83 FR 17496 - Bacillus Licheniformis
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 77 (April 20, 2018)
Federal Register Volume 83, Issue 77 (April 20, 2018)
| Page Range | 17496-17498 | |
| FR Document | 2018-08309 |
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)] [Rules and Regulations] [Pages 17496-17498] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08309] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0185; FRL-9971-54] Bacillus Licheniformis Strain FMCH001; 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 Bacillus licheniformis strain FMCH001 in or on all food commodities when used in accordance with label directions and good agricultural practices. FMC Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the exemption from a requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus licheniformis strain FMCH001 under FFDCA. DATES: This regulation is effective April 20, 2018. Objections and requests for hearings must be received on or before June 19, 2018, 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-2017-0185, 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. [[Page 17497]] 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 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-2017-0185 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 June 19, 2018. 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-2017-0185, 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 July 26, 2017 (82 FR 34664) (FRL-9963- 50), 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 6F8514) by FMC Corporation, FMC Tower at Cira Centre South, 2929 Walnut St., Philadelphia, PA 19104. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus licheniformis strain FMCH001 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner FMC Corporation, which is available in the docket via http://www.regulations.gov. No comments were received on the notice of filing. EPA added ``in or on all food commodities'' to align with the Agency's language and to more clearly define the petitioner's request. 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 Bacillus licheniformis strain FMCH001 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 document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Bacillus licheniformis strain FMCH001.'' 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 Bacillus licheniformis strain FMCH001 is not toxic, not pathogenic, and not infective. Although there may be some exposure to residues when used on all food commodities in accordance with label directions and good agricultural practices, there is a reasonable certainty that such exposure will not cause adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Bacillus licheniformis strain FMCH001. 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 Bacillus licheniformis strain FMCH001. Therefore, an exemption from the requirement of a tolerance is [[Page 17498]] established for residues of Bacillus licheniformis strain FMCH001 in or on all food commodities when used in accordance with label directions and good agricultural practices. B. Analytical Enforcement Methodology EPA is establishing an exemption from a tolerance on all food commodities without any numerical limitation and thus an analytical method is not required for enforcement purposes. IV. Statutory and Executive Order Reviews This action establishes exemptions from the requirement of a tolerance 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 exemptions 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: March 16, 2018. Richard P. Keigwin, Jr., 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. 180.1350 to subpart D to read as follows: Sec. 180.1350 Bacillus licheniformis strain FMCH001; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Bacillus licheniformis strain FMCH001 in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2018-08309 Filed 4-19-18; 8:45 am] BILLING CODE 6560-50-P
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will not result in such an expenditure, Commander, U.S. Coast Guard Sector weather, from 11 p.m. on April 22,
we do discuss the effects of this rule Maryland-National Capital Region. 2018, until 1 a.m. on April 23, 2018.
elsewhere in this preamble. (2) Designated representative means Dated: April 16, 2018.
any Coast Guard commissioned, Lonnie P. Harrison, Jr.,
F. Environment
warrant, or petty officer who has been Captain, U.S. Coast Guard, Captain of the
We have analyzed this rule under authorized by the Captain of the Port Port Maryland-National Capital Region.
Department of Homeland Security Maryland-National Capital Region to [FR Doc. 2018–08283 Filed 4–19–18; 8:45 am]
Directive 023–01 and Commandant assist in enforcement of the safety zone
BILLING CODE 9110–04–P
Instruction M16475.1D, which guide the described in paragraph (b) of this
Coast Guard in complying with the section.
National Environmental Policy Act of (b) Location. The following area is a
1969(42 U.S.C. 4321–4370f), and have ENVIRONMENTAL PROTECTION
safety zone: All navigable waters of the
determined that this action is one of a AGENCY
Patapsco River, Inner Harbor, from
category of actions that do not shoreline to shoreline, within an area 40 CFR Part 180
individually or cumulatively have a bounded on the east by longitude
significant effect on the human 076°36′12″ W, and bounded on the west [EPA–HQ–OPP–2017–0185; FRL–9971–54]
environment. This rule involves a safety by the Inner Harbor west bulkhead,
zone lasting two hours that would Bacillus Licheniformis Strain
located at Baltimore, MD. All
prohibit vessel movement within the FMCH001; Exemption From the
coordinates refer to datum NAD 1983.
Inner Harbor at Baltimore, MD. It is Requirement of a Tolerance
(c) Regulations. The general safety
categorically excluded from further zone regulations found in 33 CFR part AGENCY: Environmental Protection
review under paragraph L60(a) of 165, subpart C apply to the safety zone Agency (EPA).
Appendix A, Table 1 of DHS Instruction created by this section. ACTION: Final rule.
Manual 023–01–001–01, Rev. 01. A (1) All persons are required to comply
Record of Environmental Consideration with the general regulations governing SUMMARY: This regulation establishes an
supporting this determination is safety zones found in 33 CFR 165.23. exemption from the requirement of a
available in the docket where indicated (2) Entry into or remaining in this tolerance for residues of Bacillus
under ADDRESSES. safety zone is prohibited unless licheniformis strain FMCH001 in or on
authorized by the Coast Guard Captain all food commodities when used in
G. Protest Activities accordance with label directions and
of the Port Maryland-National Capital
The Coast Guard respects the First Region. All vessels underway within good agricultural practices. FMC
Amendment rights of protesters. this safety zone at the time it is Corporation submitted a petition to EPA
Protesters are asked to contact the implemented are to depart the zone. under the Federal Food, Drug, and
person listed in the FOR FURTHER (3) Persons desiring to transit the area Cosmetic Act (FFDCA), requesting the
INFORMATION CONTACT section to exemption from a requirement of a
of the safety zone shall obtain
coordinate protest activities so that your tolerance. This regulation eliminates the
authorization from the Captain of the
message can be received without need to establish a maximum
Port Maryland-National Capital Region
jeopardizing the safety or security of permissible level for residues of Bacillus
or designated representative. To request
people, places or vessels. licheniformis strain FMCH001 under
permission to transit the area, the
FFDCA.
List of Subjects in 33 CFR Part 165 Captain of the Port Maryland-National
Capital Region and or designated DATES: This regulation is effective April
Harbors, Marine safety, Navigation representatives can be contacted at 20, 2018. Objections and requests for
(water), Reporting and recordkeeping telephone number 410–576–2693 or on hearings must be received on or before
requirements, Security measures, marine band radio VHF–FM channel 16 June 19, 2018, and must be filed in
Waterways. (156.8 MHz). The Coast Guard vessels accordance with the instructions
For the reasons discussed in the enforcing this section can be contacted provided in 40 CFR part 178 (see also
preamble, the Coast Guard amends 33 on marine band radio VHF–FM channel Unit I.C. of the SUPPLEMENTARY
CFR part 165 as follows: 16 (156.8 MHz). Upon being hailed by INFORMATION).
a U.S. Coast Guard vessel, or other ADDRESSES: The docket for this action,
PART 165—REGULATED NAVIGATION Federal, State, or local agency vessel, by identified by docket identification (ID)
AREAS AND LIMITED ACCESS AREAS siren, radio, flashing light, or other number EPA–HQ–OPP–2017–0185, is
means, the operator of a vessel shall available at http://www.regulations.gov
■ 1. The authority citation for part 165 proceed as directed. If permission is or at the Office of Pesticide Programs
continues to read as follows: granted to enter the safety zone, all Regulatory Public Docket (OPP Docket)
Authority: 33 U.S.C. 1231; 50 U.S.C. 191; persons and vessels shall comply with in the Environmental Protection Agency
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; the instructions of the Captain of the Docket Center (EPA/DC), West William
Department of Homeland Security Delegation Port Maryland-National Capital Region Jefferson Clinton Bldg., Rm. 3334, 1301
No. 0170.1. or designated representative and Constitution Ave. NW, Washington, DC
■ 2. Add § 165.T05–0029 to read as proceed as directed while within the 20460–0001. The Public Reading Room
follows: zone. is open from 8:30 a.m. to 4:30 p.m.,
(4) Enforcement officials. The U.S. Monday through Friday, excluding legal
sradovich on DSK3GMQ082PROD with RULES
§ 165.T05–0029 Safety Zone for Fireworks Coast Guard may be assisted in the holidays. The telephone number for the
Display; Patapsco River, Inner Harbor, patrol and enforcement of the zone by Public Reading Room is (202) 566–1744,
Baltimore, MD. Federal, State, and local agencies. and the telephone number for the OPP
(a) Definitions. As used in this (d) Enforcement period. This section Docket is (703) 305–5805. Please review
section: will be enforced from 11 p.m. on April the visitor instructions and additional
(1) Captain of the Port Maryland- 21, 2018, until 1 a.m. on April 22, 2018, information about the docket available
National Capital Region means the or if necessary, due to inclement at http://www.epa.gov/dockets.
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![Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations 17497
FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket. result from aggregate exposure to the
Robert McNally, Biopesticides and Information not marked confidential pesticide chemical residue, including
Pollution Prevention Division (7511P), pursuant to 40 CFR part 2 may be all anticipated dietary exposures and all
Office of Pesticide Programs, disclosed publicly by EPA without prior other exposures for which there is
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your reliable information.’’ This includes
Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified exposure through drinking water and in
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP– residential settings but does not include
(703) 305–7090; email address: 2017–0185, by one of the following occupational exposure. Pursuant to
BPPDFRNotices@epa.gov. methods: FFDCA section 408(c)(2)(B), in
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// establishing or maintaining in effect an
www.regulations.gov. Follow the online exemption from the requirement of a
I. General Information instructions for submitting comments. tolerance, EPA must take into account
A. Does this action apply to me? Do not submit electronically any the factors set forth in FFDCA section
information you consider to be CBI or 408(b)(2)(C), which require EPA to give
You may be potentially affected by other information whose disclosure is special consideration to exposure of
this action if you are an agricultural restricted by statute. infants and children to the pesticide
producer, food manufacturer, or • Mail: OPP Docket, Environmental chemical residue in establishing a
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ tolerance or tolerance exemption and to
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. ‘‘ensure that there is a reasonable
Classification System (NAICS) codes is NW, Washington, DC 20460–0001. certainty that no harm will result to
not intended to be exhaustive, but rather • Hand Delivery: To make special infants and children from aggregate
provides a guide to help readers arrangements for hand delivery or exposure to the pesticide chemical
determine whether this document delivery of boxed information, please residue. . . .’’ Additionally, FFDCA
applies to them. Potentially affected follow the instructions at http:// section 408(b)(2)(D) requires that EPA
entities may include: www.epa.gov/dockets/contacts.html. consider ‘‘available information
• Crop production (NAICS code 111). Additional instructions on commenting concerning the cumulative effects of [a
• Animal production (NAICS code or visiting the docket, along with more particular pesticide’s] . . . residues
112). information about dockets generally, is and other substances that have a
• Food manufacturing (NAICS code common mechanism of toxicity.’’
available at http://www.epa.gov/
311). EPA evaluated the available toxicity
dockets.
• Pesticide manufacturing (NAICS and exposure data on Bacillus
code 32532). II. Background licheniformis strain FMCH001 and
B. How can I get electronic access to In the Federal Register of July 26, considered its validity, completeness,
other related information? 2017 (82 FR 34664) (FRL–9963–50), and reliability, as well as the
EPA issued a document pursuant to relationship of this information to
You may access a frequently updated human risk. A full explanation of the
FFDCA section 408(d)(3), 21 U.S.C.
electronic version of 40 CFR part 180 data upon which EPA relied and its risk
346a(d)(3), announcing the filing of a
through the Government Printing assessment based on that data can be
pesticide tolerance petition (PP 6F8514)
Office’s e-CFR site at http:// found within the document entitled
by FMC Corporation, FMC Tower at Cira
www.ecfr.gov/cgi-bin/text-idx?&c= ‘‘Federal Food, Drug, and Cosmetic Act
Centre South, 2929 Walnut St.,
ecfr&tpl=/ecfrbrowse/Title40/40tab_ (FFDCA) Considerations for Bacillus
Philadelphia, PA 19104. The petition
02.tpl. licheniformis strain FMCH001.’’ This
requested that 40 CFR part 180 be
C. How can I file an objection or hearing amended by establishing an exemption document, as well as other relevant
request? from the requirement of a tolerance for information, is available in the docket
residues of Bacillus licheniformis strain for this action as described under
Under FFDCA section 408(g), 21 ADDRESSES.
U.S.C. 346a(g), any person may file an FMCH001 in or on all food
commodities. That document referenced Based upon its evaluation, EPA
objection to any aspect of this regulation concludes that Bacillus licheniformis
and may also request a hearing on those a summary of the petition prepared by
the petitioner FMC Corporation, which strain FMCH001 is not toxic, not
objections. You must file your objection pathogenic, and not infective. Although
or request a hearing on this regulation is available in the docket via http://
there may be some exposure to residues
in accordance with the instructions www.regulations.gov. No comments
when used on all food commodities in
provided in 40 CFR part 178. To ensure were received on the notice of filing.
accordance with label directions and
proper receipt by EPA, you must EPA added ‘‘in or on all food
good agricultural practices, there is a
identify docket ID number EPA–HQ– commodities’’ to align with the
reasonable certainty that such exposure
OPP–2017–0185 in the subject line on Agency’s language and to more clearly
will not cause adverse effects. EPA also
the first page of your submission. All define the petitioner’s request.
determined that retention of the Food
objections and requests for a hearing III. Final Rule Quality Protection Act (FQPA) safety
must be in writing, and must be factor was not necessary as part of the
received by the Hearing Clerk on or A. EPA’s Safety Determination
qualitative assessment conducted for
before June 19, 2018. Addresses for mail Section 408(c)(2)(A)(i) of FFDCA Bacillus licheniformis strain FMCH001.
and hand delivery of objections and allows EPA to establish an exemption Based upon its evaluation, EPA
sradovich on DSK3GMQ082PROD with RULES
hearing requests are provided in 40 CFR from the requirement for a tolerance (the concludes that there is a reasonable
178.25(b). legal limit for a pesticide chemical certainty that no harm will result to the
In addition to filing an objection or residue in or on a food) only if EPA U.S. population, including infants and
hearing request with the Hearing Clerk determines that the exemption is ‘‘safe.’’ children, from aggregate exposure to
as described in 40 CFR part 178, please Section 408(c)(2)(A)(ii) of FFDCA residues of Bacillus licheniformis strain
submit a copy of the filing (excluding defines ‘‘safe’’ to mean that ‘‘there is a FMCH001. Therefore, an exemption
any Confidential Business Information reasonable certainty that no harm will from the requirement of a tolerance is
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established for residues of Bacillus governments, or on the distribution of directions and good agricultural
licheniformis strain FMCH001 in or on power and responsibilities among the practices.
all food commodities when used in various levels of government or between [FR Doc. 2018–08309 Filed 4–19–18; 8:45 am]
accordance with label directions and the Federal Government and Indian BILLING CODE 6560–50–P
good agricultural practices. tribes. Thus, EPA has determined that
B. Analytical Enforcement Methodology Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10, ENVIRONMENTAL PROTECTION
EPA is establishing an exemption 1999), and Executive Order 13175, AGENCY
from a tolerance on all food entitled ‘‘Consultation and Coordination
commodities without any numerical with Indian Tribal Governments’’ (65 FR 40 CFR Part 180
limitation and thus an analytical 67249, November 9, 2000), do not apply [EPA–HQ–OPP–2017–0186; FRL–9971–55]
method is not required for enforcement to this action. In addition, this action
purposes. does not impose any enforceable duty or Bacillus subtilis strain FMCH002;
IV. Statutory and Executive Order contain any unfunded mandate as Exemption From the Requirement of a
Reviews described under Title II of the Unfunded Tolerance
Mandates Reform Act (UMRA) (2 U.S.C.
This action establishes exemptions AGENCY: Environmental Protection
1501 et seq.).
from the requirement of a tolerance Agency (EPA).
under FFDCA section 408(d) in This action does not involve any ACTION: Final rule.
response to a petition submitted to EPA. technical standards that would require
The Office of Management and Budget EPA’s consideration of voluntary SUMMARY: This regulation establishes an
(OMB) has exempted these types of consensus standards pursuant to section exemption from the requirement of a
actions from review under Executive 12(d) of the National Technology tolerance for residues of Bacillus subtilis
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act strain FMCH002 in or on all food
Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note). commodities when used in accordance
October 4, 1993). Because this action with label directions and good
V. Congressional Review Act
has been exempted from review under agricultural practices. FMC Corporation
Executive Order 12866, this action is Pursuant to the Congressional Review submitted a petition to EPA under the
not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will Federal Food, Drug, and Cosmetic Act
entitled ‘‘Actions Concerning submit a report containing this rule and (FFDCA), requesting the exemption
Regulations That Significantly Affect other required information to the U.S. from a requirement of a tolerance. This
Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of regulation eliminates the need to
FR 28355, May 22, 2001), or Executive Representatives, and the Comptroller establish a maximum permissible level
Order 13045, entitled ‘‘Protection of General of the United States prior to for residues of Bacillus subtilis strain
Children from Environmental Health publication of the rule in the Federal FMCH002 under FFDCA.
Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major DATES: This regulation is effective April
April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2). 20, 2018. Objections and requests for
contain any information collections hearings must be received on or before
subject to OMB approval under the List of Subjects in 40 CFR Part 180 June 19, 2018, and must be filed in
Paperwork Reduction Act (PRA) (44 accordance with the instructions
Environmental protection,
U.S.C. 3501 et seq.) nor does it require provided in 40 CFR part 178 (see also
Administrative practice and procedure,
any special considerations under Unit I.C. of the SUPPLEMENTARY
Agricultural commodities, Pesticides
Executive Order 12898, entitled INFORMATION).
and pests, Reporting and recordkeeping
‘‘Federal Actions to Address
requirements. ADDRESSES: The docket for this action,
Environmental Justice in Minority
Populations and Low-Income Dated: March 16, 2018. identified by docket identification (ID)
Populations’’ (59 FR 7629, February 16, Richard P. Keigwin, Jr.,
number EPA–HQ–OPP–2017–0186, is
1994). available at http://www.regulations.gov
Director, Office of Pesticide Programs.
Since tolerances and exemptions that or at the Office of Pesticide Programs
are established on the basis of a petition Therefore, 40 CFR chapter I is Regulatory Public Docket (OPP Docket)
under FFDCA section 408(d), such as amended as follows: in the Environmental Protection Agency
the tolerance exemptions in this action, Docket Center (EPA/DC), West William
do not require the issuance of a PART 180—[AMENDED] Jefferson Clinton Bldg., Rm. 3334, 1301
proposed rule, the requirements of the Constitution Ave. NW, Washington, DC
Regulatory Flexibility Act (RFA) (5 ■ 1. The authority citation for part 180 20460–0001. The Public Reading Room
U.S.C. 601 et seq.) do not apply. continues to read as follows: is open from 8:30 a.m. to 4:30 p.m.,
This action directly regulates growers, Monday through Friday, excluding legal
Authority: 21 U.S.C. 321(q), 346a and 371. holidays. The telephone number for the
food processors, food handlers, and food
retailers, not States or tribes. As a result, ■ 2. Add § 180.1350 to subpart D to read Public Reading Room is (202) 566–1744,
this action does not alter the as follows: and the telephone number for the OPP
relationships or distribution of power Docket is (703) 305–5805. Please review
and responsibilities established by § 180.1350 Bacillus licheniformis strain the visitor instructions and additional
sradovich on DSK3GMQ082PROD with RULES
FMCH001; exemption from the requirement information about the docket available
Congress in the preemption provisions
of a tolerance. at http://www.epa.gov/dockets.
of FFDCA section 408(n)(4). As such,
EPA has determined that this action will An exemption from the requirement FOR FURTHER INFORMATION CONTACT:
not have a substantial direct effect on of a tolerance is established for residues Robert McNally, Biopesticides and
States or tribal governments, on the of Bacillus licheniformis strain Pollution Prevention Division (7511P),
relationship between the national FMCH001 in or on all food commodities Office of Pesticide Programs,
government and the States or tribal when used in accordance with label Environmental Protection Agency, 1200
VerDate Sep<11>2014 15:57 Apr 19, 2018 Jkt 244001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\20APR1.SGM 20APR1](https://thefederalregister.org/doc/83_FR_17573/page/3.svg)
Document Created: 2018-04-20 00:02:37
Document Modified: 2018-04-20 00:02:37
| 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 April 20, 2018. Objections and requests for hearings must be received on or before June 19, 2018, 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, | |
| FR Citation | 83 FR 17496 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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