[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Rules and Regulations]
[Pages 63027-63035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31102]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186
[OPP-300580; FRL-5755-1]
RIN 2070-AB78
Fenpropathrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fenpropathrin in or on cottonseed at 1.0 parts per million (ppm),
peanut nutmeat at 0.01 ppm, peanut vine hay at 20 ppm, strawberry at
2.0 ppm, tomato at 0.6 ppm, meat and meat by-products of cattle, goats,
hogs, horses and sheep at 0.1 ppm, fat of cattle, goats, hogs, horses
and sheep at 1.0 ppm, milk fat (reflecting 0.08 ppm in whole milk) at
2.0 ppm, and poultry meat, fat, meat by products and eggs at 0.05 ppm,
and in the processed products cottonseed oil at 3.0 ppm. It also
removes time limitations for tolerances for residues of fenpropathrin
on the same commodities that expire on November 15, 1997. Valent U.S.A.
Corporation requested this tolerance under the Federal Food, Drug and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (Pub. L. 104-170).
In addition, this regulation removes a feed additive tolerance for
cottonseed hulls at 2.0 ppm. Originally, a feed additive tolerance
existed for cottonseed soapstock at 2.0 ppm. In the November 14, 1994
Federal Register (59 FR 56454), which extended the time-limitation for
these tolerances, the Agency inadvertently changed the expression from
cottonseed soapstock to cottonseed hulls. Because a tolerance for
cottonseed hulls was never intended, the Agency is removing the
tolerance with this regulation. Also, the Agency no longer considers
cottonseed soapstock to be a significant feed commodity. Under present
residue chemistry guidelines, a tolerance for cottonseed soapstock is
no longer required. Therefore, with this regulation, the tolerance for
cottonseed soapstock is also removed.
DATES: This regulation is effective November 26, 1997. Objections and
requests for hearings must be received by EPA on or before Jnauary 26,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300580], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300580], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300580]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Beth Edwards, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-5400, e-mail:
edwards.beth@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: On April 14, 1993, EPA established time-
limited tolerances under section 408 and 409 of the Federal Food Drug
and Cosmetic Act (FFDCA), 21 U.S.C. 346 a(d) and 348 for residues of
fenpropathrin on cottonseed; meat, meat byproducts, and fat of cattle,
goats, hogs, horses, poultry, and sheep; milk fat; eggs; a food
additive tolerance in or on cottonseed oil; and a feed additive
tolerance in or on cottonseed soapstock (58 FR 19357). On September 27,
1995, EPA established time-limited tolerances for residues of
fenpropathrin on strawberries and tomatoes (60 FR 49793)(FRL-4979-1).
On July 31, 1996, EPA established time-limited tolerances for residues
of fenpropathrin on peanut hay and nutmeat (61 FR 39887)(FRL-5385-1).
These tolerances expire on November 15, 1997. Valent U.S.A., on
September 15, 1997, requested that the time limitation for tolerances
established for residues of the insecticide fenpropathrin in the
commodities mentioned above be removed based on environmental effects
data that they had submitted as a condition of the registration. Valent
U.S.A. also submitted a summary of its petition as required under the
FFDCA as amended by the Food Quality Protection Act (FQPA) of 1996
(Pub. L. 104-170).
In the Federal Register of September 25, 1997 (62 FR 50337)(FRL-
5748-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a(e) announcing the filing of pesticide petitions (PP 2F4144,
3F4186, and 4F4327) for tolerances by Valent U.S.A. Corporation, 1333
North California Blvd., Walnut Creek, CA 94596-8025. This notice
included a summary of the petitions prepared by Valent U.S.A.
Corporation, the registrant. There were no comments received in
response to the notice of filing.
The petitions requested that 40 CFR 180.466 be amended by removing
the time limitation for tolerances for residues of the insecticide and
pyrethroid fenpropathrin, in or on cottonseed at 1.0 parts per million
(ppm), peanut nutmeat at 0.01 ppm, peanut vine hay at 20 ppm,
strawberry at 2.0 ppm, tomato at 0.6 ppm, meat and meat by-products of
cattle, goats, hogs, horses and sheep at 0.1 ppm, fat of cattle, goats,
hogs, horses and sheep at 1.0 ppm, milk fat (reflecting 0.08 ppm in
whole milk) at 2.0 ppm, and poultry meat, fat, meat by-products and
eggs at 0.05 ppm, and in the processed products cottonseed oil at 3.0
ppm and cottonseed soapstock at 2.0 ppm.
The basis for time-limited tolerances that expire November 15,
1997 was given in the October 20, 1993 issue of the Federal Register
(58 FR 54094). These time-limited tolerances were predicated on the
expiration of pesticide product registrations that were made
conditional due to lack of certain ecological and environmental effects
data. The rationale for using time-limited tolerances was to encourage
[[Page 63028]]
pesticide manufacturers to comply with the conditions of registration
in a timely manner. There is no regulatory requirement to make
tolerances time-limited due to the conditional status of a product
registration under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) as amended. It is current EPA policy to no longer establish
time limitations on tolerance(s) with expiration dates if none of the
conditions of registration have any bearing on human dietary risk. The
current petition action meets that condition and thus the expiration
dates associated with specific crop tolerances are being deleted.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) 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)
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. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA. EPA generally uses the
RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This hundredfold MOE is based on the same rationale as
the hundredfold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity database, and based on the
effects seen for different durations and routes of exposure, determines
which risk assessments should be done to assure that the public is
adequately protected from any pesticide exposure scenario. Both short
and long durations of exposure are always considered. Typically, risk
assessments include ``acute,'' ``short-term,'' ``intermediate term,''
and ``chronic'' risks. These assessments are defined by the Agency as
follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a
period of 1-7 days, and therefore overlaps with the acute risk
assessment. Historically, this risk assessment was intended to address
primarily dermal and inhalation exposure which could result, for
example, from residential pesticide applications. However, since
enaction of FQPA, this assessment has been expanded to include both
dietary and non-dietary sources of exposure, and will typically
consider exposure from food, water, and residential uses when reliable
data are available. In this assessment, risks from average food and
water exposure, and high-end residential exposure, are aggregated.
High-end exposures from all three sources are not typically added
because of the very low probability of this occurring in most cases,
and because the other conservative assumptions built into the
assessment assure adequate protection of public health. However, for
cases in which high-end exposure can reasonably be expected from
multiple sources, (e.g. frequent and widespread homeowner use in a
specific geographical area), multiple high-end risks will be aggregated
and presented as part of the comprehensive risk assessment/
characterization. Since the toxicological endpoint considered in this
assessment reflects exposure over a period of at least 7 days, an
additional degree of conservatism is built into the assessment; i.e.,
the risk assessment nominally covers 1-7 days exposure, and the
toxicological endpoint/NOEL is selected to be adequate for at least 7
days of exposure. (Toxicity results at lower levels when the dosing
duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated
[[Page 63029]]
considering average exposure from all sources for representative
population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of
fenpropathrin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for residues of fenpropathrin on
cottonseed at 1.0 parts per million (ppm), peanut nutmeat at 0.01 ppm,
peanut vine hay at 20 ppm, strawberry at 2.0 ppm, tomato at 0.6 ppm,
meat and meat by-products of cattle, goats, hogs, horses and sheep at
0.1 ppm, fat of cattle, goats, hogs, horses and sheep at 1.0 ppm, milk
fat (reflecting 0.08 ppm in whole milk) at 2.0 ppm, and poultry meat,
fat, meat by-products and eggs at 0.05 ppm, and in the processed
product cottonseed oil at 3.0 ppm. EPA's assessment of the dietary
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. The nature of the toxic effects caused by fenpropathrin are
discussed below.
1. Acute toxicity studies with technical fenpropathrin: Oral
LD50 in the rat is 54.0 milligram/kilogram (mg/kg) for males
and 48.5 (mg/kg) for females - Toxicity Category I; dermal
LD50 is 1,600 mg/kg for males and 870 mg/kg for females -
Category II; acute inhalation (impossible to generate sufficient test
article vapor or aerosol to elicit toxicity) - Category IV; primary eye
irritation (no corneal involvement, mild iris and conjunctival
irritation) - Category III; and primary dermal irritation (no
irritation) - Category IV. Fenpropathrin is not a sensitizer.
2. In a subchronic oral toxicity study, rats were dosed at
concentrations of 0, 3, 30, 100, 300, or 600 ppm in the diet. The
lowest effect level (LEL) is 600 ppm (30 mg/kg/day) based on body
weight reduction (female), body tremors, and increased brain (female)
and kidney (male) weights. The NOEL is 300 ppm (15 mg/kg/day).
3. In a subchronic oral toxicity study, dogs were dosed at
concentrations of 0, 250, 500, or 1,000 ppm in the diet. A 1,000 ppm
dog was sacrificed moribund during the third week after having tremors
and showing other signs of poisoning caused by the test article.
Because of this death, the dose for this group was reduced to 750 ppm
for the remainder of the study. The LOEL is 750 ppm (18.8 mg/kg/day)
based on tremors. The NOEL is 500 ppm (12.5 mg/kg/day).
4. In a 21-day dermal toxicity study, rabbits were dosed 5 days/
week for 3 weeks on abraded or unabraded skin at doses of 0, 500,
1,200, or 3,000 mg/kg/day. There were no dose-related effects on body
weight, food consumption, clinical pathology, gross pathology, or organ
weights. Trace or mild inflammatory cell infiltration was seen in the
intact and abraded skin in all groups, including controls, and was
attributed to the test article. The systemic NOEL is > 3,000 mg/kg/day.
Local irritation only.
Although a 21-day dermal toxicity study in rabbits is available the
Agency has determined that rats are the most sensitive species to
ascertain the dermal toxicity potential of fenpropathrin. Therefore,
the lack of a 21-day dermal study in rats is data gap. This study will
be required under a special Data-Call-In letter pursuant to section
3(c)(2)(B) of FIFRA. Although these data are lacking, EPA has
sufficient toxicity data to support these tolerances and these
additional studies are not expected to significantly change the risk
assessment.
5. In a 1-year feeding study, dogs were dosed at 0, 100, 250, or
750 ppm in the diet. The systemic LEL is 250 ppm (6.25 mg/kg/day) based
on tremors in all dogs. The neurologic NOEL is 100 ppm (2.5 mg/kg/day);
the systemic NOEL is 100 ppm (2.5 mg/kg/day).
6. In a chronic feeding/carcinogenicity study, rats were dosed at
0, 50, 150, 450, or 600 ppm in the diet (0, 1.93, 5.71, 17.06, or 22.80
mg/kg/day in males, and 0, 2.43, 7.23, 19.45, or 23.98 mg/kg/day in
females). There was no evidence of carcinogenicity at any dose up to
and including 600 ppm (22.80 and 23.98 mg/kg/day in males and females,
respectively). The systemic NOEL (male) is 450 ppm (17.06 mg/kg/day).
The systemic NOEL (female) is 150 ppm (7.23 mg/kg/day); systemic LEL
(male) is 600 ppm highest dose tested (HDT); 22.80 mg/kg/day) based on
increased mortality, body tremors, increased pituitary, kidney, and
adrenal weights. The systemic LEL (female) is 450 ppm (19.45 mg/kg/day)
based on increased mortality and body tremors.
7. In a chronic feeding/carcinogenicity study, mice were dosed at
0, 40, 150, or 600 ppm in the feed (0, 3.9, 13.7, or 56.0 mg/kg/day in
males, and 0, 4.2, 16.2, or 65.2 mg/kg/day in females). As expected,
mortality was highest during the final quarter of the study, but the
incidence was similar in all dosed and control groups. No other
indications of toxicity or carcinogenicity were seen. The systemic NOEL
is > 600 ppm (HDT; male/female, 56.0/65.2 mg/kg/day).
8. In a developmental toxicity study in rats, pregnant female rats
were dosed by gavage on gestation days 6-15 at 0 (corn oil control)
0.4, 1.5, 2.0, 3.0, 6.0, or 10.0 mg/kg/day. The maternal no observed
adverse effect level (NOAEL) is 6 mg/kg/day; maternal LEL is 10 mg/kg/
day based on death, moribundity, ataxia, sensitivity to external
stimuli, spastic jumping, tremors, prostration, convulsions, hunched
posture, squinted eyes, chromodacryorrhea, and
[[Page 63030]]
lacrimation; developmental NOAEL is > 10 mg/kg/day.
9. In a developmental toxicity study in rabbits, pregnant female
New Zealand rabbits were dosed by gavage on gestation days 7 through 19
at 0, 4, 12, or 36 mg/kg/day. Maternal NOEL is 4 mg/kg/day; maternal
LEL is 12 mg/kg/day based on grooming, anorexia, flicking of the
forepaws; developmental NOEL is > 36 mg/kg/day (HDT).
10. A 3-generation reproduction study was performed in rats. Rats
were dosed with fenpropathrin at concentrations of 0, 40, 120, or 360
ppm (0, 3.0, 8.9, or 26.9 mg/kg/day in males; 0, 3.4, 10.1, or 32.0 mg/
kg/day in females, respectively). Parents (male/female): systemic NOEL
= 40 ppm (3.0/3.4 mg/kg/day); systemic LEL = 120 ppm (8.9/10.1 mg/kg/
day) based on body tremors with spasmodic muscle twitches, increased
sensitivity and maternal lethality; reproductive NOEL = 120 ppm (8.9/
10.1 mg/kg/day); reproductive LEL = 360 ppm (26.9/32.0 mg/kg/day) based
on decreased mean F1B pup weight, increased F2B
loss. Pups (male/female): developmental NOEL = 40 ppm (3.0/3.4 mg/kg/
day); developmental LEL = 120 ppm (8.9/10.1 mg/kg/day) based on body
tremors, increased mortality.
11. Studies on gene mutation and other genotoxic effects: An Ames
Assay was negative for Salmonella TA98, TA100, TA1535, TA1537, and
TA1538; and E. coli WP2uvrA (trp-) with or without metabolic
activation; Sister Chromosome Exchange in CHO-K1 Cells - there were no
increases in sister chromatid exchanges seen in the CHO-K1 cells
treated with S-33206 or the DMSO vehicle; Cytogenetics in vitro (CHO/
CA) - negative for chromosome aberrations (CA) in Chinese hamster ovary
(CHO) cells exposed in vitro to toxic doses ( 30
g/ml) without activation; and to limit of solubility (1,000
g/ml) with activation; In Vitro Assay in Mammalian Cells -
equivocal results - of no concern; DNA Damage/Repair in Bacillus
subtilis - not mutagenic or showing evidence of DNA damage at
5,000 g/paper disk.
12. In a metabolism study in rats, animals were dosed with
radiolabelled S-3206 fenpropathrin by three protocols. They were dosed
with S-3206 radiolabelled on either the alcohol or acid portion of the
molecule (i.e. [alcohol-14C]-S-3206 or [acid-
14C]-S-3206). In Experiment I, rats received 14 daily oral
low-doses of 2.5 mg/kg/day of unlabelled S-3206 followed by a 15th dose
of either the alcohol or acid radiolabelled S-3206. In Experiments II
and III, groups of rats received a single dose of either of the two
radiolabelled test articles at 2.5 mg/kg (II) or 25 mg/kg (III). No
clinical signs were seen in any rats.
The major biotransformations included oxidation at the methyl
group of the acid moiety, hydroxylation at the 4'-position of the
alcohol moiety, cleavage of the ester linkage, and conjugation with
sulfuric acid or glucuronic acid.
Four metabolites were found and characterized in the urine of rats
dosed with alcohol-radiolabel. The major metabolites were the sulfate
conjugate of 3-(4'-hydroxyphenoxy)benzoic acid and 3-phenoxybenzoic
acid (22-44% and 3-9% of the administered dose, respectively). Eight
metabolites were found in the urine of rats dosed with acid-radiolabel,
but only four were characterized. The major urinary metabolites of the
acid-labeled fenpropathrin were TMPA-glucuronic acid and TMPA-
CH2OH (11-26% and 6-10% of the administered dose,
respectively). None of the parent chemical was found in urine.
The major elimination products in the feces included the parent
chemical (13-34% of the administered dose) and four metabolites. The
fecal metabolites (and the percentage of administered dose) included
CH2OH-fenpropathrin (9-20%), 4'-OH-fenpropathrin (4-11%),
COOH-fenpropathrin (2-7%), and 4'-OH-CH2OH-fenpropathrin (2-
7%).
13. No neurological studies are available. These studies will be
required under a special Data Call-In letter pursuant to section
3(c)(2)(B) of FIFRA. Although these data are lacking, EPA has
sufficient toxicity data base to support these tolerances and these
additional studies are not expected to significantly change this risk
assessment.
B. Toxicological Endpoints
1. Acute toxicity. For acute dietary risk assessment, EPA
recommends use of a NOEL of 6.0 mg/kg/day based on clinical signs of
neurotoxicity on day one of dosing in dams from developmental toxicity
study in rats.
2. Short - and intermediate - term toxicity. toxicity. A short-
and intermediate-term risk assessment is not required for
fenpropathrin. There was no systemic toxicity at 3,000 mg/kg/day in a
21-day study in rabbits.
3. Chronic toxicity. EPA has established the RfD for fenpropathrin
at 0.025 mg/kg/day. This RfD is based on the 1-year toxicity study in
dogs with a NOEL of 2.5 mg/kg/day (tremors) with an uncertainty factor
of 100 to account for both interspecies extrapolation and intraspecies
variability.
4. Carcinogenicity. There is no evidence of carcinogenicity in any
of the chronic studies. Fenpropathrin has not yet been classified.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.466) for the residues of fenpropathrin, in or on a variety of
raw agricultural commodities. These are cottonseed (1.0 ppm),
strawberries (2.0 ppm), and tomatoes (0.6 ppm); in the fat of cattle,
goats, hogs, horses, and sheep at 1.0 ppm; in the meat of cattle,
goats, hogs, horses and sheep at 0.1 ppm; in the meat byproducts of
cattle, goats, hogs, horses and sheep at 0.1 ppm; milkfat at 2.0 ppm
(reflecting 0.08 ppm in whole milk); and poultry fat, meat, meat
byproducts, and eggs at 0.05 ppm. A food additive tolerance for
residues of fenpropathrin on cottonseed oil at 3.0 ppm has been
established under 40 CFR 185.3225. A feed additive tolerance for
residues of fenpropathrin on cottonseed soapstock at 2.0 ppm has been
established under 40 CFR 186.3225. Risk assessments were conducted by
EPA to assess dietary exposures and risks from fenpropathrin as
follows:
i. Acute exposure and risk. Acute dietary 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. The acute dietary exposure assessment
used Monte Carlo modeling incorporating anticipated residues and
percent crop treated refinements. The acute dietary Margin of Exposure
(MOE) calculated at the 99.9th percentile for the most highly exposed
population subgroup (children 1-6 years old) is 803. The MOE calculated
at the 99.9th percentile for the general U.S. population is 2,108. EPA
concludes that there is a reasonable certainty of no harm for MOEs of
100 or greater. Therefore, the acute dietary risk assessment for
fenpropathrin indicates a reasonable certainty of no harm.
ii. Chronic exposure and risk. The RfD used for the chronic
dietary analysis is 0.025 mg/kg/day. The chronic dietary exposure
assessment used anticipated residues and percent crop treated
information. The risk assessment resulted in use of 0.1% of the RfD for
the U.S. population and 0.2% of the most highly exposed population
subgroup (non-Hispanic other than black or white).
EPA notes that the acute dietary risk assessments used Monte Carlo
modeling (in accordance with Tier 3 of EPA is June 1996 ``Acute Dietary
Exposure Assessment'' guidance document) incorporating anticipated
residues and percent of crop treated refinements. The chronic dietary
risk assessment used
[[Page 63031]]
percent crop treated information and anticipated residues.
Section 408(b)(2)(E) authorizes EPA to consider available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a timeframe it
deems appropriate. Section 408(b)(2)(F) allows the Agency to use data
on the actual percent of crop treated when establishing a tolerance
only where the Agency can make the following findings: (1) that the
data used are reliable and provide a valid basis for showing the
percentage of food derived from a crop that is likely to contain
residues; (2) that the exposure estimate does not underestimate the
exposure for any significant subpopulation and; (3) where data on
regional pesticide use and food consumption are available, that the
exposure estimate does not understate exposure for any regional
population. In addition, the Agency must provide for periodic
evaluation of any estimates used.
The percent of crop treated estimates for fenpropathrin were
derived from Federal and market survey data. EPA considers these data
reliable. A range of estimates are supplied by this data and the upper
end of this range was used for the exposure assessment. By using this
upper end estimate of percent crop treated, the Agency is reasonably
certain that exposure is not underestimated for any significant
subpopulation. Further, regional consumption information is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Review
of this regional data allows the Agency to be reasonably certain that
no regional population is exposed to residue levels higher than those
estimated by the Agency. To meet the requirement for data on
anticipated residues, EPA will issue a Data Call-In (DCI) notice
pursuant to FFDCA section 408(f) requiring submission of data on
anticipated residues in conjunction with approval of the registration
under the FIFRA.
2. From drinking water. Since fenpropathrin is applied outdoors to
growing agricultural crops, the potential exists for fenpropathrin or
its metabolites to reach ground or surface water that may be used for
drinking water. Fenpropathrin is extremely insoluble in water (14 ppb),
with a high octanol/water partitioning coefficient (KOW 1.19
x 105 ) and a relatively short soil half-life for parent
and environmental metabolites. Estimates of fenpropathrin drinking
water concentrations were generated with the PRZM I and EXAMS computer
models. Based on these analyses, the contribution of water to the
dietary risk estimate is negligible. Therefore, EPA concludes that
together these data indicate that residues are not expected to occur in
drinking water.
i. Acute exposure and risk. The acute drinking water MOEs,
calculated at the 99.9th percentile, are 5,756 and 3,007 for the U.S.
population and non-nursing infants < 1="" year="" old,="" respectively.="" ii.="" chronic="" exposure="" and="" risk.="" the="" chronic="" drinking="" water="" risk="" assessment="" resulted="" in="" use="" of="" 0.3%="" and="" 1.6%="" of="" the="" rfd="" for="" the="" u.s.="" population="" and="" non-nursing="" infants="">< 1="" year="" old,="" respectively.="" 3.="" from="" non-occupational="" non-dietary="" exposure.="" fenpropathrin="" has="" no="" other="" uses,="" such="" as="" indoor="" pest="" control,="" homeowner="" or="" turf,="" that="" could="" lead="" to="" unique,="" enhanced="" exposures.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" 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.''="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data,="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" fenpropathrin="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" a="" cumulative="" risk="" assessment.="" unlike="" other="" pesticides="" for="" which="" epa="" has="" followed="" a="" cumulative="" risk="" approach="" based="" on="" a="" common="" mechanism="" of="" toxicity,="" fenpropathrin="" 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="" fenpropathrin="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" the="" acute="" aggregate="" risk="" assessment="" takes="" into="" account="" exposure="" from="" food="" and="" water.="" the="" acute="" aggregate="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" the="" u.s.="" population="" is="" 1,543.="" the="" agency="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" a="" moe="" of="" 100="" or="" larger.="" therefore,="" the="" agency="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" acute="" aggregate="" exposure="" to="" fenpropathrin="" residues="" in="" food="" and="" drinking="" water.="" 2.="" chronic="" risk.="" using="" the="" anticipated="" residue="" contribution="" (arc)="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" fenpropathrin="" from="" food="" and="" water="" will="" utilize="" 0.4%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-nursing="" infants="">< 1="" year="" old.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" [[page="" 63032]]="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" therefore,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" fenpropathrin="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" based="" on="" fenpropathrin="" not="" being="" registered="" for="" residential="" uses,="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-term="" risks="" do="" not="" exceed="" levels="" of="" concern="" (moe="" less="" than="" 100),="" and="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" fenpropathrin="" residues.="" e.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" this="" chemical="" has="" not="" yet="" been="" classified;="" however,="" there="" is="" no="" evidence="" of="" carcinogenicity="" in="" any="" of="" the="" chronic="" studies.="" epa="" believes="" that="" this="" pesticide="" does="" not="" pose="" a="" significant="" cancer="" risk.="" f.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--i.="" in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" fenpropathrin,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 3-generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" pesticide="" exposure="" during="" prenatal="" development="" to="" one="" or="" both="" parents.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" unless="" epa="" determines="" 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="" moe="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-="" species="" variability)="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.="" see="" toxicological="" profile="" in="" unit="" ii.="" a.="" of="" this="" preamble.="" iii.="" reproductive="" toxicity="" studies.="" see="" toxicological="" profile="" in="" unit="" ii.="" a.="" of="" this="" preamble.="" iv.="" pre-="" and="" post-natal="" sensitivity.="" there="" is="" no="" evidence="" of="" additional="" sensitivity="" to="" young="" rats="" or="" rabbits="" following="" pre-="" or="" postnatal="" exposure="" to="" fenpropathrin.="" v.="" conclusion.the="" data="" base="" related="" to="" pre-="" and="" post-natal="" sensitivity="" is="" complete.="" based="" on="" the="" above,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" uncertainty="" factor="" and="" that="" an="" additional="" uncertainty="" factor="" is="" not="" needed="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" acute="" risk.="" the="" aggregate="" acute="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" children="" age="" 1-6="" is="" 719.="" the="" agency="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" a="" moe="" of="" 100="" or="" larger.="" therefore,="" the="" agency="" has="" no="" acute="" aggregate="" concern="" due="" to="" exposure="" to="" fenpropathrin="" through="" food="" and="" drinking="" water.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" fenpropathrin="" from="" food="" and="" water="" will="" utilize="" 1.6%="" of="" the="" rfd="" for="" non-="" nursing="" infants.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" fenpropathrin="" residues.="" 4.="" short-="" or="" intermediate-term="" risk.="" based="" on="" fenpropathrin="" not="" being="" registered="" for="" residential="" uses,="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-term="" risks="" do="" not="" exceed="" levels="" of="" concern,="" and="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result.="" 5.="" special="" docket.="" the="" complete="" acute="" and="" chronic="" exposure="" analyses="" (including="" dietary,="" non-dietary,="" drinking="" water,="" and="" residential="" exposure,="" and="" analysis="" of="" exposure="" to="" infants="" and="" children)="" used="" for="" risk="" assessment="" purposes="" can="" be="" found="" in="" the="" special="" docket="" for="" the="" fqpa="" under="" the="" title="" ``risk="" assessment="" for="" extension="" of="" tolerances="" for="" synthetic="" pyrethroids.''="" further="" explanation="" regarding="" epa's="" decision="" regarding="" the="" additional="" safety="" factor="" can="" also="" be="" found="" in="" the="" special="" docket.="" g.="" endocrine="" disrupter="" effects="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen,="" or="" such="" other="" endocrine="" effect....''="" the="" agency="" is="" currently="" working="" with="" interested="" stakeholders,="" including="" other="" government="" agencies,="" public="" interest="" groups,="" industry="" and="" research="" scientists="" in="" developing="" a="" screening="" and="" testing="" program="" and="" a="" priority="" setting="" scheme="" to="" implement="" this="" program.="" congress="" has="" allowed="" 3="" years="" from="" the="" passage="" of="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" at="" that="" time,="" epa="" may="" require="" further="" testing="" of="" this="" active="" ingredient="" and="" end="" use="" products="" for="" endocrine="" disrupter="" effects.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" metabolism="" studies="" have="" been="" conducted="" on="" pinto="" beans,="" tomatoes,="" apples,="" cotton="" and="" tomato.="" in="" the="" earlier="" studies,="" the="" parent="" compound="" was="" found="" to="" be="" the="" major="" residue;="" remaining="" residues="" were="" characterized="" but="" not="" identified.="" the="" apple="" metabolism="" study="" was="" deemed="" fully="" adequate="" because="" the="" majority="" of="" the="" residue="" was="" the="" parent="" compound.="" the="" cotton="" temporary="" tolerances="" were="" established="" with="" an="" expiration="" date="" because="" the="" petitioner="" had="" indicated="" that="" a="" new="" cotton="" metabolism="" study="" would="" be="" conducted="" to="" further="" elucidate="" the="" nature="" of="" radioactive="" residues="" in="" cotton="" commodities.="" in="" both="" recent="" plant="" metabolism="" studies,="" on="" cotton="" and="" tomatoes,="" it="" has="" been="" concluded="" that="" the="" residue="" of="" concern="" is="" the="" parent="" compound="" fenpropathrin="" per="" se.="" metabolism="" studies="" with="" goats="" and="" poultry="" dosed="" with="" radiolabeled="" fenpropathrin="" were="" submitted="" with="" pp7f03485/fap7h05527.="" the="" majority="" of="" the="" residue="" in="" muscle,="" fat,="" and="" milk="" and="" eggs="" was="" found="" to="" be="" the="" parent="" compound,="" fenpropathrin.="" the="" residue="" in="" kidney="" and="" liver="" consisted="" mainly="" of="" various="" metabolites.="" livestock="" metabolites,="" with="" the="" possible="" exception="" of="" tmpa="" lactone,="" have="" also="" been="" [[page="" 63033]]="" identified="" in="" rat="" metabolism="" studies="" and="" their="" contributions="" to="" the="" overall="" toxicity="" of="" fenpropathrin="" have="" been="" considered.="" for="" the="" apple="" and="" pear="" tolerances,="" the="" levels="" of="" the="" metabolites="" in="" livestock="" were="" low="" enough="" not="" to="" be="" included="" in="" the="" tolerance="" expression.="" b.="" analytical="" enforcement="" methodology="" residues="" of="" fenpropathrin="" in="" peanut="" raw="" agricultural="" and="" processed="" commodities="" were="" determined="" using="" analytical="" method="" rm-22-4="" gas="" chromatography="" with="" electron="" capture="" detection="" (gc/ecd).="" an="" epa="" trial="" of="" method="" rm-22-4="" for="" fenpropathrin="" residues="" in/on="" apples="" and="" method="" rm-22a-1="" for="" residues="" of="" fenpropathrin="" in="" meat="" and="" milk="" has="" been="" successfully="" conducted.="" in="" addition,="" recovery="" of="" fenpropathrin="" was="" tested="" through="" fda="" multiresidue="" methods="" and="" fenpropathrin="" was="" found="" to="" be="" completely="" recovered="" by="" the="" pam="" i="" section="" 302="" method="" (luke="" method);="" thus="" a="" confirmatory="" method="" is="" available.="" c.="" magnitude="" of="" residues="" 1.="" plant="" commodities--field="" trial="" studies.="" for="" the="" purposes="" of="" dietary="" risk="" assessment,="" residue="" data="" generated="" from="" residue="" field="" trials="" conducted="" at="" maximum="" application="" rates="" and="" minimum="" pre-harvest="" intervals="" were="" used="" to="" estimate="" chronic="" and="" acute="" dietary="" exposure="" to="" potential="" residues="" of="" fenpropathrin.="" for="" chronic="" dietary="" exposure="" analyses,="" mean="" anticipated="" residue="" values="" were="" calculated,="" substituting="" one-half="" the="" limit="" of="" detection="" for="" those="" samples="" for="" which="" residues="" were="" reported="" as="" non-detectable.="" for="" acute="" dietary="" exposure="" analyses,="" the="" entire="" range="" of="" field="" trial="" residue="" data="" which="" reflected="" the="" current="" labeled="" maximum="" rate="" and="" minimum="" phi="" for="" single="" serving="" commodities="" were="" used="" (tier="" 3="" modeling,="" as="" outlined="" in="" ``final="" office="" policy="" for="" performing="" acute="" dietary="" exposure="" assessment,''="" d.="" edwards,="" june="" 13,="" 1996.)="" for="" those="" foods="" considered="" to="" be="" blended,="" mean="" field="" trial="" residues="" were="" calculated,="" substituting="" the="" full="" limit="" of="" detection="" for="" those="" samples="" for="" which="" residues="" were="" reported="" as="" non-="" detectable="" (tier="" 2="" modeling)="" used="" residue="" distributions="" from="" field="" trial="" studies.="" 2.="" animal="" commodities.="" for="" chronic="" dietary="" analyses,="" dietary="" burdens="" were="" calculated="" using="" mean="" field="" trial="" residues,="" adjusted="" for="" percent="" of="" crop="" treated="" and="" applying="" appropriate="" processing="" factors,="" for="" all="" feed="" items.="" for="" acute="" dietary="" analyses,="" mean="" field="" trial="" residues="" (with="" no="" adjustment="" for="" percent="" of="" crop="" treated)="" were="" used="" for="" those="" feed="" items="" that="" are="" processed="" or="" blended,="" while="" the="" highest="" field="" trial="" residue="" values="" were="" used="" for="" the="" remaining="" feed="" items.="" the="" secondary="" residue="" levels="" in="" animal="" tissues="" were="" then="" calculated="" by="" multiplying="" the="" total="" dietary="" burden="" by="" the="" tissue-to-="" feed="" ratio="" calculated="" from="" the="" lactating="" ruminant="" or="" laying="" hen="" feeding="" studies.="" d.="" international="" residue="" limits="" codex="" maximum="" residue="" limits="" (mrls)="" for="" fenpropathrin="" have="" been="" established="" which="" are="" in="" harmony="" with="" the="" u.s.="" tolerances="" for="" cottonseed="" (1.0="" ppm).="" codex="" mrls="" have="" been="" established="" which="" exceed="" the="" u.s.="" tolerances="" for="" cattle="" meat="" byproducts="" (0.05="" vs.="" 0.02="" ppm),="" cattle="" meat="" (0.5="" vs.="" 0.02="" ppm),="" whole="" milk="" (0.1="" vs="" 0.02="" ppm),="" and="" tomatoes="" (1.0="" vs.="" 0.6="" ppm).="" codex="" mrls="" have="" been="" established="" which="" are="" below="" their="" u.s.="" counterparts="" for="" eggs="" (0.01="" vs="" 0.02="" ppm)="" and="" poultry="" meat="" byproducts="" (0.01="" vs.="" 0.02="" ppm).="" there="" are="" differences="" between="" the="" section="" 408="" tolerances="" and="" the="" codex="" mrl="" values="" for="" secondary="" residues="" in="" animal="" products.="" these="" differences="" are="" mainly="" caused="" by="" differences="" in="" the="" methods="" used="" to="" calculate="" animal="" feed="" dietary="" exposure.="" the="" only="" substantial="" difference="" between="" the="" u.s.="" tolerance="" and="" the="" codex="" mrl="" value="" is="" for="" tomatoes.="" the="" jmpr="" (joint="" meeting="" on="" pesticide="" residues)="" reviewer="" required="" that="" the="" mrl="" exceed="" the="" highest="" field="" residue,="" and="" rounded="" to="" unity.="" the="" epa="" reviewer="" agreed="" with="" valent="" that="" one="" set="" of="" field="" residue="" samples="" was="" possibly="" comprised="" by="" the="" presence="" of="" a="" high="" rate="" processing="" treatment="" nearby.="" high="" outliers="" were="" ignored,="" and="" the="" tolerance="" was="" set="" at="" 0.6="" ppm.="" no="" canadian="" mrls="" have="" been="" established="" for="" residues="" of="" fenpropathrin.="" mexico="" has="" established="" a="" tolerance="" for="" residues="" of="" fenpropathrin="" on="" cottonseed="" (1.0="" ppm)="" which="" is="" in="" harmony="" with="" the="" u.s.="" tolerance.="" iv.="" conclusion="" therefore,="" these="" tolerances="" are="" established="" for="" residues="" of="" fenpropathrin="" in="" cottonseed="" at="" 1.0="" ppm,="" peanut="" nutmeat="" at="" 0.01="" ppm,="" peanut="" vine="" hay="" at="" 20="" ppm,="" strawberry="" at="" 2.0="" ppm,="" tomato="" at="" 0.6="" ppm,="" meat="" and="" meat="" by-products="" of="" cattle,="" goats,="" hogs,="" horses="" and="" sheep="" at="" 0.1="" ppm,="" fat="" of="" cattle,="" goats,="" hogs,="" horses="" and="" sheep="" at="" 1.0="" ppm,="" milk="" fat="" (reflecting="" 0.08="" ppm="" in="" whole="" milk)="" at="" 2.0="" ppm,="" and="" poultry="" meat,="" fat,="" meat="" by-products="" and="" eggs="" at="" 0.05="" ppm,="" and="" in="" the="" processed="" products="" cottonseed="" oil="" at="" 3.0="" ppm.="" in="" addition="" to="" the="" tolerances="" being="" amended,="" since="" for="" purposes="" of="" establishing="" tolerances="" fqpa="" has="" eliminated="" all="" distinctions="" between="" raw="" and="" processed="" food,="" epa="" is="" combining="" the="" tolerances="" that="" now="" appear="" in="" sec.="" 185.3225="" with="" the="" tolerances="" in="" sec.="" 180.466="" and="" is="" removing="" the="" tolerances="" under="" sec.="" 185.3225="" and="" sec.="" 186.3225.="" originally,="" the="" tolerance="" under="" sec.="" 186.3225="" was="" for="" cottonseed="" soapstock="" at="" 2.0="" ppm.="" in="" the="" federal="" register="" of="" november="" 14,="" 1994="" (59="" fr="" 56454)(frl-4919-3)="" which="" extended="" the="" time-limitation="" for="" these="" tolerances,="" the="" agency="" inadvertently="" changed="" the="" expression="" from="" cottonseed="" soapstock="" to="" cottonseed="" hulls.="" because="" a="" tolerance="" for="" cottonseed="" hulls="" was="" never="" intended,="" the="" agency="" is="" removing="" the="" tolerance="" by="" this="" regulation.="" also,="" the="" agency="" no="" longer="" considers="" cottonseed="" soapstock="" as="" a="" significant="" feed="" commodity.="" under="" present="" residue="" chemistry="" guidelines,="" a="" tolerance="" for="" cottonseed="" soapstock="" is="" no="" longer="" required.="" therefore,="" with="" this="" regulation,="" the="" tolerance="" for="" cottonseed="" soapstock="" is="" also="" removed.="" v.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" january="" 26,="" 1998,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" [[page="" 63034]]="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" confidential="" business="" information="" (cbi).="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" vi.="" public="" records="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300580]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding
the use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
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). 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) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances 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. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
VIII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
40 CFR Part 186
Environmental protection, Feed additives, Pesticides and pests.
Dated: November 14, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.466, is revised to read as follows:
Sec. 180.466 Fenpropathrin; tolerances for residues.
(a) General. Tolerances are established for residues of the
pesticide chemical fenpropathrin (alpha-cyano-3-phenoxy-benzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate) in or on the following agricultural
commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.............................. 1.0
Cattle, mbyp............................. 0.1
Cattle, meat............................. 0.1
Cottonseed............................... 1.0
Cottonseed, oil.......................... 3.0
Eggs..................................... 0.05
Goats, fat............................... 1.0
Goats, mbyp.............................. 0.1
Goats, meat.............................. 0.1
Hogs, fat................................ 1.0
Hogs, mbyp............................... 0.1
Hogs, meat............................... 0.1
Horses, fat.............................. 1.0
Horses, mbyp............................. 0.1
Horses, meat............................. 0.1
Milkfat (reflecting 0.08 ppm in whole 2.0
milk).
Peanut, hay.............................. 20.0
Peanut, nutmeat.......................... 0.01
Poultry, fat............................. 0.05
[[Page 63035]]
Poultry, mbyp............................ 0.05
Poultry, meat............................ 0.05
Sheep, fat............................... 1.0
Sheep, mbyp.............................. 0.1
Sheep, meat.............................. 0.1
Strawberry............................... 2.0
Tomato................................... 0.6
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
Sec. 185.3225 [Removed]
b. By removing Sec. 185.3225 Fenpropathrin.
PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 342, 348 and 701.
Sec. 186.3225 [Removed]
b. By removing Sec. 186.3225 Fenpropathrin.
[FR Doc. 97-31102 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F
