PMEP Home Page --> Pesticide Active Ingredient Information --> Fungicides and Nematicides --> Acetic acid to Etridiazole --> dimethomorph (Acrobat) --> dimethomorph (Acrobat) Pesticide Tolerances 4/99

dimethomorph (Acrobat) Pesticide Tolerances 4/99

  


[Federal Register: May 12, 1999 (Volume 64, Number 91)]
[Rules and Regulations]               
[Page 25451-25456]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my99-17]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300857; FRL-6079-5]
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.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a permanent tolerance for the 
residues of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propenyl]morpholine in or on potatoes, wet 
peel and time-limited tolerances for the indirect or inadvertent 
residues of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propenyl]morpholine in or on the cereal grains 
group for fo12er, forage, grain, hay and straw. American Cyanamid 
Company requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective May 12, 1999. Objections and 
requests for hearings must be received by EPA on or before July 12, 
1999.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300857], must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
requests filed with the Hearing Clerk identified by the docket control 
number, [OPP-300857], must also be submitted 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, bring a copy of 
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
     A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epa.gov. Copies of electronic objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-300857]. 
No Confidential Business Information (CBI) should be submitted through 
e-mail. Copies of electronic objections and hearing requests on this 
rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Mary Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 249, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-9354, 
waller.mary@epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Registers of March 26, 1997 
(62 FR 14418) (FRL-5594-7) and of March 10, 1999 (64 FR 11874) (FRL-
6063-3), 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) (Pub. L. 104-170) announcing 
the filing of a pesticide petition (PP) for tolerance by American 
Cyanamid Company, P.O. Box 400, Princeton, NJ 08543-0400. These notices 
included a summary of the petition prepared by American Cyanamid 
Company, the registrant. There were no comments received in response to 
the notices of filing.
    The petition requested that 40 CFR 180.493 be amended by 
establishing a tolerance for residues of the fungicide dimethomorph, 
(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-
propenyl]morpholine, in or on potatoes, wet peel at 0.15 parts per 
million (ppm) and time-limited tolerances for the indirect or 
inadvertent residues of the fungicide dimethomorph, (E,Z) 4-[3-(4-
chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine, in 
or on cereal grains group: fodder at 0.15 ppm, forage at 0.05 ppm, 
grain at 0.05 ppm, hay at 0.10 ppm, and straw at 0.15 ppm. These time-
limited tolerances will expire on May 12, 2004.

I. Background and Statutory Findings

    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).

II. 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 
dimethomorph and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a

[[Page 25452]]

tolerance for residues of the fungicide dimethomorph, (E,Z) 4-[3-(4-
chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine, in 
or on potatoes, wet peel at 0.15 ppm and time-limited tolerance for the 
indirect or inadvertent residues of dimethomorph, (E,Z) 4-[3-(4-
chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine in or 
on the cereal grains group: fodder at 0.15 ppm, forage at 0.05 ppm, 
grain at 0.05 ppm, hay at 0.10 ppm, and straw at 0.15 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerances 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 has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The tolerance for potatoes, wet peel, 
toxicological profile 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). The risk assessment for rotational 
crops addressed the changes which occurred as a result of the granting 
of time-limited tolerances for rotational crops.

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. Exposures and Risks

    1. 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 and time-limited tolerances for tomatoes at 1 
ppm (expires May 15, 1999) and cantaloupe, cucumber, squash and 
watermelon at 1 ppm (expires March 31, 2000). Anticipated residues were 
not generated as part of this risk assessment. In the dietary analysis, 
the most highly exposed subgroup, children 1-6 years, utilized only 
4.3% of the reference dose (RfD)/population adjusted dose (PAD) As a 
result, no refinement to the analysis was needed. Risk assessments were 
conducted by EPA to assess dietary exposures from dimethomorph as 
follows:
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. EPA did not 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 and risk. EPA's Dietary Exposure Evaluation 
Model (DEEM89) was used for conducting a chronic dietary (food only) 
exposure analysis (risk assessment). The analysis evaluates individual 
food consumption as reported by respondents in the USDA 1989-1991 
Nationwide Continuing Surveys for Food Intake by Individuals, and 
accumulates exposure to the chemical for each commodity. The exposure 
for each subgroup is reported as a percentage of the PAD. As the 10x 
safety factor was removed for dimethomorph, the PAD is equivalent to 
the RfD.
    In conducting this chronic tier 1 dietary risk assessment, EPA has 
made very conservative assumptions: that all commodities having 
dimethomorph tolerances contain residues of dimethomorph and those 
residues are at the level of the tolerance. These assumptions result in 
an overestimate of human dietary exposure. All Section 18 tolerances 
(i.e., cantaloupes, watermelons, cucumbers, squash, and tomatoes) are 
included in this dietary risk assessment. Using the assumptions and 
data parameters described above, the DEEM89 exposure analysis results 
in a theoretical maximum residue contribution (TMRC) that is equivalent 
to the following percentages of the PAD/RfD. The following table 
summarizes the estimated food exposures for the U.S. population, the 
population subgroups that include infants and children, the most highly 
exposed female subgroup, and all other population subgroups (excluding 
regions and seasons) with risk estimates above that of the U.S. 
population:

           Table 1.-- Summary of Food Exposure to Dimethomorph
------------------------------------------------------------------------
                                                   Exposure
                                                    (mg/kg
               Population Subgroup                 body wt/    %PAD/RfD
                                                     day)
------------------------------------------------------------------------
U.S. Population (total)..........................   0.0020             2
Hispanics........................................   0.0022             2
Non-Hispanic/non-white/non-black.................   0.0022             2
Nursing Infants..................................   0.0006           0.6
Non-nursing Infants..............................   0.0024             2
Children 1-6 years...............................   0.0043             4
Children 7-12 years..............................   0.0030             3
Females 13-19 (not pregnant or nursing)..........   0.0021             2
Males 13-19 years................................   0.0021             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, an acute water and dietary exposure risk assessment is not 
required.
    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 dietary (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 dietary 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 the U.S. Population and the population subgroup non-Hispanic/non-
white/non-black, 2,900 ppb for females 13-19 (not pregnant or nursing),

[[Page 25453]]

and 960 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. There are no registered or proposed 
residential uses for dimethomorph. Therefore, residential or inhalation 
exposures were not evaluated in the risk assessment.
    4. Cumulative exposure to substances with 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. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. No acute dietary endpoint was identified; therefore, 
EPA concludes that dimethomorph poses no appreciable acute risk.
    2. Chronic risk. EPA has concluded that aggregate exposure to 
dimethomorph from food will utilize 2% of the RfD for the U.S. 
population, 2% for females 13-19 (not pregnant or nursing), 4% for 
children 1 through 6 years of age, and 2% for non-Hispanic/non-white/
non-black. The surface drinking water levels of comparison from chronic 
exposure to dimethomorph using modeling data are 3,400 ppb for the U.S. 
population and population subgroup non-Hispanic/non-white/non-black, 
2,900 ppb for females 13-19 (not pregnant or nursing), and 960 ppb for 
children 1-6 years. These levels are all greater than the GENEEC 
chronic concentration level (24 ppb for 56 days) and the SCI-GROW 
ground level water of 0.26 ppb. EPA generally has no concern for 
exposures below 100% of the RfD because the RfD represents the level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health. There are no registered 
residential uses of dimethomorph.
    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. Although short- and intermediate-term endpoints 
were identified, there are no residential uses for dimethomorph.
    4. Aggregate cancer risk for U.S. population. Dimethomorph was 
classified as ``not likely'' to be a human carcinogen. Therefore, a 
carcinogenic aggregate risk assessment was not required.
    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 residues of dimethomorph.

E. Aggregate Risks and Determination of Safety for Infants and Children

    EPA assessed the potential for additional sensitivity of infants 
and children to residues of dimethomorph. The aggregate risks for 
dimethomorph were published in the Federal Register final rule of 
October 13, 1998 (63 FR 54587)(FRL-6036-7). There is a complete 
toxicity database for dimethomorph and exposure data is complete or is 
estimated based on data that reasonably accounts for potential 
exposures. EPA has concluded that aggregate exposure to dimethomorph 
form food will utilize 4.3% of the RFD for infants and children. EPA 
generally has no concern for exposures below 100% of the RFD because 
the RFD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Despite the potential for exposure to dimethomorph in drinking 
water, EPA does not expect the aggregate exposure to exceed 100% of the 
RFD. 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 dimethomorph residues.

III. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in potatoes is adequately understood. For 
purposes of time-limited tolerances, the residue of concern in 
rotational crops is the same as that in directly treated crops, i.e., 
dimethomorph per se. The nature of the residue in animals is adequately 
defined for section 3 registration on potatoes. Tolerances are not 
required for residues in livestock commodities at this time.

B. 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 per se in/on potatoes. A confirmatory method 
is also available (FAM 022-03).
    The method may be requested from: Calvin Furlow, PIRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Rm 101FF, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202, (703-305-5229). Based on recovery data from the 
independent laboratory validation as well as concurrent recovery data 
from limited rotational field trials, EPA concludes that Method M 3112 
gas chromatography, nitrogen phosphorus detection (GC, N-P detection) 
has been adequately validated and is suitable for collecting residue 
data on levels of dimethomorph per se in/on wheat raw agricultural 
commodities (RACs). The reported limit of quantitation of the method is 
0.05 ppm. Prior to the establishment of permanent rotational crop 
tolerances, Method M 3112 must be submitted for Agency method 
validation. Acceptance of Method M 3112 as an enforcement method is 
predicated upon completion of a successful Agency method tryout. For 
the purpose of establishing time-limited tolerances on wheat RACs, EPA 
recommended using the Food and Drug Administration's (FDA's) 
multiresidue method Protocol D as the enforcement method for 
determining residues of dimethomorph per se in/on cereal grain RACs. 
EPA noted that Method FAMS 002-04 (HPLC, UV detection), a method 
submitted in conjunction with PP#2E4054, has been determined adequate 
as an enforcement method for determining residues of dimethomorph per 
se in/on potatoes. Although the extraction procedures of Method M 3112 
are essentially similar to those of Method FAMS 002-04, the 
instrumentation and quantitation of

[[Page 25454]]

residues are different. Dimethomorph is recovered by Protocol D of 
FDA's multi-residue method protocols (PAM Vol. I).

C. Magnitude of Residues

    EPA has concluded that residue data submitted in support of the 
tolerance for potatoes indicate that a tolerance level of 0.15 ppm is 
an adequate level for potatoes, wet peel. In addition, domestic field 
trial data supported the tolerance level of 0.15 ppm on potatoes, wet 
peel and indicated that dimethomorph residues do not pose an adverse 
health risk to humans under the use conditions. Therefore, EPA has no 
objection to the establishment of a tolerance of 0.15 ppm for residues 
of the fungicide dimethomorph in/on potatoes, wet peel under 40 CFR 
180.493.
    For the purpose of establishing permanent rotational crop 
tolerances for residues of dimethomorph in/on cereal grains, the 
limited wheat rotational field trial data are inadequate because of 
poor geographic representation of data, and because residue data are 
required for other crops representative of cereal grains. However, as 
the available data indicate that most treated wheat raw agricultural 
commodity (RAC) samples bore nonquantifiable (< 0.05 ppm) residues, EPA 
recommends in favor of the establishment of time-limited tolerances for 
the forage and grain of cereal grains at 0.05 ppm, for hay of cereal 
grains at 0.10 ppm, and for the fodder and straw of cereal grains at 
0.15 ppm under 40 CFR 180.493.

D. 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.

E. Rotational Crop Restrictions

    The plant back intervals for rotational crops are: 0 days for 
potatoes; 1 month for barley, broccoli, cabbage, carrot, cauliflower, 
celery, lettuce, oats, onion, radish, spinach, sugarbeets, tobacco and 
wheat; 7 months for alfalfa, beans, clover, corn (field, sweet, seed, 
and pop), peas, rice, sorghum, and soybeans; 12 months for all other 
crops.

IV. Conclusion

    Therefore, the tolerance for residues of the fungicide 
dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-
oxo-2-propenyl]morpholine, in or on potatoes, wet peel at 0.15 ppm and 
time-limited tolerances are established for the indirect or inadvertent 
residues of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propenyl]morpholine in the cereal grains 
group: fodder at 0.15 ppm, forage at 0.05 ppm, grain at 0.05 ppm, hay 
at 0.10 ppm, and straw at 0.15 ppm. These time-limited tolerances 
expire May 12, 2004.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation as was provided in 
the old section 408 and in section 409. However, the period for filing 
objections is 60 days, rather than 30 days. EPA currently has 
procedural regulations which govern the submission of objections and 
hearing requests. These regulations will require some modification to 
reflect the new law. However, until those modifications can be made, 
EPA will continue to use those procedural regulations with appropriate 
adjustments to reflect the new law.
    Any person may, by July 12, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under ``ADDRESSES'' section (40 CFR 
178.20). A copy of the objections and/or hearing requests filed with 
the Hearing Clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). 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 tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
     If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is 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 in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). 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.

VI. Public Record and Electronic Submissions

     EPA has established a record for this regulation under docket 
control number [OPP-300857] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
     Objections and hearing requests may be sent by e-mail directly to 
EPA at:

     opp-docket@epa.gov.


     E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
     The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically into printed, paper form as they are 
received and will place the paper copies

[[Page 25455]]

in the official record which will also include all comments submitted 
directly in writing. The official record is the paper record maintained 
at the Virginia address in ``ADDRESSES'' at the beginning of this 
document.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or 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 in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerance in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously 
assessed whether establishing tolerances, exemptions from tolerances, 
raising tolerance levels or expanding exemptions might adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

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 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 the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: April 30, 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. 180.493, by revising paragraphs (a) and (d) to read as 
follows:


Sec. 180.493  Dimethomorph, tolerances for residues.

    (a) General. A tolerance is established for the residues of the 
fungicide dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propenyl]morpholine in or on the following 
commodity:


------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Potatoes, wet peel.............................................    0.15
------------------------------------------------------------------------

* * * * *

[[Page 25456]]

    (d) Indirect or inadvertent residues. Time-limited tolerances are 
established for inadvertent or indirect residues of the fungicide 
dimethomorph in or on the following raw agricultural commodities when 
present therein as a result of the application of dimethomorph to 
growing crops. The tolerances will expire and are revoked on the dates 
specified in the following table.


------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
Cereal grains group, fodder.....  0.15                May 12, 2004
Cereal grains group, forage.....  0.05                May 12, 2004
Cereal grains group, grain......  0.05                May 12, 2004
Cereal grains group, hay........  0.10                May 12, 2004
Cereal grains group, straw......  0.15                May 12, 2004
------------------------------------------------------------------------


[FR Doc. 99-11565 Filed 5-11-99; 8:45 am]
BILLING CODE 6560-50-F