81_FR_61790 81 FR 61617 - Chlorantraniliprole; Pesticide Tolerances

81 FR 61617 - Chlorantraniliprole; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 173 (September 7, 2016)

Page Range61617-61619
FR Document2016-21458

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 under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 81 Issue 173 (Wednesday, September 7, 2016)
[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Rules and Regulations]
[Pages 61617-61619]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21458]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0235; FRL-9950-04]


Chlorantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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 under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 7, 2016. Objections and 
requests for hearings must be received on or before November 7, 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: Michael Goodis, 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-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 
November 7, 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 June 22, 2016 (81 FR 40594) (FRL-9947-
32), 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# 
6E8477) by 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 the raw 
agricultural commodities teff, forage at

[[Page 61618]]

40 parts per million (ppm); teff, grain at 6.0 ppm; teff, hay at 40 
ppm; teff, straw at 40 ppm; quinoa, forage at 40 ppm; quinoa, grain at 
6.0 ppm; quinoa, hay at 40 ppm; and quinoa, straw at 40 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.
    A comment was received on the notice of filing. EPA's response to 
this comment is discussed 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), 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 in 
or on teff forage, grain, hay and straw as well as quinoa forage, 
grain, hay and straw, 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 the risk 
assessments that supported the findings made in the February 7, 2014 
Federal Register document in support of this action. The toxicity 
profile of chlorantraniliprole has not changed, and the previous risk 
assessments that supported the establishment of those tolerances remain 
valid.
    The Agency evaluated the request to establish tolerances in or on 
quinoa and teff forage, grain, hay, and straw and concluded that the 
aggregate exposure and risks would not increase as a result of the 
proposed use on quinoa and teff and are the same as those estimated in 
the February 7, 2014 final rule.
    Both quinoa and teff are prepared like other whole grains, such as 
rice and barley, and may also be used to make flour in a manner similar 
to wheat and other cereal grains. Therefore, EPA concludes that teff 
and quinoa will likely substitute in the diet for cereal grain foods, 
which are subject to tolerances for chlorantraniliprole, and would be 
assumed to contain similar residues. Additionally, since teff and 
quinoa use patterns are similar to those for wheat and barley, 
increased exposures to individuals through drinking water is not 
expected. Thus, the proposed teff and quinoa uses will not result in 
higher dietary exposure estimates.
    With respect to livestock commodities, residues of 
chlorantraniliprole in teff and quinoa livestock feeds are expected to 
be similar to those in other forages, hays, and silages for which 
chlorantraniliprole is currently registered. Therefore, there would be 
no increase in the livestock dietary burden should teff and quinoa be 
substituted in the livestock diet for other hays and silages; residues 
in meat, milk, poultry and eggs will remain the same.
    EPA concludes that the aggregate exposure and risk estimates 
presented in the most recent human health risk assessment document, 
which were not of concern to the Agency, adequately account for 
exposures and risk resulting from all chlorantraniliprole uses 
including the proposed teff and quinoa uses.
    Therefore, EPA relies upon the findings made in the February 7, 
2014 Federal Register document 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: Aggregate Human Health Risk Assessment 
for the Proposed New Uses on Teff and Quinoa'' 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 DuPont-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.
    There are no Codex MRLs for chlorantraniliprole residues in or on 
quinoa or teff.

C. Response to Comments

    EPA received one comment to the Notice of Filing that stated, in 
part, that this chemical is ``dangerous to America and to health of our 
people and life in America'' and that EPA should ``deny those 
applications from the profiteers whose only aim is to make money at our 
expense.'' The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops. However, the existing legal framework 
provided by section 408 of the FFDCA states that tolerances may be set 
when persons seeking such

[[Page 61619]]

tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. This citizen's comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the citizen has made no contention that EPA has acted in 
violation of the statutory framework.

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 quinoa, forage at 40 ppm; quinoa, grain at 6.0 ppm; quinoa, hay 
at 40 ppm; and quinoa, straw at 40 ppm; teff, forage at 40 ppm; teff, 
grain at 6.0 ppm; teff, hay at 40 ppm; and teff, straw at 40 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 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: August 26, 2016.
Michael Goodis,
Acting 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, add alphabetically the entries ``Quinoa, forage'', 
``Quinoa, grain'', ``Quinoa, hay'', ``Quinoa, straw'', ``Teff, 
forage'', ``Teff, grain'', ``Teff, hay'', and ``Teff, straw'' to the 
table in paragraph (a) to read as follows:


Sec.  180.628  Chlorantraniliprole; pesticide tolerances.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Quinoa, forage..........................................              40
Quinoa, grain...........................................             6.0
Quinoa, hay.............................................              40
Quinoa, straw...........................................              40
 
                                * * * * *
Teff, forage............................................              40
Teff, grain.............................................             6.0
Teff, hay...............................................              40
Teff, straw.............................................              40
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-21458 Filed 9-6-16; 8:45 am]
BILLING CODE 6560-50-P



                                                        Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Rules and Regulations                                         61617

                                           Jennifer Haggins, Marine Safety Unit                    178 (see also Unit I.C. of the                        and may also request a hearing on those
                                           Pittsburgh, U.S. Coast Guard; telephone                 SUPPLEMENTARY INFORMATION).                           objections. You must file your objection
                                           412–221–0807, email                                     ADDRESSES:    The docket for this action,             or request a hearing on this regulation
                                           Jennifer.L.Haggins@uscg.mil.                            identified by docket identification (ID)              in accordance with the instructions
                                           SUPPLEMENTARY INFORMATION: The Coast                    number EPA–HQ–OPP–2013–0235, is                       provided in 40 CFR part 178. To ensure
                                           Guard will enforce the Safety Zone for                  available at http://www.regulations.gov               proper receipt by EPA, you must
                                           the annual Pittsburgh Pirates Fireworks                 or at the Office of Pesticide Programs                identify docket ID number EPA–HQ–
                                           listed in 33 CFR 165.801 Table 1, Sector                Regulatory Public Docket (OPP Docket)                 OPP–2013–0235 in the subject line on
                                           Ohio Valley, No. 1 from 8:00 p.m. to                    in the Environmental Protection Agency                the first page of your submission. All
                                           11:30 p.m. on September 10, 2016.                       Docket Center (EPA/DC), West William                  objections and requests for a hearing
                                           Should inclement weather require                        Jefferson Clinton Bldg., Rm. 3334, 1301               must be in writing, and must be
                                           rescheduling, the safety zone will be                   Constitution Ave. NW., Washington, DC                 received by the Hearing Clerk on or
                                           within 48 hours of the scheduled date.                  20460–0001. The Public Reading Room                   before November 7, 2016. Addresses for
                                           Entry into the safety zone is prohibited                is open from 8:30 a.m. to 4:30 p.m.,                  mail and hand delivery of objections
                                           unless authorized by the COTP or a                      Monday through Friday, excluding legal                and hearing requests are provided in 40
                                           designated representative. Persons or                   holidays. The telephone number for the                CFR 178.25(b).
                                           vessels desiring to enter into or passage               Public Reading Room is (202) 566–1744,                  In addition to filing an objection or
                                           through the safety zone must request                    and the telephone number for the OPP                  hearing request with the Hearing Clerk
                                                                                                   Docket is (703) 305–5805. Please review               as described in 40 CFR part 178, please
                                           permission from the COTP or a
                                                                                                   the visitor instructions and additional               submit a copy of the filing (excluding
                                           designated representative. If permission
                                                                                                   information about the docket available                any Confidential Business Information
                                           is granted, all persons and vessels shall
                                                                                                   at http://www.epa.gov/dockets.                        (CBI)) for inclusion in the public docket.
                                           comply with the instructions of the
                                                                                                                                                         Information not marked confidential
                                           COTP or designated representative.                      FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                         pursuant to 40 CFR part 2 may be
                                              This notice of enforcement is issued                 Michael Goodis, Registration Division                 disclosed publicly by EPA without prior
                                           under authority of 33 CFR 165.801 and                   (7505P), Office of Pesticide Programs,                notice. Submit the non-CBI copy of your
                                           5 U.S.C. 552(a). In addition to this                    Environmental Protection Agency, 1200                 objection or hearing request, identified
                                           notice in the Federal Register, the Coast               Pennsylvania Ave. NW., Washington,                    by docket ID number EPA–HQ–OPP–
                                           Guard will provide the maritime                         DC 20460–0001; main telephone                         2013–0235, by one of the following
                                           community with advance notification of                  number: (703) 305–7090; email address:                methods:
                                           this enforcement period via Local                       RDFRNotices@epa.gov.                                    • Federal eRulemaking Portal: http://
                                           Notice to Mariners and updates via                      SUPPLEMENTARY INFORMATION:                            www.regulations.gov. Follow the online
                                           Marine Information Broadcasts.                                                                                instructions for submitting comments.
                                                                                                   I. General Information
                                           L. Mcclain, Jr.,                                                                                              Do not submit electronically any
                                           Commander, U.S. Coast Guard, Captain of                 A. Does this action apply to me?                      information you consider to be CBI or
                                           the Port Pittsburgh.                                       You may be potentially affected by                 other information whose disclosure is
                                           [FR Doc. 2016–21439 Filed 9–6–16; 8:45 am]              this action if you are an agricultural                restricted by statute.
                                           BILLING CODE 9110–04–P                                  producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                                                                                   pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                   list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                                                                                   Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                           ENVIRONMENTAL PROTECTION
                                                                                                   not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                           AGENCY                                                                                                        arrangements for hand delivery or
                                                                                                   provides a guide to help readers
                                                                                                   determine whether this document                       delivery of boxed information, please
                                           40 CFR Part 180                                                                                               follow the instructions at http://
                                                                                                   applies to them. Potentially affected
                                           [EPA–HQ–OPP–2013–0235; FRL–9950–04]                     entities may include:                                 www.epa.gov/dockets/contacts.html.
                                                                                                      • Crop production (NAICS code 111).                Additional instructions on commenting
                                           Chlorantraniliprole; Pesticide                             • Animal production (NAICS code                    or visiting the docket, along with more
                                           Tolerances                                              112).                                                 information about dockets generally, is
                                                                                                      • Food manufacturing (NAICS code                   available at http://www.epa.gov/
                                           AGENCY:  Environmental Protection                                                                             dockets.
                                                                                                   311).
                                           Agency (EPA).                                              • Pesticide manufacturing (NAICS
                                           ACTION: Final rule.
                                                                                                                                                         II. Summary of Petitioned-for Tolerance
                                                                                                   code 32532).
                                                                                                                                                            In the Federal Register of June 22,
                                           SUMMARY:   This regulation establishes                  B. How can I get electronic access to                 2016 (81 FR 40594) (FRL–9947–32),
                                           tolerances for residues of                              other related information?                            EPA issued a document pursuant to
                                           chlorantraniliprole in or on multiple                      You may access a frequently updated                FFDCA section 408(d)(3), 21 U.S.C.
                                           commodities which are identified and                    electronic version of EPA’s tolerance                 346a(d)(3), announcing the filing of a
                                           discussed later in this document.                       regulations at 40 CFR part 180 through                pesticide petition (PP# 6E8477) by IR–
                                           Interregional Research Project Number 4                 the Government Printing Office’s e-CFR                4, 500 College Road East, Princeton, NJ
                                           (IR–4) requested the tolerances under                   site at http://www.ecfr.gov/cgi-bin/text-             08540. The petition requested that 40
                                           the Federal Food, Drug, and Cosmetic                    idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  CFR part 180 be amended by
                                           Act (FFDCA).                                            40tab_02.tpl.                                         establishing tolerances for residues of
ehiers on DSK5VPTVN1PROD with RULES




                                           DATES: This regulation is effective                                                                           the insecticide chlorantraniliprole, 3-
                                           September 7, 2016. Objections and                       C. How can I file an objection or hearing             bromo-N-[4-chloro-2-methyl-6-
                                           requests for hearings must be received                  request?                                              [(methylamino)-carbonyl]phenyl]-1-(3-
                                           on or before November 7, 2016, and                        Under FFDCA section 408(g), 21                      chloro-2-pyridinyl)-1H-pyrazole-5-
                                           must be filed in accordance with the                    U.S.C. 346a, any person may file an                   carboxamide, in or on the raw
                                           instructions provided in 40 CFR part                    objection to any aspect of this regulation            agricultural commodities teff, forage at


                                      VerDate Sep<11>2014   14:50 Sep 06, 2016   Jkt 238001   PO 00000   Frm 00035   Fmt 4700   Sfmt 4700   E:\FR\FM\07SER1.SGM   07SER1


                                           61618        Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Rules and Regulations

                                           40 parts per million (ppm); teff, grain at              supported the establishment of those                  assessment was not necessary may be
                                           6.0 ppm; teff, hay at 40 ppm; teff, straw               tolerances remain valid.                              found in the document,
                                           at 40 ppm; quinoa, forage at 40 ppm;                       The Agency evaluated the request to                ‘‘Chlorantraniliprole: Aggregate Human
                                           quinoa, grain at 6.0 ppm; quinoa, hay at                establish tolerances in or on quinoa and              Health Risk Assessment for the
                                           40 ppm; and quinoa, straw at 40 ppm.                    teff forage, grain, hay, and straw and                Proposed New Uses on Teff and
                                           That document referenced a summary of                   concluded that the aggregate exposure                 Quinoa’’ in docket ID number EPA–HQ–
                                           the petition prepared on behalf of IR–4                 and risks would not increase as a result              OPP–2013–0235.
                                           by DuPont Crop Protection, the                          of the proposed use on quinoa and teff
                                                                                                   and are the same as those estimated in                IV. Other Considerations
                                           registrant, which is available in the
                                           docket EPA–HQ–OPP–2013–0235 at                          the February 7, 2014 final rule.                      A. Analytical Enforcement Methodology
                                           http://www.regulations.gov.                                Both quinoa and teff are prepared like
                                                                                                   other whole grains, such as rice and                     Adequate enforcement methodology,
                                              A comment was received on the                                                                              liquid chromatography mass
                                           notice of filing. EPA’s response to this                barley, and may also be used to make
                                                                                                   flour in a manner similar to wheat and                spectrometry/mass spectrometry (LC/
                                           comment is discussed in Unit IV.C.                                                                            MS/MS); Method DuPont-11374, is
                                                                                                   other cereal grains. Therefore, EPA
                                           III. Aggregate Risk Assessment and                      concludes that teff and quinoa will                   available to enforce the tolerance
                                           Determination of Safety                                 likely substitute in the diet for cereal              expression.
                                                                                                   grain foods, which are subject to                        The method may be requested from:
                                              Section 408(b)(2)(A)(i) of FFDCA                                                                           Chief, Analytical Chemistry Branch,
                                           allows EPA to establish a tolerance (the                tolerances for chlorantraniliprole, and
                                                                                                   would be assumed to contain similar                   Environmental Science Center, 701
                                           legal limit for a pesticide chemical                                                                          Mapes Rd., Ft. Meade, MD 20755–5350;
                                           residue in or on a food) only if EPA                    residues. Additionally, since teff and
                                                                                                   quinoa use patterns are similar to those              telephone number: (410) 305–2905;
                                           determines that the tolerance is ‘‘safe.’’                                                                    email address: residuemethods@
                                           Section 408(b)(2)(A)(ii) of FFDCA                       for wheat and barley, increased
                                                                                                   exposures to individuals through                      epa.gov.
                                           defines ‘‘safe’’ to mean that ‘‘there is a
                                           reasonable certainty that no harm will                  drinking water is not expected. Thus,                 B. International Residue Limits
                                                                                                   the proposed teff and quinoa uses will
                                           result from aggregate exposure to the                                                                            In making its tolerance decisions, EPA
                                                                                                   not result in higher dietary exposure
                                           pesticide chemical residue, including                                                                         seeks to harmonize U.S. tolerances with
                                                                                                   estimates.
                                           all anticipated dietary exposures and all                  With respect to livestock                          international standards whenever
                                           other exposures for which there is                      commodities, residues of                              possible, consistent with U.S. food
                                           reliable information.’’ This includes                   chlorantraniliprole in teff and quinoa                safety standards and agricultural
                                           exposure through drinking water and in                  livestock feeds are expected to be                    practices. EPA considers the
                                           residential settings, but does not include              similar to those in other forages, hays,              international maximum residue limits
                                           occupational exposure. Section                          and silages for which                                 (MRLs) established by the Codex
                                           408(b)(2)(C) of FFDCA requires EPA to                   chlorantraniliprole is currently                      Alimentarius Commission (Codex), as
                                           give special consideration to exposure                  registered. Therefore, there would be no              required by FFDCA section 408(b)(4).
                                           of infants and children to the pesticide                increase in the livestock dietary burden              The Codex Alimentarius is a joint
                                           chemical residue in establishing a                      should teff and quinoa be substituted in              United Nations Food and Agriculture
                                           tolerance and to ‘‘ensure that there is a               the livestock diet for other hays and                 Organization/World Health
                                           reasonable certainty that no harm will                  silages; residues in meat, milk, poultry              Organization food standards program,
                                           result to infants and children from                     and eggs will remain the same.                        and it is recognized as an international
                                           aggregate exposure to the pesticide                        EPA concludes that the aggregate                   food safety standards-setting
                                           chemical residue. . . .’’                               exposure and risk estimates presented                 organization in trade agreements to
                                              Consistent with FFDCA section                        in the most recent human health risk                  which the United States is a party. EPA
                                           408(b)(2)(D), EPA has reviewed the                      assessment document, which were not                   may establish a tolerance that is
                                           available scientific data and other                     of concern to the Agency, adequately                  different from a Codex MRL; however,
                                           relevant information in support of this                 account for exposures and risk resulting              FFDCA section 408(b)(4) requires that
                                           action. EPA has sufficient data to assess               from all chlorantraniliprole uses                     EPA explain the reasons for departing
                                           the hazards of and to make a                            including the proposed teff and quinoa                from the Codex level.
                                           determination on aggregate exposure for                 uses.                                                    There are no Codex MRLs for
                                           chlorantraniliprole in or on teff forage,                  Therefore, EPA relies upon the                     chlorantraniliprole residues in or on
                                           grain, hay and straw as well as quinoa                  findings made in the February 7, 2014                 quinoa or teff.
                                           forage, grain, hay and straw, consistent                Federal Register document in support
                                           with FFDCA section 408(b)(2).                                                                                 C. Response to Comments
                                                                                                   of this rule. EPA concludes that there is
                                              In the Federal Register of February 7,               a reasonable certainty that no harm will                EPA received one comment to the
                                           2014 (79 FR 7397) (FRL–9905–56), EPA                    result to the general population, or to               Notice of Filing that stated, in part, that
                                           established tolerances for residues of                  infants and children from aggregate                   this chemical is ‘‘dangerous to America
                                           chlorantraniliprole in or on fruit, stone,              exposure to chlorantraniliprole                       and to health of our people and life in
                                           group 12–12, except cherry, chickasaw                   residues.                                             America’’ and that EPA should ‘‘deny
                                           plum, and damson plum at 4.0 ppm;                          For a detailed discussion of the                   those applications from the profiteers
                                           onion, green subgroup 3–07B at 3.0                      aggregate risk assessments and                        whose only aim is to make money at our
                                           ppm; peanut, hay at 90 ppm; and peanut                  determination of safety for these                     expense.’’ The Agency understands the
                                           at 0.06 ppm. EPA is relying upon the                    tolerances, please refer to the February              commenter’s concerns and recognizes
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                                           risk assessments that supported the                     7, 2014 Federal Register document and                 that some individuals believe that
                                           findings made in the February 7, 2014                   its supporting documents, available at                pesticides should be banned on
                                           Federal Register document in support                    http://www.regulations.gov in docket ID               agricultural crops. However, the existing
                                           of this action. The toxicity profile of                 number EPA–HQ–OPP–2013–0235.                          legal framework provided by section
                                           chlorantraniliprole has not changed,                    Further information about EPA’s                       408 of the FFDCA states that tolerances
                                           and the previous risk assessments that                  determination that an updated risk                    may be set when persons seeking such


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                                                        Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Rules and Regulations                                                             61619

                                           tolerances or exemptions have                           in the preemption provisions of FFDCA                 § 180.628 Chlorantraniliprole; pesticide
                                           demonstrated that the pesticide meets                   section 408(n)(4). As such, the Agency                tolerances.
                                           the safety standard imposed by that                     has determined that this action will not                  (a) * * *
                                           statute. This citizen’s comment appears                 have a substantial direct effect on States
                                           to be directed at the underlying statute                or tribal governments, on the                                                                            Parts per
                                                                                                                                                                      Commodity
                                           and not EPA’s implementation of it; the                                                                                                                           million
                                                                                                   relationship between the national
                                           citizen has made no contention that                     government and the States or tribal
                                           EPA has acted in violation of the                       governments, or on the distribution of                   *              *             *              *          *
                                           statutory framework.                                    power and responsibilities among the                  Quinoa,      forage ......................                     40
                                           V. Conclusion                                           various levels of government or between               Quinoa,      grain ........................                   6.0
                                                                                                   the Federal Government and Indian                     Quinoa,      hay ..........................                   40
                                              Therefore, tolerances are established                tribes. Thus, the Agency has determined               Quinoa,      straw .......................                    40
                                           for residues of chlorantraniliprole, 3-                 that Executive Order 13132, entitled
                                           bromo-N-[4-chloro-2-methyl-6-                                                                                    *              *              *             *          *
                                                                                                   ‘‘Federalism’’ (64 FR 43255, August 10,               Teff,   forage ...........................                     40
                                           [(methylamino)-carbonyl]phenyl]-1-(3-                   1999) and Executive Order 13175,
                                           chloro-2-pyridinyl)-1H-pyrazole-5-                                                                            Teff,   grain .............................                   6.0
                                                                                                   entitled ‘‘Consultation and Coordination              Teff,   hay ................................                   40
                                           carboxamide, in or on quinoa, forage at                 with Indian Tribal Governments’’ (65 FR               Teff,   straw .............................                    40
                                           40 ppm; quinoa, grain at 6.0 ppm;                       67249, November 9, 2000) do not apply
                                           quinoa, hay at 40 ppm; and quinoa,                      to this action. In addition, this action                  *              *              *            *          *
                                           straw at 40 ppm; teff, forage at 40 ppm;                does not impose any enforceable duty or
                                           teff, grain at 6.0 ppm; teff, hay at 40                 contain any unfunded mandate as                       *        *         *        *         *
                                           ppm; and teff, straw at 40 ppm.                         described under Title II of the Unfunded              [FR Doc. 2016–21458 Filed 9–6–16; 8:45 am]
                                           VI. Statutory and Executive Order                       Mandates Reform Act (UMRA) (2 U.S.C.                  BILLING CODE 6560–50–P

                                           Reviews                                                 1501 et seq.).
                                                                                                      This action does not involve any
                                              This action establishes tolerances                                                                         ENVIRONMENTAL PROTECTION
                                                                                                   technical standards that would require
                                           under FFDCA section 408(d) in                                                                                 AGENCY
                                                                                                   Agency consideration of voluntary
                                           response to a petition submitted to the
                                                                                                   consensus standards pursuant to section
                                           Agency. The Office of Management and                                                                          40 CFR Part 228
                                                                                                   12(d) of the National Technology
                                           Budget (OMB) has exempted these types
                                           of actions from review under Executive                  Transfer and Advancement Act                          [EPA–R04–OW–2016–0356; FRL–9951–96–
                                           Order 12866, entitled ‘‘Regulatory                      (NTTAA) (15 U.S.C. 272 note).                         Region 4]
                                           Planning and Review’’ (58 FR 51735,                     VII. Congressional Review Act                         Ocean Dumping: Modification of an
                                           October 4, 1993). Because this action                     Pursuant to the Congressional Review                Ocean Dredged Material Disposal Site
                                           has been exempted from review under                     Act (5 U.S.C. 801 et seq.), EPA will                  Offshore of Charleston, South Carolina
                                           Executive Order 12866, this action is                   submit a report containing this rule and
                                           not subject to Executive Order 13211,                                                                         AGENCY:  Environmental Protection
                                                                                                   other required information to the U.S.                Agency (EPA).
                                           entitled ‘‘Actions Concerning                           Senate, the U.S. House of
                                           Regulations That Significantly Affect                                                                         ACTION: Final rule and technical
                                                                                                   Representatives, and the Comptroller
                                           Energy Supply, Distribution, or Use’’ (66                                                                     amendment.
                                                                                                   General of the United States prior to
                                           FR 28355, May 22, 2001) or Executive                    publication of the rule in the Federal
                                           Order 13045, entitled ‘‘Protection of                                                                         SUMMARY:    The Environmental Protection
                                                                                                   Register. This action is not a ‘‘major                Agency (EPA) is approving a
                                           Children from Environmental Health                      rule’’ as defined by 5 U.S.C. 804(2).
                                           Risks and Safety Risks’’ (62 FR 19885,                                                                        modification of the ocean dredged
                                           April 23, 1997). This action does not                   List of Subjects in 40 CFR Part 180                   material disposal site (ODMDS) offshore
                                           contain any information collections                                                                           of Charleston, South Carolina pursuant
                                                                                                     Environmental protection,                           to the Marine Protection, Research and
                                           subject to OMB approval under the                       Administrative practice and procedure,
                                           Paperwork Reduction Act (PRA) (44                                                                             Sanctuaries Act, as amended (MPRSA).
                                                                                                   Agricultural commodities, Pesticides                  The primary purpose for the site
                                           U.S.C. 3501 et seq.), nor does it require               and pests, Reporting and recordkeeping
                                           any special considerations under                                                                              modification is to serve the long-term
                                                                                                   requirements.                                         need for a location to dispose of
                                           Executive Order 12898, entitled
                                                                                                      Dated: August 26, 2016.                            material dredged from the Charleston
                                           ‘‘Federal Actions to Address
                                           Environmental Justice in Minority                       Michael Goodis,                                       Harbor federal navigation channel, and
                                           Populations and Low-Income                              Acting Director, Registration Division, Office        to provide a location for the disposal of
                                           Populations’’ (59 FR 7629, February 16,                 of Pesticide Programs.                                dredged material for persons who have
                                           1994). Since tolerances and exemptions                    Therefore, 40 CFR chapter I is                      received a permit for such disposal. The
                                           that are established on the basis of a                  amended as follows:                                   modified site will be subject to ongoing
                                           petition under FFDCA section 408(d),                                                                          monitoring and management to ensure
                                           such as the tolerances in this final rule,              PART 180—[AMENDED]                                    continued protection of the marine
                                           do not require the issuance of a                                                                              environment. In addition, the EPA now
                                                                                                   ■ 1. The authority citation for part 180              issues a technical amendment to correct
                                           proposed rule, the requirements of the
                                                                                                   continues to read as follows:                         a clerical error in the proposed rule.
                                           Regulatory Flexibility Act (RFA) (5
                                           U.S.C. 601 et seq.), do not apply.                          Authority: 21 U.S.C. 321(q), 346a and 371.        DATES: The effective date of this final
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                                              This action directly regulates growers,              ■  2. In § 180.628, add alphabetically the            action shall be October 7, 2016.
                                           food processors, food handlers, and food                entries ‘‘Quinoa, forage’’, ‘‘Quinoa,                 ADDRESSES: Docket: All documents in
                                           retailers, not States or tribes, nor does               grain’’, ‘‘Quinoa, hay’’, ‘‘Quinoa, straw’’,          the Docket are listed in the
                                           this action alter the relationships or                  ‘‘Teff, forage’’, ‘‘Teff, grain’’, ‘‘Teff, hay’’,     www.regulations.gov index. Although
                                           distribution of power and                               and ‘‘Teff, straw’’ to the table in                   listed in the index, some information
                                           responsibilities established by Congress                paragraph (a) to read as follows:                     may not be publicly available, e.g.,


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Document Created: 2016-09-07 11:50:50
Document Modified: 2016-09-07 11:50:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective September 7, 2016. Objections and requests for hearings must be received on or before November 7, 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).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation81 FR 61617 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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