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pyrithiobac-sodium Time-Limited Pesticide Tolerance 10/99

  


ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300935; FRL-6386-5]
RIN 2070-AB78

 
Pyrithiobac Sodium Salt; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends the time-limited tolerance for 
residues of the herbicide pyrithiobac sodium salt (sodium 2-chloro-6-
[(4,6-dimethoxypyrimidin-2-yl)thio]benzoate) in or on cottonseed at 
0.02 parts per million (ppm). E.I. du Pont de Nemours and Co., Inc., 
requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1966. The 
tolerance will expire on September 30, 2001.

DATES: This regulation is effective October 20, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300935, 
must be received by EPA on or before December 20, 1999.

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-300935 in the 
subject line on the first page of your response.

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) 308-5697, e-mail: 
tompkins.james@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            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-300935. 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, 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.

[[Page 56465]]

II. Background and Statutory Findings

    In the Federal Register of July 14, 1999 (64 FR 37972) (FRL-6085-
5), 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 4F4391) for a tolerance by E.I. 
du Pont de Nemours & Co., Inc., Barley Mill Plaza, P.O. Box 80038, 
Wilmington, DE 19880-0038. This notice included a summary of the 
petition prepared by du Pont, the registrant. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.487 be amended by extending 
the time-limited tolerance for residues of the herbicide pyrithiobac 
sodium salt (sodium 2-chloro-6-[(4,6-dimethoxypyrimidin-2-
yl)thio]benzoate) in or on cottonseed at 0.02 ppm. This tolerance will 
expire on September 30, 2001.
    In the Federal Register of October 25, 1995 (60 FR 54607) (FRL-
4982-8), EPA established a time-limited tolerance for residues of the 
herbicide pyrithiobac sodium in or on cottonseed at 0.02 ppm. The time 
limited tolerance expired on September 30, 1997. In the Federal 
Register of October 22, 1997 (62 FR 54778) (FRL-5742-5), EPA 
established a time-limited tolerance for residues of the herbicide 
pyrithiobac sodium in or on cottonseed at 0.02 ppm. This time-limited 
tolerance expires on September 30, 1999.
    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 time-limited tolerance for residues of pyrithiobac 
sodium on cottonseed at 0.02 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 pyrithiobac sodium 
are discussed in this unit.
    1. A rat acute oral study with a LD<INF>50</INF> of 3,300 
milligrams/kilogram (mg/kg) for males and a LD<INF>50</INF> 3,200 mg/kg 
for females.
    2. A 90-day rat feeding study with a no observed adverse effect 
level (NOAEL) of 50 ppm (3.25 mg/kg/day for males and 4.14 mg/kg/day 
for females) and a lowest observed adverse effect level (LOAEL) of 500 
ppm (31.8 mg/kg/day for males and 40.5 mg/kg/day for females), based on 
decrease body weight gains and increased rate of hepatic B-oxidation in 
males.
    3. A 90-day mouse feeding study with a NOAEL of 500 ppm (83.1 mg/
kg/day for males and 112 mg/kg/day for females) and a LOAEL of 1,500 
ppm (263 mg/kg/day for males and 384 mg/kg/day for females) based on 
increased liver weight and an increased incidence of hepatocellular 
hypertrophy in males and decreased neutrophil count in females.
    4. A 3-month dog feeding study with a NOAEL of 5,000 ppm (165 mg/
kg/day) and a LOAEL of 20,000 ppm (626 mg/kg/day), based on decrease 
red blood cell count, hemoglobin, and hematocrit in females and 
increased liver weight in both sexes.
    5. A 21-day rat dermal study with a dermal irritation NOAEL of 50 
mg/kg/day and a dermal irritation LOAEL of 500 mg/kg/day based on 
increased incidence of erythema and edema, and with a systemic dermal 
NOAEL of 500 mg/kg/day and a systemic dermal LOAEL of 1,200 mg/kg/day 
based on body weight gain inhibition.
    6. A 90-day rat neurotoxicity screening battery with a systemic 
NOAEL of 7,000 ppm (466 mg/kg/day for males and 588 mg/kg/day for 
females) and a Systemic LOAEL of 20,000 ppm (1,376 mg/kg/day for males 
and 1,609 mg/kg/day for females), based on decreased hind grip strength 
and increased foot spay in males, and a neurotoxicity NOAEL of 20,000 
ppm highest dose tested (HDT).
    7. A 78-week dietary carcinogenicity study in mice with a NOAEL of 
1,500 ppm 217 mg/kg/day (males) and 319 mg/kg/day (females) and a LOAEL 
of 5,000 ppm 745 mg/kg/day (males) and 1,101 mg/kg/day (females) based 
on decreased body weight/gain in both sexes, treatment related increase 
in the incidence of foci/focus of hepatocellular alternation in males, 
and increased incidence of glomerulonephropathy murine in both sexes, 
and an increased incidence of infarct in the kidney and keratopathy of 
the eyes. There was evidence of carcinogenicity based on significant 
differences in the pair-wise comparisons of hepatocellular adenomas and 
combined adenoma/carcinoma in the 150 and 1,500 dose groups (but not at 
the high dose of 5,000 ppm) with the controls. The carcinogenic effects 
observed are discussed below.
    8. A 24-month rat chronic feeding/carcinogenicity study with a 
systemic NOAEL of 1,500 ppm (58.7 mg/kg/day for males and 278 mg/kg/day 
for females) and a systemic LOAEL of 5,000 ppm (200 mg/kg/day for males 
and 918 mg/kg/day for females) based on decreases in body weight, body 
weight gains and food efficiency in females, increased incidence of eye 
lesions in males and females, mild changes in hematology and urinalysis 
in both sexes, clinical signs suggestive of urinary tract dysfunction 
in males and females, increased incidence of focal cystic degeneration 
in the liver in males, increased rate of hepatic peroxisomal B-
oxidation in males and an increased incidence of inflammatory and 
degenerative lesions in the kidney in females. There was evidence of 
carcinogenicity based on a significant dose-related increasing trend in 
kidney tubular combined adenoma/carcinoma in male rats and a 
significant dose related increasing trend in kidney

[[Page 56466]]

tubular bilateral and/or unilateral adenomas in females. The 
carcinogenic effects observed are discussed further below.
    9. A 1-year dog chronic feeding study with a NOAEL of 5,000 ppm 
(143 mg/kg/day for males and 166 mg/kg/day for females) and a LOAEL of 
20,000 ppm (580 mg/kg/day for males and 647 mg/kg/day for females) 
based on decreases in body weight gain and increased liver weight.
    10. A 2-generation reproduction study in rats with a maternal NOAEL 
of 1,500 ppm (103 mg/kg/day) and a maternal LOAEL of 7,500 ppm (508 mg/
kg/day ppm), based on decreased body weight/gain and food efficacy. The 
reproductive and offspring NOAEL is 7,500 ppm (508 mg/kg/day) and the 
reproductive and offspring LOAEL is 20,000 ppm (1,551 mg/kg/day), based 
on decreased pup body weight.
    11. A developmental toxicity study in rabbits with a maternal and 
developmental NOAEL of 300 mg/kg and a maternal LOAEL of 1,000 mg/kg 
based on deaths, decreased body weight gain and feed consumption, 
increased incidence of clinical signs, and an increase in abortions and 
a developmental LOAEL of 1,000 mg/kg, based on decreased fetal body 
weight gain.
    12. A developmental toxicity study in rats with a maternal NOAEL 
200 mg/kg and a maternal LOAEL of 600 mg/kg due to increased incidence 
of peritoneal staining. The Developmental NOAEL is 600 mg/kg and the 
developmental LOAEL is 1,800 mg/kg based on the increased incidence of 
skeletal variations.
    13. No evidence of gene mutation was observed in a test for 
induction of forward mutations at the HGPRT locus in Chinese hamster 
ovary cells. No evidence was observed for inducing reverse gene 
mutation in two independent assays with Salmonella typhimurium with and 
without mammalian metabolic activation. Pyrithiobac sodium was negative 
for the induction of micronuclei in the bone marrow cells of mice, and 
negative for induction of unscheduled DNA synthesis in rat primary 
hepatocytes. Pyrithiobac sodium was positive for inducing chromosome 
aberrations assay in human lymphocytes.
    14. A rat metabolism study showed that radio labeled pyrithiobac 
sodium is excreted in urine and feces with >90% being eliminated within 
48 hours. A sex difference was observed in the excretion and 
biotransformation. Females excreted a greater amount of the radiolabel 
in the urine than males following all doing regimens, with a 
corresponding lower amount being eliminated in the feces compared to 
the males.

B. Toxicological Endpoints

    1. Acute toxicity. EPA has concluded that no endpoint exists to 
suggest any evidence of significant toxicity from one-day or single-
event exposure.
    2. Short- 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 Reference Dose (RfD) 
for pyrithiobac sodium at 0.587 milligrams/kilogram/day (mg/kg/day). 
This RfD is based on the systemic NOAEL of 58.7 mg/kg/day for males in 
the rat 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 concluded that the available data provide 
limited evidence of the carcinogenicity of pyrithiobac sodium in mice 
and rats and has classified pyrithiobac sodium as a Group C (possible 
human carcinogen with limited evidence of carcinogenicity in animals) 
in accordance with Agency guidelines, published in the Federal Register 
in 1986 (51 FR 33992; September 24, 1986) and recommended that for the 
purpose of risk characterization a low dose extrapolation model should 
be applied to the experimental animal tumor data for quantification for 
human risk (Q1*). This decision was based on liver adenomas, carcinomas 
and combined adenoma/carcinomas in the male mouse and rare kidney 
tubular adenomas, carcinomas and combined adenoma/carcinomas in male 
rats. The unit risk, Q1* (mg/kg/day)<SUP>-1</SUP>, of pyrithiobac 
sodium is 1.05 x 10<SUP>-3</SUP> (mg/kg/day)<SUP>-1</SUP> in human 
equivalents based on male kidney tumors.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.487) for the residues of pyrithiobac sodium in or on the raw 
agricultural commodity cottonseed at 0.02 ppm until September 30, 1999. 
Processing studies for cotton have shown that pyrithiobac sodium does 
not concentrate in cottonseed processed commodities. Risk assessments 
were conducted by EPA to assess dietary exposures and risks from 
herbicide pyrithiobac sodium salt (sodium 2-chloro-6-[(4,6-
dimethoxypyrimidin-2-yl)thio]benzoate) as follows:
    Based on assumption that 100% of the crop is treated with 
pyrithiobac sodium, the upper bound limit of the carcinogenic risk from 
food is calculated in the range of 1 incidence in a billion (1.0 x 
10<SUP>-9</SUP>).
    Using the NOAEL of 58.7 mg/kg/day from the most sensitive species 
in the rat chronic feeding study with a 100-fold safety factor, the RfD 
for systemic effects is 0.58 mg/kg/day. The theoretical maximum residue 
contribution (TMRC) from the established and proposed tolerances is 
0.000001 mg/kg/day and utilizes less than 1% of the RfD for the overall 
U. S. population. For exposure of the most highly exposed subgroup in 
the population, children aged 1-6 years, the TMRC is 0.000001 mg/kg/day 
which is still less than 1% of the RfD.
    2. From drinking water. Pyrithiobac sodium 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 7.76 parts per billion (ppb) and for ground water is 
0.778 ppb. Based on the estimated exposures to pyrithiobac sodium from 
drinking water, the percentage of the RfD utilized for children (1-6) 
would be 0.1% of the RfD. The exposure for the general U.S. population 
would be less than 0.1% of the RfD.
    The worst case estimate for cancer risk from the estimated residues 
of pyrithiobac sodium in drinking water is 2.3 x 10<SUP>-7</SUP>.
    3. From non-dietary exposure. There are no non-food uses of 
pyrithiobac sodium 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 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 pyrithiobac sodium salt 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, 
pyrithiobac sodium salt does not appear to produce a toxic metabolite 
produced by other

[[Page 56467]]

substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that pyrithiobac sodium salt 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).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute, short- 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 
pyrithiobac sodium on cotton.
    2. Chronic risk. Using the TMRC exposure assumptions described in 
this unit, EPA has concluded that aggregate exposure to pyrithiobac 
sodium from food and water will utilize less than 0.1% of the RfD for 
the U.S. population. The major identifiable subgroup with the highest 
aggregate exposure is children (1-6 years), the aggregate exposure to 
pyrithiobac sodium from food and drinking water will utilize less than 
0.2% 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.
    3. Aggregate cancer risk for U.S. population. Based on the upper 
bound potency factor (Q1*) of 1.05 x 10<SUP>-3</SUP> (mg/kg/
day)<SUP>-1</SUP>, the aggregate upper bound lifetime cancer risk from 
the use of pyrithiobac sodium on cotton from worst case estimates of 
residues in food and drinking water is 2.3 x 10<SUP>-7</SUP>.
    4. 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 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 pyrithiobac sodium, 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. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology data base for pyrithiobac sodium 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.
    iii. Conclusion. There is a complete toxicity data base for 
pyrithiobac sodium and exposure data are complete or are estimated 
based on data that reasonably accounts for potential exposures.
    2. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to pyrithiobac sodium 
for children and infants from food and drinking water will utilize less 
than 0.2% 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.
    3. 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 metabolism of pyrithiobac sodium in plants and animals is 
adequately understood for purposes of this tolerance.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (High Pressure Liquid 
Chromatography-Ultra Violet (HPLC-UV) with column switching) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460; telephone number: (703) 305-5229; e-mail address: 
furlow.calvin@epa.gov.

C. Magnitude of Residues

    The nature of the residue in plants is adequately understood for 
the purposes of this time-limited tolerance.

D. International Residue Limits

    There are no Codex Alimentarius Commission (Codex) Maximum Residue 
Levels (MRLs) for pyrithiobac sodium.

E. Rotational Crop Restrictions

    No tolerances for inadvertent residues of pyrithiobac sodium are 
required in rotational crops.

V. Conclusion

    Therefore, the time-limited tolerance for residues of pyrithiobac 
sodium in cottonseed at 0.02 ppm is extended until September 30, 2001.

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.

[[Page 56468]]

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-300935 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 December 
20, 1999.
    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, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, 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, 401 M St., SW., 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, 401 M St., SW., 
Washington, DC 20460.
    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-300935, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., 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 section 408(d) of the 
FFDCA 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 prior consultation with State, local, and tribal 
government officials as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993) and Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), or special 
consideration of environmental justice related issues under 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). 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 12612, 
entitled Federalism (52 FR 41685, October 30, 1987). This action 
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 the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C. 346a(b)(4). 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). In addition, 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.

[[Page 56469]]

VIII. Submission to Congress and the Comptroller General I11The 
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 rule in 
the Federal Register. This 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: October 5, 1999.

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. In Sec.  180.487, by revising paragraph (a) to read as follows:


Sec.  180.487   Pyrithiobac sodium; tolerances for residues.

    (a) General. Time-limited tolerances to expire on September 30, 
2001 are established for residues of the herbicide, pyrithiobac-sodium, 
sodium 2-chloro-6-[(4,6-dimethoxypyrimidin-2-yl)thio]benzoate, in or on 
the following raw agricultural commodities:



------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Cottonseed......................  0.02                9/30/01
------------------------------------------------------------------------


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[FR Doc. 99-27392 Filed 10-19-99; 8:45 am]
BILLING CODE 6560-50-F