[Federal Register Volume 64, Number 202 (Wednesday, October 20, 1999)]
[Rules and Regulations]
[Pages 56464-56469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27392]
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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
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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 LD50 of 3,300
milligrams/kilogram (mg/kg) for males and a LD50 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)-1, of pyrithiobac
sodium is 1.05 x 10-3 (mg/kg/day)-1 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
10-9).
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 10-7.
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 10-3 (mg/kg/
day)-1, 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 10-7.
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
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-27392 Filed 10-19-99; 8:45 am]
BILLING CODE 6560-50-F
