[Federal Register Volume 64, Number 91 (Wednesday, May 12, 1999)]
[Rules and Regulations]
[Pages 25451-25456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11565]
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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.
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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
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Exposure
(mg/kg
Population Subgroup body wt/ %PAD/RfD
day)
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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
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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
