82 FR 44942 - Oxathiapiprolin; Pesticide Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 186 (September 27, 2017)
Federal Register Volume 82, Issue 186 (September 27, 2017)
| Page Range | 44942-44945 | |
| FR Document | 2017-20747 |
[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)] [Rules and Regulations] [Pages 44942-44945] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20747] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0049; FRL-9966-68] Oxathiapiprolin; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- [[Page 44943]] SUMMARY: This regulation establishes a tolerance for residues of the fungicide oxathiapiprolin in or on cacao bean, dried bean. Interregional Research Project Number 4 (IR-4) requested the tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 27, 2017. Objections and requests for hearings must be received on or before November 27, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0049, 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: Michael L. Goodis, Director, Registration Division (7505P), 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 EPA's tolerance regulations at 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, 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-2016-0049 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 27, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0049, 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. Summary of Petitioned-For Tolerance In the Federal Register of Tuesday, 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 petition (PP# 6E8505) by Interregional Research Project Number 4 (IR- 4). The petition requested that 40 CFR 180.685 be amended by establishing tolerances for residues of the fungicide oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]- 1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]- ethanone, in or on cacao bean, bean at 0.10 parts per million (ppm); cacao bean, roasted bean at 0.15 ppm; cacao bean, chocolate at 0.15 ppm; and cacao bean, cocoa powder at 0.15 ppm. A summary of the petition prepared by IR-4 is available in the docket, http://www.regulations.gov. There were no comments received on the notice of filing. Based upon review of the data supporting the petition, EPA is establishing tolerances that differ from what the petitioner requested including; the commodity definition, tolerance level, and for which commodities. The reasons for these changes are explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance 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. . . .'' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has [[Page 44944]] sufficient data to assess the hazards of and to make a determination on aggregate exposure for oxathiapiprolin including exposure resulting from the tolerance established by this action, consistent with FFDCA section 408(b)(2). In the Federal Register of Monday, December 5, 2016 (81 FR 87463) (FRL-9954-69), EPA established tolerances for residues of oxathiapiprolin in or on several food commodities. The risk assessments supporting that action aggregated dietary and non-occupational exposures from existing and proposed uses of oxathiapiprolin, including from the exposures associated with the tolerances requested in this action. That assessment, which included the tolerances in today's action, concluded that the tolerances are safe; therefore, EPA is incorporating the findings in that Federal Register document and the supporting risk assessments as the basis for the safety finding in this tolerance rulemaking. In brief, the Agency determined that the lack of toxicity of oxathiapiprolin warranted a qualitative risk assessment, without the need for the additional Food Quality Protection Act safety factor to protect infants and children. Specific information on the studies received and the nature of the adverse effects caused by oxathiapiprolin as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document, ``Oxathiapiprolin--New Active Ingredient Human Health Risk Assessment of Uses on Turf, Ornamentals, and a Number of Crops'' dated June 25, 2015, in docket ID number EPA- HQ-OPP-2016-0049-0018. In addition, an abbreviated human health risk assessment document was developed to support the proposed uses of oxathiapiprolin on multiple crops, including cacao. That document, ``SUBJECT: Oxathiapiprolin. Human Health Risk Assessment to Support the Registration of New Uses of the Fungicide on Various Crops'' dated October 31, 2016 is available in docket ID number EPA-HQ-OPP-2016-0049- 0017. In conclusion, based on the findings of the December 5, 2016 Federal Register document and the supporting documents, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to oxathiapiprolin residues. IV. Other Considerations A. Analytical Enforcement Methodology Method 30422 (Supplement No. 1) was developed for plant commodities, and Method 31138 was developed for livestock commodities. Residues of oxathiapiprolin and associated metabolites are extracted from crop or livestock commodity samples using a solution of formic acid, water and acetonitrile, and diluted with acetonitrile and water. Both methods use liquid chromotography with tandem mass spectrometry (LC/MS/MS), specifically reverse-phase liquid chromatography (LC), and detection by electrospray tandem mass spectrometry (MS/MS). The FDA multi-residue methods are not suitable for detection and enforcement of oxathiapiprolin residues or associated metabolites. However, the European Multiresidue Method (DFG Method S19) and the QuEChERS Multiresidue Method have shown success in some matrices. Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch/BEAD/OPP, Environmental Science Center, 701 Mapes Rd., Ft. George G. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established maximum residue limits (MRLs) for oxathiapiprolin. C. Revisions to Petitioned-For Tolerances A tolerance is established for ``Cacao bean, dried bean'', rather than ``Cacao bean, bean'', to comply with current Agency crop-naming policy. Also, EPA determined that tolerances for residues of oxathiapiprolin in or on the processed commodities of cacao bean, roasted bean; cacao bean, chocolate; and cacao bean, cocoa powder are unnecessary because these commodities are covered by cacao bean, dried bean tolerance. Finally, the tolerance for cacao bean, dried bean is being established at 0.15 ppm, rather than at 0.1 ppm as requested, based on the available residue data. V. Conclusion Therefore, a tolerance is established for residues of the fungicide oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3- isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3- (trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on cacao bean, dried bean at 0.15 ppm. VI. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory [[Page 44945]] 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, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 Agency 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). VII. 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: August 29, 2017. Michael L. Goodis, Director, Registration Division, 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. In Sec. 180.685, redesignate paragraph (a)(1) as paragraph (a) and add alphabetically the following commodity ``Cacao bean, dried bean'' to the table in paragraph (a) in alphabetical order to read as follows: Sec. 180.685 Oxathiapiprolin; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Cacao bean, dried bean...................................... 0.15 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2017-20747 Filed 9-26-17; 8:45 am] BILLING CODE 6560-50-P
![44942 Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations
section 180.411(a) since it will now does not impose any enforceable duty or potato, subgroup 1D’’ to the table in
have a national registration. contain any unfunded mandate as paragraph (a);
described under Title II of the Unfunded ■ h. Add alphabetically the
VI. Statutory and Executive Order
Mandates Reform Act (UMRA) (2 U.S.C. commodities ‘‘Fescue, forage’’; and
Reviews
1501 et seq.). ‘‘Fescue, hay’’ to the table in paragraph
This action establishes tolerances This action does not involve any (c); and
under FFDCA section 408(d) in technical standards that would require ■ i. Remove the commodity ‘‘Rhubarb’’
response to a petition submitted to the Agency consideration of voluntary from the table in paragraph (c).
Agency. The Office of Management and consensus standards pursuant to section The additions read as follows:
Budget (OMB) has exempted these types 12(d) of the National Technology
of actions from review under Executive § 180.411 Fluazifop-P-butyl; tolerances for
Transfer and Advancement Act
Order 12866, entitled ‘‘Regulatory residues.
(NTTAA) (15 U.S.C. 272 note).
Planning and Review’’ (58 FR 51735, (a) * * *
October 4, 1993). Because this action VII. Congressional Review Act
has been exempted from review under Pursuant to the Congressional Review Parts per
Commodity
Executive Order 12866, this action is million
Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, submit a report containing this rule and
entitled ‘‘Actions Concerning other required information to the U.S. * * * * *
Regulations That Significantly Affect Senate, the U.S. House of Bushberry subgroup 13–07B ...... 0.30
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller Caneberry subgroup 13–07A ..... 0.08
FR 28355, May 22, 2001) or Executive General of the United States prior to
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal * * * * *
Children from Environmental Health Register. This action is not a ‘‘major Fruit, small vine climbing, except
Risks and Safety Risks’’ (62 FR 19885, fuzzy kiwifruit, subgroup 13–
rule’’ as defined by 5 U.S.C. 804(2). 07F .......................................... 0.03
April 23, 1997). This action does not
contain any information collections List of Subjects in 40 CFR Part 180
* * * * *
subject to OMB approval under the Environmental protection, Lettuce, head .............................. 3.0
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, Lettuce, leaf ................................ 5.0
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides
any special considerations under and pests, Reporting and recordkeeping * * * * *
Executive Order 12898, entitled requirements. Onion, bulb, subgroup 3–07A .... 0.50
‘‘Federal Actions to Address Onion, green ............................... 1.5
Environmental Justice in Minority Dated: August 30, 2017.
Populations and Low-Income Michael L. Goodis, * * * * *
Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of Rhubarb ...................................... 0.50
1994). Pesticide Programs.
Since tolerances and exemptions that * * * * *
Therefore, 40 CFR chapter I is Strawberry .................................. 3.0
are established on the basis of a petition amended as follows: Vegetable, tuberous and corm,
under FFDCA section 408(d), such as except potato, subgroup 1D ... 1.5
the tolerance in this final rule, do not PART 180—[AMENDED]
require the issuance of a proposed rule, * * * * *
the requirements of the Regulatory ■ 1. The authority citation for part 180 (c) * * *
Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371. Parts per
This action directly regulates growers, Commodity million
food processors, food handlers, and food ■ 2. In § 180.411:
retailers, not States or tribes, nor does ■ a. Add alphabetically the
this action alter the relationships or commodities ‘‘Bushberry subgroup 13– * * * * *
distribution of power and 07B’’; ‘‘Caneberry subgroup 13–07A’’; Fescue, forage ............................ 4.0
responsibilities established by Congress and ‘‘Fruit, small vine climbing, except Fescue, hay ................................ 15
in the preemption provisions of FFDCA fuzzy kiwifruit, subgroup 13–07F’’ to
* * * * *
section 408(n)(4). As such, the Agency the table in paragraph (a);
has determined that this action will not ■ b. Remove the commodity ‘‘Grape’’ in
* * * * *
have a substantial direct effect on States the table in paragraph (a); [FR Doc. 2017–20748 Filed 9–26–17; 8:45 am]
or tribal governments, on the ■ c. Add alphabetically the
BILLING CODE 6560–50–P
relationship between the national commodities ‘‘Lettuce, head’’ and
government and the States or tribal ‘‘Lettuce, leaf’’ to the table in paragraph
governments, or on the distribution of (a); ENVIRONMENTAL PROTECTION
power and responsibilities among the ■ d. Remove the commodity ‘‘Onion, AGENCY
various levels of government or between bulb’’ in the table in paragraph (a);
the Federal Government and Indian ■ e. Add alphabetically the 40 CFR Part 180
asabaliauskas on DSKBBXCHB2PROD with RULES
tribes. Thus, the Agency has determined commodities ‘‘Onion, bulb, subgroup 3–
that Executive Order 13132, entitled 07A’’; ‘‘Onion, green’’; ‘‘Rhubarb’’; and [EPA–HQ–OPP–2016–0049; FRL–9966–68]
‘‘Federalism’’ (64 FR 43255, August 10, ‘‘Strawberry’’;
1999) and Executive Order 13175, ■ f. Remove the commodity ‘‘Sweet
Oxathiapiprolin; Pesticide Tolerance
entitled ‘‘Consultation and Coordination potato, roots’’ in the table in paragraph AGENCY: Environmental Protection
with Indian Tribal Governments’’ (65 FR (a); Agency (EPA).
67249, November 9, 2000) do not apply ■ g. Add alphabetically the commodity
ACTION: Final rule.
to this action. In addition, this action ‘‘Vegetable, tuberous and corm, except
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![Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 44943
SUMMARY: This regulation establishes a B. How can I get electronic access to II. Summary of Petitioned-For
tolerance for residues of the fungicide other related information? Tolerance
oxathiapiprolin in or on cacao bean, In the Federal Register of Tuesday,
dried bean. Interregional Research You may access a frequently updated
electronic version of EPA’s tolerance December 20, 2016 (81 FR 92758) (FRL–
Project Number 4 (IR–4) requested the 9956–04), EPA issued a document
tolerance under the Federal Food, Drug, regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR pursuant to FFDCA section 408(d)(3), 21
and Cosmetic Act (FFDCA). U.S.C. 346a(d)(3), announcing the filing
site at http://www.ecfr.gov/cgi-bin/text-
DATES: This regulation is effective of a pesticide petition (PP# 6E8505) by
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40
September 27, 2017. Objections and tab_02.tpl. Interregional Research Project Number 4
requests for hearings must be received (IR–4). The petition requested that 40
on or before November 27, 2017, and C. How can I file an objection or hearing CFR 180.685 be amended by
must be filed in accordance with the request? establishing tolerances for residues of
instructions provided in 40 CFR part the fungicide oxathiapiprolin, 1-[4-[4-[5-
178 (see also Unit I.C. of the Under FFDCA section 408(g), 21
(2,6-difluorophenyl)-4,5-dihydro-3-
SUPPLEMENTARY INFORMATION).
U.S.C. 346a, any person may file an
isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-
objection to any aspect of this regulation
ADDRESSES: The docket for this action, [5-methyl-3-(trifluoromethyl)-1H-
and may also request a hearing on those
identified by docket identification (ID) pyrazol-1-yl]-ethanone, in or on cacao
objections. You must file your objection
number EPA–HQ–OPP–2016–0049, is bean, bean at 0.10 parts per million
or request a hearing on this regulation
available at http://www.regulations.gov (ppm); cacao bean, roasted bean at 0.15
in accordance with the instructions
or at the Office of Pesticide Programs ppm; cacao bean, chocolate at 0.15 ppm;
provided in 40 CFR part 178. To ensure
Regulatory Public Docket (OPP Docket) and cacao bean, cocoa powder at 0.15
proper receipt by EPA, you must
in the Environmental Protection Agency ppm. A summary of the petition
identify docket ID number EPA–HQ–
Docket Center (EPA/DC), West William prepared by IR–4 is available in the
OPP–2016–0049 in the subject line on
Jefferson Clinton Bldg., Rm. 3334, 1301 docket, http://www.regulations.gov.
the first page of your submission. All
Constitution Ave. NW., Washington, DC There were no comments received on
objections and requests for a hearing
20460–0001. The Public Reading Room the notice of filing.
must be in writing, and must be
is open from 8:30 a.m. to 4:30 p.m., Based upon review of the data
received by the Hearing Clerk on or
Monday through Friday, excluding legal supporting the petition, EPA is
before November 27, 2017. Addresses
holidays. The telephone number for the establishing tolerances that differ from
for mail and hand delivery of objections
Public Reading Room is (202) 566–1744, what the petitioner requested including;
and hearing requests are provided in 40
and the telephone number for the OPP the commodity definition, tolerance
CFR 178.25(b).
Docket is (703) 305–5805. Please review level, and for which commodities. The
In addition to filing an objection or reasons for these changes are explained
the visitor instructions and additional
hearing request with the Hearing Clerk in Unit IV.C.
information about the docket available
as described in 40 CFR part 178, please
at http://www.epa.gov/dockets. III. Aggregate Risk Assessment and
submit a copy of the filing (excluding
FOR FURTHER INFORMATION CONTACT: any Confidential Business Information Determination of Safety
Michael L. Goodis, Director, (CBI)) for inclusion in the public docket. Section 408(b)(2)(A)(i) of FFDCA
Registration Division (7505P), Office of Information not marked confidential allows EPA to establish a tolerance (the
Pesticide Programs, Environmental pursuant to 40 CFR part 2 may be legal limit for a pesticide chemical
Protection Agency, 1200 Pennsylvania disclosed publicly by EPA without prior residue in or on a food) only if EPA
Ave. NW., Washington, DC 20460–0001; notice. Submit the non-CBI copy of your determines that the tolerance is ‘‘safe.’’
main telephone number: (703) 305– objection or hearing request, identified Section 408(b)(2)(A)(ii) of FFDCA
7090; email address: RDFRNotices@ by docket ID number EPA–HQ–OPP– defines ‘‘safe’’ to mean that ‘‘there is a
epa.gov. 2016–0049, by one of the following reasonable certainty that no harm will
SUPPLEMENTARY INFORMATION: methods: result from aggregate exposure to the
• Federal eRulemaking Portal: http:// pesticide chemical residue, including
I. General Information all anticipated dietary exposures and all
www.regulations.gov. Follow the online
A. Does this action apply to me? instructions for submitting comments. other exposures for which there is
Do not submit electronically any reliable information.’’ This includes
You may be potentially affected by exposure through drinking water and in
information you consider to be CBI or
this action if you are an agricultural residential settings, but does not include
other information whose disclosure is
producer, food manufacturer, or occupational exposure. Section
restricted by statute.
pesticide manufacturer. The following 408(b)(2)(C) of FFDCA requires EPA to
list of North American Industrial • Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/ give special consideration to exposure
Classification System (NAICS) codes is of infants and children to the pesticide
not intended to be exhaustive, but rather DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001. chemical residue in establishing a
provides a guide to help readers tolerance and to ‘‘ensure that there is a
determine whether this document • Hand Delivery: To make special reasonable certainty that no harm will
applies to them. Potentially affected arrangements for hand delivery or result to infants and children from
asabaliauskas on DSKBBXCHB2PROD with RULES
entities may include: delivery of boxed information, please aggregate exposure to the pesticide
• Crop production (NAICS code 111). follow the instructions at http:// chemical residue. . . .’’
• Animal production (NAICS code www.epa.gov/dockets/contacts.html. Consistent with FFDCA section
112). Additional instructions on 408(b)(2)(D), and the factors specified in
• Food manufacturing (NAICS code commenting or visiting the docket, FFDCA section 408(b)(2)(D), EPA has
311). along with more information about reviewed the available scientific data
• Pesticide manufacturing (NAICS dockets generally, is available at http:// and other relevant information in
code 32532). www.epa.gov/dockets. support of this action. EPA has
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sufficient data to assess the hazards of IV. Other Considerations C. Revisions to Petitioned-For
and to make a determination on Tolerances
A. Analytical Enforcement Methodology
aggregate exposure for oxathiapiprolin A tolerance is established for ‘‘Cacao
including exposure resulting from the Method 30422 (Supplement No. 1) bean, dried bean’’, rather than ‘‘Cacao
tolerance established by this action, was developed for plant commodities, bean, bean’’, to comply with current
consistent with FFDCA section and Method 31138 was developed for Agency crop-naming policy. Also, EPA
408(b)(2). livestock commodities. Residues of determined that tolerances for residues
In the Federal Register of Monday, oxathiapiprolin and associated of oxathiapiprolin in or on the
December 5, 2016 (81 FR 87463) (FRL– metabolites are extracted from crop or processed commodities of cacao bean,
9954–69), EPA established tolerances livestock commodity samples using a roasted bean; cacao bean, chocolate; and
for residues of oxathiapiprolin in or on solution of formic acid, water and cacao bean, cocoa powder are
several food commodities. The risk acetonitrile, and diluted with unnecessary because these commodities
assessments supporting that action acetonitrile and water. Both methods are covered by cacao bean, dried bean
aggregated dietary and non-occupational use liquid chromotography with tandem tolerance. Finally, the tolerance for
exposures from existing and proposed mass spectrometry (LC/MS/MS), cacao bean, dried bean is being
uses of oxathiapiprolin, including from specifically reverse-phase liquid established at 0.15 ppm, rather than at
the exposures associated with the chromatography (LC), and detection by 0.1 ppm as requested, based on the
tolerances requested in this action. That electrospray tandem mass spectrometry available residue data.
assessment, which included the (MS/MS). V. Conclusion
tolerances in today’s action, concluded The FDA multi-residue methods are
that the tolerances are safe; therefore, Therefore, a tolerance is established
not suitable for detection and for residues of the fungicide
EPA is incorporating the findings in that enforcement of oxathiapiprolin residues oxathiapiprolin, 1-[4-[4-[5-(2,6-
Federal Register document and the or associated metabolites. However, the difluorophenyl)-4,5-dihydro-3-
supporting risk assessments as the basis European Multiresidue Method (DFG isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-
for the safety finding in this tolerance Method S19) and the QuEChERS [5-methyl-3-(trifluoromethyl)-1H-
rulemaking. In brief, the Agency Multiresidue Method have shown pyrazol-1-yl]-ethanone, in or on cacao
determined that the lack of toxicity of success in some matrices. bean, dried bean at 0.15 ppm.
oxathiapiprolin warranted a qualitative
risk assessment, without the need for Adequate enforcement methodology VI. Statutory and Executive Order
the additional Food Quality Protection (LC/MS/MS) is available to enforce the Reviews
Act safety factor to protect infants and tolerance expression. The method may
This action establishes a tolerance
children. be requested from: Chief, Analytical
under FFDCA section 408(d) in
Chemistry Branch/BEAD/OPP,
Specific information on the studies response to a petition submitted to the
Environmental Science Center, 701 Agency. The Office of Management and
received and the nature of the adverse
Mapes Rd., Ft. George G. Meade, MD Budget (OMB) has exempted these types
effects caused by oxathiapiprolin as
20755–5350; telephone number: (410) of actions from review under Executive
well as the no-observed-adverse-effect-
305–2905; email address: residue Order 12866, entitled ‘‘Regulatory
level (NOAEL) and the lowest-observed-
methods@epa.gov. Planning and Review’’ (58 FR 51735,
adverse-effect-level (LOAEL) from the
toxicity studies can be found at http:// B. International Residue Limits October 4, 1993). Because this action
www.regulations.gov in the document, has been exempted from review under
‘‘Oxathiapiprolin—New Active In making its tolerance decisions, EPA Executive Order 12866, this action is
Ingredient Human Health Risk seeks to harmonize U.S. tolerances with not subject to Executive Order 13211,
Assessment of Uses on Turf, international standards whenever entitled ‘‘Actions Concerning
Ornamentals, and a Number of Crops’’ possible, consistent with U.S. food Regulations That Significantly Affect
dated June 25, 2015, in docket ID safety standards and agricultural Energy Supply, Distribution, or Use’’ (66
number EPA–HQ–OPP–2016–0049– practices. EPA considers the FR 28355, May 22, 2001) or Executive
0018. In addition, an abbreviated human international maximum residue limits Order 13045, entitled ‘‘Protection of
health risk assessment document was (MRLs) established by the Codex Children from Environmental Health
developed to support the proposed uses Alimentarius Commission (Codex), as Risks and Safety Risks’’ (62 FR 19885,
of oxathiapiprolin on multiple crops, required by FFDCA section 408(b)(4). April 23, 1997). This action does not
including cacao. That document, The Codex Alimentarius is a joint contain any information collections
‘‘SUBJECT: Oxathiapiprolin. Human United Nations Food and Agriculture subject to OMB approval under the
Organization/World Health Paperwork Reduction Act (PRA) (44
Health Risk Assessment to Support the
Organization food standards program, U.S.C. 3501 et seq.), nor does it require
Registration of New Uses of the
and it is recognized as an international any special considerations under
Fungicide on Various Crops’’ dated
food safety standards-setting Executive Order 12898, entitled
October 31, 2016 is available in docket
‘‘Federal Actions to Address
ID number EPA–HQ–OPP–2016–0049– organization in trade agreements to
Environmental Justice in Minority
0017. which the United States is a party. EPA
Populations and Low-Income
may establish a tolerance that is
asabaliauskas on DSKBBXCHB2PROD with RULES
In conclusion, based on the findings Populations’’ (59 FR 7629, February 16,
of the December 5, 2016 Federal different from a Codex MRL; however,
1994).
Register document and the supporting FFDCA section 408(b)(4) requires that Since tolerances and exemptions that
documents, EPA concludes that there is EPA explain the reasons for departing are established on the basis of a petition
a reasonable certainty that no harm will from the Codex level. under FFDCA section 408(d), such as
result to the general population, or to The Codex has not established the tolerance in this final rule, do not
infants and children from aggregate maximum residue limits (MRLs) for require the issuance of a proposed rule,
exposure to oxathiapiprolin residues. oxathiapiprolin. the requirements of the Regulatory
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![Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Rules and Regulations 44945
Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371. post-crash conditions, NHTSA adopts
seq.), do not apply. ■ 2. In § 180.685, redesignate paragraph electrical safety requirements to protect
This action directly regulates growers, (a)(1) as paragraph (a) and add against direct and indirect contact of
food processors, food handlers, and food alphabetically the following commodity high voltage sources during everyday
retailers, not States or tribes, nor does ‘‘Cacao bean, dried bean’’ to the table in operation of electric-powered vehicles.
this action alter the relationships or paragraph (a) in alphabetical order to Also, NHTSA adopts an optional
distribution of power and read as follows: method of meeting post-crash electrical
responsibilities established by Congress safety requirements, consistent with that
in the preemption provisions of FFDCA § 180.685 Oxathiapiprolin; tolerances for in GTR No. 13, involving use of physical
section 408(n)(4). As such, the Agency residues. barriers to prevent direct or indirect
has determined that this action will not (a) * * * contact (by occupants, emergency
have a substantial direct effect on States services personnel and others) with high
or tribal governments, on the Parts per voltage sources.
Commodity
relationship between the national million
DATES:
government and the States or tribal Effective date: This final rule is
governments, or on the distribution of * * * * * effective September 27, 2017.
power and responsibilities among the Cacao bean, dried bean ............. 0.15 Compliance date: The compliance
various levels of government or between date for the amendments in this final
the Federal Government and Indian * * * * * rule is September 27, 2018. Optional
tribes. Thus, the Agency has determined early compliance is permitted.
that Executive Order 13132, entitled * * * * * Petitions for reconsideration: Petitions
‘‘Federalism’’ (64 FR 43255, August 10, [FR Doc. 2017–20747 Filed 9–26–17; 8:45 am]
for reconsideration of this final rule
1999) and Executive Order 13175, BILLING CODE 6560–50–P
must be received not later than
entitled ‘‘Consultation and Coordination November 13, 2017.
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply ADDRESSES: Petitions for reconsideration
DEPARTMENT OF TRANSPORTATION of this final rule must refer to the docket
to this action. In addition, this action
does not impose any enforceable duty or National Highway Traffic Safety and notice number set forth above and
contain any unfunded mandate as Administration be submitted to the Administrator,
described under Title II of the Unfunded National Highway Traffic Safety
Mandates Reform Act (UMRA) (2 U.S.C. 49 CFR Part 571 Administration, 1200 New Jersey
1501 et seq.). Avenue SE., Washington, DC 20590.
This action does not involve any [Docket No. NHTSA–2017–0085] Note that all petitions received will be
technical standards that would require posted without change to http://
RIN 2127–AL68
Agency consideration of voluntary www.regulations.gov, including any
consensus standards pursuant to section Federal Motor Vehicle Safety personal information provided.
12(d) of the National Technology Standards; Electric-Powered Vehicles: Privacy Act: Please see the Privacy
Transfer and Advancement Act Electrolyte Spillage and Electrical Act heading under Rulemaking
(NTTAA) (15 U.S.C. 272 note). Shock Protection Analyses and Notices.
FOR FURTHER INFORMATION CONTACT: For
VII. Congressional Review Act AGENCY: National Highway Traffic technical issues, you may call William
Pursuant to the Congressional Review Safety Administration (NHTSA), J. Sánchez, Office of Crashworthiness
Act (5 U.S.C. 801 et seq.), EPA will Department of Transportation (DOT). Standards (telephone: 202–493–0248)
submit a report containing this rule and ACTION: Final rule. (fax: 202–493–2990). For legal issues,
other required information to the U.S. you may call Deirdre Fujita, Office of
Senate, the U.S. House of SUMMARY: NHTSA is issuing this final Chief Counsel (telephone: 202–366–
Representatives, and the Comptroller rule to amend Federal Motor Vehicle 2992) (fax: 202–366–3820). Address:
General of the United States prior to Safety Standard (FMVSS) No. 305, National Highway Traffic Safety
publication of the rule in the Federal ‘‘Electric-powered vehicles: Electrolyte Administration, U.S. Department of
Register. This action is not a ‘‘major spillage and electrical shock Transportation, 1200 New Jersey
rule’’ as defined by 5 U.S.C. 804(2). protection,’’ to adopt various electrical Avenue SE., West Building,
safety requirements found in Global Washington, DC 20590.
List of Subjects in 40 CFR Part 180 Technical Regulation (GTR) No. 13,
Environmental protection, SUPPLEMENTARY INFORMATION:
‘‘Hydrogen and fuel cell vehicles,’’ and
Administrative practice and procedure, other sources. This final rule updates Table of Contents
Agricultural commodities, Pesticides FMVSS No. 305 using modern and I. Executive Summary
and pests, Reporting and recordkeeping harmonized safety requirements and a. Overview
requirements. facilitates the introduction of new b. Summary of the Final Rule and
Dated: August 29, 2017. technologies, including hydrogen fuel Highlighted Differences With the NPRM
Michael L. Goodis, cell vehicles (HFCVs) and 48-volt mild 1. Every Day (Normal) Vehicle Operations
Director, Registration Division, Office of hybrid technologies. This final rule is a i. Direct Contact Protection From High
asabaliauskas on DSKBBXCHB2PROD with RULES
Pesticide Programs. deregulatory action. It imposes no costs Voltage Sources
and adjusts FMVSS No. 305 to give ii. Indirect Contact Protection From High
Therefore, 40 CFR chapter I is Voltage Sources
more flexibility to manufacturers not
amended as follows: iii. Electrical Isolation of High Voltage
only to use modern electrical safety Sources
PART 180—[AMENDED] designs to produce electric vehicles, but iv. Monitoring Systems
also to introduce new technologies to v. Electrical Safety During Charging
■ 1. The authority citation for part 180 the U.S. market. To expand FMVSS No. vi. Mitigating Driver Error
continues to read as follows: 305’s performance requirements beyond 2. Post-Crash Safety
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Document Created: 2018-10-24 14:46:35
Document Modified: 2018-10-24 14:46:35
| 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 27, 2017. Objections and requests for hearings must be received on or before November 27, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael L. Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email | |
| FR Citation | 82 FR 44942 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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