[Federal Register Volume 66, Number 180 (Monday, September 17, 2001)]
[Rules and Regulations]
[Pages 47979-47994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23087]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301171; FRL-6801-1]
RIN 2070-AB78


Zeta-cypermethrin and its Inactive R-isomers; Pesticide 
Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of zeta-
cypermethrin and its inactive R-isomers in or on alfalfa, hay at 15 
parts per million (ppm), alfalfa, forage at 5.0 ppm, alfalfa, seed at 
0.5 ppm; beets, sugar, roots at 0.05 ppm, beets, sugar, tops at 0.20 
ppm; corn, field, grain at 0.05 ppm, corn, pop, grain at 0.05 ppm, 
corn, field, forage at 0.20 ppm, corn, field, stover at 3.0 ppm, corn, 
pop, stover at 3.0 ppm, corn, sweet, (K + CWHR) at 0.05 ppm, corn, 
sweet, forage at 15 ppm, corn, sweet, stover at 15 ppm; onions, green 
at 3.0 ppm; leafy vegetables except Brassica at 10 ppm, head and stem 
Brassica at 2.0 ppm, leafy Brassica at 14 ppm; sugarcane at 0.6 ppm; 
rice, grain at 1.5 ppm, rice, straw at 2.0 ppm, rice, hulls at 6.0 ppm; 
fat of cattle, goat, horse, sheep, hogs at 1.0 ppm, meat of cattle, 
goat, horse, sheep, hogs at 0.1 ppm, milk, fat at 2.50 ppm (reflecting 
0.10 ppm in whole milk), poultry, fat at 0.05 ppm, poultry, meat at 
0.05 ppm, poultry, meat by-products at 0.05 ppm, and eggs at 0.05 ppm. 
FMC Corporation, 1735 Market Street, Philadelphia, PA 19103 requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective September 17, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301171, 
must be received by EPA on or before November 16, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301171 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Linda A. DeLuise, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave, NW., 
Washington, DC 20460; telephone number: (703) 305-5428; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

[[Page 47980]]



------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated 
electronic version of 40 CFR part 180 is available at http://
www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301171. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 23, 1998 (63 FR 34176) (FRL-5795-
1), and September 8, 1999 (64 FR 48829) FRL-6097-6), EPA issued notices 
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a announcing the filing of pesticide petitions (PP) (PF 
813 and PF 888) for tolerances by FMC Corporation, 1735 Market Street, 
Philadelphia, PA 19103.
    These notices included a summary of the petition prepared by FMC 
Corporation, the registrant. There were no comments received in 
response to these notices of filing.
    The petitions requested that 40 CFR 180.418 be amended by 
establishing a tolerance for residues of the insecticide zeta-
cypermethrin, in or on the following raw agricultural commodities:
    1. PP 9F6040 proposed a tolerance for rice, grain at 1.2 parts per 
million (ppm), rice, straw at 2.0 ppm and rice, hulls at 16.0 ppm. 
Based on EPA's review of processing studies, the petition was revised 
by the petitioner to propose a tolerance of 1.5 ppm on rice grain and 
6.0 ppm on rice hulls.
    2. PP 8F4970 proposed a tolerance for leafy vegetables (except 
Brassica vegetables) group (Crop Group 4) at 10.0 ppm, Brassica, head 
and stem (Crop Group 5A) at 2.0 ppm and Brassica, leafy (Crop Group 5B) 
at 14.0 ppm. These tolerances as proposed are adequate.
    3. PP 9F3067 proposed a tolerance for sugar beets, roots at 0.05 
ppm, and sugar beets, tops at 0.20 ppm; sugarcane at 0.60 ppm; corn, 
grain (field, seed and pop) at 0.05 ppm; green onions at 6.0 ppm; 
alfalfa seed at 0.5 ppm, alfalfa forage at 10.0 ppm, and alfalfa hay at 
30.0 ppm; and corn, sweet (K + CWHR) at 0.1 ppm, corn, forage and corn, 
fodder at 30.0 ppm; poultry, meat at 0.05 ppm, poultry, meat by-
products at 0.05 ppm, poultry, fat at 0.05 ppm and eggs at 0.05 ppm; 
meat of cattle, goats, hogs, horses, and sheep at 0.3 ppm; fat of 
cattle, goats, hogs, horses, and sheep at 2.0 ppm; and milk, fat at 1.0 
ppm (reflecting 0.2 ppm in whole milk). Based on EPA's review of the 
field residue and animal feeding data the petition was revised by the 
petitioner to:
    a. Propose tolerances of 0.05 ppm for sweet corn (K + CWHR) and 15 
ppm for sweet corn forage and stover. (Note that stover is the correct 
term instead of fodder).
    b. Propose separate tolerance for field corn grain and pop corn 
grain at 0.05 ppm.
    c. Delete the proposed seed corn tolerance since it is covered by 
field corn.
    d. Propose separate tolerances for field corn stover and pop corn 
stover at 3.0 ppm and field corn forage at 0.20 ppm.
    e. Reduce the proposed 6.0 ppm tolerance on green onion to 3.0 ppm.
    f. Propose the following livestock commodity tolerances as a result 
of the increased dietary burden: animal (cattle, goat, hog, horse, 
sheep) meat at 0.1 ppm; fat at 1.0 ppm; and milk fat at 2.5 ppm 
(reflecting 0.10 ppm in whole milk).
    g. Propose tolerances for alfalfa seed, forage and hay, 
respectively at 0.5 ppm, 5 ppm, and 15 ppm.
    Based upon the isomer composition of zeta-cypermethrin with four 
insecticidally less active ones at a concentration of 1% each, EPA is 
proposing the current tolerance expression be revised by adding the 
phrase and its inactive R-isomers after the chemical name.
    Although EPA had requested a number of changes to the initial 
petitions and Notice of Filings, the nature of the changes, i.e. 
reduction in tolerance levels, clarification and correction of 
commodity terms are not considered significant nor do they alter the 
risk assessment. Therefore EPA is issuing this as a final action.
    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

[[Page 47981]]

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. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. 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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of zeta-cypermethrin and its 
inactive R-isomers in or on alfalfa, hay at 15 parts per million (ppm), 
alfalfa, forage at 5.0 ppm, alfalfa, seed at 0.5 ppm; beets, sugar, 
roots at 0.05 ppm, beets, sugar, tops at 0.20 ppm; corn, field, grain 
at 0.05 ppm, corn, pop, grain at 0.05 ppm, corn, field, forage at 0.20 
ppm, corn, field, stover at 3.0 ppm, corn, pop, stover at 3.0 ppm, 
corn, sweet, (K + CWHR) at 0.05 ppm, corn, sweet, forage at 15 ppm, 
corn, sweet, stover at 15 ppm; onions, green at 3.0 ppm; leafy 
vegetables except Brassica at 10 ppm, head and stem Brassica at 2.0 
ppm, leafy Brassica at 14 ppm; sugarcane at 0.6 ppm; rice, grain at 1.5 
ppm, rice, hulls at 6.0 ppm; rice, straw at 2.0 ppp; fat of cattle, 
goat, horse, sheep, hogs at 1.0 ppm, meat of cattle, goat, horse, 
sheep, hogs 0.1 ppm, milk, fat at 2.5 ppm (reflecting 0.10 ppm in whole 
milk), poultry, fat at 0.05 ppm, poultry, meat at 0.05 ppm, poultry, 
meat by-products at 0.05 ppm; and eggs at 0.05 ppm. EPA's assessment of 
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 zeta-cypermethrin 
and its inactive R-isomers are discussed in the following Table 1 as 
well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed. Zeta-cypermethrin is an enriched isomer of cypermethrin. In 
order to select toxicity endpoints for the purposes of risk assessment, 
bridging data on zeta-cypermethrin were submitted so that the toxicity 
of zeta-cypermethrin could be compared with that of cypermethrin and 
the data bases could be combined to form one complete data base for 
both chemicals. In the selection of toxicity endpoints, studies 
conducted with zeta-cypermethrin were used wherever possible. When an 
endpoint was selected using a study conducted with cypermethrin, a 
rationale was provided on why this particular endpoint was protective 
for exposure to zeta-cypermethrin.

         Table 1.--Subchronic, Chronic, and Other Toxicity Zeta-Cypermethrin and Cypermethrin Technical*
----------------------------------------------------------------------------------------------------------------
            Guideline No.                     Study Type                Results             Toxicity Category
----------------------------------------------------------------------------------------------------------------
870.1000                               Acute oral - rat - zeta- LD50                     II
                                        cypermethrin            (M): 134.4 mg/kg.......
                                                                (F): 86.0 mg/kg........
                                                                Clinical signs of
                                                                 neurotoxicity
                                                                 observed..
----------------------------------------------------------------------------------------------------------------
870.1000                               Acute oral -             LD50                     II
                                        cypermethrin            (M): 247 mg/kg.........
                                                                (F): 309 mg/kg females.
                                                                Deaths: 150 mg/kg,
                                                                 usually in first day.
                                                                 Clinical signs of
                                                                 neurotoxicity, gait
                                                                 abnormalities; some
                                                                 persisting to 14 days..
----------------------------------------------------------------------------------------------------------------
870.1100                               Acute Dermal             LD50 >4,920 mg/kg/day.   III
                                       Rats - cypermethrin....   Clinical signs of       III
                                       Rabbits - cypermethrin.   neurotoxicity.
                                                                Abraded skin: LD50
                                                                 >2,460 mg/kg.
                                                                 Lacrimation, discharge
                                                                 from the eye and
                                                                 nervous and shaking.
----------------------------------------------------------------------------------------------------------------
870.1200                               Acute inhalation - rat - LC50: male (not          IV
                                         cypermethrin            calculated but higher
                                                                 than female)
                                                                LC50: female 2.5 (1.6-
                                                                 3.4) mg/L..
                                                                Clinical signs of
                                                                 neurotoxicity. MMAD
                                                                 ranged from 2.22 to
                                                                 2.62 m.
----------------------------------------------------------------------------------------------------------------
870.2400                               Primary eye irritation - Slight redness of        III
                                         rabbit cypermethrin     conjunctivae, chemosis
                                                                 and discharge.
                                                                 Persisted to day 7.
----------------------------------------------------------------------------------------------------------------

[[Page 47982]]

 
870.2500                               Primary skin irritation  Slight to mild erythema  IV
                                        rabbit - cypermethrin    on intact and abraded
                                                                 skin. Reversed by 48
                                                                 hours. Primary
                                                                 Irritation Index: 0.71
----------------------------------------------------------------------------------------------------------------
870.2600                               Dermal sensitization -   Not a sensitizer in      N/A
                                        cypermethrin             Buehler assay.
                                                                 Moderate sensitizer in
                                                                 Magnusson Kligman
                                                                 Maximization method.
----------------------------------------------------------------------------------------------------------------


     Table 2.--Toxicity Profiles of Zeta-Cypermethrin Technical and
                         Cypermethrin Technical*
------------------------------------------------------------------------
         Guideline No.                Study Type           Results
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = M = 13.8
                                  toxicity - rat:     (M), 16.3 (F) mg/
                                  zeta-cypermethrin   kg/day
                                                     LOAEL = 28.2 mg/kg/
                                                      day (M) based on
                                                      decreased body
                                                      weight, body
                                                      weight gain and
                                                      food consumption;
                                                      at 55.7 mg/kg/day,
                                                      mortality as well
                                                      as decreased RBC,
                                                      WBC, HGB and HCT
                                                      plus increase in
                                                      BUN.
                                                     32.2 mg/kg/day (F)
                                                      based on decreased
                                                      body weight, body
                                                      weight gain and
                                                      food consumption
                                                      as well as
                                                      interference with
                                                      estrous cycle and
                                                      decreased glucose;
                                                      mortality at 65.2
                                                      mg/kg/day.
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = 7.5 mg/kg/
                                  toxicity - rat:     day
                                  cypermethrin       LOAEL = 75 mg/kg/
                                                      day based on
                                                      decreased body
                                                      weight in both
                                                      sexes.
------------------------------------------------------------------------
870.3150                         90-Day oral         NOAEL = 24.6 (M),
                                  toxicity in dogs    34.3 (F) mg/kg/day
                                  (feeding):         LOAEL = 37.0 (M),
                                  cypermethrin        45.2 (F) mg/kg/day
                                                      based on tremors
                                                      as well as
                                                      decreased body
                                                      weight and body
                                                      weight gains in
                                                      both sexes.
------------------------------------------------------------------------
870.3150                         90-Day oral         NOAEL = 12.5 mg/kg/
                                  toxicity in dogs    day
                                  (feeding):         LOAEL = 37.5 mg/kg/
                                  cypermethrin        day based on
                                                      clinical signs
                                                      (whole body
                                                      tremors,
                                                      exaggerated gait,
                                                      ataxia,
                                                      incoordination,
                                                      hyperaesthesia,
                                                      licking and
                                                      chewing of paws;
                                                      diarrhea,
                                                      anorexia) and
                                                      decreased body
                                                      weight
------------------------------------------------------------------------
870.3200                         21-Day dermal       NOAEL =
                                  toxicity - rat:    Systemic: 1,000 mg/
                                  zeta-cypermethrin   kg/day.
                                                     Dermal: <100 mg/kg/
                                                      day
                                                     LOAEL =
                                                     Systemic: >1,000 mg/
                                                      kg/day (Limit
                                                      Dose)
                                                     Dermal: 100 mg/kg/
                                                      day, based on
                                                      erythema and/or
                                                      eschar 1/10 M and
                                                      6/10 F;
                                                      desquamation 0/10
                                                      M and 2/10 F (no
                                                      effects in any M
                                                      or F controls).
------------------------------------------------------------------------
870.3200                         21-Day dermal       NOAEL =
                                  toxicity -         Systemic nonabraded
                                  rabbit:             animals: 200 mg/kg/
                                  cypermethrin        day (HDT)
                                                     Dermal: 20 mg/kg/
                                                      day
                                                     LOAEL = Systemic
                                                      nonabraded
                                                      animals: >200 mg/
                                                      kg/day (HDT)
                                                     Dermal: 200 mg/kg/
                                                      day based on signs
                                                      of dermal
                                                      irritation
------------------------------------------------------------------------
870.3465                         21-Day inhalation   NOAEL = 0.01 mg/L
                                  toxicity -          (2.7 mg/kg/day)
                                  cypermethrin       LOAEL = 0.05 mg/L
                                                      based on decreases
                                                      in body weight
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal
                                  developmental in   NOAEL = 12.5 mg/kg/
                                  rats - zeta-        day
                                  cypermethrin       LOAEL = 25 mg/kg/
                                                      day, based on
                                                      ataxia, urine-
                                                      stained abdominal
                                                      fur, fecal-stained
                                                      perineal fur,
                                                      decreased food
                                                      consumption and
                                                      decreased body
                                                      weight gain.
                                                     Developmental
                                                     NOAEL  35 mg/kg/day
                                                     LOAEL = > 35 mg/kg/
                                                      day
------------------------------------------------------------------------

[[Page 47983]]

 
870.3700                         Prenatal            Maternal
                                  developmental in   NOAEL = 17.5 mg/kg/
                                  rats -              day
                                  cypermethrin       LOAEL = 35 mg/kg/
                                                      day based on
                                                      decreased body
                                                      weight gain; at 70
                                                      mg/kg/day, splayed
                                                      limbs, spasms and
                                                      hypersensitivity
                                                      to noise and
                                                      convulsions.
                                                     Developmental
                                                     NOAEL = 70 mg/kg/
                                                      day (HDT)
                                                     LOAEL = >70 mg/kg/
                                                      day
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal
                                  developmental in   NOAEL = 100 mg/kg/
                                  rabbits -           day
                                  cypermethrin       LOAEL = 450 mg/kg/
                                                      day based on
                                                      decreased body
                                                      weight gain;
                                                      anorexia, abdomino-
                                                      genital staining,
                                                      decreased feces
                                                      and red or pink
                                                      material in the
                                                      pan (few does). At
                                                      700, anorexia,
                                                      abdomino-genital
                                                      staining,
                                                      decreased feces
                                                      and red or pink
                                                      material in the
                                                      pan were observed.
                                                     Developmental
                                                     NOAEL = 700 mg/kg/
                                                      day
                                                     LOAEL = >700 mg/kg/
                                                      day (highest dose
                                                      tested)
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal
                                  developmental in   NOAEL = 30 mg/kg/
                                  rabbits -           day
                                  cypermethrin       LOAEL > 30 mg/kg/
                                                      day (HDT)
                                                     Developmental
                                                     NOAEL = 30 mg/kg/
                                                      day
                                                     LOAEL = > 30 mg/kg/
                                                      day (highest dose
                                                      tested)
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/Systemic
                                  fertility effects  NOAEL = 7 mg/kg/day
                                  - zeta-            LOAEL = 27 mg/kg/
                                  cypermethrin        day based on
                                                      decreased body
                                                      weight gain (most
                                                      noticeable during
                                                      lactation) and
                                                      increased relative
                                                      brain weights M
                                                      and F; at 45 mg/kg/
                                                      day, some
                                                      neurotoxic
                                                      clinical signs in
                                                      a few animals
                                                      (some mortality) .
                                                     Reproductive
                                                     NOAEL = 45 mg/kg/
                                                      day
                                                     LOAEL >45 mg/kg/day
                                                      (highest dose
                                                      tested).
                                                     Offspring
                                                     NOAEL = 7 mg/kg/day
                                                     LOAEL = 27 mg/kg/
                                                      day, based on
                                                      decreased body
                                                      weight gain during
                                                      lactation; at 45
                                                      mg/kg/day, pup
                                                      mortality.
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/Offspring
                                  fertility effects  NOAEL = 7.5 mg/kg/
                                  - cypermethrin      day
                                                     LOAEL = 50/37.5 mg/
                                                      kg/day based on
                                                      decreased body
                                                      weight gain in
                                                      both sexes and
                                                      decreased mean
                                                      litter weight gain
                                                      during lactation.
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/Systemic
                                  fertility effects  NOAEL = 5 mg/kg/day
                                  - cypermethrin     LOAEL = 25: based
                                                      on decreased body
                                                      weight gain.
                                                     Offspring
                                                     NOAEL = 5 mg/kg/day
                                                     LOAEL = 25: based
                                                      on decreased body
                                                      weight gain
                                                      (lactation day
                                                      21).
------------------------------------------------------------------------
870.4100                         Chronic toxicity    NOAEL = 7.5 mg/kg/
                                  rats -              day
                                  cypermethrin       LOAEL = 75 mg/kg/
                                                      day based on
                                                      decreases in body
                                                      weight gain (both
                                                      sexes)
------------------------------------------------------------------------
870.4100                         Chronic toxicity    NOAEL = 1 mg/kg/day
                                  dogs (capsule) -   LOAEL = 5 mg/kg/day
                                  cypermethrin        based on
                                                      gastrointestinal
                                                      effects (liquid
                                                      stool); at 15 mg/
                                                      kg/day, body
                                                      tremors, gait
                                                      abnormalities, in
                                                      coordination,
                                                      disorientation and
                                                      hypersensitivity
                                                      to noise plus
                                                      decrease in body
                                                      weight.
------------------------------------------------------------------------
870.4100                         Chronic toxicity    NOAEL = 6 mg/kg/day
                                  dogs (feeding) -    (M), 5.7 mg/kg/day
                                  cypermethrin        (F)
                                                     LOAEL = 20.4 mg/kg/
                                                      day (M) based on
                                                      abnormal clinical
                                                      signs (tremors,
                                                      excessive
                                                      salivation,
                                                      irregular gait);
                                                      at 33.9 mg/kg/day,
                                                      mortality. 18.1 mg/
                                                      kg/day (F) based
                                                      on decreased body
                                                      weight and weight
                                                      gains.
------------------------------------------------------------------------

[[Page 47984]]

 
870.4200                         Carcinogenicity     NOAEL = 7.5 mg/kg/
                                  rats -              day
                                  cypermethrin       LOAEL = 75 mg/kg/
                                                      day based on
                                                      decreases in body
                                                      weight gain (both
                                                      sexes). No
                                                      evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4300                         Carcinogenicity     NOAEL = 14 mg/kg/
                                  mice -              day
                                  cypermethrin       LOAEL = 57 mg/kg/
                                                      day (M) based on
                                                      increased absolute
                                                      (20%) liver
                                                      weights
                                                     Females, there was
                                                      a 15% increase in
                                                      relative liver
                                                      weights only at
                                                      229 mg/kg/day.
                                                     Cancer: positive
                                                      for induction of
                                                      benign
                                                      alveologenic
                                                      neoplasms.
------------------------------------------------------------------------
870.5265                         Salmonella          Very weak positive
                                  typhimurium         response (2-fold
                                  reverse mutation    increase in
                                  assay - zeta-       revertants/plate)
                                  cypermethrin        in strain TA100 at
                                                      10,000 g/
                                                      plate without S-9
                                                      activation in two
                                                      separate
                                                      experiments. Doses
                                                      of 3,333 and 5,000
                                                      g/plate
                                                      gave 1.5 and 1.6-
                                                      fold increases in
                                                      revertants/plate,
                                                      respectively. Zeta-
                                                      cypermethrin
                                                      considered a
                                                      possible weak
                                                      mutagen under the
                                                      conditions of the
                                                      assay.
------------------------------------------------------------------------
870.5265                         Salmonella          Negative up to
                                  typhimurium and     doses of 2,500
                                  S. cerevisiae       g/plate
                                  reverse mutation
                                  assay -
                                  cypermethrin
------------------------------------------------------------------------
870.5300                         Gene mutation in    CHO-K1-BH4,
                                  mammalian cells     subclone D1 cells.
                                  in culture zeta-    No evidence of
                                  cypermethrin        increased forward
                                                      mutation rate at
                                                      the HGPRT locus at
                                                      any dose tested up
                                                      to and beyond
                                                      solubility limit.
------------------------------------------------------------------------
870.5300                         Gene mutation in    CHO-K1-BH4,
                                  mammalian cells     subclone D1 cells.
                                  in culture          No evidence of
                                  cypermethrin        increased forward
                                                      mutation rate at
                                                      the HGPRT locus at
                                                      any dose tested up
                                                      to and beyond
                                                      solubility limit.
------------------------------------------------------------------------
870.5375                         In vitro            The study
                                  cytogenetics zeta-  demonstrates that
                                  cypermethrin        zeta-cypermethrin
                                                      is not mutagenic
                                                      in the mouse
                                                      lymphoma assay
                                                      (L5178Y cell line)
                                                      at the above doses
                                                      with or without
                                                      metabolic
                                                      activation.
------------------------------------------------------------------------
870.5380                         In vivo             No evidence of
                                  cytogenetics zeta-  structural
                                  cypermethrin        chromosomal
                                                      aberrations in rat
                                                      bone marrow at
                                                      either 6, 18, or
                                                      30 hours post
                                                      dosing.
------------------------------------------------------------------------
870.5380                         In vivo             No evidence of
                                  cytogenetics        structural
                                  cypermethrin        chromosomal
                                                      aberrations in rat
                                                      bone marrow at 20
                                                      or 40 mg/kg.
------------------------------------------------------------------------
870.5550                         Unscheduled DNA     No unscheduled DNA
                                  synthesis in        synthesis was
                                  mammalian cells     observed at any
                                  in culture zeta-    dose level up to
                                  cypermethrin        4,500 g/
                                                      mL in male rat
                                                      (Fischer 344)
                                                      liver primary
                                                      hepatocyte
                                                      cultures under the
                                                      conditions of this
                                                      assay. Minimal
                                                      cytotoxicity was
                                                      observed at the
                                                      highest doses.
                                                      Incomplete
                                                      solubility of the
                                                      test compound in
                                                      culture media was
                                                      observed,
                                                      particularly at
                                                      higher doses.
------------------------------------------------------------------------
870.5550                         Unscheduled DNA     No unscheduled DNA
                                  synthesis in        synthesis was
                                  mammalian cells     observed at any
                                  in culture          dose level up to
                                  cypermethrin        200 mg/kg in corn
                                                      oil in Alpk:APfSD
                                                      strain rats
                                                      (males) assessed 4
                                                      and 12 hours post
                                                      dosing. 200 mg/kg
                                                      dose was
                                                      considered near
                                                      the MTD.
------------------------------------------------------------------------
870.5450                         Dominant lethal     No evidence of
                                  assay in the        dominant lethal
                                  rodent              activity in CD-1
                                  cypermethrin        strain mice up to
                                                      10 mg/kg/day for 5
                                                      consecutive days.
------------------------------------------------------------------------
870.6200                         Acute               NOAEL = 10 mg/kg/
                                  neurotoxicity       day
                                  screening battery  LOAEL = 50 mg/kg/
                                  - zeta-             day based on
                                  cypermethrin        clinical signs
                                                      (abdominogenital
                                                      staining, oral
                                                      discharge, splayed
                                                      hindlimbs,
                                                      staggered gait and
                                                      tremors); FOB
                                                      findings (abnormal
                                                      mobile posture,
                                                      splayed hindlimbs,
                                                      soiled fur and
                                                      unable to walk);
                                                      at 250, more
                                                      severe findings.
------------------------------------------------------------------------
870.6200                         Acute               NOAEL = 30 mg/kg/
                                  neurotoxicity       day
                                  screening battery  LOAEL = 100 mg/kg
                                  - cypermethrin      based primarily on
                                                      ataxia and related
                                                      conditions
                                                      (staggered or
                                                      impaired gait,
                                                      decreased
                                                      activity, splayed
                                                      hindlimbs and limp
                                                      conditions, in
                                                      addition to
                                                      decreased motor
                                                      activity in males
                                                      and females on
                                                      days 0, 1, or 2).
------------------------------------------------------------------------
870.6200                         Acute               NOAEL =  20 mg/kg/
                                  neurotoxicity       day
                                  screening battery  LOAEL = 20 mg/kg
                                  - cypermethrin      based on decreased
                                                      motor activity and
                                                      gait
                                                      abnormalities.
------------------------------------------------------------------------

[[Page 47985]]

 
870.6200                         Subchronic          NOAEL = 5.0 mg/kg/
                                  neurotoxicity       day (M); 31.5 mg/
                                  screening battery   kg/day (F)
                                  - zeta-            LOAEL =
                                  cypermethrin       26.3 mg/kg/day (M)
                                                      based on decreased
                                                      motor activity,
                                                      increased landing
                                                      foot splay, and
                                                      decreased body
                                                      weights, body
                                                      weight gains, and
                                                      food consumption
                                                     55.6 mg/kg/day (F)
                                                      based on decreased
                                                      body weights, body
                                                      weight gains, and
                                                      food consumption.
------------------------------------------------------------------------
870.6200                         Subchronic          NOAEL = 31 mg/kg/
                                  neurotoxicity       day
                                  screening battery  LOAEL = 77 mg/kg/
                                  - cypermethrin      day based on the
                                                      following:
                                                     Males: decreased
                                                      body weight gain
                                                      and increased
                                                      landing foot
                                                      splay;
                                                     Females: ataxia,
                                                      splayed hindlimbs,
                                                      impaired gait and
                                                      decreased feces as
                                                      well as decreased
                                                      body weight gain.
------------------------------------------------------------------------
870.7485                         Metabolism and      Several studies
                                  pharmacokinetics    with both rats,
                                                      dogs and mice are
                                                      available to
                                                      support the
                                                      requirement for
                                                      metabolism in
                                                      mammals. Some of
                                                      these studies
                                                      assess individual
                                                      cis and trans
                                                      radiolabelled
                                                      isomers and other
                                                      studies assess the
                                                      metabolism of
                                                      cypermethrin with
                                                      the label in
                                                      either the
                                                      cyclopropyl of the
                                                      phenoxybenzyl
                                                      ring. In general,
                                                      the following has
                                                      been demonstrated
                                                      from these
                                                      studies:
                                                      cypermethrin is
                                                      readily absorbed
                                                      from the
                                                      gastrointestinal
                                                      tract and
                                                      extensively
                                                      metabolized. It
                                                      mostly excreted in
                                                      the urine that
                                                      contains several
                                                      characterized
                                                      metabolites
                                                      derived from
                                                      conjugation of the
                                                      hydrolysis
                                                      products of the
                                                      parent compound
                                                      following cleavage
                                                      of the esteratic
                                                      linkage site.
------------------------------------------------------------------------
870.7600                         Dermal penetration  No study is
                                                      available.
------------------------------------------------------------------------
*Zeta-cypermethrin is bridged to data base with cypermethrin. Therefore,
  studies on both are included.

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10\-6\ or one in a million). Under 
certain specific circumstances, MOE calculations will be used for the 
carcinogenic risk assessment. In this non-linear approach, a ``point of 
departure'' is identified below which carcinogenic effects are not 
expected. The point of departure is typically a NOAEL based on an 
endpoint related to cancer effects though it may be a different value 
derived from the dose response curve. To estimate risk, a ratio of the 
point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for zeta-cypermethrin and its inactive R-isomers used for 
human risk assessment is shown in the following Table 3:

 Table 3.--Summary of the Toxicological Dose and Endpoints for Zeta-Cypermethrin and Its Inactive R-isomers for
                                          Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk      FQPA SF* and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = 10 mg/kg/day     FQPA SF = 1              Acute neurotoxicity
 including infants and children)       UF = 100...............  aPAD = acute RfD.......   study in the rat (zeta-
                                       Acute RfD = 0.10 mg/kg/  FQPA SF = 0.10 mg/kg/     cypermethrin).
                                        day.                     day.                    LOAEL = 50 mg/kg/day
                                                                                          based on clinical
                                                                                          signs of toxicity and
                                                                                          FOB findings.
----------------------------------------------------------------------------------------------------------------

[[Page 47986]]

 
Chronic dietary (all populations)      NOAEL = 6 mg/kg/day      FQPA SF = 1              Chronic feeding study
                                       UF = 100...............  cPAD = chronic RfD.....   in the dog
                                       Chronic RfD = 0.06 mg/   FQPA SF = 0.06 mg/kg/     (cypermethrin).
                                        kg/day.                  day.                    LOAEL = 20.4/18.1 mg/kg/
                                                                                          day based on clinical
                                                                                          signs of neurotoxicity
                                                                                          and mortality in
                                                                                          males, and decreased
                                                                                          body weights and body
                                                                                          weight gains in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Short-term incidental oral (1 to 7     NOAEL = 10 mg/kg/day     LOC for MOE = 100        Acute neurotoxicity
 days) (residential)                                             (residential)            study in the rat (zeta-
                                                                                          cypermethrin).
                                                                                         LOAEL = 50 mg/kg/day
                                                                                          based on clinical
                                                                                          signs of neurotoxicity
                                                                                          and changes in the FOB
----------------------------------------------------------------------------------------------------------------
Intermediate-term incidental oral (1   NOAEL = 5.0 mg/kg/day    LOC for MOE = 100        Subchronic
 week to several months)                                         (residential)            neurotoxicity study in
 (residential)                                                                            the rat (zeta-
                                                                                          cypermethrin).
                                                                                         LOAEL = 26.3 mg/kg/day
                                                                                          based on decreased
                                                                                          motor activity,
                                                                                          increased landing foot
                                                                                          splay, and decreased
                                                                                          body weights, body
                                                                                          weight gains, and food
                                                                                          consumption
----------------------------------------------------------------------------------------------------------------
Short- and intermediate-term dermal    No hazard identified to  Not applicable           No systemic effects in
 (1 to 7 days and 1 week to several     support quantitation                              21-day dermal study up
 months) (residential)                  of risk.                                          to 1,000 mg/kg/day and
                                                                                          no observed
                                                                                          developmental effects
                                                                                          in developmental
                                                                                          studies.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    Oral study NOAEL= 6 mg/  LOC for MOE = 100        Chronic feeding study
 lifetime) (residential)                kg/day (dermal           (residential)            in the dog
                                        absorption rate =                                 (cypermethrin).
                                        2.5%)                                            LOAEL = 20.4/18.1 mg/kg/
                                                                                          day based on clinical
                                                                                          signs of neurotoxicity
                                                                                          and mortality in
                                                                                          males, and decreased
                                                                                          body weights and body
                                                                                          weight gains in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Inhalation (all durations)             Inhalation study NOAEL   LOC for MOE = 100        21-Day inhalation study
 (residential)                          = 0.01 mg/L (2.7 mg/kg/  (residential) for        in the rat
                                        day)                     short- and               (cypermethrin).
                                                                 intermediate-term       LOAEL = 0.05 mg/L/day
                                                                 exposure.                based on body weight
                                                                Long-term exposure: LOC   decrease
                                                                 for MOE 300 for the
                                                                 lack of alternative
                                                                 study. Route-to-route
                                                                 estimation would
                                                                 result in less
                                                                 protective endpoint..
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      N/A                      Category C (possible     Mouse oncogenicity
                                                                 human carcinogen). No    study with
                                                                 quantization required    cypermethrin.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.418) for the residues of zeta-cypermethrin, in 
or on a variety of raw agricultural commodities: Cabbage at 2.0 ppm, 
animal fat (cattle, goat, hog, horse, and sheep) at 0.05 ppm, animal 
meat by-products at 0.05 ppm, animal meat at 0.05 ppm, cottonseed at 
0.5 ppm, head lettuce at 10.0 ppm, milk at 0.05 ppm, bulb onions at 
0.10 ppm, and pecans at 0.05 ppm. Tolerances for cypermethrin (parent 
compound) are the same as those for zeta-cypermethrin with the 
exception that there are cypermethrin tolerances for green onions at 
6.0 ppm, heads and stem Brassica at 2.0 ppm and leafy Brassica at 14.0 
ppm. Risk assessments were conducted by EPA to assess dietary exposures 
from zeta-cypermethrin and its inactive R-isomers in food as follows:
    Zeta-cypermethrin is an enriched-enantiomer version of the 
insecticide cypermethrin. Both cypermethrin and zeta-cypermethrin are 
mixtures of eight isomers, with the active components consisting of the 
S-enantiomers (``S''configuration at the cyano bearing carbon). The two 
differ in that cypermethrin has a 50:50 R/S ratio whereas zeta-
cypermethrin is enriched in the S-enantiomers with a ratio of 90:10 of 
S/R. The enriched isomer formulation provides for similar insect 
control but at lower use rates. Since use of both cypermethrin and 
zeta-

[[Page 47987]]

cypermethrin result in human exposure to the same eight isomers, 
dietary and non-dietary (residential) aggregate risk assessment was 
conducted by adding the uses of the two chemicals.
    i. Acute exposure. 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 Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: Tolerance-level residues and 100% crop treated 
have been used in these analyses for all commodities having either 
established or proposed tolerances of cypermethrin or zeta-
cypermethrin. In cases where a commodity has an established tolerance 
for cypermethrin and a proposed tolerance for zeta-cypermethrin, the 
larger of the two values was used in the assessment. DEEM\TM\ default 
processing factors were used for all commodities in this assessment.

                   Table 4.--Summary of Acute Dietary Exposure and Risk for Zeta-Cypermethrin
----------------------------------------------------------------------------------------------------------------
                                                                       Acute Dietary
           Population Subgroup           -----------------------------------------------------------------------
                                             Dietary Exposure (mg/kg/day)                    %aPAD
----------------------------------------------------------------------------------------------------------------
U.S. population                                                     0.020013                                  20
----------------------------------------------------------------------------------------------------------------
Infants (<1 year old)                                               0.021554                                  22
----------------------------------------------------------------------------------------------------------------
Children (1-6 years)                                                0.030121                                  30
----------------------------------------------------------------------------------------------------------------
Females (13-50 years)                                               0.019736                                  20
----------------------------------------------------------------------------------------------------------------

    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: 
Tolerance-level residues and 100% crop treated have been used in these 
analyses for all commodities having either established or proposed 
tolerances of cypermethrin or zeta-cypermethrin. For chronic risk 
assessments, residue estimates for foods (e.g., apples) or food-forms 
(e.g., apple juice) of interest are multiplied by the averaged 
consumption estimate of each food/food-form of each population 
subgroup. Exposure estimates are expressed in mg/kg bwt/day and as a 
percent of the cPAD.

                  Table 5.--Summary of Chronic Dietary Exposure and Risk for Zeta-Cypermethrin
----------------------------------------------------------------------------------------------------------------
                                                                      Chronic Dietary
           Population Subgroup           -----------------------------------------------------------------------
                                             Dietary Exposures (mg/kg/day)                   %cPAD
----------------------------------------------------------------------------------------------------------------
U.S. population                                                     0.006477                                  11
----------------------------------------------------------------------------------------------------------------
Infants (<1 year old)                                               0.005748                                  10
----------------------------------------------------------------------------------------------------------------
Children (1-6 years)                                                0.011906                                  20
----------------------------------------------------------------------------------------------------------------
Females (13-50 years)                                               0.005749                                  10
----------------------------------------------------------------------------------------------------------------

    As shown by the summarized acute and chronic results in Tables 4 
and 5, all risk estimates fall below EPA's level of concern 
(100% PAD). All exposures are Tier 1 estimates that are 
extremely conservative and likely overestimate actual dietary exposure. 
Refinements to the analyses in the form of percent crop treated 
considerations and/or anticipated residues would likely reduce the 
exposure and risk estimates for zeta-cypermethrin.
    iii. Cancer. Cypermethrin has been classified as a Category C, 
possible human carcinogen, based on an increased incidence of lung 
adenomas and adenomas plus carcinomas combined in female mice (Cancer 
Peer Review Committee, 1988). The evidence was not considered strong 
enough to warrant a quantitative estimation of human risk. Cypermethrin 
has not been classified under the more current, Proposed Guidelines for 
Carcinogen Risk Assessment (April 10, 1996). Because zeta-cypermethrin 
is an enriched isomer of cypermethrin, it is also classified as a 
Category C carcinogen and a RfD approach was recommended for human risk 
assessment purposes.
    2. Dietary exposure from drinking water. Based on the available 
data, cypermethrin/zeta-cypermethrin is a moderately persistent 
chemical that primarily degrades by photolysis in water and 
biodegradation. Depending on the environmental circumstances, it may 
persist for periods of months post-treatment. Cypermethrin is tightly 
bound to soil particles and is not likely to move to ground waters. 
However, the degradate DCVA is mobile and likely to reach ground 
waters. Additional information about the mobility of this degradate has 
been requested. Cypermethrin can contaminate surface waters through 
spray drift. Under some conditions it may also have a potential for 
runoff into surface waters (primarily through erosion), for several 
months post-application. Since zeta-cypermethrin is preferentially 
associated to the soils, the fraction of the chemical in the water 
column should be small. In addition, it is expected that treatment of 
drinking waters would remove substantial portions of cypermethrin/zeta-
cypermethrin present in water.

[[Page 47988]]

Although the Agency has not addressed residues of DCVA in water, we 
have concluded that DCVA does not need to be included in the dietary 
risk for food.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow ground water. For a screening-level assessment for surface 
water, EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a 
tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that 
uses a specific high-end runoff scenario for pesticides. While both 
FIRST and PRZM/EXAMS incorporate an index reservoir environment, the 
PRZM/EXAMS model includes a percent crop area factor as an adjustment 
to account for the maximum percent crop coverage within a watershed or 
drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use EECs from these models 
to quantify drinking water exposure and risk as a %RfD or %PAD. Instead 
drinking water levels of comparison (DWLOCs) are calculated and used as 
a point of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to cypermethrin and zeta-
cypermethrin and its inactive R-isomers, they are further discussed in 
the aggregate risk sections below.
    Based on the FIRST and SCI-GROW models, the EECs of cypermethrin 
and zeta-cypermethrin and its inactive R-isomers for acute exposures 
are estimated to be 8.9 parts per billion (ppb) for surface water and 
0.006 ppb for ground water. The EECs for chronic exposures are 
estimated to be 0.46 ppb ppb for surface water and 0.006 ppb for ground 
water. These values generally represent upper-bound estimates of the 
concentrations that might be found in surface water and ground water 
due to the use of cypermethrin on Brassica vegetables, which has the 
highest application rate among both cypermethrin and zeta-cypermethrin 
on all crops over which the chemicals are applied.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Zeta-cypermethrin and its inactive R-isomers is not registered for 
use on any sites that would result in residential exposure. However, 
cypermethrin does have indoor and outdoor residential uses (zeta-
cypermethrin is an enriched-enantiomer version of the insecticide 
cypermethrin). The analytical method does not distinguish cypermethrin 
from zeta-cypermethrin, and the toxicological endpoints are the same. 
Therefore, dietary and non-dietary residential aggregate risk 
assessment is conducted by adding the uses of the two chemicals.
    4. Cumulative exposure to substances with a 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.''
    EPA does not have, at this time, available data to determine 
whether zeta-cypermethrin and its inactive R-isomers 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, Zeta-cypermethrin and its inactive R-isomers 
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 zeta-cypermethrin and its inactive R-isomers has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 
FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. 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 prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure 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 margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. The data demonstrated no 
indication of increased sensitivity of rats or rabbits to in utero and/
or postnatal exposure to either zeta-cypermethrin or cypermethrin. In 
the prenatal developmental toxicity studies in rats, there was no 
evidence of developmental toxicity at the highest dose tested (35 mg/
kg/day). Maternal toxicity (decreased body weight gain (both 
chemicals), and food consumption, ataxia, urine and feces-stained for 
(zeta-cypermethrin)) was observed at the LOAEL of 25 mg/kg/day. The 
maternal NOAELs were established at 12.5 mg/kg/day for zeta-
cypermethrin and 17.5 mg/kg/day for cypermethrin. In the definitive 
rabbit developmental toxicity study conducted with cypermethrin, the 
maternal LOAEL was 450 mg/kg/day based on decreased body weight gain. 
No developmental toxicity was observed at dose levels up to 700 mg/kg/
day. In the two-generation reproduction study in rats conducted with 
zeta-cypermethrin, offspring toxicity (decreased pup weight gain during 
lactation) was observed at the same treatment level which resulted in 
parental systemic toxicity (NOAEL: 27 mg/kg/day; LOAEL: 45 mg/kg/day). 
In the definitive multigeneration reproduction study conducted with 
cypermethrin, the parental NOAEL/LOAEL is lower than the pup NOAEL/
LOAEL, both based on decreases in body weight gain (2.5/7.5 mg/kg/day 
for the parents versus 7.5/37.5 mg/kg/day for the pups).
    iii. Conclusion. There is a complete toxicity data base for zeta-
cypermethrin and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposure based on the 
considerations above. The safety factor can be removed for zeta-
cypermethrin and its inactive R-isomers

[[Page 47989]]

because: (1) There is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure; (2) the requirement of a developmental 
neurotoxicity study is not based on criteria reflecting special concern 
for the developing fetuses or young which are generally used for 
requiring a DNT study - and a safety factor (e.g., neuropathy in adult 
animals; CNS malformations following prenatal exposure; brain weight or 
sexual maturation changes in offspring; and/or functional changes in 
offspring) and therefore does not warrant an FQPA safety factor; and 
(3) the dietary (food and drinking water) and non-dietary exposure 
assessments will not underestimate the potential exposures for infants 
and children.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to zeta- 
cypermethrin and its inactive R-isomers will occupy 20% of the aPAD for 
the U.S. population, 20% of the aPAD for females 13 years and older, 
22% of the aPAD for infants (<1 year old), and 30% of the aPAD for 
children (1-6 years). In addition, there is potential for acute dietary 
exposure to zeta-cypermethrin and its inactive R-isomers in drinking 
water. After calculating DWLOCs and comparing them to the EECs for 
surface and ground water, EPA does not expect the aggregate exposure to 
exceed 100% of the aPAD, as shown in the following Table 6:

                         Table 6.--Aggregate Risk Assessment for Acute Exposure to Zeta-Cypermethrin and its Inactive R-isomers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Ground Water      Surface Water
                   Population Subgroup                       aPAD,mg/kg/day      %aPAD (Food)        EEC1, ppb          EEC1, ppb      Acute DWLOC2, ppb
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                         0.10                20%              0.006                8.9              2,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                               0.10                22%              0.006                8.9                780
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                                0.10                30%              0.006                8.9                700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                               0.10                20%              0.006                8.9              2,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
1EECs resulting from the maximum proposed application rate (Cypermethrin on Brassica vegetables)
2The acute DWLOC was calculated as follows:
DWLOC (g/L)  = maximum water  exposure  (mg/kg/day)  x  body  weight (kg)  consumption  (L/day)  x  0.001  mg/g

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to zeta- 
cypermethrin and its inactive R-isomers from food will utilize 11% of 
the cPAD for the U.S. population, 10% of the cPAD for all infants (< 1 
year old), and 20% of the cPAD for children (1-6 years old).
    There are no residential uses for zeta-cypermethrin and its 
inactive R-isomers that result in chronic residential exposure to zeta-
cypermethrin and its inactive R-isomers. However, cypermethrin does 
have indoor and outdoor residential uses (zeta-cypermethrin is an 
enriched-enantiomer version of the insecticide cypermethrin). The 
analytical method does not distinguish cypermethrin from zeta-
cypermethrin, and the toxicological endpoints are the same. Therefore, 
dietary and non-dietary residential aggregate risk assessment is 
conducted by adding the uses of the two chemicals. Based on the use 
pattern, chronic residential exposure to residues of zeta-cypermethrin 
and its inactive R-isomers is not expected. In addition, there is 
potential for chronic dietary exposure to zeta-cypermethrin and its 
inactive R-isomers in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
the following Table 7:

[[Page 47990]]



                                          Table 7.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Ground Water      Surface Water     Chronic DWLOC2,
                   Population Subgroup                     cPAD, (mg/kg/day)     %cPAD (Food)       EEC1, (ppb)        EEC1, (ppb)           (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                         0.06                11%              0.006               0.46              1,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                               0.06                10%              0.006               0.46                540
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                                0.06                20%              0.006               0.46                480
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                               0.06                10%              0.006               0.46              1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 EECs resulting from the maximum proposed application rate (cypermethrin on Brassica vegetables)
2 Chronic DWLOCs were calculated as follows: DWLOC (g/L) = maximum water  exposure  (mg/kg/day)  x  body  weight (kg)  consumption  (L/
  day)  x  0.001  mg/g

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Zeta-cypermethrin and its inactive R-isomers is currently not 
registered for use that could result in short-term residential 
exposure; however, cypermethrin does have indoor and outdoor 
residential uses (zeta-cypermethrin is an enriched-enantiomer version 
of the insecticide cypermethrin). Cypermethrin registered residential 
uses constitute short- and intermediate-term exposure scenarios; 
endpoints have been selected for short- and intermediate-term 
incidental oral and inhalation exposures, and the acceptable MOEs for 
short- and intermediate-term exposures are 100. Since the toxicological 
effects through the inhalation exposure route are similar to those 
toxicological effects through the oral routes, short-term aggregate 
risk assessment was conducted adding inhalation, oral non-dietary 
exposure, and average food and water exposure.
    Since all the acceptable MOEs are at the same level, the aggregate 
risks for population subgroups can be estimated by calculating 
aggregate Margin of Exposure values (MOEaggregate).
MOEaggregate = 1/(1/MOEI + 1/MOED + 1/
MOEO + 1/MOEfood + 1/MOEwater)
    where I = inhalation, D = dermal (no dermal endpoints was selected 
for zeta-cypermethrin), O = non-dietary oral, MOEfood = 
average food from the chronic DEEM run.
    As residue values in water from monitoring data are not available, 
therefore, as with the acute dietary aggregate risk estimate, for the 
short- and intermediate-term aggregate risk assessments, the DWLOCs 
have to be back calculated.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 1,500 for adult males, 1,700 for 
adult females, 830 for a child, and 1,700 for infants. These aggregate 
MOEs do not exceed the Agency's level of concern for aggregate exposure 
to food and residential uses. In addition, short-term DWLOCs were 
calculated and compared to the EECs for chronic exposure of zeta-
cypermethrin and its inactive R-isomers in ground and surface water. 
After calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in the following Table 
8:

                       Table 8.--Aggregate Risk Assessment for Short-Term Exposure to Zeta-Cypermethrin and its Inactive R-Isomers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Aggregate MOE                         Surface Water
                   Population Subgroup                      Target Aggregate      (food and      Ground Water EEC2  EEC2 (g/   DWLOC3 (1      (g/L)           L)               m>g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult male                                                               100              1,500              0.006               0.46              3,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult female                                                             100              1,700              0.006               0.46              2,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Child                                                                    100                670              0.006               0.46                850
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants                                                                  100              1,100              0.006               0.46                910
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Aggregate MOE (food and residential) = 1  [(1  MOE food) + (1  MOE oral) + (1  MOE dermal) + (1  MOE
  inhalation)]
2 The crop producing the highest level was used.
3 DWLOC (g/L) = allowable water exposure (mg/kg/day) x body weight (kg) water consumption (L) x 10-3 mg/g body weights for male,
  female, and children are 70, 60, and 10 kg. Water consumption for male, female, and children are 2, 2, and 1 L/day

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Zeta-cypermethrin and its inactive R-isomers is currently not 
registered for use that could result in intermediate-term residential 
exposure; however, cypermethrin does have indoor and outdoor 
residential uses (zeta-cypermethrin is an enriched-enantiomer version 
of the insecticide cypermethrin). Cypermethrin registered residential 
uses constitute short- and intermediate-term exposure scenarios; 
endpoints have been selected for short- and intermediate-term 
incidental oral and inhalation exposures, and the acceptable MOEs for 
short- and intermediate-term exposures are 100. Since the toxicological 
effects through the inhalation exposure route are similar to those 
toxicological effects through the oral routes, short-term aggregate 
risk assessment was conducted adding inhalation, oral non-dietary 
exposure, and average food and water exposure.

[[Page 47991]]

    Since all the acceptable MOEs are at the same level, the aggregate 
risks for population subgroups can be estimated by calculating 
aggregate Margin of Exposure values (MOEaggregate).
MOEaggregate = 1/(1/MOEI + 1/MOED + 1/
MOEO + 1/MOEfood + 1/MOEwater)
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 760 for 
adult males, 860 for adult females, 350 for a child and 600 for 
infants. These aggregate MOEs do not exceed the Agency's level of 
concern for aggregate exposure to food and residential uses. In 
addition, intermediate-term DWLOCs were calculated and compared to the 
EECs for chronic exposure of zeta-cypermethrin and its inactive R-
isomers in ground and surface water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect intermediate-term aggregate exposure to exceed the Agency's 
level of concern, as shown in the following Table 9:

                       Table 9.--Aggregate Risk Assessment for Short-Term Exposure to Zeta-Cypermethrin and its Inactive R-Isomers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Aggregate MOE                         Surface Water
                   Population Subgroup                      Target Aggregate      (food and      Ground Water EEC2  EEC2 (g/   DWLOC3 (1      (g/L)           L)               m>g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult male                                                               100                760              0.006               0.46              1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult female                                                             100                860              0.006               0.46              1,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Child                                                                    100                350              0.006               0.46                360
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants                                                                  100                600              0.006               0.46                420
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Aggregate MOE (food and residential) = 1  [(1MOE food) + (1  MOE oral) + (1  MOE dermal) + (1  MOE
  inhalation)]
2 The crop producing the highest level was used.
3 DWLOC (g/L) = allowable water exposure (mg/kg/day) x body weight (kg) water consumption (L) x 10-3 mg/g body weights for male,
  female, and children are 70, 60, and 10 kg. Water consumption for male, female, and children are 2, 2, and 1 L/day

    5. Aggregate cancer risk for U.S. population. Cypermethrin/zeta-
cypermethrin has been classified as a Category C carcinogen, based on 
an increased incidence of lung adenomas and adenomas plus carcinomas 
combined in female mice. However, the evidence was not considered 
strong enough to warrant a quantitative estimation of human risk. An 
RfD approach was recommended for human risk assessment purposes. 
Dietary risk concerns due to long-term consumption of zeta-cypermethrin 
are adequately addressed in the chronic exposure analysis. For the U.S. 
population only 11% of RfD is occupied by chronic food and water 
exposure.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to zeta-cypermethrin and its inactive R-isomers residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of 
cypermethrin residues in plants and animal products in PAM II (Method 
I). This method involves initial acetone-hexane extraction, followed by 
partitioning with water. The organic layer is evaporated, then 
redissolved in cyclohexane-methylene chloride and passed through a gel 
permeation column. The eluate is evaporated, redissolved in hexane and 
passed through a Florisil column. Cypermethrin residues are analyzed by 
gas chromatography (GC) with an electron capture detector (ECD). Since 
zeta-cypermethrin is an isomer enriched form of cypermethrin, and the 
PAM II method is not stereospecific, this method is considered adequate 
for enforcement of the proposed tolerances of zeta-cypermethrin.

B. International Residue Limits

    1. Current status indicates that a Codex maximum residue level 
(MRL) of 0.05 ppm for residues of cypermethrin has been established for 
sweet corn (corn-on-the-cob). Based on zeta-cypermethrin residues 
observed in sweet corn ears in the U.S. field trials, the sweet corn 
tolerance for zeta-cypermethrin is lowered to 0.05 ppm to achieve 
harmonization with Codex. No Codex MRLs have been established for sweet 
corn forage/fodder. Canadian or Mexican MRLs have not been established 
for residues of cypermethrin in/on sweet corn ears or forage/fodder.
    2. Current status indicates that Codex, Canadian, or Mexican MRLs 
have been established for residues of zeta-cypermethrin (or 
cypermethrin) in/on alfalfa forage (5 ppm), maize (0.05 ppm), maize 
fodder (5 ppm), bulb onion (0.1 ppm), root and tuber vegetables (0.05 
ppm), sweet corn on the cob (0.05 ppm), and vegetable oils (0.5 ppm). 
The recommended tolerances will be the same as the international 
tolerances for maize (as applied to field, seed, and pop corn), bulb 
onions, and root and tuber vegetables (applied to sugar beets). The 
U.S. field corn fodder tolerance will be lower than the maize fodder 
tolerance; however, it is unlikely that maize fodder will be shipped to 
the U.S. In addition, if it were imported, from a practical enforcement 
perspective, the higher tolerance needed for sweet corn stover (15 ppm; 
PP 4F3012) would likely apply. Since there is no processed food 
tolerance for corn oil, the field corn grain tolerance of 0.05 ppm 
would apply. The international tolerance for vegetable oils is much 
higher (0.5 ppm) and cannot be harmonized with the U.S. tolerance as 
the later would have to be set much higher than necessary.
    3. Current status indicates that no Codex, Canadian, or Mexican 
MRLs have been established for residues of zeta-cypermethrin in/on 
rice.
    4. Current status indicates that a Codex MRL of 2 ppm for residues 
of cypermethrin (racemic) has been established for head lettuce and 1 
ppm for Brassica vegetables. This is inconsistent with the proposed 
U.S. tolerance of 10.0 ppm for zeta-cypermethrin for Crop Group 4 
(leafy vegetables except Brassica), 2.0 ppm for Crop Group 5A (head and 
stem Brassica), and 14.0 ppm for Crop Group 5B (leafy Brassica). 
Harmonization of U.S. tolerances with Codex tolerances is not possible 
because at the proposed maximal use rates, residues greater than

[[Page 47992]]

the Codex MRLs were found in the U.S. field trials. No Mexican MRLs 
have been established for residues of cypermethrin or zeta-cypermethrin 
in any relevant crop, but Canada has established cypermethrin MRLs of 
1.0 ppm for celery and 0.5 ppm for broccoli, cabbage, cauliflower, and 
Brussels sprouts.

V. Conclusion

    Therefore, the tolerances are established for residues of zeta-
cypermethrin and its inactive R-isomers in or on alfalfa, hay at 15 
ppm, alfalfa, forage at 5.0 ppm, alfalfa, seed at 0.5 ppm; beets, 
sugar, roots at 0.05 ppm, beets, sugar, tops at 0.20 ppm; corn, field, 
grain at 0.05 ppm, corn, pop, grain at 0.05 ppm, corn, field, forage at 
0.20 ppm, corn, field, stover at 3.0 ppm, corn, pop, stover at 3.0 ppm, 
corn, sweet, (K + CWHR) at 0.05 ppm, corn, sweet, forage at 15 ppm, 
corn, sweet, stover at 15 ppm; onions, green at 3.0 ppm; leafy 
vegetables except Brassica at 10 ppm, head and stem Brassica at 2.0 
ppm, leafy Brassica at 14 ppm; sugarcane at 0.6 ppm; rice, grain at 1.5 
ppm, rice, straw at 2.0 ppm, rice, hulls at 6.0 ppm; fat of cattle, 
goat, horse, sheep, hogs at 1.0 ppm; meat of cattle, goat, horse, 
sheep, hogs at 0.1 ppm; milk, fat at 2.5 ppm (reflecting 0.10 ppm in 
whole milk); poultry, fat at 0.05 ppm, poultry, meat at 0.05 ppm, 
poultry, meat by-products at 0.05 ppm; and eggs at 0.05 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301171 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
16, 2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301171, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance 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). Because this rule has

[[Page 47993]]

been exempted from review under Executive Order 12866 due to its lack 
of significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any other Agency action under 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Since tolerances and exemptions that are established on the 
basis of a petition under FFDCA section 408(d), such as the tolerance 
in this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive Order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). For these same reasons, the 
Agency has determined that this rule does not have any tribal 
implications as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure meaningful and timely input by 
tribal officials in the development of regulatory policies that have 
tribal implications. Policies that have tribal implications is defined 
in the Executive Order to include regulations that have substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal government and the Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes. This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: September 6, 2001.
Peter Caulkins,
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. 321(q), 346(a) and 371.

    2. Section 180.418 is amended by revising paragraph (a)(2) to read 
as follows:


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

    (a) * * *
    (2) Tolerances are established for residues of the insecticide Z-
cypermethrin (S-cyano(3-phenoxyphenyl) methyl ())(cis-trans 
3-(2,2-dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate and its 
inactive R-isomers in or on the following raw agricultural commodities:

 
------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, hay.........................................              15.00
Alfalfa, forage......................................               5.00
Alfalfa, seed........................................               0.50
Beets, sugar, roots..................................               0.05
Beets, sugar, tops...................................               0.20
Brassica, head and stem..............................               2.00
Brassica, leafy......................................              14.00
Cabbage..............................................               2.00
Cattle, fat..........................................               1.00
Cattle, mbyp.........................................               0.05
Cattle, meat.........................................               1.00
Corn, field, grain...................................               0.05
Corn, pop, grain.....................................               0.05
Corn, field, forage..................................               0.20
Corn, field, stover..................................               3.00
Corn, pop, stover....................................               3.00
Corn, sweet, (K + CWHR)..............................               0.05
Corn, sweet, forage..................................              15.00
Corn, sweet, stover..................................              15.00
Cottonseed...........................................                0.5
Eggs.................................................               0.05
Goat, mbyp...........................................               0.05
Goat, meat...........................................               1.00
Hogs, fat............................................               1.00
Hogs, mbyp...........................................               0.05
Hogs, meat...........................................               1.00
Horse, fat...........................................               1.00
Horse, mbyp..........................................               0.05
Horse, meat..........................................               1.00
Leafy vegetables except, Brassica....................              10.00
Lettuce, head........................................              10.00
Milk.................................................               0.05
Milk, fat (reflecting 0.10 in whole milk)............               2.50
Onions, bulb.........................................               0.10
Onions, green........................................               3.00
Pecans...............................................               0.05
Poultry, fat.........................................               0.05

[[Page 47994]]

 
Poultry, mbyp........................................               0.05
Poultry, meat........................................               0.05
Rice, grain..........................................               1.50
Rice, hulls..........................................               6.00
Rice, straw..........................................               2.00
Sheep, fat...........................................               1.00
Sheep, mbyp..........................................               0.05
Sheep, meat..........................................               1.00
Sugarcane............................................               0.60
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* * * * *

FR Doc. 01-23087 Filed 9-14-01; 8:45 am
BILLING CODE 6560-50-S