[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Rules and Regulations]
[Page 60255-60261]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc07-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0234; FRL-8152-4]
Fluazinam; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fluazinam in or on aronia berry; buffalo currant; bushberry subgroup
13B; Chilean guava; European barberry; ginseng; highbush cranberry;
honeysuckle, edible; jostaberry; juneberry; lingonberry; native
currant; pea and bean, dried shelled, except soybean, subgroup 6C,
except pea; pea and bean, succulent shelled, subgroup 6B, except pea;
salal; sea buckthorn; turnip, greens; vegetable, Brassica leafy, group
5; and vegetable, legume, edible-podded, subgroup 6A, except pea.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 24, 2007. Objections and
requests for hearings must be received on or before December 24, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0234. 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
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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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to 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-2007-0234 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 December 24, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0234, 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 April 30, 2007 (72 FR 21261-21263) (FRL-
8124-5), 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
6E7137 and 6E7139) by Interregional Research Project Number 4 (IR-4),
500 College Road East, Suite 201W, Princeton, New Jersey, 08540. PP
6E7137 requested that 40 CFR 180.574 be amended by establishing
tolerances for residues of the fungicide fluazinam in or on Vegetable,
legume, edible podded, subgroup 6A, except pea at 0.15 parts per
million (ppm); Brassica, leafy greens, subgroup 5B at 0.02 ppm;
Brassica, head and stem, subgroup 5A at 0.01 ppm; and turnip, tops at
0.02 ppm; and residues of fluazinam and its metabolite AMGT in or on
Bushberry subgroup 13B; berry, aronia; blueberry, lowbush; currant,
buffalo; guava, chilean; barberry, European; cranberry, highbush;
honeysuckle; jostaberry; Juneberry; lingonberry; currant, native;
salal; and buckthorn, sea at 4.5 ppm. PP 6E7139 requested that 40 CFR
180.574 be amended by establishing tolerances for residues of fluazinam
in or on ginseng at 3.0 ppm; bean, dry at 0.01 ppm; and pea and bean,
succulent shelled, subgroup 6B, except pea at 0.02 ppm. That notice
referenced a summary of the petition prepared by ISK Biosciences
Corporation, the registrant, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified commodity terms and/or tolerance levels for most commodities.
EPA has also determined that the tolerances for berries should include
parent fluazinam only. The reasons for these changes are explained in
Unit V.
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
[[Page 60257]]
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 section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for the petitioned-for
tolerances for residues of fluazinam on Aronia berry at 7.0 ppm;
buffalo currant at 7.0 ppm; bushberry subgroup 13B at 7.0 ppm; Chilean
guava at 7.0 ppm; European barberry at 7.0 ppm; ginseng at 4.5 ppm;
highbush cranberry at 7.0 ppm; honeysuckle, edible at 7.0 ppm;
jostaberry at 7.0 ppm; juneberry at 7.0 ppm; lingonberry at 7.0 ppm;
native currant at 7.0 ppm; pea and bean, dried shelled, except soybean,
subgroup 6C, except pea at 0.02 ppm; pea and bean, succulent shelled,
subgroup 6B, except pea at 0.04 ppm; salal at 7.0 ppm; sea buckthorn at
7.0 ppm; turnip, greens at 0.01 ppm; vegetable, Brassica leafy, group 5
at 0.01 ppm; and vegetable, legume, edible-podded, subgroup 6A, except
pea at 0.10 ppm. EPA's assessment of exposures and risks associated
with establishing these 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 fluazinam 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
in the document ``Fluazinam: Human Health Risk
Assessment for Proposed Use on Edible-Podded Beans, Shelled Succulent
and Dried Beans, Brassica Leafy Vegetables, Bushberries, and Ginseng''.
The referenced document is available in the docket established by this
action, which is described under ADDRESSES, and is identified as EPA-
HQ-OPP-2007-0234-0003 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/pesticides/factsheets/riskassess.htm
.
A summary of the toxicological endpoints for fluazinam used for
human risk assessment can be found at http://www.regulations.gov in
document ``Fluazinam: Human Health Risk Assessment for Proposed Use on
Edible-Podded Beans, Shelled Succulent and Dried Beans, Brassica Leafy
Vegetables, Bushberries, and Ginseng'' at pages 25-26 in docket ID
number EPA-HQ-OPP-2007-0234.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazinam, EPA considered exposure under the petitioned-for
tolerances as well as all existing fluazinam tolerances in 40 CFR
180.574. EPA also considered exposure to residues of the metabolite
AMGT, which has been identified as a metabolite of toxicological
concern in all crops except peanuts, root and tuber vegetables and bulb
vegetables. EPA assessed dietary exposures from fluazinam and AMGT 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 U.S. Department of Agriculture (USDA) 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
of fluazinam. AMGT residues were calculated based on the mean ratio of
metabolite to parent seen in field trials. For crops where this
information was not available (Brassica and legume vegetables), a
conservative, upper-bound ratio derived from metabolism studies was
used to estimate AMGT 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 of fluazinam. AMGT residues were calculated as described for
the acute dietary exposure assessment.
iii. Cancer. In accordance with the 2005 Guidelines for Carcinogen
Risk Assessment, for fluazinam there is ``Suggestive evidence of
carcinogenic potential.'' This determination is based on weight of
evidence considerations where a concern for potential carcinogenic
effects in humans is raised, but the animal data are judged not
sufficient for a stronger conclusion.
Carcinogenicity studies were conducted in rats and mice. In rats,
increased incidences of thyroid gland follicular cell tumors were seen
in males
[[Page 60258]]
but not in females. In mice, there were conflicting results with regard
to hepatocarcinogenicity. In one study benign and malignant liver
tumors were seen in males; no liver tumors were seen in females. In the
second study, carcinogenic response was equivocal and tumors did not
occur in a dose-related manner. In males, the dose that induced liver
tumors in the first study failed to induce liver tumors in the same
strain of mice in the second study. In the second study, in females,
liver tumors were seen only at an excessive toxic dose. There was no
evidence of mutagenicity either in in vivo or in vitro assays. No
chemicals structurally related to fluazinam were identified as
carcinogens.
Since the evidence for carcinogenicity is not sufficient to
indicate anything greater than a suggestion of a carcinogenic
potential, EPA concludes that quantification of cancer risk would not
be scientifically appropriate, as it attaches greater significance to
the positive cancer findings than the entire dataset warrants. Further,
due to the equivocal and inconsistent nature of the cancer response in
the rat and mouse studies (in rats, effects seen only in males; in
mice, one study showed effects only in males but even these effects
were not reproducible), EPA finds that when judged qualitatively the
data indicate no greater than a negligible risk of cancer.
Additionally, it is noted that the point of departure (1.1 milligrams/
kilograms/day) (mg/kg/day)) selected for deriving the chronic reference
dose will adequately account for all chronic effects determined to
result from exposure to fluazinam in chronic animal studies, including
the equivocal cancer effects.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for fluazinum. Tolerance level residues and 100 PCT were
assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for fluazinam 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
fluazinam. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Groundwater (SCI-GROW) models, the estimated
environmental concentrations (EECs) of fluazinam for acute exposures
are estimated to be 71.0 parts per billion (ppb) for surface water and
0.187 ppb for ground water. The EECs for chronic exposures are
estimated to be 17.7 ppb for surface water and 0.187 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 71.0 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 17.7 ppb was used to
assess the contribution to 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). Fluazinam is not
registered for use on any sites that would result in residential
exposure.
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.''
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 fluazinam and any other
substances and fluazinam 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 fluazinam 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
EPA's website at http://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 (``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. The prenatal and postnatal
toxicology database for fluazinam includes rat and rabbit developmental
toxicity studies, a developmental neurotoxicity study in rats and a 2-
generation reproduction toxicity study in rats.
There was no evidence of increased qualitative or quantitative
susceptibility of fetuses following in utero exposure to fluazinam in
the rabbit developmental study and no evidence of increased
susceptibility of offspring in the 2-generation reproduction study in
rats. However, there was evidence of increased qualitative
susceptibility of fetuses to fluazinam in the developmental toxicity
study in rats. In this study, increased incidences of facial/palate
clefts and other rare deformities in the fetuses were observed in the
presence of minimal maternal toxicity. In a developmental neurotoxicity
study, decreases in body weight and body weight gain and a delay in
completion of balano-preputial separation were observed in pups. These
effects were seen in the absence of maternal effects, suggesting
increased quantitative susceptibility of the offspring.
Although there is qualitative evidence of increased susceptibility
in young in the developmental toxicity study in rats, there are no
residual uncertainties with regard to prenatal and/or postnatal
toxicity following in utero exposure of rats or rabbits. Considering
the overall toxicity profile and the doses and endpoints selected for
risk assessment for fluazinam, the degree of concern for the effects
observed in the study is low. There is a clear NOAEL for the fetal
effects seen, the effects occurred in the presence of maternal
toxicity, and they were only seen at the highest dose tested.
Additionally, the NOAEL of 50 mg/kg/day identified in this
developmental toxicity study in rats is significantly higher than the
NOAEL used (7 mg/kg/day) to establish the acute Reference Dose (aRfD)
of 0.07 mg/kg/day (females 13-49); thus, the aRfD is
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protective of any potential developmental effects.
Quantitative evidence of increased susceptibility was also observed
in a developmental neurotoxicity study in rats. In pups, there were
decreases in body weight and body weight gain during lactation, and
delayed preputial separation observed at 10 mg/kg/day (NOAEL=2 mg/kg/
day). Although the NOAEL of 2 mg/kg/day is lower than that used for the
acute RfD for females 13-49 (7 mg/kg/day), the effects noted in the
developmental neurotoxicity study are attributable to multiple doses
and are considered postnatal effects. Therefore, the study endpoint is
not appropriate either for acute dietary exposures or for use with the
population subgroup females 13-49 (with this subgroup the concern is
for prenatal exposures). The chronic RfD of 0.011 mg/kg/day is based on
a lower NOAEL of 1.1 mg/kg/day and is considered protective of
potential developmental effects.
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 fluazinam is complete in regard to
pre-and postnatal toxicity and neurotoxicity.
ii. A developmental neurotoxicity study (DNT) in rats was submitted
to address the presence of neurotoxic lesions observed after fluazinam
exposure in sub-chronic and chronic toxicity studies and to address the
qualitative susceptibility seen in the rat developmental toxicity
study. In the DNT study, there were no neurotoxic effects observed in
either dams or pups. However, there was evidence of quantitative
susceptibility for other effects in the DNT study, based on decreases
in body weight and body weight gain, and delayed preputial separation
in pups in the absence of maternal toxicity. There are no residual
uncertainties for these effects, and toxicity endpoints and traditional
UFs to be used in the risk assessment will be protective of these
potential developmental effects.
iii. Although there is qualitative evidence of increased
susceptibility in the prenatal developmental study in rats, the risk
assessment team did not identify any residual uncertainties after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment of fluazinam. The degree of concern for prenatal and/or
postnatal toxicity is low.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. Conservative ground and
surface water modeling estimates were used. These assessments will not
underestimate the exposure and risks posed by fluazinam.
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, EPA performed two different acute risk
assessments - one focusing on females 13 to 49 years old and designed
to protect against prenatal effects and the other focusing on acute
effects relevant to all other population groups. The more sensitive
acute endpoint was seen as to prenatal effects rather than other acute
effects. For females 13 to 49 years old, the acute dietary exposure
from food and water will occupy 8% of the aPAD addressing prenatal
effects. As to acute effects other than prenatal effects, the acute
dietary exposure from food and water to fluazinam will occupy 3% of the
aPAD for infants less than 1-year old, the population group receiving
the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to fluazinam
from food and water will utilize 16% of the cPAD for infants less than
1-year old, the population group with the greatest estimated exposure.
There are no residential uses for fluazinam that result in chronic
residential exposure to fluazinam.
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). Fluazinam is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency'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). Fluazinam is
not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. The Agency has
determined that quantification of human cancer risk is not necessary
for fluazinam and that the chronic risk assessment based on the
established cPAD is protective of potential cancer effects. Based on
the results of the chronic risk assessment discussed above in Unit
III.E.2, EPA concludes that fluazinam 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, or to infants and children from aggregate
exposure to fluazinam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography with electron-
capture detection) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed Codex MRLs for residues of
fluazinam in plant or animal commodities.
V. Conclusion
Based upon review of the data supporting the petition, EPA has
modified the proposed tolerances as follows:
The tolerances for Bushberry subgroup 13B and related
berries were increased from 4.5 ppm to 7.0 ppm based on analyses of the
residue field trial data using the Agency's Tolerance Spreadsheet in
accordance with the Agency's Guidance for Setting Pesticide Tolerances
Based on Field Trial Data. Although IR-4 proposed tolerances for
combined residues of fluazinam and AMGT on these commodities, EPA
determined, based on the low levels of AMGT seen in the field trials,
that only parent fluazinam should be included in the tolerance
expression.
The commodity terms for dry beans and succulent shelled
legumes were
[[Page 60260]]
revised to read ``Pea and bean, dried shelled, except soybean, subgroup
6C, except pea'' and ``Pea and bean, succulent shelled, subgroup 6B,
except pea'' to agree with recommended commodity terms in the Office of
Pesticide Program's Food and Feed Commodity Vocabulary. Tolerances for
these commodities were increased from 0.01 ppm to 0.02 ppm (dried) and
from 0.02 ppm to 0.04 ppm (succulent) to account for the 50%
dissipation of residues observed in the storage stability study.
The commodity term for edible-podded legume vegetables was
revised to read ``Vegetable, legume, edible-podded, subgroup 6A, except
pea'' to agree with the Food and Feed Commodity Vocabulary. The
tolerance level was decreased from 0.15 ppm to 0.10 ppm based on
maximum residues seen in the field trials, since 80% of the residues
were non-detectable and, therefore, not appropriate for analysis using
the Tolerance Spreadsheet.
IR-4 proposed separate tolerances of 0.02 ppm and 0.01 ppm
for ``Leafy Brassica greens subgroup'' and ``Head and stem Brassica
subgroup'', respectively. EPA determined that a single tolerance of
0.01 ppm covering the entire crop group ``Vegetable, Brassica leafy,
group 5'' would be appropriate, based on the results of field trials
showing no residues above the method limit of quantitation (LOQ) in any
of the representative commodities (broccoli, cabbage and mustard
greens). The tolerance for turnip greens was revised from 0.02 to 0.01
ppm on the same basis.
The tolerance for ginseng was increased from 3.00 ppm to
4.5 ppm to account for dissipation of residues observed in the storage
stability study.
Therefore, tolerances are established for residues of fluazinam, 3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine, in or on Aronia berry at 7.0 ppm;
buffalo currant at 7.0 ppm; bushberry subgroup 13B at 7.0 ppm; Chilean
guava at 7.0 ppm; European barberry at 7.0 ppm; ginseng at 4.5 ppm;
highbush cranberry at 7.0 ppm; honeysuckle, edible at 7.0 ppm;
jostaberry at 7.0 ppm; juneberry at 7.0 ppm; lingonberry at 7.0 ppm;
native currant at 7.0 ppm; pea and bean, dried shelled, except soybean,
subgroup 6C, except pea at 0.02 ppm; pea and bean, succulent shelled,
subgroup 6B, except pea at 0.04 ppm; salal at 7.0 ppm; sea buckthorn at
7.0 ppm; turnip, greens at 0.01 ppm; vegetable, Brassica leafy, group 5
at 0.01 ppm; and vegetable, legume, edible-podded, subgroup 6A, except
pea at 0.10 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 11, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.574 is amended by removing the heading General from
paragraph (a)(1) and adding General to paragraph (a) and by
alphabetically adding the following commodities to the table in
paragraph (a)(1) to read as follows:
Sec. 180.574 Fluazinam; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Aronia berry............................................... 7.0
Buffalo currant............................................ 7.0
Bushberry subgroup 13B..................................... 7.0
Chilean guava.............................................. 7.0
European barberry.......................................... 7.0
Ginseng.................................................... 4.5
Highbush cranberry......................................... 7.0
[[Page 60261]]
Honeysuckle, edible........................................ 7.0
Jostaberry................................................. 7.0
Juneberry.................................................. 7.0
Lingonberry................................................ 7.0
Native currant............................................. 7.0
Pea and bean, dried shelled, except soybean, subgroup 6C, 0.02
except pea................................................
Pea and bean, succulent shelled, subgroup 6B, except pea... 0.04
* * * * *
Salal...................................................... 7.0
Sea buckthorn.............................................. 7.0
Turnip, greens............................................. 0.01
Vegetable, Brassica leafy, group 5......................... 0.01
Vegetable, legume, edible-podded, subgroup 6A, except pea.. 0.10
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-20581 Filed 10-23-07; 8:45 am]
BILLING CODE 6560-50-S