[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]
[[Page 9979]]
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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: 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 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: errico.philip@epamail.epa.gov.
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
LD50, category IV for inhalation LC50 and dermal irritation
and category V for dermal LC50.
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
[[Page 9980]]
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 14C-label (>78%) eliminated in the urine within 24
hours. Analysis of the excreta indicated that 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 14C-label was
eliminated as expired CO2. 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:="">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, 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
