81 FR 38601 - Chlorantraniliprole; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 114 (June 14, 2016)
Federal Register Volume 81, Issue 114 (June 14, 2016)
| Page Range | 38601-38604 | |
| FR Document | 2016-13910 |
[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)] [Rules and Regulations] [Pages 38601-38604] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13910] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2013-0235; FRL-9946-75] Chlorantraniliprole; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of chlorantraniliprole in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested the tolerances associated with pesticide petition number (PP) 5E8371, under the Federal Food, Drug, and Cosmetic Act (FFDCA). Additionally, the Agency is amending the existing tolerance for egg that was inadvertently omitted in a previous action. DATES: This regulation is effective June 14, 2016. Objections and requests for hearings must be received on or before August 15, 2016, 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-2013-0235, 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: Susan Lewis, 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 [[Page 38602]] 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-2013-0235 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 15, 2016. 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-2013-0235, 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 August 26, 2015 (80 FR 51759) (FRL-9931- 74), 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) 5E8371 by Interregional Research Project Number 4 (IR-4), 500 College Road East, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6- [(methylamino)-carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5- carboxamide, in or on nut, tree, group 14-12 at 0.02 parts per million (ppm); and fruit, stone, group 12-12 at 2.5 ppm. This petition additionally requested that 40 CFR 180.628 be amended by revising the existing tolerance in or on artichoke, globe from 4.0 ppm to 2.0 ppm; and hop, dried cones from 90 ppm to 40 ppm. Upon establishment of the tolerances associated with (PP) 5E8371, IR-4 requests to remove the following existing tolerances in 40 CFR 180.628: Nut, tree, group 14 at 0.04 ppm; pistachio at 0.04 ppm; fruit, stone, group 12-12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; cherry, sweet at 2.0 ppm; cherry, tart at 2.0 ppm; plum, chickasaw at 2.0 ppm; and plum, damson at 2.0 ppm. That document referenced a summary of the petition prepared on behalf of IR-4 by DuPont Crop Protection, the registrant, which is available in the docket EPA-HQ-OPP-2013-0235 at http://www.regulations.gov. There were no comments 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), EPA has reviewed the available scientific data 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 chlorantraniliprole, consistent with FFDCA section 408(b)(2). In the Federal Register of February 7, 2014 (79 FR 7397) (FRL-9905- 56), EPA established tolerances for residues of chlorantraniliprole in or on fruit, stone, group 12-12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; onion, green subgroup 3-07B at 3.0 ppm; peanut, hay at 90 ppm; and peanut at 0.06 ppm. EPA is relying upon those risk assessments and the findings made in the February 7, 2014 Federal Register document in support of this action. The toxicity profile of chlorantraniliprole has not changed. Moreover, because EPA is simply lowering the previously assessed tolerance levels (where the EPA assumed tolerance-level residues for all crops and including the tree nut group 14-12 at 0.02 ppm), the previous dietary estimates also do not change as a result of this action. Therefore, the previously published risk assessments that supported the establishment of those tolerances remain valid. The petitioner requested to lower currently established tolerances for residues of chlorantraniliprole in/on hops dried cones from 90 ppm to 40 ppm and globe artichoke from 4.0 ppm to 2.0 ppm in order to harmonize with the Codex maximum residue limits (MRLs). Crop field trial studies were submitted for hops and globe artichoke that indicate lowering these tolerances are appropriate and will support the existing U.S. registrations. The petitioner also requested to lower the existing tolerance of 4.0 ppm for stone fruit group 12-12, except cherry, chickasaw plum, and damson plum and remove the cherry, sweet; cherry, tart; plum, chickasaw; and plum, damson tolerances established at 2.0 ppm and establish a tolerance for stone fruit crop group 12-12 at 2.5 ppm to align with the Canadian MRL. EPA has determined that the existing residue chemistry data support this new tolerance level, which is lower than the current tolerances for some commodities and higher for others. Further, the petitioner requested to convert the tree nut crop group 14 to tree nut crop group 14-12 and to remove the tolerance for pistachio to lower the tolerance for the group (and for the now- included pistachio commodity) from 0.40 ppm to 0.02 ppm to harmonize the U.S. tolerance with the Codex and Canadian MRLs. EPA has determined that the existing residue chemistry data support the request for crop group conversion and for lowering the tolerance level. [[Page 38603]] Furthermore, EPA issued a final rule in the Federal Register of September 18, 2013, concerning the addition of certain commodities to the 40 CFR 180.628. The EPA determined that the tolerance level for egg should be increased from 0.2 ppm to 1.0 ppm, and EPA assessed egg using the tolerance of 1.0 ppm in 2013 as well as in February 2014. This was inadvertently omitted from the table in the 2013 Final Rule. Therefore, this document corrects that omission. Therefore, EPA relies upon the findings made in the February 7, 2014, Federal Register document, as well as the review of the additional globe artichoke and dried cones hop field trial data and existing residue chemistry data in support of this rule. 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 chlorantraniliprole residues. For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer to the February 7, 2014, Federal Register document and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2013-0235. Further information about EPA's determination that an updated risk assessment was not necessary may be found in the document, ``Chlorantraniliprole (DPX-E2Y45): Petition for Updating Crop Group Tolerances for Nut Tree Group 14-12 and Fruit Stone Group 12-12, and Amending Established Tolerances for Chlorantraniliprole in/on Artichoke Globe and Hop Dried Cones.'' in docket ID number EPA-HQ-OPP- 2013-0235. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, liquid chromatography mass spectrometry/mass spectrometry (LC/MS/MS); Method uPont-11374, is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 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. Based on the data supporting the petition, EPA has harmonized chlorantraniliprole tolerances in or on artichoke, globe at 2.0 ppm; hop, dried cones at 40 ppm; and nut, tree, group 14-12 at 0.02 ppm with established Codex MRLs. C. International Trade Considerations In this rulemaking, EPA is reducing the tolerances for hops, dried cones from 90 ppm to 40 ppm; globe artichoke from 4.0 ppm to 2.0 ppm; lowering the existing tolerance of 4.0 ppm for stone fruit group 12-12, except cherry, chickasaw plum, and damson plum and establishing a lower tolerance for stone fruit crop group 12-12 at 2.5 ppm; and converting and lowering the tree nut crop group 14 and pistachio tolerances to tree nut crop group 14-12 at 0.40 ppm to 0.02 ppm. The petitioner requested these reductions in order to harmonize with Codex and Canadian MRLs. The reduction is appropriate based on available data and residue levels resulting from registered use patterns. In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures Agreement, EPA notified the WTO of the request to revise these tolerances on September 14, 2015 as WTO notification G/SPS/N/USA/2778. In this action, EPA is allowing the existing higher tolerances to remain in effect for 6 months following the publication of this rule in order to allow a reasonable interval for producers in the exporting countries to adapt to the requirements of these modified tolerances. On December 14, 2016, those existing higher tolerances will expire, and the new reduced tolerances for artichoke, globe; fruit, stone, group 12-12; hop, dried cones; and nut, tree, group 14-12 will remain to cover residues of chlorantraniliprole on those commodities. Before that date, residues of chlorantraniliprole on those commodities would be permitted up to the higher tolerance levels; after that date, residues of chlorantraniliprole on artichoke, globe; the commodities contained in stone fruit group 12-12 and tree nut group 14-12; and hop, dried cones will need to comply with the new lower tolerance levels. This reduction in tolerance is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods. V. Conclusion Therefore, tolerances are established for residues of chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)- carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on in or on artichoke, globe at 2.0 ppm; fruit, stone, group 12-12 at 2.5 ppm; hop, dried cones at 40 ppm; and nut, tree, group 14-12 at 0.02 ppm. Upon establishment of the aforementioned tolerances, the Agency is removing the tolerances for cherry, sweet at 2.0 ppm; cherry, tart at 2.0 ppm; plum, chickasaw at 2.0 ppm; and plum, damson at 2.0 ppm as they are subsumed within the newly established group 12-12 tolerances. The Agency is adding an expiration date of December 14, 2016 to the existing tolerances for artichoke, globe at 4.0 ppm; nut, tree, group 14 at 0.04 ppm; pistachio at 0.04 ppm; fruit, stone, group 12-12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; and hop, dried cones at 90 ppm. Residues of chlorantraniliprole will be covered by these higher tolerances until the expiration date, after which time, they will need to comply with the lower tolerances being established today. Finally, the Agency is amending the existing tolerance for egg (increasing the tolerance level from 0.2 ppm to 1.0 ppm) to finalize its efforts to establish that tolerance in the Federal Register of September 18, 2013. 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 [[Page 38604]] 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 tolerances 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: May 31, 2016. Susan Lewis, 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. 180.628, in the table in paragraph (a): 0 a. Remove the entries for ``Cherry, sweet,'' ``Cherry, tart,'' ``Plum, chickasaw,'' and ``Plum, damson;'' 0 b. Revise the entry for ``Egg;'' 0 c. Amend the existing entries by adding a footnote for ``Artichoke, globe,'' ``Fruit, stone, group 12-12, except cherry, chickasaw plum, and damson plum,'' ``Hop, dried cones,'' ``Nut, tree, group 14,'' and ``Pistachio;'' and 0 d. Add alphabetically the entries for ``Artichoke, globe,'' ``Fruit, stone, group 12-12,'' ``Hop, dried cones,'' and ``Nut, tree, group 14- 12.'' The additions and revisions read as follows: Sec. 180.628 Chlorantraniliprole; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Artichoke, globe \1\.................................... 4.0 Artichoke, globe........................................ 2.0 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Egg..................................................... 1.0 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Fruit, stone, group 12-12............................... 2.5 Fruit, stone, group 12-12, except cherry, chickasaw 4.0 plum, and damson plum \1\.............................. ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Hop, dried cones \1\.................................... 90 Hop, dried cones........................................ 40 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Nut, tree, group 14 \1\................................. 0.04 Nut, tree, group 14-12.................................. 0.02 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Pistachio \1\........................................... 0.04 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ \1\ This tolerance expires on December 14, 2016. * * * * * [FR Doc. 2016-13910 Filed 6-13-16; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations 38601
do discuss the effects of this rule § 165.T08–0389 Safety Zone, Ohio River, the existing tolerance for egg that was
elsewhere in this preamble. East Liverpool, OH. inadvertently omitted in a previous
(a) Location. The following area is a action.
F. Environment safety zone: Ohio River mile 43.2 to DATES: This regulation is effective June
We have analyzed this rule under mile 43.6. 14, 2016. Objections and requests for
Department of Homeland Security (b) Enforcement. This rule will be hearings must be received on or before
Management Directive 023–01 and enforced, from 10:00 p.m. until 11:30 August 15, 2016, and must be filed in
p.m. on July 2, 2016. accordance with the instructions
Commandant Instruction M16475.lD,
(c) Regulations. (1) In accordance with provided in 40 CFR part 178 (see also
which guide the Coast Guard in
the general regulations in § 165.23 of Unit I.C. of the SUPPLEMENTARY
complying with the National this part, entry into this zone is
Environmental Policy Act of 1969, (42 INFORMATION).
prohibited unless authorized by the
U.S.C. 4321–4370f), and have Captain of the Port Pittsburgh or a ADDRESSES: The docket for this action,
determined that this action is one of a designated representative. identified by docket identification (ID)
category of actions that do not (2) Persons or vessels requiring entry number EPA–HQ–OPP–2013–0235, is
individually or cumulatively have a into or passage through the zone must available at http://www.regulations.gov
significant effect on the human request permission from the Captain of or at the Office of Pesticide Programs
environment. This rule involves a safety the Port Pittsburgh or a designated Regulatory Public Docket (OPP Docket)
zone lasting less than two hours that representative. The Captain of the in the Environmental Protection Agency
will prohibit entry on the Ohio River Pittsburgh representative may be Docket Center (EPA/DC), West William
between mile 43.2 and mile 43.6, during contacted at 412–221–0807. Jefferson Clinton Bldg., Rm. 3334, 1301
the barge-based firework event. It is (3) All persons and vessels shall Constitution Ave. NW., Washington, DC
categorically excluded from further comply with the instructions of the 20460–0001. The Public Reading Room
review under paragraph 34 (g) of Figure Captain of the Port Pittsburgh or their is open from 8:30 a.m. to 4:30 p.m.,
2–1 of the Commandant Instruction. An designated representative. Designated Monday through Friday, excluding legal
environmental analysis checklist Captain of the Port representatives holidays. The telephone number for the
include United States Coast Guard Public Reading Room is (202) 566–1744,
supporting this determination and a
commissioned, warrant, and petty and the telephone number for the OPP
Categorical Exclusion Determination are
officers. Docket is (703) 305–5805. Please review
available in the docket where indicated
(d) Information broadcasts. The the visitor instructions and additional
under ADDRESSES. We seek any
Captain of the Port Pittsburgh or a information about the docket available
comments or information that may lead at http://www.epa.gov/dockets.
to the discovery of a significant designated representative will inform
the public through broadcast notices to FOR FURTHER INFORMATION CONTACT:
environmental impact from this rule.
mariners of the enforcement period for Susan Lewis, Registration Division
G. Protest Activities the safety zone as well as any changes (7505P), Office of Pesticide Programs,
in the planned schedule. Environmental Protection Agency, 1200
The Coast Guard respects the First Pennsylvania Ave. NW., Washington,
Dated: May 27, 2016.
Amendment rights of protesters. DC 20460–0001; main telephone
Protesters are asked to contact the L. McClain, Jr.,
number: (703) 305–7090; email address:
person listed in the FOR FURTHER Commander, U.S. Coast Guard, Acting
Captain of the Port Pittsburgh.
RDFRNotices@epa.gov.
INFORMATION CONTACT section to SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–14027 Filed 6–13–16; 8:45 am]
coordinate protest activities so that your
message can be received without BILLING CODE 9110–04–P I. General Information
jeopardizing the safety or security of A. Does this action apply to me?
people, places or vessels.
ENVIRONMENTAL PROTECTION You may be potentially affected by
List of Subjects in 33 CFR Part 165 AGENCY this action if you are an agricultural
producer, food manufacturer, or
Marine safety, Navigation (water), 40 CFR Part 180 pesticide manufacturer. The following
Reporting and recordkeeping list of North American Industrial
requirements, Security measures, [EPA–HQ–OPP–2013–0235; FRL–9946–75]
Classification System (NAICS) codes is
Waterways. Chlorantraniliprole; Pesticide not intended to be exhaustive, but rather
For the reasons discussed in the Tolerances provides a guide to help readers
preamble, the Coast Guard amends 33 determine whether this document
AGENCY: Environmental Protection applies to them. Potentially affected
CFR part 165 as follows: Agency (EPA). entities may include:
PART 165—REGULATED NAVIGATION ACTION: Final rule. • Crop production (NAICS code 111).
AREAS AND LIMITED ACCESS AREAS • Animal production (NAICS code
SUMMARY: This regulation establishes 112).
tolerances for residues of • Food manufacturing (NAICS code
■ 1. The authority citation for part 165 chlorantraniliprole in or on multiple 311).
continues to read as follows: commodities which are identified and • Pesticide manufacturing (NAICS
sradovich on DSK3TPTVN1PROD with RULES
Authority: 33 U.S.C. 1231; 50 U.S.C. 191; discussed later in this document. code 32532).
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Interregional Research Project Number 4
Department of Homeland Security Delegation (IR–4) requested the tolerances B. How can I get electronic access to
No. 0170.1. associated with pesticide petition other related information?
number (PP) 5E8371, under the Federal You may access a frequently updated
■ 2. Add § 165.T08–0389 to read as Food, Drug, and Cosmetic Act (FFDCA). electronic version of EPA’s tolerance
follows: Additionally, the Agency is amending regulations at 40 CFR part 180 through
VerDate Sep<11>2014 16:33 Jun 13, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1](https://thefederalregister.org/doc/81_FR_38715/page/1.svg)
![38602 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations
the Government Printing Office’s e-CFR pesticide petition (PP) 5E8371 by relevant information in support of this
site at http://www.ecfr.gov/cgi-bin/text- Interregional Research Project Number 4 action. EPA has sufficient data to assess
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ (IR–4), 500 College Road East, the hazards of and to make a
40tab_02.tpl. Princeton, NJ 08540. The petition determination on aggregate exposure for
requested that 40 CFR part 180 be chlorantraniliprole, consistent with
C. How can I file an objection or hearing
amended by establishing tolerances for FFDCA section 408(b)(2).
request? In the Federal Register of February 7,
residues of the insecticide
Under FFDCA section 408(g), 21 chlorantraniliprole, 3-bromo-N-[4- 2014 (79 FR 7397) (FRL–9905–56), EPA
U.S.C. 346a, any person may file an chloro-2-methyl-6-[(methylamino)- established tolerances for residues of
objection to any aspect of this regulation carbonyl]phenyl]-1-(3-chloro-2- chlorantraniliprole in or on fruit, stone,
and may also request a hearing on those pyridinyl)-1H-pyrazole-5-carboxamide, group 12–12, except cherry, chickasaw
objections. You must file your objection in or on nut, tree, group 14–12 at 0.02 plum, and damson plum at 4.0 ppm;
or request a hearing on this regulation parts per million (ppm); and fruit, stone, onion, green subgroup 3–07B at 3.0
in accordance with the instructions group 12–12 at 2.5 ppm. This petition ppm; peanut, hay at 90 ppm; and peanut
provided in 40 CFR part 178. To ensure additionally requested that 40 CFR at 0.06 ppm. EPA is relying upon those
proper receipt by EPA, you must 180.628 be amended by revising the risk assessments and the findings made
identify docket ID number EPA–HQ– existing tolerance in or on artichoke, in the February 7, 2014 Federal Register
OPP–2013–0235 in the subject line on globe from 4.0 ppm to 2.0 ppm; and document in support of this action. The
the first page of your submission. All hop, dried cones from 90 ppm to 40 toxicity profile of chlorantraniliprole
objections and requests for a hearing ppm. Upon establishment of the has not changed. Moreover, because
must be in writing, and must be tolerances associated with (PP) 5E8371, EPA is simply lowering the previously
received by the Hearing Clerk on or IR–4 requests to remove the following assessed tolerance levels (where the
before August 15, 2016. Addresses for existing tolerances in 40 CFR 180.628: EPA assumed tolerance-level residues
mail and hand delivery of objections Nut, tree, group 14 at 0.04 ppm; for all crops and including the tree nut
and hearing requests are provided in 40 pistachio at 0.04 ppm; fruit, stone, group 14–12 at 0.02 ppm), the previous
CFR 178.25(b). group 12–12, except cherry, chickasaw dietary estimates also do not change as
In addition to filing an objection or plum, and damson plum at 4.0 ppm; a result of this action. Therefore, the
hearing request with the Hearing Clerk cherry, sweet at 2.0 ppm; cherry, tart at previously published risk assessments
as described in 40 CFR part 178, please 2.0 ppm; plum, chickasaw at 2.0 ppm; that supported the establishment of
submit a copy of the filing (excluding and plum, damson at 2.0 ppm. That those tolerances remain valid.
any Confidential Business Information document referenced a summary of the The petitioner requested to lower
(CBI)) for inclusion in the public docket. petition prepared on behalf of IR–4 by currently established tolerances for
Information not marked confidential DuPont Crop Protection, the registrant, residues of chlorantraniliprole in/on
pursuant to 40 CFR part 2 may be which is available in the docket EPA– hops dried cones from 90 ppm to 40
disclosed publicly by EPA without prior HQ–OPP–2013–0235 at http:// ppm and globe artichoke from 4.0 ppm
notice. Submit the non-CBI copy of your www.regulations.gov. to 2.0 ppm in order to harmonize with
objection or hearing request, identified There were no comments received in the Codex maximum residue limits
by docket ID number EPA–HQ–OPP– response to the notice of filing. (MRLs). Crop field trial studies were
2013–0235, by one of the following submitted for hops and globe artichoke
III. Aggregate Risk Assessment and that indicate lowering these tolerances
methods: Determination of Safety
• Federal eRulemaking Portal: http:// are appropriate and will support the
www.regulations.gov. Follow the online Section 408(b)(2)(A)(i) of FFDCA existing U.S. registrations. The
instructions for submitting comments. allows EPA to establish a tolerance (the petitioner also requested to lower the
Do not submit electronically any legal limit for a pesticide chemical existing tolerance of 4.0 ppm for stone
information you consider to be CBI or residue in or on a food) only if EPA fruit group 12–12, except cherry,
other information whose disclosure is determines that the tolerance is ‘‘safe.’’ chickasaw plum, and damson plum and
restricted by statute. Section 408(b)(2)(A)(ii) of FFDCA remove the cherry, sweet; cherry, tart;
• Mail: OPP Docket, Environmental defines ‘‘safe’’ to mean that ‘‘there is a plum, chickasaw; and plum, damson
Protection Agency Docket Center (EPA/ reasonable certainty that no harm will tolerances established at 2.0 ppm and
DC), (28221T), 1200 Pennsylvania Ave. result from aggregate exposure to the establish a tolerance for stone fruit crop
NW., Washington, DC 20460–0001. pesticide chemical residue, including group 12–12 at 2.5 ppm to align with
• Hand Delivery: To make special all anticipated dietary exposures and all the Canadian MRL. EPA has determined
arrangements for hand delivery or other exposures for which there is that the existing residue chemistry data
delivery of boxed information, please reliable information.’’ This includes support this new tolerance level, which
follow the instructions at http:// exposure through drinking water and in is lower than the current tolerances for
www.epa.gov/dockets/contacts.html. residential settings, but does not include some commodities and higher for
Additional instructions on commenting occupational exposure. Section others. Further, the petitioner requested
or visiting the docket, along with more 408(b)(2)(C) of FFDCA requires EPA to to convert the tree nut crop group 14 to
information about dockets generally, is give special consideration to exposure tree nut crop group 14–12 and to
available at http://www.epa.gov/ of infants and children to the pesticide remove the tolerance for pistachio to
dockets. chemical residue in establishing a lower the tolerance for the group (and
tolerance and to ‘‘ensure that there is a for the now-included pistachio
II. Summary of Petitioned-For
sradovich on DSK3TPTVN1PROD with RULES
reasonable certainty that no harm will commodity) from 0.40 ppm to 0.02 ppm
Tolerance result to infants and children from to harmonize the U.S. tolerance with the
In the Federal Register of August 26, aggregate exposure to the pesticide Codex and Canadian MRLs. EPA has
2015 (80 FR 51759) (FRL–9931–74), chemical residue. . . .’’ determined that the existing residue
EPA issued a document pursuant to Consistent with FFDCA section chemistry data support the request for
FFDCA section 408(d)(3), 21 U.S.C. 408(b)(2)(D), EPA has reviewed the crop group conversion and for lowering
346a(d)(3), announcing the filing of a available scientific data and other the tolerance level.
VerDate Sep<11>2014 16:33 Jun 13, 2016 Jkt 238001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1](https://thefederalregister.org/doc/81_FR_38715/page/2.svg)
![Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations 38603
Furthermore, EPA issued a final rule international maximum residue limits date, residues of chlorantraniliprole on
in the Federal Register of September 18, (MRLs) established by the Codex artichoke, globe; the commodities
2013, concerning the addition of certain Alimentarius Commission (Codex), as contained in stone fruit group 12–12
commodities to the 40 CFR 180.628. The required by FFDCA section 408(b)(4). and tree nut group 14–12; and hop,
EPA determined that the tolerance level The Codex Alimentarius is a joint dried cones will need to comply with
for egg should be increased from 0.2 United Nations Food and Agriculture the new lower tolerance levels. This
ppm to 1.0 ppm, and EPA assessed egg Organization/World Health reduction in tolerance is not
using the tolerance of 1.0 ppm in 2013 Organization food standards program, discriminatory; the same food safety
as well as in February 2014. This was and it is recognized as an international standard contained in the FFDCA
inadvertently omitted from the table in food safety standards-setting applies equally to domestically
the 2013 Final Rule. Therefore, this organization in trade agreements to produced and imported foods.
document corrects that omission. which the United States is a party. EPA
V. Conclusion
Therefore, EPA relies upon the may establish a tolerance that is
findings made in the February 7, 2014, different from a Codex MRL; however, Therefore, tolerances are established
Federal Register document, as well as FFDCA section 408(b)(4) requires that for residues of chlorantraniliprole, 3-
the review of the additional globe EPA explain the reasons for departing bromo-N-[4-chloro-2-methyl-6-
artichoke and dried cones hop field trial from the Codex level. [(methylamino)-carbonyl]phenyl]-1-(3-
data and existing residue chemistry data Based on the data supporting the chloro-2-pyridinyl)-1H-pyrazole-5-
in support of this rule. EPA concludes petition, EPA has harmonized carboxamide, in or on in or on
that there is a reasonable certainty that chlorantraniliprole tolerances in or on artichoke, globe at 2.0 ppm; fruit, stone,
no harm will result to the general artichoke, globe at 2.0 ppm; hop, dried group 12–12 at 2.5 ppm; hop, dried
population, or to infants and children cones at 40 ppm; and nut, tree, group cones at 40 ppm; and nut, tree, group
from aggregate exposure to 14–12 at 0.02 ppm with established 14–12 at 0.02 ppm. Upon establishment
chlorantraniliprole residues. Codex MRLs. of the aforementioned tolerances, the
For a detailed discussion of the Agency is removing the tolerances for
C. International Trade Considerations cherry, sweet at 2.0 ppm; cherry, tart at
aggregate risk assessments and
In this rulemaking, EPA is reducing 2.0 ppm; plum, chickasaw at 2.0 ppm;
determination of safety for these
the tolerances for hops, dried cones and plum, damson at 2.0 ppm as they
tolerances, please refer to the February
from 90 ppm to 40 ppm; globe artichoke are subsumed within the newly
7, 2014, Federal Register document and
from 4.0 ppm to 2.0 ppm; lowering the established group 12–12 tolerances. The
its supporting documents, available at
existing tolerance of 4.0 ppm for stone Agency is adding an expiration date of
http://www.regulations.gov in docket ID
fruit group 12–12, except cherry, December 14, 2016 to the existing
number EPA–HQ–OPP–2013–0235.
chickasaw plum, and damson plum and tolerances for artichoke, globe at 4.0
Further information about EPA’s
establishing a lower tolerance for stone ppm; nut, tree, group 14 at 0.04 ppm;
determination that an updated risk
fruit crop group 12–12 at 2.5 ppm; and pistachio at 0.04 ppm; fruit, stone,
assessment was not necessary may be converting and lowering the tree nut group 12–12, except cherry, chickasaw
found in the document, crop group 14 and pistachio tolerances plum, and damson plum at 4.0 ppm;
‘‘Chlorantraniliprole (DPX–E2Y45): to tree nut crop group 14–12 at 0.40 and hop, dried cones at 90 ppm.
Petition for Updating Crop Group ppm to 0.02 ppm. The petitioner Residues of chlorantraniliprole will be
Tolerances for Nut Tree Group 14–12 requested these reductions in order to covered by these higher tolerances until
and Fruit Stone Group 12–12, and harmonize with Codex and Canadian the expiration date, after which time,
Amending Established Tolerances for MRLs. The reduction is appropriate they will need to comply with the lower
Chlorantraniliprole in/on Artichoke based on available data and residue tolerances being established today.
Globe and Hop Dried Cones.’’ in docket levels resulting from registered use Finally, the Agency is amending the
ID number EPA–HQ–OPP–2013–0235. patterns. existing tolerance for egg (increasing the
IV. Other Considerations In accordance with the World Trade tolerance level from 0.2 ppm to 1.0
Organization’s (WTO) Sanitary and ppm) to finalize its efforts to establish
A. Analytical Enforcement Methodology Phytosanitary Measures Agreement, that tolerance in the Federal Register of
Adequate enforcement methodology, EPA notified the WTO of the request to September 18, 2013.
liquid chromatography mass revise these tolerances on September 14,
2015 as WTO notification G/SPS/N/ VI. Statutory and Executive Order
spectrometry/mass spectrometry (LC/
USA/2778. In this action, EPA is Reviews
MS/MS); Method uPont-11374, is
available to enforce the tolerance allowing the existing higher tolerances This action establishes tolerances
expression. to remain in effect for 6 months under FFDCA section 408(d) in
The method may be requested from: following the publication of this rule in response to a petition submitted to the
Chief, Analytical Chemistry Branch, order to allow a reasonable interval for Agency. The Office of Management and
Environmental Science Center, 701 producers in the exporting countries to Budget (OMB) has exempted these types
Mapes Rd., Ft. Meade, MD 20755–5350; adapt to the requirements of these of actions from review under Executive
telephone number: (410) 305–2905; modified tolerances. On December 14, Order 12866, entitled ‘‘Regulatory
email address: residuemethods@ 2016, those existing higher tolerances Planning and Review’’ (58 FR 51735,
epa.gov. will expire, and the new reduced October 4, 1993). Because this action
tolerances for artichoke, globe; fruit, has been exempted from review under
B. International Residue Limits
sradovich on DSK3TPTVN1PROD with RULES
stone, group 12–12; hop, dried cones; Executive Order 12866, this action is
In making its tolerance decisions, EPA and nut, tree, group 14–12 will remain not subject to Executive Order 13211,
seeks to harmonize U.S. tolerances with to cover residues of chlorantraniliprole entitled ‘‘Actions Concerning
international standards whenever on those commodities. Before that date, Regulations That Significantly Affect
possible, consistent with U.S. food residues of chlorantraniliprole on those Energy Supply, Distribution, or Use’’ (66
safety standards and agricultural commodities would be permitted up to FR 28355, May 22, 2001) or Executive
practices. EPA considers the the higher tolerance levels; after that Order 13045, entitled ‘‘Protection of
VerDate Sep<11>2014 16:33 Jun 13, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1](https://thefederalregister.org/doc/81_FR_38715/page/3.svg)
![38604 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations
Children from Environmental Health Register. This action is not a ‘‘major Parts per
Commodity
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). million
April 23, 1997). This action does not
List of Subjects in 40 CFR Part 180 Hop, dried cones .................. 40
contain any information collections
subject to OMB approval under the Environmental protection,
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure,
* * * * *
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides
any special considerations under and pests, Reporting and recordkeeping Nut, tree, group 14 1
............. 0.04
Executive Order 12898, entitled requirements. Nut, tree, group 14–12 ......... 0.02
‘‘Federal Actions to Address Dated: May 31, 2016.
Environmental Justice in Minority Susan Lewis,
Populations and Low-Income * * * * *
Director, Registration Division, Office of
Populations’’ (59 FR 7629, February 16, Pesticide Programs. Pistachio 1 ............................. 0.04
1994).
Since tolerances and exemptions that Therefore, 40 CFR chapter I is
are established on the basis of a petition amended as follows: * * * * *
under FFDCA section 408(d), such as
the tolerances in this final rule, do not PART 180—[AMENDED] 1 This tolerance expires on December 14,
2016.
require the issuance of a proposed rule, ■ 1. The authority citation for part 180
the requirements of the Regulatory * * * * *
continues to read as follows: [FR Doc. 2016–13910 Filed 6–13–16; 8:45 am]
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371. BILLING CODE 6560–50–P
This action directly regulates growers, ■ 2. In § 180.628, in the table in
food processors, food handlers, and food paragraph (a):
retailers, not States or tribes, nor does ■ a. Remove the entries for ‘‘Cherry,
ENVIRONMENTAL PROTECTION
this action alter the relationships or sweet,’’ ‘‘Cherry, tart,’’ ‘‘Plum, AGENCY
distribution of power and chickasaw,’’ and ‘‘Plum, damson;’’
responsibilities established by Congress 40 CFR Part 180
■ b. Revise the entry for ‘‘Egg;’’
in the preemption provisions of FFDCA ■ c. Amend the existing entries by [EPA–HQ–OPP–2014–0749; FRL–9942–23]
section 408(n)(4). As such, the Agency adding a footnote for ‘‘Artichoke,
has determined that this action will not globe,’’ ‘‘Fruit, stone, group 12–12, Clofentezine; Pesticide Tolerances
have a substantial direct effect on States except cherry, chickasaw plum, and AGENCY: Environmental Protection
or tribal governments, on the damson plum,’’ ‘‘Hop, dried cones,’’ Agency (EPA).
relationship between the national ‘‘Nut, tree, group 14,’’ and ‘‘Pistachio;’’ ACTION: Final rule.
government and the States or tribal and
governments, or on the distribution of ■ d. Add alphabetically the entries for SUMMARY: This regulation establishes
power and responsibilities among the ‘‘Artichoke, globe,’’ ‘‘Fruit, stone, group tolerances for residues of clofentezine in
various levels of government or between 12–12,’’ ‘‘Hop, dried cones,’’ and ‘‘Nut, or on multiple commodities which are
the Federal Government and Indian tree, group 14–12.’’ identified and discussed later in this
tribes. Thus, the Agency has determined The additions and revisions read as document. Interregional Research
that Executive Order 13132, entitled follows: Project Number 4 (IR–4) requested these
‘‘Federalism’’ (64 FR 43255, August 10, tolerances under the Federal Food,
1999) and Executive Order 13175, § 180.628 Chlorantraniliprole; tolerances Drug, and Cosmetic Act (FFDCA).
entitled ‘‘Consultation and Coordination for residues.
DATES: This regulation is effective June
with Indian Tribal Governments’’ (65 FR (a) * * * 14, 2016. Objections and requests for
67249, November 9, 2000) do not apply hearings must be received on or before
to this action. In addition, this action Parts per
Commodity August 15, 2016, and must be filed in
million
does not impose any enforceable duty or accordance with the instructions
contain any unfunded mandate as provided in 40 CFR part 178 (see also
described under Title II of the Unfunded * * * * * Unit I.C. of the SUPPLEMENTARY
Mandates Reform Act (UMRA) (2 U.S.C. INFORMATION).
1501 et seq.). Artichoke, globe 1 .................. 4.0
This action does not involve any Artichoke, globe .................... 2.0 ADDRESSES: The docket for this action,
technical standards that would require identified by docket identification (ID)
Agency consideration of voluntary number EPA–HQ–OPP–2014–0749, is
* * * * * available at http://www.regulations.gov
consensus standards pursuant to section
12(d) of the National Technology or at the Office of Pesticide Programs
Egg ....................................... 1.0
Transfer and Advancement Act Regulatory Public Docket (OPP Docket)
(NTTAA) (15 U.S.C. 272 note). in the Environmental Protection Agency
* * * * * Docket Center (EPA/DC), West William
VII. Congressional Review Act Jefferson Clinton Bldg., Rm. 3334, 1301
Pursuant to the Congressional Review Fruit, stone, group 12–12 ..... 2.5 Constitution Ave. NW., Washington, DC
sradovich on DSK3TPTVN1PROD with RULES
Act (5 U.S.C. 801 et seq.), EPA will Fruit, stone, group 12–12, 20460–0001. The Public Reading Room
submit a report containing this rule and except cherry, chickasaw is open from 8:30 a.m. to 4:30 p.m.,
plum, and damson plum 1 4.0 Monday through Friday, excluding legal
other required information to the U.S.
Senate, the U.S. House of holidays. The telephone number for the
Representatives, and the Comptroller * * * * * Public Reading Room is (202) 566–1744,
General of the United States prior to and the telephone number for the OPP
publication of the rule in the Federal Hop, dried cones 1 ................ 90 Docket is (703) 305–5805. Please review
VerDate Sep<11>2014 16:33 Jun 13, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1](https://thefederalregister.org/doc/81_FR_38715/page/4.svg)
Document Created: 2016-06-14 02:59:13
Document Modified: 2016-06-14 02:59:13
| 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, 2016. Objections and requests for hearings must be received on or before August 15, 2016, 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 | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 81 FR 38601 | |
| 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