[Federal Register Volume 65, Number 46 (Wednesday, March 8, 2000)]
[Rules and Regulations]
[Pages 12129-12134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5635]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.J[email protected].

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 [email protected], 
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: [email protected]. 
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