[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76388-76391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (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 
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

[[Page 76389]]

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: (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 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

[[Page 76390]]

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) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
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                                * * * * *
Fruit, stone, group 12-12...............................             2.0
 
                                * * * * *
Nut, tree, group 14-12, except pistachio................            0.02

[[Page 76391]]

 
 
                                * * * * *
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