83 FR 47074 - Beauveria bassiana Strain PPRI 5339; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 181 (September 18, 2018)
Federal Register Volume 83, Issue 181 (September 18, 2018)
| Page Range | 47074-47076 | |
| FR Document | 2018-20285 |
[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)] [Rules and Regulations] [Pages 47074-47076] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20285] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0608; FRL-9983-67] Beauveria bassiana Strain PPRI 5339; 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 Beauveria bassiana strain PPRI 5339 in or on all food commodities when this pesticide chemical is used in accordance with label directions and good agricultural practices. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Beauveria bassiana strain PPRI 5339 in or on all food commodities under FFDCA. DATES: This regulation is effective September 18, 2018. Objections and requests for hearings must be received on or before November 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-2016-0608, 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]. [[Page 47075]] 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-2016-0608 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 November 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-2016-0608, 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 December 20, 2016 (81 FR 92758) (FRL- 9956-04), 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 6F8485) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the insecticide Beauveria bassiana strain PPRI 5339 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner BASF Corporation and 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 of 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 Beauveria bassiana strain PPRI 5339 and considered their 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 document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Beauveria bassiana strain PPRI 5339'' (Safety Determination). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. The available data demonstrated that Beauveria bassiana strain PPRI 5339 is not toxic, pathogenic, or infective through most of the routes of exposure, except through inhalation where it is highly toxic by itself (100% active ingredient). When Beauveria bassiana strain PPRI 5339 is combined with an oil and its concentration is decreased (8% active ingredient), however, data demonstrated it is not toxic through inhalation. Although there may be some exposure to residues when Beauveria bassiana strain PPRI 5339 is used on food commodities in accordance with label directions and good agricultural practices, there is a lack of concern due to the lack of toxicity from dietary exposure to Beauveria bassiana strain PPRI 5339. There are no residential uses currently associated with Beauveria bassiana strain PPRI 5339. In the event residential uses may be sought in the future, those exposures would not be aggregated with the dietary exposure due to the difference in toxic effects. Moreover, EPA intends to mitigate the potential for inhalation risk through terms on any associated registration(s). EPA also determined in the Safety Determination that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Beauveria bassiana strain PPRI 5339. Based upon its evaluation in the Safety Determination, EPA concludes that there is a reasonable certainty that [[Page 47076]] no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Beauveria bassiana strain PPRI 5339. Therefore, an exemption from the requirement of a tolerance is established for residues of Beauveria bassiana strain PPRI 5339 in or on all food commodities when this pesticide chemical is used in accordance with label directions and good agricultural practices. B. Analytical Enforcement Methodology An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation. IV. Statutory and Executive Order Reviews This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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: September 7, 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. 180.1362 to subpart D to read as follows: Sec. 180.1362 Beauveria bassiana strain PPRI 5339; exemption from the requirement of a tolerance. Residues of Beauveria bassiana strain PPRI 5339 are exempt from the requirement of a tolerance in or on all food commodities when this pesticide chemical is used in accordance with label directions and good agricultural practices. [FR Doc. 2018-20285 Filed 9-17-18; 8:45 am] BILLING CODE 6560-50-P
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of Management and Budget under U.S. Senate, the U.S. House of ENVIRONMENTAL PROTECTION
Executive Orders 12866 (58 FR 51735, Representatives, and the Comptroller AGENCY
October 4, 1993) and 13563 (76 FR 3821, General of the United States prior to
January 21, 2011); publication of the rule in the Federal 40 CFR Part 180
• is not an Executive Order 13771 (82 Register. A major rule cannot take effect [EPA–HQ–OPP–2016–0608; FRL–9983–67]
FR 9339, February 2, 2017) regulatory until 60 days after it is published in the
action because actions such as SIP Federal Register. This action is not a Beauveria bassiana Strain PPRI 5339;
approvals are exempted under ‘‘major rule’’ as defined by 5 U.S.C. Exemption From the Requirement of a
Executive Order 12866; 804(2). Tolerance
• does not impose an information
Under section 307(b)(1) of the Clean AGENCY: Environmental Protection
collection burden under the provisions
Air Act, petitions for judicial review of Agency (EPA).
of the Paperwork Reduction Act (44
this action must be filed in the United
U.S.C. 3501 et seq.); ACTION: Final rule.
• is certified as not having a States Court of Appeals for the
significant economic impact on a appropriate circuit by November 19, SUMMARY: This regulation establishes an
substantial number of small entities 2018. Filing a petition for exemption from the requirement of a
under the Regulatory Flexibility Act (5 reconsideration by the Administrator of tolerance for residues of Beauveria
U.S.C. 601 et seq.); this final rule does not affect the finality bassiana strain PPRI 5339 in or on all
• does not contain any unfunded of this action for the purposes of judicial food commodities when this pesticide
mandate or significantly or uniquely review nor does it extend the time chemical is used in accordance with
affect small governments, as described within which a petition for judicial label directions and good agricultural
in the Unfunded Mandates Reform Act review may be filed, and shall not practices. BASF Corporation submitted
of 1995 (Pub. L. 104–4); postpone the effectiveness of such rule a petition to EPA under the Federal
• does not have Federalism or action. This action may not be Food, Drug, and Cosmetic Act (FFDCA),
implications as specified in Executive challenged later in proceedings to requesting an exemption from the
Order 13132 (64 FR 43255, August 10, enforce its requirements (See section requirement of a tolerance. This
1999); 307(b)(2)). regulation eliminates the need to
• is not an economically significant List of Subjects in 40 CFR Part 52 establish a maximum permissible level
regulatory action based on health or for residues of Beauveria bassiana strain
safety risks subject to Executive Order Environmental protection, Air PPRI 5339 in or on all food commodities
13045 (62 FR 19885, April 23, 1997); pollution control, Carbon monoxide, under FFDCA.
• is not a significant regulatory action Incorporation by reference, DATES: This regulation is effective
subject to Executive Order 13211 (66 FR Intergovernmental relations, Lead, September 18, 2018. Objections and
28355, May 22, 2001); Nitrogen dioxide, Ozone, Particulate requests for hearings must be received
• is not subject to requirements of matter, Reporting and recordkeeping on or before November 19, 2018, and
Section 12(d) of the National requirements, Sulfur oxides, Volatile must be filed in accordance with the
Technology Transfer and Advancement organic compounds. instructions provided in 40 CFR part
Act of 1995 (15 U.S.C. 272 note) because 178 (see also Unit I.C. of the
Authority: 42 U.S.C. 7401 et seq.
this action does not involve technical SUPPLEMENTARY INFORMATION).
standards; and Dated: September 5, 2018.
• does not provide the EPA with the ADDRESSES: The docket for this action,
Chris Hladick,
discretionary authority to address, as identified by docket identification (ID)
Regional Administrator, Region 10.
appropriate, disproportionate human number EPA–HQ–OPP–2016–0608, is
health or environmental effects, using 40 CFR part 52 is amended as follows: available at http://www.regulations.gov
practicable and legally permissible or at the Office of Pesticide Programs
methods, under Executive Order 12898 PART 52—APPROVAL AND Regulatory Public Docket (OPP Docket)
(59 FR 7629, February 16, 1994). PROMULGATION OF in the Environmental Protection Agency
The SIP is not approved to apply on IMPLEMENTATION PLANS Docket Center (EPA/DC), West William
any Indian reservation land and is also Jefferson Clinton Bldg., Rm. 3334, 1301
not approved to apply in any other area ■ 1. The authority citation for Part 52 Constitution Ave. NW, Washington, DC
where the EPA or an Indian tribe has continues to read as follows: 20460–0001. The Public Reading Room
demonstrated that a tribe has is open from 8:30 a.m. to 4:30 p.m.,
Authority: 42 U.S.C. 7401 et seq.
jurisdiction. In those areas of Indian Monday through Friday, excluding legal
country, the rule does not have tribal Subpart MM—Oregon holidays. The telephone number for the
implications as specified by Executive Public Reading Room is (202) 566–1744,
Order 13175 (65 FR 67249, November 9, and the telephone number for the OPP
■ 2. Section 52.1992 is added to read as
2000). Docket is (703) 305–5805. Please review
follows:
The Congressional Review Act, 5 the visitor instructions and additional
U.S.C. 801 et seq., as added by the Small § 52.1992 Interstate Transport for the 2012 information about the docket available
Business Regulatory Enforcement PM2.5 NAAQS. at http://www.epa.gov/dockets.
Fairness Act of 1996, generally provides (a) The EPA approves Oregon’s SIP FOR FURTHER INFORMATION CONTACT:
that before a rule may take effect, the revision submitted on October 20, 2015, Robert McNally, Biopesticides and
agency promulgating the rule must Pollution Prevention Division (7511P),
daltland on DSKBBV9HB2PROD with RULES
addressing the requirements of CAA
submit a rule report, which includes a section 110(a)(2)(D)(i)(I) for the 2012 Office of Pesticide Programs,
copy of the rule, to each House of the PM2.5 NAAQS. Environmental Protection Agency, 1200
Congress and to the Comptroller General Pennsylvania Ave. NW, Washington, DC
of the United States. The EPA will (b) [Reserved] 20460–0001; main telephone number:
submit a report containing this action [FR Doc. 2018–20172 Filed 9–17–18; 8:45 am] (703) 305–7090; email address:
and other required information to the BILLING CODE 6560–50–P BPPDFRNotices@epa.gov.
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![Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Rules and Regulations 47075
SUPPLEMENTARY INFORMATION: instructions for submitting comments. infants and children to the pesticide
Do not submit electronically any chemical residue in establishing a
I. General Information
information you consider to be CBI or tolerance or tolerance exemption and to
A. Does this action apply to me? other information whose disclosure is ‘‘ensure that there is a reasonable
You may be potentially affected by restricted by statute. certainty that no harm will result to
this action if you are an agricultural • Mail: OPP Docket, Environmental infants and children from aggregate
producer, food manufacturer, or Protection Agency Docket Center (EPA/ exposure to the pesticide chemical
pesticide manufacturer. The following DC), (28221T), 1200 Pennsylvania Ave. residue. . . .’’ Additionally, FFDCA
list of North American Industrial NW, Washington, DC 20460–0001. section 408(b)(2)(D) requires that EPA
Classification System (NAICS) codes is • Hand Delivery: To make special consider ‘‘available information
not intended to be exhaustive, but rather arrangements for hand delivery or concerning the cumulative effects of [a
provides a guide to help readers delivery of boxed information, please particular pesticide’s] . . . residues and
determine whether this document follow the instructions at http:// other substances that have a common
applies to them. Potentially affected www.epa.gov/dockets/contacts.html. mechanism of toxicity.’’
entities may include: Additional instructions on commenting EPA evaluated the available
• Crop production (NAICS code 111). or visiting the docket, along with more toxicological and exposure data on
• Animal production (NAICS code information about dockets generally, is Beauveria bassiana strain PPRI 5339
112). available at http://www.epa.gov/ and considered their validity,
• Food manufacturing (NAICS code dockets. completeness, and reliability, as well as
311). the relationship of this information to
• Pesticide manufacturing (NAICS II. Background human risk. A full explanation of the
code 32532). In the Federal Register of December data upon which EPA relied and its risk
20, 2016 (81 FR 92758) (FRL–9956–04), assessment based on those data can be
B. How can I get electronic access to found within the document entitled
EPA issued a document pursuant to
other related information? ‘‘Federal Food, Drug, and Cosmetic Act
FFDCA section 408(d)(3), 21 U.S.C.
You may access a frequently updated 346a(d)(3), announcing the filing of a (FFDCA) Safety Determination for
electronic version of 40 CFR part 180 pesticide tolerance petition (PP 6F8485) Beauveria bassiana strain PPRI 5339’’
through the Government Printing by BASF Corporation, 26 Davis Dr., (Safety Determination). This document,
Office’s e-CFR site at http://www.ecfr. Research Triangle Park, NC 27709. The as well as other relevant information, is
gov/cgi-bin/text-idx?&c=ecfr&tpl=/ petition requested that 40 CFR part 180 available in the docket for this action as
ecfrbrowse/Title40/40tab_02.tpl. be amended by establishing an described under ADDRESSES.
exemption from the requirement of a The available data demonstrated that
C. How can I file an objection or hearing
tolerance for residues of the insecticide Beauveria bassiana strain PPRI 5339 is
request?
Beauveria bassiana strain PPRI 5339 in not toxic, pathogenic, or infective
Under FFDCA section 408(g), 21 through most of the routes of exposure,
or on all food commodities. That
U.S.C. 346a(g), any person may file an except through inhalation where it is
document referenced a summary of the
objection to any aspect of this regulation highly toxic by itself (100% active
petition prepared by the petitioner
and may also request a hearing on those ingredient). When Beauveria bassiana
BASF Corporation and available in the
objections. You must file your objection strain PPRI 5339 is combined with an
docket via http://www.regulations.gov.
or request a hearing on this regulation oil and its concentration is decreased
There were no comments received in
in accordance with the instructions (8% active ingredient), however, data
response to the notice of filing.
provided in 40 CFR part 178. To ensure demonstrated it is not toxic through
proper receipt by EPA, you must III. Final Rule inhalation. Although there may be some
identify docket ID number EPA–HQ– exposure to residues when Beauveria
A. EPA’s Safety Determination
OPP–2016–0608 in the subject line on bassiana strain PPRI 5339 is used on
the first page of your submission. All Section 408(c)(2)(A)(i) of FFDCA food commodities in accordance with
objections and requests for a hearing allows EPA to establish an exemption label directions and good agricultural
must be in writing, and must be from the requirement of a tolerance (the practices, there is a lack of concern due
received by the Hearing Clerk on or legal limit for a pesticide chemical to the lack of toxicity from dietary
before November 19, 2018. Addresses residue in or on a food) only if EPA exposure to Beauveria bassiana strain
for mail and hand delivery of objections determines that the exemption is ‘‘safe.’’ PPRI 5339. There are no residential uses
and hearing requests are provided in 40 Section 408(c)(2)(A)(ii) of FFDCA currently associated with Beauveria
CFR 178.25(b). defines ‘‘safe’’ to mean that ‘‘there is a bassiana strain PPRI 5339. In the event
In addition to filing an objection or reasonable certainty that no harm will residential uses may be sought in the
hearing request with the Hearing Clerk result from aggregate exposure to the future, those exposures would not be
as described in 40 CFR part 178, please pesticide chemical residue, including aggregated with the dietary exposure
submit a copy of the filing (excluding all anticipated dietary exposures and all due to the difference in toxic effects.
any Confidential Business Information other exposures for which there is Moreover, EPA intends to mitigate the
(CBI)) for inclusion in the public docket. reliable information.’’ This includes potential for inhalation risk through
Information not marked confidential exposure through drinking water and in terms on any associated registration(s).
pursuant to 40 CFR part 2 may be residential settings but does not include EPA also determined in the Safety
disclosed publicly by EPA without prior occupational exposure. Pursuant to Determination that retention of the Food
FFDCA section 408(c)(2)(B), in
daltland on DSKBBV9HB2PROD with RULES
notice. Submit the non-CBI copy of your Quality Protection Act (FQPA) safety
objection or hearing request, identified establishing or maintaining in effect an factor was not necessary as part of the
by docket ID number EPA–HQ–OPP– exemption from the requirement of a qualitative assessment conducted for
2016–0608, by one of the following tolerance, EPA must take into account Beauveria bassiana strain PPRI 5339.
methods: the factors set forth in FFDCA section Based upon its evaluation in the
• Federal eRulemaking Portal: http:// 408(b)(2)(C), which require EPA to give Safety Determination, EPA concludes
www.regulations.gov. Follow the online special consideration to exposure of that there is a reasonable certainty that
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no harm will result to the U.S. relationships or distribution of power § 180.1362 Beauveria bassiana strain PPRI
population, including infants and and responsibilities established by 5339; exemption from the requirement of a
children, from aggregate exposure to Congress in the preemption provisions tolerance.
residues of Beauveria bassiana strain of FFDCA section 408(n)(4). As such, Residues of Beauveria bassiana strain
PPRI 5339. Therefore, an exemption EPA has determined that this action will PPRI 5339 are exempt from the
from the requirement of a tolerance is not have a substantial direct effect on requirement of a tolerance in or on all
established for residues of Beauveria States or tribal governments, on the food commodities when this pesticide
bassiana strain PPRI 5339 in or on all relationship between the national chemical is used in accordance with
food commodities when this pesticide government and the States or tribal label directions and good agricultural
chemical is used in accordance with governments, or on the distribution of practices.
label directions and good agricultural power and responsibilities among the [FR Doc. 2018–20285 Filed 9–17–18; 8:45 am]
practices. various levels of government or between BILLING CODE 6560–50–P
B. Analytical Enforcement Methodology the Federal Government and Indian
tribes. Thus, EPA has determined that
An analytical method is not required Executive Order 13132, entitled ENVIRONMENTAL PROTECTION
because EPA is establishing an ‘‘Federalism’’ (64 FR 43255, August 10, AGENCY
exemption from the requirement of a 1999), and Executive Order 13175,
tolerance without any numerical entitled ‘‘Consultation and Coordination 40 CFR Part 300
limitation. with Indian Tribal Governments’’ (65 FR [EPA–HQ–SFUND–1990–0011; FRL–9983–
IV. Statutory and Executive Order 67249, November 9, 2000), do not apply 84—Region 5]
Reviews to this action. In addition, this action
This action establishes a tolerance does not impose any enforceable duty or National Oil and Hazardous
exemption under FFDCA section 408(d) contain any unfunded mandate as Substances Pollution Contingency
in response to a petition submitted to described under Title II of the Unfunded Plan National Priorities List: Partial
EPA. The Office of Management and Mandates Reform Act (UMRA) (2 U.S.C. Deletion of the Beloit Corporation
Budget (OMB) has exempted these types 1501 et seq.). Superfund Site
of actions from review under Executive This action does not involve any AGENCY: Environmental Protection
Order 12866, entitled ‘‘Regulatory technical standards that would require Agency (EPA).
Planning and Review’’ (58 FR 51735, EPA’s consideration of voluntary
ACTION: Withdrawal of direct final rule.
October 4, 1993). Because this action consensus standards pursuant to section
has been exempted from review under 12(d) of the National Technology SUMMARY: On July 16, 2018, the
Executive Order 12866, this action is Transfer and Advancement Act Environmental Protection Agency (EPA)
not subject to Executive Order 13211, (NTTAA) (15 U.S.C. 272 note). published a Notice of Intent for Partial
entitled ‘‘Actions Concerning Deletion and a direct final Notice of
V. Congressional Review Act
Regulations That Significantly Affect Partial Deletion for the Research Center
Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review Property (RCP) of the Beloit Superfund
FR 28355, May 22, 2001), or Executive Act (5 U.S.C. 801 et seq.), EPA will Site (Beloit Site) from the National
Order 13045, entitled ‘‘Protection of submit a report containing this rule and Priorities List (NPL). EPA is
Children from Environmental Health other required information to the U.S. withdrawing the direct final Notice of
Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of Partial Deletion because EPA did not
April 23, 1997), nor is it considered a Representatives, and the Comptroller provide timely notice of the publication
regulatory action under Executive Order General of the United States prior to of this rulemaking through publication
13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal of an advertisement in a local
and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major newspaper as required by EPA policy.
FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2). DATES: This withdrawal of the direct
does not contain any information final action 83 FR 32798 (July 16, 2018)
collections subject to OMB approval List of Subjects in 40 CFR Part 180
is effective as of September 14, 2018.
under the Paperwork Reduction Act Environmental protection,
(PRA), 44 U.S.C. 3501 et seq., nor does FOR FURTHER INFORMATION CONTACT:
Administrative practice and procedure, Randolph Cano, NPL Deletion
it require any special considerations Agricultural commodities, Pesticides
under Executive Order 12898, entitled Coordinator, U.S. Environmental
and pests, Reporting and recordkeeping Protection Agency Region 5 (SR–6J), 77
‘‘Federal Actions to Address requirements.
Environmental Justice in Minority West Jackson Boulevard, Chicago, IL
Populations and Low-Income Dated: September 7, 2018. 60604, (312) 886–6036, or via email at
Populations’’ (59 FR 7629, February 16, Richard P. Keigwin, Jr., cano.randolph@epa.gov.
1994). Director, Office of Pesticide Programs. SUPPLEMENTARY INFORMATION: On July
Since tolerances and exemptions that 16, 2018, the EPA published a Notice of
are established on the basis of a petition Therefore, 40 CFR chapter I is Intent for Partial Deletion (83 FR 32825)
under FFDCA section 408(d), such as amended as follows: and a direct final Notice of Partial
the tolerance exemption in this action, Deletion (83 FR 32798) for the Research
do not require the issuance of a PART 180—[AMENDED] Center Property (RCP) of the Beloit
Superfund Site (Beloit Site) from the
daltland on DSKBBV9HB2PROD with RULES
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 ■ 1. The authority citation for part 180 National Priorities List (NPL). After
U.S.C. 601 et seq.) do not apply. continues to read as follows: consideration of the comments received,
This action directly regulates growers, Authority: 21 U.S.C. 321(q), 346a and 371. if appropriate, EPA will publish a
food processors, food handlers, and food Notice of Partial Deletion in the Federal
retailers, not States or tribes. As a result, ■ 2. Add § 180.1362 to subpart D to read Register based on the parallel Notice of
this action does not alter the as follows: Intent for Partial Deletion and place a
VerDate Sep<11>2014 16:42 Sep 17, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\FR\FM\18SER1.SGM 18SER1](https://thefederalregister.org/doc/83_FR_47255/page/3.svg)
Document Created: 2018-09-18 01:18:21
Document Modified: 2018-09-18 01:18:21
| 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 September 18, 2018. Objections and requests for hearings must be received on or before November 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 47074 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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