[Federal Register Volume 62, Number 182 (Friday, September 19, 1997)]
[Rules and Regulations]
[Pages 49158-49163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24939]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300550; FRL-5744-2]
RIN 2070-AB78
Cloransulam-methyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
cloransulam-methyl in or on soybeans, soybean forage and soybean hay.
DowElanco requested this tolerance 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 September 19, 1997. Objections and
requests for hearings must be received by EPA on or before November 18,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300550], 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-300550], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), 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-300550]. 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: James A. Tompkins,
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) 305-5697, e-mail:
tompkins.jim@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 26, 1997
(52 FR 14421)(FRL-5592-8), EPA, issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide petition (PP) 5F4560 for tolerance
by DowElanco, 9330 Zionville Road, Indianapolis, IN 46268-1054. This
notice included a summary of the petition prepared by DowElanco. There
were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180 be amended by establishing
tolerances for residues of the herbicide cloransulam-methyl, N-(2-
carboxymethyl-6-chlorophenyl)-5-ethoxy-7-fluoro-(1,2,4)-triazolo[1,5c]-
pyrimidine-2-sulfonamide, in or on soybean seed at 0.02 parts per
million (ppm), soybean forage at 0.1 ppm, and soybean hay at 0.2 ppm.
The tolerance expression is being editorially amended to read
cloransulam-methyl plus its acid, cloransulam, calculated as parent
ester.
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 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
[[Page 49159]]
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 percent 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 3
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 groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
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
[[Page 49160]]
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.
Percent of crop treated estimates are derived from Federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants <1 year="" old)="" was="" not="" regionally="" based.="" 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="" cloransulam-methyl,="" n-(2-carboxymethyl-6-chlorophenyl)-5-ethoxy-7-="" fluoro-(1,2,4)-triazolo[1,5c]-pyrimidine-2-sulfonamide,="" and="" to="" make="" a="" determination="" on="" aggregate="" exposure,="" consistent="" with="" section="" 408(b)(2),="" tolerances="" for="" residues="" of="" cloransulam-methyl="" plus="" its="" acid,="" cloransulam,="" calculated="" as="" parent="" ester="" on="" soybean="" seed="" at="" 0.02="" ppm,="" soybean="" forage="" at="" 0.1="" ppm,="" and="" soybean="" hay="" at="" 0.2="" ppm.="" epa's="" assessment="" of="" the="" dietary="" exposures="" and="" risks="" associated="" with="" establishing="" the="" tolerance="" follows.="" a.="" toxicological="" profile="" epa="" has="" evaluated="" the="" available="" toxicity="" data="" and="" considered="" its="" validity,="" completeness,="" and="" reliability="" as="" well="" as="" the="" relationship="" of="" the="" results="" of="" the="" studies="" to="" human="" risk.="" epa="" has="" also="" considered="" available="" information="" concerning="" the="" variability="" of="" the="" sensitivities="" of="" major="" identifiable="" subgroups="" of="" consumers,="" including="" infants="" and="" children.="" the="" nature="" of="" the="" toxic="" effects="" caused="" by="" cloransulam-methyl="" are="" discussed="" below.="" 1.="" a="" rat="" acute="" oral="" study="" with="" a="">50 greater than 5,000
milligrams (mg)/kilogram (kg) for males and for females.
2. A 90-day mouse feeding study with a No Observed Effect Level
(NOEL) of 50 mg/kg/day for males and a Lowest Observed Effect Level
(LOEL) of 100 mg/kg/day for males based on increased levels of alkaline
phosphatase and increased liver weights and an increase in the size of
hepatocytes.
3. A 21-day rabbit dermal study with a Dermal Irritation NOEL
greater than 1,000 mg/kg/day for males and females and with a Systemic
NOEL of 500 mg/kg/day (males and females) and a Systemic LOEL of 1,000
mg/kg/day based on decreased red cell count, hemoglobin and hematocrit,
anisocytosis and macrocytosis of red cells for females.
4. A carcinogenicity study in mice with a NOEL of 10 mg/kg/day for
both sexes and a LOEL of 100 mg/kg/day (males and females) based on a
decrease in renal tubule vacuolation in male mice, increased size of
centrilobular and midzonal hepatocytes accompanied by altered
tinctorial properties in females and centrilobular hepatocyte
hypertrophy in males. Total tumor incidence (adenoma + carcinoma) was
not increased by dosing with cloransulam-methyl.
5. A rat chronic feeding/carcinogenicity study with a NOEL of 75
mg/kg/day and LOEL of 325 mg/kg/day for both sexes based on significant
increase in hemoglobin, hematocrit, and red cell count in males,
activities of the liver enzymes aspartate and alanine aminotransferase
as well as alkaline phosphatase were decreased in males, cholesterol
was decreased in females, specific gravity of urine was decreased in
females, increased relative wight in liver and relative weight of
testes in males, males exhibited an increased incidence of collecting
duct hypertrophy and females exhibited increased incidence of
vacuolation in the kidney. There was no evidence of carcinogenicity for
cloransulam-methyl in this study.
6. A dog chronic feeding study with a NOEL of 10 mg/kg/day and a
LOEL of 50 mg/kg/day based on hepatocellular hypertrophy and
accumulation of pigment, and increased activity of alkaline phosphatase
and alanine aminotransferase liver enzymes and decrease in albumin and
total bilirubin.
7. A two-generation reproduction study in rats with a Parental
Systemic Toxicity NOEL of 10 mg/kg/day and a Parental Systemic Toxicity
LOEL of 100 mg/kg/day ppm based on hypertrophy of the collecting ducts
and vacuolation consistent with fatty changes. The Reproductive and
Developmental NOEL is 100 mg/kg/day and the Reproductive and
Developmental LOEL is 500 mg/kg/day based on decreased live pups and
increased pup deaths.
8. A developmental toxicity study in rabbits with a Maternal NOEL
of 100 mg/kg/day and Developmental NOEL of 300 mg/kg/day (Highest Dose
Tested [HDT]) and a Maternal LOEL of 300 mg/kg/day based on reduced
weight gain, food efficiency, increased abortions, and cesarean section
observations.
9. A developmental toxicity study in rats with a Maternal NOEL and
Developmental NOEL of 1,000 mg/kg/day (HDT).
10. In a mouse micronucleus assay no lethality or evidence of
target tissue cytotoxicity and no significant increase in frequency of
micro nucleated polychromatic erythrocytes were observed. In two
cytogenetic assays, cloransulam-methyl did not induce either cytotoxic
or clastogenic effects in rat lymphocytes. In a cultured chinese
hamster ovary cell study, cloransulam-methyl was neither cytotoxic nor
mutagenic.
11. A rat metabolism study showed that radio labeled cloransulam-
methyl was excreted mainly via urine in females and urine and feces in
males. Less than 0.1% of administered dose was found in any tissue at
72 hours post-dose.
B. Toxicological Endpoints
1. Acute toxicity. EPA has concluded that a risk estimate is not
required since no endpoint exists to suggest any evidence of
significant toxicity from one-day or single-event exposure.
2. Short - term and intermediate - term toxicity. EPA has
concluded that available evidence does not indicate any evidence of
significant toxicity from short and intermediate term exposure.
3. Chronic toxicity. EPA has established the RfD for cloransulam-
methyl at 0.1 milligrams/kilogram/day (mg/kg/day). This RfD is based on
the systemic NOEL of 10 mg/kg/day in the dog chronic feeding study with
a 100-fold safety factor to account for interspecies extrapolation and
intraspecies variability.
4. Carcinogenicity. The Health Effects Division Carcinogenicity
Peer Review Committee has classified cloransulam-methyl as ``not
likely'' to be carcinogenic to humans based on the lack of
carcinogenicity in rats and mice.
C. Exposures and Risks
1. From food and feed uses. The proposed tolerances would be the
first tolerances established in 40 CFR part 180 for the residues of
cloransulam-
[[Page 49161]]
methyl plus its acid, cloransulam, calculated as parent ester in or on
raw agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures and risks from cloransulam-methyl as follows:
The dietary risk assessment uses very conservative assumptions that
100% of the soybeans will contain cloransulam-methyl residues and that
these residues would be at the tolerance level. The theoretical maximum
residue contribution (TMRC) from the proposed tolerances is 0.000007
mg/kg/day and utilizes 0.007 percent of the RfD for the overall U. S.
population. For exposure of the most highly exposed subgroup in the
population, non-nursing infants, the TMRC is 0.000033 mg/kg/day which
utilizes 0.033 percent of the RfD.
2. From drinking water. Cloransulam-methyl concentration in surface
water has been estimated by using the Generic Expected Environmental
Concentrations (GENEEC) model. The worst case exposure estimate for
surface water is 1.83 parts per billion (ppb). Based on the estimated
exposures to Cloransulam-methyl from drinking water, the percentage of
the RfD utilized for a child would be 0.183% of the Reference Dose
(RfD). The exposure for a female would be 0.061% of the RfD.
3. From non-dietary exposure. There are no non-food uses of
cloransulam-methyl currently registered under the Federal Insecticide,
Fungicide and Rodenticide Act, as amended. No non-dietary exposures are
expected for the general population.
4. Cumulative exposure to substances with common mechanism of
toxicity. Cloransulam-methyl is a triazolopyrimidine sulfonamide
herbicide. Another member of this class is Flumetsulam. 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 does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether cloransulam-methyl 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,
cloransulam-methyl does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that cloransulam-methyl has a
common mechanism of toxicity with other substances.
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute, short-term, and intermediate-term risk. EPA has concluded
that no endpoint exists to suggest any evidence of significant toxicity
from acute, short-term or intermediate-term exposures from the use of
cloransulam-methyl on soybeans.
2. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
cloransulam-methyl from food and drinking water will utilize less than
0.061% of the RfD for females 20 years old (not pregnant - not
nursing). For the major identifiable subgroup with the highest
aggregate exposure, non-nursing infants, the aggregate exposure to
cloransulam-methyl from food and drinking water will utilize less than
0.216% of the RfD. EPA generally has no concern for exposures below
100% of the RfD because the RfD represents the level at or below which
daily aggregate dietary exposure over a lifetime will not pose
appreciable risks to human health.
E. Aggregate Cancer Risk for U.S. Population
EPA has classified cloransulam-methyl as ``not likely'' to be
carcinogenic to humans based on the lack of carcinogenicity in rats and
mice.
F. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children. a. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of cloransulam-methyl, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. Reproduction studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
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 database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise
[[Page 49162]]
concerns regarding the adequacy of the standard MOE/safety factor.
b. Developmental and Reproductive toxicity studies. The pre- and
post-natal toxicology data base for cloransulam-methyl is complete with
respect to current toxicological data requirements. The results of
these studies indicate that infants and children are not more sensitive
to exposure, based on the results of the oral rat and rabbit
developmental toxicity studies and the 2-generation reproductive
toxicity study in rats. Therefore, EPA concludes that an additional
ten-fold safety factor is not necessary.
2. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
cloransulam-methyl from food and drinking water will utilize less than
0.216% of the RfD for infants and children. EPA generally has no
concern for exposures below 100% of the RfD because the RfD represents
the level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. EPA concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to cloransulam-methyl
residues.
III. Other Considerations
A. Metabolism In Plants and Animals
The metabolism of cloransulam-methyl in plants and animals is
adequately understood for purposes of this tolerance.
B. Analytical Enforcement Methodology
An adequate analytical method, Capillary Gas Chromatography with
Mass Spectrometry is available for enforcement purposes. Because of the
long lead time from establishing these tolerances to publication of the
enforcement methodology in the Pesticide Analytical Manual, Vol. II,
the analytical methodology is being made available in the interim to
anyone interested in pesticide enforcement when requested from: Calvin
Furlow, Public Information and Records Integrity Branch, Information
Resources and Services Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Room 1130A, CM #2, 1921 Jefferson
Davis Highway, Arlington, VA 22202, (703-305-5937).
C. Magnitude of Residues
The nature of the residue in plants is adequately understood for
the purposes of this tolerance. Based on the results of animal
metabolism studies it is unlikely that significant residues would occur
in secondary animal commodities from this use.
D. Rotational Crop Restrictions
No tolerances for inadvertent residues of cloransulam-methyl are
required in rotational crops. The restrictions that appear on the
labeling proposed for registration under the Federal Insecticide
Fungicide and Rodenticide Act (FIFRA), as amended, are due to potential
of phytotoxicity to susceptible plants.
E. International Residue Limits
There are no Codex Alimentarius Commission (Codex) Maximum Residue
Levels (MRLs) for cloransulam-methyl.
IV. Conclusion
The analysis for cloransulam-methyl using tolerance level residues
for all population subgroups examined by EPA shows the use on soybeans
will not cause exposure at which the Agency believes there is an
appreciable risk. Based on the information cited above, EPA has
determined that establishing tolerances for residues of cloransulam-
methyl plus its acid, cloransulam, calculated as parent ester in or on
soybean seed at 0.02 parts per million (ppm), soybean forage at 0.1
ppm, and soybean hay at 0.2 ppm will be safe; therefore, the tolerances
are established as set forth below.
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 November 18, 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 above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as
Confidential Business Information (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-300550] (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 (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, 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 from of encryption.
[[Page 49163]]
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 in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 29, 1997.
Daniel M. Barolo,
Director, 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. By adding Sec. 180.514 to read as follows:
Sec. 180.514 Cloransulam-methyl; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide, cloransulam-methyl, N-(2-carboxymethyl-6-chlorophenyl)-5-
ethoxy-7-fluoro-(1,2,4)-triazolo[1,5c]-pyrimidine-2-sulfonamide, plus
its acid, cloransulam, calculated as parent ester in or on the
following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Soybean, forage............................................ 0.1
Soybean, hay............................................... 0.2
Soybean seed............................................... 0.02
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-24939 Filed 9-18-97; 8:45 am]
BILLING CODE 6560-50-F
