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pyridate (Lentagran, Tough) Pesticide Tolerance 4/00

  


[Federal Register: May 3, 2000 (Volume 65, Number 86)]
[Rules and Regulations]
[Page 25647-25652]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my00-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300989; FRL-6550-9]
RIN 2070-AB78


Pyridate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of pyridate in or on peppermint tops, spearmint tops, Brassica, head
and stem subgroup, and collards. The Interregional Research Project
Number 4 and Novartis Crop Protection, Inc., requested these tolerances
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.

DATES: This regulation is effective May 3, 2000. Objections and
requests for hearings, identified by docket control number OPP-300989,
must be received by EPA on or before July 3, 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-300989 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (703) 308-3194; and
e-mail address: brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-300989. 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

[[Page 25648]]

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.

II. Background and Statutory Findings

    In the Federal Register of January 24, 2000 (65 FR 3682) (FRL-6399-
6), and August 5, 1998 (63 FR 41835) (FRL-6017-1), EPA issued notices
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 pesticide
petitions (PP) 9E6025 and 6F4754 for tolerances by the Interregional
Research Project Number 4, New Jersey Agricultural Experiment Station,
Rutgers University, New Brunswick, NJ 08903, and Novartis Crop
Protection Inc., 18300 Greensboro, NC 27419-8300, respectively. These
notices included a summary of petitions prepared by Novartis Crop
Protection Inc., the registrant. There were no comments received in
response to the notice of filing.
    These petitions requested that 40 CFR 180.462 be amended by
establishing tolerances for combined residues of the herbicide
pyridate, [O-(6-chloro-3-phenyl-4-pyridazinyl)-S-octyl-carbonothioate
and the metabolite CL-9673 (6-chloro-3-phenyl-pyradazine-4-ol), and
conjugates of CL-9673], in or on peppermint tops and spearmint tops at
0.20, Brassica, head and stem subgroup, and collards at 0.03 parts 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 tolerances for combined residues of pyridate on
peppermint tops and spearmint tops at 0.20 ppm, Brassica, head and stem
subgroup, and collards at 0.03 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerances
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 pyridate are
discussed in Unit II.A. of the Final Rule on Pyridate Pesticide
Tolerance published in the Federal Register on October 7, 1998 (63 FR
53837) (FRL 6036-2).

B. Toxicological Endpoints

    1. Acute toxicity. The acute dietary endpoint selected for the
acute dietary risk assessment was 20 milligrams/kilogram/day (mg/kg/
day) based on the subchronic (90-day) dog study with a no observed
adverse effect level (NOAEL) of 20 mg/kg/day. The lowest observed
adverse effect level (LOAEL) was 60 mg/kg/day based on ataxia and
emesis observed within 1-3 hours of dosing beginning on the first day.
An uncertainty factor of 100 (10X for interspecies extrapolation and
10X for intraspecies variations) was used to determine the acute
Reference Dose (RfD) of 0.2 mg/kg/day. The acute Population Adjusted
Dose (aPAD) is equal to the acute RfD divided by the FQPA Safety
Factor. Since the FQPA Safety Factor was reduced to 1X, the aPAD is
equal to the acute RfD.
    2.Chronic toxicity. EPA has established the chronic RfD for
pyridate at 0.11 mg/kg/day. This RfD is based on a NOAEL of 10.8 mg/kg/
day from the chronic/carcinogenicity study in rats where decreased body
weight gain was reported at the LOAEL of 67.5 mg/kg/day. This dose was
supported by the results of the 3-generation reproduction toxicity
study. The NOAEL was 10.8 mg/kg/day based on the reported decrease in
pup weights at 67.5 mg/kg/day on postnatal day 14 and 21 in both
generations. An uncertainty factor of 100 (10X for interspecies
extrapolation and 10X for intraspecies variation) was used to determine
the chronic Reference Dose (cRfD) of 0.11 mg/kg/day. The chronic
Population Adjusted Dose (cPAD) is equal to the chronic RfD divided by
the FQPA Safety Factor. Since the FQPA Safety Factor was reduced to 1X,
the cPAD is equal to the chronic RfD.
    3. Carcinogenicity. Pyridate is not carcinogenic in either the rat
or the mouse. Therefore, no carcinogenic endpoint was selected.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.462) for the combined residues of pyridate, in or on a variety
of raw agricultural commodities. Permanent tolerances are established
for combined residues of pyridate, the metabolite CL-9673, and
conjugates of CL-9673 in/on cabbage, corn, and peanut at 0.03 ppm. Risk
assessments were conducted by EPA to assess dietary exposures from
pyridate 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. Tier 1 acute dietary exposure analyses
from food for pyridate were performed with the Dietary Exposure
Evaluation Model (DEEMTM) using published and proposed
tolerance level residues and 100% crop treated (CT) for all
commodities. Therefore, the acute risk was analyzed at the 95th
percentile. The acute dietary risk estimates from food are less than 1%
of the aPAD for the general U.S. population and all population
subgroups. The results of the analyses indicate that the acute dietary
risks from food associated with the existing and proposed uses of
pyridate do not exceed EPA's level of concern for the U.S. population
or any population subgroup.
    ii. Chronic exposure and risk. Tier 1 chronic dietary exposure
analyses from food for pyridate were performed with the
DEEMTM using published and proposed tolerance level residues
and

[[Page 25649]]

100% CT for all commodities. The chronic dietary risk from food
estimates are less than 1% of the cPAD for the general U.S. population
and all population subgroups. The results of the analyses indicate that
the chronic dietary risks from food associated with the existing and
proposed uses of pyridate do not exceed EPA's level of concern for the
U.S. population or any population subgroup
    2. From drinking water. Although pyridate does not possess the
environmental fate parameters associated with a compound that could
leach to ground water, the fate parameters of its degradate CL-9673
seem to indicate that it has the potential to leach to ground water
especially in soils of low organic matter. In unusual conditions such
as flooding, where an aerobic conditions exist in the top soil layers
for up to 60 days, CL-9673 could persist and possibly leach to ground
water or run off to surface water. Pyridate is not listed in the EPA
Pesticides in Ground Water Database, nor is there an EPA Maximum
Contaminant Level or health advisory.
    The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
    The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end run off scenario for pesticides. GENEEC incorporates
a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use the estimates
environmental concentration (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparisons (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to pyridate, they are further
discussed in the aggregate risk sections below.
    EPA has calculated DWLOCs for both acute and chronic risks. To
calculate the DWLOC for acute exposure relative to an acute toxicity
endpoint, the acute dietary food exposure (from DEEM was subtracted
from the aPAD to obtain the acceptable acute exposure to pyridate in
drinking water. To calculate the DWLOC for chronic (non-cancer)
exposure relative to a chronic toxicity endpoint, the chronic dietary
food exposure (from DEEM) was subtracted from the cPAD to obtain the
acceptable chronic (non-cancer) exposure to pyridate in drinking water.
DWLOCs were then calculated using default body weights and drinking
water consumption figures.
    i. Acute exposure. Based on the GENEEC and SCI-GROW models the EECs
of pyridate in drinking water for acute exposures are estimated to be
97 parts per billion (ppb) for surface water and 5 ppb for ground
water.
    ii.Chronic exposure. Based on the GENEEC and SCI-GROW models the
EECs in drinking water for chronic exposures are estimated to be 25 ppb
for surface water and 5 pbb for ground water.
    3. From non-dietary exposure. There are no residential or non-
occupational uses for pyridate; therefore, residential exposures are
not 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 pyridate 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,
pyridate 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 pyridate 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 risk. A high-end exposure estimate from residues in food
was calculated for the general U.S. population and all population
subgroups. The acute dietary exposure from food for all populations
subgroups (1% aPAD) is below EPA's level of concern. The maximum EECs
of pyridate in surface and ground water are less than EPA's DWLOCs for
pyridate as a contribution to acute aggregate exposure (Table 1).

                             Table 1. Aggregate Risk Assessement for Acute Exposure
----------------------------------------------------------------------------------------------------------------
                                                                  Food
              Population Subgroups                % aPAD mg/    Exposure     SCI-GROW      GENEEC    DWLOC (ppb)
                                                    kg/day     mg/kg/day      (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population (48 contiguous states).........            1     0.000151            5           97        7,000
Non-nursing infants............................            1     0.000278            5           97        2,000
Children 1-6 yrs. old..........................            1     0.000303            5           97        2,000
Females 13+ yrs. old (nursing) (60 kg body                 1     0.000149            5           97        7,000
 weight assumed)...............................
Males 13-19 yrs. old...........................            1     0.000141            5           97        7,000
----------------------------------------------------------------------------------------------------------------

[[Page 25650]]

    Therefore, EPA concludes with reasonable certainty that residues of
pyridate in drinking water do not contribute significantly to the
aggregate acute human health risk at the present time considering the
present uses and uses proposed in this action. Acute risk estimates
resulting from aggregate exposure to pyridate in food and water are
below EPA's level of concern for all population subgroups.
    2. Chronic risk. Using the Tier 1 exposure assumptions described in
this unit, EPA has concluded that aggregate exposure to pyridate from
food will utilize 1% of the cPAD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is infants or
children. EPA generally has no concern for exposures below 100% of the
cPAD because the cPAD 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 pyridate
in drinking water, EPA does not expect the aggregate exposure to exceed
100% of the cPAD, as indicated in Table 2.

                             Table 2. Chronic (Non-Cancer) Aggregate Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Food
                                                 cPAD  mg/kg/   Exposure     SCI-GROW      GENEEC    DWLOC (ppb)
                                                     day       mg/kg/day      (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population (48 contiguous states).........            1     0.000048            5           25        3,900
Non-nursing infants............................            1     0.000121            5           25        1,100
Children 1-6 yrs...............................            1     0.000114            5           25        1,100
Females 13+ (nursing)..........................            1     0.000046            5           25        3,900
Males 13-19 yrs................................            1     0.000057            5           25        3,900
----------------------------------------------------------------------------------------------------------------

    EPA concludes that there is a reasonable certainty that no harm
will result from aggregate chronic exposure to pyridate residues.
    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. Because there are no uses of pyridate that could
result in residential exposures, the short- and intermediate-term
aggregate risk assessment for pyridate takes into account exposure
estimates only from dietary consumption of pyridate (food and drinking
water). EPA concludes that there is a reasonable certainty that no harm
will result from aggregate short- and intermediate-term exposure to
pyridate residues.
    4. Aggregate cancer risk for U.S. population. Pyridate is not
carcinogenic in either the rat or the mouse, and therefore is not
expected to pose a cancer risk to humans.
    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 pyridate 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 pyridate, 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. The developmental toxicity
study in Wistar HAN rats resulted in increased incidences of missing
and ossified sternebrae and decreased fetal body weight. Maternal
toxicity was characterized by a decrease in the mean body weight and
food consumption and clinical signs which were indicative of
neurotoxicity (ventral body position, dyspnea, sedation and loss of
reaction to external stimuli). Developmental and maternal NOAELs were
165 mg/kg/day. In the developmental toxicity study in New Zealand White
rabbits, no developmental effects were reported at the NOAEL of 600 mg/
kg/day and maternal toxicity was characterized by decreased body weight
and body weight gain, decreased food consumption, increased incidences
of dried feces and increased incidences of abortion at the LOAEL of 600
mg/kg/day. The maternal NOAEL was 300 mg/kg/day.
    iii. Reproductive toxicity study. The 3-generation reproduction
study in rats resulted in a decrease in maternal body weight gain and a
decrease in pup weight gain at postnatal days 14 and 21. Both parental
and offspring toxicity were reported at the high dose of 67.5 mg/kg/
day.
    iv. Prenatal and postnatal sensitivity. The data demonstrated no
indication of increased sensitivity in utero and postnatal exposure to
pyridate.
    v. Conclusion. There is a complete toxicity data base for pyridate,
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. The Agency believes that
reliable data support using the standard 100-fold safety factor for
assessing sensitivity to residues of pyridate and that an additional
10-fold margin of safety for infants and children is not warranted.
    2. Acute risk. As presented in Table 1 above, EPA does not expect
the aggregate exposure to exceed 100% of the aPAD.
    3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to pyridate from food
will utilize 1% of the cPAD for infants and children. EPA generally has
no concern for exposures below 100% of the cPAD,

[[Page 25651]]

because the cPAD 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 pyridate in
drinking water, EPA does not expect the aggregate exposure to exceed
100% of the cPAD.
    4. Short- or intermediate-term risk. Because there are no uses of
pyridate that could result in residential exposures, the acute
aggregate risk assessment for pyridate takes into account exposure
estimates only from dietary consumption of pyridate (food and drinking
water).
    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 pyridate residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in plants and ruminant animals is
adequately understood. The residue of concern in plants consist of
pyridate, the metabolite CL-9673, and conjugates of CL-9673, all
expressed as pyridate.

B. Analytical Enforcement Methodology

    The analytical method is a total residue procedure using
ultraviolet-high pressure liquid chromotography. The method has
undergone validation in EPA laboratories and is suitable to enforce
tolerances.
    The method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

C. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits
for residues of pyridate in the subject crops. Therefore, a
compatibility issue is not relevant to the proposed tolerances.

V. Conclusion

    Therefore, the tolerance is established for combined residues of
pyridate and its metabolite CL-9673 and conjugates of CL-9673, in or on
peppermint tops and spearmint tops at 0.20 ppm, Brassica, head and stem
subgroup, and collards at 0.03 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-300989 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 July 3,
2000.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW., Washington, DC 20460. You may also deliver your request to
the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St.,
SW., Washington, DC 20460. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg.,
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    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-300989, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 file
format or ASCII file format. Do not include any CBI in your electronic
copy. You may also submit an electronic copy of your request at many
Federal Depository Libraries.

[[Page 25652]]

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 tolerances under FFDCA section 408(d)
in response to the petitions 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: April 17, 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. In Sec. 180.462, by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec. 180.462  Pyridate; tolerance for residues.

* * * * *
    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem subgroup.............................   0.03

                  *        *        *        *        *
Collards.....................................................   0.03

                  *        *        *        *        *
Peppermint tops..............................................   0.20

                  *        *        *        *        *
Spearmint tops...............................................   0.20
------------------------------------------------------------------------

* * * * *

[FR Doc. 00-10813 Filed 5-2-00; 8:45 am]
BILLING CODE 6560-50-F