[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: [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