[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: [email protected]. 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:
[email protected].
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:
[email protected].
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