[Federal Register: August 29, 2007 (Volume 72, Number 167)]
[Rules and Regulations]
[Page 49651-49654]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au07-3]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0349; FRL-8142-1]
Spinosad; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
spinosad in or on fish; fish-shellfish, mollusc; and fish-shellfish,
crustacean. Dow AgroSciences LLC requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 29, 2007. Objections and
requests for hearings must be received on or before October 29, 2007,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0349. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in
[[Page 49652]]
the docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.
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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, 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-2007-0349 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before October 29, 2007.
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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0349, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted
during the Docket's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8128-1),
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7191) by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN
46268-1053. The petition requested that 40 CFR 180.495 be amended by
establishing tolerances for residues of the insecticide spinosad in or
on fish; fish-shellfish, molluscs and fish-shellfish crustaceans at 4.0
parts per million (ppm). Spinosad is a fermentation product of
Saccharopolyspora spinosa, consisting of two related active
ingredients: Spinosyn A (Factor A; CAS 131929-60-7) or 2-[(6-
deoxy-2,3,4-tri-O -methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-
(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D;
CAS 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione. That notice referenced a summary of the petition prepared by Dow
AgroSciences LLC, the registrant, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 the FFDCA requires EPA to give special
consideration to exposure of infants and children to the
[[Page 49653]]
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....'' These provisions were added to the FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 the petitioned-for tolerances
for residues of spinosad on fish; fish-shellfish, crustacean; and fish-
shellfish, mollusc at 4.0 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
On March 21, 2007 the Agency published a final rule (72 FR 13168
FRL-8114-4) establishing tolerances for residues of spinosad in or on
hop, dried cones at 22 ppm and amaranth, grain, stover at 10 ppm;
cattle, meat at 2.0 ppm; sheep, meat at 2.0 ppm; goat, meat at 2.0 ppm;
horse, meat at 2.0 ppm; poultry, meat at 0.10 ppm; cattle, fat at 50
ppm; sheep, fat at 50 ppm; goat, fat at 50 ppm; horse, fat at 50 ppm;
poultry, fat at 1.3 ppm; milk at 7.0 ppm; milk, fat at 85 ppm; egg at
0.30 ppm; cattle, meat byproducts, except liver at 5.0 ppm; sheep, meat
byproducts, except liver at 5.0 ppm; goat, meat byproducts, except
liver at 5.0 ppm; horse, meat byproducts, except liver at 5.0 ppm;
poultry meat byproducts at 0.10 ppm; cattle, liver at 10 ppm; sheep,
liver at 10 ppm; goat, liver at 10 ppm; and horse, liver at 10 ppm.
When the Agency conducted the risk assessments in support of this
tolerance action it assumed that spinosad residues would be present on
fish and shellfish (crustacean and mollusc) as well as on all foods
covered by the proposed and established tolerances. Residues on fish
and shellfish were included because there was a pending application
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
7 U.S.C. 136 et seq., to register spinosad for aquatic use as a
mosquito larvacide, a use the Agency determined could result in
residues in fish and shellfish. Therefore, establishing the fish and
shellfish tolerances will not change the most recent estimated
aggregate risks resulting from use of spinosad, as discussed in the
Federal Register of March 21, 2007. Refer to the March 21, 2007 (72 FR
13168) Federal Register document, available at http://www.regulations.gov
, for a detailed discussion of the aggregate risk
assessments and determination of safety. EPA relies upon those risk
assessments and the findings made in the Federal Register document in
support of this action.
Based on the risk assessments discussed in the final rule published
in the Federal Register of March 21, 2007 (72 FR 13168), EPA concludes
that there is a reasonable certainty that no harm will result to the
general population, and to infants and children from aggregate exposure
to spinosad residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Liquid Chromatography/Mass
Spectroscopy - Accelerated Climate Prediction Initiative) 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;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed CODEX Maximum Residue Limits
(MRLs) or Canadian or Mexican MRLs for residues of spinosad in or on
fish or shellfish.
V. Conclusion
Therefore, tolerances are established for residues of spinosad,
consisting of the related active ingredients Spinosyn A, 2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-
(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D, 2-[(6-deoxy-
2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-
amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on fish; fish-
shellfish, crustacean; and fish-shellfish, mollusc at 4.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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 final rule 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 section 408(d) of FFDCA, 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 final rule 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 section
408(n)(4) of FFDCA. 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 6,
2000) do not apply to this rule. In addition, This rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
[[Page 49654]]
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: August 17, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.495 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.495 Spinosad; tolerances for residues.
(a) * * *
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Expiration/Revocation
Commodity Parts per million Date
------------------------------------------------------------------------
* * * * *
Fish........................ 4.0 None
Fish-shellfish, crustacean.. 4.0 None
Fish-shellfish, mollusc..... 4.0 None
* * * * *
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* * * * *
[FR Doc. E7-16897 Filed 8-28-07; 8:45 am]
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