40 CFR 158.2130 - Microbial pesticides residue data requirements table. | Title 40 - Protection of Environment | Code of Federal Regulations

§ 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.

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.

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.

2013-02-28; 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.

2013-02-28; 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 158.2130 - Microbial pesticides residue data requirements table.

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