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Cyfluthrin (Bayer). November 26, 1997. Pesticide Tolerances. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p31101.htm
[Federal Register: November 26, 1997 (Volume 62, Number 228)]
[Rules and Regulations]
[Page 63010-63019]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no97-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300582; FRL-5755-2]
RIN 2070-AB78
Cyfluthrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
cyfluthrin in or on the raw agricultural commodities in or on the
following raw agricultural commodities: alfalfa; alfalfa, hay;
aspirated grain fractions; carrots; cattle, fat; cattle, meat; cattle,
meat by-products (mbyp); citrus, crop group; citrus dried pulp; citrus
oil; cottonseed; cottonseed,
[[Page 63011]]
hulls; cottonseed, oil; eggs; goats, fat; goats, meat; goats, mbyp;
hogs, fat; hogs, meat; hogs, mbyp; horses, fat; horses, meat; horses,
mbyp; milkfat; peppers; poultry, fat; poultry, meat; poultry, mbyp;
radishes; sheep, fat; sheep, meat; sheep, mbyp; sorghum, fodder;
sorghum, forage; sorghum, grain; sugarcane; sugarcane, molasses;
sunflower, forage; sunflower, seed; tomato; tomato, concentrated
products; and tomato, pomace (wet and dry). It also removes time
limitations for tolerances for residues of cyfluthrin on the same
commodities. Bayer Ag Corporation requested these tolerances under the
Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective November 26, 1997. Objections and
requests for hearings must be received by EPA on or before January 26,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300582], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300582], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300582]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, Product
Manager 13, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address:
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-
6100, e-mail: larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 25, 1988
(53 FR 1924), EPA established time-limited tolerances under Section 408
and 409 of the Federal Food Drug and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d) and 348 for residues of cyfluthrin. These tolerances expire on
November 15, 1997. On September 15, 1997, Bayer requested that the time
limitation for tolerances established for residue of the insecticide
cyfluthrin in the above mentioned commodities be removed based on
environmental effects data that they had submitted as a condition of
the registration and time-limited tolerances. Bayer also submitted a
summary of its petition as required under the FFDCA as amended by the
Food Quality Protection Act (FQPA) of 1996 (Pub. L. 104-170).
In the Federal Register of Thursday, September 25, 1997 (62 FR
50337) (FRL-5748-2), EPA issued a notice pursuant to section 408 of the
FFDCA, 21 U.S.C. 346a(e) announcing the filing of pesticide petitions
(4F3046, 9F3731, 3F4204, 4F4313, 2F4137, and 4F4313 and food/feed
additive petitions 4H5427, 9H5574, 3H5670, 4H5686, and 4H5687) for
tolerances by the Bayer Ag Corporation, 8400 Hawthorn Rd., Kansas City,
MO 64120. This notice included a summary of the petitions prepared by
the Bayer Ag Corporation. There were no comments received in response
to the notice of filing.
The petitions requested that 40 CFR 180.436 be amended by
establishing permanent tolerances for residues of the insecticide
cyfluthrin, in or on alfalfa, carrots, citrus, cotton, peppers,
radishes, sorghum, sugarcane, sweet corn, sunflowers and tomatoes at
the following levels part per million (ppm): alfalfa, 5.0 ppm; alfalfa,
hay, at 10.0 ppm; aspirated grain fractions at 300 ppm; carrots at 0.2
ppm; cattle, fat, at 5.0 ppm; cattle, meat, at 0.4 ppm; cattle, mbyp at
0.4 ppm; citrus, crop group, at 0.2 ppm; citrus, dried pulp at 0.3 ppm;
citrus oil, at 0.3 ppm; cottonseed at 1.0 ppm; cottonseed, oil, at 2.0
ppm; cottonseed, hulls, at 2.0 ppm; eggs at 0.01 ppm; goats, fat, at
5.0 ppm; goats, meat, at 0.4 ppm; goats, mbyp at 0.4 ppm; hogs, fat, at
5.0 ppm; hogs, meat, at 0.4 ppm; hogs, mbyp at 0.4 ppm; horses, fat, at
5.0 ppm; horses, meat, at 0.4 ppm; horses, mbyp at 0.4 ppm; milkfat, at
15.0 ppm (representing 0.5 ppm in whole milk); peppers, at 0.5 ppm;
poultry, fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, mbyp at
0.01 ppm; radishes at 1.0 ppm; sheep, fat, at 5.0 ppm; sheep, meat, at
0.4 ppm; sheep, mbyp at 0.4 ppm; sorghum, fodder, at 5.0 ppm; sorghum,
forage,
at 2.0 ppm; sorghum, grain at 4.0 ppm; sugarcane, at 0.05 ppm;
sugarcane, molasses, at 0.2 ppm; sunflower, forage, at 1.0 ppm;
sunflower, seed, at 0.02 ppm; tomato, at 0.2 ppm; tomato, concentrated
products, at 0.5 ppm; and tomato, pomace (wet and dry) at 5.0 ppm.
In the Notice of Filing, the established tolerance levels for
cattle, fat; goat, fat; hog, fat; and horse, fat were incorrectly
listed as 1.0 ppm. The correct tolerance level for these commodities is
5.0 ppm as stipulated in PP No. 2F4137 in the Federal Register of July
31, 1996 (61 FR 39883)(FRL-5387-2). A tolerance level of 5.0 ppm was
considered by EPA for risk assessment purposes.
The basis for time-limited tolerances that expire November 15, 1997
was given in the Federal Register of October 20, 1993 (58 FR 54094).
These time-limited tolerances were predicated on the expiration of
pesticide product registrations that were made conditional due to lack
of certain ecological and environmental effects data. The rationale for
using time-limited tolerances was to encourage pesticide manufacturers
to comply with the conditions of registration in a timely manner. There
is no regulatory requirement to make tolerances time-limed due to the
conditional status of a product registration under the Federal
Insecticide, Fungicide, Rodenticide Act (FIFRA) as amended. It is
current EPA policy to no longer establish time limitations on
tolerances with expiration dates if none of the conditions of
registration have any bearing on human dietary risk. This current
action meets that condition and thus expiration dates associated with
specific crop tolerances are being deleted.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a
[[Page 63012]]
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in ground water
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if
[[Page 63013]]
each food item contained pesticide residues equal to the tolerance. In
evaluating food exposures, EPA takes into account varying consumption
patterns of major identifiable subgroups of consumers, including
infants and children. The TMRC is a ``worst case'' estimate since it is
based on the assumptions that food contains pesticide residues at the
tolerance level and that 100% of the crop is treated by pesticides that
have established tolerances. If the TMRC exceeds the RfD or poses a
lifetime cancer risk that is greater than approximately one in a
million, EPA attempts to derive a more accurate exposure estimate for
the pesticide by evaluating additional types of information
(anticipated residue data and/or percent of crop treated data) which
show, generally, that pesticide residues in most foods when they are
eaten are well below established tolerances.
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of
cyfluthrin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for tolerances for residues of
cyfluthrin on alfalfa, carrots, citrus, cotton, peppers, radishes,
sorghum, sugarcane, sunflowers and tomatoes at the following levels
(ppm): alfalfa, forage, at 5.0 ppm; alfalfa, hay, at 10.0 ppm;
aspirated grain fractions at 300 ppm; carrots at 0.2 ppm; cattle, fat,
at 5.0 ppm; cattle, meat, at 0.4 ppm; cattle, mbyp at 0.4 ppm; citrus,
crop group, at 0.2 ppm; citrus dried pulp, at 0.3 ppm; citrus oil, at
0.3 ppm; cottonseed at 1.0 ppm; cottonseed, hulls, at 2.0 ppm;
cottonseed, oil, at 2.0 ppm; eggs at 0.01 ppm; goats, fat, at 5.0 ppm;
goats, meat, at 0.4 ppm; goats, mbyp at 0.4 ppm; hogs, fat, at 5.0 ppm;
hogs, meat, at 0.4 ppm; hogs, mbyp at 0.4 ppm; horses, fat, at 5.0 ppm;
horses, meat, at 0.4 ppm; horses, mbyp at 0.4 ppm; milkfat, at 15.0 ppm
(representing 0.5 ppm in whole milk); peppers, at 0.5 ppm; poultry,
fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, mbyp at 0.01
ppm; radishes at 1.0 ppm; sheep, fat, at 5.0 ppm; sheep, meat, at 0.4
ppm; sheep, mbyp at 0.4 ppm; sorghum, fodder, at 5.0 ppm; sorghum,
forage, at 2.0 ppm; sorghum, grain at 4.0 ppm; sugarcane, at 0.05 ppm;
sugarcane, molasses, at 0.2 ppm; sunflower, forage, at 1.0 ppm;
sunflower, seed, at 0.02 ppm; tomato, at 0.2 ppm; tomato, concentrated
products, at 0.5 ppm; and tomato, pomace (wet and dry) at 5.0 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by cyfluthrin are
discussed below.
1. Acute toxicity. The required toxicity battery studies for acute
oral (LD<INF>50</INF> <gr-thn-eq>16.2 mg/kg), dermal (LD<INF>50</INF>
>5,000 mg/kg), inhalation (LC<INF>50</INF> <gr-thn-eq>0.468 mg/L),
primary eye irritation (category III), primary dermal irritation
(category IV), and dermal sensitization have been conducted and were
found adequate. Cyfluthrin is not a dermal sensitizer.
2. Mutagenicity. There are seven acceptable studies upon which the
Agency based its evaluation: three reverse mutation assays (Salmonella
typhimurium , E. coli and Saccharomyces cerevisiae ); one reverse
mutation, mitotic recombination and conversion assay in Saccharomyces
cerevisiae ; one CHO/HGPRT assay; one sister chromatid exchange assay
in CHO cells; and one UDS assay in primary rat hepatocytes. All these
studies were negative. There is no mutagenicity concern.
3. Reproductive and developmental toxicity-- i. Oral developmental
study in rats. Cyfluthrin was administered via gavage to pregnant
female rats during days 6-15 of gestation at dose levels of 0, 1, 3, or
10 milligrams/kilograms/day (mg/kg/day). A maternal LOEL was not
observed. (i.e. the maternal NOEL is >10 mg/kg/day). A developmental
LOEL was not observed. The developmental NOEL is >10 mg/kg/day. This
developmental study in rats was classified core guideline.
ii. Oral developmental study in rabbits. Cyfluthrin was
administered via gavage to pregnant female rabbits during days 6-18 of
gestation at dose levels of 0, 20, 60, or 180 mg/kg/day. The maternal
LOEL is 60 mg/kg/day based on decreased body weight gain and food
consumption during the dosing period. The maternal NOEL is 20 mg/kg/
day. The developmental LOEL is 60 mg/kg/day based on increased numbers
of resorptions and percent incidence of postimplantation loss. The
developmental NOEL is 20 mg/kg/day. This study was classified core
guideline.
iii. Rat developmental studies via inhalation. In the first two
studies, pregnant female rats at day 0 gestation were exposed head-only
to cyfluthrin concentrations of 0, 1.1, 4.7 or 23.7 mg/m<SUP>3</SUP>/
day (milligrams/per cubic meter/day) for 6 hours/day on gestation days
6 through 15. In the second study, the dams were exposed to analytical
concentrations of 0, 0.09, 0.25, 0.59 or 4.2 mg/m<SUP>3</SUP> of the
test material. The dams were sacrificed on day 20 and their pups
removed by caesarian section. The maternal NOEL was 1.1 mg/
m<SUP>3</SUP> and the maternal LOEL was 4.7 mg/m<SUP>3</SUP> (reduced
motility, dyspnea, piloerection, ungroomed coats and eye irritation.
The developmental NOEL was 0.59 mg/m<SUP>3</SUP> and the developmental
LOEL was 1.1 mg/m<SUP>3</SUP> (increases in the incidence of runts and
skeletal anomalies in the sternum (1.1 mg/m<SUP>3</SUP> and above);
increases in post-implantation losses and decreases in pup weights (4.7
mg/m<SUP>3</SUP> and above) and increased incidences of late embryonic
deaths, in skeletal anomalies in the extremities, pelvis and skull and
in microphthalmia (23.7 mg/m<SUP>3</SUP>). The study was graded core
minimum.
In a third study, In a developmental toxicity study via inhalation,
cyfluthrin was administered to female rats at 0.46, 2.55, 11.9 or 12.8
mg/m<SUP>3</SUP> exposure levels for gestational days 6 through 15 in a
nose only inhalation chamber. The rats were exposed to the test
material 6 hours per day, 7 days per week. The maternal NOEL/LOEL were
< 0.46/<0.46 mg/m<SUP>3</SUP> based on decreased body weight gain and
reduced relative food efficiency. The developmental NOEL/LOEL were
0.46/2.55 mg/m<SUP>3</SUP> based on reduced fetal and placental weight,
reduced ossification in the phalanx, metacarpals and vertebrae. This
study was classified as core guideline.
iv. 3-Generation reproduction study. Cyfluthrin was administered in
the diet to male and female rats dose levels of 0, 50, 150, or 450 ppm
(actual animal intake; 0, 2.5, 7.5, or 22.5 mg/kg/day). The LOEL for
parental toxicity was 450 ppm (22.5 mg/kg/day) based on decreased body
weight gains. The NOEL for parental toxicity is 150 ppm (7.5 mg/kg/
day). The LOEL for reproductive toxicity was 150 ppm (7.5 mg/kg/day)
based on decreased viability and lactational indices and decreased pup
body weight gains. The reproductive NOEL was 50 ppm (2.5 mg/kg/day).
The multigeneration reproductive study in the rat was classified core
minimum.
4. Subchronic toxicity-- i. 28-Day oral toxicity study in rats.
Cyfluthrin was administered to SPF-Wistar rats via gavage at 0, 5, 20,
or 80 (40) mg/kg/day. The high dose was 80 mg/kg/day during
[[Page 63014]]
the first and third weeks and 40 mg/kg/day during the second and fourth
weeks. The LOEL was 80 (40) mg/kg/day in both sexes based on clinical
signs of nerve toxicity, decreases in body weight gain, and changes in
liver and adrenal weights. The NOEL was 20 mg/kg/day. This study was
classified as core minimum.
ii. 28-Day oral toxicity study in rats. Rats were dosed with
cyfluthrin in the diet at 0, 100, 300, or 1,000 ppm (equivalent to 0,
5, 15, or 50 mg/kg/day). The LOEL was 15 mg/kg/day in both sexes based
on decreased blood glucose. The NOEL was 5 mg/kg/day. This study was
classified core supplementary.
iii. 3 Month feeding study in rats. SPF Wistar rats were dosed with
cyfluthrin in the diet at 0, 30, 100, or 300 ppm (equivalent to 0, 1.5,
5, or 15 mg/kg/day) for 3 months. No treatment related effects were
observed at any of the levels tested, thus the NOEL for this 3-month
rat feeding study was 15 mg/kg/day for both sexes. This study was
classified core minimum.
iv. 6 Month dog feeding study. Cyfluthrin was administered in the
diet to dogs at 0, 65, 200 or 600 ppm (equivalent to 0, 1.62, 5 or 15
mg/kg/day) for 26 weeks. The LOEL for this study was 15 mg/kg/day for
both sexes, based on neurological effects (hindlimb abnormalities) and
gastrointestinal disturbances. The NOEL was 5 mg/kg/day for males and
females. The study was classified as core minimum.
v. 21-Day dermal study in rats. In a 21-day repeated dose dermal
toxicity study, male and female rats were treated with cyfluthrin by
dermal occlusion at target doses of 0, 100, 340, or 1,000 mg/kg/day for
6 hours/day (average actual dose levels were 0, 113, 376 or 1,077 mg/
kg/day). No mortality was observed, and there were no treatment-related
effects on body weight, ophthalmology, organ weights, clinical
biochemistry, or hematology. The LOEL for dermal effects was 376 mg/kg/
day for male and female Sprague-Dawley rats based on gross and
histological skin lesions. The NOEL for dermal effects was for
technical Baythroid was 113 mg/kg/day. The LOEL for systemic effects
was 1,077 mg/kg/day based on decreased food consumption, red nasal
discharge and urine staining. The NOEL for systemic effects was 376 mg/
kg/day. This study was classified as acceptable.
vi. 3-Week inhalation toxicity studies in rats-- a. Wistar rats
were dynamically exposed by nose-only inhalation to cyfluthrin in at
concentrations of 0, 2.3, 11.5, or 69.6 mg/ for 6 hours/day, 5
consecutive days/week for 3 weeks (total of 15 exposures). The LOEL was
2.3 mg/m<SUP> 3</SUP>, based on the treatment-related effects on body
weight and temperature observed during the 3-week exposure period. A
NOEL was not established; therefore, this study was repeated using
lower doses.
b. Wistar rats were dynamically exposed by nose-only inhalation to
cyfluthrin at concentrations of 0, 0.4, 1.4, or 10.5 mg/m<SUP>3</SUP>
for 6 hours/day, 5 consecutive days/week for 3 weeks (total of 15
exposures). The LOEL was 10.5 mg/m<SUP>3</SUP>, based on the treatment-
related behavioral effects as well as effects on body and organ
(spleen) weights. The NOEL is 1.4 mg/m<SUP>3</SUP>. These studies were
classified as core minimum.
vii. 4-Week inhalation toxicity study in rats. Rats were
dynamically exposed by inhalation (nose only) to cyfluthrin at
concentrations of 0, 0.44, 6.04, or 46.6 mg/m<SUP>3</SUP> for 6 hours/
day, 5 consecutive days/week for 4 weeks (20 exposures). The LOEL is
6.04 mg/m<SUP>3</SUP> based on the decrease in body and thymus weights,
hypothermia, reduction in leukocytes counts (females), and low serum
protein. The NOEL is 0.44 mg/m<SUP>3</SUP>. This subacute inhalation
toxicity study in rats was classified as supplementary.
viii. 13-Week inhalation toxicity study in rats. Rats were
dynamically exposed by head-only inhalation to cyfluthrin at
concentrations of 0, 0.09, 0.71, or 4.51 mg/m<SUP>3</SUP> for 6 hours/
day, 5 consecutive days/week for 13 weeks. All animals survived the 13-
week study, and no treatment-related changes were observed in organ
weight, gross pathology, and histopathology. The LOEL was 0.71 mg/
m<SUP>3</SUP>, based on the treatment-related behavioral effects in
females as well as the increased urinary protein in males. The NOEL was
0.09 mg/m<SUP>3</SUP>. This study was classified as core minimum.
5. Chronic toxicity-- i. 1 Year dog study. Cyfluthrin was fed to
beagle dogs at 0, 40, 160, or 640 ppm (equivalent to 0, 1, 4, or 16 mg/
kg/day) for 52 weeks. The NOEL was 4 mg/kg bw/day. The LOEL was 16 mg/
kg/day for both sexes, based on slight ataxia in two dogs on single
occasions, decreased body weight in males, and on observations of
increased vomiting and diarrhea at the high dose. The NOEL is 4 mg/kg/
day. This study was classified as core minimum.
ii. Chronic/carcinogenicity-rat. Cyfluthrin was administered for 24
months in the diet to rats at dose levels of 0, 50, 150, or 450 ppm
(equivalent to 2.02, 6.19, or 19.20 mg/kg/day in males and 2.71, 8.15,
or 25.47 mg/kg/day in females based on food consumption and body
weights). The chronic LOEL was 150 ppm (equivalent to 6.19 mg/kg/day in
males and 8.15 mg/kg/day in females) based on decreased body weights in
the high-dose animals and the mid-dose males. The chronic NOEL was 50
ppm (equivalent to 2.02 mg/kg/day in males and 2.71 mg/kg/day in
females). Under the conditions of this study, there was no evidence of
carcinogenic potential. The study was classified core minimum for both
chronic toxicity and oncogenicity.
iii. Chronic/carcinogenicity- mouse. In a chronic/carcinogenicity
study, cyfluthrin was administered in the diet for 23 months to mice at
dose levels of 0, 50, 200, or 800 ppm (equivalent to 11.6, 45.8, or
194.5 mg/kg/day in males and 15.3, 63.0, or 259.9 in females based on
food consumption and body weights). There were no treatment related
changes noted in the clinical observation, food consumption,
hematology, gross observation, organ weight, and microscopic data. The
chronic LOEL is 50 ppm (equivalent to 11.6 mg/kg/day in males and 15.3
mg/kg/day in females) based on increased alkaline phosphatase activity
in the dosed males. A chronic NOEL was not established in male and
female mice. Under the conditions of this study, there was no evidence
of carcinogenic potential. This study was classified core minimum for
carcinogenicity and supplementary for chronic toxicity.
6. Animal metabolism. Metabolism studies in rats showed that
cyfluthrin is rapidly absorbed and excreted, mostly as conjugated
metabolites in the urine, within 48 hours. An enterohepatic circulation
was observed.
7. Neurotoxicity. Other studies evaluated included a subacute oral
neurotoxicity study in rats (LOEL of 50/mg/kg/day; no NOEL observed); a
second subacute oral neurotoxicity study (NOEL of 40 mg/kg/day); a
subchronic neurotoxicity study in rats (NOEL <60 mg/kg/day), and a
subacute inhalation study in mice NOEL for pups, 0.006 mg/L; parental
NOEL 0.058 mg/L HDT). These studies were all graded acceptable/
guideline. Additional neurotoxicity data may be required under a
special Data-Call-In letter pursuant to section 3(c)(2)(B) of FIFRA.
Although these data are lacking, EPA has a sufficient toxicity data
base to support these tolerances and these additional studies are not
expected to significantly change its risk assessment.
B. Toxicological Endpoints
1. Acute toxicity. To assess acute dietary risk, the Agency used an
endpoint of 20 mg/kg/day, the NOEL from the oral developmental toxicity
study in rabbits.
2. Short - and intermediate - term toxicity. For the short and
intermediate
[[Page 63015]]
term dermal exposures, the Agency used a NOEL of 20 mg/kg/day from the
rabbit developmental study. The dermal absorption rate was 25%. This
factor is based on the weight of evidence available for structurally
related pyrethroids. For the short term inhalation exposures, the
Agency used a NOEL of 0.00044 mg/L based on decreases in body and
thymus weights, hypothermia, and clinical pathology at 0.00604 mg/L in
a 28-day inhalation study. The recommended MOE is 300 which includes
FQPA considerations. For the intermediate term inhalation exposure, the
Agency used a NOEL of 0.00009 mg/L based on behavioral effects in rats
at 0.00071 mg/L in a 90-day inhalation study. The additional certainty
factor was included for inhalation because an inhalation study is
available in the mouse which indicates increased sensitivity of the
pups in comparison to the dams.
3.Chronic toxicity. EPA has established the RfD for cyfluthrin at
0.008 mg/kg/day. This RfD is based on a chronic/carcinogenicity feeding
study in the rat with a NOEL of 2.5 mg/kg/day and an uncertainty factor
of 300.
4. Carcinogenicity. Cyfluthrin has been classified as a Group E
chemical (evidence of non-carcinogenicity for humans) by the Agency.
The classification was based on a lack of convincing evidence of
carcinogenicity in adequate studies with two animal species, rat and
mouse.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.436) for the parent residues of cyfluthrin, in or on a variety
of raw agricultural commodities. For purposes of dietary risk
assessment, residue data generated from residue field trials conducted
at maximum application rates and minimum preharvest intervals were
used. To assess secondary exposure from edible animal commodities,
animal dietary burdens were calculated using mean field trial residues,
adjusted for percent crop treated and applying appropriate processing
factors for all feed items. Risk assessments were conducted by EPA to
assess dietary exposures and risks from cyfluthrin as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a day or single exposure. For the acute dietary exposure analysis
for cyfluthrin treated raw agricultural commodities and processed food
items, residue field trial data incorporating percent crop treated
refinement and anticipated residues were used in Monte Carlo modeling
(in accordance with Tier 3 of EPA June 1996 ``Acute Dietary Exposure
Assessment'' guidance document). The acute exposure via food was
estimated as 0.004917 mg/kg/day for adults in the U.S., and 0.010687
mg/kg/day for nonnursing infants < 1 year old (most highly exposed
subgroup. To assess acute dietary risk, the Agency used an endpoint of
20 mg/kg/day, the NOEL from the oral developmental toxicity study in
rabbits. The resulting margin of exposure (MOE) is 4,068 for the
general U.S. population, and 1,871 for nonnursing infants < 1 year old.
For cyfluthrin, EPA generally has no concern for MOEs over 300.
ii. Chronic exposure and risk. The chronic dietary exposure
assessment incorporated tolerance values and percent crop treated
information. The RfD used was 0.008 mg/kg/day. Exposure was estimated
at 0.000076 mg/kg/day for the U.S. population, and 0.000151 mg/kg/day
for nonnursing infants < 1 year old. The percent RfD occupied is 1.0 %
for the U.S. population, and 1.9% for infants < 1 year old. EPA
generally has no concern for RfD of less than 100%
Section 408(b)(2)(E) authorizes EPA to consider available data and
information on the anticipated residue levels of pesticides residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided five years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar use data on the actual
percent of crop treated when establishing a tolerance only where the
Agency can make the following findings: (1) That the data used are
reliable and provide a valid basis for showing the percentage of food
derived from a crop that is likely to contain residues; (2) that the
exposure estimate does not underestimate the exposure for any
significant subpopulation and; (3) where data on regional pesticide use
and food consumption are available, that the exposure estimate does not
understate exposure for any regional population. In addition the Agency
must provide for periodic evaluation of any estimates used.
The percent of crop treated estimates for cypermethrin were derived
from federal and market basket survey data. EPA considers these data
reliable. A range of estimates supplied by this data and upper end of
this range was used for the exposure assessment. By using this upper
end estimate of percent crop treated, the Agency is reasonably certain
that exposure is not underestimated for any significant subpopulation.
Further, regional consumption information is taken into account through
EPA's computer based model for evaluating exposure of significant
subpopulations including several regional groups. Review of this
regional data allows the Agency to be reasonably certain that no
regional population is exposed to residue levels higher than those
estimated by the Agency. To meet the requirement for data on
anticipated residues, EPA will issue a Data Call-In (DCI) notice
pursuant to FFDCA section 408(f) requiring submission of data on
anticipated residues in conjunction with approval of the registration
under FIFRA.
2. From drinking water. There is no established Maximum
Concentration Level for residues of cyfluthrin in drinking water.
Although data indicate little potential for soil mobility or leaching,
cyfluthrin is moderately persistent. Estimates were generated with the
PRZM I and EXAMS computer models in 1993 for comparative ecological
risk assessment for these chemicals.
i. Acute exposure and risk. The acute drinking water exposure and
risk estimates for cyfluthrin for the general U.S. population as
estimated by the Agency was 0.000054 mg/kg/day. The acute drinking
water exposure and risk estimate for non-nursing infants <1 year old
was 0.000104 mg/kg/day. Using these values and an endpoint of 20 mg/kg/
day, the margin of exposure (MOE) for the U.S. population is estimated
at 368,982. For non-nursing infants <1 year old, the MOE is estimated
at 192,308. For cyfluthrin, the Agency general has concern for risk
estimates only below 300.
ii. Chronic exposure and risk. For the U.S. population, exposure is
estimated at 0.000001 mg/kg/day, resulting in negligible risk. For
nonnursing infants < 1 year old, exposure is estimated as 0.000005 mg/
kg/day, which occupies 0.1% of the RfD.
3. From non-dietary exposure. Cyfluthrin is currently registered
for use on non-food sites including golf courses, ornamental shrubs,
indoor foggers, wood surfaces, lawns, and carpet. Nonoccupational
exposure to cyfluthrin may occur as a result of inhalation or contact
from indoor residential, indoor commercial, and outdoor residential
uses.
Short- and intermediate-term exposure and risk. Exposure is
estimated at 0.00524 mg/kg/day for the
[[Page 63016]]
U.S. population, and 0.00810 mg/kg/day for nonnursing infants < 1 year
old.
4. Cumulative exposure to substances with common mechanism of
toxicity. Cyfluthrin is a member of the synthetic pyrethroid class of
pesticides. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
The Agency believes that ``available information'' in this context
might include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common
mechanisms of toxicity and conducting cumulative risk assessments. For
most pesticides, although the Agency has some information in its files
that may turn out to be helpful in eventually determining whether a
pesticide shares a common mechanism of toxicity with any other
substances, EPA doe not at this time have the methodologies to resolve
the complex scientific issues concerning common mechanism of toxicity
in a meaningful way. EPA has begun a pilot process to study this issue
further through the examination of particular classes of pesticides.
The Agency hopes that the results of this pilot process will increase
the Agency's scientific understanding of this question such that EPA
will be able to develop and apply scientific principles for better
determining which chemicals have a common mechanism of toxicity and
evaluation the cumulative effects of such chemicals. The Agency
anticipates, however, that even as its understanding of the science of
common mechanisms increases, decisions on specific classes of chemicals
will be heavily dependent on chemical specific data, much of which may
not be presently available.
Four members of the insecticide class Pyrethroids produce a common
metabolite known as DCVA. These insecticides are cyfluthrin,
cypermethrin, z-cypermethrin and permethrin. Although the residues of
DCVA can be estimated, no toxicology data on the compound per se are
available to directly conduct a hazard evaluation and thereby establish
an appropriate endpoint for use in a joint risk assessment. To date,
for the purpose of assessing the risk of the parent compound the
toxicity of DCVA has been assumed to be equivalent to the parent
compound. However, due to the different toxicological profiles of
cyfluthrin, cypermethrin, z-cypermethrin, and permethrin, EPA does not
believe that it would be appropriate to cumulate DCVA for these
pesticides, or DCVA residues from one of these pesticides with the
parent of another of these pesticides, in conducting the risk
assessment for these pesticides.
Accordingly, EPA does not have, at this time, available data to
determine whether cyfluthrin 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,
cyfluthrin does not appear to produce a toxic metabolite produces by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that cyfluthrin has a common mechanism of toxicity
with other substances.
D. Aggregate Risks and Determination of Safety for U.S. Population
The Agency has determined that an aggregate systemic (oral) and
dermal exposure risk assessment is appropriate for cyfluthrin because
of concern for the developmental effects seen after oral exposure. An
aggregate oral and inhalation exposure risk assessment is also
appropriate due to similarity in systemic toxicity observed in rats via
these routes.
1. Acute risk. Aggregate acute dietary exposure is estimated at
0.004971 mg/kg/day resulting in a MOE of 4,023 for the U.S. population.
2. Chronic risk. EPA has concluded that aggregate exposure to
cyfluthrin from food and water is estimated at 0.000076 mg/kg/day and
will utilize 1% of the RfD for the U.S. population.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. For the general U.S. population, exposure is
estimated at 0.0053 mg/kg/day, resulting in an MOE of 3,800.
E. Aggregate Cancer Risk for U.S. Population
Cyfluthrin has been classified as a Group E chemical (evidence of
non-carcinogenicity for humans) by the Agency. The classification was
based on a lack of convincing evidence of carcinogenicity in adequate
studies with two animal species, rat and mouse. Therefore there is no
concern for cancer in humans.
EPA concludes that there is a reasonable certainty that no harm
will result from aggregate exposure to cyfluthrin residues.
F. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- In general. In
assessing the potential for additional sensitivity of infants and
children to residues of cyfluthrin, EPA considered data from a
developmental toxicity study in the rat (see unit II.A.3. of this
preamble). In addition, data from a 7-day inhalation study conducted
with mouse dams and their offspring were considered (see also unit
II.A.3.). There were no data gaps for the assessment of the effects of
cyfluthrin following in utero or early postnatal exposure. Suggested
sensitivity of rats to in utero exposure to cyfluthrin was
hypothetically linked to bradypnea in the dams and was judged not be a
valid consideration in the calculation of risk. However, evidence of
increased sensitivity of young rats following pre- and/or postnatal
exposure to cyfluthrin was observed in the two-generation reproduction
study and in the 7-day inhalation study in mice.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the data base unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes a 3-fold safety factor for children is appropriate
for cyfluthrin based on lack of severity of the effect.
Based on the submitted studies, EPA concludes that reliable data
support the use of a 300-fold uncertainty factor for infants and
children.
2. Acute exposure. For nonnursing infants <1year old, the aggregate
acute exposure is 0.010791 mg/kg/day, with a resulting MOE of 1,853.
For cyfluthrin, EPA has no concern for MOEs over 300.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
cyfluthrin from food and water will utilize 2% of the RfD for infants
and children (nonnursing infants <1 year old). EPA generally has no
concern for exposures below 100% of the RfD because the RfD represents
the level at or below which daily aggregate dietary exposure over a
[[Page 63017]]
lifetime will not pose appreciable risks to human health.
4. Short- or intermediate-term risk. Using the conservative
exposure assumptions described above, EPA has concluded that aggregate
nondietary exposure to cyfluthrin to infants <1 year is 0.008255 mg/kg/
day. The MOE is estimated at 2,400.
Therefore, it may be concluded that there is reasonable certainty
that no harm will result to infants and children from aggregate
exposure to cyfluthrin residues.
5. Special Docket. The complete acute and chronic exposure analyses
(including dietary, non-dietary, drinking water, and residential
exposure, and analysis of exposure to infants and children) used for
risk assessment purposes can be found in the Special Docket for the
FQPA under the title ``Risk Assessment for Extension of Tolerances for
Synthetic Pyrethroids.'' Further explanation regarding EPA's decision
regarding the additional safety factor can also be found in the Special
Docket.
G. Endocrine Disrupter Effects
EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts ) ``may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect...'' The Agency is
currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research
scientists in developing a screening and testing program and a priority
setting scheme to implement the program. Congress has allowed 3 years
from passage of FQPA (August 3, 1999) to implement this program. At
that time, EPA may require further testing of this active ingredient
and end use products for endocrine disruption effects.
III. Other Considerations
A. Metabolism In Plants and Animals
The metabolism of cyfluthrin in plants and animals is adequately
understood. Studies have been conducted to delineate the metabolism of
radio labeled cyfluthrin in various crops and animals all showing
similar results. The residue of concern is cyfluthrin.
B. Analytical Enforcement Methodology
Adequate analytical methodology (gas/liquid chromatography with an
electron capture detector) is available for enforcement purposes.
C. Magnitude of Residues
Field trial residue and feeding study data have been submitted and
reviewed in support of tolerances on alfalfa, carrots, citrus, cotton,
peppers, radishes, sorghum, sugarcane, sunflowers and tomatoes.
Tolerances to support these uses were proposed in pesticide petitions
4F3046, 9F3731, 3F4204, 4F4313, 2F4137, and 4F4313 and food/feed
additive petitions 4H5427, 9H5574, 3H5670, 4H5686, and 4H5687.
D. International Residue Limits
Codex maximum residue levels (MRLs) are establish for residues of
cyfluthrin in milk, whole (0.01 ppm) ; cottonseed (0.05 ppm); peppers,
sweet (0.2 ppm); and tomatoes (0.5 ppm). Mexico has established a
tolerance on cottonseed at 1 ppm. There are no Canadian tolerances for
cyfluthrin. As indicated in unit II. of this preamble there are
differences between the section 408 tolerances and the Codex MRL values
for specific commodities. These differences could be caused by
differences in methods to establish tolerances, calculation of animal
dietary exposure, and as a result of different agricultural practices.
EPA will specifically address these differences when the pesticides are
reregistered and the tolerances made permanent.
IV. Conclusion
Therefore, the tolerances are established for residues of
cyfluthrin in/on alfalfa, 5.0 ppm; alfalfa, hay, at 10.0 ppm; aspirated
grain fractions at 300 ppm; carrots at 0.2 ppm; cattle, fat, at 5.0
ppm; cattle, meat, at 0.4 ppm; cattle, mbyp at 0.4 ppm; citrus, crop
group, at 0.2 ppm; citrus dried pulp, at 0.3 ppm; citrus oil, at 0.3
ppm; cottonseed at 1.0 ppm; cottonseed, oil, at 2.0 ppm; cottonseed,
hulls, at 2.0 ppm; eggs at 0.01 ppm; goats, fat, at 5.0 ppm; goats,
meat, at 0.4 ppm; goats, mbyp at 0.4 ppm; hogs, fat, at 5.0 ppm; hogs,
meat, at 0.4 ppm; hogs, mbyp at 0.4 ppm; horses, fat, at 5.0 ppm;
horses, meat, at 0.4 ppm; horses, mbyp at 0.4 ppm; milkfat, at 15.0 ppm
(representing 0.5 ppm in whole milk); peppers, at 0.5 ppm; poultry,
fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, mbyp at 0.01
ppm; radishes at 1.0 ppm; sheep, fat, at 5.0 ppm; sheep, meat, at 0.4
ppm; sheep, mbyp at 0.4 ppm; sorghum, fodder, at 5.0 ppm; sorghum,
forage, at 2.0 ppm; sorghum, grain at 4.0 ppm; sugarcane, at 0.05 ppm;
sugarcane, molasses, at 0.2 ppm; sunflower, forage, at 1.0 ppm;
sunflower, seed, at 0.02 ppm; tomato, at 0.2 ppm; tomato, concentrated
products, at 0.5 ppm; and tomato, pomace (wet and dry) at 5.0 ppm.
tomatoes at ppm.
In addition to the tolerances being amended, since for purposes of
establishing tolerances FQPA has eliminated distinctions between raw
and processed food, EPA is combining the tolerances that appear in
Secs. 185.1250 and 186.1250 with Sec. 186.436 and is removing
tolerances under Secs. 185.1250 and 186.1250.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by January 26, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection
[[Page 63018]]
with an objection or hearing request may be claimed confidential by
marking any part or all of that information as CBI. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2. A copy of the information that does not contain
CBI must be submitted for inclusion in the public record. Information
not marked confidential may be disclosed publicly by EPA without prior
notice.
VI. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300582] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
VIII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
40 CFR Part 186
Environmental protection, Animal feeds, Pesticides and pests.
Dated: November 14, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.436 is amended as follows:
i. By designating the text following the heading in paragraph (a)
as paragraph (a)(1) and by revising the table in newly designated
paragraph (a)(1).
ii. Paragraph (b) is redesignated as paragraph (a)(2).
iii. New paragraphs (b), (c), and (d) are added and reserved with
headings.
The revised table to Sec. 180.436 reads as follows:
Sec. 180.436 Cyfluthrin; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa........................................ 5.0
Alfalfa, hay................................... 10.0
Aspirated grain fractions...................... 300
Carrots........................................ 0.20
Cattle, fat.................................... 5.0
Cattle, mbyp................................... 0.40
Cattle, meat................................... 0.40
Citrus, crop group............................. 0.2
Citrus, dried pulp............................. 0.3
Citrus, oil.................................... 0.3
Cottonseed..................................... 1.0
Cottonseed hulls............................... 2.0
Cottonseed oil................................. 2.0
Eggs........................................... 0.01
Goats, fat..................................... 5.0
Goats, mbyp.................................... 0.40
Goats, meat.................................... 0.40
Hogs, fat...................................... 5.0
Hogs, mbyp..................................... 0.40
Hogs, meat..................................... 0.40
Hops, dried.................................... 20.0
Hops, fresh.................................... 4.0
Horses, fat.................................... 5.0
Horses, mbyp................................... 0.40
Horses, meat................................... 0.40
Milkfat (reflecting 0.5 ppm in whole milk)..... 15.0
[[Page 63019]]
Peppers........................................ 0.50
Poultry, fat................................... 0.01
Poultry, mbyp.................................. 0.01
Poultry, meat.................................. 0.01
Radishes....................................... 1.0
Sheep, fat..................................... 5.0
Sheep, mbyp.................................... 0.40
Sheep, meat.................................... 0.40
Sorghum, fodder................................ 5.0
Sorghum, forage................................ 2.0
Sorghum, grain................................. 4.0
Sugarcane...................................... 0.05
Sugarcane, molasses............................ 0.20
Sunflower, forage.............................. 5.0
Sunflower, seed................................ 0.02
Tomato......................................... 0.20
Tomato, concentrated products.................. 0.5
Tomato, pomace................................. 5.0
------------------------------------------------------------------------
(2) * * *
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
Sec. 185.1250 [Removed]
b. In Sec. 185.1250:
i. Paragraph (c) introductory text, (c)(1), (c)(2), and (c)(3) are
transferred to Sec. 180.436 and redesignated as paragraph (a)(3)
introductory text, (a)(3)(i), (a)(3)(ii), and (a)(3)(iii),
respectively.
ii. The remainder of Sec. 185.1250 is removed.
PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 342, 348, and 701.
Sec. 186.1250 [Removed]
b. In Sec. 186.1250:
i. Paragraph (c) introductory text, (c)(1), (c)(2), and (c)(3) are
transferred to Sec. 180.436 and redesignated as paragraph (a)(4)
introductory text, (a)(4)(i), (a)(4)(ii), and (a)(4)(iii),
respectively.
ii. The remainder of Sec. 186.1250 is removed.
[FR Doc. 97-31101 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F