[Federal Register Volume 62, Number 43 (Wednesday, March 5, 1997)]
[Rules and Regulations]
[Pages 9979-9984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5415]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300457; FRL-5592-2]
RIN 2070-AB78


Clofencet; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes tolerances for the residues of the 
plant growth regulator (hybridizing agent) clofencet, [2-(4-
chlorophenyl)-3-ethyl-2,5-dihydro-5-oxo-4-pyridazinecarboxylic acid, 
potassium salt] expressed as the free acid, active ingredient code 
128726, CAS No. 82697-71-0 in or on the raw agricultural commodities 
wheat as a primary application; in or on the cereal grains group 
(except rice, wild rice, sweet corn and wheat) and soybeans as 
rotational crops; and in animal products. Monsanto Co. submitted a 
petition to EPA under the Federal Food, Drug and Cosmetic Act as 
amended by the Food Quality Protection Act of 1996 requesting the 
tolerances.

EFFECTIVE DATE:  This rule becomes effective March 5, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [OPP-300457], may be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
document control number and submitted to: Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, bring copy of objections and hearing 
requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
22202. 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 objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: <a href="/cdn-cgi/l/email-protection#81eef1f1ace5eee2eae4f5c1e4f1e0ece0e8edafe4f1e0afe6eef7"><span class="__cf_email__" data-cfemail="670817174a0308040c0213270217060a060e0b4902170649000811">[email protected]</span></a>. 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 in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number 
[OPP-300457]. 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. Additional information on electronic submissions can be 
found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Philip V. Errico, Product 
Manager (PM) 25, 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: Rm. 
241, CM #2, 1921 Jefferson Davis Highway., Arlington, VA 22202, (703) 
305-6027; e-mail: <a href="/cdn-cgi/l/email-protection#e28790908b818dcc928a8b8e8b92a28792838f838b8ecc879283cc858d94"><span class="__cf_email__" data-cfemail="2d485f5f444e42035d454441445d6d485d4c404c444103485d4c034a425b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 7, 1996 
(61 FR 41153), (PF-667; FRL-5388-7), EPA issued a notice announcing 
that Monsanto Company, 700 14th St., NW., Suite 1100, Washington, DC 
20005, had submitted pesticide petition 4F4346 to EPA which requested 
that the Administrator, pursuant to section 408 of the Federal Food, 
Drug and Cosmetic Act (FFDCA), amend 40 CFR part 180 to establish 
tolerances for residues of clofencet, [2-(4-chlorophenyl)-3-ethyl-2,5-
dihydro-5-oxo-4-pyridazinecarboxylic acid, potassium salt] expressed as 
the free acid, in or on the raw agricultural commodities: wheat grain 
at 250 parts per million (ppm), wheat hay at 40 ppm, wheat straw at 50 
ppm and wheat forage at 10 ppm; in the animal product commodities of 
cattle, goats, hogs, horses and sheep: fat at 0.04 ppm, kidney at 10 
ppm, meat at 0.15 ppm, meat by-products (except kidney) at 0.5 ppm and 
milk at 0.02 ppm; in animal product commodities of poultry: eggs at 1 
ppm, fat at 0.04 ppm, meat at 0.15 ppm and meat by-products at 0.20 
ppm; and rotational crop tolerances in the raw agricultural 
commodities: soybeans at 30 ppm, soybean hay at 10 ppm and soybean 
forage at 10 ppm; cereal grains group (except rice, wild rice, sweet 
corn and wheat): grain at 20 ppm, straw at 4 ppm, forage at 4 ppm, 
stover (fodder) at 1 ppm and hay at 15 ppm.
    In the Federal Register of December 12, 1996 (61 FR 65392), (PF-
678; FRL-5576-2), EPA issued a second notice to bring the Notice into 
conformity with the Food Quality Protection Act (FQPA) of 1996. The 
notice contained a summary of the petition prepared by the petitioner, 
Monsanto Co., including information and arguments to support its 
conclusion that the petition complied with FQPA. It was stated in the 
notice that the conclusions and arguments were not of the EPA.
    There were no comments received in response to the notices of 
filing.
    The data submitted in the petition and other relevant material have 
been evaluated. The toxicological data listed below were considered in 
support of these tolerances.

I. Toxicology Profile

    1. A battery of acute toxicity studies placing technical clofencet 
in toxicity category II for eye irritation, category III for oral 
LD<INF>50, category IV for inhalation LC<INF>50 and dermal irritation 
and category V for dermal LC<INF>50.
    2. A 90-day rat neurotoxicity study at doses of 0, 200, 2,000 or 
20,000 ppm (males = 0, 12.3, 124.5 or 1,232 milligrams per kilogram per 
day (mg/kg/day); females = 0, 15.2, 149.8 or 1,537.2 mg/kg/day) with a 
No Observed Effect Level (NOEL) of 2,000 ppm in females based on 
decreased body weight gain in females and 20,000 ppm in males. At the 
20,000 ppm (Highest Dose Tested (HDT)), no neurotoxicity was observed 
in either male or female rats.
    3. A 21-day rat dermal toxicity study at doses of 0, 100, 300 or 
1,000 mg/kg/day which showed no significant toxic effects at any dose 
tested with a systemic and dermal NOEL of 1,000 mg/kg/day.
    4. A 90-day dog feeding study at doses of 0, 10, 50, 200 or 500 mg/
kg/day with a NOEL of 50 mg/kg/day based on histological findings in 
the thymus and testes.
    5. A 90-day rat feeding study at doses of 0, 200, 1,000, 5,000 or 
20,000 ppm (males = 0, 12, 60, 311 or 1,207 mg/kg/day; females = 0, 15, 
75, 373 or 1,477 mg/kg/day) with a NOEL of 5,000 ppm in the diet based 
on decreased cumulative weight gain and slightly increased kidney 
weights in females.
    6. A rat developmental toxicity study at doses of 0, 100, 300 or 
1,000 mg/kg/day with a maternal and developmental NOEL of 1,000 mg/kg/
day HDT. There was no developmental toxicity considered to be the 
result of clofencet administration.
    7. A rabbit developmental toxicity study at doses of 0, 50, 150 or 
500 mg/kg/day) with a maternal and developmental NOEL of 150 mg/kg/day 
based on mortality, increased abortions and decreased body weight gain, 
decreased food consumption, lower fetal body weights, increased 
incidence of fetal hydrocephalus and an increase in

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the number of fetuses/litters with unossified bones.
    8. A rat two-generation reproduction study at dietary 
concentrations of 0, 500, 5,000 or 20,000 ppm (males = 0, 38, 393 or 
1,602 mg/kg/day; females = 0, 52, 529 or 2,044 mg/kg/day) with a 
maternal NOEL of 5,000 ppm based on suggestive increase in mortality, 
decrease in body weight/weight gains and lung pathology. The 
reproductive NOEL is 500 ppm based on an increase in pup mortality in 
F1a and F1b during lactation days 1 to 4 and decreased body weights 
during lactation.
    9. A 1-year dog chronic toxicity study at doses of 0, 5, 30 or 200 
mg/kg/day. The NOEL was 5 mg/kg/day based on liver and epididymal/
testicular effects.
    10. An 18-month mouse carcinogenicity study at doses of 0, 70, 300, 
3,000 or 7,000 ppm (males = 0, 11.45, 50.31, 501.20 or 1,228.22 mg/kg/
day; females = 0, 16.92, 70.67, 710.79 or 1,608.46 mg/kg/day) with a 
systemic NOEL of 3,000 ppm based on decreased survival as well as bone 
marrow myeloid hyperplasia, lung congestion and skin fibrosis in males 
and an increased incidence of histiocytic sarcomas in females at 7,000 
ppm (HDT).
    11. A 2-year rat chronic/carcinogenicity study at dietary doses of 
0, 100, 1,000, 10,000 or 20,000 ppm (males = 0, 4.7, 47, 470 or 989 
milligrams per kilogram of body weight per day (mg/kg bwt/day)); 
females = 0, 5.9, 58, 607 or 1,288 mg/kg bwt/day) with a systemic NOEL 
of 1,000 ppm based on hematuria, white/gray lung foci and kidney 
lesions. Clofencet at 20,000 ppm (HDT) may cause an increase in the 
number of animals with hepatocellular carcinomas and adenomas/
carcinomas in males and an increase in thyroid C-cell adenomas in males 
and females.
    12. A metabolism study in rats indicated that clofencet was rapidly 
absorbed and excreted by 7 days post-dosing, with the majority of the 
administered <SUP>14C-label (>78%) eliminated in the urine within 24 
hours. Analysis of the excreta indicated that <SUP>14C MON 21200 was 
eliminated mostly unmetabolized in the urine (87.9 to 92.1% of the 
administered dose) and in the feces (4.5 to 9.1% of the administered 
dose). Less than 1% was of the administered <SUP>14C-label was 
eliminated as expired CO<INF>2. Less than 1% was retained in the tissue 
at 7 days post-dosing, indicating low bioaccumulation. There were no 
apparent sex- or dose-related differences in the absorption, 
distribution, metabolism or elimination.
    13. Acceptable studies on gene mutation and other genotoxic 
effects: Ames Salmonella Assay; CHO/HGPRT Point Mutation Assay; In 
Vitro Cytogenetics Assay in Human Lymphocytes; Mouse Micronucleus 
Assay; and In Vivo/In Vitro Hepatocyte DNA Repair Assay yielded 
negative results.

II. Dose Response Assessment

    Reference dose (RfD). The RfD represents the level at or below 
which daily aggregate dietary exposure over a lifetime will not pose 
appreciable risks to human health. The RfD is determined by using the 
toxicological end-point or the NOEL for the most sensitive mammalian 
toxicological study. To assure the adequacy of the RfD, the Agency uses 
an uncertainty factor in deriving it. The factor is usually 100 to 
acount for both interspecies extrapolation and intraspecies variability 
represented by the toxicological data. The EPA has determined a RfD of 
0.05 mg/kg/day with an uncertainty factor of 100 for this risk 
assessment, based on a NOEL of 5.0 mg/kg/day from a 1-year feeding 
study in dogs which demonstrated the effect of epididymitis, tubular 
degeneration and absence of spermatozoa as endpoint effects.
    Carcinogenicity classification. Using the Guidelines for 
Carcinogenic Risk Assessment published September 24, 1986 (51 FR 
33992), the EPA has classified clofencet as Group ``C'' for 
carcinogenicity (possible human carcinogen) based on the increase in 
histiocytic sarcomas (malignant) by both pair-wise and trend analyses 
in female mice. The thyroid C-cell tumors in male rats (mainly benign) 
were considered to have occurred only at an excessive dose. There were 
no apparent genotoxicity concerns and little additional support for 
carcinogenicity based on structure-activity relationship (SAR) with a 
related wheat hybridizing agent, fenridazon; therefore, the EPA's 
Carcinogenicity Peer Review Committee recommended that for the purpose 
of risk characterization, the RfD approach be used for quantitation of 
human risk.

III. Residential Exposure Assessment

    The toxicological endpoint of concern for residential exposure is 
systemic toxicity resulting from chronic exposure. There are no 
proposed residential uses for clofencet and it is not likely to be 
applied in or near residential areas; therefore, there are no 
residential risk concerns.

IV. Dietary Exposure Assessment

    Use of a pesticide results or may reasonably be expected to result, 
directly or indirectly, in pesticide residues in food. Primary residues 
or indirect/inadvertent residues in agricultural commodities are 
determined by chemical analysis. To account for the diversity of 
growing conditions, cultural practices, soil types, climatic 
conditions, crop varieties and methods of application of the pesticide, 
data from studies that represent the commodities are collected and 
evaluated to determine an appropriate level of residue that would not 
be exceeded if the pesticide is used as represented in the studies.
    1. Plant/animal metabolism and magnitude of the residue. The nature 
of the residue (metabolism) of clofencet in plants and animals is 
adequately understood for the purposes of these tolerances. There are 
no Codex maximum residue levels established for residues of clofencet 
on wheat or the rotational crops. The residue of concern to be 
regulated is the parent, clofencet.
    2. Residue analytical methods. The analytical method proposed for 
detecting and measuring levels of clofencet in or on the commodities 
with a limit of detection that allows monitoring of food with residues 
at or above the levels set in the tolerance for primary and rotational 
crops includes derivatization of clofencet to its methyl ester followed 
by analysis via gas chromatography with electron capture detection, 
however, for rotational crops, it is necessary to first hydrolyze 
clofencet-sugar conjugates to clofencet before proceeding with 
derivatization. The method for animal tissues includes derivatization 
of clofencet to its methyl ester followed by analysis via HPLC with UV 
detection. For milk and eggs, analysis is achieved by extraction, 
concentration and direct analysis via HPLC with UV detection. EPA will 
provide information on this method to the Food and Drug Administration 
(FDA). Because of the long lead time from establishing these tolerances 
to publication, the enforcement methodology is being made available in 
the interim to anyone interested in pesticide enforcement when 
requested by mail from: Calvin Furlow, Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Rm. 1130A, 
CM #2, 1921 Jefferson-Davis Highway, Arlington, VA 22202, (703) 305-
5937.

[[Page 9981]]

    The presence of the pesticide or degradates of the pesticide in 
potable water may also be a source of dietary exposure that must be 
considered in establishing a tolerance level for an agricultural 
commodity.

V. Aggregate Exposures Assessment

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food, including water, and all other non-occupational exposures. The 
aggregate sources of exposure the Agency looks at include food, 
drinking water or groundwater, and exposure through pesticide use in 
gardens, lawns, or buildings (residential and other indoor uses).
    1. Acute dietary. There is no concern for acute effects due to 
dietary exposure to clofencet.
    2. Chronic dietary. Tolerances in this petition are based on 
residues from field trial data. Using the Dietary Risk Evaluation 
System (DRES), a routine chronic exposure analysis was based on 0.1% 
crop treated and on tolerance values for wheat and rotational crops 
listed in this petition. Although percent crop treated were used, the 
estimate is conservative, since it is assumed that 100% of the fields 
treated with clofencet in the United States are rotated to cereal 
grains group crops (except rice, wild rice, sweet corn and wheat) and 
soybeans at the same time. At this time, there is no concern for 
chronic effects due to exposure of clofencet in the diet.
    3. Drinking water. Because the Agency lacks specific water- related 
exposure data for most pesticides, EPA has commenced and nearly 
completed a process to identify a reasonable yet conservative bounding 
figure for the potential contribution of water related exposure to the 
aggregate risk posed by a pesticide. In developing the bounding figure, 
EPA estimated residue levels in water for a number of specific 
pesticides using various data sources. The Agency then applied the 
estimated residue levels, in conjunction with appropriate toxicological 
endpoints (RfD's or acute dietary NOEL's) and assumptions about body 
weight and consumption, to calculate, for each pesticide, the increment 
of aggregate risk contributed by consumption of water containing that 
pesticide. This analysis is included in the docket for this rulemaking. 
While EPA has not yet pinpointed the appropriate bounding figure for 
consumption of water containing pesticides, the ranges the Agency is 
continuing to examine are all well below the level that would cause 
clofencet to exceed the RfD by granting the tolerances being considered 
in this document. The Agency has therefore concluded that the potential 
exposures associated with clofencet in water, even at the higher levels 
the Agency is considering as a conservative upper bound, will not 
prevent the Agency from determining that there is a reasonable 
certainty of no harm.
    4. Non-occupational non-dietary. Since the proposed use does not 
involve residential use and since clofencet is not likely to be used in 
or near residential areas, non-occupational non-dietary exposure is not 
expected.
    5. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also policies and methodologies for 
conducting cumulative risk assessments. While the Agency has some 
information in its files that may be helpful in determining whether a 
pesticide shares a common mechanism of toxicity with any other 
substances, EPA does not at this time have the methodology to resolve 
the 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 enable it 
to develop and apply policies for evaluating the cumulative effects of 
chemicals having a common mechanism of toxicity. At present, however, 
the Agency does not know how to apply the information in its files 
concerning common mechanism issues to most risk assessments.
    In making individual tolerance decisions, the Agency will determine 
whether: (1) It has sufficient information to determine that a 
pesticide does not appear to share a common mechanism of toxicity with 
other substances; or (2) it is unable to conclude that a pesticide does 
not share a common mechanism of toxicity with other substances.
    For pesticides falling into the first category, the Agency will 
explain its determination and factor the determination into the 
tolerance decision. For pesticides falling into the second category, 
the Agency will conclude that it does not have sufficient available 
information concerning common mechanism of toxicity to scientifically 
apply that information to the tolerance decision, the tolerance 
decision will be reached based upon the best available and useful 
information for the individual chemical, and a risk assessment will be 
performed for the tolerance action assuming that no common mechanism of 
toxicity exists. However, tolerance decisions falling into the second 
category will be reexamined by the Agency after EPA establishes 
methodologies and procedures for integrating information concerning 
common mechanism into its risk assessments. In such circumstances, 
related registration actions may be conditioned upon the provision of 
such data as may be necessary to evaluate common mechanism of toxicity 
issues in a risk assessment.
    In the case of clofencet, EPA has not yet determined whether or how 
to include this chemical in a cumulative risk assessment. This 
tolerance determination therefore does not take into account common 
mechanism issues. After EPA develops a methodology for applying common 
mechanism of toxicity issues to risk assessments, the Agency will 
develop a process (either as part of the periodic review of pesticides 
or otherwise) to reexamine those tolerance decisions made earlier. The 
registrant must submit, upon EPA's request and according to a schedule 
determined by the Agency, such information as the Agency directs to be 
submitted in order to evaluate issues related to whether clofencet 
share(s) a common mechanism of toxicity with any other substance and, 
if so, whether any tolerances for clofencet needs to be modified or 
revoked.

VI. Determination of Safety for the U.S. Population and Non-nursing 
Infants

    Using the Dietary Risk Evaluation System (DRES), a routine chronic 
dietary exposure analysis was based on use of 0.1% of the wheat crop 
treated, and 0.1% of the cereal grains group crops (except rice, wild 
rice, sweet corn and wheat) and soybeans as rotated crops in fields 
previously containing wheat treated with clofencet, and tolerance 
levels established in this document. Percent crop treated of 0.1% is 
based on the petitioner's expectations that up to 33,000 acres of wheat 
grown for seed will be treated in the year 2000. This 33,000 acres is 
0.05% of the approximate 70,000,000 acres of wheat which is grown for 
grain in the United States. Pursuant to section 408(b)(2)(F) of FFDCA 
as amended, the Agency may, when assessing chronic dietary risk, 
consider available data and information on the percent of food actually 
treated

[[Page 9982]]

with the pesticide chemical, and finds that the data are reliable and 
provides a valid basis to show what percentage of the food derived from 
such crop is likely to contain such pesticide chemical residue, finds 
that the exposure estimate does not understate exposure for any 
significant subpopulation group, finds that, if data are available on 
pesticide use and consumption of food in a particular area, the 
population in such area is not dietarily exposed to residues above 
those estimated by the Agency, and provides for the periodic 
reevaluation of the estimate of anticipated dietary exposure.
    The Agency believes the above conditions have been met for the 
conditions stated above. Based on the available information and the use 
of this conservative risk assessment, EPA finds the exposure estimate 
does not understate exposure for any significant subpopulation group. 
Also, EPA has no data that show clofencet use on wheat grown for seed, 
and consumption of food in a particular area differ significantly from 
that used in the conservative risk assessment stated herein. 
Registration of end-use product(s) containing clofencet conditioned on 
production of no more clofencet than necessary to treat no more than 
35,000 acres per year. The additional 2,000 acres was requested by the 
registrant, and does not significantly effect the results of this risk 
determination. Before the petitioner can increase production of product 
for treatment of greater than 35,000 acres per year, permission from 
the Agency must be obtained. The petitioner must also provide annual 
reports on production of end-use products containing clofencet, number 
of acres treated, and a best estimate of which crops and how many acres 
were planted as rotational crops on fields previously planted to wheat 
treated with clofencet. The registrant must also provide field residue 
data on wheat grain, forage, hay and straw from commercially treated 
crop beginning 18 months after wheat grain is first harvested. Field 
residue trials on the rotated crops listed in this document may also be 
required. The Agency will provide for periodic reevaluation of the 
dietary exposure, if warranted, with percent crop treated, acres of 
wheat treated, end-use product production information provided by the 
petitioner and other available sources, and submitted field residue 
data. The reason for using 0.1% instead of 0.05% crop treated is to 
allow expansion of use if other conditions of registration are 
satisfied. Before expansion beyond 0.1% is allowed, reevaluation of the 
dietary exposure may be performed using all available information as 
necessary.
    Based on the conservative dietary assessment presented above, the 
proposed use of clofencet uses 0.73% of the RfD for the U.S. population 
and for the most highly exposed subgroups, 0.6% for non-nursing infants 
(<1 year old), 1.6% for children (1 to 6 years old) and 1.2% for 
children (7 to 12 years old). The risk estimate from combined food and 
water sources is expected to be below 25% of the RfD even with the 
addition of a reasonable bounding figure for the contribution from 
drinking water. EPA concluded there is a reasonable certainty that no 
harm will occur from aggregate exposure to clofencet for this directed 
use on wheat and the subsequent rotational crops [cereal grains group 
(except rice, wild rice, sweet corn and wheat) and soybeans].

VII. Determination of Safety for Infants and Children

    Risk to infants and children was determined by the use of the two 
developmental toxicity studies in rats and rabbits and the two-
generation reproduction study in rats noted above. The developmental 
toxicity studies evaluates the potential for adverse effects on the 
developing organism resulting from exposure during prenatal development 
to the female parent. The reproduction study provides information 
relating to effects from exposure to the chemical on the reproductive 
capability of both (mating) parents and on systemic toxicity.
    FFDCA section 408 provides that the EPA shall apply an additional 
safety factor of 10 in the case of threshold effects for infants and 
children to account for pre- and post-natal toxicity and the 
completeness of the database unless EPA determines, based on reliable 
data, that a different safety factor would be appropriate. EPA believes 
that reliable data support using a different safety factor (usually 
100X (100 times)) and not the additional safety factor when EPA has a 
complete data base and when the severity of the effect in infants or 
children or the potency or unusual toxic properties of a compound do 
not raise concerns regarding the adequacy of the traditional safety 
factors. The Agency believes that an additional safety factor for 
infants and children is not warranted here. First, a complete set of 
developmental and reproductive studies have been submitted and EPA has 
found them to be acceptable. Second, since the NOELs from the 
developmental and reproductive studies are 7.6X to 200X (7.6 times to 
200 times) higher than the NOEL used for the RfD, the Agency does not 
believe the effects seen in these studies are of such concern to 
require an additional safety factor. Accordingly, the Agency believes 
the RfD has an adequate margin of protection for infants and children. 
The percent of the RfD that would be utilized by the aggregate exposure 
to clofencet will range from 0.6% for non-nursing infants to 1.6% for 
children 1 to 6 years old. EPA concluded that there is reasonable 
certainty that no harm will occur to infants and children from 
aggregate exposure to clofencet.

VIII. Other Considerations

    Endocrine effects. No specific tests have been conducted with 
clofencet to determine whether the chemical may have an effect in 
humans that is similar to an effect produced by a naturally occuring 
estrogen or other endocrine effects. However, there were no significant 
findings in other relative toxicity studies, i.e., teratology and 
multi-generation reproductive studies, which would suggest that 
clofencet produces these kinds of effects.

IX. 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 
the new section 408(e) and (1)(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 governs 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 May 5, 1997 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 below (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 issue(s) on

[[Page 9983]]

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). 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 issue(s) in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). Information submitted in connection with an 
objection or hearing request may be claimed confidential by marking any 
part or all of that information as ``Confidential Business 
Information'' (CBI). Information marked as CBI 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.

X. Public Docket

    A record has been established for this rulemaking and all written 
comments for this rule under docket number [OPP-300457]. A public 
version of this record, 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 Response and Program Resources Branch, Field 
Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA. EPA has also established a special record for 
post-FQPA tolerances which contains documents of general applicability. 
This record can be found in the same location.
    Electronic comments may be sent directly to EPA at:
    <a href="/cdn-cgi/l/email-protection#8fe0ffffa2ebe0ece4eafbcfeaffeee2eee6e3a1eaffeea1e8e0f9"><span class="__cf_email__" data-cfemail="adc2dddd80c9c2cec6c8d9edc8ddccc0ccc4c183c8ddcc83cac2db">[email protected]</span></a>.


    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, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place paper copies in 
the official rulemaking record.

XI. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements subject 
to approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., 
it is not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty, or contain 
any ``unfunded mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, 1993), or special considerations as required by Executive 
Order 12898 (59 FR 7629, February 16, 1994).
    Because tolerances established on the basis of a petition under 
section 408(d) of FFDCA do not require issuance of a proposed rule, the 
regulatory flexibility analysis requirements of the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 604(a), do not apply. Prior to the 
recent amendment of the FFDCA, EPA had treated such rulemakings as 
subject to the RFA; however, the amendments to the FFDCA clarify that 
no proposal is required for such rulemakings and hence that the RFA is 
inapplicable.
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA 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 the 
rule in today's Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

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

    Dated: February 24, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 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. By adding Sec. 180.497, to read as follows:


Sec. 180.497   Clofencet; tolerances for residues.

    (a) Tolerances--general. Tolerances are established for the plant 
growth regulator (hybridizing agent) clofencet, [2-(4-chlorophenyl)-3-
ethyl-2,5 dihydro-5-oxo-4-pyridazinecarboxylic acid, potassium salt] 
expressed as the free acid in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                              Parts per 
                        Commodities                            million  
------------------------------------------------------------------------
Cattle, fat................................................         0.04
Cattle, kidney.............................................         10.0
Cattle, mbyp (except kidney)...............................          0.5
Cattle, meat...............................................         0.15
Eggs.......................................................          1.0
Goats, fat.................................................         0.04
Goats, kidney..............................................         10.0
Goats, mbyp (except kidney)................................          0.5
Goats, meat................................................         0.15
Hogs, fat..................................................         0.04
Hogs, kidney...............................................         10.0
Hogs, mbyp (except kidney).................................          0.5
Hogs, meat.................................................         0.15
Horses, fat................................................         0.04
Horses, kidney.............................................         10.0
Horses, mbyp (except kidney)...............................          0.5
Horses, meat...............................................         0.15
Milk.......................................................         0.02
Poultry, fat...............................................         0.04
Poultry, mbyp..............................................         0.20
Poultry, meat..............................................         0.15
Sheep, fat.................................................         0.04
Sheep, kidney..............................................         10.0
Sheep, mbyp (except kidney)................................          0.5
Sheep, meat................................................         0.15
Wheat, forage..............................................         10.0
Wheat, grain...............................................        250.0
Wheat, hay.................................................         40.0
Wheat, straw...............................................         50.0
------------------------------------------------------------------------

    (b) Tolerances for Indirect or inadvertent residues.  Tolerances 
are established for indirect or inadvertent residues of the plant 
growth regulator (hybridizing agent) clofencet, [2-(4-chlorophenyl)-3-
ethyl-2,5-dihydro-5-oxo-4-pyridazinecarboxylic acid, potassium salt] 
expressed as the free acid in or on the following raw agricultural 
commodities when present therein as a result of the application of 
clofencet to the growing crops in paragraph (a) of this section:

------------------------------------------------------------------------
                                                              Parts per 
                        Commodities                            million  
------------------------------------------------------------------------
Cereal grains group (except rice, wild rice, sweet corn and             
 wheat), forage............................................          4.0

[[Page 9984]]

                                                                        
Cereal grains group (except rice, wild rice, sweet corn and             
 wheat, grain..............................................         20.0
Cereal grains group (except rice, wild rice, sweet corn and             
 wheat), hay...............................................         15.0
Cereal grains group (except rice, wild rice, sweet corn and             
 wheat), stover (fodder)...................................          1.0
Cereal grains group (except rice, wild rice, sweet corn and             
 wheat), straw.............................................          4.0
Soybeans...................................................         30.0
Soybean, forage............................................         10.0
Soybean, hay...............................................         10.0
------------------------------------------------------------------------

[FR Doc. 97-5415 Filed 3-4-97; 8:45 am]
BILLING CODE 6560-50-F


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