82 FR 38844 - Prothioconazole; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 157 (August 16, 2017)
Federal Register Volume 82, Issue 157 (August 16, 2017)
| Page Range | 38844-38846 | |
| FR Document | 2017-17336 |
[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)] [Rules and Regulations] [Pages 38844-38846] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17336] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0286; FRL-9964-40] Prothioconazole; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a tolerance for residues of prothioconazole in or on Sunflower subgroup 20B at 0.2 parts per million (ppm). Bayer CropScience requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective August 16, 2017. Objections and requests for hearings must be received on or before October 16, 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-2016-0286, 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, P.E., 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-2016-0286 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 October 16, 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-2016-0286, 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 July 20, 2016 (81 FR 47150) (FRL-9948- 45), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announced the filing of a pesticide petition (PP 6E8469) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. This petition requested that 40 CFR 180.626 be amended by establishing tolerances for residues of prothioconazole in or on imported commodities in the sunflower subgroup 20B at 0.2 ppm. This document referenced a summary of a petition prepared by Bayer CropScience, the registrant, which are available in the docket, http://www.regulations.gov. No comments were received in response to the notice of filing. 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 [[Page 38845]] and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for prothiconazole including exposure resulting from the tolerance established by this action. A. Risk Assessment In the Federal Register of November 10, 2016 (81 FR 78917) (FRL- 9953-71), EPA established tolerances for residues of prothioconazole in or on cotton, gin byproducts at 4.0 ppm and the cottonseed subgroup 20C at 0.4 ppm. Because much of the safety assessment of prothioconazole for the current action remains the same, EPA is relying in part upon the findings made in the November 10, 2016 final rule in support of this action. A summary of the toxicological profile and endpoints used for human risk assessment is discussed in Units III.A. and III.B of the November 10, 2016 final rule. In evaluating dietary exposure for this action, EPA considered exposure under the petitioned-for tolerances as well as all existing prothioconazole tolerances in 40 CFR 180.626. The residue data used for the acute and chronic dietary exposure assessments have not changed since the assessment supporting the November 10, 2016 final rule, except to incorporate the recommended tolerance on commodities associated with Sunflower subgroup 20B, for which the Agency assumed tolerance-level residues and 100 percent crop treated. For a summary of how EPA assessed these dietary exposures, see Unit III.C.1 of the November 10, 2016 final rule. In addition, because the requested sunflower subgroup tolerance is not accompanied by a corresponding request for a U.S. registration for use of prothioconazole on the commodities in the sunflower subgroup, the drinking water and residential exposure assessments remain the same. A summary of EPA's assessment of drinking water exposure and residential exposure is discussed in Units III.C.2. and III.C.3. A summary of EPA's conclusions about the cumulative effects of prothioconazole can be found in Unit III.C.4. of the November 10, 2016 final rule; however, since the November 10, 2016 final rule was published, the Agency has updated its dietary exposure and risk analysis for the common triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), triazolylacetic acid (TAA), and triazolylpyruvic acid (TP). The update was completed in association with registration requests for several triazole fungicides and includes, inter alia, the potential exposure to the common triazole metabolites resulting from the use of prothioconazole on commodities in the sunflower subgroup 20B. That analysis concluded that risk estimates were below the Agency's level of concern for all population groups. This assessment may be found on http://www.regulations.gov by searching for the following title and docket number: ``Common Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk Assessment to Address the New Section 3 Registrations For Use of Difenoconazole on Rice and Cotton.'' (located in docket ID number EPA-HQ-OPP-2016-0254). Because there have been no changes to the potential for prenatal and postnatal toxicity or in the completeness of data with respect to toxicity and exposure, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the additional tenfold (10x) margin of safety required under section 408(b)(2)(C) (``FQPA safety factor'') were reduced to 1x. A summary of EPA's rationale for this determination is discussed in Unit III.D. of the November 10, 2016 final rule. B. Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure exists. Using the exposure assumptions discussed above and in the November 10, 2016 final rule, EPA assessed acute and chronic dietary exposure from food and drinking water and concluded that the new tolerances on sunflower subgroup 20B do not change the risk estimates from the November 10, 2016 final rule. The acute dietary exposure utilized 40% of the aPAD for females 13-49 years old at the 95th percentile. The chronic dietary exposure utilized 32% of the cPAD for the U.S. population, and 77% for all infants (<1 year), the most highly exposed population subgroup. Because there are no existing or proposed residential uses for prothioconazole, there are no exposures expected via the residential exposure pathway. Therefore, all aggregate risk estimates are expected to be equivalent to dietary (food and drinking water) risk estimates mentioned above. Therefore, 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 prothioconazole residues. For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer both to the November 10, 2016 final rule and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2015-0722, and to the risk assessment for this current action ``Prothioconazole: Human Health Risk Assessment for the Petition for a Tolerance Without U.S. Registration for Residues in/on sunflower subgroup 20B.'' in docket ID number EPA-HQ-OPP-2016-0286. IV. Other Considerations A. Analytical Enforcement Methodology Adequate liquid chromatography with tandem mass spectrometry (LC/ MS/MS) methods are available for enforcing prothioconazole tolerances in crop and livestock commodities. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-350; 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. There is currently a Codex MRL for sunflower/safflower established at 0.05 ppm. The U.S. EPA is establishing a tolerance on sunflower at 0.2 ppm to harmonize with a major trading partner, Canada, in order to have a harmonized North America MRL for the Sunflower subgroup 20B. A tolerance cannot be established at the lower Codex MRL [[Page 38846]] because it would present a trade irritant for sunflower commodities coming into the United States. V. Conclusion Therefore, a tolerance is established for residues of prothioconazole, in or on sunflower subgroup 20B at 0.2 parts ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances 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 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: July 26, 2017. Michael 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. 180.626, add alphabetically the entry ``Sunflower subgroup 20B'' to the table in paragraph (a)(1), and add footnote 1 to the table to read as follows: Sec. 180.626 Prothioconazole; tolerances for residues. (a) * * * (1) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Sunflower subgroup 20B \1\.................................. 0.2 * * * * * ------------------------------------------------------------------------ \1\ There are no U.S. registrations allowing use of prothioconazole on the commodities in the Sunflower subgroup 20B as of August 16, 2017. * * * * * [FR Doc. 2017-17336 Filed 8-15-17; 8:45 am] BILLING CODE 6560-50-P
![38844 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations
* * * * * pesticide manufacturer. The following • Mail: OPP Docket, Environmental
[FR Doc. 2017–17231 Filed 8–15–17; 8:45 am] list of North American Industrial Protection Agency Docket Center (EPA/
BILLING CODE 6560–50–P Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave.
not intended to be exhaustive, but rather NW., Washington, DC 20460–0001.
provides a guide to help readers • Hand Delivery: To make special
ENVIRONMENTAL PROTECTION determine whether this document arrangements for hand delivery or
AGENCY applies to them. Potentially affected delivery of boxed information, please
entities may include: follow the instructions at http://
40 CFR Part 180 • Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
[EPA–HQ–OPP–2016–0286; FRL–9964–40] • Animal production (NAICS code Additional instructions on
112). commenting or visiting the docket,
Prothioconazole; Pesticide Tolerances • Food manufacturing (NAICS code along with more information about
311). dockets generally, is available at http://
AGENCY: Environmental Protection www.epa.gov/dockets.
Agency (EPA). • Pesticide manufacturing (NAICS
ACTION: Final rule. code 32532). II. Summary of Petitioned-For
Tolerance
B. How can I get electronic access to
SUMMARY: This regulation establishes a In the Federal Register of July 20,
other related information?
tolerance for residues of 2016 (81 FR 47150) (FRL–9948–45),
prothioconazole in or on Sunflower You may access a frequently updated EPA issued a document pursuant to
subgroup 20B at 0.2 parts per million electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
(ppm). Bayer CropScience requested regulations at 40 CFR part 180 through 346a(d)(3), announced the filing of a
this tolerance under the Federal Food, the Government Printing Office’s e-CFR pesticide petition (PP 6E8469) by Bayer
Drug, and Cosmetic Act (FFDCA). site at http://www.ecfr.gov/cgi-bin/text- CropScience, P.O. Box 12014, 2 T.W.
DATES: This regulation is effective idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Alexander Drive, Research Triangle
August 16, 2017. Objections and 40tab_02.tpl. Park, NC 27709. This petition requested
requests for hearings must be received C. How can I file an objection or hearing that 40 CFR 180.626 be amended by
on or before October 16, 2017, and must request? establishing tolerances for residues of
be filed in accordance with the prothioconazole in or on imported
instructions provided in 40 CFR part Under FFDCA section 408(g), 21 commodities in the sunflower subgroup
178 (see also Unit I.C. of the U.S.C. 346a, any person may file an 20B at 0.2 ppm. This document
SUPPLEMENTARY INFORMATION). objection to any aspect of this regulation referenced a summary of a petition
ADDRESSES: The docket for this action, and may also request a hearing on those prepared by Bayer CropScience, the
identified by docket identification (ID) objections. You must file your objection registrant, which are available in the
number EPA–HQ–OPP–2016–0286, is or request a hearing on this regulation docket, http://www.regulations.gov. No
available at http://www.regulations.gov in accordance with the instructions comments were received in response to
or at the Office of Pesticide Programs provided in 40 CFR part 178. To ensure the notice of filing.
Regulatory Public Docket (OPP Docket) proper receipt by EPA, you must
identify docket ID number EPA–HQ– III. Aggregate Risk Assessment and
in the Environmental Protection Agency
OPP–2016–0286 in the subject line on Determination of Safety
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301 the first page of your submission. All Section 408(b)(2)(A)(i) of FFDCA
Constitution Ave. NW., Washington, DC objections and requests for a hearing allows EPA to establish a tolerance (the
20460–0001. The Public Reading Room must be in writing, and must be legal limit for a pesticide chemical
is open from 8:30 a.m. to 4:30 p.m., received by the Hearing Clerk on or residue in or on a food) only if EPA
Monday through Friday, excluding legal before October 16, 2017. Addresses for determines that the tolerance is ‘‘safe.’’
holidays. The telephone number for the mail and hand delivery of objections Section 408(b)(2)(A)(ii) of FFDCA
Public Reading Room is (202) 566–1744, and hearing requests are provided in 40 defines ‘‘safe’’ to mean that ‘‘there is a
and the telephone number for the OPP CFR 178.25(b). reasonable certainty that no harm will
Docket is (703) 305–5805. Please review In addition to filing an objection or result from aggregate exposure to the
the visitor instructions and additional hearing request with the Hearing Clerk pesticide chemical residue, including
information about the docket available as described in 40 CFR part 178, please all anticipated dietary exposures and all
at http://www.epa.gov/dockets. submit a copy of the filing (excluding other exposures for which there is
FOR FURTHER INFORMATION CONTACT:
any Confidential Business Information reliable information.’’ This includes
Michael L. Goodis, P.E., Director, (CBI)) for inclusion in the public docket. exposure through drinking water and in
Registration Division (7505P), Office of Information not marked confidential residential settings, but does not include
Pesticide Programs, Environmental pursuant to 40 CFR part 2 may be occupational exposure. Section
Protection Agency, 1200 Pennsylvania disclosed publicly by EPA without prior 408(b)(2)(C) of FFDCA requires EPA to
Ave. NW., Washington, DC 20460–0001; notice. Submit the non-CBI copy of your give special consideration to exposure
main telephone number: (703) 305– objection or hearing request, identified of infants and children to the pesticide
7090; email address: RDFRNotices@ by docket ID number EPA–HQ–OPP– chemical residue in establishing a
epa.gov. 2016–0286, by one of the following tolerance and to ‘‘ensure that there is a
methods: reasonable certainty that no harm will
pmangrum on DSK3GDR082PROD with RULES
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// result to infants and children from
I. General Information www.regulations.gov. Follow the online aggregate exposure to the pesticide
instructions for submitting comments. chemical residue. . . .’’
A. Does this action apply to me? Do not submit electronically any Consistent with FFDCA section
You may be potentially affected by information you consider to be CBI or 408(b)(2)(D), and the factors specified in
this action if you are an agricultural other information whose disclosure is FFDCA section 408(b)(2)(D), EPA has
producer, food manufacturer, or restricted by statute. reviewed the available scientific data
VerDate Sep<11>2014 16:15 Aug 15, 2017 Jkt 241001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\16AUR1.SGM 16AUR1](https://thefederalregister.org/doc/82_FR_39001/page/1.svg)
![38846 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations
because it would present a trade irritant that Executive Order 13132, entitled Parts
for sunflower commodities coming into ‘‘Federalism’’ (64 FR 43255, August 10, Commodity per
the United States. 1999) and Executive Order 13175, million
V. Conclusion entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR * * * * *
Therefore, a tolerance is established 67249, November 9, 2000) do not apply Sunflower subgroup 20B 1 .......... 0.2
for residues of prothioconazole, in or on
to this action. In addition, this action
sunflower subgroup 20B at 0.2 parts * * * * *
does not impose any enforceable duty or
ppm.
contain any unfunded mandate as 1 There
are no U.S. registrations allowing
VI. Statutory and Executive Order described under Title II of the Unfunded use of prothioconazole on the commodities in
Reviews Mandates Reform Act (UMRA) (2 U.S.C. the Sunflower subgroup 20B as of August 16,
2017.
This action establishes tolerances 1501 et seq.).
under FFDCA section 408(d) in This action does not involve any * * * * *
response to a petition submitted to the [FR Doc. 2017–17336 Filed 8–15–17; 8:45 am]
technical standards that would require
Agency. The Office of Management and Agency consideration of voluntary BILLING CODE 6560–50–P
Budget (OMB) has exempted these types consensus standards pursuant to section
of actions from review under Executive 12(d) of the National Technology
Order 12866, entitled ‘‘Regulatory ENVIRONMENTAL PROTECTION
Transfer and Advancement Act AGENCY
Planning and Review’’ (58 FR 51735,
(NTTAA) (15 U.S.C. 272 note).
October 4, 1993). Because this action
has been exempted from review under 40 CFR Part 180
VII. Congressional Review Act
Executive Order 12866, this action is
not subject to Executive Order 13211, Pursuant to the Congressional Review [EPA–HQ–OPP–2017–0108; FRL–9964–53]
entitled ‘‘Actions Concerning Act (5 U.S.C. 801 et seq.), EPA will
Regulations That Significantly Affect submit a report containing this rule and Fatty Acids, Rape-Oil, Triesters With
Energy Supply, Distribution, or Use’’ (66 other required information to the U.S. Polyethylene Glycol Ether With
FR 28355, May 22, 2001) or Executive Senate, the U.S. House of Glycerol (3:1); Tolerance Exemption
Order 13045, entitled ‘‘Protection of Representatives, and the Comptroller AGENCY: Environmental Protection
Children from Environmental Health General of the United States prior to Agency (EPA).
Risks and Safety Risks’’ (62 FR 19885, publication of the rule in the Federal
April 23, 1997). This action does not Register. This action is not a ‘‘major ACTION: Final rule.
contain any information collections rule’’ as defined by 5 U.S.C. 804(2).
subject to OMB approval under the SUMMARY: This regulation establishes an
Paperwork Reduction Act (PRA) (44 List of Subjects in 40 CFR Part 180 exemption from the requirement of a
U.S.C. 3501 et seq.), nor does it require tolerance for residues of fatty acids,
any special considerations under Environmental protection, rape-oil, triesters with polyethylene
Executive Order 12898, entitled Administrative practice and procedure, glycol ether with glycerol (3:1) (CAS
‘‘Federal Actions to Address Agricultural commodities, Pesticides Reg. No. 688045–21–8) when used as an
Environmental Justice in Minority and pests, Reporting and recordkeeping inert ingredient in a pesticide chemical
Populations and Low-Income requirements. formulation. Seppic, Inc. submitted a
Populations’’ (59 FR 7629, February 16, Dated: July 26, 2017. petition to EPA under the Federal Food,
1994). Drug, and Cosmetic Act (FFDCA),
Michael Goodis,
Since tolerances and exemptions that requesting an exemption from the
Director, Registration Division, Office of requirement of a tolerance. This
are established on the basis of a petition
Pesticide Programs. regulation eliminates the need to
under FFDCA section 408(d), such as
the tolerance in this final rule, do not Therefore, 40 CFR chapter I is establish a maximum permissible level
require the issuance of a proposed rule, amended as follows: for residues of fatty acids, rape-oil,
the requirements of the Regulatory triesters with polyethylene glycol ether
Flexibility Act (RFA) (5 U.S.C. 601 et PART 180—[AMENDED] with glycerol (3:1) on food or feed
seq.), do not apply. commodities.
This action directly regulates growers, ■ 1. The authority citation for part 180
food processors, food handlers, and food DATES: This regulation is effective
continues to read as follows: August 16, 2017. Objections and
retailers, not States or tribes, nor does
this action alter the relationships or Authority: 21 U.S.C. 321(q), 346a and 371. requests for hearings must be received
distribution of power and on or before October 16, 2017, and must
■ 2. In § 180.626, add alphabetically the be filed in accordance with the
responsibilities established by Congress entry ‘‘Sunflower subgroup 20B’’ to the
in the preemption provisions of FFDCA instructions provided in 40 CFR part
table in paragraph (a)(1), and add 178 (see also Unit I.C. of the
section 408(n)(4). As such, the Agency
footnote 1 to the table to read as follows: SUPPLEMENTARY INFORMATION).
has determined that this action will not
have a substantial direct effect on States § 180.626 Prothioconazole; tolerances for ADDRESSES: The docket for this action,
or tribal governments, on the residues. identified by docket identification (ID)
pmangrum on DSK3GDR082PROD with RULES
relationship between the national number EPA–HQ–OPP–2017–0108, is
government and the States or tribal (a) * * * available at http://www.regulations.gov
governments, or on the distribution of (1) * * * or at the Office of Pesticide Programs
power and responsibilities among the Regulatory Public Docket (OPP Docket)
various levels of government or between in the Environmental Protection Agency
the Federal Government and Indian Docket Center (EPA/DC), West William
tribes. Thus, the Agency has determined Jefferson Clinton Bldg., Rm. 3334, 1301
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Document Created: 2017-08-16 10:27:06
Document Modified: 2017-08-16 10:27:06
| 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 August 16, 2017. Objections and requests for hearings must be received on or before October 16, 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, P.E., 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 38844 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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