Cyprodinil; Time-Limited Pesticide Tolerance, 63997-64000 [E7-22233]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations
rmajette on PROD1PC64 with RULES
180.570. Seasonal application rates are
not necessary when numerical
tolerances are already established.
Based on the information in this
preamble, EPA concludes that there is a
reasonable certainty of no harm to the
general population, including infants
and children, from aggregate exposure
to residues of isoxadifen-ethyl and its
metabolite. Accordingly, EPA finds that
the tolerances described above for
residues of isoxadifen-ethyl and its
metabolite will be safe. EPA is
establishing tolerances for residues of
isoxadifen-ethyl and its metabolite
when it is used as an inert ingredient
safener in pesticide formulations.
IV. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
exemption 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
VerDate Aug<31>2005
14:53 Nov 13, 2007
Jkt 214001
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).
V. 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: November 5, 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 180.570 is amended by
revising paragraph (a) to read as follows:
I
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
63997
§ 180.570 Isoxadifen-ethyl; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of isoxadifenethyl (ethyl 5,5-diphenyl-2-isoxazoline3-carboxylate, (CAS No. 163520–33–0),
and its metabolite: 4,5-dihydro-5,5diphenyl-3-isoxazolecarboxylic acid,
when used as an inert ingredient
(safener) in or on the following raw
agricultural commodities:
Commodity
Parts per
million
Corn, field, grain .......................
Corn, field, forage .....................
Corn, field, stover .....................
Corn, oil ....................................
Corn, pop, grain ........................
Corn, pop, stover ......................
Corn, sweet, forage ..................
Corn, sweet, kernel plus cob
with husk removed ................
Corn, sweet, stover ..................
0.08
0.20
0.40
0.50
0.04
0.25
0.30
0.04
0.45
(2) Tolerances are established for the
residues of isoxadifen-ethyl (3isoxazolecarboxylic acid, 4,5-dihydro5,5-diphenyl-, ethyl ester (CAS No.
164520–33–0)), and its metabolites 4,5dihydro-5,5-diphenyl-3isoxazolecarboxylic acid and b-hydroxyb-benzenepropanenitrile when used as
an inert ingredient (safener) in or on the
following raw agricultural commodities:
Commodity
Parts per
million
Rice, grain ................................
Rice, hulls .................................
Rice, straw ................................
0.10
0.50
0.25
[FR Doc. E7–22223 Filed 11–13–07; 8:45 am]
BILLING CODE 6560-50-S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0119; FRL–8156–8]
Cyprodinil; Time-Limited Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation extends timelimited tolerances for residues of
cyprodinil in or on onion, dry bulb;
onion, green; and strawberry.
Interregional Research Project Number 4
(IR-4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
The tolerances will expire on December
31, 2009.
E:\FR\FM\14NOR1.SGM
14NOR1
63998
Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations
This regulation is effective
November 14, 2007. Objections and
requests for hearings must be received
on or before January 14, 2008, 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–2005–0119. 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
website 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 OPP
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:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305-5218; e-mail address:
stanton.susan@epa.gov.
DATES:
SUPPLEMENTARY INFORMATION:
I. General Information
rmajette on PROD1PC64 with RULES
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).
VerDate Aug<31>2005
14:53 Nov 13, 2007
Jkt 214001
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
also access a frequently updated
electronic version of 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 FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2005–0119 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
on or before January 14, 2008.
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 your
copies, identified by docket ID number
EPA–HQ–OPP–2005–0119, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
• 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. Background and Statutory Findings
In the Federal Register of September
28, 2007 (72 FR 55204-55207) (FRL–
8147–1), EPA issued a notice pursuant
to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 8E5012) by
Interregional Research Project Number 4
(IR-4), 500 College Road East, Suite 201
W, Princeton, NJ 08540-6635. The
petition requested that 40 CFR 180.532
be amended by extending the timelimited tolerances to December 31, 2009
for residues of the fungicide cyprodinil,
4-cyclopropyl-6-methyl-N-phenyl-2pyrimidinamine, in or on onion, dry
bulb at 0.60 parts per million (ppm);
onion, green at 4.0 ppm; and strawberry
at 5.0 ppm. This notice referenced a
summary of the petition prepared by
Syngenta Crop Protection, 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.
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....’’
E:\FR\FM\14NOR1.SGM
14NOR1
Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of FFDCA
and a complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
rmajette on PROD1PC64 with RULES
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, 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 section 408(b)(2) of
FFDCA, for a tolerance for residues of
cyprodinil on onion, dry bulb at 0.60
ppm; onion, green at 4.0 ppm; and
strawberry at 5.0 ppm.
In the Federal Register of October 20,
2004 (69 FR 61599-61605, FRL–7682–1)
the Agency published a Final rule
establishing tolerances for residues of
cyprodinil in or on almond, hulls; bean,
dry; bean, succulent; and leafy greens
subgroup 4A, except spinach. When the
Agency conducted the risk assessments
in support of this tolerance action it
assumed that cyprodinil residues would
be present on dry bulb onion, green
onion and strawberry as well as on all
foods covered by the proposed and
established tolerances. Residues on dry
bulb onion, green onion and strawberry
were included because there were
existing time-limited tolerances for
these commodities. Therefore,
extending the dry bulb onion, green
onion and strawberry tolerances will not
change the most recent estimated
aggregate risks resulting from use of
cyprodinil, as discussed in the October
20, 2004 Federal Register, cited above.
Refer to the October 20, 2004 Federal
Register document, cited above, 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 assessment
discussed in the final rule published in
the Federal Register of October 20,
2004, cited above, 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 cyprodinil
residues.
VerDate Aug<31>2005
14:53 Nov 13, 2007
Jkt 214001
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high-performance liquid
chromatography (HPLC)/ultra-violet
(UV) Method AG- 631B) is available to
enforce the tolerance expression. The
method is substantially identical to
earlier methods (Methods AG-631, AG631A and REM 141.01) that have been
adequately validated by independent
laboratories and the Agency. 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: residuemethods@epa.gov.
B. International Residue Limits
Codex maximum residue limits
(MRLs) have been established for
residues of cyprodinil in or on
strawberries at 2 ppm and dry bulb
onions at 0.3 ppm. The Codex MRLs are
lower than the time-limited tolerances
in the United States (5.0 ppm on
strawberry and 0.6 ppm on dry bulb
onions) in part because of differences in
use patterns here and in Europe. The
U.S. tolerances are based on higher
seasonal application rates and/or shorter
pre-harvest intervals. The higher U.S.
tolerances also reflect uncertainties in
the submitted field trial data for these
crops. To address these uncertainties,
EPA required additional field trials on
strawberries and onions as a condition
of registration. The new field trials have
been submitted and are undergoing
review at the Agency. In its decision
regarding permanent tolerances for
strawberry and dry bulb onions, EPA
will consider international residue
limits, including Codex MRLs, and
make every effort to harmonize if
possible.
V. Conclusion
Therefore, these tolerances are
extended for residues of cyprodinil, 4cyclopropyl-6-methyl-N-phenyl-2pyrimidinamine, in or on onion, dry
bulb at 0.6 ppm; onion, green at 4.0
ppm; and strawberry at 5.0 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
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
63999
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).
E:\FR\FM\14NOR1.SGM
14NOR1
64000
Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations
VII. Congressional Review Act
DEPARTMENT OF COMMERCE
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).
National Oceanic and Atmospheric
Administration
List of Subjects in 40 CFR Part 180
rmajette on PROD1PC64 with RULES
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
50 CFR Part 648
[Docket No. 070709299–7300–01]
RIN 0648–AV75
Fisheries of the Northeastern United
States; Northeast Multispecies
Fishery; Temporary Haddock Size
Limit Extension
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; emergency
action extended, and request for
comments.
AGENCY:
SUMMARY: NMFS continues the haddock
minimum size implemented by an
August 10, 2007, emergency final rule
that is set to expire on February 6, 2008.
Specifically, this temporary rule
Dated: November 2, 2007.
continues the commercial minimum
Daniel J. Rosenblatt,
haddock size of 18 inches (45.7 cm) that
Acting Director, Registration Division, Office
was reduced from the previous
of Pesticide Programs.
minimum size of 19 inches (48.3 cm).
This action is taken pursuant to NOAA’s
I Therefore, 40 CFR chapter I is
authority to issue emergency measures
amended as follows:
under the Magnuson-Stevens Fishery
Conservation and Management Act
PART 180—[AMENDED]
(Magnuson-Stevens Act). The intent of
this extension is to continue measures
I 1. The authority citation for part 180
intended to reduce regulatory discards
continues to read as follows:
of Georges Bank (GB) and Gulf of Maine
Authority: 21 U.S.C. 321(q), 346a and 371.
(GOM) haddock to prevent excessive
waste and comply with the goals of
I 2. Section 180.532 is amended by
reducing discards and maintaining the
revising the table in paragraph (a)(2) to
rebuilding programs of the Northeast
read as follows:
(NE) Multispecies Fishery Management
Plan (FMP), while helping to achieve
§ 180.532 Cyprodinil; tolerances for
optimum yield at the same time. This
residues.
action is intended to reduce discarding
(a) * * *
and maintain consistency with the FMP
(2) * * *
and the Magnuson-Stevens Act.
DATES: The expiration date of the
Parts per Expiration/rev- emergency rule published August 10,
Commodity
million
ocation date
2007 (72 FR 44979), is extended to
Onion, bulb .......
0.60
12/31/09 August 10, 2008. NMFS will accept
Onion, green .....
4.0
12/31/09 comments through December 14, 2007.
Strawberry ........
5.0
12/31/09 ADDRESSES: You may submit comments,
identified by 0648–AV75, by any one of
the following methods:
*
*
*
*
*
• Electronic Submissions: Submit all
[FR Doc. E7–22233 Filed 11–13–07; 8:45 am]
electronic public comments via the
BILLING CODE 6560–50–S
Federal e-rulemaking Portal.
• Mail: Paper, disk, or CD-ROM
comments should be sent to Patricia A.
Kurkul, Regional Administrator,
National Marine Fisheries Service, One
Blackburn Drive, Gloucester, MA 01930.
Mark the outside of the envelope,
‘‘Comments on the Haddock Size Limit
Extension.’’
VerDate Aug<31>2005
14:53 Nov 13, 2007
Jkt 214001
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
• Fax: (978) 281–9135.
Instructions: All comments received
are part of the public record and will
generally be posted to https://
www.regulations.gov without change.
All Personal Identifying Information (for
example, name, address, etc.)
voluntarily submitted by the commenter
may be publically accessible. Do not
submit Confidential Business
Information or otherwise sensitive or
protected information.
NMFS will accept anonymous
comments. Attachments to electronic
comments will be accepted in Microsoft
Word, Excel, WordPerfect, or Adobe
PDF formats only.
FOR FURTHER INFORMATION CONTACT:
Thomas A. Warren, Fishery Policy
Analyst, (978) 281–9347, fax (978) 281–
9135.
SUPPLEMENTARY INFORMATION:
Background
This temporary final rule extends the
emergency commercial minimum
haddock size of 18 inches (45 cm),
authorized by section 305(c) of the
Magnuson-Stevens Act, in order to
reduce excessive discarding of GB and
GOM haddock. The historical
commercial haddock minimum size of
19 inches (48.3 cm) was reduced by
temporary emergency action to 18
inches (45 cm) on August 10, 2007 (72
FR 44979). That Secretarial action was
taken in response to the New England
Fishery Management Council (Council)
vote on June 21, 2007, to recommend
that the Secretary of Commerce take
action to lower the minimum size of
haddock to 17 inches (43.2 cm) for
vessels fishing on GB. A written request
from the Council to NMFS for such
action was dated June 25, 2007.
Available information from the
Council and data from observed trips to
the Eastern U.S./Canada Area indicated
that there were large amounts of
discarding of haddock occurring
because only a small fraction of the
haddock from an exceptionally large
year class being caught on GB has
reached the minimum size of 19 inches
(48.3 cm). Observer data showed a
discard-to-kept ratio of over 1 lb (0.45
kg) of haddock discarded to every
pound of haddock landed. Cumulative
haddock discards from the Eastern U.S./
Canada Area from May 1, 2007, through
October 24, 2007, were estimated at
approximately 700,000 lb (318 mt).
The reason for these large amounts of
discards is that the very large 2003 year
class of haddock, which is the largest
since 1963, is growing more slowly than
previously anticipated. Recent survey
data indicate an average GB haddock
E:\FR\FM\14NOR1.SGM
14NOR1
]]>Agencies
[Federal Register Volume 72, Number 219 (Wednesday, November 14, 2007)]
[Rules and Regulations]
[Pages 63997-64000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22233]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0119; FRL-8156-8]
Cyprodinil; Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation extends time-limited tolerances for residues
of cyprodinil in or on onion, dry bulb; onion, green; and strawberry.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA). The
tolerances will expire on December 31, 2009.
[[Page 63998]]
DATES: This regulation is effective November 14, 2007. Objections and
requests for hearings must be received on or before January 14, 2008,
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-2005-0119. 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 website 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 OPP
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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@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:
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 also access a
frequently updated electronic version of 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 FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2005-0119 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 on or before January 14, 2008.
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 your copies, identified by docket ID
number EPA-HQ-OPP-2005-0119, 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. Background and Statutory Findings
In the Federal Register of September 28, 2007 (72 FR 55204-55207)
(FRL-8147-1), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 8E5012) by Interregional Research Project Number 4 (IR-4),
500 College Road East, Suite 201 W, Princeton, NJ 08540-6635. The
petition requested that 40 CFR 180.532 be amended by extending the
time-limited tolerances to December 31, 2009 for residues of the
fungicide cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine,
in or on onion, dry bulb at 0.60 parts per million (ppm); onion, green
at 4.0 ppm; and strawberry at 5.0 ppm. This notice referenced a summary
of the petition prepared by Syngenta Crop Protection, 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.
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....''
[[Page 63999]]
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, 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 section
408(b)(2) of FFDCA, for a tolerance for residues of cyprodinil on
onion, dry bulb at 0.60 ppm; onion, green at 4.0 ppm; and strawberry at
5.0 ppm.
In the Federal Register of October 20, 2004 (69 FR 61599-61605,
FRL-7682-1) the Agency published a Final rule establishing tolerances
for residues of cyprodinil in or on almond, hulls; bean, dry; bean,
succulent; and leafy greens subgroup 4A, except spinach. When the
Agency conducted the risk assessments in support of this tolerance
action it assumed that cyprodinil residues would be present on dry bulb
onion, green onion and strawberry as well as on all foods covered by
the proposed and established tolerances. Residues on dry bulb onion,
green onion and strawberry were included because there were existing
time-limited tolerances for these commodities. Therefore, extending the
dry bulb onion, green onion and strawberry tolerances will not change
the most recent estimated aggregate risks resulting from use of
cyprodinil, as discussed in the October 20, 2004 Federal Register,
cited above. Refer to the October 20, 2004 Federal Register document,
cited above, 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 assessment discussed in the final rule published
in the Federal Register of October 20, 2004, cited above, 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 cyprodinil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high-performance liquid
chromatography (HPLC)/ultra-violet (UV) Method AG- 631B) is available
to enforce the tolerance expression. The method is substantially
identical to earlier methods (Methods AG-631, AG-631A and REM 141.01)
that have been adequately validated by independent laboratories and the
Agency. 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
Codex maximum residue limits (MRLs) have been established for
residues of cyprodinil in or on strawberries at 2 ppm and dry bulb
onions at 0.3 ppm. The Codex MRLs are lower than the time-limited
tolerances in the United States (5.0 ppm on strawberry and 0.6 ppm on
dry bulb onions) in part because of differences in use patterns here
and in Europe. The U.S. tolerances are based on higher seasonal
application rates and/or shorter pre-harvest intervals. The higher U.S.
tolerances also reflect uncertainties in the submitted field trial data
for these crops. To address these uncertainties, EPA required
additional field trials on strawberries and onions as a condition of
registration. The new field trials have been submitted and are
undergoing review at the Agency. In its decision regarding permanent
tolerances for strawberry and dry bulb onions, EPA will consider
international residue limits, including Codex MRLs, and make every
effort to harmonize if possible.
V. Conclusion
Therefore, these tolerances are extended for residues of
cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on
onion, dry bulb at 0.6 ppm; onion, green at 4.0 ppm; and strawberry at
5.0 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 64000]]
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: November 2, 2007.
Daniel J. Rosenblatt,
Acting 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 180.532 is amended by revising the table in paragraph (a)(2)
to read as follows:
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) * * *
(2) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Onion, bulb.................................. 0.60 12/31/09
Onion, green................................. 4.0 12/31/09
Strawberry................................... 5.0 12/31/09
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-22233 Filed 11-13-07; 8:45 am]
BILLING CODE 6560-50-S
