[Federal Register Volume 78, Number 137 (Wednesday, July 17, 2013)]
[Proposed Rules]
[Pages 42736-42739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16904]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0107; FRL-9391-6]
RIN 2070-ZA16
Spirotetramat; Proposed Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish tolerances for residues of
spirotetramat in or on persimmon and sweet corn, kernel plus cob with
husks removed; and to revise established tolerances in or on feijoa,
papaya, and Spanish lime under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: Comments must be received on or before August 16, 2013.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0107, 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 Confidential Business
Information (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.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; 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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. This Proposal
EPA, on its own initiative, under FFDCA section 408(e), 21 U.S.C.
346a(e), is proposing to establish a tolerance for residues of the
insecticide spirotetramat, in or on corn, sweet, kernel plus cob with
husks removed at 1.5 parts per million (ppm). Additionally, EPA has
noted several errors published in 40 CFR 180.641 that the Agency is
also proposing to correct. Established tolerances for residues of
spirotetramat in or on feijoa, papaya, and Spanish lime in 40 CFR
[[Page 42737]]
180.641(a)(1) are incorrectly listed and the previously recommended
tolerance for residues in or on persimmon is missing. The tolerances
are proposed to be corrected as follows: Feijoa from 0.30 ppm to 2.5
ppm; papaya from 2.5 ppm to 0.40 ppm; Spanish lime from 0.60 ppm to 13
ppm; and persimmon at 2.5 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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of FFDCA section 408 and a complete description
of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
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 spirotetramat in or
on corn, sweet, kernel plus cob with husks removed; feijoa; papaya;
Spanish lime; and persimmon. As discussed below, EPA is relying upon
the findings in the preamble to the May 15, 2013 rule establishing
tolerances for spirotetramat (78 FR 28507) (FRL-9382-8) and supporting
risk assessments to establish and revise these tolerances.
On May 15, 2013, EPA published a final rule establishing tolerances
for residues of the insecticide spirotetramat, (cis-3-(2,5-
dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl
carbonate) and its metabolites in or on taro leaves; watercress;
pomegranate; banana; bulb vegetable group 3-07; low growing berry,
except strawberry, subgroup 13-07H; bushberry subgroup 13-07B; globe
artichoke; pome fruit group 11-10; fruiting vegetable group 8-10;
citrus fruit group 10-10; pineapple; coffee, green bean; and instant
coffee, based on EPA's conclusion that aggregate exposure to
spirotetramat 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 15, 2013 final rule: persimmon and sweet corn, kernel plus cob
with husks removed; and revised tolerances in or on feijoa, papaya, and
Spanish lime.
Since the publication of the May 15, 2013 final rule, the toxicity
profile of spirotetramat has not changed, and the risk assessments that
supported the establishment of those spirotetramat tolerances published
in the May 15, 2013 Federal Register remain valid. Those risk
assessments also recommended the proposed new uses and revised
tolerances listed above. Therefore, EPA is relying on those risk
assessments in order to propose the new and revised tolerances. For a
detailed discussion of the aggregate risk assessments and determination
of safety for the proposed tolerances, please refer to the May 15, 2013
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 proposed rule.
IV. Background for This Proposal
On February 4, 2011, President Barack Obama and the Prime Minister
of Canada, Stephen Harper, announced the creation of the United States-
Canada Regulatory Cooperation Council (RCC) in order to increase
regulatory transparency and coordination between the two countries. One
of the areas of focus of the RCC is in agricultural production, in
particular, the further alignment of crop protection product approvals
and establishment of U.S. tolerances and Canadian maximum residue
limits (MRLs) for major and minor uses of pesticides in both countries.
One action item identified through the activities of the RCC was
the initiation of a pilot project for the joint review of residue data
for spirotetramat in the United States and Canada, whereby both
countries would work together to further align practices and
tolerances/MRLs resulting from the joint review of domestic and import
tolerances/MRLs in both countries.
Although Canada's Pest Management Regulatory Agency (PMRA) had
received a petition for the use of spirotetramat on sweet corn in
Canada, EPA did not. So, as part of the RCC pilot project to work
together and align tolerances/MRLs, EPA is proposing a tolerance
without U.S. registration for residues of spirotetramat and its
metabolites and degradates in or on corn, sweet, kernel plus cob with
husks removed based on the evaluation of the sweet corn residue data.
As noted above, EPA has also considered the sweet corn use in its risk
assessments, and has made a determination of safety finding for the
use. Additional information regarding the RCC pilot project may be
found at the following Web site: http://www.epa.gov/oppfead1/international/naftatwg/us-canada-rcc.html.
In addition to the proposed use of spirotetramat in or on sweet
corn, EPA has identified several errors contained in 40 CFR 180.641.
EPA is also proposing to correct these errors. Established tolerances
for residues of spirotetramat in or on feijoa, papaya, and Spanish lime
in 40 CFR 180.641(a)(1) are incorrectly listed and the previously
recommended tolerance for residues in or on persimmon is missing. The
tolerances are proposed to be corrected as follows: Feijoa from 0.30
ppm to 2.5 ppm; papaya from 2.5 ppm to 0.40 ppm; Spanish lime from 0.60
ppm to 13 ppm; and persimmon at 2.5 ppm.
In the last risk assessment relied upon for the May 15, 2013 rule,
EPA took a conservative approach by utilizing tolerance values of 2.5
ppm for feijoa (which is higher than the established tolerance), papaya
(which is the value of the established tolerance), and persimmon and 13
ppm for Spanish lime (which is higher than the established tolerance).
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 spirotetramat residues. Further information about EPA's
risk assessment and determination of safety supporting the tolerances
established in the May 15, 2013 Federal Register action, as well as the
proposed new and revised spirotetramat tolerances can be found at
http://www.regulations.gov in the document entitled: ``Spirotetramat.
[[Page 42738]]
Human-Health Risk Assessment for the Proposed Uses in/on Taro, Leaves;
Watercress; Pomegranate; Banana; Vegetable, Bulb, Group 3-07; Low
growing Berry Subgroup 13-07H, Except Strawberry and Lowbush Blueberry;
Bushberry Subgroup 13-07B; Artichoke, Globe; Vegetable, Fruiting, Group
8-10; Fruit, Pome, Group 11-10; Fruit, Citrus, Group 10-10; Pineapple;
and Coffee; and Tolerances without U.S. Registration in/on Corn, Sweet,
Kernel Plus Cob with Husks Removed as Part of the U.S.-Canada
Regulatory Cooperation Council (RCC) Pilot Project.'' Further
information regarding correcting the errors for spirotetramat in 40 CFR
180.641 may be found in the document: ``Spirotetramat: Acute and
Chronic Dietary (Food and Drinking Water) Exposure and Risk Assessment
to Support the Section 3 Registration Request For Use of Spirotetramat
on Taro, Leaves; Watercress; Pomegranate; Banana; Vegetable, Bulb,
Group 3-07; Low growing Berry Subgroup 13-07H, Except Strawberry and
Lowbush Blueberry; Bushberry Subgroup 13-07B; Artichoke, Globe;
Vegetable, Fruiting, Group 8-10; Fruit, Pome, Group 11-10; Fruit,
Citrus, Group 10-10; Pineapple; and Coffee; and Tolerances without U.S.
Registration in/on Corn, Sweet, Kernel Plus Cob with Husks Removed as
Part of the U.S.-Canada Regulatory Cooperation Council (RCC) Pilot
Project.'' Both documents may be found in docket ID number EPA-HQ-OPP-
2012-0107.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, a high-performance liquid
chromatography with tandem mass spectrometry (HPLC-MS/MS), is available
to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established a MRL for spirotetramat in or on papaya
at 0.4 mg/kg. While the EPA originally assessed for a tolerance in or
on papaya at 0.35 ppm, the Agency is proposing to revise the tolerance
to 0.40 ppm in order to harmonize with Codex. There is no risk concern
with proposing a tolerance in or on papaya at 0.40 ppm because EPA
assessed the dietary estimates using the conservative assumption of 2.5
ppm in the risk assessments supporting the use. Therefore, the dietary
estimate is expected to slightly decrease upon the establishment of the
revised papaya tolerance.
VI. Conclusion
Tolerances are proposed for residues of spirotetramat in corn,
sweet, kernel plus cob with husks removed at 1.5 ppm, and persimmon at
2.5 ppm. Amended tolerances are also proposed in or on feijoa from 0.30
ppm to 2.5 ppm; papaya from 2.5 ppm to 0.40 ppm; and Spanish lime from
0.60 ppm to 13 ppm.
VII. Statutory and Executive Order Reviews
This proposed rule proposes to establish tolerances under FFDCA
section 408(d). 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 proposed rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this proposed
rule 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). This proposed rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), or
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 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); or OMB review or any
Agency action under Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). 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 of 1995 (NTTAA) (15 U.S.C. 272
note).
Pursuant to the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether
establishment of tolerances, exemptions from tolerances, raising of
tolerance levels, expansion of exemptions, or revocations might
significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
These analyses for tolerance establishments and modifications, and for
tolerance revocations were published on May 4, 1981 (46 FR 24950) and
on December 17, 1997 (62 FR 66020), respectively, and were provided to
the Chief Counsel for Advocacy of the Small Business Administration.
Taking into account this analysis, and available information concerning
the pesticides listed in this proposed rule, the Agency hereby
certifies that this proposed action will not have significant negative
economic impact on a substantial number of small entities. Any comments
about the Agency's determination should be submitted to the EPA along
with comments on the proposal, and will be addressed prior to issuing a
final rule.
In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999). Executive Order 13132 requires EPA to develop
an accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national
[[Page 42739]]
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This
proposed rule directly regulates growers, food processors, food
handlers, and food retailers, not States. This action does not alter
the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of FFDCA section
408(n)(4). For these same reasons, the Agency has determined that this
proposed rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This proposed rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 2, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be 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. 180.641, in the table in paragraph (a), alphabetically add
the commodities ``Corn, sweet, kernel plus cob with husks removed'' and
``Persimmon'' and revise the entries for ``Feijoa'', ``Papaya'' and
``Spanish lime,'' and footnote 1 to read as follows:
Sec. 180.641 Spirotetramat; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Corn, sweet, kernel plus cob with husks removed \1\........ 1.5
* * * * *
Feijoa..................................................... 2.5
* * * * *
Papaya..................................................... 0.40
* * * * *
Persimmon.................................................. 2.5
* * * * *
Spanish lime............................................... 13
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of [date of effective date of
final rule] for use on corn, sweet, kernel plus cob with husks
removed.
* * * * *
[FR Doc. 2013-16904 Filed 7-16-13; 8:45 am]
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