83 FR 27711 - Extract of Swinglea glutinosa;
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 115 (June 14, 2018)
Federal Register Volume 83, Issue 115 (June 14, 2018)
| Page Range | 27711-27713 | |
| FR Document | 2018-12809 |
[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)] [Rules and Regulations] [Pages 27711-27713] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12809] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0565; FRL-9977-75] Extract of Swinglea glutinosa; 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 Extract of Swinglea glutinosa in or on all food commodities when used in accordance with label directions and good agricultural practices. Gowan Company LLC 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 Extract of Swinglea glutinosa under FFDCA. DATES: This regulation is effective June 14, 2018. Objections and requests for hearings must be received on or before August 13, 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-2017-0565, 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). 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-2017-0565 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 August 13, 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-2017-0565, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Background In the Federal Register of January 26, 2018 (83 FR 3658) (FRL-9971- 46), 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 6F8504) by Gowan Company LLC, P.O. Box 5569, Yuma, AZ 85366-5569. The petition requested that 40 CFR 180 be amended by establishing an exemption from the [[Page 27712]] requirement of a tolerance for residues of the biochemical fungicide Extract of Swinglea glutinosa in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner, Gowan Company LLC, 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.'' FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. EPA evaluated the available toxicity and exposure data on Extract of Swinglea glutinosa and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Extract of Swinglea glutinosa is extracted from the leaves of Swinglea glutinosa. Commonly known as Tabog, the plant is found in southeast Asian and South American countries and is also commercially cultivated for ornamental purposes. As a pesticidal active ingredient, Extract of Swinglea glutinosa is intended for use as a fungicide on growing crops and ornamentals in agricultural, greenhouse, turf, recreational, and commercial landscape use sites to control fungal diseases such as powdery mildew and sour rot. The antifungal mode of action (MOA) of Extract of Swinglea glutinosa is likely cell membrane disruption, attributable to the terpene constituents in the essential oil of the extract. This mode of action is similar to that observed in other essential oils that are considered biopesticides, such as tea tree oil, rosemary oil and thyme oil. The constituent compounds in Extract of Swinglea glutinosa are ubiquitous in fruits and vegetables and are regularly consumed by humans as part of a normal diet. The constituent compounds are also biodegradable; and the active ingredient is highly soluble in water and will degrade rapidly in aqueous environments. Based on the data submitted in support of this petition and the dietary risk assessment conducted by the Agency, EPA concludes that there is a reasonable certainty of no harm from aggregate exposures to Extract of Swinglea glutinosa, including the consumption of food treated with this active ingredient in accordance with label directions and good agricultural practices. EPA has made this determination because available toxicology data indicate that the active ingredient is not acutely toxic, subchronically toxic, mutagenic, or developmentally toxic via repeat oral exposure. As such, the Agency has not identified any endpoints of concern for Extract of Swinglea glutinosa and has conducted a qualitative assessment of exposure. The Agency has also determined that residues Extract of Swinglea glutinosa in drinking water are not expected to be significant when products are used according to label instructions. The active ingredient is applied at low concentrations, is very soluble in water, and degrades rapidly in aqueous solutions. Non-occupational exposures are not expected since Extract of Swinglea glutinosa is only intended for commercial agricultural and landscaping use. A full explanation of the data upon which EPA relied and its dietary risk assessment based on those data can be found within the April 10, 2018, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Extract of Swinglea glutinosa.'' 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 Extract of Swinglea glutinosa is not toxic. No toxic endpoints were established for oral toxicity, dermal toxicity or inhalation toxicity. Exposure to Extract of Swinglea glutinosa via pesticidal use is not expected to exceed any levels of concern. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary due to the lack of threshold effects. Therefore, 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 Extract of Swinglea glutinosa. Therefore, EPA is establishing an exemption from the requirement of a tolerance for residues of Extract of Swinglea glutinosa when applied pre-harvest in accordance with label directions and good agricultural practices. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes due to the lack of concern about safety for Extract of Swinglea glutinosa at any exposure level. 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 [[Page 27713]] 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: May 29, 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. 180.1356 to subpart D to read as follows: Sec. 180.1356 Extract of Swinglea glutinosa; exemption from the requirement of a tolerance. Residues of the biochemical pesticide Extract of Swinglea glutinosa are exempt from the requirement of a tolerance in or on all food commodities when applied pre-harvest in accordance with label directions and good agricultural practices. [FR Doc. 2018-12809 Filed 6-13-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27711
anchor within the safety zone unless provided in 40 CFR part 178 (see also C. How can I file an objection or hearing
authorized by the Captain of the Port Unit I.C. of the SUPPLEMENTARY request?
Detroit (COTP), or his on-scene INFORMATION).
Under FFDCA section 408(g), 21
representative. U.S.C. 346a(g), any person may file an
(2) The safety zone is closed to all ADDRESSES: The docket for this action,
identified by docket identification (ID) objection to any aspect of this regulation
vessel traffic, except as may be and may also request a hearing on those
permitted by the COTP or his on-scene number EPA–HQ–OPP–2017–0565, is
available at http://www.regulations.gov objections. You must file your objection
representative. or request a hearing on this regulation
(3) The ‘‘on-scene representative’’ of or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in accordance with the instructions
COTP is any Coast Guard
in the Environmental Protection Agency provided in 40 CFR part 178. To ensure
commissioned, warrant or petty officer
Docket Center (EPA/DC), West William proper receipt by EPA, you must
or a Federal, State, or local law
Jefferson Clinton Bldg., Rm. 3334, 1301 identify docket ID number EPA–HQ–
enforcement officer designated by or
Constitution Ave. NW, Washington, DC OPP–2017–0565 in the subject line on
assisting the Captain of the Port Detroit
20460–0001. The Public Reading Room the first page of your submission. All
to act on his behalf.
is open from 8:30 a.m. to 4:30 p.m., objections and requests for a hearing
(4) Vessel operators shall contact the
Monday through Friday, excluding legal must be in writing, and must be
COTP or his on-scene representative to
holidays. The telephone number for the received by the Hearing Clerk on or
obtain permission to enter or operate
Public Reading Room is (202) 566–1744, before August 13, 2018. Addresses for
within the safety zone. The COTP or his
and the telephone number for the OPP mail and hand delivery of objections
on-scene representative may be
Docket is (703) 305–5805. Please review and hearing requests are provided in 40
contacted via VHF Channel 16 or at
the visitor instructions and additional CFR 178.25(b).
(313) 568–9464. Vessel operators given
information about the docket available In addition to filing an objection or
permission to enter or operate in the
at http://www.epa.gov/dockets. hearing request with the Hearing Clerk
regulated area must comply with all
as described in 40 CFR part 178, please
directions given to them by the COTP or FOR FURTHER INFORMATION CONTACT: submit a copy of the filing (excluding
his on-scene representative. Robert McNally, Biopesticides and any Confidential Business Information
Dated: June 6, 2018. Pollution Prevention Division (7511P), (CBI)) for inclusion in the public docket.
Jeffrey W. Novak, Office of Pesticide Programs, Information not marked confidential
Captain, U.S. Coast Guard, Captain of the Environmental Protection Agency, 1200 pursuant to 40 CFR part 2 may be
Port Detroit. Pennsylvania Ave. NW, Washington, DC disclosed publicly by EPA without prior
[FR Doc. 2018–12756 Filed 6–13–18; 8:45 am] 20460–0001; main telephone number: notice. Submit the non-CBI copy of your
BILLING CODE 9110–04–P (703) 305–7090; email address: objection or hearing request, identified
BPPDFRNotices@epa.gov. by docket ID number EPA–HQ–OPP–
SUPPLEMENTARY INFORMATION:
2017–0565, by one of the following
ENVIRONMENTAL PROTECTION methods:
AGENCY I. General Information • Federal eRulemaking Portal: http://
www.regulations.gov. Follow the online
A. Does this Action apply to me? instructions for submitting comments.
40 CFR Part 180
You may be potentially affected by Do not submit electronically any
[EPA–HQ–OPP–2017–0565; FRL–9977–75]
this action if you are an agricultural information you consider to be CBI or
Extract of Swinglea glutinosa; producer, food manufacturer, or other information whose disclosure is
Exemption From the Requirement of a pesticide manufacturer. The following restricted by statute.
Tolerance list of North American Industrial • Mail: OPP Docket, Environmental
Classification System (NAICS) codes is Protection Agency Docket Center (EPA/
AGENCY: Environmental Protection DC), (28221T), 1200 Pennsylvania Ave.
not intended to be exhaustive, but rather
Agency (EPA). NW, Washington, DC 20460–0001.
provides a guide to help readers
ACTION: Final rule. determine whether this document • Hand Delivery: To make special
applies to them. Potentially affected arrangements for hand delivery or
SUMMARY: This regulation establishes an delivery of boxed information, please
exemption from the requirement of a entities may include:
follow the instructions at http://
tolerance for Extract of Swinglea • Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
glutinosa in or on all food commodities • Animal production (NAICS code Additional instructions on commenting
when used in accordance with label 112). or visiting the docket, along with more
directions and good agricultural information about dockets generally, is
practices. Gowan Company LLC • Food manufacturing (NAICS code
311). available at http://www.epa.gov/
submitted a petition to EPA under the dockets.
Federal Food, Drug, and Cosmetic Act • Pesticide manufacturing (NAICS
(FFDCA) requesting an exemption from code 32532). II. Background
the requirement of a tolerance. This In the Federal Register of January 26,
B. How can I get electronic access to
regulation eliminates the need to 2018 (83 FR 3658) (FRL–9971–46), EPA
other related information?
establish a maximum permissible level issued a document pursuant to FFDCA
for residues of Extract of Swinglea You may access a frequently updated section 408(d)(3), 21 U.S.C. 346a(d)(3),
daltland on DSKBBV9HB2PROD with RULES
glutinosa under FFDCA. electronic version of 40 CFR part 180 announcing the filing of a pesticide
DATES: This regulation is effective June through the Government Printing tolerance petition (PP 6F8504) by
14, 2018. Objections and requests for Office’s e-CFR site at http:// Gowan Company LLC, P.O. Box 5569,
hearings must be received on or before www.ecfr.gov/cgi-bin/text- Yuma, AZ 85366–5569. The petition
August 13, 2018, and must be filed in idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ requested that 40 CFR 180 be amended
accordance with the instructions 40tab_02.tpl. by establishing an exemption from the
VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1](https://thefederalregister.org/doc/83_FR_27826/page/1.svg)
![27712 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations
requirement of a tolerance for residues data available to EPA support the choice products are used according to label
of the biochemical fungicide Extract of of a different factor. instructions. The active ingredient is
Swinglea glutinosa in or on all food EPA evaluated the available toxicity applied at low concentrations, is very
commodities. That document referenced and exposure data on Extract of soluble in water, and degrades rapidly
a summary of the petition prepared by Swinglea glutinosa and considered their in aqueous solutions. Non-occupational
the petitioner, Gowan Company LLC, validity, completeness, and reliability, exposures are not expected since Extract
which is available in the docket via as well as the relationship of this of Swinglea glutinosa is only intended
http://www.regulations.gov. There were information to human risk. EPA also for commercial agricultural and
no comments received in response to considered available information landscaping use. A full explanation of
the notice of filing. concerning the variability of the the data upon which EPA relied and its
sensitivities of major identifiable dietary risk assessment based on those
III. Final Rule subgroups of consumers, including data can be found within the April 10,
A. EPA’s Safety Determination infants and children. 2018, document entitled ‘‘Federal Food,
Extract of Swinglea glutinosa is Drug, and Cosmetic Act (FFDCA)
Section 408(c)(2)(A)(i) of FFDCA extracted from the leaves of Swinglea Considerations for Extract of Swinglea
allows EPA to establish an exemption glutinosa. Commonly known as Tabog, glutinosa.’’ This document, as well as
from the requirement for a tolerance (the the plant is found in southeast Asian other relevant information, is available
legal limit for a pesticide chemical and South American countries and is in the docket for this action as described
residue in or on a food) only if EPA also commercially cultivated for under ADDRESSES.
determines that the exemption is ‘‘safe.’’ ornamental purposes. As a pesticidal Based upon its evaluation, EPA
Section 408(c)(2)(A)(ii) of FFDCA active ingredient, Extract of Swinglea concludes that Extract of Swinglea
defines ‘‘safe’’ to mean that ‘‘there is a glutinosa is intended for use as a glutinosa is not toxic. No toxic
reasonable certainty that no harm will fungicide on growing crops and endpoints were established for oral
result from aggregate exposure to the ornamentals in agricultural, greenhouse, toxicity, dermal toxicity or inhalation
turf, recreational, and commercial toxicity. Exposure to Extract of Swinglea
pesticide chemical residue, including
landscape use sites to control fungal glutinosa via pesticidal use is not
all anticipated dietary exposures and all
diseases such as powdery mildew and expected to exceed any levels of
other exposures for which there is
sour rot. The antifungal mode of action concern. EPA also determined that
reliable information.’’ This includes
(MOA) of Extract of Swinglea glutinosa retention of the Food Quality Protection
exposure through drinking water and in
is likely cell membrane disruption, Act (FQPA) safety factor was not
residential settings but does not include attributable to the terpene constituents
occupational exposure. Pursuant to necessary due to the lack of threshold
in the essential oil of the extract. This effects.
FFDCA section 408(c)(2)(B), in mode of action is similar to that Therefore, EPA concludes that there is
establishing or maintaining in effect an observed in other essential oils that are a reasonable certainty that no harm will
exemption from the requirement of a considered biopesticides, such as tea result to the U.S. population, including
tolerance, EPA must take into account tree oil, rosemary oil and thyme oil. The infants and children, from aggregate
the factors set forth in FFDCA section constituent compounds in Extract of exposure to residues of Extract of
408(b)(2)(C), which require EPA to give Swinglea glutinosa are ubiquitous in Swinglea glutinosa. Therefore, EPA is
special consideration to exposure of fruits and vegetables and are regularly establishing an exemption from the
infants and children to the pesticide consumed by humans as part of a requirement of a tolerance for residues
chemical residue in establishing a normal diet. The constituent of Extract of Swinglea glutinosa when
tolerance or tolerance exemption and to compounds are also biodegradable; and applied pre-harvest in accordance with
‘‘ensure that there is a reasonable the active ingredient is highly soluble in label directions and good agricultural
certainty that no harm will result to water and will degrade rapidly in practices.
infants and children from aggregate aqueous environments.
exposure to the pesticide chemical Based on the data submitted in B. Analytical Enforcement Methodology
residue . . . .’’ Additionally, FFDCA support of this petition and the dietary An analytical method is not required
section 408(b)(2)(D) requires that EPA risk assessment conducted by the for enforcement purposes due to the
consider ‘‘available information Agency, EPA concludes that there is a lack of concern about safety for Extract
concerning the cumulative effects of [a reasonable certainty of no harm from of Swinglea glutinosa at any exposure
particular pesticide’s] . . . residues and aggregate exposures to Extract of level.
other substances that have a common Swinglea glutinosa, including the
mechanism of toxicity.’’ FFDCA section consumption of food treated with this IV. Statutory and Executive Order
408(b)(2)(C) provides that EPA shall active ingredient in accordance with Reviews
apply an additional tenfold (10X) label directions and good agricultural This action establishes a tolerance
margin of safety for infants and children practices. EPA has made this exemption under FFDCA section 408(d)
in the case of threshold effects to determination because available in response to a petition submitted to
account for prenatal and postnatal toxicology data indicate that the active EPA. The Office of Management and
toxicity and the completeness of the ingredient is not acutely toxic, Budget (OMB) has exempted these types
database on toxicity and exposure subchronically toxic, mutagenic, or of actions from review under Executive
unless EPA determines based on reliable developmentally toxic via repeat oral Order 12866, entitled ‘‘Regulatory
data that a different margin of safety exposure. As such, the Agency has not Planning and Review’’ (58 FR 51735,
will be safe for infants and children. identified any endpoints of concern for October 4, 1993). Because this action
daltland on DSKBBV9HB2PROD with RULES
This additional margin of safety is Extract of Swinglea glutinosa and has has been exempted from review under
commonly referred to as the FQPA conducted a qualitative assessment of Executive Order 12866, this action is
Safety Factor (SF). In applying this exposure. The Agency has also not subject to Executive Order 13211,
provision, EPA either retains the default determined that residues Extract of entitled ‘‘Actions Concerning
value of 10X, or uses a different Swinglea glutinosa in drinking water are Regulations That Significantly Affect
additional safety factor when reliable not expected to be significant when Energy Supply, Distribution, or Use’’ (66
VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1](https://thefederalregister.org/doc/83_FR_27826/page/2.svg)
![Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27713
FR 28355, May 22, 2001) or Executive submit a report containing this rule and to establish allowable catch limits for
Order 13045, entitled ‘‘Protection of other required information to the U.S. each stock within the fishery to control
Children from Environmental Health Senate, the U.S. House of overfishing while allowing optimum
Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller yield, consistent with the Magnuson-
April 23, 1997); nor is it considered a General of the United States prior to Stevens Fishery Conservation and
regulatory action under Executive Order publication of the rule in the Federal Management Act. The intent of this
13771, entitled ‘‘Reducing Regulations Register. This action is not a ‘‘major action is to inform the public of these
and Controlling Regulatory Costs’’ (82 rule’’ as defined by 5 U.S.C. 804(2). specifications for the 2018 fishing year,
FR 9339, February 3, 2017). This action projected specifications for 2019–2020,
does not contain any information List of Subjects in 40 CFR Part 180
and the regulatory correction.
collections subject to OMB approval Environmental protection, DATES: Effective June 14, 2018, through
under the Paperwork Reduction Act Administrative practice and procedure, April 30, 2019.
(PRA), 44 U.S.C. 3501 et seq., nor does Agricultural commodities, Pesticides ADDRESSES: Copies of these
it require any special considerations and pests, Reporting and recordkeeping specifications, including the
under Executive Order 12898, entitled requirements. Environmental Assessment (EA),
‘‘Federal Actions to Address Dated: May 29, 2018. Regulatory Flexibility Act Analyses, and
Environmental Justice in Minority other supporting documents for the
Richard P. Keigwin, Jr.,
Populations and Low-Income action, are available upon request from
Director, Office of Pesticide Programs.
Populations’’ (59 FR 7629, February 16, Thomas A. Nies, Executive Director,
1994). Therefore, 40 CFR chapter I is
New England Fishery Management
Since tolerances and exemptions that amended as follows:
Council, Mid-Atlantic Fishery
are established on the basis of a petition
PART 180—[AMENDED] Management Council, 50 Water Street,
under FFDCA section 408(d), such as
Newburyport, MA 01950. These
the tolerance exemption in this action,
■ 1. The authority citation for part 180 documents are also accessible via the
do not require the issuance of a
proposed rule, the requirements of the continues to read as follows: internet at www.nefmc.org.
Regulatory Flexibility Act (RFA) (5 Authority: 21 U.S.C. 321(q), 346a and 371. FOR FURTHER INFORMATION CONTACT:
U.S.C. 601 et seq.) do not apply. ■ 2. Add § 180.1356 to subpart D to read Cynthia Hanson, Fishery Management
This action directly regulates growers, as follows: Specialist, (978) 281–9180.
food processors, food handlers, and food SUPPLEMENTARY INFORMATION:
retailers, not States or tribes. As a result, § 180.1356 Extract of Swinglea glutinosa;
exemption from the requirement of a Background
this action does not alter the
relationships or distribution of power tolerance. The small-mesh multispecies fishery
and responsibilities established by Residues of the biochemical pesticide is managed by the New England Fishery
Congress in the preemption provisions Extract of Swinglea glutinosa are exempt Management Council within the
of FFDCA section 408(n)(4). As such, from the requirement of a tolerance in Northeast Multispecies Fishery
EPA has determined that this action will or on all food commodities when Management Plan (FMP). The fishery is
not have a substantial direct effect on applied pre-harvest in accordance with composed of five stocks of three species
States or tribal governments, on the label directions and good agricultural of hakes: Northern silver hake; southern
relationship between the national practices. silver hake; northern red hake; southern
government and the States or tribal [FR Doc. 2018–12809 Filed 6–13–18; 8:45 am] red hake; and offshore hake. Southern
governments, or on the distribution of BILLING CODE 6560–50–P
silver hake and offshore hake are often
power and responsibilities among the grouped together and collectively
various levels of government or between referred to as ‘‘southern whiting.’’
the Federal Government and Indian Amendment 19 to the FMP (78 FR
DEPARTMENT OF COMMERCE 20260; April 4, 2013) established a
tribes. Thus, EPA has determined that
Executive Order 13132, entitled National Oceanic and Atmospheric process and framework for setting catch
‘‘Federalism’’ (64 FR 43255, August 10, Administration specifications for the small-mesh
1999), and Executive Order 13175, fishery. The FMP requires the
entitled ‘‘Consultation and Coordination 50 CFR Part 648 specification of an overfishing limit
with Indian Tribal Governments’’ (65 FR (OFL), acceptable biological catch
67249, November 9, 2000), do not apply [Docket No. 180209147–8509–02] (ABC), annual catch limit (ACL), and
to this action. In addition, this action total allowable landings (TAL) for each
RIN 0648–BH76
does not impose any enforceable duty or stock within the fishery for up to three
contain any unfunded mandate as Fisheries of the Northeastern United years at a time, based on the most recent
described under Title II of the Unfunded States; 2018–2020 Small-Mesh stock projections for upcoming years.
Mandates Reform Act (UMRA) (2 U.S.C. Multispecies Specifications This action implements the Council’s
1501 et seq.). recommended small-mesh multispecies
This action does not involve any AGENCY: National Marine Fisheries specifications for the 2018 fishing year,
technical standards that would require Service (NMFS), National Oceanic and announces projected 2019 and 2020
EPA’s consideration of voluntary Atmospheric Administration (NOAA), specifications as recommended by the
consensus standards pursuant to section Commerce. Council, and makes a minor regulatory
daltland on DSKBBV9HB2PROD with RULES
12(d) of the National Technology ACTION: Final rule. correction.
Transfer and Advancement Act The proposed rule for this action
(NTTAA) (15 U.S.C. 272 note). SUMMARY: NMFS issues final 2018 and published in the Federal Register on
projected 2019–2020 specifications for April 12, 2018 (83 FR 15780), and
V. Congressional Review Act the small-mesh multispecies fishery, comments were accepted through April
Pursuant to the Congressional Review and corrects an error from a previous 27, 2018. Additional background
Act (5 U.S.C. 801 et seq.), EPA will action. The specifications are necessary information regarding the development
VerDate Sep<11>2014 15:55 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1](https://thefederalregister.org/doc/83_FR_27826/page/3.svg)
Document Created: 2018-06-14 01:39:12
Document Modified: 2018-06-14 01:39:12
| 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 June 14, 2018. Objections and requests for hearings must be received on or before August 13, 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 27711 | |
| 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