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paraquat Pesticide Tolerances for Emergency Exemptions 11/99

  


[Federal Register: November 22, 1999 (Volume 64, Number 224)]
[Rules and Regulations]
[Page 63714-63720]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no99-32]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300949; FRL-6392-9]
RIN 2070-AB78


Paraquat; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
residues of paraquat (1,1'-di-methyl-4,4'-bipyridinium-ion) in or on
artichokes. This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
artichokes. This regulation establishes a maximum permissible level for
residues of paraquat in this food commodity. The tolerance will expire
and is revoked on December 31, 2000.

DATES: This regulation is effective November 22, 1999. Objections and
requests for hearings, identified by docket control number OPP-300949,
must be received by EPA on or before January 21, 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 VII. of the ``SUPPLEMENTARY
INFORMATION.'' To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300949 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number:(703) 308-9364; and e-mail address: pemberton.libby@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially 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 Potentially
              Categories                NAICS       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

[[Page 63715]]

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-300949. 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.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408 (l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing a tolerance for residues of the herbicide paraquat, in or
on artichokes at 0.05 part per million (ppm). This tolerance will
expire and is revoked on December 31, 2000. EPA will publish a document
in the Federal Register to remove the revoked tolerance from the Code
of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
    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. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Paraquat on Artichokes and FFDCA
Tolerances

    Simazine has been used in the past to control common chickweed,
mustard, Bermuda buttercup, certain grasses and older weeds in
artichokes. With the imminent cancellation of simazine on artichokes,
the industry purchased all existing stocks. However, growers are
expected to deplete the existing stocks of simazine, labeled for
artichokes by September of 1999. EPA has authorized under FIFRA section
18 the use of paraquat on artichokes for control of weeds in
California. After having reviewed the submission, EPA concurs that
emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of paraquat in or on
artichokes. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on December 31, 2000, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on artichokes after that
date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by this tolerance at the time of that
application. EPA will take action to revoke this tolerance earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether paraquat meets
EPA's registration requirements for use on artichokes or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of paraquat by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for any State other than California to use this pesticide on this crop
under section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
paraquat , contact the Agency's Registration Division at the address
provided under ``FOR FURTHER INFORMATION CONTACT.''

IV. Aggregate Risk Assessment and Determination of Safety

    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) .
    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 paraquat
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of
paraquat on artichokes at 0.05 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,

[[Page 63716]]

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 paraquat are discussed in
this unit.

B. Toxicological Endpoint

    1. Acute toxicity. An acute reference dose (acute RfD) of 0.03
milligrams per kilogram per day (mg/kg/day) has been identified for
females 13+ years old and the general population including infants and
children. For females 13+ the acute RfD is based on the maternal no
observable adverse effects level (NOAEL) of 3 milligrams/kilogram/day
(mg/kg/day) derived from the combined results of two developmental
studies in rats. The effects of concern are delayed ossification of the
forelimb and hindlimb digits. The maternal NOAEL of 3 mg/kg/day has
also been identified as the endpoint of concern for the acute RfD for
the general population including infants and children. The effects of
concern are based on clinical signs of toxicity, decreased body weight
gain, and respiratory distress and histopatholgy of the lungs An
uncertainty factor (UF) of 100 (10x for inter-species extrapolation and
10x for intra-species variability) is appropriate. The 10x FQPA Safety
factor to account for enhanced sensitivity of infants and children as
required by FFDCA section 408 (b)(2)(C) was reduced to 1x for acute
exposures. The acute Population Adjusted Dose (aPAD) is a modification
of the acute RfD to accommodate the FQPA Safety Factor. The aPAD is
equal to the acute RfD divided by the FQPA Safety Factor. Therefore,
for females 13+ years old and the general population including infants
and children the dietary aPAD is 0.03 mg/kg/day.
    2. Short- and intermediate-term toxicity. The NOAEL of 3.0 mg/kg/
day derived from the combined results of two developmental studies in
rats was identified as the short- and intermediate-term endpoints for
dermal exposures. At lowest observable adverse effects level (LOAEL) of
5.0 mg/kg/day, there were clinical signs of toxicity, decreased body
weight gain, and lung histopathology. A 0.3% dermal absorption rate
should be used in risk assessments.
    3. Chronic toxicity. EPA has established the chronic RfD for
paraquat at 0.0045 mg/kg/day. The chronic RfD is based on the NOAEL of
0.45 mg/kg/day from a one year oral study in dogs. At the LOAEL of 0.93
mg/kg/day the effects were chronic pneumonitd. An UF of 100 (10x for
inter-species extrapolation and 10x for intra-species variability is
appropriate. The 10x FQPA Safety factor to account for enhanced
sensitivity of infants and children as required by FFDCA section 408
(b)(2)(C) is not applicable because the endpoint used in deriving the
chronic RfD is based on chronic pneumonitd (not developmental or
neurotoxic effects) in adult dogs after chronic exposure and thus are
not relevant for enhanced sensitivity to infants and children. The
chronic Population Adjusted Dose (cPAD) is a modification of the
chronic RfD to accommodate the FQPA Safety Factor. The cPAD is equal to
the chronic RfD divided by the FQPA Safety Factor. Hence for chronic
exposures, the cPAD and chronic RfD are the same (0.0045 mg/kg/day).
     4. Carcinogenicity. Paraquat is classified as Group E (no evidence
of carcinogenicity in humans).

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.205) for the residues of paraquat, in or on a variety of raw
agricultural commodities. Tolerances have also been established for
fat, kidney, meat, and meat byproducts for cattle, goats, hogs, horses,
poultry and sheep as well as tolerances for eggs and milk. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from paraquat 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 one day or single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-91 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. At the 95th percentile exposure
level, assuming 100 percent crop treated and tolerance level residues
for all commodities, 13 percent of the aPAD was utilized for the U.S.
Population and 23 percent of the aPAD was utilized for children (1-6
years old), the subgroup with the highest exposure. The results of this
analysis indicate that the acute dietary risk associated with existing
uses and the proposed use of paraquat is below the Agency's level of
concern.
    ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment the DEEMTM analysis evaluated the individual
food consumption as reported by respondents in the USDA 1989-91
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. Assuming
tolerance level residues for all commodities and 100 percent crop
treated values, 31 percent of the cPAD was utilized for the U.S.
Population and 69 percent of the cPAD was utilized for children (1-6
years old), the subgroup with the highest exposure. The results of this
analysis indicate that the chronic dietary risk associated with
existing uses and the proposed use of paraquat is below the Agency's
level of concern.
    2. From drinking water. Paraquat dichloride binds strongly to soil
clay particles and it did not leach from the surface in terrestrial
field dissipation studies. There were, however, detections of paraquat
in drinking water wells from two states cited in the Pesticides in
Ground Water Database (1991). These detections are not considered to be
representative of normal paraquat use. Therefore, paraquat is not
expected to be a groundwater contaminant or concern based on normal use
patterns.
    Due to its persistent nature, paraquat could potentially be found
in surface water systems associated with soil particles carried by
erosion, however, paraquat is immobile in most soils, and at very high
application rates (50-1000X), there was no desorption of paraquat from
soils. Therefore, based on paraquat's normal use patterns and unique
environmental fate characteristics, exposures to paraquat in drinking
water are not expected to be obtained from surface water sources.
    3. From non-dietary exposure. Paraquat is not registered on any use
sites which would result in non-dietary, non-occupational exposure.
Therefore, EPA expects only dietary and occupational exposure from the
use of paraquat.
    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 paraquat 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

[[Page 63717]]

common mechanism of toxicity, paraquat 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 paraquat has a
common mechanism of toxicity with other substances. For more
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. Acute aggregate exposure takes into account acute
dietary food and water exposures plus other indoor and outdoor non-
occupational exposure. Since paraquat is not registered on any use
sites which would result in non-dietary, non-occupational exposure and
exposure to ground or surface water is not expected, the only non-
occupational exposure to paraquat is expected through consumption of
food. Therefore acute aggregate risk to paraquat is assumed to be the
same as estimated risk from food and feed uses: at the 95th percentile
exposure level, assuming 100 percent crop treated and tolerance level
residues for all commodities, 13 percent of the aPAD was utilized for
the U.S. Population.
    2. Chronic risk. Chronic-term aggregate exposure takes into account
chronic dietary food and water plus other indoor and outdoor non-
occupational exposure. Since there are no non-dietary, non-occupational
exposures expected from the use of this chemical and paraquat is not
expected to reach ground or surface water, the only non-occupational
exposure to paraquat is anticipated through consumption of food.
Therefore chronic aggregate risk to paraquat is expected be the same as
the estimated risk from food and feed uses: assuming tolerance level
residues for all commodities and 100 percent crop treated values, 31
percent of the cPAD was utilized for the U.S. Population.
    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. Paraquat is not registered on any use sites which
would result in non-dietary, non-occupational exposure. Therefore no
short- and intermediate-term aggregate risk assessments are needed.
    4. Aggregate cancer risk for U.S. population. Paraquat is
classified as Group E (no evidence of carcinogenicity in 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 paraquat 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 paraquat, EPA considered data from
developmental toxicity studies in the rat and mice 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 during 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 MOE and 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. In a developmental study in
rats, the maternal NOAEL is 8 mg/kg/day (HDT). No LOAEL was identified
and there were no maternal or developmental effects observed in the
study.
    In another developmental study in rats, the maternal NOAEL is 1 mg/
kg/day based on thin and hunched appearance, decreased body weight
gain, and histological changes in the lungs and kidneys of non-
survivors at 5 mg/kg/day (LOAEL). The developmental NOAEL is 1 mg/kg/
day based on delayed ossification in the fore- and hindlimb digits at 5
mg/kg/day (LOAEL). (The overall maternal and developmental NOAEL for
the rat is considered 3 mg/kg/day based on the results from two
developmental studies.)
    In a developmental study in mice, the maternal NOAEL is 5 mg/kg/day
based on statistically significant decreases in body weight gain at 10
mg/kg/day (LOAEL). The developmental NOAEL is 5 mg/kg/day based on
statistically significant decreases in body weight gain at 10 mg/kg/day
(LOAEL).
    In another developmental study in mice, the maternal NOAEL is 15
mg/kg/day based clinical signs, death, decreased body weight gain,
decreased body weight, increased organ weight (lung w/ trachea,
kidney), dark red lung lobes, and possible decrease in pregnancy rate
at 25 mg/kg/day (LOAEL). The developmental NOAEL is 15 mg/kg/day based
on decreased mean fetal weight, retarded ossification of occipital,
increased number with extra 14th ribs, increased number with unossified
astragalus in the hindlimb, and an increased number with  6
caudal centra.
    iii. Reproductive toxicity study. In a 2-generation reproductive
study in rats, the NOAEL for paternal toxicity is 1.25 mg/kg/day based
on increased incidence of alveolar histiocytes, discolored lungs,
fibrosis, edema at the LOAEL of 3.75 mg/kg/day. There were no
reproductive effects seen in this study therefore, the reproductive
NOAEL/LOAEL is 7.5 mg/kg/day (HDT).
    iv. Prenatal and postnatal sensitivity. The Agency has determined
that there is no indication of additional sensitivity to young rats or
mice following pre-and/or postnatal exposure to paraquat.
    v. Conclusion. There is a complete toxicity data base for paraquat
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. Data provided no
indication of increased sensitivity of rats or mice to in utero and/or
postnatal exposure to paraquat. Based on this, EPA concludes that
reliable data support the use of the standard 100-fold uncertainty
factor, and that an additional uncertainty factor is not needed to
protect the safety of infants and children.
    2. Acute risk. Acute aggregate exposure takes into account acute
dietary food and water exposures plus other indoor and outdoor non-
occupational exposures. Since paraquat is not registered on any use
sites which would result in non-dietary, non-

[[Page 63718]]

occupational exposure and is not expected in ground or surface water,
the only non-occupational exposure to paraquat is expected through
consumption of food. Therefore acute aggregate risk to paraquat is
assumed to be the same as estimated risk from food and feed uses; at
the 95th percentile exposure level, assuming 100 percent crop treated
and tolerance level residues for all commodities, 23 percent of the
aPAD was utilized for utilized for children, 1-6 years old, the major
identifiable subgroup with the highest aggregate exposure.
    3. Chronic risk. Chronic-term aggregate exposure takes into account
chronic dietary food and water plus other indoor and outdoor non-
occupational exposure. Since there are no non-dietary, non-occupational
exposures expected from the use of this chemical and paraquat is not
expected to reach ground or surface water, the only non- occupational
exposure to paraquat is expected through consumption of food. Therefore
chronic aggregate risk to paraquat is assumed to be the same as the
estimated risk from food and feed uses; assuming tolerance level
residues for all commodities and 100 percent crop treated values, 69
percent of the cPAD was utilized for children, 1-6 years old, the major
identifiable subgroup with the highest aggregate exposure.
    4. Short- or 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. Paraquat is not registered on any use sites which
would result in non-dietary, non-occupational exposure. Therefore no
short- and intermediate-term aggregate risk assessments are needed.
    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 paraquat residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The qualitative nature of the residue in plants and animals has is
understood. The residue of concern is the parent compound, paraquat,
only, as specified in 40 CFR 180.205.

B. Analytical Enforcement Methodology

     Method I of PAM, Vol. II (spectrophotometric), is adequate for
tolerance enforcement purposes. In addition, the Agency concluded that
Method 1B adequately recovers paraquat cation residues from samples of
potatoes and soybeans treated with radiolabeled paraquat.

C. Magnitude of Residues

    Residues of paraquat are not expected to exceed 0.05 ppm in/on
artichokes as a result of this section 18. No animal feed items are
associated with the proposed use.

D. International Residue Limits

    No CODEX, Canadian, and/or Mexican MRLs/tolerances have been
established for residues of paraquat on artichoke. Therefore, there are
no issues of international harmonization associated with this action.

E. Rotational Crop Restrictions

     Artichokes are a perennial crop and are not normally rotated;
therefore, a discussion of rotational crop requirements is not germane
to this petition.

VI. Conclusion

    Therefore, the tolerance is established for residues of paraquat in
artichokes at 0.05 ppm.

VII. 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-300949 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 January
21, 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, 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

[[Page 63719]]

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 VII.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 the docket control number OPP-300949, 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA
section 408. 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 FIFRA
section 18 petition under FFDCA section 408, 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).

IX. Submission to Congress and the General Accounting Office

    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: November 4, 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), 346(a) and 371.

    2. In Sec. 180.205, the table to paragraph (b) is amended by adding
alphabetically an entry for ``artichokes'' to read as follows:

Sec. 180.205   Paraquat; tolerances for residues.

*        *         *         *         *
    (b) Section 18 emergency exemptions. ***

[[Page 63720]]

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
                  *        *        *        *        *
Artichokes......................  0.05                12/31/00
                  *        *        *        *        *
------------------------------------------------------------------------

 *         *         *         *         *

[FR Doc. 99-30411 Filed 11-19-99; 8:45 am]
BILLING CODE 6560-50-F