[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58385-58390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25053]


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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: 
[email protected].

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
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                                     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: 
[email protected].

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 [email protected], 
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: [email protected]. 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