Trichoderma asperelloides, 28201-28203 [2015-11960]
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Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Rules and Regulations
§ 52.2320
Identification of plan.
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*
*
*
*
(c) * * *
(79) Revisions to the Utah State
Implementation Plan involving Utah
Rule R307–311; Utah County: Trading
of Emission Budgets for Transportation
Conformity. The Utah Air Quality Board
adopted this SIP revision on March 4,
2015, it became state effective on March
5, 2015, and was submitted by the
Governor to EPA by a letter dated March
9, 2015.
(i) Incorporation by reference.
(A) Utah Rules R307, Environmental
Quality, Air Quality, R307–311, Utah
County: Trading of Emission Budgets for
Transportation Conformity. Effective
March 5, 2015, as proposed in the Utah
State Bulletin on January 1, 2015 and
published on April 1, 2015 as effective.
[FR Doc. 2015–11784 Filed 5–15–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
[EPA–HQ–OPP–2012–0963; FRL–9926–87]
Trichoderma asperelloides strain JM41R;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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.
DATES: 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).
asabaliauskas on DSK5VPTVN1PROD with RULES
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0963, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
ADDRESSES:
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17:45 May 15, 2015
Jkt 235001
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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be 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).
• Pesticide manufacturing (NAICS
code 32532).
B. 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 https://
www.ecfr.gov/cgi-bin/textidx?&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
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28201
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 public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background
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 prepared by
the petitioner BASF Corporation, which
is available in the docket via https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Subsequently, the petitioner provided
additional data (i.e., DNA sequence
E:\FR\FM\18MYR1.SGM
18MYR1
28202
Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Rules and Regulations
work based on newly published
taxonomies) on the identity of the
pesticide 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.
asabaliauskas on DSK5VPTVN1PROD with RULES
III. Final Rule
A. EPA’s Safety Determination
Section 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.’’
Section 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
pesticide 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 pesticide 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
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17:45 May 15, 2015
Jkt 235001
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
strain 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.
B. 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
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). Because 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
subject 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
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
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Since tolerances and exemptions that
are established on the basis of a petition
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 note).
V. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, 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).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
E:\FR\FM\18MYR1.SGM
18MYR1
Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Rules and Regulations
Dated: May 2, 2015.
Jack E. Housenger,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1331 to subpart D to read
as follows:
■
§ 180.1331 Trichoderma asperelloides
strain JM41R; exemption from the
requirement of a tolerance.
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.
[FR Doc. 2015–11960 Filed 5–15–15; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 1
[WT Docket Nos. 13–238 and 13–32, WC
Docket No. 11–59; FCC 14–153]
Acceleration of Broadband
Deployment by Improving Wireless
Facilities Siting Policies
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the Federal
Communications Commission
(Commission) announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years,
certain information collection
requirements associated with the
Commission’s Report and Order
regarding the Acceleration of Broadband
Deployment by Improving Wireless
Facilities Siting Policies, FCC 14–153.
This document is consistent with the
Report and Order, which stated that the
Commission would publish a document
in the Federal Register announcing
OMB approval and the effective date of
the new information collection
requirements.
DATES: 47 CFR 1.40001(c)(3)(i),
1.140001(c)(3)(iii), and 1.140001(c)(4),
published at 80 FR 1238, January 8,
2015, are effective on May 18, 2015.
FOR FURTHER INFORMATION CONTACT:
Cathy Williams by email at
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SUMMARY:
VerDate Sep<11>2014
17:45 May 15, 2015
Jkt 235001
Cathy.Williams@fcc.gov and telephone
at (202) 418–2918.
SUPPLEMENTARY INFORMATION: This
document announces that, on May 5,
2015, OMB approved certain
information collection requirements
contained in the Commission’s Report
and Order, FCC 14–153, published at 80
FR 1238, January 8, 2015. The OMB
Control Number is 3060–1208. The
Commission publishes this document as
an announcement of the effective date of
these information collection
requirements.
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the FCC is notifying the public that it
received OMB approval on May 5, 2015,
for the new information collection
requirements contained in the
Commission’s rules at 47 CFR
1.40001(c)(3)(i), 1.140001(c)(3)(iii), and
1.140001(c)(4). Under 5 CFR part 1320,
an agency may not conduct or sponsor
a collection of information unless it
displays a current, valid OMB Control
Number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
Paperwork Reduction Act that does not
display a current, valid OMB Control
Number. The OMB Control Number is
3060–1208.
The foregoing notice is required by
the Paperwork Reduction Act of 1995,
Public Law 104–13, October 1, 1995,
and 44 U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–1208.
OMB Approval Date: May 5, 2015.
OMB Expiration Date: May 31, 2018.
Title: Acceleration of Broadband
Deployment by Improving Wireless
Facilities Siting Policies.
Form Number: N/A.
Respondents: Individuals or
households, business or other for-profit
entities, not-for-profit institutions and
State, local or Tribal governments.
Number of Respondents and
Responses: 1,350 respondents; 3,597
responses.
Estimated Time per Response: .5
hours to 1 hour.
Frequency of Response: Third-party
disclosure reporting requirement.
Obligation to Respond: Required to
obtain or retain benefits. Statutory
authority for this information collection
is contained in Sections 1, 2, 4(i), 7, 201,
301, 303, and 309 of the
Communications Act of 1934, as
amended, and Sections 6003, 6213, and
6409(a) of the Middle Class Tax Relief
and Job Creation Act of 2012, Pub. L.
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28203
112–96, 126 Stat. 156, 47 U.S.C. 151,
152, 154(i), 157, 201, 301, 303, 309,
1403, 1433, and 1455(a).
Total Annual Burden: 3,535 hours.
Total Annual Cost: None.
Nature and Extent of Confidentiality:
There is no need for confidentiality with
this collection of information.
Privacy Act Impact Assessment: This
information collection may affect
individuals or households. However,
the information collection consists of
third-party disclosures in which the
Commission has no direct involvement.
Personally identifiable information (PII)
is not being collected by, made available
to, or made accessible by the
Commission. There are no additional
impacts under the Privacy Act.
Needs and Uses: The Commission
requested OMB approval for new
disclosure requirements pertaining to
subpart CC of part 1 of the
Commission’s rules. This subpart was
adopted to implement and enforce
Section 6409(a) of the Middle Class Tax
Relief and Job Creation Act of 2012.
Section 6409(a) provides, in part, that ‘‘a
State or local government may not deny,
and shall approve, any eligible facilities
request for a modification of an existing
wireless tower or base station that does
not substantially change the physical
dimensions of such tower or base
station.’’ 47 U.S.C. 1455(a)(1). In subpart
CC, the Commission adopted definitions
of ambiguous terms, procedural
requirements, and remedies to provide
guidance to all stakeholders on the
proper interpretation of the provision
and to enforce its requirements,
reducing delays in the review process
for wireless infrastructure modifications
and facilitating the rapid deployment of
wireless infrastructure.
The following are the information
collection requirements in connection
with subpart CC of part 1 of the
Commission’s rules:
• 47 CFR 1.40001(c)(3)(i)—To toll the
60-day review timeframe on grounds
that an application is incomplete, the
reviewing State or local government
must provide written notice to the
applicant within 30 days of receipt of
the application, clearly and specifically
delineating all missing documents or
information. Such delineated
information is limited to documents or
information meeting the standard under
paragraph (c)(1) of Section 1.40001.
• 47 CFR 1.40001(c)(3)(iii)—
Following a supplemental submission
from the applicant, the State or local
government will have 10 days to notify
the applicant in writing if the
supplemental submission did not
provide the information identified in
the State or local government’s original
E:\FR\FM\18MYR1.SGM
18MYR1
Agencies
[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Rules and Regulations]
[Pages 28201-28203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11960]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0963; FRL-9926-87]
Trichoderma asperelloides strain JM41R; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0963, is available at https://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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be 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).
Pesticide manufacturing (NAICS code 32532).
B. 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 https://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 public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be 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: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background
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
prepared by the petitioner BASF Corporation, which is available in the
docket via https://www.regulations.gov. There were no comments received
in response to the notice of filing.
Subsequently, the petitioner provided additional data (i.e., DNA
sequence
[[Page 28202]]
work based on newly published taxonomies) on the identity of the
pesticide 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
A. EPA's Safety Determination
Section 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.'' Section 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 pesticide 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 pesticide
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 strain 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.
B. 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
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). Because 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 subject 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 Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition 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 note).
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, 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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 28203]]
Dated: May 2, 2015.
Jack E. Housenger,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Add Sec. 180.1331 to subpart D to read as follows:
Sec. 180.1331 Trichoderma asperelloides strain JM41R; exemption from
the requirement of a tolerance.
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.
[FR Doc. 2015-11960 Filed 5-15-15; 8:45 am]
BILLING CODE 6560-50-P