Spinosad; Pesticide Tolerance, 49651-49654 [E7-16897]
Download as PDF
<![CDATA[
49651
Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Rules and Regulations
ebenthall on PRODPC61 with RULES
ppm, and separate tolerances are
established for the reaction product,
propylene chlorohydrin, in or on fig;
grape, raisin; and plum, prune, dried, at
3.0, 4.0, and 2.0 ppm, respectively. The
use directions currently listed in 40 CFR
180.491 paragraphs (a)(1), (a)(2), (a)(4)
and (a)(5) are also being removed.
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,
VerDate Aug<31>2005
15:07 Aug 28, 2007
Jkt 211001
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).
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.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.491 is amended by
revising paragraph (a) to read as follows:
I
§ 180.491 Propylene oxide; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of propylene
oxide when used as a postharvest
fumigant in or on the following food
commodities:
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
Parts per
million
Commodity
Cocoa bean, bean ....................
Fig .............................................
Grape, raisin .............................
Gum, edible ..............................
Nutmeat, processed, except
peanuts .................................
Plum, prune, dried ....................
Spices, processed ....................
300
3.0
1.0
300
300
2.0
300
(2) Tolerances are established for the
reaction product, propylene
chlorohydrin, from use of propylene
oxide as a postharverst fumigant, in or
on the following food commodities:
Parts per
million
Commodity
Fig .............................................
Grape, raisin .............................
Plum, prune, dried ....................
*
*
*
*
3.0
4.0
2.0
*
[FR Doc. E7–17010 Filed 8–28–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0349; FRL–8142–1]
Spinosad; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of spinosad in or
on fish; fish-shellfish, mollusc; and fishshellfish, 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 https://
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
E:\FR\FM\29AUR1.SGM
29AUR1
49652
Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Rules and Regulations
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
https://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:
ebenthall on PRODPC61 with RULES
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
VerDate Aug<31>2005
15:07 Aug 28, 2007
Jkt 211001
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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://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: https://
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,
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
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 -methyla-L-manno-pyranosyl)oxy]-13-[[5(dimethylamino)-tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15dione; and Spinosyn D (Factor D; CAS
#131929–63–0) or 2-[(6-deoxy-2,3,4-triO-methyl-a-L-manno-pyranosyl)oxy]13-[[5-(dimethyl-amino)-tetrahydro-6methyl-2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15dione. That notice referenced a
summary of the petition prepared by
Dow AgroSciences LLC, the registrant,
which is available to the public in the
docket, https://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
E:\FR\FM\29AUR1.SGM
29AUR1
ebenthall on PRODPC61 with RULES
Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Rules and Regulations
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 https://
www.regulations.gov, for a detailed
VerDate Aug<31>2005
15:07 Aug 28, 2007
Jkt 211001
49653
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
IV. Other Considerations
seq., nor does it require any special
A. Analytical Enforcement Methodology considerations under Executive Order
12898, entitled Federal Actions to
Adequate enforcement methodology
Address Environmental Justice in
(Liquid Chromatography/Mass
Minority Populations and Low-Income
Spectroscopy - Accelerated Climate
Populations (59 FR 7629, February 16,
Prediction Initiative) is available to
1994).
enforce the tolerance expression. The
Since tolerances and exemptions that
method may be requested from: Chief,
are established on the basis of a petition
Analytical Chemistry Branch,
under section 408(d) of FFDCA, such as
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350; the tolerance in this final rule, do not
require the issuance of a proposed rule,
telephone number: (410) 305–2905; email address: residuemethods@epa.gov. the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
B. International Residue Limits
seq.) do not apply.
This final rule directly regulates
There are no established or proposed
growers, food processors, food handlers
CODEX Maximum Residue Limits
and food retailers, not States or tribes,
(MRLs) or Canadian or Mexican MRLs
nor does this action alter the
for residues of spinosad in or on fish or
relationships or distribution of power
shellfish.
and responsibilities established by
V. Conclusion
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
Therefore, tolerances are established
the Agency has determined that this
for residues of spinosad, consisting of
action will not have a substantial direct
the related active ingredients Spinosyn
effect on States or tribal governments,
A, 2-[(6-deoxy-2,3,4-tri-O-methyl-a-Lon the relationship between the
manno-pyranosyl)oxy]-13-[[5National government and the States or
(dimethylamino)-tetrahydro-6-methyltribal governments, or on the
2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- distribution of power and
responsibilities among the various
tetradecahydro-14-methyl-1H-aslevels of government or between the
Indaceno[3,2-d]oxacyclododecin-7,15Federal Government and Indian tribes.
dione; and Spinosyn D, 2-[(6-deoxyThus, the Agency has determined that
2,3,4-tri-O-methyl-a-L-mannopyranosyl)oxy]-13-[[5-(dimethyl-amino)- Executive Order 13132, entitled
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]- Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
tetradecahydro-4,14-methyl-1H-as67249, November 6, 2000) do not apply
Indaceno[3,2-d]oxacyclododecin-7,15to this rule. In addition, This rule does
dione, in or on fish; fish-shellfish,
not impose any enforceable duty or
crustacean; and fish-shellfish, mollusc
contain any unfunded mandate as
at 4.0 ppm.
described under Title II of the Unfunded
VI. Statutory and Executive Order
Mandates Reform Act of 1995 (UMRA)
Reviews
(Public Law 104–4).
This action does not involve any
This final rule establishes a tolerance
technical standards that would require
under section 408(d) of FFDCA in
Agency consideration of voluntary
response to a petition submitted to the
consensus standards pursuant to section
Agency. The Office of Management and
Budget (OMB) has exempted these types 12(d) of the National Technology
Transfer and Advancement Act of 1995
of actions from review under Executive
(NTTAA), Public Law 104–113, section
Order 12866, entitled Regulatory
12(d) (15 U.S.C. 272 note).
Planning and Review (58 FR 51735,
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.
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
E:\FR\FM\29AUR1.SGM
29AUR1
49654
Federal Register / Vol. 72, No. 167 / Wednesday, August 29, 2007 / Rules and Regulations
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.
Therefore, 40 CFR chapter I is
amended as follows:
I
Commodity
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.495 is amended by
alphabetically adding the following
commodities to the table in paragraph
(a) to read as follows:
I
§ 180.495 Spinosad; tolerances for
residues.
(a) * * *
Parts per million
*
*
*
*
Fish ....................................................................................................................................................
Fish-shellfish, crustacean ..................................................................................................................
Fish-shellfish, mollusc ........................................................................................................................
*
*
*
*
*
*
*
*
*
[FR Doc. E7–16897 Filed 8–28–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0428; FRL–8138–6]
Flusilazole; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
ebenthall on PRODPC61 with RULES
AGENCY:
SUMMARY: This regulation establishes
time-limited tolerances for residues of
flusilazole in or on soybean seed,
soybean aspirated grain fractions, and
soybean oil. This action is in response
to EPA’s granting of emergency
exemptions under section 18 of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing
use of the pesticide on soybeans. This
regulation establishes maximum
permissible levels for residues of
flusilazole in these food commodities.
The tolerances expire and are revoked
on December 31, 2010.
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
VerDate Aug<31>2005
15:07 Aug 28, 2007
Jkt 211001
identification (ID) number EPA–HQ–
OPP–2007–0428. To access the
electronic docket, go to https://
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
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 either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are
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:
Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9356; e-mail address:
conrath.andrea@epa.gov.
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
Expiration/Revocation
Date
*
4.0
4.0
4.0
None
None
None
*
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:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides 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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
E:\FR\FM\29AUR1.SGM
29AUR1
]]>Agencies
[Federal Register Volume 72, Number 167 (Wednesday, August 29, 2007)]
[Rules and Regulations]
[Pages 49651-49654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16897]
-----------------------------------------------------------------------
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 https://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 https://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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://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: https://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, https://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 https://
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
