Submission to the Secretaries of Agriculture and Health and Human Services; Declaration of Prion as a Pest Under FIFRA; Related Amendments; and Availability of Final Test Guidelines

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-19406
RIN	2070-AJ26
	EPA-HQ-OPP-2010-0427
	FRL-9357-9

ENVIRONMENTAL PROTECTION AGENCY

Notification of submission to the Secretaries of Agriculture and Health and Human Services.

40 CFR Parts 152, 158 and 161

Summary

This document notifies the public as required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the United States Department of Health and Human Services (HHS) a draft regulatory document concerning Declaration of Prion as a Pest Under FIFRA; Related Amendments; and Availability of Final Test Guidelines. The draft regulatory document is not available to the public until after it has been signed and made available by EPA.

40 CFR 158.34 - Flagging of studies for potential adverse effects.

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