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Diclosulam (DowAgro). March 8, 2000. Pesticide Tolerances in or on soybean and peanut at 0.02 ppm. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2000/March/Day-08/p5635.htm
[Federal Register: March 8, 2000 (Volume 65, Number 46)]
[Rules and Regulations]
[Page 12129-12134]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr00-20]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300977; FRL-6492-3]
RIN 2070-AB78
Diclosulam; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
diclosulam, N-(2,6-dichlorophenyl)-5-ethoxy-7-
fluoro[1,2,4]triazolo[1,5-c]pyrimidine-2-sulfonamide], in or on soybean
seed and peanut nutmeat. Dow AgroSciences requested this tolerance
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.
DATES: This regulation is effective March 8, 2000. Objections and
requests for hearings, identified by docket control number OPP-300977,
must be received by EPA on or before May 8, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300977 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703)
[[Page 12130]]
305-5697; and e-mail address: Tompkins.Jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300977. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2 (CM #2), 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of November 20, 1998 (63 FR 64484) (FRL-
6030-9), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of a pesticide petition (PP) for a tolerance by
Dow AgroSciences. This notice included a summary of the petition
prepared by Dow AgroSciences, the registrant. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of the herbicide diclosulam, in
or on soybean and peanut at 0.02 part per million (ppm).
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 certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. * * *''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of diclosulam on soybean seed
and peanut nutmeat at 0.020 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 diclosulam are
discussed in this unit.
In general, the toxicology studies conducted on diclosulam
demonstrate that it has few or no biologically significant toxic
effects at relatively low-dose levels in many animal studies.
Diclosulam generally has low acute toxicity (Toxicity Category III) and
is not a dermal sensitizer. The BF-564 (84.3% active ingredient (a.i.))
appeared to be slightly more irritating to the skin and eye than XDE-
564 (97.6% a.i.). No significant treatment-related effects were noted
in 21-day dermal studies in rabbits. Based on oral feeding studies, the
primary target organs are the liver and kidney. In a subchronic rat
feeding study, the primary target organ is the liver including
increased relative organ weight, hepatocellular hypertrophy, and slight
multifocal necrosis. Decreased body weight and kidney lesions were also
noted. Liver effects were also noted in a subchronic dog study and
included increased relative liver weight, centrilobular hepatocellular
changes, and hepatocellular necrosis accompanied by elevated ALP, AST,
and ALT. Other effects were decreased body weight, decreased food
consumption, and renal changes in addition to hematological and
clinical chemistry effects that were considered
[[Page 12131]]
secondary to the debilitated condition of the animals. In a chronic
toxicity/oncogenicity study in the rat, the kidney is identified as a
target organ. Changes in clinical chemistry and urinalysis parameters
(indicative of altered renal tubule function) included increased
creatinine, decreased urine specific gravity, increased urine volume,
and decreased urinary protein concentration; also, microscopic renal
tubular pathology was noted. The kidney was also a target organ in a
mouse carcinogenicity study. Among the observed kidney effects were
reduced vacuolization in the tubular epithelium, lower absolute and
relative kidney weights, and focal dilatation with hyperplasia of the
epithelial lining in the cortical tubules. Diclosulam was classified as
a ``not likely human carcinogen'' based on the lack of evidence of
carcinogenicity in rats or mice fed diclosulam, and the lack of
evidence of mutagenic activity. Based on the results of several
subchronic, chronic, and developmental reproductive toxicity studies,
there was no evidence of neurotoxicity. Diclosulam is not a
developmental or reproductive toxicant and there was no evidence for
increased susceptibility of rat or rabbit fetuses to in utero exposure
or rat pups to postnatal exposure to diclosulam.
B. Toxicological Endpoints
1. Acute toxicity. In acute toxicology studies (rat acute
neurotoxicity, rat developmental toxicity, and rabbit developmental
toxicity) there were no acute effects observed due to a single dose.
Therefore, no acute reference dose (RfD) was selected and an acute
dietary risk assessment is not required.
2. Short- and intermediate-term toxicity. The toxicological
endpoint for short- and intermediate-term inhalation risk assessments
is a maternal/developmental no observable adverse effect level (NOAEL)
of 10 milligrams/kilograms/day (mg/kg/day) based on the dose-dependent
increased abortions, and decreased maternal body weight gain, food
consumption, and fecal output in the rabbit oral developmental study.
Because this study is an oral dosing study, route-to-route
extrapolation is required. A margin of exposure (MOE) of 100 or greater
is adequate for occupational exposure risk assessments. A short- and
intermediate-term dermal risk assessment is not required, and no short-
or intermediate-term dermal toxicity endpoints were established. In a
short- and intermediate-term dermal toxicology study (21-day rabbit
dermal toxicity study), there was no systemic toxicity at the limit
dose of 1,000 mg/kg/day.
3.Chronic toxicity. EPA has established a chronic RfD of 0.05 mg/
kg/day NOAEL equals 5 mg/kg/day; Uncertainty Factor (UF) = 100) for use
in assessing chronic dietary risk. This chronic RfD is based on the 2-
year combined chronic feeding/carcinogenicity study in rats, in which
the following effects were observed at the lowest observable adverse
effect level (LOAEL) of 100 mg/kg/day in both sexes: statistically
significant decreases in body weight gain, changes in renal tubule and
kidney function parameters, and increased incidence of male kidney
pelvic epithelium hyperplasia.
4. Carcinogenicity. In accordance with the 1996 Cancer Risk
Assessment Guidelines, the Agency classified diclosulam as a ``not
likely human carcinogen'' based on the lack of evidence of
carcinogenicity in mice or rats. Therefore, diclosulam is not expected
to pose a cancer risk.
C. Exposures and Risks
1. From food and feed uses. Risk assessments were conducted by EPA
to assess dietary exposures from as follows:
i.Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. In acute toxicology studies (rat acute
neurotoxicity, rat developmental toxicity, and rabbit developmental
toxicity) there were no acute effects observed due to a single dose.
Therefore, no acute risk is expected, and an acute risk assessment is
inappropriate.
ii. Chronic exposure and risk. The Agency used the Dietary Exposure
Evaluation Model (DEEM ) software for conducting a chronic (non-cancer)
dietary (food) risk analysis for residues in food. The chronic dietary
risk analysis was based on the assumptions of tolerance level residues
(0.020 ppm for peanut nutmeat and soybean seed), 100 percent of crop
treated, and the chronic population-adjusted dose (PAD) of 0.05 mg/kg/
day. The resulting dietary food exposures occupy 1% of the chronic PAD
for all population subgroups. These results should be viewed as
conservative (health protective) risk estimates. Refinements such as
use of percent crop-treated information and/or anticipated residue
values would yield even lower estimates of chronic dietary exposure
from residues in food. In accordance with the 1996 Cancer Risk
Assessment Guidelines, EPA classified diclosulam as a ``not likely
human carcinogen'' based on the lack of evidence of carcinogenicity in
mice or rats. Thus, diclosulam is not expected to pose a cancer risk.
2. From drinking water --i. Acute exposure and risk. As explained
above, diclosulam is not expected to pose an acute risk.
ii.Chronic exposure and risk. Drinking Water Levels of Comparison
(DWLOCs) range from 490 to 1,700 g/L for all population
subgroups. DWLOCs were calculated based on the chronic PAD (0.05 mg/kg/
day) and the chronic dietary (food only) exposure for each population
subgroup. The estimated environmental concentrations (EECs) for
assessing chronic aggregate dietary risk are 0.035 parts per billion
(ppb) in ground water and 1.28 ppb in surface water. The chronic EECs
are less than the Agency's level of comparison (the DWLOC value for
each population subgroup) for diclosulam residues in drinking water as
a contribution to chronic aggregate exposure.
3. From non-dietary exposure. There are no residential uses
associated with diclosulam. Therefore, no non-dietary exposure due to
residential use is expected.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether diclosulam 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,
diclosulam 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 diclosulam has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
[[Page 12132]]
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. As explained above, diclosulam is not expected to
pose an acute risk.
2. Chronic risk. Using the theoretical maximum residue contribution
(TMRC) exposure assumptions described in this unit, EPA has concluded
that aggregate exposure to diclosulam from food will utilize 1% of the
PAD RfD for the U.S. population and all identified subpopulations. EPA
generally has no concern for exposures below 100% of the PAD because
the PAD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for dietary exposure to diclosulam in
drinking water, EPA does not expect the aggregate exposure to exceed
100% of the RfD.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. However, there are not residential uses for
diclosulam and risks from dietary exposures from residues in food and
water are addressed by the acute and chronic risk assessments.
4. Aggregate cancer risk for U.S. population. As explained above,
diclosulam is not expected to pose a cancer risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to diclosulam residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children --i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of diclosulam, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. 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 prenatal and postnatal toxicity and
the completeness of the data base unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (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 uncertainty factor (usually 100 for combined
interspecies and intraspecies 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 concerns regarding the adequacy of the standard MOE/safety
factor.
ii. Developmental toxicity studies. See Unit III.A. of this notice.
iii. Reproductive toxicity study. See Unit III.A. of this notice.
iv. Prenatal and postnatal sensitivity. Based on the available
data, there is no indication of increased susceptibility of rats or
rabbits to in utero and/or to postnatal exposure to diclosulam. In the
prenatal developmental toxicity studies, there was no apparent
developmental toxicity in rats or rabbits at or below the maternal
toxicity NOAEL values (vide supra). In the prenatal rabbit
developmental toxicity study, there were dose-dependent increased late
(gestational date 21-27) abortions at or above 65 mg/kg/day. The Agency
considers the dose-related increased abortions as an adverse fetal
effect despite the fact that the abortions were probably related to
maternal toxicity, the aborted fetuses were viable, and there was no
increase in intra-uterine deaths (early or late resorptions). Both the
maternal and developmental NOAEL/LOAEL were considered to be 10/65 mg/
kg/day based on the dose-related increased abortions. There were other
maternal effects, including decreased maternal body weight gain, food
consumption, and fecal output; however, there were no other treatment-
related fetal or developmental effects, including gravid uterine or
fetal body weights, and gross, visceral, or skeletal changes. On the
other hand, in the 2-generation rat reproduction study, the parental
and developmental/ offspring systemic toxicity NOAEL/LOAEL were at or
above the limit dose of 1,000 mg/kg/day.
v. Conclusion. The toxicological data base for diclosulam is
adequate to support registration and tolerances. The Ames mutagenicity
test is considered to be unacceptable because the highest dose tested
was not high enough. However, EPA has sufficient information concerning
mutagenicity and has concluded that diclosulam is not a mutagen based
on the Mouse Micronucleus Assay, CHO/HGPRT Forward Gene Mutation,
Chromosomal Aberration Assay--Rat Lymphocytes tests. Also, both the
acute neurotoxicity study (guideline) and the 1-year neurotoxicity
study (non-guideline) are classified unacceptable pending the
submission of additional information; however, these studies are not
required to assess these tolerances or for registration of these uses.
Exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. Given the completeness of
the toxicity and exposure data bases, and the lack of prenatal and
postnatal sensitivity, EPA concluded that an additional safety factor
to protect infants and children was not necessary and that a risk
assessment using only the traditional safety factors would protect the
safety of infants and children.
2. Acute risk. As explained above, diclosulam is not expected to
pose an acute risk.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to diclosulam from food
will utilize 1% of the chronic PAD for infants and children. EPA
generally has no concern for exposures below 100% of the chronic PAD
because the PAD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health. Despite the potential for exposure to diclosulam in
drinking water, EPA does not expect the aggregate exposure to exceed
100% of the PAD.
4. Short- or intermediate-term risk. As explained above, there are
no residential uses for diclosulam and thus any short-term or
intermediate term risks are adequately addressed by the chronic and
acute assessments.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
The nature (metabolism) of diclosulam residues in plants and
livestock is adequately understood for the purposes of these
tolerances. In all the plant and animal metabolism studies submitted,
the residues of
[[Page 12133]]
concern were parent diclosulam only. The tolerances for soybean and
peanut commodities are expressed in terms of diclosulam.
B. Analytical Enforcement Methodology
The petitioner has proposed Capillary Gas Chromatography/Mass
Selective Detection Methods GRM 96.01, GRM 94.19, and GRM 94.19.S1 for
the enforcement of tolerances in peanut and soybean. Method validation
recoveries indicate that these methods adequately recover residues of
diclosulam from peanut, soybean, and their processed commodities. The
validated limit of quantitation (LOQ) is 0.01 ppm for all commodities
and the limit of detection (LOD) was estimated to be 0.003 ppm for all
matrices. Adequate independent method validation data have been
submitted for this method.
C. Magnitude of Residues
The submitted soybean and peanut field trial data are adequate. The
available residue data support the proposed tolerance at 0.020 ppm for
residues of diclosulam in/on soybean seed. Residues were nondetectable
(0.003 ppm) in/on all 81 samples of soybeans treated at 1-1.5x.
Diclosulam residues were also nondetectable (0.003 ppm) in/on seed
harvested from applications at exaggerated rates (5 3 and 8x). The
processing data indicate that residues of diclosulam do not concentrate
in soybean processed commodities. The proposed label includes a
restriction against grazing treated areas or harvesting forage and hay
from treated areas; therefore, tolerances for residues in/on soybean
forage and hay are not required at this time.
In peanuts, the available residue data support the proposed
tolerance at 0.020 ppm for residues of diclosulam in/on peanut
nutmeats. Residues were nondetectable (0.003 ppm) in/on all 22 samples
of nutmeats treated at 1.4x. Diclosulam residues were also
nondetectable (0.003 ppm) in/on nut meats harvested from applications
at exaggerated rates (5 3 and 8x). The proposed label includes a
restriction against grazing treated areas or harvesting forage and hay
from treated areas. As all peanut nutmeat samples from the RAC field
trials and exaggerated rate trials showed residues of diclosulam 0.003
ppm (LOD), no tolerances for residues of diclosulam in peanut processed
commodities are required. No tolerance for residues in/on peanut hay is
needed since the proposed label includes a restriction against grazing
treated areas or harvesting forage and hay from treated areas.
D. International Residue Limits
There are no established or proposed Codex, Canadian or Mexican
limits for residues of diclosulam in/on plant or animal commodities.
E. Rotational Crop Restrictions
The petitioner has proposed the following plantback restrictions
for rotated crops: 4 months for wheat and barley; 6 months for oat and
rye; 9 months for cotton, soybeans, and peanuts; 18 months for corn,
rice, tobacco, and sorghum; and 30 months for all other crops due to
phytotoxicity. EPA has determined that these plantback restrictions are
adequate.
V. Conclusion
Therefore, the tolerance is established for residues of diclosulam
in soybean seed and peanut nutmeat at 0.020 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300977 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before May 8,
2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW., Washington, DC 20460. You may also deliver your request to
the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St.,
SW., Washington, DC 20460. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg.,
1200 Pennsylvania Ave., NW., Washington, DC 20460.
[[Page 12134]]
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-300977, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 file
format or ASCII file format. Do not include any CBI in your electronic
copy. You may also submit an electronic copy of your request at many
Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); 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 or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 29, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180 [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a) and 371.
2. Section 180.543 is added to read as follows:
Sec. 180.543 Diclosulam; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide diclosulam [N-(2,6-dichlorophenyl)-5-ethoxy-7-fluoro[1,2,4]
triazolo[1,5-c]pyrimidine-2-sulfonamide] in or on the following raw
agricultural commodities as follows:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Peanut nutmeat............................ 0.020
Soybean seed.............................. 0.020
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 00-5635 Filed 3-7-00; 8:45 am]
BILLING CODE 6560-50-F