[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30987-30990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14091]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0066; FRL-9962-60]


Pyroxsulam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyroxsulam in or on teff, grain; teff, forage; teff, hay; and teff, 
straw. Dow AgroSciences LLC requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 5, 2017. Objections and 
requests for hearings must be received on or before September 5, 2017, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0066, 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

[[Page 30988]]

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-2016-0066 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 
September 5, 2017. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0066, 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 March 16, 2016 (81 FR 14030) (FRL-9942-
86), 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 
5E8439) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 
46268. The petition requested that 40 CFR 180.638 be amended by 
establishing tolerances for residues of the herbicide pyroxsulam, N-
(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-
(trifluoromethyl)-3-pyridinesulfonamide, in or on teff, grain at 0.01 
parts per million (ppm); teff, forage 0.06 ppm; teff, hay 0.01 ppm; and 
teff, straw 0.03 ppm. The published notice of filing (NOF) mistakenly 
listed the following incorrect tolerances for residues of pyroxsulam in 
or on the cereal crops: teff at 0.06 parts per million (ppm); teff, 
forage at 0.01 ppm; teff, grain at 0.03 ppm; teff, hay at 0.01 ppm; and 
teff, straw at 0.01 ppm. That document referenced a summary of the 
petition containing the correct tolerance amounts prepared by Dow 
AgroSciences LLC, the registrant, which is available in the docket, 
http://www.regulations.gov. Comments were received on the notice of 
filing. EPA's response to these comments 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), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure, consistent with FFDCA section 
408(b)(2).
    In the Federal Register of February 27, 2008 (73 FR 10402) (FRL-
8349-9), EPA established tolerances for residues of pyroxsulam in or on 
wheat, forage; wheat, grain; wheat, hay; and wheat, straw at the same 
levels as those requested for residues in or on corresponding teff 
commodities. Since these wheat tolerances were established in 2008, the 
toxicological profile and the endpoints for assessment have not 
changed. Moreover, as explained below, EPA has concluded that the new 
tolerances for teff commodities does not alter the previous conclusions 
about the potential aggregate exposure to pyroxsulam residues.
    Although teff residue data were not submitted with this petition, 
EPA concluded that the level of pyroxsulam residues on teff commodities 
would be the same or similar to the level of pyroxsulam residues on 
wheat commodities, based on the similarity in application rates. 
Furthermore, EPA concluded that because teff is a likely substitute for 
wheat products, there would be no additional exposure to pyroxsulam 
residues beyond what was

[[Page 30989]]

previously assessed to support the wheat tolerances. Finally, because 
there is no corresponding request for a U.S. registration allowing use 
of pyroxsulam on teff, there are no additional drinking water or 
residential exposures beyond previous assessments.
    Based on this assessment of potential exposure from use of 
pyroxsulam on teff and the findings supporting the February 27, 2008 
tolerances established for wheat commodities, 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 
pyroxsulam residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for the proposed tolerances, please refer to 
the February 27, 2008 Federal Register document and its supporting 
documents as well as Human Health Risk Assessments D431295, D. Dotson, 
3/25/2016 and D439358, D. Dotson, 4/21/2017 available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2006-0785.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology, Method GRM 04.17, an Liquid 
chromatography with tandem mass spectrometry (LC/MS/MS) method, 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.
    The Codex has not established a MRL for pyroxsulam.

C. Response to Comments

    EPA received two comments to the published Notice of Filing. Both 
comments stated, in part and without any supporting information, that 
EPA should deny this petition because it is a harmful and toxic 
chemical with no benefits. The Agency recognizes that some individuals 
believe that pesticides should be banned on agricultural crops. The 
existing legal framework provided by section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), however, states that tolerances may be 
set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. EPA has assessed the effects of this chemical on human 
health and determined that aggregate exposure to it will be safe. These 
comments provide no information to support an alternative conclusion.

D. Revisions to Petitioned-For Tolerances

    EPA is revising the tolerance expression to clarify (1) that, as 
provided in FFDCA section 408(a)(3), the tolerance covers metabolites 
and degradates of pyroxsulam not specifically mentioned; and (2) that 
compliance with the specified tolerance levels is to be determined by 
measuring only the specific compounds mentioned in the tolerance 
expression.

V. Conclusion

    Therefore, tolerances are established for residues of pyroxsulam, 
N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-
(trifluoromethyl)-3-pyridinesulfonamide, in or on teff, forage 0.06 
ppm; teff, grain at 0.01 ppm; teff, hay 0.01 ppm; and teff, straw at 
0.03 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory 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.

[[Page 30990]]

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 19, 2017.
Daniel Rosenblatt,
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.  180.638:
0
a. Revise paragraph (a) introductory text; and
0
b. Add alphabetically the commodities ``teff, forage''; ``teff, 
grain''; ``teff, hay''; and ``teff, straw''; and footnote 1 to the 
table in paragraph (a).
    The revision and additoins read as follows:


Sec.  180.638  Pyroxsulam; tolerances for residues.

    (a) General. Tolerances are established for residues of pyroxsulam, 
including its metabolites and degradates, in or on the commodities 
listed in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only pyroxsulam, N-
(5,7-dimethoxy[l, 2,4]triazolo[l, 5-a]pyrimidin-2-yl)-2-methoxy-4-
(trifluoromethyl)-3-pyridinesulfonamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Teff, forage \1\............................................        0.06
Teff, grain \1\.............................................        0.01
Teff, hay \1\...............................................        0.01
Teff, straw \1\.............................................        0.03
 
                               * * * * *
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\1\ There are no U.S. registrations on teff as of May 8, 2017.

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[FR Doc. 2017-14091 Filed 7-3-17; 8:45 am]
BILLING CODE 6560-50-P