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dimethomorph (Acrobat) Pesticide Tolerances 9/00


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[Federal Register: September 29, 2000 (Volume 65, Number 190)]
[Rules and Regulations]
[Page 58385-58390]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se00-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301062; FRL-6747-9]
RIN 2070-AB78


Dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propenyl]morpholine; Pesticide Tolerances

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes permanent tolerances for residues
of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-
oxo-2- propenyl]morpholine in or on dried hops cones, grapes, raisins,
tomato fruit, and tomato paste. American Cyanamid Company 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 September 29, 2000. Objections and
requests for hearings, identified by docket control number OPP-301062,
must be received by EPA on or before November 28, 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-301062 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT  By mail: Mary Waller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
telephone number: (703) 308-9354; and e-mail address:
waller.mary@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:

[[Page 58386]]

------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            Potentially
                                                      Affected  Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' 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-301062. 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

    In the Federal Register of March 26, 1997, 62 FR 14418 (FRL-5594-7)
and March 8, 2000, 65 FR 12244 (FRL-6491-4), 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 (7F4816 and 8F4946) for tolerances by American Cyanamid
Company, P.O. Box 400, Princeton, NJ 08543-0400. These notices included
summaries of the petitions prepared by American Cyanamid Company, the
registrant. There were no comments received in response to the notice
of filing.
    The petitions requested that 40 CFR 180.493 be amended by
establishing tolerances for residues of the fungicide dimethomorph,
(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-
propenyl]morpholine, in or on dried hops cones at 60 ppm, grapes at 3.5
ppm, raisins at 6.0 ppm, tomato fruit at 0.5 ppm, and tomato paste at
1.0 part per million (ppm).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of dimethomorph, (E,Z) 4-[3-(4-
chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine on
dried hops cones at 60 ppm, grapes at 3.5 ppm, raisins at 6.0 ppm,
tomato fruit at 0.5 ppm, and tomato paste at 1.0 ppm. EPA's assessment
of exposures and risks associated with establishing the tolerances are
as follows.

A. Toxicological Profile

    EPA has previously 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
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The toxicological profile for dimethomorph was
addressed in the risk assessment published in the Federal Register
final rule of October 13, 1998 (63 FR 54587) (FRL-6036-7).

B. Toxicological Endpoints

    The toxicological endpoints for dimethomorph were addressed in the
risk assessment published in the Federal Register final rule of October
13, 1998 (63 FR 54587) (FRL-6036-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.493) for the residues of dimethomorph, (E,Z) 4-
[3-(4-chlorophenyl)- 3-(3,4-dimethoxyphenyl)-1-oxo-2-
propenyl]morpholine in or on potatoes at 0.05 ppm, potatoes, wet peel
at 0.15 ppm and time-limited tolerances have been established for
cantaloupe, cucumber, squash and watermelon at 1 ppm (expires September
30, 2001) and on the cereal grains group: fodder at 0.15 ppm, forage
and grain at 0.05 ppm, hay at 0.10 ppm, and straw at 0.15 ppm. Risk
assessments were conducted by EPA to assess dietary exposures from
dimethomorph as follows:
    i. Acute exposure. 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. EPA did not

[[Page 58387]]

select a dose and endpoint for an acute dietary risk assessment because
of the lack of toxicological effects attributable to a single exposure
(dose) in either the rat or the rabbit developmental toxicity studies.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\DM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following very conservative assumptions were made for
the chronic exposure assessments: that all commodities having
dimethomorph tolerances will contain residues of dimethomorph and those
residues will be at the level of the tolerance. These assumptions
result in an overestimate of human dietary exposure. All Section 18
tolerances (cantaloupes, watermelons, cucumbers, and squash) are
included in this dietary risk assessment. Using the assumptions and
data parameters described above, the DEEM-89 exposure analysis results
in a theoretical maximum residue contribution (TMRC) that is equivalent
to the following percentages of the PAD/RfD. The following Table 1
summarizes the estimated food exposures for the U.S. population, all
infants (<1 year old), the population subgroups that include children,
and the most highly exposed female and male subgroups.

           Table 1.--Summary of Food Exposure to Dimethomorph
------------------------------------------------------------------------
                                     Exposure (mg/kg
        Population Subgroup            body wt/day)         %PAD/RfD
------------------------------------------------------------------------
U.S. Population (total)                      0.002547                  3
All Infants (<1 year                         0.005947                  6
Children 1-6 years                           0.007407                  7
Children 7-12 years                          0.002939                  3
Females 13-50 years                          0.001936                  2
Males (20+years)                             0.001840                  2
------------------------------------------------------------------------

    2. From drinking water. EPA used SCI-GROW (Screening Concentration
In Ground Water) and GENEEC (Generic Estimated Environmental
Concentration) models to determine the estimated environmental
concentrations (EECs) of dimethomorph residues in ground and surface
water. The EEC reported for dimethomorph residues in ground water is
0.26 parts per billion (ppb). The EEC for surface water is 28 ppb for
acute and 24 ppb for chronic (56-day).
    i. Acute exposure and risk. Because no acute dietary endpoint was
determined, no acute risks are posed by exposure to dimethomorph.
    ii. Chronic exposure and risk. EPA conducts the drinking water risk
assessment by using the worst case scenario of estimated environmental
concentration (EEC) found from either ground or surface water. The EEC
reported for dimethomorph residues in ground water using SCI-GROW is
0.26 ppb. This is much less than the surface water EEC (24 ppb for 56
days) generated using GENEEC. Therefore, only the surface water EEC
will be used in conducting the aggregate dietary (food + water) risk
assessment. Based on the chronic food exposure and using default body
weights and water consumption figures, chronic drinking water levels of
comparison (DWLOCs) for drinking water were calculated. To calculate
the chronic DWLOC, the chronic food exposure (from DEEM analysis) is
subtracted from the chronic PAD/RfD. DWLOCs are then calculated using
the default body weights and drinking water consumption figures. EPA's
surface drinking water levels of comparison from chronic exposure to
dimethomorph using modeling data are 3,400 ppb for U.S. population and
for males (20+ years), 2,900 ppb for females 13-50, 970 ppb for
children 7-12 years, 940 ppb for infants <1 year and 930 ppb for
children 1-6 years. These levels are all greater than the GENEEC
concentration level (24 ppb for 56 days). Therefore, EPA does not
expect exposure to dimethomorph in drinking water to be above the level
of concern.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Dimethomorph is not
registered for use on any sites that would result in residential
exposure.
    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 dimethomorph 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,
dimethomorph 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 dimethomorph 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. Safety Factor for Infants and Children

    1. In general. 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 on toxicity and exposure
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.
    2. Prenatal and postnatal sensitivity. EPA assessed the potential
for additional sensitivity of infants and children to residues of
dimethomorph in the Federal Register final rule of

[[Page 58388]]

October 13, 1998 (63 FR 54587)(FRL-6036-7).
    3. Conclusion. There is a complete toxicity database for
dimethomorph and exposure data are complete or are estimated based on
data that reasonably account for potential exposures. EPA determined
that the 10x factor to protect infants and children be removed.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking 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 residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day)= cPAD
- (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
    1. Acute risk. No acute dietary endpoint was identified; therefore,
EPA concludes that dimethomorph poses no appreciable acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dimethomorph from food will utilize 3% of the cPAD for the U.S.
population, 6 % of the cPAD for infants (<1 year) and 7% of the cPAD
for children (16 years). There are no residential uses for dimethomorph
that result in chronic residential exposure to dimethomorph. The
aggregate risk assessment for chronic (non-cancer) exposure to
dimethomorph is shown in the following Table 2:

              Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Dimethomorph
----------------------------------------------------------------------------------------------------------------
                                                                                          Surface
                     Population Subgroup                      cPAD mg/kg/     % cPAD     Water EEC     Chronic
                                                                  day         (Food)       (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                                       0.1            3            8        3,400
All infants (<1 year)                                                 0.1            6            8          940
Children 16 years                                                     0.1            7            8          930
Children 7-12 years                                                   0.1            3            8          970
Females 13-50 years                                                   0.1            2            8        2,900
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Dimethomorph is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Dimethomorph
is not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Dimethomorph was
classified as ``not likely'' to be a human carcinogen.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to dimethomorph residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method FAMS 002-04 high performance liquid chromatography using
ultra-violet detection (HPLC, UV detection) is adequate for determining
residues of dimethomorph in tomatoes, grapes or hops. Confirmatory
methods are available for tomatoes, raisins, and hops. Cyanamid Method
2577 can be used for tomatoes, FAMS 076-01 can be used for raisins, and
FAMS 073-03 can be used for hops. The method may be requested from:
Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

    There are no Canadian, Mexican, or Codex MRLs established for
dimethomorph for the commodities associated with this request;
consequently, a discussion of international harmonization is not
relevant.

V. Conclusion

    Therefore, tolerances are established for residues of dimethomorph,
(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-
propenyl]morpholine on dried hops cones at 60 ppm, grapes at 3.5 ppm,
raisins at 6.0 ppm, tomato fruit at 0.5 ppm, and tomato paste at 1.0
ppm.

[[Page 58389]]

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-301062 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 November
28, 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, 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 email 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, 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, 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-301062, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 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.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and LowIncome 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

[[Page 58390]]

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: September 21, 2000.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as
follows:

    Authority:  21 U.S.C. 321(q), (346a) and 371.

    2. Section 180.493 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:

Sec. 180.493  Dimethomorph, tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Grapes\1\                                   3.5
Hops, cones, dried\1\                       60
                  *      *      *        *      *
Raisins\1\                                  6.0
Tomatoes, fruit                             0.5
Tomatoes, paste                             1.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of August 25, 2000, for the use
  of dimethomorph on the growing crops, grapes, hops, and raisins.

* * * * *

[FR Doc. 00-25053 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-S
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Last Modified: 10/19/2000
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