[Federal Register: January 9, 2008 (Volume 73, Number 6)]
[Rules and Regulations]
[Page 1503-1508]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja08-5]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0541; FRL-8343-5]
Difenoconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes, increases, and removes tolerances
for residues of difenoconazole and also establishes tolerances for
combined residues of difenoconazole and its metabolite, CGA-205375, in
or on various commodities. In addition, this regulation revokes
tolerances for secondary residues in poultry, fat, meat, and meat
byproducts. Syngenta Crop Protection, Inc., requested these tolerances
under the Federal, Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective January 9, 2008. Objections and
requests for hearings must be received on or before March 10, 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-2007-0541. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov 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 in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: 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:
whitehurst.janet@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
[[Page 1504]]
not limited to those engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0541 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before March 10, 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 this copy, identified by docket ID number
EPA-HQ-OPP-2007-0541, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of August 22, 2007 (72 FR 47010-47012)
(FRL-8142-5), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petitions (PP 6E7120 and PP 6F7115) by Syngenta Crop Protection, Inc.,
P.O. Box 18300, Greensboro, NC 27419. The petitions requested that 40
CFR 180.475 be amended by establishing a tolerance for residues of the
fungicide difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-
methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on fruit,
pome, group 11 at 0.6 parts per million (ppm) (PP 6F7115); vegetable,
fruiting, group 8 at 0.5 ppm (PP 6F7115); vegetables, tuberous and
corm, subgroup 1C at 0.02 ppm (PP 6F7115); sugar beet roots at 0.3 ppm
(PP 6F7115); sugar beet tops at 7.0 ppm (PP 6F7115); and imported whole
papaya fruit at 0.3 ppm (PP 6E7120). That notice referenced a summary
of the petition prepared by Syngenta Crop Protection, Inc., the
registrant, which is available to the public in the docket, http://www.regulations.gov.
Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
determined that several of the proposed tolerances need to be raised,
lowered, or revoked. Additionally, EPA also determined that the
pesticide uses for the proposed tolerances would result in residues of
difenoconazole and CGA-205375 in or on the egg; milk; fat, meat, meat
byproducts; and liver of ruminants that need tolerances.
The need to revise the tolerance expression for livestock is based
on the previously submitted ruminant metabolism studies, the new foliar
uses, and the need to include CGA 205375 in the risk assessment. The
uses on pome fruit, sugar beets, and tuberous and corm vegetables
included potential cattle feedstuffs (cull potatoes, processed potato
waste, sugar beet molasses, sugar beet pulp, and wet apple pomace), and
therefore resulted in a greater potential for the transfer of residues
to meat and milk.
For poultry, based on the calculated dietary burdens and the
submitted feeding study data, the Agency concluded that the currently
established tolerances for secondary residues in poultry, meat, fat and
meat byproducts should be removed. Additionally, the tolerance for
residues of difenoconazole in eggs should be altered to include
residues of CGA-205375 and the tolerance level should be increased to
0.10 ppm (to account for CGA-205375).
III. Aggregate Risk Assessment and Determination of Safety
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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data
[[Page 1505]]
and other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for the petitioned-for tolerances for residues of
difenoconazole as revised by EPA. EPA's assessment of exposures and
risks associated with establishing the tolerances 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 adverse effects caused by difenoconazole 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 http://www.regulations.gov.
The referenced document is available in the docket
established for this action, which is described under ADDRESSES, and is
identified as EPA-HQ-OPP-2007-0541 in that docket.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
A summary of the toxicological endpoints for difenoconazole used
for human risk assessment can be found at http://www.regulations.gov in
the document entitled ``Difenoconazole in/on Fruiting Vegetables, Pome
Fruit, Sugar Beets, Tuberous and Corm Vegetables, and Imported
Papaya,'' Health Effects Division (HED) Risk Assessment on page 13 in
docket ID number EPA-HQ-OPP-2007-0541.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to difenoconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing difenoconazole
tolerances in (40 CFR 180.475). EPA assessed dietary exposures from
difenoconazole 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 1-day or single exposure.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
insert 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake
by Individuals (CSFII). As to residue levels in food, EPA assumed all
foods for which there are tolerances were treated and contain
tolerance-level residues.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for
which there are tolerances were treated and contain tolerance-level
residues.
iii. Cancer. A cancer dietary exposure assessment was not conducted
for difenoconazole because the cancer NOAEL is higher than the chronic
NOAEL; therefore, the chronic dietary risk estimate is more protective.
iv. Anticipated residue and percent crop treated (PCT) information.
The Agency did not use anticipated residue estimates or PCT
information.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for difenoconazole in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of difenoconazole. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
difenoconazole are 0.00128 parts per billion (ppb) for acute
groundwater and 0.00108 ppb for chronic groundwater. The EECs for
surface water are estimated to be 13.3 ppb and 9.43 ppb for 1-in-10
year annual peak and 1-in-10 year annual average concentrations
respectively.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. In this assessment, 1-in-10-
year annual peak (13.3 ppb) and 1-in10-year annual mean (9.43 ppb)
residue values were used for acute and chronic dietary exposure
assessments respectively.
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).
Difenoconazole is currently registered for the following
residential non-dietary sites: Ornamentals. EPA assessed residential
exposure using the following assumptions: Residential pesticide
handlers will be exposed to short-term duration (1-30 days only). The
dermal and inhalation (short-term) residential exposure was assessed
for ``homeowners'' mixer/loader/applicator wearing short pants and
short-sleeved shirts as well as shoes plus socks using garden hose-end
sprayer, ``pump-up'' compressed air sprayer, and backpack sprayer. A
MOE of 100 is adequate to protect residential pesticide handlers from
exposures to difenoconazole. MOEs are >100; therefore are not of
concern. With respect to residential
[[Page 1506]]
postapplication exposures, no significant postapplication exposure is
anticipated from ornamentals by residents; therefore, no residential
postapplication assessment was conducted.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
Difenoconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative
.
Difenoconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including difenoconazole, EPA conducted
a human health risk assessment for exposure to 1,2,4-triazole,
triazolylalanine, and triazolylacetic acid resulting from the use of
all current and pending uses of any triazole-derived fungicide. The
risk assessment is a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of UFs) and potential dietary and non-dietary
exposures (i.e., high-end estimates of both dietary and non-dietary
exposures). In addition, the Agency retained the additional 10X FQPA
safety factor for the protection of infants and children. The
assessment includes evaluations of risks for various subgroups,
including those comprised of infants and children. The Agency's
complete risk assessment is found in the propiconazole reregistration
docket at http://www.regulations.gov, docket ID number EPA-HQ-OPP-2005-
0497.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (10X) 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 database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor. 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 FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. Developmental toxicity
studies showed no increased sensitivity in fetuses as compared to
maternal animals following in utero exposures in rats and rabbits, and
pre-/postnatal exposure in the 2-generation reproduction toxicity study
in rats. There was no evidence of abnormalities in the development of
the fetal nervous system in the pre-/postnatal studies.
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:
i. The toxicity database for difenoconazole is complete.
ii. There is no indication that difenoconazole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that difenoconazole results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. The dietary food exposure assessments were performed based on
100% CT and tolerance-level residues. Conservative ground and surface
water modeling estimates were used. Similarly conservative residential
SOPs were used to assess postapplication exposure to children as well
as incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by difenoconazole.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to difenoconazole will occupy 8% of the aPAD for the population group
all infants (< 1 year old) receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
difenoconazole from food and water will utilize 56% of the cPAD for the
population group (children 1-2). Based on the use pattern, chronic
residential exposure to residues of difenoconazole is not expected.
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).
Difenoconazole is currently registered for uses that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic food and water and short-term
exposures for difenoconazole.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs of
[[Page 1507]]
greater than or equal to 170, and are therefore not 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). The Agency
believes residential pesticide handlers will be exposed to short-term
duration (1-30 days) only. Therefore, intermediate-and long-term
aggregate risk are not of concern.
5. Aggregate cancer risk for U.S. population. As explained in Unit
III.C.1.iii., the chronic risk assessment is protective of any cancer
risk for difenoconazole.
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 or to infants and children from aggregate
exposure to difenoconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology: liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS) method 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) have
been established for difenoconazole.
C. Response to Comments
One comment 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
difenoconazole, 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, tolerances are established for residues of
difenoconazole in or on vegetable, fruiting, group 8 at 0.60 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; beet, sugar at
0.01 ppm; papaya (imported) at 0.30 ppm; apple, wet pomace 4.5 ppm;
beet, sugar, dried pulp at 1.9 ppm; and potato, processed waste at 0.04
ppm. The tolerance for fruit, pome group 11 is increased from 0.6 ppm
to 1.0 ppm. Tolerances for pome fruit, group 11 and barley, grain are
established for domestic use. Tolerances for secondary residues in
poultry, meat, fat, and meat byproducts are revoked. Tolerances as
listed in the table of paragraph (a) in 40 CFR 180.475 are removed for
milk, meat of cattle, hog, goat, horse, and sheep; meat byproduct
(except liver) of cattle, hog, goat, horse, and sheep; fat of cattle,
hog, goat, horse, and sheep; liver of cattle, hog, goat, horse, and
sheep; and eggs. Tolerances for combined residues of CGA-205375 are
established in or on milk at 0.01 ppm; meat of cattle, hog, goat,
horse, and sheep at 0.05 ppm; meat byproduct (except liver) of cattle,
hog, goat, horse, and sheep at 0.10 ppm; fat of cattle, hog, goat,
horse, and sheep at 0.10 ppm; liver of cattle, hog, goat, horse, and
sheep at 0.20 ppm; and eggs at 0.10 ppm; and are listed in a table in
newly created paragraph (a)(2) of 40 CFR 180.475.
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 9, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 1508]]
Dated: December 28, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.475 is amended by revising paragraph (a) to read as
follows:
Sec. 180.475 Difenoconazole; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
fungicide difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-
methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on the
following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple, wet pomace.......................................... 4.5
Banana\1\.................................................. 0.2
Barley, grain.............................................. 0.1
Barley, hay................................................ 0.05
Barley, straw.............................................. 0.05
Beet, sugar................................................ 0.01
Beet, sugar, dried pulp.................................... 1.9
Canola, seed............................................... 0.01
Corn, sweet, forage........................................ 0.01
Corn, sweet, kernel plus cob with husks removed............ 0.01
Corn, sweet, stover........................................ 0.01
Cotton, gin byproducts..................................... 0.05
Cotton, undelinted seed.................................... 0.05
Fruit, pome group 11....................................... 1.0
Grape\1\................................................... 0.10
Papaya\1\.................................................. 0.30
Potato, processed waste.................................... 0.04
Rye, grain\1\.............................................. 0.1
Vegetable, fruiting, group 8............................... 0.60
Vegetable, tuberous and corm, subgroup 1C.................. 0.01
------------------------------------------------------------------------
\1\ There are no U.S. registrations.
(2) Tolerances are established for residues of the fungicide
difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-
dioxolan-2-ylmethyl]-1H-1,2,4-triazole, and its metabolite, CGA-205375,
1-[2-chloro-4-(4-chloro-phenoxy)phenyl]-2-[1,2,4]triazol-1-yl-ethanol,
in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.10
Cattle, liver.............................................. 0.20
Cattle, meat............................................... 0.05
Cattle, meat byproduct (except liver)...................... 0.10
Eggs....................................................... 0.10
Goat, fat.................................................. 0.10
Goat, liver................................................ 0.20
Goat, meat................................................. 0.05
Goat, meat byproduct (except liver)........................ 0.10
Hog, fat................................................... 0.10
Hog, liver................................................. 0.20
Hog, meat.................................................. 0.05
Hog, meat byproduct (except liver)......................... 0.10
Horse, fat................................................. 0.10
Horse, liver............................................... 0.20
Horse, meat................................................ 0.05
Horse, meat byproduct (except liver)....................... 0.10
Milk....................................................... 0.01
Sheep, fat................................................. 0.10
Sheep, liver............................................... 0.20
Sheep, meat................................................ 0.05
Sheep, meat byproduct (except liver)....................... 0.10
------------------------------------------------------------------------
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[FR Doc. E8-15 Filed 1-8-08; 8:45 am]
BILLING CODE 6560-50-S