82 FR 30987 - Pyroxsulam; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 127 (July 5, 2017)

Page Range		30987-30990
FR Document		2017-14091
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).
Federal Register, Volume 82 Issue 127 (Wednesday, July 5, 2017)
[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30987-30990]
From the Federal Register Online  [www.thefederalregister.org]
[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
 
                               * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations on teff as of May 8, 2017.

* * * * *
[FR Doc. 2017-14091 Filed 7-3-17; 8:45 am]
BILLING CODE 6560-50-P
Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations 30987

U.S.C. 3501 et seq.), nor does it require 1999) and Executive Order 13175, Dated: June 12, 2017.
any special considerations under entitled ‘‘Consultation and Coordination Michael L. Goodis,
Executive Order 12898, entitled with Indian Tribal Governments’’ (65 FR Director, Registration Division, Office of
‘‘Federal Actions to Address 67249, November 9, 2000) do not apply Pesticide Programs.
Environmental Justice in Minority to this action. In addition, this action Therefore, 40 CFR chapter I is
Populations and Low-Income does not impose any enforceable duty or amended as follows:
Populations’’ (59 FR 7629, February 16, contain any unfunded mandate as
1994). described under Title II of the Unfunded PART 180—[AMENDED]
Since tolerances and exemptions that Mandates Reform Act (UMRA) (2 U.S.C.
are established on the basis of a petition 1501 et seq.). ■ 1. The authority citation for part 180
under FFDCA section 408(d), such as This action does not involve any continues to read as follows:
the tolerance in this final rule, do not technical standards that would require
require the issuance of a proposed rule, Agency consideration of voluntary Authority: 21 U.S.C. 321(q), 346a and 371.
the requirements of the Regulatory consensus standards pursuant to section ■ 2. In the table in paragraph (a) of
Flexibility Act (RFA) (5 U.S.C. 601 et 12(d) of the National Technology
seq.), do not apply. § 180.653;
Transfer and Advancement Act
This action directly regulates growers, (NTTAA) (15 U.S.C. 272 note). ■ a. Add alphabetically the entries
food processors, food handlers, and food ‘‘Bushberry subgroup 13–07B’’;
retailers, not States or tribes, nor does VII. Congressional Review Act ‘‘Caneberry subgroup 13–07A’’; ‘‘Fruit,
this action alter the relationships or Pursuant to the Congressional Review small, vine climbing, except fuzzy
distribution of power and Act (5 U.S.C. 801 et seq.), EPA will kiwifruit, subgroup 13–07F’’; ‘‘Fruit,
responsibilities established by Congress submit a report containing this rule and stone, group 12–12’’; ‘‘Fruit, tropical
in the preemption provisions of FFDCA other required information to the U.S. and subtropical, small fruit, edible peel,
section 408(n)(4). As such, the Agency Senate, the U.S. House of subgroup 23A’’; ‘‘Hop, dried cones’’;
has determined that this action will not Representatives, and the Comptroller and ‘‘Nut, tree, group 14–12’’;
have a substantial direct effect on States General of the United States prior to ■ b. Remove the footnote 1 from the
or tribal governments, on the publication of the rule in the Federal entry for ‘‘Coffee, green bean’’; and
relationship between the national Register. This action is not a ‘‘major
government and the States or tribal ■ c. Remove the entries for ‘‘Fruit, stone,
rule’’ as defined by 5 U.S.C. 804(2).
governments, or on the distribution of group 12’’; ‘‘Grape’’; ‘‘Nut, tree, group
power and responsibilities among the List of Subjects in 40 CFR Part 180 14’’; ‘‘Olive’’; and ‘‘Pistachio’’.
various levels of government or between Environmental protection, The additions read as follows:
the Federal Government and Indian Administrative practice and procedure,
tribes. Thus, the Agency has determined Agricultural commodities, Pesticides § 180.653 Indaziflam; tolerances for
residues.
that Executive Order 13132, entitled and pests, Reporting and recordkeeping
‘‘Federalism’’ (64 FR 43255, August 10, requirements. (a) * * *

* * * * * * *
Bushberry subgroup 13–07B ............................................................................................................................................................... 0.01
Caneberry subgroup 13–07A .............................................................................................................................................................. 0.01
Coffee, green bean .............................................................................................................................................................................. 0.01

* * * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................................................................................................. 0.01
Fruit, stone, group 12–12 .................................................................................................................................................................... 0.01
Fruit, tropical and subtropical, small fruit, edible peel, subgroup 23A ................................................................................................ 0.01
Hop, dried cones ................................................................................................................................................................................. 0.06
Nut, tree, group 14–12 ........................................................................................................................................................................ 0.01

* * * * * * *

* * * * * SUMMARY: This regulation establishes ADDRESSES: The docket for this action,
[FR Doc. 2017–14107 Filed 7–3–17; 8:45 am] tolerances for residues of pyroxsulam in identified by docket identification (ID)
BILLING CODE 6560–50–P or on teff, grain; teff, forage; teff, hay; number EPA–HQ–OPP–2016–0066, is
and teff, straw. Dow AgroSciences LLC available at http://www.regulations.gov
requested these tolerances under the or at the Office of Pesticide Programs
ENVIRONMENTAL PROTECTION Federal Food, Drug, and Cosmetic Act Regulatory Public Docket (OPP Docket)
AGENCY (FFDCA). in the Environmental Protection Agency
40 CFR Part 180 Docket Center (EPA/DC), West William
DATES: This regulation is effective July Jefferson Clinton Bldg., Rm. 3334, 1301
5, 2017. Objections and requests for
sradovich on DSK3GMQ082PROD with RULES

[EPA–HQ–OPP–2016–0066; FRL–9962–60] Constitution Ave. NW., Washington, DC
hearings must be received on or before 20460–0001. The Public Reading Room
Pyroxsulam; Pesticide Tolerances September 5, 2017, and must be filed in is open from 8:30 a.m. to 4:30 p.m.,
accordance with the instructions Monday through Friday, excluding legal
AGENCY: Environmental Protection provided in 40 CFR part 178 (see also
Agency (EPA). holidays. The telephone number for the
Unit I.C. of the SUPPLEMENTARY Public Reading Room is (202) 566–1744,
ACTION: Final rule. INFORMATION). and the telephone number for the OPP

VerDate Sep<11>2014 16:11 Jul 03, 2017 Jkt 241001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\05JYR1.SGM 05JYR1
Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations 30989

previously assessed to support the EPA explain the reasons for departing Regulations That Significantly Affect
wheat tolerances. Finally, because there from the Codex level. Energy Supply, Distribution, or Use’’ (66
is no corresponding request for a U.S. The Codex has not established a MRL FR 28355, May 22, 2001) or Executive
registration allowing use of pyroxsulam for pyroxsulam. Order 13045, entitled ‘‘Protection of
on teff, there are no additional drinking Children from Environmental Health
C. Response to Comments
water or residential exposures beyond Risks and Safety Risks’’ (62 FR 19885,
previous assessments. EPA received two comments to the April 23, 1997). This action does not
Based on this assessment of potential published Notice of Filing. Both contain any information collections
exposure from use of pyroxsulam on teff comments stated, in part and without subject to OMB approval under the
and the findings supporting the any supporting information, that EPA Paperwork Reduction Act (PRA) (44
February 27, 2008 tolerances established should deny this petition because it is U.S.C. 3501 et seq.), nor does it require
for wheat commodities, EPA concludes a harmful and toxic chemical with no any special considerations under
that there is a reasonable certainty that benefits. The Agency recognizes that Executive Order 12898, entitled
no harm will result to the general some individuals believe that pesticides ‘‘Federal Actions to Address
population, or to infants and children should be banned on agricultural crops. Environmental Justice in Minority
from aggregate exposure to pyroxsulam The existing legal framework provided Populations and Low-Income
residues. by section 408 of the Federal Food, Populations’’ (59 FR 7629, February 16,
For a detailed discussion of the Drug, and Cosmetic Act (FFDCA), 1994).
aggregate risk assessments and however, states that tolerances may be Since tolerances and exemptions that
determination of safety for the proposed set when persons seeking such are established on the basis of a petition
tolerances, please refer to the February tolerances or exemptions have under FFDCA section 408(d), such as
27, 2008 Federal Register document and demonstrated that the pesticide meets the tolerance in this final rule, do not
its supporting documents as well as the safety standard imposed by that require the issuance of a proposed rule,
Human Health Risk Assessments statute. EPA has assessed the effects of the requirements of the Regulatory
D431295, D. Dotson, 3/25/2016 and this chemical on human health and Flexibility Act (RFA) (5 U.S.C. 601 et
D439358, D. Dotson, 4/21/2017 determined that aggregate exposure to it seq.), do not apply.
available at http://www.regulations.gov will be safe. These comments provide This action directly regulates growers,
in docket ID number EPA–HQ–OPP– no information to support an alternative food processors, food handlers, and food
2006–0785. conclusion. retailers, not States or tribes, nor does
this action alter the relationships or
IV. Other Considerations D. Revisions to Petitioned-For distribution of power and
Tolerances responsibilities established by Congress
A. Analytical Enforcement Methodology
EPA is revising the tolerance in the preemption provisions of FFDCA
An adequate enforcement expression to clarify (1) that, as section 408(n)(4). As such, the Agency
methodology, Method GRM 04.17, an provided in FFDCA section 408(a)(3), has determined that this action will not
Liquid chromatography with tandem the tolerance covers metabolites and have a substantial direct effect on States
mass spectrometry (LC/MS/MS) degradates of pyroxsulam not or tribal governments, on the
method, is available to enforce the specifically mentioned; and (2) that relationship between the national
tolerance expression. compliance with the specified tolerance government and the States or tribal
The method may be requested from: levels is to be determined by measuring governments, or on the distribution of
Chief, Analytical Chemistry Branch, only the specific compounds mentioned power and responsibilities among the
Environmental Science Center, 701 in the tolerance expression. various levels of government or between
Mapes Rd., Ft. Meade, MD 20755–5350; the Federal Government and Indian
telephone number: (410) 305–2905; V. Conclusion tribes. Thus, the Agency has determined
email address: residuemethods@ Therefore, tolerances are established that Executive Order 13132, entitled
epa.gov. for residues of pyroxsulam, N-(5,7- ‘‘Federalism’’ (64 FR 43255, August 10,
B. International Residue Limits dimethoxy[1,2,4]triazolo[1,5- 1999) and Executive Order 13175,
a]pyrimidin-2-yl)-2-methoxy-4- entitled ‘‘Consultation and Coordination
In making its tolerance decisions, EPA (trifluoromethyl)-3- with Indian Tribal Governments’’ (65 FR
seeks to harmonize U.S. tolerances with pyridinesulfonamide, in or on teff, 67249, November 9, 2000) do not apply
international standards whenever forage 0.06 ppm; teff, grain at 0.01 ppm; to this action. In addition, this action
possible, consistent with U.S. food teff, hay 0.01 ppm; and teff, straw at does not impose any enforceable duty or
safety standards and agricultural 0.03 ppm. contain any unfunded mandate as
practices. EPA considers the described under Title II of the Unfunded
international maximum residue limits VI. Statutory and Executive Order
Reviews Mandates Reform Act (UMRA) (2 U.S.C.
(MRLs) established by the Codex 1501 et seq.).
Alimentarius Commission (Codex), as This action establishes a tolerance This action does not involve any
required by FFDCA section 408(b)(4). under FFDCA section 408(d) in technical standards that would require
The Codex Alimentarius is a joint response to a petition submitted to the Agency consideration of voluntary
United Nations Food and Agriculture Agency. The Office of Management and consensus standards pursuant to section
Organization/World Health Budget (OMB) has exempted these types 12(d) of the National Technology
Organization food standards program, of actions from review under Executive Transfer and Advancement Act
sradovich on DSK3GMQ082PROD with RULES

and it is recognized as an international Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note).
food safety standards-setting Planning and Review’’ (58 FR 51735,
organization in trade agreements to October 4, 1993). Because this action VII. Congressional Review Act
which the United States is a party. EPA has been exempted from review under Pursuant to the Congressional Review
may establish a tolerance that is Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
different from a Codex MRL; however, not subject to Executive Order 13211, submit a report containing this rule and
FFDCA section 408(b)(4) requires that entitled ‘‘Actions Concerning other required information to the U.S.

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Document Created: 2017-07-04 02:01:03
Document Modified: 2017-07-04 02:01:03
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective 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).
Contact		Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		82 FR 30987
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements