81 FR 86579 - Muscodor albus Strain SA-13 and the Volatiles Produced on Rehydration; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 231 (December 1, 2016)
Federal Register Volume 81, Issue 231 (December 1, 2016)
| Page Range | 86579-86581 | |
| FR Document | 2016-28884 |
[Federal Register Volume 81, Number 231 (Thursday, December 1, 2016)] [Rules and Regulations] [Pages 86579-86581] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28884] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0919; FRL-9952-88] Muscodor albus Strain SA-13 and the Volatiles Produced on Rehydration; 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 Muscodor albus strain SA-13 and the volatiles produced on rehydration in and on all food commodities when used in accordance with label directions and good agricultural practices. Marrone Bio Innovations, Inc. 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 Muscodor albus strain SA-13 and the volatiles produced on rehydration under FFDCA. DATES: This regulation is effective December 1, 2016. Objections and requests for hearings must be received on or before January 30, 2017, 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-2014-0919, 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: 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 [[Page 86580]] number: (703) 305-7090; email address: [email protected]. 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 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-2014-0919 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 January 30, 2017. 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-2014-0919, 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 In the Federal Register of January 28, 2015 (80 FR 4527) (FRL-9921- 55), 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 4F8271) by Marrone Bio Innovations, Inc. (MBI), 2121 Second Street, Suite B-107, Davis, CA 95618. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of sterile grain inoculated with Muscodor albus strain SA-13 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner MBI, which is available in the docket via http://www.regulations.gov. There were no comments received in response to this notice of filing. EPA revised the active ingredient name from ``sterile grain inoculated with Muscodor albus strain SA-13'' to ``Muscodor albus strain SA-13 and the volatiles produced on rehydration.'' The reason for this change is explained in Unit III.C. 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 Muscodor albus strain SA-13 and the volatiles produced on rehydration 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 November 8, 2016, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Muscodor albus Strain SA-13 and the Volatiles Produced on Rehydration.'' 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 Muscodor albus strain SA-13 is not toxic, is not pathogenic, and is not infective. Further, the volatiles produced by Muscodor albus strain SA-13 are not toxic. Although there may be some exposure to residues of Muscodor albus strain SA-13 when used as a fungicide, nematocide, insecticide or bactericide on food, there is no potential for adverse effects due to the lack of toxicity, pathogenicity, or infectivity. EPA also determined that retention of the Food Quality Protection Act Safety Factor (FQPA SF) was not necessary as part of the qualitative assessment conducted for Muscodor albus strain SA-13 and the volatiles produced on rehydration. 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 [[Page 86581]] residues of Muscodor albus strain SA-13 and the volatiles produced on rehydration. Therefore, an exemption from the requirement of a tolerance is established for residues of Muscodor albus strain SA-13 and the volatiles produced on rehydration 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 because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. Revision to the Requested Tolerance Exemption One modification has been made to the requested tolerance exemption. When MBI first submitted this petition in 2014, it described the pesticide chemical as ``sterile grain inoculated with Muscodor albus strain SA-13.'' After conducting a review of this petition and evaluating a tolerance exemption established in 2005 for another strain of Muscodor albus (QST 20799) (70 FR 56569), which has the same mode of action as Muscodor albus strain SA-13, EPA is changing the pesticide chemical name to ``Muscodor albus strain SA-13 and the volatiles produced on rehydration.'' This revision better reflects the possible residues that may occur on food commodities and the data/information submitted to support the petition. 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. Dated: November 15, 2016. Jack 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. 180.1340 to subpart D to read as follows: Sec. 180.1340 Muscodor albus strain SA-13 and the volatiles produced on rehydration; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Muscodor albus strain SA-13 and the volatiles produced on rehydration in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2016-28884 Filed 11-30-16; 8:45 am] BILLING CODE 6560-50-P
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underscoring the high likelihood that ADDRESSES: The docket for this ENVIRONMENTAL PROTECTION
SARs involving FBME are actually deviation, [USCG–2016–1015] is AGENCY
under-inclusive. Given FinCEN’s available at http://www.regulations.gov.
concern regarding FBME’s willingness Type the docket number in the 40 CFR Part 180
to evade AML regulations that may have ‘‘SEARCH’’ box and click ‘‘SEARCH’’. [EPA–HQ–OPP–2014–0919; FRL–9952–88]
inhibited the identification of Click on Open Docket Folder on the line
suspicious activity by U.S. financial associated with this deviation. Muscodor albus Strain SA–13 and the
institutions, a comparison of SARs filed FOR FURTHER INFORMATION CONTACT: If Volatiles Produced on Rehydration;
on FBME compared to other Cypriot you have questions on this temporary Exemption From the Requirement of a
financial institutions would not deviation, call or email Mr. Michael Tolerance
necessarily portray the relevant risk Thorogood, Bridge Administration
posed by FBME. AGENCY: Environmental Protection
Branch Fifth District, Coast Guard, Agency (EPA).
More broadly, FinCEN notes that
telephone 757–398–6557, email
setting a benchmark as FBME suggests ACTION: Final rule.
Michael.R.Thorogood@uscg.mil.
could simply set a target for banks or
customers wishing to evade money SUPPLMENTARY INFORMATION: The New SUMMARY: This regulation establishes an
laundering controls. Instead, the agency Jersey Department of Transportation, exemption from the requirement of a
reviews relevant information and who owns the S.R. 88/Veterans tolerance for residues of Muscodor albus
determines whether all of that Memorial Bridge, has requested a strain SA–13 and the volatiles produced
information, taken together, justifies temporary deviation from the current on rehydration in and on all food
action under Section 311. FinCEN is operating schedule is set out in 33 CFR commodities when used in accordance
daily immersed in the global flow of 117.5, to facilitate replacement of a with label directions and good
financial intelligence, including SARs, defective coupling and floating shaft of agricultural practices. Marrone Bio
and is tasked as a policy matter with the bridge. Innovations, Inc. submitted a petition to
identifying concerns within that Under this temporary deviation, the EPA under the Federal Food, Drug, and
intelligence stream. As discussed above, bridge will be in the closed-to- Cosmetic Act (FFDCA), requesting an
FinCEN assesses that the volume of navigation position at 9 p.m. December exemption from the requirement of a
shell company activity reflected in the 7, 2016 to 6 a.m. December 8, 2016. The tolerance. This regulation eliminates the
Administrative Record, including SARs bridge is a vertical lift bridge and has a need to establish a maximum
filed on FBME, is substantial. vertical clearance in the closed-to- permissible level for residues of
navigation position of 31 feet above Muscodor albus strain SA–13 and the
Dated: November 23, 2016. volatiles produced on rehydration under
Jamal El-Hindi, mean high water.
FFDCA.
Deputy Director, Financial Crimes The Point Pleasant Canal is used by
DATES: This regulation is effective
Enforcement Network. a variety of vessels including,
recreational vessels and tug and barge December 1, 2016. Objections and
[FR Doc. 2016–28752 Filed 11–30–16; 8:45 am]
traffic. The Coast Guard has carefully requests for hearings must be received
BILLING CODE 4810–02–P on or before January 30, 2017, and must
considered the nature and volume of
vessel traffic on the waterway in be filed in accordance with the
publishing this temporary deviation. instructions provided in 40 CFR part
DEPARTMENT OF HOMELAND 178 (see also Unit I.C. of the
SECURITY Vessels able to pass through the SUPPLEMENTARY INFORMATION).
bridge in the closed-to-navigation
ADDRESSES: The docket for this action,
Coast Guard position may do so at any time. The
bridge will not be able to open for identified by docket identification (ID)
33 CFR Part 117 emergencies and there is no immediate number EPA–HQ–OPP–2014–0919, is
alternative route for vessels to pass in available at http://www.regulations.gov
[Docket No. USCG–2016–1015] or at the Office of Pesticide Programs
the closed position. The Coast Guard
will also inform the users of the Regulatory Public Docket (OPP Docket)
Drawbridge Operation Regulation; New in the Environmental Protection Agency
Jersey Intracoastal Waterway (NJICW), waterway through our Local and
Broadcast Notices to Mariners of the Docket Center (EPA/DC), West William
Point Pleasant Canal, Point Pleasant, Jefferson Clinton Bldg., Rm. 3334, 1301
NJ change in operating schedule for the
bridge so that vessel operators can Constitution Ave. NW., Washington, DC
AGENCY: Coast Guard, DHS. arrange their transits to minimize any 20460–0001. The Public Reading Room
ACTION:Notice of deviation from impact caused by the temporary is open from 8:30 a.m. to 4:30 p.m.,
drawbridge regulation. deviation. Monday through Friday, excluding legal
holidays. The telephone number for the
In accordance with 33 CFR 117.35(e), Public Reading Room is (202) 566–1744,
SUMMARY: The Coast Guard has issued a
the drawbridge must return to its regular and the telephone number for the OPP
temporary deviation from the operating
operating schedule immediately at the Docket is (703) 305–5805. Please review
schedule that governs the S.R. 88/
end of the effective period of this the visitor instructions and additional
Veterans Memorial Bridge across the
temporary deviation. This deviation information about the docket available
NJICW (Point Pleasant Canal), mile 3.0,
from the operating regulations is at http://www.epa.gov/dockets.
at Point Pleasant, NJ. The deviation is
authorized under 33 CFR 117.35.
jstallworth on DSK7TPTVN1PROD with RULES
necessary to facilitate and complete FOR FURTHER INFORMATION CONTACT:
urgent bridge maintenance. This Dated: November 28, 2016. Robert McNally, Biopesticides and
deviation allows the bridge to remain in Hal R. Pitts, Pollution Prevention Division (7511P),
the closed-to-navigation position. Bridge Program Manager, Fifth Coast Guard Office of Pesticide Programs,
DATES: The deviation is effective 9 p.m. District. Environmental Protection Agency, 1200
on Wednesday, December 7, 2016 to 6 [FR Doc. 2016–28852 Filed 11–30–16; 8:45 am] Pennsylvania Ave. NW., Washington,
a.m. on Thursday, December 8, 2016. BILLING CODE 9110–04–P DC 20460–0001; main telephone
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number: (703) 305–7090; email address: 2014–0919, by one of the following other exposures for which there is
BPPDFRNotices@epa.gov. methods: reliable information.’’ This includes
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// exposure through drinking water and in
www.regulations.gov. Follow the online residential settings but does not include
I. General Information instructions for submitting comments. occupational exposure. Pursuant to
A. Does this action apply to me? Do not submit electronically any FFDCA section 408(c)(2)(B), in
information you consider to be CBI or establishing or maintaining in effect an
You may be potentially affected by other information whose disclosure is exemption from the requirement of a
this action if you are an agricultural restricted by statute. tolerance, EPA must take into account
producer, food manufacturer, or • Mail: OPP Docket, Environmental the factors set forth in FFDCA section
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ 408(b)(2)(C), which require EPA to give
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. special consideration to exposure of
Classification System (NAICS) codes is NW., Washington, DC 20460–0001. infants and children to the pesticide
not intended to be exhaustive, but rather • Hand Delivery: To make special chemical residue in establishing a
provides a guide to help readers arrangements for hand delivery or tolerance or tolerance exemption and to
determine whether this document delivery of boxed information, please ‘‘ensure that there is a reasonable
applies to them. Potentially affected follow the instructions at http:// certainty that no harm will result to
entities may include: www.epa.gov/dockets/contacts.html. infants and children from aggregate
• Crop production (NAICS code 111). Additional instructions on commenting exposure to the pesticide chemical
• Animal production (NAICS code or visiting the docket, along with more residue . . . .’’ Additionally, FFDCA
112). information about dockets generally, is section 408(b)(2)(D) requires that EPA
• Food manufacturing (NAICS code consider ‘‘available information
available at http://www.epa.gov/
311). concerning the cumulative effects of ‘‘[a
dockets.
• Pesticide manufacturing (NAICS particular pesticide’s]’’ . . . residues
code 32532). II. Background and other substances that have a
B. How can I get electronic access to In the Federal Register of January 28, common mechanism of toxicity.’’
other related information? 2015 (80 FR 4527) (FRL–9921–55), EPA EPA evaluated the available toxicity
issued a document pursuant to FFDCA and exposure data on Muscodor albus
You may access a frequently updated strain SA–13 and the volatiles produced
section 408(d)(3), 21 U.S.C. 346a(d)(3),
electronic version of 40 CFR part 180 on rehydration and considered its
announcing the filing of a pesticide
through the Government Printing validity, completeness, and reliability,
tolerance petition (PP 4F8271) by
Office’s e-CFR site at http:// as well as the relationship of this
Marrone Bio Innovations, Inc. (MBI),
www.ecfr.gov/cgi-bin/text- information to human risk. A full
2121 Second Street, Suite B–107, Davis,
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ explanation of the data upon which EPA
CA 95618. The petition requested that
40tab_02.tpl. relied and its risk assessment based on
40 CFR part 180 be amended by
C. How can I file an objection or hearing establishing an exemption from the that data can be found within the
request? requirement of a tolerance for residues November 8, 2016, document entitled
of sterile grain inoculated with ‘‘Federal Food, Drug, and Cosmetic Act
Under FFDCA section 408(g), 21 (FFDCA) Considerations for Muscodor
U.S.C. 346a(g), any person may file an Muscodor albus strain SA–13 in or on
all food commodities. That document albus Strain SA–13 and the Volatiles
objection to any aspect of this regulation Produced on Rehydration.’’ This
and may also request a hearing on those referenced a summary of the petition
prepared by the petitioner MBI, which document, as well as other relevant
objections. You must file your objection information, is available in the docket
or request a hearing on this regulation is available in the docket via http://
www.regulations.gov. There were no for this action as described under
in accordance with the instructions ADDRESSES.
provided in 40 CFR part 178. To ensure comments received in response to this
notice of filing. Based upon its evaluation, EPA
proper receipt by EPA, you must concludes that Muscodor albus strain
identify docket ID number EPA–HQ– EPA revised the active ingredient
name from ‘‘sterile grain inoculated SA–13 is not toxic, is not pathogenic,
OPP–2014–0919 in the subject line on and is not infective. Further, the
the first page of your submission. All with Muscodor albus strain SA–13’’ to
‘‘Muscodor albus strain SA–13 and the volatiles produced by Muscodor albus
objections and requests for a hearing strain SA–13 are not toxic. Although
must be in writing, and must be volatiles produced on rehydration.’’ The
there may be some exposure to residues
received by the Hearing Clerk on or reason for this change is explained in
of Muscodor albus strain SA–13 when
before January 30, 2017. Addresses for Unit III.C.
used as a fungicide, nematocide,
mail and hand delivery of objections III. Final Rule insecticide or bactericide on food, there
and hearing requests are provided in 40 is no potential for adverse effects due to
CFR 178.25(b). A. EPA’s Safety Determination
the lack of toxicity, pathogenicity, or
In addition to filing an objection or Section 408(c)(2)(A)(i) of FFDCA infectivity. EPA also determined that
hearing request with the Hearing Clerk allows EPA to establish an exemption retention of the Food Quality Protection
as described in 40 CFR part 178, please from the requirement for a tolerance (the Act Safety Factor (FQPA SF) was not
submit a copy of the filing (excluding legal limit for a pesticide chemical necessary as part of the qualitative
any Confidential Business Information residue in or on a food) only if EPA assessment conducted for Muscodor
jstallworth on DSK7TPTVN1PROD with RULES
(CBI)) for inclusion in the public docket. determines that the exemption is ‘‘safe.’’ albus strain SA–13 and the volatiles
Information not marked confidential Section 408(c)(2)(A)(ii) of FFDCA produced on rehydration.
pursuant to 40 CFR part 2 may be defines ‘‘safe’’ to mean that ‘‘there is a Based upon its evaluation, EPA
disclosed publicly by EPA without prior reasonable certainty that no harm will concludes that there is a reasonable
notice. Submit the non-CBI copy of your result from aggregate exposure to the certainty that no harm will result to the
objection or hearing request, identified pesticide chemical residue, including U.S. population, including infants and
by docket ID number EPA–HQ–OPP– all anticipated dietary exposures and all children, from aggregate exposure to
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residues of Muscodor albus strain SA– ‘‘Federal Actions to Address Dated: November 15, 2016.
13 and the volatiles produced on Environmental Justice in Minority Jack Housenger,
rehydration. Therefore, an exemption Populations and Low-Income Director, Office of Pesticide Programs.
from the requirement of a tolerance is Populations’’ (59 FR 7629, February 16, Therefore, 40 CFR chapter I is
established for residues of Muscodor 1994). amended as follows:
albus strain SA–13 and the volatiles Since tolerances and exemptions that
produced on rehydration in or on all are established on the basis of a petition PART 180—[AMENDED]
food commodities when used in under FFDCA section 408(d), such as
accordance with label directions and the tolerance exemption in this action, ■ 1. The authority citation for part 180
good agricultural practices. do not require the issuance of a continues to read as follows:
proposed rule, the requirements of the Authority: 21 U.S.C. 321(q), 346a and 371.
B. Analytical Enforcement Methodology Regulatory Flexibility Act (RFA) (5
An analytical method is not required U.S.C. 601 et seq.) do not apply. ■ 2. Add § 180.1340 to subpart D to read
for enforcement purposes because EPA This action directly regulates growers, as follows:
is establishing an exemption from the food processors, food handlers, and food
§ 180.1340 Muscodor albus strain SA–13
requirement of a tolerance without any retailers, not States or tribes. As a result, and the volatiles produced on rehydration;
numerical limitation. this action does not alter the exemption from the requirement of a
relationships or distribution of power tolerance.
C. Revision to the Requested Tolerance
and responsibilities established by An exemption from the requirement
Exemption
Congress in the preemption provisions of a tolerance is established for residues
One modification has been made to of FFDCA section 408(n)(4). As such,
the requested tolerance exemption. of Muscodor albus strain SA–13 and the
EPA has determined that this action will volatiles produced on rehydration in or
When MBI first submitted this petition not have a substantial direct effect on
in 2014, it described the pesticide on all food commodities when used in
States or tribal governments, on the accordance with label directions and
chemical as ‘‘sterile grain inoculated relationship between the national
with Muscodor albus strain SA–13.’’ good agricultural practices.
government and the States or tribal
After conducting a review of this [FR Doc. 2016–28884 Filed 11–30–16; 8:45 am]
governments, or on the distribution of
petition and evaluating a tolerance power and responsibilities among the BILLING CODE 6560–50–P
exemption established in 2005 for various levels of government or between
another strain of Muscodor albus (QST the Federal Government and Indian
20799) (70 FR 56569), which has the ENVIRONMENTAL PROTECTION
tribes. Thus, EPA has determined that
same mode of action as Muscodor albus AGENCY
Executive Order 13132, entitled
strain SA–13, EPA is changing the ‘‘Federalism’’ (64 FR 43255, August 10,
pesticide chemical name to ‘‘Muscodor 40 CFR Part 180
1999), and Executive Order 13175,
albus strain SA–13 and the volatiles entitled ‘‘Consultation and Coordination [EPA–HQ–OPP–2015–0412; FRL–9950–89]
produced on rehydration.’’ This revision with Indian Tribal Governments’’ (65 FR
better reflects the possible residues that Quizalofop Ethyl; Pesticide Tolerances
67249, November 9, 2000), do not apply
may occur on food commodities and the to this action. In addition, this action AGENCY: Environmental Protection
data/information submitted to support does not impose any enforceable duty or Agency (EPA).
the petition. contain any unfunded mandate as ACTION: Final rule.
IV. Statutory and Executive Order described under Title II of the Unfunded
Reviews Mandates Reform Act (UMRA) (2 U.S.C. SUMMARY: This regulation establishes
1501 et seq.). tolerances for residues of quizalofop
This action establishes a tolerance This action does not involve any ethyl in or on crayfish and rice grain.
exemption under FFDCA section 408(d) technical standards that would require Nissan Chemical Industries, Ltd.
in response to a petition submitted to EPA’s consideration of voluntary requested these tolerances under the
EPA. The Office of Management and consensus standards pursuant to section Federal Food, Drug, and Cosmetic Act
Budget (OMB) has exempted these types 12(d) of the National Technology (FFDCA).
of actions from review under Executive Transfer and Advancement Act
Order 12866, entitled ‘‘Regulatory DATES: This regulation is effective
(NTTAA) (15 U.S.C. 272 note). December 1, 2016. Objections and
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action V. Congressional Review Act requests for hearings must be received
has been exempted from review under Pursuant to the Congressional Review on or before January 30, 2017, and must
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will be filed in accordance with the
not subject to Executive Order 13211, submit a report containing this rule and instructions provided in 40 CFR part
entitled ‘‘Actions Concerning other required information to the U.S. 178 (see also Unit I.C. of the
Regulations That Significantly Affect Senate, the U.S. House of SUPPLEMENTARY INFORMATION).
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller ADDRESSES: The docket for this action,
FR 28355, May 22, 2001), or Executive General of the United States prior to identified by docket identification (ID)
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal number EPA–HQ–OPP–2015–0412, is
Children from Environmental Health Register. This action is not a ‘‘major available at http://www.regulations.gov
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). or at the Office of Pesticide Programs
jstallworth on DSK7TPTVN1PROD with RULES
April 23, 1997). This action does not Regulatory Public Docket (OPP Docket)
contain any information collections List of Subjects in 40 CFR Part 180 in the Environmental Protection Agency
subject to OMB approval under the Environmental protection, Docket Center (EPA/DC), West William
Paperwork Reduction Act (PRA), 44 Administrative practice and procedure, Jefferson Clinton Bldg., Rm. 3334, 1301
U.S.C. 3501 et seq., nor does it require Agricultural commodities, Pesticides Constitution Ave. NW., Washington, DC
any special considerations under and pests, Reporting and recordkeeping 20460–0001. The Public Reading Room
Executive Order 12898, entitled requirements. is open from 8:30 a.m. to 4:30 p.m.,
VerDate Sep<11>2014 13:50 Nov 30, 2016 Jkt 241001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\01DER1.SGM 01DER1](https://thefederalregister.org/doc/81_FR_86810/page/3.svg)
Document Created: 2018-02-14 09:00:43
Document Modified: 2018-02-14 09:00:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective December 1, 2016. Objections and requests for hearings must be received on or before January 30, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY 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 | |
| FR Citation | 81 FR 86579 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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