[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Rules and Regulations]
[Pages 61617-61619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
 
                                * * * * *
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[FR Doc. 2016-21458 Filed 9-6-16; 8:45 am]
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