83 FR 17498 - Bacillus subtilis
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 77 (April 20, 2018)
Federal Register Volume 83, Issue 77 (April 20, 2018)
| Page Range | 17498-17500 | |
| FR Document | 2018-08317 |
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)] [Rules and Regulations] [Pages 17498-17500] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08317] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0186; FRL-9971-55] Bacillus subtilis strain FMCH002; 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 subtilis strain FMCH002 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 subtilis strain FMCH002 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-2017-0186, 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 [[Page 17499]] 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). 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-2017-0186 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-2017-0186, 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 6F8515) by FMC Corporation, FMC Tower at Cira Center South, 2929 Walnut Street, 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 subtilis strain FMCH002 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. One comment was received in response to the notice of filing. EPA's response to this comment is discussed in Unit III.C. EPA added ``for residues'' and ``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 subtilis strain FMCH002 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 subtilis strain FMCH002.'' 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 subtilis strain FMCH002 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, such exposure is unlikely to cause any 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 subtilis strain FMCH002. 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 subtilis strain FMCH002. Therefore, an exemption from the requirement of a tolerance is established for residues of Bacillus subtilis strain FMCH002 in or on all food commodities when used in [[Page 17500]] 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. C. Response to Comments One comment on the Notice of Filing was received. That comment opposed allowing residues of this pesticide on food but provided no additional information to support a conclusion that the substance is unsafe. EPA evaluated the available information on Bacillus subtilis strain FMCH002, including toxicity and potential exposure, and concluded, in accordance with the statutory requirements of the FFDCA, that the exemption would be safe. The commenter has provided no basis for a different conclusion. 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. 180.1351 to subpart D to read as follows: Sec. 180.1351 Bacillus subtilis strain FMCH002; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Bacillus subtilis strain FMCH002 in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2018-08317 Filed 4-19-18; 8:45 am] BILLING CODE 6560-50-P
![17498 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations
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_17575/page/1.svg)
![Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations 17499
Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified other exposures for which there is
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP– reliable information.’’ This includes
(703) 305–7090; email address: 2017–0186, by one of the following exposure through drinking water and in
BPPDFRNotices@epa.gov. methods: residential settings but does not include
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// occupational exposure. Pursuant to
www.regulations.gov. Follow the online FFDCA section 408(c)(2)(B), in
I. General Information instructions for submitting comments. establishing or maintaining in effect an
A. Does this action apply to me? Do not submit electronically any exemption from the requirement of a
information you consider to be CBI or tolerance, EPA must take into account
You may be potentially affected by
other information whose disclosure is the factors set forth in FFDCA section
this action if you are an agricultural
restricted by statute. 408(b)(2)(C), which require EPA to give
producer, food manufacturer, or
• Mail: OPP Docket, Environmental special consideration to exposure of
pesticide manufacturer. The following
Protection Agency Docket Center (EPA/ infants and children to the pesticide
list of North American Industrial
DC), (28221T), 1200 Pennsylvania Ave., chemical residue in establishing a
Classification System (NAICS) codes is
NW, Washington, DC 20460–0001. tolerance or tolerance exemption and to
not intended to be exhaustive, but rather • Hand Delivery: To make special ‘‘ensure that there is a reasonable
provides a guide to help readers arrangements for hand delivery or certainty that no harm will result to
determine whether this document delivery of boxed information, please infants and children from aggregate
applies to them. Potentially affected follow the instructions at http:// exposure to the pesticide chemical
entities may include: www.epa.gov/dockets/contacts.html. residue . . . .’’ Additionally, FFDCA
• Crop production (NAICS code 111). Additional instructions on commenting section 408(b)(2)(D) requires that EPA
• Animal production (NAICS code or visiting the docket, along with more consider ‘‘available information
112). information about dockets generally, is concerning the cumulative effects of [a
• Food manufacturing (NAICS code available at http://www.epa.gov/ particular pesticide’s] . . . residues
311). dockets. and other substances that have a
• Pesticide manufacturing (NAICS
II. Background common mechanism of toxicity.’’
code 32532).
EPA evaluated the available toxicity
B. How can I get electronic access to In the Federal Register of July 26, and exposure data on Bacillus subtilis
other related information? 2017 (82 FR 34664) (FRL–9963–50), strain FMCH002 and considered its
EPA issued a document pursuant to validity, completeness, and reliability,
You may access a frequently updated FFDCA section 408(d)(3), 21 U.S.C.
electronic version of 40 CFR part 180 as well as the relationship of this
346a(d)(3), announcing the filing of a information to human risk. A full
through the Government Printing pesticide tolerance petition (PP 6F8515)
Office’s e-CFR site at http:// explanation of the data upon which EPA
by FMC Corporation, FMC Tower at Cira relied and its risk assessment based on
www.ecfr.gov/cgi-bin/text-idx?&c= Center South, 2929 Walnut Street,
ecfr&tpl=/ecfrbrowse/Title40/40tab_ that data can be found within the
Philadelphia, PA 19104. The petition document entitled ‘‘Federal Food, Drug,
02.tpl. requested that 40 CFR part 180 be and Cosmetic Act (FFDCA)
C. How can I file an objection or hearing amended by establishing an exemption Considerations for Bacillus subtilis
request? from the requirement of a tolerance for strain FMCH002.’’ This document, as
Under FFDCA section 408(g), 21 residues of Bacillus subtilis strain well as other relevant information, is
U.S.C. 346a(g), any person may file an FMCH002 in or on all food available in the docket for this action as
objection to any aspect of this regulation commodities. That document referenced described under ADDRESSES.
and may also request a hearing on those a summary of the petition prepared by Based upon its evaluation, EPA
objections. You must file your objection the petitioner FMC Corporation, which concludes that Bacillus subtilis strain
or request a hearing on this regulation is available in the docket via http:// FMCH002 is not toxic, not pathogenic,
in accordance with the instructions www.regulations.gov. One comment was and not infective. Although there may
provided in 40 CFR part 178. To ensure received in response to the notice of be some exposure to residues when
proper receipt by EPA, you must filing. EPA’s response to this comment used on all food commodities in
identify docket ID number EPA–HQ– is discussed in Unit III.C. accordance with label directions and
OPP–2017–0186 in the subject line on EPA added ‘‘for residues’’ and ‘‘in or good agricultural practices, such
the first page of your submission. All on all food commodities’’ to align with exposure is unlikely to cause any
objections and requests for a hearing the Agency’s language and to more adverse effects. EPA also determined
must be in writing, and must be clearly define the petitioner’s request. that retention of the Food Quality
received by the Hearing Clerk on or III. Final Rule Protection Act (FQPA) safety factor was
before June 19, 2018. Addresses for mail not necessary as part of the qualitative
and hand delivery of objections and A. EPA’s Safety Determination assessment conducted for Bacillus
hearing requests are provided in 40 CFR Section 408(c)(2)(A)(i) of FFDCA subtilis strain FMCH002.
178.25(b). allows EPA to establish an exemption Based upon its evaluation, EPA
In addition to filing an objection or from the requirement for a tolerance (the concludes that there is a reasonable
hearing request with the Hearing Clerk legal limit for a pesticide chemical certainty that no harm will result to the
as described in 40 CFR part 178, please residue in or on a food) only if EPA U.S. population, including infants and
sradovich on DSK3GMQ082PROD with RULES
submit a copy of the filing (excluding determines that the exemption is ‘‘safe.’’ children, from aggregate exposure to
any Confidential Business Information Section 408(c)(2)(A)(ii) of FFDCA residues of Bacillus subtilis strain
(CBI)) for inclusion in the public docket. defines ‘‘safe’’ to mean that ‘‘there is a FMCH002. Therefore, an exemption
Information not marked confidential reasonable certainty that no harm will from the requirement of a tolerance is
pursuant to 40 CFR part 2 may be result from aggregate exposure to the established for residues of Bacillus
disclosed publicly by EPA without prior pesticide chemical residue, including subtilis strain FMCH002 in or on all
notice. Submit the non-CBI copy of your all anticipated dietary exposures and all food commodities when used in
VerDate Sep<11>2014 15:57 Apr 19, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\20APR1.SGM 20APR1](https://thefederalregister.org/doc/83_FR_17575/page/2.svg)
![17500 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations
accordance with label directions and subject to OMB approval under the EPA’s consideration of voluntary
good agricultural practices. Paperwork Reduction Act (PRA) (44 consensus standards pursuant to section
U.S.C. 3501 et seq.) nor does it require 12(d) of the National Technology
B. Analytical Enforcement Methodology
any special considerations under Transfer and Advancement Act
EPA is establishing an exemption Executive Order 12898, entitled (NTTAA) (15 U.S.C. 272 note).
from a tolerance on all food ‘‘Federal Actions to Address
commodities without any numerical V. Congressional Review Act
Environmental Justice in Minority
limitation, and thus an analytical Populations and Low-Income Pursuant to the Congressional Review
method is not required for enforcement Populations’’ (59 FR 7629, February 16, Act (5 U.S.C. 801 et seq.), EPA will
purposes. 1994). submit a report containing this rule and
C. Response to Comments Since tolerances and exemptions that other required information to the U.S.
are established on the basis of a petition Senate, the U.S. House of
One comment on the Notice of Filing Representatives, and the Comptroller
under FFDCA section 408(d), such as
was received. That comment opposed General of the United States prior to
the tolerance exemptions in this action,
allowing residues of this pesticide on publication of the rule in the Federal
do not require the issuance of a
food but provided no additional Register. This action is not a ‘‘major
proposed rule, the requirements of the
information to support a conclusion that
Regulatory Flexibility Act (RFA) (5 rule’’ as defined by 5 U.S.C. 804(2).
the substance is unsafe. EPA evaluated
U.S.C. 601 et seq.) do not apply. List of Subjects in 40 CFR Part 180
the available information on Bacillus
subtilis strain FMCH002, including This action directly regulates growers,
food processors, food handlers, and food Environmental protection,
toxicity and potential exposure, and
retailers, not States or tribes. As a result, Administrative practice and procedure,
concluded, in accordance with the
this action does not alter the Agricultural commodities, Pesticides
statutory requirements of the FFDCA,
relationships or distribution of power and pests, Reporting and recordkeeping
that the exemption would be safe. The
and responsibilities established by requirements.
commenter has provided no basis for a
different conclusion. Congress in the preemption provisions Dated: March 16, 2018.
of FFDCA section 408(n)(4). As such, Richard P. Keigwin, Jr.,
IV. Statutory and Executive Order EPA has determined that this action will Director, Office of Pesticide Programs.
Reviews not have a substantial direct effect on
This action establishes exemptions States or tribal governments, on the Therefore, 40 CFR chapter I is
from the requirement of a tolerance relationship between the national amended as follows:
under FFDCA section 408(d) in government and the States or tribal
governments, or on the distribution of PART 180—[AMENDED]
response to a petition submitted to EPA.
The Office of Management and Budget power and responsibilities among the
■ 1. The authority citation for part 180
(OMB) has exempted these types of various levels of government or between
continues to read as follows:
actions from review under Executive the Federal Government and Indian
Order 12866, entitled ‘‘Regulatory tribes. Thus, EPA has determined that Authority: 21 U.S.C. 321(q), 346a and 371.
Planning and Review’’ (58 FR 51735, Executive Order 13132, entitled ■ 2. Add § 180.1351 to subpart D to read
October 4, 1993). Because this action ‘‘Federalism’’ (64 FR 43255, August 10, as follows:
has been exempted from review under 1999), and Executive Order 13175,
Executive Order 12866, this action is entitled ‘‘Consultation and Coordination § 180.1351 Bacillus subtilis strain
FMCH002; exemption from the requirement
not subject to Executive Order 13211, with Indian Tribal Governments’’ (65 FR
of a tolerance.
entitled ‘‘Actions Concerning 67249, November 9, 2000), do not apply
Regulations That Significantly Affect to this action. In addition, this action An exemption from the requirement
Energy Supply, Distribution, or Use’’ (66 does not impose any enforceable duty or of a tolerance is established for residues
FR 28355, May 22, 2001), or Executive contain any unfunded mandate as of Bacillus subtilis strain FMCH002 in
Order 13045, entitled ‘‘Protection of described under Title II of the Unfunded or on all food commodities when used
Children from Environmental Health Mandates Reform Act (UMRA) (2 U.S.C. in accordance with label directions and
Risks and Safety Risks’’ (62 FR 19885, 1501 et seq.). good agricultural practices.
April 23, 1997). This action does not This action does not involve any [FR Doc. 2018–08317 Filed 4–19–18; 8:45 am]
contain any information collections technical standards that would require BILLING CODE 6560–50–P
sradovich on DSK3GMQ082PROD with RULES
VerDate Sep<11>2014 15:57 Apr 19, 2018 Jkt 244001 PO 00000 Frm 00024 Fmt 4700 Sfmt 9990 E:\FR\FM\20APR1.SGM 20APR1](https://thefederalregister.org/doc/83_FR_17575/page/3.svg)
Document Created: 2018-04-20 00:02:55
Document Modified: 2018-04-20 00:02:55
| 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, DC 20460-0001; main telephone number: | |
| FR Citation | 83 FR 17498 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR