`[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Rules and Regulations]
[Pages 63228-63235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30947]



[[Page 63227]]

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Part IV





Environmental Protection Agency





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40 CFR Part 180



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Cypermethrin and Zeta-Cypermethrin; Pesticide Tolerance; Final Rules

  Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / 
Rules and Regulations  

[[Page 63228]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300583; FRL-5755-3]
RIN 2070-AB78


Cypermethrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes permanent tolerances for residues 
of cypermethrin ()alpha-cyano-(3-
phenoxyphenyl)methyl()cis,trans-3(2,2-dichloroethyenyl)-
2,2-dimethylcyclopropane carboxylate in or on the commodities brassica, 
head and stem at 2.0 parts per million (ppm); brassica, leafy at 14.0 
ppm; cattle, fat at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat 
byproducts (mbyp) at 0.05 ppm; cottonseed at 0.5 ppm; goats, fat at 
0.05 ppm; goats, meat at 0.05 ppm; goats, mbyp at 0.05 ppm; hogs, fat 
at 0.05 ppm; hogs, meat at 0.05 ppm; hogs, mbyp at 0.05 ppm; horses, 
fat at 0.05 ppm; horses, meat at 0.05 ppm; horses, mbyp at 0.05 ppm; 
lettuce, head at 10.0 ppm; milk at 0.05 ppm; onions, bulb at 0.10 ppm; 
pecans 0.05 ppm; sheep, fat at 0.05; sheep, meat at 0.05 ppm; and 
sheep, mbyp at 0.05 ppm. It also removes the time limitations for 
tolerances for cypermethrin on the same commodities expires on November 
15, 1997. FMC Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996.

DATES: This regulation is effective November 26, 1997. Objections and 
requests for hearings must be received by EPA on or before January 26, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, OPP-300583, 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-300583, 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, Crystal Mall #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]. Follow the instructions in 
Unit VI. of this preamble. No Confidential Business Information (CBI) 
should be submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: By mail: George T. Larocca, Product 
Manager (PM-13), 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-
6100, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 15, 1984 (49 
FR 24864), 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 cypermethrin. These tolerances expire 
on November 15, 1997. On September 15, 1997, FMC Corporation requested 
that the time limitation for tolerances established for residues of the 
insecticide cypermethrin in these commodities be removed based on 
environmental effects data that they had submitted as a condition of 
the registration. FMC Corporation also submitted a summary of its 
petitions 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 2F2623, 
4F2986, 4F2986, 3F2824, 7F3498, 4F3011, and 4F4291) for tolerances by 
the FMC Corporation, 1735 Market St., Philadelphia, PA 19103. This 
notice included a summary of the petitions prepared by the FMC 
Corporation. There were no comments received in response to the notice 
of filing. The petitions requested that 40 CFR 180.418 be amended by 
removing the time limitations for tolerances of the insecticide 
cypermethrin (()alpha-cyano-(3-
phenoxyphenyl)methyl()cis,trans-3(2,2-dichloroethyenyl)-
2,2-dimethylcyclopropane carboxylate) in or on the commodities 
brassica, head and stem at 2.0 ppm; brassica, leafy at 14.0 ppm; 
cattle, fat at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, mbyp at 0.05 
ppm; cottonseed at 0.5 ppm; goats, fat at 0.05 ppm; goats, meat at 0.05 
ppm; goats, mbyp at 0.05 ppm; hogs, fat at 0.05 ppm; hogs, meat at 0.05 
ppm; hogs, mbyp at 0.05 ppm; horses, fat at 0.05 ppm; horses, meat at 
0.05 ppm; horses, mbyp at 0.05 ppm; lettuce, head at 10.0 ppm; milk at 
0.05 ppm; onions, bulb at 0.10 ppm; pecans 0.05 ppm; sheep, fat at 
0.05; sheep, meat at 0.05 ppm; and sheep, mbyp at 0.05 ppm. Tolerances 
for livestock commodities were inadvertently not listed in the notice 
of filing, although the tolerance petition, PP2F2623 previously 
establishing these tolerances was listed. The livestock commodity 
tolerances were considered by EPA for risk assessment purposes.
    The basis for time-limited tolerances that expire November 15, 
1997, was given in the October 20, 1993, 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 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, Rodenticide Act (FIFRA), as 
amended. It is current EPA policy to no longer establish time 
limitations on tolerances with expiration dates if none of the 
conditions of registration have any bearing on human dietary risk. The 
current petition actions meet 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) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section

[[Page 63229]]

408(b)(2)(C) of the FFDCA requires EPA to give special consideration to 
exposure of infants and children to the pesticide chemical residue in 
establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue....''
    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% 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 
100-fold MOE is based on the same rationale as the 100-fold 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 data base, 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 considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, section 408 of the FFDCA 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 
ground water 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

[[Page 63230]]

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) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action, EPA has sufficient data to assess the hazards of 
cypermethrin and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for tolerances for 
residues of cypermethrin in or on the commodities brassica, head and 
stem at 2.0 ppm; brassica, leafy at 14.0 ppm; cattle, fat at 0.05 ppm; 
cattle, meat at 0.05 ppm; cattle, mbyp at 0.05 ppm; cottonseed at 0.5 
ppm; goats, fat at 0.05 ppm; goats, meat at 0.05 ppm; goats, mbyp at 
0.05 ppm; hogs, fat at 0.05 ppm; hogs, meat at 0.05 ppm; hogs, mbyp at 
0.05 ppm; horses, fat at 0.05 ppm; horses, meat at 0.05 ppm; horses, 
mbyp at 0.05 ppm; lettuce, head at 10.0 ppm; milk at 0.05 ppm; onions, 
bulb at 0.10 ppm; pecans 0.05 ppm; sheep, fat at 0.05; sheep, meat at 
0.05 ppm; and sheep, mbyp at 0.05 ppm. EPA's assessment of the dietary 
exposures and risks associated with establishing the tolerance 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 cypermethrin are 
discussed in this unit.
    1. Acute toxicity. The required battery of acute toxicity studies 
has been submitted and found adequate. The findings were as follows: 
oral toxicity, LD50 > 263 milligram/kilogram (mg/kg); dermal 
toxicity, LD50 > 2,460 mg/kg; inhalation toxicity 
LC50, 2.5 mg/liter (L); primary eye irritation--Toxicity 
Category III; primary dermal irritation --Toxicity Category IV. 
Cypermethrin is considered to be a dermal sensitizer.
    2. Mutagenicity. The Agency has reviewed several mutagenicity 
studies. Types include an Ames mutagenicity assay; a dominant lethal 
study, a mouse lymphoma mutagenicity assay, a Chinese hamster ovary/
hypoxanthine quanine phosphoribose transferase (CHO/HGPRT) assay, and a 
bone marrow cytogenic study. The data base for mutagenicity is 
considered to be adequate. Based on the available mutagenicity studies, 
there are no concerns for mutagenicity at this time.
    3. Reproductive and developmental toxicity--i. Developmental 
toxicity study in the rat. Cypermethrin was administered by gavage to 
rats at dose levels of 0, 17.5, 35, or 70 mg/kg/day on days 6-15 of 
gestation. The maternal lowest-observed effect level (LOEL) is 35 mg/
kg/day, based on bodyweight. The maternal NOEL is 17.5 mg/kg/day. The 
developmental LOEL was > 70 mg/kg/day. The developmental NOEL is > 70 
mg/kg/day. The developmental toxicity study in the rat was classified 
acceptable.
    ii. Developmental toxicity study in the rabbit. Cypermethrin was 
administered to rabbits by gelatin capsule at dose levels of 0, 3, 10, 
or 30 mg/kg/day on days 6 to 18 inclusive of gestation. There were no 
effects on the does of any kind reported. The maternal LOEL was > 30 
mg/kg/day. The maternal NOEL is > 30 mg/kg/day. There were no treatment 
related effects on either the skeletal or visceral structures reported. 
The developmental LOEL is > 30 mg/kg/day. The developmental NOEL was > 
30 mg/kg/day. The developmental toxicity study in the rabbit is 
classified supplementary and does not satisfy the guideline requirement 
for a developmental toxicity study in the rabbit. The study was not 
considered upgradeable because the dose levels selected are too low.
    iii. Developmental toxicity study in the rabbit. Cypermethrin was 
administered to 20 New Zealand White rabbits per dose group by gavage 
at dose levels of 0, 100, 450, or 700 mg/kg/day from days 7 through 19 
of gestation. The does were sacrificed on day 29 of gestation. The 
maternal LOEL was 450 mg/kg/day, based on bodyweight gain. The maternal 
NOEL was 100 mg/kg/day. There were no indications of developmental 
toxicity. The NOEL and LOEL for developmental toxicity was > 700 mg/kg/
day. This study in the rabbit was classified acceptable.
    iv. Three-generation reproduction study in rats. Cypermethrin was 
administered to rats at dose levels of 0, 50, 150, or 1,000/750 ppm 
(reduced to 750 ppm after 12 weeks because of severe neurological 
symptoms). These dose levels correspond to 2.5, 7.5, or 50/37.5 mg/kg/
day. Three successive generations were produced, each consisting of two 
separate breedings to produce six sets of litters. The LOEL is 150 ppm 
(7.5 mg/kg/day) based on consistent decreased bodyweight gain in both 
sexes. The NOEL was 50 ppm (2.5 mg/kg/day). The study was classified 
acceptable.
    4. Subchronic toxicity. The data base for subchronic toxicity is 
considered to be complete except for a series 82-4 subchronic 
inhalation toxicity study of 90-days duration. This study is required 
if inhalation exposure is for periods greater than 21-days.
    i. Subchronic oral study in the rat. Cypermethrin was administered 
to rats at dose levels of 0, 75, 150, or 1,500 ppm (corresponding to 0, 
3.75, 7.5, or 75 mg/kg/day) for 90 days. The LOEL is 1,500 ppm (75 mg/
kg/day) based on bodyweight. The NOEL was 150 ppm (7.5 mg/kg/day). This 
study did not satisfy the guideline requirement for a subchronic oral 
study (82-1) in rats, but did not require upgrading because an 
acceptable chronic feeding study with rats was available.
    ii. Subchronic oral study in the dog. Cypermethrin was administered 
to beagle dogs at dose levels of 0, 5, 50, 500, or 1,500 ppm 
(corresponding to 0.125, 1.25, 12.5, and 37.5 mg/kg/day) for 13 weeks. 
The NOEL is 500 ppm (12.5 mg/kg/day). This subchronic toxicity study 
was classified supplementary.
    iii. 21-Day dermal study in the rabbit. Cypermethrin was applied at 
dose levels of control, 2, 20, or 200 mg/kg/day applied in 20% weight/
weight (w/w) basis PEG 300 with daily applications for 3 weeks for a 
total of 15 applications. The LOEL is 200 mg/kg/day based on liver 
effects. The NOEL is 20 mg/kg/day. This subchronic dermal toxicity 
study was classified acceptable and satisfies the guideline requirement 
for a subchronic dermal study (82-2) in rabbit.
    iv. 21-Day inhalation study in the rat. Cypermethrin was 
administered to rats by nose only exposure at concentrations of 0, 
0.01, 0.05, or 0.25 mg/L for 6 hours per day, 5 days per week for a 
total of 15 exposures. The LOEL was 0.05 mg/L based mainly on 
bodyweight decrease. The NOEL was 0.01 mg/L. This study was classified 
acceptable.
    5. Chronic toxicity/carcinogenicity--i. Chronic oral study in the 
dog. Cypermethrin was administered to beagle dogs at dose levels of 0, 
1, 5, or 15 mg/kg/day for 52 weeks. The LOEL

[[Page 63231]]

was 5 mg/kg/day based on gastrointestinal effects. The NOEL is 1 mg/kg/
day. This chronic toxicity study was classified acceptable.
    ii. Carcinogenicity study in the mouse. Cypermethrin was 
administered to mice at dose levels of control-1, control-2, 100, 400, 
and 1,600 ppm (corresponding to 0, 0, 14, 57, or 229 mg/kg/day) for 97 
weeks for males and 101 weeks for females. The LOEL was 400 ppm (57 mg/
kg/day) based on liver weight. The NOEL was 100 ppm (14 mg/kg/day). 
This study was determined to be positive for induction of benign 
alveologenic neoplasms. This carcinogenicity study was classified 
acceptable and satisfies the guideline requirement for a 
carcinogenicity study (83-2) in mice.
    iii. Chronic feeding/oncogenicity study in the rat. Cypermethrin 
was administered to rats at dose levels of control-1, control-2, 20, 
150, or 1500 ppm (corresponding to 0, 0, 1, 7.5, or 75 mg/kg/day) for 2 
years. The LOEL is 1,500 ppm (75 mg/kg/day) based on bodyweight. The 
NOEL was 150 ppm (7.5 mg/kg/day). Cypermethrin was not considered to be 
oncogenic in this study. A possible association with increased 
testicular interstitial tumors was not considered definite. This 
chronic toxicity/carcinogenicity study was classified as acceptable and 
satisfies the guideline requirement for a chronic oral feeding/
carcinogenicity study (83-5) in rats.
    6. Metabolism. Studies in rats, dogs, and mice are available to 
support the requirement of metabolism in mammals. Studies show that 
cypermethrin is readily absorbed from the gastrointestinal tract and 
extensively metabolized. It is mostly excreted in the urine. Studies 
submitted to the Agency were acceptable. No additional data are 
required.
    7. Neurotoxicity. Additional data considered by the Agency included 
an acute delayed type neurotoxicity in hens, an acute neurotoxicity 
screening study in rats with a NOEL of 30 mg/kg and a LOEL of 100 mg/
kg, and a subchronic neurotoxicity screening study in rats with a NOEL 
of 31 mg/kg/day and a LOEL of 77 mg/kg/day. Additional data will be 
required under a special Data Call-In (DCI) letter pursuant to section 
3(c)(2)(B) of FIFRA. Although these data are lacking EPA has a 
sufficient toxicity data base to support these tolerances and these 
additional studies are not expected to significantly change its risk 
assessment.

B. Toxicological Endpoints

    1. Acute toxicity. To assess risk from acute dietary exposure, the 
Agency used a NOEL of 1.0 mg/kg/day based on increased incidence of 
passage of liquid stools at 5 mg/kg/day and above starting the first 
weeks of dosing in a the chronic-dog study.
    2. Short- and intermediate-term toxicity.To assess risk from (non-
food) short- and intermediate-term dermal exposure, the Agency used a 
NOEL of 5 mg/kg/day from the chronic-dog study, incorporating 25% 
dermal absorption. A dermal absorption rate of 25% was derived based on 
the weight-of-evidence available for structurally related pyrethroids. 
For exposure via inhalation, the Agency used a NOEL of 0.01 mg/L from 
the 21-day inhalation study in rats.
    3. Chronic toxicity. EPA has established the RfD for cypermethrin 
at 0.01 mg/kg/day. This RfD is based on a NOEL of 1.0 mg/kg/day from 
the chronic-dog study with an uncertainty factor of 100.
    4. Carcinogenicity. Using its Guidelines for Carcinogen Risk 
Assessment published September 24, 1986 (51 FR 33992) the 
Carcinogenicity Peer Review Committee (CPRC) has classified 
cypermethrin as a Group C chemical, possible human carcinogen, based on 
increased incidence of lung adenomas in female mice, but did not 
recommend assignment of a cancer potency factor (Q*1) for a linear 
quantitative cancer risk assessment. Instead, the CPRC recommended the 
RfD approach. Based on the CPRC's recommendation that the RfD approach 
be used to assess dietary cancer risk, a quantitative linear dietary 
cancer risk assessment was not performed. Human health risk concerns 
due to long-term consumption of cypermethrin residues are adequately 
addressed by the dietary risk evaluation chronic exposure analysis 
using the RfD.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.418) for the residues of cypermethrin. For the purposes of 
dietary risk assessment, residue data generated from residue field 
trials conducted at maximum application rates and minimum preharvest 
intervals were used. To assess secondary exposure from edible animal 
commodities, animal dietary burdens were calculated using mean field 
trial residue, adjusted for percent crop treated and applying 
appropriate processing factors for all feed items. Risk assessments 
were conducted by EPA to assess dietary exposures and risks from 
cypermethrin 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 (in accordance with Tier 3 of EPA June 1996 
``Acute Dietary Exposure Assessment'' guidance document) incorporating 
anticipated residues and percent crop treated refinement. The acute 
exposure via dietary intake for the U.S. Population is estimated at 
0.004438 mg/kg/day. The acute dietary risk estimated by as MOE at the 
99.9th percentile for the U.S. population is 225. The acute dietary 
exposure for children is 0.005465 mg/kg/day with a resulting MOE of 
183. EPA concludes that there is a reasonable certainty of no harm for 
MOEs of 100 or greater.
    ii. Chronic exposure and risk. The chronic dietary exposure 
assessment incorporated anticipated residues, tolerance values, FDA and 
PDP monitoring data, and percent crop treated information. The RfD used 
was 0.01 mg/kg/day. For the U.S. population, the exposure was estimated 
at 0.000025 mg/kg/day. The risk assessment resulted in use of 0.3% of 
the RfD. For children 0.000042 mg/kg/day, which uses 0.4% of the RfD.
    Section 408(b)(2)(E) of the FFDCA authorizes EPA to consider 
available data and information on the anticipated residue levels of 
pesticides 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 use 
data on the actual percent of crop treated when establishing a 
tolerance only where the Agency can make the following findings:
    a. 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.
    b. That the exposure estimate does not underestimate the exposure 
for any significant subpopulation.
    c. 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 cypermethrin were derived 
from Federal and market basket survey data.

[[Page 63232]]

EPA considers these data reliable. A range of estimates supplied by 
this data and 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 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 section 408(f) of the FFDCA requiring 
submission of data on anticipated residues in conjunction with approval 
of the registration under FIFRA.
    2. From drinking water. Studies show that cypermethrin is immobile 
in soil and does not leach into ground water. Drinking water residue 
levels were estimated using the PRZM1/EXAMS computer models in 1993 for 
comparative ecological risk assessment.
    i. Acute exposure and risk. For the U.S. population, acute exposure 
is estimated at 0.000126 mg/kg/day (MOE = 7,965). For non-nursing 
infants < 1 year old, exposure is estimated at 0.000242 mg/kg/day (MOE 
= 4,138).
    ii. Chronic exposure and risk. For the U.S. population, chronic 
exposure is estimated at 0.000005 mg/kg/day, or essentially 0% of the 
RfD. For non-nursing infants < 1 year old, exposure is estimated at 
0.000021 mg/kg/day, or 0.2% of the RfD.
    3. From non-dietary exposure. i. Cypermethrin is currently 
registered for use on lawns and carpets. Non-occupational exposure to 
cypermethrin may occur as a result of inhalation or contact from indoor 
residential, indoor commercial, and outdoor residential uses. Using 
surrogate data and conservative exposure scenarios, the Agency has 
estimated combined inhalation, dermal, and oral non-dietary exposure.
    ii. Short- and intermediate-term exposure and risk. For the U.S. 
population, exposure is estimated at 0.0000515 mg/kg/day. For infants 
less than 1 year old, the exposure is estimated at 0.00259 mg/kg/day.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' 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.
    Four members of the insecticide class pyrethroids produce a common 
metabolite known as DCVA (3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropane carboxylic acid). These insecticides are 
cyfluthrin, cypermethrin, zeta-cypermethrin and permethrin. Although 
the residues of DCVA can be estimated, no toxicology data on the 
compound per se are available to directly conduct a hazard evaluation 
and thereby establish an appropriate endpoint for use in a joint risk 
assessment. To date, for the purpose of assessing the risk of the 
parent compound the toxicity of DCVA has been assumed to be equivalent 
to the parent compound. However, due to the different toxicological 
profiles of cyfluthrin, cypermethrin, permethrin, and zeta-
cypermethrin, EPA does not believe that it would be appropriate to 
cumulate DCVA for these pesticides, or DCVA residues from one of these 
pesticides with the parent of another of these pesticides, in 
conducting the risk assessment for these pesticides.
    Accordingly, EPA does not have, at this time, available data to 
determine whether cypermethrin has a common mechanism of toxicity with 
other substances or how to include this pesticide in a cumulative risk 
assessment. For the purposes of this tolerance action, therefore, EPA 
has not assumed that cypermethrin has a common mechanism of toxicity 
with other substances.

D. Aggregate Risks and Determination of Safety for U.S. Population

    The Agency has determined that an aggregate systemic oral and 
dermal exposure risk assessment is not appropriate due to difference in 
the toxicity endpoints observed between the oral (neurotoxicity) and 
dermal (hepatotoxicity) routes. An aggregate oral and inhalation risk 
assessment is appropriate due to the similarity of toxicity 
(neurotoxicity) observed in rats via these routes.
    1. Acute risk. Aggregate acute risk represents the sum of acute 
food and acute drinking water exposure. For cypermethrin, the aggregate 
acute exposure is estimated at 0.004564 mg/kg/day, with a resulting MOE 
of 219 for the adult U.S. population.
    2. Chronic risk. Aggregate chronic exposure is the sum of chronic 
exposure from food and chronic water. Using the exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
cypermethrin from food and water will utilize 0.3% of the RfD for the 
U.S. population. 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 from aggregate exposure to 
cypermethrin 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 short-term and 
intermediate-term residential exposure. For cypermethrin, exposure is 
estimated at 0.000082 mg/kg/day, with a resulting MOE of 61,000 for the 
U.S. population.

E. Aggregate Cancer Risk for U.S. Population

    Cypermethrin is classified as a weak Group C carcinogen based on 
the increased incidence of lung adenomas in female mice. An RfD 
approach was recommended for human risk assessment purposes. Therefore, 
a quantitative dietary cancer risk

[[Page 63233]]

assessment was not performed. Dietary risk concerns due to long-term 
consumption of cypermethrin are adequately addressed in the chronic 
exposure analysis. For the U.S. population, less than 1% of the RfD is 
occupied by aggregate chronic food and water exposure.

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 cypermethrin, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a three-
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.
    Section 408 of the FFDCA provides that EPA shall apply an 
additional 10-fold 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 data base 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 10-fold 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. In the prenatal developmental 
toxicity studies in rats and rabbits, there was no evidence of 
developmental toxicity at the highest dose tested (70 mg/kg/day in rats 
and 700 mg/kg/day in rabbits).
    iii. Reproductive toxicity study. An acceptable three-generation 
reproduction study in rats has been submitted. Offspring toxicity was 
observed only at the highest dietary level tested, (700/1,000 ppm; 50/
37.5 mg/kg/day), while toxicity in parental animals was observed at the 
lower treatment levels. The parental systemic NOEL was 50 ppm (2.5 mg/
kg/day) and the parental systemic LOEL was 150 ppm (7.5 mg/kg/day).
    iv. Pre- and post-natal sensitivity. The developmental and 
reproductive toxicity data demonstrated no indications of increased 
pre- and post-natal sensitivity.
    v. Based on the above, EPA concludes that reliable data support the 
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. For children 1 to 6 years old, (most highly exposed 
subgroup), the aggregate acute exposure is estimated at 0.005572 mg/kg/
day, with a resulting MOE of 179. EPA generally has no concern for MOEs 
over 100.
    3. Chronic risk. Using conservative exposure assumptions, EPA has 
concluded that aggregate chronic exposure to cypermethrin from food and 
water is estimated at 0.000044 mg/kg/day for children 1 to 6 years old 
(most highly exposed subgroup) will utilize 0.4% of the RfD.
    4. Short- or 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 short-term and 
intermediate-term residential exposure. The MOE for non-nursing infants 
< 1 year old (most highly exposed subgroup) is estimated at 1,900.
    Therefore, it may be concluded that there is reasonable certainty 
that no harm will result to infants and children from aggregate 
exposure to cypermethrin residues.
    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 the program. Congress has allowed 3 years 
from 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 disruption effects.

III. Other Considerations

A. Metabolism in Plants and Animals

    The metabolism of cypermethrin in plants and animals is adequately 
understood. Studies have been conducted to delineate the metabolism of 
radiolabelled cypermethrin in various crops all showing similar 
results. The residue of concern is cypermethrin parent.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology Gas Chromatography with Electron 
Capture Detection (GC/ECD) is available in PAM II for enforcement of 
the tolerances.

C. Magnitude of Residues

    Crop field trial residue data and animal feeding data from studies 
conducted at the maximum label rates for brassica, head and stem; 
brassica, leafy; cotton; lettuce, head; onions, bulb; and pecans show 
that the established cypermethrin tolerances on brassica, head and stem 
at 2.0 ppm; brassica, leafy at 14.0 ppm; cattle, fat at 0.05 ppm, 
cattle, meat at 0.05 ppm, cattle, mbyp at 0.05 ppm; cottonseed of 0.5 
ppm; hogs, fat at 0.05 ppm, hogs, meat at 0.05 ppm, hogs, mbyp at 0.05 
ppm; horses, fat at 0.05 ppm, horses, meat at 0.05 ppm, horses, mbyp at 
0.05 ppm; lettuce, head at 10.0 ppm; milk at 0.05 ppm; onions, bulb at 
0.10 ppm; pecans 0.05 ppm; sheep, fat at 0.05 ppm, sheep, meat at 0.05 
ppm; and sheep, mbyp at 0.05 ppm will not be exceeded when the 
cypermethrin products labeled for these uses are used as directed.

D. International Residue Limits

    The Codex tolerances for cypermethrin are: Brassica vegetables, 1 
ppm; lettuce, 2 ppm; milk, 0.05 ppm; onions, bulb, 0.1 ppm; meat, fat 
basis, 0.2 ppm; mammalian edible mby, 0.05 ppm. Mexico has established 
a tolerance for cottonseed at 0.5 ppm. There are no Canadian tolerances 
established for cypermethrin. As indicated in Unit II. of this 
preamble, there are differences between the FFDCA section 408 
tolerances and the Codex Maximum Residue Limits (MRLs) value for 
specific

[[Page 63234]]

commdities. These differences could be caused by differences in methods 
to establish tolerances, calculation of animal feed dietary exposure, 
and as a result of different agricultural practices. EPA will 
specifically address these differences when the pesticides are 
reregistered and the tolerances made permanent.

IV. Conclusion

    Therefore, permanent tolerances are established for residues of 
cypermethrin in or on the commodities brassica, head and stem at 2.0 
ppm; brassica, leafy at 14.0 ppm; cattle, fat at 0.05 ppm; cattle, meat 
at 0.05 ppm; cattle, mbyp at 0.05 ppm; cottonseed at 0.5 ppm; goats, 
fat at 0.05 ppm; goats, meat at 0.05 ppm; goats, mbyp at 0.05 ppm; 
hogs, fat at 0.05 ppm; hogs, meat at 0.05 ppm; hogs, mbyp at 0.05 ppm; 
horses, fat at 0.05 ppm; horses, meat at 0.05 ppm; horses, mbyp at 0.05 
ppm; lettuce, head at 10.0 ppm; milk at 0.05 ppm; onions, bulb at 0.10 
ppm; pecans 0.05 ppm; sheep, fat at 0.05; sheep, meat at 0.05 ppm; and 
sheep, mbyp at 0.05 ppm.

V. Objections and Hearing Requests

    New section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a tolerance regulation issued by 
EPA under new section 408(e) and (l)(6) of the FFDCA as was provided in 
the old section 408 and in section 409 of FFDCA. 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 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 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 Record and Electronic Submissions

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number OPP-300583 (including comments and data submitted electronically 
as described below). 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 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Objections and hearing requests will also be accepted on 
disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of 
objections and hearing requests in electronic form must be identified 
by the docket control number, OPP-300583. No 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.

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.

[[Page 63235]]

 This is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: 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 180.418 is revised to read as follows:


Sec. 180.418  Cypermethrin and an isomer zeta-cypermethrin; tolerances 
for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide cypermethrin ()alpha cyano-(3-
phenoxyphenyl)methyl()cis,trans-3(2,2-dichloroethenyl-2,2-
dimethylcyclopropanecarboxylate in or on the following commodities:

                                                                        
------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Brassica, head and stem....................................          2.0
Brassica, leafy............................................         14.0
Cattle, fat................................................         0.05
Cattle, mbyp...............................................         0.05
Cattle, meat...............................................         0.05
Cottonseed.................................................          0.5
Goats, fat.................................................         0.05
Goats, mbyp................................................         0.05
Goats, meat................................................         0.05
Hogs, fat..................................................         0.05
Hogs, mbyp.................................................         0.05
Hogs, meat.................................................         0.05
Horses, fat................................................         0.05
Horses, mbyp...............................................         0.05
Horses, meat...............................................         0.05
Lettuce, head..............................................         10.0
Milk.......................................................         0.05
Onions, bulb...............................................         0.10
Pecans.....................................................         0.05
Sheep, fat.................................................         0.05
Sheep, mbyp................................................         0.05
Sheep, meat................................................         0.05
------------------------------------------------------------------------

    (2) [Reserved]
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 97-30947 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F`