[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76388-76391]
[FR Doc No: 2015-31053]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0822; FRL-9939-52]

Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
azoxystrobin in or on quinoa grain, ti leaves, ti roots, and modifies
the existing tolerances for the stone fruit group 12 and tree nut group
14 to read ``stone fruit group 12-12'' and ``tree nut group 14-12,
except pistachio'' respectively. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 9, 2015. Objections and
requests for hearings must be received on or before February 8, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0822, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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-2014-0822 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
February 8, 2016. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0822, 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 4, 2015 (80 FR 11611) (FRL-9922-
68), 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
4E8319) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of azoxystrobin (methyl (E)-2-{2-
[6-(2-cyanophenoxy) pyrimidin-4-yloxy]phenyl{time} -3-methoxyacrylate)
and the Z isomer of azoxystrobin (methyl (Z)-2-{2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl{time} -3-methoxyacrylate) in or
on the raw agricultural commodities ti palm, leaves at 50 parts per
million (ppm); ti palm, roots at 0.5 ppm; fruit, stone, group 12-12 at
2.0 ppm; and nut, tree, group 14-12 at 0.02 ppm. Upon the approval of
the aforementioned tolerances, the petitioner requested to remove the
established tolerances for azoxystrobin in or on the raw agricultural
commodities fruit, stone, group 12 at 1.5 ppm; and nut, tree, group 14
at 0.02 ppm. That document referenced a summary of the petition
prepared by Syngenta Crop Protection, the registrant, which is
available in the docket, http://www.regulations.gov. EPA received two
comments in response to the March 4, 2015 Notice of Filing that simply
said ``Good.''
    In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-
9935-29), EPA amended the initial notice of filing for pesticide
petition (PP 4E8319), including the commodity quinoa grain at 3.0 ppm
in addition to the commodities originally requested and listed above.
Comments were received

to the notice of filing. EPA's response to these comments is discussed
in Unit IV.C.
    EPA has modified the tolerance for the tree nut group 14-12 to
exclude pistachio. The reason for this change is explained in Unit
IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
. ''
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with FFDCA
section 408(b)(2), for tolerances for residues of azoxystrobin in or on
quinoa grain, ti palm leaves, ti palm roots, the stone fruit group 12-
12, and the tree nut group 14-12. As discussed below, EPA is relying
upon the findings in the preamble to the rule published in the Federal
Register May 1, 2015 (80 FR 24824) (FRL-9926-24) establishing
tolerances for azoxystrobin and supporting risk assessments to
establish and modify these tolerances.
    On May 1, 2015, EPA published a final rule establishing tolerances
for residues of azoxystrobin in or on coffee, green bean; pear, Asian;
and tea, dried based on the Agency's conclusion that aggregate exposure
to azoxystrobin is safe for the general population, including infants
and children. In addition to the tolerances listed above, EPA also
considered the following uses in the risk assessments that supported
the May 1, 2015 final rule: Ti palm leaves, ti palm roots, the stone
fruit group 12-12, and the tree nut group 14-12 and also separately
evaluated the request to establish a tolerance in or on quinoa grain.
    Since the publication of the May 1, 2015 final rule, the toxicity
profile of azoxystrobin has not changed, and the risk assessments that
supported the establishment of those azoxystrobin tolerances published
in the May 1, 2015 Federal Register remain valid. Those risk
assessments also support the establishment of the tolerances that are
the subject of this action. The Agency also evaluated the request to
establish a tolerance in or on quinoa grain at 3.0 ppm and concluded
that the aggregate exposure and risks would not increase as a result of
the proposed use on quinoa and are the same as those estimated in the
May 1 final rule. Therefore, EPA is relying on those risk assessments
in order to establish the new tolerances. For a detailed discussion of
the aggregate risk assessments and determination of safety for the
proposed tolerances, please refer to the May 1, 2015 Federal Register
document and its supporting documents, available at http://www.regulations.gov. EPA relies upon those supporting risk assessments
and the findings made in the Federal Register document in support of
this 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 azoxystrobin residues. Further information about EPA's risk
assessment and determination of safety supporting the tolerances
established in the May 1, 2015 Federal Register action, as well as the
new azoxystrobin tolerances can be found at http://www.regulations.gov
in the documents entitled: ``Azoxystrobin. Human Health Aggregate Risk
Assessment for Permanent Tolerances on Imported Asian Pear, Imported
Tea, and Imported Coffee; Establishment of Permanent Tolerances on Ti
Palm and for Crop Group Conversions for Stone Fruits Group 12-12 and
Tree Nut Group 14-12 Crop Groups'' and ``Azoxystrobin. Addendum to
Human Health Aggregate Risk Assessment D423691 and D418374, Dated 4/7/
2015, to Support a New Use on Quinoa.'' The documents may be found in
docket ID number EPA-HQ-OPP-2014-0822.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with a
nitrogenphosphorus detector (GC/NPD) method, RAM 243/04) is available
to enforce the tolerance expression for residues of azoxystrobin and
its Z-isomer in crop commodities. This method (designated RAM 243,
dated 5/15/98) has been submitted to FDA for inclusion in the Pesticide
Analytical Manual (PAM), Volume II.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 quinoa grain or ti palm
leaves or roots.
    The Codex has established an MRL for stone fruit at 2 milligram/
kilogram (mg/kg), which is harmonized with the U.S. tolerance of 2 ppm.
    The Codex has established an MRL of 0.01 mg/kg for tree nuts. The
US crop group tolerance is based on a residue definition of
azoxystrobin plus the Z-isomer (R230310). Residues were < 0.01 ppm for
each component in the almond and pecan trials. Therefore, the tolerance
estimate is 0.02 ppm, the sum of the components. The Codex residue
definition is parent only, which support the 0.01 mg/kg MRL. The US
tolerance cannot be harmonized with Codex at this time.

C. Response to Comments

    Four comments were received in response to the October 21, 2015
notice of filing. The first comment asserted that no residues should be
allowed and that the pesticide should not be approved for sale or use.
The second stated that pesticides are ``causing normally

healthy people to have serious life treating (sic) health issues and is
making many Americans overweight'' and the commenter did not want their
food to have pesticide residues. The third commenter stated that they
were very allergic to any chemical and demanded that all chemical
treatments must be rejected and stopped. The Agency understands the
commenters' concerns and recognizes that some individuals believe that
pesticides should be banned on agricultural crops. However, the
existing legal framework provided by section 408 of the FFDCA states
that tolerances may be set when persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute. The comments appear to be directed at
the underlying statute and not EPA's implementation of it; the citizens
have made no contention that EPA has acted in violation of the
statutory framework.
    The fourth comment was from the Center for Biological Diversity and
concerned endangered species; specifically stating that EPA cannot
approve this new use prior to completion of consultations with the U.S.
Fish and Wildlife Service and the National Marine Fisheries Service
(``the Services''). This comment is not relevant to the Agency's
evaluation of safety of the azoxystrobin tolerances; section 408 of the
FFDCA focuses on potential harms to human health and does not permit
consideration of effects on the environment.

D. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerance for ``Nut, tree, group 14-12'' is
being modified to read ``Nut, tree, group 14-12, except pistachio''
because an existing tolerance for pistachio exists at a higher level
(0.50 ppm). In addition, although the petition requested tolerances for
ti palm leaves and roots, EPA is establishing tolerances for ``ti,
leaves'' and ``ti, roots'' to be consistent with its food and feed
commodity vocabulary.

V. Conclusion

    Therefore, tolerances are established for residues of azoxystrobin
(methyl (E)-2-{2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl{time} -3-
methoxyacrylate) and the Z isomer of azoxystrobin (methyl (Z)-2-{2-[6-
(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl{time} -3-methoxyacrylate) in
or on the raw agricultural commodities quinoa, grain at 3.0 ppm; ti,
leaves at 50 ppm; and ti, roots at 0.5 ppm. Additionally, the existing
tolerance for ``fruit, stone, group 12'' is modified to read ``fruit,
stone, group 12-12'' and to increase the tolerance level from 1.5 ppm
to 2.0 ppm. Finally, the existing tolerance for ``nut, tree, group 14''
is modified to read ``nut, tree, group 14-12, except pistachio.''

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 2, 2015.
Susan 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.  180.507:
0
a. Add alphabetically the commodities to the table in paragraph (a)(1).
0
b. Revise the commodities ``fruit, stone, group 12'' and ``nut, tree,
group 14'' in paragraph (a)(1).
    The additions and revisions read as follows:

Sec.  180.507  Azoxystrobin; tolerances for residues.

    (a)(1) * * *

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                                                             Parts per
                        Commodity                             million
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                                * * * * *
Fruit, stone, group 12-12...............................             2.0

                                * * * * *
Nut, tree, group 14-12, except pistachio................            0.02

                                * * * * *
Quinoa, grain...........................................             3.0

                                * * * * *
Ti, leaves..............................................            50.0
Ti, roots...............................................             0.5

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[FR Doc. 2015-31053 Filed 12-8-15; 8:45 am]
 BILLING CODE 6560-50-P