82 FR 49745 - Bacillus amyloliquefaciens Strain F727; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 207 (October 27, 2017)
Federal Register Volume 82, Issue 207 (October 27, 2017)
| Page Range | 49745-49747 | |
| FR Document | 2017-23469 |
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)] [Rules and Regulations] [Pages 49745-49747] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23469] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0348; FRL-9968-40] Bacillus amyloliquefaciens Strain F727; 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 amyloliquefaciens strain F727 in or on all food commodities when used in accordance with label directions and good agricultural practices. Marrone Bio Innovations 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 Bacillus amyloliquefaciens strain F727 under FFDCA. DATES: This regulation is effective October 27, 2017. Objections and requests for hearings must be received on or before December 26, 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-2016-0348, 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 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). [[Page 49746]] 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-2016-0348 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 December 26, 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-2016-0348, 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 August 29, 2016 (81 FR 59165) (FRL-9950- 22), 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 6F8444) by Marrone Bio Innovations, 1540 Drew Ave., 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 Bacillus amyloliquefaciens strain F727 in and on all food commodities. That document referenced a summary of the petition prepared by the petitioner Marrone Bio Innovations, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the 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 toxicological and exposure data on Bacillus amyloliquefaciens strain F727 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 those data can be found within the August 24, 2017, document, entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Bacillus amyloliquefaciens strain F727.'' 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 amyloliquefaciens strain F727 is not toxic, pathogenic, or 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 be safe due to the lack of potential for 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 amyloliquefaciens strain F727. 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 amyloliquefaciens strain F727. Therefore, an exemption from the requirement of a tolerance is established for residues of Bacillus amyloliquefaciens strain F727 in and on all food commodities when used in accordance with label directions and good agricultural practices. B. Analytical Enforcement Methodology Due to the lack of toxicity, infectivity, or pathogenicity of Bacillus amyloliquefaciens strain F727, EPA has determined that there is no need for an analytical method to measure and detect residues in or on food. 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 [[Page 49747]] 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: October 11, 2017. 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. 180.1347 to subpart D to read as follows: Sec. 180.1347 Bacillus amyloliquefaciens strain F727; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Bacillus amyloliquefaciens strain F727 in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2017-23469 Filed 10-26-17; 8:45 am] BILLING CODE 6560-50-P
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H. Civil Justice Reform which guide the Coast Guard in exemption from the requirement of a
This rule meets applicable standards complying with the National tolerance. This regulation eliminates the
in sections 3(a) and 3(b)(2) of E.O. Environmental Policy Act of 1969 (42 need to establish a maximum
12988, (‘‘Civil Justice Reform’’), to U.S.C. 4321–4370f), and have concluded permissible level for residues of Bacillus
minimize litigation, eliminate that this action is one of a category of amyloliquefaciens strain F727 under
ambiguity, and reduce burden. actions which do not individually or FFDCA.
cumulatively have a significant effect on
I. Protection of Children the human environment. This final rule DATES: This regulation is effective
is categorically excluded under section October 27, 2017. Objections and
We have analyzed this rule under E.O.
2.B.2, figure 2–1, paragraphs (34)(d) and requests for hearings must be received
13045 (‘‘Protection of Children from
(e) of the Instruction and under section on or before December 26, 2017, and
Environmental Health Risks and Safety
6(a) of the ‘‘Appendix to National must be filed in accordance with the
Risks’’). This rule is not an
Environmental Policy Act: Coast Guard instructions provided in 40 CFR part
economically significant rule and would
Procedures for Categorical Exclusions, 178 (see also Unit I.C. of the
not create an environmental risk to
SUPPLEMENTARY INFORMATION).
health or risk to safety that might Notice of Final Agency Policy’’ (67 FR
disproportionately affect children. 48243, July 23, 2002). This final rule ADDRESSES: The docket for this action,
involves the safe loading capacity and identified by docket identification (ID)
J. Indian Tribal Governments required amount of flotation material for number EPA–HQ–OPP–2016–0348, is
This rule does not have tribal certain recreational boats, which available at http://www.regulations.gov
implications under E.O. 13175 concerns equipping of vessels, as well or at the Office of Pesticide Programs
(‘‘Consultation and Coordination with as equipment and vessel operation Regulatory Public Docket (OPP Docket)
Indian Tribal Governments’’), because it safety standards. This rule supports the in the Environmental Protection Agency
would not have a substantial direct Coast Guard’s maritime safety mission. Docket Center (EPA/DC), West William
effect on one or more Indian tribes, on A Record of Environmental Jefferson Clinton Bldg., Rm. 3334, 1301
the relationship between the Federal Consideration (REC) supporting this Constitution Ave. NW., Washington, DC
Government and Indian tribes, or on the determination is available in the docket 20460–0001. The Public Reading Room
distribution of power and as discussed in the ADDRESSES section of is open from 8:30 a.m. to 4:30 p.m.,
responsibilities between the Federal this rule. Monday through Friday, excluding legal
Government and Indian tribes. holidays. The telephone number for the
List of Subjects in 33 CFR Part 183
K. Energy Effects Public Reading Room is (202) 566–1744,
Marine safety. and the telephone number for the OPP
We have analyzed this rule under E.O. ■ For the reasons discussed in the Docket is (703) 305–5805. Please review
13211 (‘‘Actions Concerning preamble, the interim rule amending 33 the visitor instructions and additional
Regulations That Significantly Affect CFR part 183 that was published at 82 information about the docket available
Energy Supply, Distribution, or Use’’). FR 16512 on April 5, 2017, is adopted at http://www.epa.gov/dockets.
We have determined that it is not a as a final rule without change.
‘‘significant energy action’’ under that FOR FURTHER INFORMATION CONTACT:
order because it is not a ‘‘significant Dated: October 23, 2017. Robert McNally, Biopesticides and
regulatory action’’ under E.O. 12866 and Jennifer F. Williams, Pollution Prevention Division (7511P),
is not likely to have a significant Captain, U.S. Coast Guard, Director of Office of Pesticide Programs,
adverse effect on the supply, Inspections and Compliance. Environmental Protection Agency, 1200
distribution, or use of energy. [FR Doc. 2017–23384 Filed 10–26–17; 8:45 am] Pennsylvania Ave. NW., Washington,
BILLING CODE 9110–04–P DC 20460–0001; main telephone
L. Technical Standards number: (703) 305–7090; email address:
The National Technology Transfer BPPDFRNotices@epa.gov.
and Advancement Act, codified as a ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION:
note to 15 U.S.C. 272, directs agencies AGENCY
to use voluntary consensus standards in I. General Information
their regulatory activities unless the 40 CFR Part 180 A. Does this action apply to me?
agency provides Congress, through
[EPA–HQ–OPP–2016–0348; FRL–9968–40]
OMB, with an explanation of why using You may be potentially affected by
these standards would be inconsistent Bacillus amyloliquefaciens Strain this action if you are an agricultural
with applicable law or otherwise F727; Exemption From the producer, food manufacturer, or
impractical. Voluntary consensus Requirement of a Tolerance pesticide manufacturer. The following
standards are technical standards (e.g., list of North American Industrial
specifications of materials, performance, AGENCY: Environmental Protection Classification System (NAICS) codes is
design, or operation; test methods; Agency (EPA). not intended to be exhaustive, but rather
sampling procedures; and related ACTION: Final rule. provides a guide to help readers
management systems practices) that are determine whether this document
developed or adopted by voluntary SUMMARY: This regulation establishes an applies to them. Potentially affected
consensus standards bodies. exemption from the requirement of a entities may include:
asabaliauskas on DSKBBXCHB2PROD with RULES
This rule uses a voluntary consensus tolerance for residues of Bacillus • Crop production (NAICS code 111).
standard: The current ABYC S–30. amyloliquefaciens strain F727 in or on
all food commodities when used in • Animal production (NAICS code
M. Environment accordance with label directions and 112).
We have analyzed this rule under good agricultural practices. Marrone Bio • Food manufacturing (NAICS code
Department of Homeland Security Innovations submitted a petition to EPA 311).
Management Directive 023–01 and under the Federal Food, Drug, and • Pesticide manufacturing (NAICS
Commandant Instruction M16475.lD, Cosmetic Act (FFDCA), requesting an code 32532).
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![49746 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Rules and Regulations
B. How can I get electronic access to II. Background human risk. A full explanation of the
other related information? In the Federal Register of August 29, data upon which EPA relied and its risk
2016 (81 FR 59165) (FRL–9950–22), assessment based on those data can be
You may access a frequently updated found within the August 24, 2017,
electronic version of 40 CFR part 180 EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C. document, entitled ‘‘Federal Food, Drug,
through the Government Printing and Cosmetic Act (FFDCA)
Office’s e-CFR site at http:// 346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 6F8444) Considerations for Bacillus
www.ecfr.gov/cgi-bin/text- amyloliquefaciens strain F727.’’ This
by Marrone Bio Innovations, 1540 Drew
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ document, as well as other relevant
Ave., Davis, CA 95618. The petition
40tab_02.tpl. information, is available in the docket
requested that 40 CFR part 180 be
C. How can I file an objection or hearing amended by establishing an exemption for this action as described under
request? from the requirement of a tolerance for ADDRESSES.
residues of Bacillus amyloliquefaciens Based upon its evaluation, EPA
Under FFDCA section 408(g), 21 strain F727 in and on all food concludes that Bacillus
U.S.C. 346a(g), any person may file an commodities. That document referenced amyloliquefaciens strain F727 is not
objection to any aspect of this regulation a summary of the petition prepared by toxic, pathogenic, or infective. Although
and may also request a hearing on those the petitioner Marrone Bio Innovations, there may be some exposure to residues
objections. You must file your objection which is available in the docket via when used on all food commodities in
or request a hearing on this regulation http://www.regulations.gov. There were accordance with label directions and
in accordance with the instructions no comments received in response to good agricultural practices, there is a
provided in 40 CFR part 178. To ensure the notice of filing. reasonable certainty that such exposure
proper receipt by EPA, you must will be safe due to the lack of potential
identify docket ID number EPA–HQ– III. Final Rule for adverse effects. EPA also determined
OPP–2016–0348 in the subject line on A. EPA’s Safety Determination that retention of the Food Quality
the first page of your submission. All Protection Act (FQPA) safety factor was
Section 408(c)(2)(A)(i) of FFDCA not necessary as part of the qualitative
objections and requests for a hearing
allows EPA to establish an exemption assessment conducted for Bacillus
must be in writing, and must be from the requirement for a tolerance (the
received by the Hearing Clerk on or amyloliquefaciens strain F727.
legal limit for a pesticide chemical Based upon its evaluation, EPA
before December 26, 2017. Addresses for residue in or on a food) only if EPA
mail and hand delivery of objections concludes that there is a reasonable
determines that the exemption is ‘‘safe.’’ certainty that no harm will result to the
and hearing requests are provided in 40 Section 408(c)(2)(A)(ii) of FFDCA
CFR 178.25(b). U.S. population, including infants and
defines ‘‘safe’’ to mean that ‘‘there is a children, from aggregate exposure to
In addition to filing an objection or reasonable certainty that no harm will residues of Bacillus amyloliquefaciens
hearing request with the Hearing Clerk result from aggregate exposure to the strain F727. Therefore, an exemption
as described in 40 CFR part 178, please pesticide chemical residue, including from the requirement of a tolerance is
submit a copy of the filing (excluding all anticipated dietary exposures and all established for residues of Bacillus
any Confidential Business Information other exposures for which there is amyloliquefaciens strain F727 in and on
(CBI)) for inclusion in the public docket. reliable information.’’ This includes all food commodities when used in
Information not marked confidential exposure through drinking water and in accordance with label directions and
pursuant to 40 CFR part 2 may be residential settings but does not include good agricultural practices.
disclosed publicly by EPA without prior occupational exposure. Pursuant to
notice. Submit the non-CBI copy of your FFDCA section 408(c)(2)(B), in B. Analytical Enforcement Methodology
objection or hearing request, identified establishing or maintaining in effect an Due to the lack of toxicity, infectivity,
by docket ID number EPA–HQ–OPP– exemption from the requirement of a or pathogenicity of Bacillus
2016–0348, by one of the following tolerance, EPA must take into account amyloliquefaciens strain F727, EPA has
methods: the factors set forth in FFDCA section determined that there is no need for an
• Federal eRulemaking Portal: http:// 408(b)(2)(C), which require EPA to give analytical method to measure and detect
www.regulations.gov. Follow the online special consideration to exposure of residues in or on food.
instructions for submitting comments. infants and children to the pesticide
chemical residue in establishing a IV. Statutory and Executive Order
Do not submit electronically any Reviews
information you consider to be CBI or tolerance or tolerance exemption and to
other information whose disclosure is ‘‘ensure that there is a reasonable This action establishes a tolerance
restricted by statute. certainty that no harm will result to exemption under FFDCA section 408(d)
infants and children from aggregate in response to a petition submitted to
• Mail: OPP Docket, Environmental exposure to the pesticide chemical EPA. The Office of Management and
Protection Agency Docket Center (EPA/ residue . . . .’’ Additionally, FFDCA Budget (OMB) has exempted these types
DC), (28221T), 1200 Pennsylvania Ave. section 408(b)(2)(D) requires that EPA of actions from review under Executive
NW., Washington, DC 20460–0001. consider ‘‘available information Order 12866, entitled ‘‘Regulatory
• Hand Delivery: To make special concerning the cumulative effects of [a Planning and Review’’ (58 FR 51735,
arrangements for hand delivery or particular pesticide’s] . . . residues and October 4, 1993). Because this action
asabaliauskas on DSKBBXCHB2PROD with RULES
delivery of boxed information, please other substances that have a common has been exempted from review under
follow the instructions at http:// mechanism of toxicity.’’ Executive Order 12866, this action is
www.epa.gov/dockets/contacts.html. EPA evaluated the available not subject to Executive Order 13211,
Additional instructions on commenting toxicological and exposure data on entitled ‘‘Actions Concerning
or visiting the docket, along with more Bacillus amyloliquefaciens strain F727 Regulations That Significantly Affect
information about dockets generally, is and considered its validity, Energy Supply, Distribution, or Use’’ (66
available at http://www.epa.gov/ completeness, and reliability, as well as FR 28355, May 22, 2001), or Executive
dockets. the relationship of this information to Order 13045, entitled ‘‘Protection of
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Children from Environmental Health Register. This action is not a ‘‘major the AbilityOne Program pursuant to the
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). authority of 41 U.S.C. 8501. Through
April 23, 1997). This action does not this program, employment opportunities
List of Subjects in 40 CFR Part 180
contain any information collections are provided to people who are blind or
subject to OMB approval under the Environmental protection, severely disabled through the provisions
Paperwork Reduction Act (PRA), 44 Administrative practice and procedure, of products and services to the Federal
U.S.C. 3501 et seq., nor does it require Agricultural commodities, Pesticides Government.
any special considerations under and pests, Reporting and recordkeeping Pursuant to 5 U.S.C. 301, the head of
Executive Order 12898, entitled requirements. an Executive department or military
‘‘Federal Actions to Address Dated: October 11, 2017. department may prescribe regulations
Environmental Justice in Minority Richard P. Keigwin, Jr., for the government of his department,
Populations and Low-Income Director, Office of Pesticide Programs. the conduct of its employees, the
Populations’’ (59 FR 7629, February 16, distribution and performance of its
1994). Therefore, 40 CFR chapter I is business, and the custody, use, and
Since tolerances and exemptions that amended as follows: preservation of its records, papers, and
are established on the basis of a petition property. The part does not authorize
under FFDCA section 408(d), such as PART 180—[AMENDED]
withholding information from the
the tolerance exemption in this action, public or limiting the availability of
■ 1. The authority citation for part 180
do not require the issuance of a records to the public.
continues to read as follows:
proposed rule, the requirements of the The United States Supreme Court
Regulatory Flexibility Act (RFA) (5 Authority: 21 U.S.C. 321(q), 346a and 371. held in United States ex rel. Touhy v.
U.S.C. 601 et seq.) do not apply. ■ 2. Add § 180.1347 to subpart D to read Ragen, 340 U.S. 462 (1951), that the
This action directly regulates growers, as follows: head of a Federal agency may make the
food processors, food handlers, and food determination on his/her sole authority
retailers, not States or tribes. As a result, § 180.1347 Bacillus amyloliquefaciens
to produce documents and authorize
this action does not alter the strain F727; exemption from the
requirement of a tolerance. employee’s testimony in response to a
relationships or distribution of power subpoena or other demand for
and responsibilities established by An exemption from the requirement
information.
Congress in the preemption provisions of a tolerance is established for residues This regulation governs the
of FFDCA section 408(n)(4). As such, of Bacillus amyloliquefaciens strain Committee’s procedures for authorizing
EPA has determined that this action will F727 in or on all food commodities or denying such demands. In addition to
not have a substantial direct effect on when used in accordance with label the updates for the Touhy case, the
States or tribal governments, on the directions and good agricultural Committee made technical corrections
relationship between the national practices. to include changes to the mailing
government and the States or tribal [FR Doc. 2017–23469 Filed 10–26–17; 8:45 am]
address and changed ‘‘JWOD’’ to
governments, or on the distribution of BILLING CODE 6560–50–P
‘‘AbilityOne’’ the operating name of the
power and responsibilities among the agency since 2010. Changes to this
various levels of government or between section of the CFR were last made in
the Federal Government and Indian COMMITTEE FOR PURCHASE FROM 1994. On July 18, 2017, the Committee
tribes. Thus, EPA has determined that PEOPLE WHO ARE BLIND OR published a proposed rule outlining
Executive Order 13132, entitled SEVERELY DISABLED these changes on https://
‘‘Federalism’’ (64 FR 43255, August 10, www.federalregister.gov/. No comments
1999), and Executive Order 13175, 41 CFR Part 51–11
were received and this rule is being
entitled ‘‘Consultation and Coordination RIN 3037–AA04 finalized with no additional changes.
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply Touhy Regulations Regulatory Analysis
to this action. In addition, this action Executive Order 12866, Regulatory
does not impose any enforceable duty or AGENCY: Committee for Purchase From
People Who Are Blind or Severely Planning and Review, and Executive
contain any unfunded mandate as Order 13563, Improving Regulation and
described under Title II of the Unfunded Disabled.
ACTION: Final rule.
Regulatory Review
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.). Executive Orders 12866 and 13563
SUMMARY: The Committee for Purchase direct agencies to assess all costs and
This action does not involve any
From People Who Are Blind or Severely benefits of available regulatory
technical standards that would require
Disabled (Committee) has revised alternatives and, if regulation is
EPA’s consideration of voluntary
procedures to respond to subpoenas or necessary, to select regulatory
consensus standards pursuant to section
other official demands for information approaches that maximize net benefits
12(d) of the National Technology
and testimony served upon itself or its (including potential economic,
Transfer and Advancement Act
employees. environmental, public health and safety
(NTTAA) (15 U.S.C. 272 note).
DATES: This rule is effective November effects, distribute impacts, and equity).
V. Congressional Review Act 27, 2017 Executive Order 13563 emphasizes the
asabaliauskas on DSKBBXCHB2PROD with RULES
Pursuant to the Congressional Review FOR FURTHER INFORMATION CONTACT: importance of quantifying both costs
Act (5 U.S.C. 801 et seq.), EPA will Timi Kenealy, (703) 603–2100, Email: and benefits, of reducing costs, of
submit a report containing this rule and CMTEFedReg@AbilityOne.gov. harmonizing rules, and of promoting
other required information to the U.S. SUPPLEMENTARY INFORMATION: flexibility. This rule benefits the public
Senate, the U.S. House of and the United States Government by
Representatives, and the Comptroller Background providing clear procedures for members
General of the United States prior to The Committee, operating as the U.S. of the public and Government
publication of the rule in the Federal AbilityOne Commission, administers employees to follow when official
VerDate Sep<11>2014 16:30 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\27OCR1.SGM 27OCR1](https://thefederalregister.org/doc/82_FR_49952/page/3.svg)
Document Created: 2017-10-27 02:06:42
Document Modified: 2017-10-27 02:06:42
| 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 October 27, 2017. Objections and requests for hearings must be received on or before December 26, 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 number: (703) 305-7090; email | |
| FR Citation | 82 FR 49745 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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