Fluopicolide; Pesticide Tolerance, 14443-14447 [E7-5628]
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Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Rules and Regulations
14443
Appendix Q to Subpart G of Part 82—
Unacceptable Substitutes Listed in the
March 28, 2007 Final Rule, Effective
May 29, 2007.
FOAM BLOWING UNACCEPTABLE SUBSTITUTES
End use
Substitute
Decision
—Rigid polyurethane commercial refrigeration ...............
—Rigid polyurethane sandwich panels.
HCFC–22; HCFC–142b as
substitutes for HCFC–
141b.
Unacceptable 1 ..................
Alternatives exist with
lower or zero-ODP.
HCFC–22; HCFC–142b as
substitutes for CFCs.
Unacceptable 2 ..................
Alternatives exist with
lower or zero-ODP.
—Rigid polyurethane slabstock and other foams.
—Rigid polyurethane and polyisocyanurate laminated
boardstock.
—Rigid polyurethane appliance.
—Rigid polyurethane spray and commercial refrigeration, and sandwich panels.
—Rigid polyurethane slabstock and other foams.
—Polystyrene extruded insulation boardstock and billet.
—Phenolic insulation board and bunstock.
—Flexible polyurethane.
—Polystyrene extruded sheet.
Further information
1 For existing users of HCFC–22 and HCFC–142b as of November 4, 2005 other than in marine applications, the unacceptability determination
is effective on March 1, 2008; for existing users of HCFC–22 and HCFC–142b as of November 4, 2005 in marine applications, including marine
flotation foam, the unacceptability determination is effective on September 1, 2009. For an existing user of HCFC–22 or HCFC–142b that currently operates in only one facility that it does not own, and is scheduled to transition to a non-ODS, flammable alternative to coincide with a
move to a new facility and installation of new process equipment that cannot be completed by March 1, 2008, the unacceptability determination
is effective January 1, 2010.
2 For existing users of HCFC–22 and HCFC–142b in polystyrene extruded insulation boardstock and billet and the other foam end uses, as of
November 4, 2005, the unacceptability determination is effective on January 1, 2010.
Unit I.C. of the SUPPLEMENTARY
3. In Appendix K to Subpart G, the
second table (Foam Blowing—
Acceptable Substitutes) is removed.
I
INFORMATION).
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–481; FRL–8120–1]
Fluopicolide; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of fluopicolide in
or on imported grape at 2.0 parts per
million (ppm), and grape, raisin at 6.0
ppm with no U.S. registration. Bayer
CropScience AG requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act of
1996 (FQPA). The tolerance petition and
data was transferred to Valent U.S.A.
Corporation on January 9, 2006.
DATES: This regulation is effective
March 28, 2007. Objections and requests
for hearings must be received on or
before May 29, 2007, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
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A. Does This Action Apply to Me?
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0481. All documents in the
docket are listed in the index for the
docket. 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
telephone number is (703) 305-5805.
ADDRESSES:
[FR Doc. E7–5491 Filed 3–27–07; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
Janet Whitehurst, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305-6129; e-mail address:
janet.whitehurst@epa.gov.
SUPPLEMENTARY INFORMATION:
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I. General Information
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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),
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 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
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the person listed under FOR FURTHER
INFORMATION CONTACT.
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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 the FFDCA, as
amended by the 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–2006–0481 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 May 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 your copies, identified
by docket ID number EPA–HQ–OPP–
2006–0481, 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,
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excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 3055805.
II. Petition for Tolerance
In the Federal Register of January 24,
2007 (72 FR 3132) (FRL–8110–9), 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 5E6903) by Valent
U.S.A. Corporation, Walnut Creek, CA
94596-8025. The petition requested that
40 CFR part 180 be amended by
establishing a tolerance for residues of
the fungicide fluopicolide, 2,6-dichloroN-[[3-chloro-5-(trifluoromethyl)-2pyridinyl]methyl] benzamide, in or on
imported grape, juice, and grape, wine
at 2.0 ppm and the processed
commodity grape, raisin at 9.0 ppm.
That notice referenced a summary of the
petition prepared by Valent U.S.A.
Corporation, the registrant, which is
available to the public in the docket,
https://www.regulations.gov. Comments
were received on the notice of filing.
EPA’s response to these comments are
discussed in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
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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
fluopicolide in or on grape at 2.0 ppm
and grape, raisin at 6.0 ppm. EPA’s
assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
fluopicolide as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can
be found at https://www.regulations.gov.
The referenced document is available in
docket ID EPA–HQ–OPP–2006–0481.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (the NOAEL) from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the lowest
dose at which adverse effects of concern
are identified (the LOAEL) is sometimes
used for risk assessment if no NOAEL
was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
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principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/factsheets/riskassess.htm and
https://www.epa.gov/oppfead1/trac/
science.
A summary of the toxicological
endpoints for fluopicolide used for
human risk assessment can be found at
https://www.regulations.gov. The
referenced document is available in
docket ID EPA–HQ–OPP–2006–0481.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have not been
established (40 CFR 180.627) for the
residues of fluopicolide, in or imported
grapes. There are no registrations for use
of fluopicolide in the United States.
There are no major livestock feed items
associated with the use on imported
grapes. Therefore, residues in livestock
commodities are not relevant to the
establishment of import tolerances for
grapes. Risk assessments were
conducted by EPA to assess dietary
exposures from fluopicolide in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a one-day or
single exposure.
No acute reference dose was
established nor was a dietary endpoint
identified in either the general
population or for females aged 13-49
years. There were no appropriate
studies that demonstrated evidence of
toxicity attributable to a single dose of
fluopicolide for these populations. As a
result, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCIDTM), which incorporates
food consumption data as reported by
respondents in the USDA 1994–1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to
the chemical for each commodity. The
dietary assessment included grape
commodities, as the only source of
residues for fluopicolide. It was
assumed that 100% of all grape
commodities contained tolerance level
residues.
iii. Cancer. Fluopicolide is not likely
to be carcinogenic to humans; therefore,
a cancer exposure assessment was not
conducted.
iv. Anticipated residue and percent
crop treated (PCT) information.
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Anticipated residues/PCT data were not
needed to refine the risk assessment so
they were not used.
2. Dietary exposure from drinking
water. Since there are no existing U.S.
registrations for fluopicolide, no
residues from fluopicolide are expected
to occur in drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). No
occupational exporue to fluopicolide is
expected to occur in the U.S. as a result
of fluopicolide on imported grapes.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
fluopicolide and any other substances
and fluopicolide does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
not assumed that fluopicolide has a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see the policy statements
released by EPA’s Office of Pesticide
Programs concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
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14445
assessments either directly through use
of a margin of exposure analysis or
through using uncertainty (safety)
factors in calculating a dose level that
poses no appreciable risk to humans. In
applying this provision, EPA either
retains the default value of 10X when
reliable data do not support the choice
of a different factor, or, if reliable data
are available, EPA uses a different
additional safety factor value based on
the use of traditional uncertainty factors
and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
Acceptable/guideline studies for
developmental toxicity in rats and
rabbits as well as a 2-generation
reproduction study in rats were
available for consideration during
endpoint selection. There is no evidence
of susceptibility following in utero and/
or postnatal exposure in the rabbit
developmental toxicity study or in the
2-generation rat reproduction study.
Although qualitative susceptibility was
observed in the rat developmental
toxicity study, there is low concern for
these effects because the offspring
effects (reduced growth and skeletal
defects) are well characterized and
accompanied by maternal toxicity.
There are no residual uncertainties
concerning pre- and post-natal toxicity.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to 1X. That
decision is based on the following
findings: There is a complete toxicity
database for fluopicolide. There are no
residual uncertainties concerning preand post-natal toxicity and no
neurotoxicity concerns. The dietary
food exposure assessment utilizes
tolerance level residues and 100% CT.
There is no potential for drinking water
exposure. There is no potential for
residential exposure.
E. Aggregate Risks and Determination of
Safety
In accordance with the FQPA, EPA
must consider and aggregate pesticide
exposures and risks from three major
sources: Food, drinking water, and
residential exposures. In an aggregate
assessment, exposures from relevant
sources are added together and
compared to quantitative estimates of
hazard (e.g., a NOAEL or PAD), or the
risks themselves can be aggregated.
When aggregating exposures and risks
from various sources, EPA considers
both the route and duration of
exposure.The registrant is seeking
import tolerances on grapes and its
processed commodities and the risk
assessment includes only dietary
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exposure to fluopicolide. There is no
expectation that exposure to
fluopicolide would occur via water
consumption or residential use.
Therefore, an aggregate exposure risk
assessment is equivalent to the dietary
risk assessment.
1. Acute risk. Because there was no
evidence of toxicity for fluopicolide
attributable to a single dose,
fluopicolide is not expected to pose an
acute risk.
2. Chronic risk. As there are no U.S.
registrations or proposed registrations,
the chronic aggregate risk is equivalent
to the chronic dietary risk for
fluopicolide residues in food. The
chronic dietary exposure estimates are
<1% cPAD for the general U.S.
population and 3% cPAD for children 12 years old, the most highly exposed
subgroup. The dietary risk estimates are
all below EPA’s level of concern.
3. Short-term risk. Short–term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). As
there are no U.S. registrations or
proposed registrations for fluopicolide,
there will be no exposures from
residential uses or residues in drinking
water. Therefore, the aggregate risk is
the risk from food (grape commodities)
only. The dietary risk estimates are all
below EPA’s level of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). As there are no U.S.
registrations or proposed registrations
for fluopicolide, there will be no
exposures from residential uses or
residues in drinking water. Therefore,
the aggregate risk is the risk from food
(grape commodities) only. The dietary
risk estimates are all below EPA’s level
of concern.
5. Aggregate cancer risk for U.S.
population. Fluopicolide is not likely to
be carcinogenic to humans; therefore,
fluopicolide is not expected to pose a
cancer risk.
6. Determination of safety. Based on
these risk assessments, 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 fluopicolide
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
liquid chromatography/mass
spectrometry/mass spectrometry (LC/
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MS/MS) is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
No Codex, Canadian, or Mexican
maximum residue limits (MRLs) or
tolerances have been established for
fluopicolide.
C. Response to Coments
One comment dated June 14, 2006,
was received from B. Sachau. Ms.
Sachau’s comments regarding general
exposure to pesticides contained no
scientific data or evidence to rebut the
Agency’s conclusion that there is a
reasonable certainty that no harm will
result from aggregate exposure to
fluopicolide, including all anticipated
dietary exposures and other exposures
for which there is reliable information.
This comment as well as her comments
regarding animal testing have been
responded to by the Agency on several
occasions. For examples, see the
Federal Register issues of January 7,
2005 (70 FR 1349) (FRL–7691–4) and
October 29, 2004 (69 FR 63083) (FRL–
7681–9).
V. Conclusion
Therefore, the tolerance is established
for residues of fluopicolide, 2,6dichloro-N-[[3-chloro-5(trifluoromethyl)-2pyridinyl]methyl]benzamide, in or on
grape at a tolerance level of 2.0 parts per
million (ppm), and grape, raisin at a
tolerance level of 6.0 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 due to its lack of
significance, 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). 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., or impose any
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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). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). 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. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism(64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
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67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
§ 180.627
residues.
VII. Congressional Review Act
Federal Emergency Management
Agency
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, 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: March 21, 2007.
Steven Bradbury,
Acting Director, Office of Pesticides Program.
Therefore, 40 CFR chapter I is
amended as follows:
I
pwalker on PROD1PC71 with RULES
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 180.627 is added to subpart
C to read as follows:
VerDate Aug<31>2005
16:03 Mar 27, 2007
Jkt 211001
(a) General. Tolerances are
established for residues of fluopicolide,
2,6-dichloro-N-[[3-chloro-5(trifluoromethyl)-2-pyridinyl]methyl]
benzamide, in or on the following
commodities.
Commodity
Parts per million
Grape ................................
Grape, raisin .....................
2.0
6.0
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E7–5628 Filed 3–27–07; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HOMELAND
SECURITY
44 CFR Part 65
Changes in Flood Elevation
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
SUMMARY: Modified Base (1% annualchance) Flood Elevations (BFEs) are
finalized for the communities listed
below. These modified BFEs will be
used to calculate flood insurance
premium rates for new buildings and
their contents.
DATES: The effective dates for these
modified BFEs are indicated on the
following table and revise the Flood
Insurance Rate Maps (FIRMs) in effect
for the listed communities prior to this
date.
ADDRESSES: The modified BFEs for each
community are available for inspection
at the office of the Chief Executive
Officer of each community. The
respective addresses are listed in the
table below.
FOR FURTHER INFORMATION CONTACT:
PART 180—[AMENDED]
I
Fluopicolide; tolerances for
William R. Blanton, Jr., Engineering
Management Section, Mitigation
Division, Federal Emergency
Management Agency, 500 C Street, SW.,
Washington, DC 20472, (202) 646–3151.
SUPPLEMENTARY INFORMATION: The
Federal Emergency Management Agency
(FEMA) makes the final determinations
listed below of the modified BFEs for
PO 00000
Frm 00055
Fmt 4700
Sfmt 4700
14447
each community listed. These modified
BFEs have been published in
newspapers of local circulation and
ninety (90) days have elapsed since that
publication. The Mitigation Division
Director of FEMA resolved any appeals
resulting from this notification.
The modified BFEs are not listed for
each community in this notice.
However, this final rule includes the
address of the Chief Executive Officer of
the community where the modified
BFEs determinations are available for
inspection.
The modified BFEs are made pursuant
to section 206 of the Flood Disaster
Protection Act of 1973, 42 U.S.C. 4105,
and are in accordance with the National
Flood Insurance Act of 1968, 42 U.S.C.
4001 et seq., and with 44 CFR part 65.
For rating purposes, the currently
effective community number is shown
and must be used for all new policies
and renewals.
The modified BFEs are the basis for
the floodplain management measures
that the community is required to either
adopt or to show evidence of being
already in effect in order to qualify or
to remain qualified for participation in
the National Flood Insurance Program
(NFIP).
These modified BFEs, together with
the floodplain management criteria
required by 44 CFR 60.3, are the
minimum that are required. They
should not be construed to mean that
the community must change any
existing ordinances that are more
stringent in their floodplain
management requirements. The
community may at any time enact
stricter requirements of its own, or
pursuant to policies established by other
Federal, State, or regional entities.
These modified BFEs are used to meet
the floodplain management
requirements of the NFIP and are also
used to calculate the appropriate flood
insurance premium rates for new
buildings built after these elevations are
made final, and for the contents in these
buildings. The changes in BFEs are in
accordance with 44 CFR 65.4.
National Environmental Policy Act.
This final rule is categorically excluded
from the requirements of 44 CFR part
10, Environmental Consideration. An
environmental impact assessment has
not been prepared.
Regulatory Flexibility Act. As flood
elevation determinations are not within
the scope of the Regulatory Flexibility
Act, 5 U.S.C. 601–612, a regulatory
flexibility analysis is not required.
Regulatory Classification. This final
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866 of September 30,
E:\FR\FM\28MRR1.SGM
28MRR1
Agencies
[Federal Register Volume 72, Number 59 (Wednesday, March 28, 2007)]
[Rules and Regulations]
[Pages 14443-14447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5628]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-481; FRL-8120-1]
Fluopicolide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fluopicolide in or on imported grape at 2.0 parts per million (ppm),
and grape, raisin at 6.0 ppm with no U.S. registration. Bayer
CropScience AG requested this tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
of 1996 (FQPA). The tolerance petition and data was transferred to
Valent U.S.A. Corporation on January 9, 2006.
DATES: This regulation is effective March 28, 2007. Objections and
requests for hearings must be received on or before May 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-2006-0481. All documents in the
docket are listed in the index for the docket. 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 telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6129; e-mail address:
janet.whitehurst@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), 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 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
[[Page 14444]]
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 the FFDCA, as amended by the 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-2006-0481 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 May 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 your copies, identified by docket
ID number EPA-HQ-OPP-2006-0481, 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 telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of January 24, 2007 (72 FR 3132) (FRL-8110-
9), 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
5E6903) by Valent U.S.A. Corporation, Walnut Creek, CA 94596-8025. The
petition requested that 40 CFR part 180 be amended by establishing a
tolerance for residues of the fungicide fluopicolide, 2,6-dichloro-N-
[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl] benzamide, in or on
imported grape, juice, and grape, wine at 2.0 ppm and the processed
commodity grape, raisin at 9.0 ppm. That notice referenced a summary of
the petition prepared by Valent U.S.A. Corporation, the registrant,
which is available to the public in the docket, https://
www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments are discussed in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.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 fluopicolide in or
on grape at 2.0 ppm and grape, raisin at 6.0 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by fluopicolide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://
www.regulations.gov. The referenced document is available in docket ID
EPA-HQ-OPP-2006-0481.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general
[[Page 14445]]
principles EPA uses in risk characterization at https://www.epa.gov/
pesticides/factsheets/riskassess.htm and https://www.epa.gov/oppfead1/
trac/science.
A summary of the toxicological endpoints for fluopicolide used for
human risk assessment can be found at https://www.regulations.gov. The
referenced document is available in docket ID EPA-HQ-OPP-2006-0481.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have not
been established (40 CFR 180.627) for the residues of fluopicolide, in
or imported grapes. There are no registrations for use of fluopicolide
in the United States. There are no major livestock feed items
associated with the use on imported grapes. Therefore, residues in
livestock commodities are not relevant to the establishment of import
tolerances for grapes. Risk assessments were conducted by EPA to assess
dietary exposures from fluopicolide in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
No acute reference dose was established nor was a dietary endpoint
identified in either the general population or for females aged 13-49
years. There were no appropriate studies that demonstrated evidence of
toxicity attributable to a single dose of fluopicolide for these
populations. As a result, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The dietary assessment included grape commodities, as the only source
of residues for fluopicolide. It was assumed that 100% of all grape
commodities contained tolerance level residues.
iii. Cancer. Fluopicolide is not likely to be carcinogenic to
humans; therefore, a cancer exposure assessment was not conducted.
iv. Anticipated residue and percent crop treated (PCT) information.
Anticipated residues/PCT data were not needed to refine the risk
assessment so they were not used.
2. Dietary exposure from drinking water. Since there are no
existing U.S. registrations for fluopicolide, no residues from
fluopicolide are expected to occur in drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). No occupational
exporue to fluopicolide is expected to occur in the U.S. as a result of
fluopicolide on imported grapes.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fluopicolide and any other
substances and fluopicolide does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that fluopicolide has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at https://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
margin of exposure analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional uncertainty factors and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity. Acceptable/guideline studies
for developmental toxicity in rats and rabbits as well as a 2-
generation reproduction study in rats were available for consideration
during endpoint selection. There is no evidence of susceptibility
following in utero and/or postnatal exposure in the rabbit
developmental toxicity study or in the 2-generation rat reproduction
study. Although qualitative susceptibility was observed in the rat
developmental toxicity study, there is low concern for these effects
because the offspring effects (reduced growth and skeletal defects) are
well characterized and accompanied by maternal toxicity. There are no
residual uncertainties concerning pre- and post-natal toxicity.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings: There is a
complete toxicity database for fluopicolide. There are no residual
uncertainties concerning pre- and post-natal toxicity and no
neurotoxicity concerns. The dietary food exposure assessment utilizes
tolerance level residues and 100% CT. There is no potential for
drinking water exposure. There is no potential for residential
exposure.
E. Aggregate Risks and Determination of Safety
In accordance with the FQPA, EPA must consider and aggregate
pesticide exposures and risks from three major sources: Food, drinking
water, and residential exposures. In an aggregate assessment, exposures
from relevant sources are added together and compared to quantitative
estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can
be aggregated. When aggregating exposures and risks from various
sources, EPA considers both the route and duration of exposure.The
registrant is seeking import tolerances on grapes and its processed
commodities and the risk assessment includes only dietary
[[Page 14446]]
exposure to fluopicolide. There is no expectation that exposure to
fluopicolide would occur via water consumption or residential use.
Therefore, an aggregate exposure risk assessment is equivalent to the
dietary risk assessment.
1. Acute risk. Because there was no evidence of toxicity for
fluopicolide attributable to a single dose, fluopicolide is not
expected to pose an acute risk.
2. Chronic risk. As there are no U.S. registrations or proposed
registrations, the chronic aggregate risk is equivalent to the chronic
dietary risk for fluopicolide residues in food. The chronic dietary
exposure estimates are <1% cPAD for the general U.S. population and 3%
cPAD for children 1-2 years old, the most highly exposed subgroup. The
dietary risk estimates are all below EPA's level of concern.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). As there are no U.S.
registrations or proposed registrations for fluopicolide, there will be
no exposures from residential uses or residues in drinking water.
Therefore, the aggregate risk is the risk from food (grape commodities)
only. The dietary risk estimates are all below EPA's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). As there are
no U.S. registrations or proposed registrations for fluopicolide, there
will be no exposures from residential uses or residues in drinking
water. Therefore, the aggregate risk is the risk from food (grape
commodities) only. The dietary risk estimates are all below EPA's level
of concern.
5. Aggregate cancer risk for U.S. population. Fluopicolide is not
likely to be carcinogenic to humans; therefore, fluopicolide is not
expected to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, 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 fluopicolide residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
No Codex, Canadian, or Mexican maximum residue limits (MRLs) or
tolerances have been established for fluopicolide.
C. Response to Coments
One comment dated June 14, 2006, was received from B. Sachau. Ms.
Sachau's comments regarding general exposure to pesticides contained no
scientific data or evidence to rebut the Agency's conclusion that there
is a reasonable certainty that no harm will result from aggregate
exposure to fluopicolide, including all anticipated dietary exposures
and other exposures for which there is reliable information. This
comment as well as her comments regarding animal testing have been
responded to by the Agency on several occasions. For examples, see the
Federal Register issues of January 7, 2005 (70 FR 1349) (FRL-7691-4)
and October 29, 2004 (69 FR 63083) (FRL-7681-9).
V. Conclusion
Therefore, the tolerance is established for residues of
fluopicolide, 2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide, in or on grape at a tolerance level of 2.0
parts per million (ppm), and grape, raisin at a tolerance level of 6.0
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 due to its lack of
significance, 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). 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., or 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). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
[[Page 14447]]
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: March 21, 2007.
Steven Bradbury,
Acting Director, Office of Pesticides Program.
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.
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2. Section 180.627 is added to subpart C to read as follows:
Sec. 180.627 Fluopicolide; tolerances for residues.
(a) General. Tolerances are established for residues of
fluopicolide, 2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl] benzamide, in or on the following commodities.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Grape..................................... 2.0
Grape, raisin............................. 6.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E7-5628 Filed 3-27-07; 8:45 am]
BILLING CODE 6560-50-S