80_FR_22495 80 FR 22418 - Saflufenacil; Pesticide Tolerances

80 FR 22418 - Saflufenacil; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 77 (April 22, 2015)

Page Range22418-22420
FR Document2015-09394

This regulation establishes tolerances for residues of saflufenacil in or on alfalfa, forage and alfalfa, hay. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 77 (Wednesday, April 22, 2015)
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Rules and Regulations]
[Pages 22418-22420]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09394]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0339; FRL-9923-57]


Saflufenacil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
saflufenacil in or on alfalfa, forage and alfalfa, hay. BASF 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 22, 2015. Objections and 
requests for hearings must be received on or before June 22, 2015, 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-2014-0339, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing 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

[[Page 22419]]

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-2014-0339 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 June 22, 2015. 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-2014-0339, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), 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 
4F8256) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR part 
180 be amended by establishing tolerances for residues of the herbicide 
saflufenacil (2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-
methylethyl)amino]sulfonyl]benzamide) and its metabolites, N-[2-chloro-
5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-
fluorobenzoyl]-N'-isopropylsulfamide and N-[4-chloro-2-fluoro-5-
({[(isopropylamino)sulfonyl]amino{time} carbonyl)phenyl]urea, 
calculated as the stoichiometric equivalent of saflufenacil, in or on 
alfalfa, forage at 0.075 parts per million (ppm) and alfalfa, hay at 
0.10 ppm. That document referenced a summary of the petition prepared 
by BASF Corporation, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA agrees 
with the tolerance levels proposed by BASF Corporation for alfalfa 
commodities with the minor exception of a rounding adjustment for the 
alfalfa, forage tolerance from 0.075 ppm to 0.80 ppm.

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 for saflufenacil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with saflufenacil follows.
    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The toxicology database for the saflufenacil is considered complete 
for the purpose of risk assessment. In the Federal Register of 
September 3, 2014 (79 FR 52215) (FRL-9912-91), EPA published a final 
rule establishing tolerances for residues of saflufenacil and its 
metabolites in or on barley, grass, olive, livestock, and wheat 
commodities based on EPA's conclusion that aggregate exposure to 
saflufenacil is safe for the general population, including infants and 
children. Since that rulemaking, the toxicity profile for saflufenacil 
has not changed. The requested tolerances will not result in residues 
on human food commodities, only animal feed. The available residue data 
submitted for use in alfalfa indicates that the dietary burden for 
livestock will not change from the current levels that were previously 
assessed for use in grass pastures. Therefore, the residues of 
saflufenicil on alfalfa from the proposed new use will not impact the 
existing human dietary and aggregate risk assessments for saflufenacil. 
For a detailed discussion of the aggregate risk assessments and 
determination of safety, as well as a summary of the toxicological 
endpoints used for human risk assessment, please refer to the final 
rules published in the Federal Register of February 21, 2014 (79 FR 
9861) (FRL-9905-87) and September 3, 2014 (79 FR 52215) (FRL-9912-91). 
EPA relies upon those supporting risk assessments and the findings made 
in the Federal Register documents in support of this final rule.
    Based on the risk assessments and information described above, 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 saflufenacil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectroscopy/mass spectroscopy (LC-MS/MS) (Method D0603/04)) 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;

[[Page 22420]]

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 saflufenacil in or on alfalfa, forage or alfalfa, 
hay at this time.

C. Revisions to Petitioned-For Tolerances

    EPA has modified the tolerance level proposed for alfalfa, forage, 
from 0.075 ppm to 0.08 ppm, which is the appropriate rounding class 
according to the tolerance calculation procedures of the Organization 
for Economic Co-operation and Development (OECD) that EPA utilizes.

 V. Conclusion

    Therefore, tolerances are established for residues of, saflufenacil 
and its metabolites, in or on alfalfa, forage at 0.08 ppm and alfalfa, 
hay at 0.10 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 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. 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: April 9, 2015.
Susan T. Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.649, add alphabetically the commodities to the table in 
paragraph (a)(1) to read as follows:


Sec.  180.649  Saflufenacil; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................            0.08
Alfalfa, hay............................................            0.10
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-09394 Filed 4-21-15; 08:45 am]
BILLING CODE 6560-50-P



                                                22418             Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Rules and Regulations

                                                fee payable under Section 119(b)(1)(B)                    (b) * * *                                              Unit I.C. of the SUPPLEMENTARY
                                                ‘‘to reflect any changes occurring in the                 (1) * * *                                              INFORMATION).
                                                cost of living as determined by the most                  (vi) 2015: 27 cents per subscriber per                 ADDRESSES:    The docket for this action,
                                                recent Consumer Price Index (for all                     month (for each month of 2015).1                        identified by docket identification (ID)
                                                consumers and for all items) [CPI–U]                      (2) * * *                                              number EPA–HQ–OPP–2014–0339, is
                                                published by the Secretary of Labor                       (vi) 2015: 56 cents per subscriber per                 available at http://www.regulations.gov
                                                before December 1 of the preceding                       month (for each month of 2015).2                        or at the Office of Pesticide Programs
                                                year.’’ Section 119 also requires that                     Dated: April 16, 2015.                                Regulatory Public Docket (OPP Docket)
                                                ‘‘[n]otification of the adjusted fees shall              Suzanne M. Barnett,                                     in the Environmental Protection Agency
                                                be published in the Federal Register at                                                                          Docket Center (EPA/DC), West William
                                                                                                         Chief Copyright Royalty Judge.
                                                least 25 days before January 1.’’ 17                                                                             Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                         [FR Doc. 2015–09284 Filed 4–21–15; 8:45 am]
                                                U.S.C. 119(c)(2). Today’s notice fulfills                                                                        Constitution Ave. NW., Washington, DC
                                                this notice obligation.2                                 BILLING CODE 1410–72–P
                                                                                                                                                                 20460–0001. The Public Reading Room
                                                   The change in the cost of living as                                                                           is open from 8:30 a.m. to 4:30 p.m.,
                                                determined by the CPI–U during the                                                                               Monday through Friday, excluding legal
                                                period from the most recent index                        ENVIRONMENTAL PROTECTION
                                                                                                                                                                 holidays. The telephone number for the
                                                published before December 1, 2013, to                    AGENCY
                                                                                                                                                                 Public Reading Room is (202) 566–1744,
                                                the most recent index published before                                                                           and the telephone number for the OPP
                                                December 1, 2014, is 1.7%.3 Application                  40 CFR Part 90
                                                                                                                                                                 Docket is (703) 305–5805. Please review
                                                of the 1.7% COLA to the current rate for                 Control of Emissions From Nonroad                       the visitor instructions and additional
                                                the secondary transmission of broadcast                  Spark-Ignition Engines at or Below 19                   information about the docket available
                                                stations by satellite carriers for private               Kilowatts                                               at http://www.epa.gov/dockets.
                                                home viewing—27 cents per subscriber                                                                             FOR FURTHER INFORMATION CONTACT:
                                                per month — results in a rate of 27 cents                CFR Correction                                          Susan Lewis, Registration Division
                                                per subscriber per month (rounded to                                                                             (7505P), Office of Pesticide Programs,
                                                the nearest cent). See 37 CFR                            ■ In Title 40 of the Code of Federal
                                                                                                         Regulations, Parts 87 to 95, revised as of              Environmental Protection Agency, 1200
                                                386.2(b)(1). Application of the 1.7%                                                                             Pennsylvania Ave. NW., Washington,
                                                COLA to the current rate for viewing in                  July 1, 2014, on page 199, in § 90.116,
                                                                                                         after paragraph (a) and before the first                DC 20460–0001; main telephone
                                                commercial establishments—55 cents                                                                               number: (703) 305–7090; email address:
                                                per subscriber per month—results in an                   paragraph (1), add paragraph (b)
                                                                                                         introductory text to read as follows: ‘‘(b)             RDFRNotices@epa.gov.
                                                adjusted rate of 56 cents per subscriber
                                                                                                         Engines will be divided into classes by                 SUPPLEMENTARY INFORMATION:
                                                per month (rounded to the nearest cent).
                                                See 37 CFR 386.2(b)(2).                                  the following:’’.                                       I. General Information
                                                                                                         [FR Doc. 2015–09241 Filed 4–21–15; 8:45 am]
                                                List of Subjects in 37 CFR Part 386                      BILLING CODE 1505–01–D
                                                                                                                                                                 A. Does this action apply to me?
                                                    Copyright, Satellite, Television.                                                                               You may be potentially affected by
                                                                                                                                                                 this action if you are an agricultural
                                                Final Regulations                                        ENVIRONMENTAL PROTECTION                                producer, food manufacturer, or
                                                  In consideration of the foregoing, the                 AGENCY                                                  pesticide manufacturer. The following
                                                Judges amend part 386 of title 37 of the                                                                         list of North American Industrial
                                                Code of Federal Regulations as follows:                  40 CFR Part 180                                         Classification System (NAICS) codes is
                                                                                                         [EPA–HQ–OPP–2014–0339; FRL–9923–57]                     not intended to be exhaustive, but rather
                                                PART 386—ADJUSTMENT OF                                                                                           provides a guide to help readers
                                                ROYALTY FEES FOR SECONDARY                               Saflufenacil; Pesticide Tolerances                      determine whether this document
                                                TRANSMISSIONS BY SATELLITE                                                                                       applies to them. Potentially affected
                                                CARRIERS                                                 AGENCY:  Environmental Protection
                                                                                                                                                                 entities may include:
                                                                                                         Agency (EPA).                                              • Crop production (NAICS code 111).
                                                ■ 1. The authority citation for part 386                 ACTION: Final rule.                                        • Animal production (NAICS code
                                                continues to read as follows:                                                                                    112).
                                                    Authority: 17 U.S.C. 119(c), 801(b)(1).              SUMMARY:   This regulation establishes                     • Food manufacturing (NAICS code
                                                                                                         tolerances for residues of saflufenacil in              311).
                                                ■ 2. Section 386.2 is amended by adding
                                                paragraphs (b)(1)(vi) and (b)(2)(vi) to
                                                                                                         or on alfalfa, forage and alfalfa, hay.                    • Pesticide manufacturing (NAICS
                                                                                                         BASF Corporation requested these                        code 32532).
                                                read as follows:                                         tolerances under the Federal Food,
                                                § 386.2 Royalty fee for secondary                        Drug, and Cosmetic Act (FFDCA).                         B. How can I get electronic access to
                                                transmission by satellite carriers.                                                                              other related information?
                                                                                                         DATES: This regulation is effective April
                                                *       *     *       *      *                           22, 2015. Objections and requests for                     You may access a frequently updated
                                                                                                         hearings must be received on or before                  electronic version of EPA’s tolerance
                                                  2 Given passage of the act extending the Section
                                                                                                         June 22, 2015, and must be filed in                     regulations at 40 CFR part 180 through
                                                119 license in December 2014, publication of the         accordance with the instructions                        the Government Publishing Office’s e-
                                                rate adjustment 25 days prior to January 1, 2015,                                                                CFR site at http://www.ecfr.gov/cgi-bin/
                                                would have been impracticable, if not impossible.        provided in 40 CFR part 178 (see also
                                                                                                                                                                 text-idx?&c=ecfr&tpl=/ecfrbrowse/
mstockstill on DSK4VPTVN1PROD with RULES




                                                On March 30, 2015, the Judges published notice of
                                                the commencement of a proceeding to set rates               1 This is the 2014 rate adjusted for the amount of   Title40/40tab_02.tpl.
                                                under section 119 of the Copyright Act, but              inflation as measured by the change in the
                                                subsequently withdrew the notice after determining       Consumer Price Index for All Urban Consumers All        C. How can I file an objection or hearing
                                                that the reauthorization of STELA obviated the need      Items from October 2013 to October 2014.                request?
                                                for a rate proceeding.                                      2 This is the 2014 rate adjusted for the amount of
                                                  3 On November 20, 2014, the Bureau of Labor            inflation as measured by the change in the
                                                                                                                                                                   Under FFDCA section 408(g), 21
                                                Statistics announced that the CPI–U increased 1.7%       Consumer Price Index for All Urban Consumers All        U.S.C. 346a, any person may file an
                                                over the last 12 months.                                 Items from October 2013 to October 2014.                objection to any aspect of this regulation


                                           VerDate Sep<11>2014    18:54 Apr 21, 2015   Jkt 235001   PO 00000   Frm 00062   Fmt 4700   Sfmt 4700   E:\FR\FM\22APR1.SGM   22APR1


                                                                 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Rules and Regulations                                         22419

                                                and may also request a hearing on those                 sulfonyl]benzamide) and its metabolites,              studies to human risk. EPA has also
                                                objections. You must file your objection                N-[2-chloro-5-(2,6-dioxo-4-                           considered available information
                                                or request a hearing on this regulation                 (trifluoromethyl)-3,6-dihydro-1(2H)-                  concerning the variability of the
                                                in accordance with the instructions                     pyrimidinyl)-4-fluorobenzoyl]-N’-                     sensitivities of major identifiable
                                                provided in 40 CFR part 178. To ensure                  isopropylsulfamide and N-[4-chloro-2-                 subgroups of consumers, including
                                                proper receipt by EPA, you must                         fluoro-5-({[(isopropylamino)sulfonyl]                 infants and children.
                                                identify docket ID number EPA–HQ–                       amino}carbonyl)phenyl]urea, calculated                   The toxicology database for the
                                                OPP–2014–0339 in the subject line on                    as the stoichiometric equivalent of                   saflufenacil is considered complete for
                                                the first page of your submission. All                  saflufenacil, in or on alfalfa, forage at             the purpose of risk assessment. In the
                                                objections and requests for a hearing                   0.075 parts per million (ppm) and                     Federal Register of September 3, 2014
                                                must be in writing, and must be                         alfalfa, hay at 0.10 ppm. That document               (79 FR 52215) (FRL–9912–91), EPA
                                                received by the Hearing Clerk on or                     referenced a summary of the petition                  published a final rule establishing
                                                before June 22, 2015. Addresses for mail                prepared by BASF Corporation, the                     tolerances for residues of saflufenacil
                                                and hand delivery of objections and                     registrant, which is available in the                 and its metabolites in or on barley,
                                                hearing requests are provided in 40 CFR                 docket, http://www.regulations.gov.                   grass, olive, livestock, and wheat
                                                178.25(b).                                              There were no comments received in                    commodities based on EPA’s conclusion
                                                  In addition to filing an objection or                 response to the notice of filing.                     that aggregate exposure to saflufenacil is
                                                hearing request with the Hearing Clerk                     Based upon review of the data                      safe for the general population,
                                                as described in 40 CFR part 178, please                 supporting the petition, EPA agrees with              including infants and children. Since
                                                submit a copy of the filing (excluding                  the tolerance levels proposed by BASF
                                                                                                                                                              that rulemaking, the toxicity profile for
                                                any Confidential Business Information                   Corporation for alfalfa commodities
                                                                                                                                                              saflufenacil has not changed. The
                                                (CBI)) for inclusion in the public docket.              with the minor exception of a rounding
                                                                                                                                                              requested tolerances will not result in
                                                Information not marked confidential                     adjustment for the alfalfa, forage
                                                                                                                                                              residues on human food commodities,
                                                pursuant to 40 CFR part 2 may be                        tolerance from 0.075 ppm to 0.80 ppm.
                                                                                                                                                              only animal feed. The available residue
                                                disclosed publicly by EPA without prior
                                                                                                        III. Aggregate Risk Assessment and                    data submitted for use in alfalfa
                                                notice. Submit the non-CBI copy of your                 Determination of Safety                               indicates that the dietary burden for
                                                objection or hearing request, identified
                                                                                                           Section 408(b)(2)(A)(i) of FFDCA                   livestock will not change from the
                                                by docket ID number EPA–HQ–OPP–
                                                                                                        allows EPA to establish a tolerance (the              current levels that were previously
                                                2014–0339, by one of the following
                                                                                                        legal limit for a pesticide chemical                  assessed for use in grass pastures.
                                                methods:
                                                                                                                                                              Therefore, the residues of saflufenicil on
                                                  • Federal eRulemaking Portal: http://                 residue in or on a food) only if EPA
                                                                                                        determines that the tolerance is ‘‘safe.’’            alfalfa from the proposed new use will
                                                www.regulations.gov. Follow the online
                                                                                                        Section 408(b)(2)(A)(ii) of FFDCA                     not impact the existing human dietary
                                                instructions for submitting comments.
                                                                                                        defines ‘‘safe’’ to mean that ‘‘there is a            and aggregate risk assessments for
                                                Do not submit electronically any
                                                                                                        reasonable certainty that no harm will                saflufenacil. For a detailed discussion of
                                                information you consider to be CBI or
                                                                                                        result from aggregate exposure to the                 the aggregate risk assessments and
                                                other information whose disclosure is
                                                                                                        pesticide chemical residue, including                 determination of safety, as well as a
                                                restricted by statute.
                                                  • Mail: OPP Docket, Environmental                     all anticipated dietary exposures and all             summary of the toxicological endpoints
                                                Protection Agency Docket Center (EPA/                   other exposures for which there is                    used for human risk assessment, please
                                                DC), (28221T), 1200 Pennsylvania Ave.                   reliable information.’’ This includes                 refer to the final rules published in the
                                                NW., Washington, DC 20460–0001.                         exposure through drinking water and in                Federal Register of February 21, 2014
                                                  • Hand Delivery: To make special                      residential settings, but does not include            (79 FR 9861) (FRL–9905–87) and
                                                arrangements for hand delivery or                       occupational exposure. Section                        September 3, 2014 (79 FR 52215) (FRL–
                                                delivery of boxed information, please                   408(b)(2)(C) of FFDCA requires EPA to                 9912–91). EPA relies upon those
                                                follow the instructions at http://                      give special consideration to exposure                supporting risk assessments and the
                                                www.epa.gov/dockets/contacts.html.                      of infants and children to the pesticide              findings made in the Federal Register
                                                  Additional instructions on                            chemical residue in establishing a                    documents in support of this final rule.
                                                commenting or visiting the docket,                      tolerance and to ‘‘ensure that there is a                Based on the risk assessments and
                                                along with more information about                       reasonable certainty that no harm will                information described above, EPA
                                                dockets generally, is available at http://              result to infants and children from                   concludes that there is a reasonable
                                                www.epa.gov/dockets.                                    aggregate exposure to the pesticide                   certainty that no harm will result to the
                                                                                                        chemical residue. . . .’’                             general population or to infants and
                                                II. Summary of Petitioned-For                              Consistent with FFDCA section                      children from aggregate exposure to
                                                Tolerance                                               408(b)(2)(D), and the factors specified in            saflufenacil residues.
                                                   In the Federal Register of August 1,                 FFDCA section 408(b)(2)(D), EPA has
                                                2014 (79 FR 44729) (FRL–9911–67),                       reviewed the available scientific data                IV. Other Considerations
                                                EPA issued a document pursuant to                       and other relevant information in                     A. Analytical Enforcement Methodology
                                                FFDCA section 408(d)(3), 21 U.S.C.                      support of this action. EPA has
                                                346a(d)(3), announcing the filing of a                  sufficient data to assess the hazards of                 Adequate enforcement methodology
                                                pesticide petition (PP 4F8256) by BASF                  and to make a determination on                        (liquid chromatography/mass
                                                Corporation, 26 Davis Drive, P.O. Box                   aggregate exposure for saflufenacil                   spectroscopy/mass spectroscopy (LC–
                                                13528, Research Triangle Park, NC                       including exposure resulting from the                 MS/MS) (Method D0603/04)) is
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                                                27709–3528. The petition requested that                 tolerances established by this action.                available to enforce the tolerance
                                                40 CFR part 180 be amended by                           EPA’s assessment of exposures and risks               expression.
                                                establishing tolerances for residues of                 associated with saflufenacil follows.                    The method may be requested from:
                                                the herbicide saflufenacil (2-chloro-5-                    EPA has evaluated the available                    Chief, Analytical Chemistry Branch,
                                                [3,6-dihydro-3-methyl-2,6-dioxo-4-                      toxicity data and considered its validity,            Environmental Science Center, 701
                                                (trifluoromethyl)-1(2H)-pyrimidinyl]-4-                 completeness, and reliability as well as              Mapes Rd., Ft. Meade, MD 20755–5350;
                                                fluoro-N-[[methyl(1-methylethyl)amino]                  the relationship of the results of the                telephone number: (410) 305–2905;


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                                                22420                    Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Rules and Regulations

                                                email address: residuemethods@                                              of actions from review under Executive                                       entitled ‘‘Consultation and Coordination
                                                epa.gov.                                                                    Order 12866, entitled ‘‘Regulatory                                           with Indian Tribal Governments’’ (65 FR
                                                                                                                            Planning and Review’’ (58 FR 51735,                                          67249, November 9, 2000) do not apply
                                                B. International Residue Limits
                                                                                                                            October 4, 1993). Because this action                                        to this action. In addition, this action
                                                   In making its tolerance decisions, EPA                                   has been exempted from review under                                          does not impose any enforceable duty or
                                                seeks to harmonize U.S. tolerances with                                     Executive Order 12866, this action is                                        contain any unfunded mandate as
                                                international standards whenever                                            not subject to Executive Order 13211,                                        described under Title II of the Unfunded
                                                possible, consistent with U.S. food                                         entitled ‘‘Actions Concerning                                                Mandates Reform Act (UMRA) (2 U.S.C.
                                                safety standards and agricultural                                           Regulations That Significantly Affect                                        1501 et seq.).
                                                practices. EPA considers the                                                Energy Supply, Distribution, or Use’’ (66                                      This action does not involve any
                                                international maximum residue limits                                        FR 28355, May 22, 2001) or Executive                                         technical standards that would require
                                                (MRLs) established by the Codex                                             Order 13045, entitled ‘‘Protection of                                        Agency consideration of voluntary
                                                Alimentarius Commission (Codex), as                                         Children from Environmental Health                                           consensus standards pursuant to section
                                                required by FFDCA section 408(b)(4).                                        Risks and Safety Risks’’ (62 FR 19885,                                       12(d) of the National Technology
                                                The Codex Alimentarius is a joint                                           April 23, 1997). This action does not                                        Transfer and Advancement Act
                                                United Nations Food and Agriculture                                         contain any information collections                                          (NTTAA) (15 U.S.C. 272 note).
                                                Organization/World Health                                                   subject to OMB approval under the
                                                Organization food standards program,                                        Paperwork Reduction Act (PRA) (44                                            VII. Congressional Review Act
                                                and it is recognized as an international                                    U.S.C. 3501 et seq.), nor does it require                                      Pursuant to the Congressional Review
                                                food safety standards-setting                                               any special considerations under                                             Act (5 U.S.C. 801 et seq.), EPA will
                                                organization in trade agreements to                                         Executive Order 12898, entitled                                              submit a report containing this rule and
                                                which the United States is a party. EPA                                     ‘‘Federal Actions to Address                                                 other required information to the U.S.
                                                may establish a tolerance that is                                           Environmental Justice in Minority                                            Senate, the U.S. House of
                                                different from a Codex MRL; however,                                        Populations and Low-Income                                                   Representatives, and the Comptroller
                                                FFDCA section 408(b)(4) requires that                                       Populations’’ (59 FR 7629, February 16,                                      General of the United States prior to
                                                EPA explain the reasons for departing                                       1994).                                                                       publication of the rule in the Federal
                                                from the Codex level. The Codex has not                                        Since tolerances and exemptions that                                      Register. This action is not a ‘‘major
                                                established a MRL for saflufenacil in or                                    are established on the basis of a petition                                   rule’’ as defined by 5 U.S.C. 804(2).
                                                on alfalfa, forage or alfalfa, hay at this                                  under FFDCA section 408(d), such as
                                                                                                                            the tolerance in this final rule, do not                                     List of Subjects in 40 CFR Part 180
                                                time.
                                                                                                                            require the issuance of a proposed rule,                                       Environmental protection,
                                                C. Revisions to Petitioned-For                                              the requirements of the Regulatory                                           Administrative practice and procedure,
                                                Tolerances                                                                  Flexibility Act (RFA) (5 U.S.C. 601 et                                       Agricultural commodities, Pesticides
                                                  EPA has modified the tolerance level                                      seq.), do not apply.                                                         and pests, Reporting and recordkeeping
                                                proposed for alfalfa, forage, from 0.075                                       This action directly regulates growers,                                   requirements.
                                                ppm to 0.08 ppm, which is the                                               food processors, food handlers, and food
                                                                                                                                                                                                           Dated: April 9, 2015.
                                                appropriate rounding class according to                                     retailers, not States or tribes, nor does
                                                                                                                                                                                                         Susan T. Lewis,
                                                the tolerance calculation procedures of                                     this action alter the relationships or
                                                                                                                            distribution of power and                                                    Director, Registration Division, Office of
                                                the Organization for Economic Co-                                                                                                                        Pesticide Programs.
                                                operation and Development (OECD) that                                       responsibilities established by Congress
                                                EPA utilizes.                                                               in the preemption provisions of FFDCA                                          Therefore, 40 CFR chapter I is
                                                                                                                            section 408(n)(4). As such, the Agency                                       amended as follows:
                                                V. Conclusion                                                               has determined that this action will not
                                                  Therefore, tolerances are established                                     have a substantial direct effect on States                                   PART 180—[AMENDED]
                                                for residues of, saflufenacil and its                                       or tribal governments, on the
                                                                                                                            relationship between the national                                            ■ 1. The authority citation for part 180
                                                metabolites, in or on alfalfa, forage at
                                                                                                                            government and the States or tribal                                          continues to read as follows:
                                                0.08 ppm and alfalfa, hay at 0.10 ppm.
                                                                                                                            governments, or on the distribution of                                           Authority: 21 U.S.C. 321(q), 346a and 371.
                                                VI. Statutory and Executive Order                                           power and responsibilities among the
                                                Reviews                                                                                                                                                  ■ 2. In § 180.649, add alphabetically the
                                                                                                                            various levels of government or between                                      commodities to the table in paragraph
                                                  This action establishes tolerances                                        the Federal Government and Indian                                            (a)(1) to read as follows:
                                                under FFDCA section 408(d) in                                               tribes. Thus, the Agency has determined
                                                response to a petition submitted to the                                     that Executive Order 13132, entitled                                         § 180.649 Saflufenacil; tolerances for
                                                Agency. The Office of Management and                                        ‘‘Federalism’’ (64 FR 43255, August 10,                                      residues.
                                                Budget (OMB) has exempted these types                                       1999) and Executive Order 13175,                                                 (a) General. (1) * * *

                                                                                                                                                                                                                                                           Parts per
                                                                                                                                           Commodity                                                                                                        million

                                                Alfalfa, forage .......................................................................................................................................................................................           0.08
                                                Alfalfa, hay ...........................................................................................................................................................................................          0.10
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                                                *        *         *         *         *
                                                [FR Doc. 2015–09394 Filed 4–21–15; 08:45 am]
                                                BILLING CODE 6560–50–P




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Document Created: 2015-12-16 08:27:24
Document Modified: 2015-12-16 08:27:24
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 April 22, 2015. Objections and requests for hearings must be received on or before June 22, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 22418 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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