Document ID: EPA-HQ-OPP-2007-0349-0003
Agency: epa
Document Type: Rule
Title: Spinosad; Pesticide Tolerance
Posted Date: 2007-08-29T04:00Z

[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]                         

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

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.

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

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]

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. 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) * * *

------------------------------------------------------------------------
                                                  Expiration/Revocation
          Commodity           Parts per million            Date
------------------------------------------------------------------------
                                * * * * *
Fish........................                4.0                     None
Fish-shellfish, crustacean..                4.0                     None
Fish-shellfish, mollusc.....                4.0                     None
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-16897 Filed 8-28-07; 8:45 am]

BILLING CODE 6560-50-S