美國豁免木霉菌株殘留限量要求（Trichoderma asperelloides）

ACTION

Final Rule.

UMMARY

This regulation establishes an exemption from the requirement of a

tolerance for residues of Trichoderma asperelloides strain JM41R in or on all

food commodities when used in accordance with label directions and good

agricultural practices. BASF Corporation submitted a petition to EPA under the

Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the

requirement of a tolerance. This regulation eliminates the need to establish a

maximum permissible level for residues of Trichoderma asperelloides strain JM41R

under FFDCA.

TABLE OF ConTENTS

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DATES:

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

UPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

. How can I get electronic access to other related information?

C. How can I file an objection or hearing request?

II. Background

III. Final Rule

A. EPA‘s Safety Determination

. Analytical Enforcement Methodology

IV. Statutory and Executive Order Reviews

V. Congressional Review Act

List of Subjects in 40 CFR Part 180

ART 180—[AMENDED]

DATES:

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This regulation is effective May 18, 2015. Objections and requests for

hearings must be received on or before July 17, 2015, and must be filed in

accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C.

of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

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The docket for this action, identified by docket identification (ID)

umber EPA-HQ-OPP-2012-0963, is available at http://www.regulations.gov or at

the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the

Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson

Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001.

The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through

Friday, excluding legal holidays. The telephone number for the Public Reading

Room is (202) 566-1744, and the telephone number for the OPP Docket is (703)

305-5805. Please review the visitor instructions and additional information

about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

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Robert McNally, Biopesticides and Pollution Prevention Division (7511P),

Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania

Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090;

email address: BPPDFRNotices@epa.gov.

UPPLEMENTARY INFORMATION:

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I. General Information

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A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural

roducer, food manufacturer, or pesticide manufacturer. The following list of

orth American Industrial Classification System (NAICS) codes is not intended to

e exhaustive, but rather provides a guide to help readers determine whether

this document applies to them. Potentially affected entities may include:

Crop production (NAICS code 111).

Animal production (NAICS code 112).

Food manufacturing (NAICS code 311).

esticide manufacturing (NAICS code 32532).

. How can I get electronic access to other related information?

You may access a frequently updated electronic version of 40 CFR part 180

through the Government Printing Office‘s e-CFR site at

http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an

objection to any aspect of this regulation and may also request a hearing on

those objections. You must file your objection or request a hearing on this

regulation in accordance with the instructions provided in 40 CFR part 178. To

ensure proper receipt by EPA, you must identify docket ID number

EPA-HQ-OPP-2012-0963 in the subject line on the first page of your submission.

All objections and requests for a hearing must be in writing, and must be

received by the Hearing Clerk on or before July 17, 2015. Addresses for mail and

hand delivery of objections and hearing requests are provided in 40 CFR

178.25(b).

In addition to filing an objection or hearing request with the Hearing

Clerk as described in 40 CFR part 178, please submit a copy of the filing

(excluding any Confidential Business Information (CBI)) for inclusion in the

ublic docket. Information not marked confidential pursuant to 40 CFR part 2 may

e disclosed publicly by EPA without prior notice. Submit the non-CBI copy of

your objection or hearing request, identified by docket ID number

EPA-HQ-OPP-2012-0963, by one of the following methods:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the online

instructions for submitting comments. Do not submit electronically any

information you consider to be CBI or other information whose disclosure is

restricted by statute.

Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC),

(28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

Hand Delivery: To make special arrangements for hand delivery or delivery

of boxed information, please follow the instructions at

http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting

or visiting the docket, along with more information about dockets generally, is

available at http://www.epa.gov/dockets.

II. Background

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In the Federal Register of February 21, 2014 (79 FR 9870) (FRL-9904-98),

EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3),

announcing the filing of a pesticide tolerance petition (PP 2F8102) by BASF

Corporation, 26 Davis Dr., Research Triangle Park, NC 27709. The petition

requested that 40 CFR part 180 be amended by establishing an exemption from the

requirement of a tolerance for residues of Trichoderma fertile strain JM41R in

or on all food commodities. That document referenced a summary of the petition

repared by the petitioner BASF Corporation, which is available in the docket

via http://www.regulations.gov. There were no comments received in response to

the notice of filing.

ubsequently, the petitioner provided additional data (i.e., DNA

equencework based on newly published taxonomies) on the identity of the

esticide to EPA. After reviewing these data, EPA concluded that the correct

identity of the pesticide was Trichoderma asperelloides strain JM41R and not

Trichoderma fertile strain JM41R. In order to give the public an opportunity to

comment on this new information, EPA republished its receipt of this tolerance

exemption petition filing with an updated and accurate description in the

Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-55) and placed a

revised petition from BASF Corporation into the docket. There were no comments

received in response to the republished notice of filing.

III. Final Rule

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A. EPA‘s Safety Determination

ection 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption

from the requirement for a tolerance (the legal limit for a pesticide chemical

residue in or on a food) only if EPA determines that the exemption is “safe.”

ection 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a

reasonable certainty that no harm will result from aggregate exposure to the

esticide chemical residue, including all anticipated dietary exposures and all

other exposures for which there is reliable information.” This includes exposure

through drinking water and in residential settings but does not include

occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing

or maintaining in effect an exemption from the requirement of a tolerance, EPA

must take into account the factors set forth in FFDCA section 408(b)(2)(C),

which require EPA to give special consideration to exposure of infants and

children to the pesticide chemical residue in establishing a tolerance or

tolerance exemption, and to “ensure that there is a reasonable certainty that no

harm will result to infants and children from aggregate exposure to the

esticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D)

requires that EPA consider “available information concerning the cumulative

effects of [a particular pesticide‘s] . . . residues and other substances that

have a common mechanism of toxicity.”

EPA evaluated the available toxicity and exposure data on Trichoderma

asperelloides strain JM41R and considered its validity, completeness, and

reliability, as well as the relationship of this information to human risk. A

full explanation of the data upon which EPA relied and its risk assessment based

on that data can be found within the April 20, 2015, document entitled “Federal

Food, Drug, and Cosmetic Act (FFDCA) Considerations for Trichoderma

asperelloides strain JM41R.” This document, as well as other relevant

information, is available in the docket for this action as described under

ADDRESSES. based upon its evaluation, EPA concludes that there is a reasonable

certainty that no harm will result to the U.S. population, including infants and

children, from aggregate exposure to residues of Trichoderma asperelloides

train JM41R. Therefore, an exemption from the requirement of a tolerance is

established for residues of Trichoderma asperelloides strain JM41R in or on all

food commodities when used in accordance with label directions and good

agricultural practices.

. Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes for the

reasons contained in the April 20, 2015, document entitled “Federal Food, Drug,

and Cosmetic Act (FFDCA) Considerations for Trichoderma asperelloides strain

JM41R” and because EPA is establishing an exemption from the requirement of a

tolerance without any numerical limitation.

IV. Statutory and Executive Order Reviews

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This action establishes a tolerance exemption under FFDCA section 408(d)

in response to a petition submitted to EPA. The Office of Management and Budget

(OMB) has exempted these types of actions from review under Executive Order

12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

ecause this action has been exempted from review under Executive Order 12866,

this action is not subject to Executive Order 13211, entitled “Actions

Concerning Regulations That Significantly Affect Energy Supply, Distribution, or

Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection

of Children from Environmental Health Risks and Safety Risks” (62 FR 19885,

April 23, 1997). This action does not contain any information collections

ubject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501

et seq., nor does it require any special considerations under Executive Order

12898, entitled “Federal Actions to Address Environmental Justice in Minority

opulations and Low-Income Populations” (59 FR 7629, February 16, 1994).

ince tolerances and exemptions that are established on the basis of a

etition under FFDCA section 408(d), such as the tolerance exemption in this

action, do not require the issuance of a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

This action directly regulates growers, food processors, food handlers,

and food retailers, not States or tribes. As a result, this action does not

alter the relationships or distribution of power and responsibilities

established by Congress in the preemption provisions of FFDCA section 408(n)(4).

As such, EPA has determined that this action will not have a substantial direct

effect on States or tribal governments, on the relationship between the national

government and the States or tribal governments, or on the distribution of power

and responsibilities among the various levels of government or between the

Federal Government and Indian tribes. Thus, EPA has determined that Executive

Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive

Order 13175, entitled “Consultation and Coordination with Indian Tribal

Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In

addition, this action does not impose any enforceable duty or contain any

unfunded mandate as described under Title II of the Unfunded Mandates Reform Act

(UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require

EPA‘s consideration of voluntary consensus standards pursuant to section 12(d)

of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272

ote).

V. Congressional Review Act

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ursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will

ubmit a report containing this rule and other required information to the U.S.

enate, the U.S. House of Representatives, and the Comptroller General of the

United States prior to publication of the rule in the Federal Register. This

action is not a “major rule” as defined by 5 U.S.C. 804(2).