[Federal Register Volume 59, Number 159 (Thursday, August 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20327]
[[Page Unknown]]
[Federal Register: August 18, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0E3859/R2077; FRL-4907-3]
RIN 2070-AB78
Procymidone; Pesticide Tolerance for Wine Grapes
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes a permanent tolerance for residues
of the fungicide procymidone, N-(3,5-dichlorophenyl)-1,2-
dimethylcyclopropane-1,2-dicarboximide, in or on the raw agricultural
commodity (RAC) wine grapes at 5.0 parts per million (ppm). Sumitomo
Chemical Co., Ltd., petitioned EPA to establish this regulation setting
the maximum permissible level for residues of procymidone in or on wine
grapes.
EFFECTIVE DATE: This regulation becomes effective August 12, 1994.
ADDRESSES: Written objections, identified by the document control
number, [PP 0E3859/R2077], may be submitted to: Hearing Clerk (1900),
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington,
DC 20460. A copy of any objections and hearing requests filed with the
Hearing Clerk should be identified by the document control number and
submitted to: Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring copy of objections and hearing requests to: Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees
accompanying objections shall be labeled ``Tolerance Petition Fees''
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
FOR FURTHER INFORMATION CONTACT: By mail: Steve Robbins, Acting Product
Manager (PM) 21, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 227, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202, (703)-305-6900.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 31, 1994
(59 FR 15145), EPA issued a proposed rule that gave notice that the
Sumitomo Chemical Co., Ltd., had petitioned EPA under section 408 of
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, to establish
a permanent tolerance for procymidone in or on wine grapes at 5.0 ppm.
Because EPA has added additional documentation to the public docket on
the proposed tolerance under section 408 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 346a) for residues of the fungicide procymidone
on wine grapes, EPA reopened and extended for 30 days the comment
period on the proposed rule. The announcement of the reopening/
extension was published in the Federal Register of June 30, 1994 (59 FR
33723).
I. Commments on the Proposal
In response to the March 31, 1994 proposed rule, seven comments
were received.
1. Four comments supported establishing a permanent tolerance.
2. The National Coalition Against the Misuse of Pesticides (NCAMP)
lodged a five-point comment addressing enforceability of the tolerance,
the risk assessment, the exposure calculation, the Agency's tolerance-
setting procedures, and international trade versus health concern
issues. The paraphrased comments and the EPA responses follow:
NCAMP Comment 1. EPA is proposing an unenforceable tolerance. EPA
is setting a tolerance on grapes to be used in imported wine, not on
the wine itself. We believe that the EPA, with the information it now
has, is unable to make determinations about the residues on the grapes.
At no time do the grapes themselves enter the U.S. or come within its
legal arm. A tolerance which cannot be regulated or enforced is
meaningless and not protective of public health and the environment.
The tolerance should be set on the product that can be regulated, i.e.,
the wine.
EPA's Response. NCAMP is mistaken on the enforceability of the
procymidone tolerance for wine grapes. This tolerance is fully
enforceable against wine. Wine containing procymidone residues at a
level greater than the 5-ppm wine grape tolerance would be adulterated
as a matter of law under the FFDCA. See 21 U.S.C. 342(a)(2). Any other
commodity found to contain residues of procymidone, including fresh
table grapes, grape juice, and raisins, would be considered adulterated
and subject to seizure by the FDA. Moreover, EPA does have adequate
data on procymidone residues in wine grapes. Field trial data from 39
locations in France, Germany, Hungary, Italy, Spain, Bulgaria,
Australia, Argentina, and Chile (multiple plots in some locations) were
submitted for review and were determined overall to reflect adequately
the use patterns of procymidone. Wine grapes were treated at 1 to 2
times the maximum label rate, which varied by location (typical 1 X
rate was 0.7 lb ai/A/yr, multiple applications), according to label
directions. Grape samples were harvested at Post Harvest Intervals
(PHIs) generally ranging from 5 to 28 days and analyzed for
procymidone. Details of the analyses and storage stability data were
submitted and adequately support the residue data. The appropriate
tolerance level for wine grapes was determined to be 5 ppm.
NCAMP Comments 2 and 3. EPA conducted a risk assessment on wine
grapes assuming residues at less than half the proposed legal limit. It
is not protective of the public health to set a tolerance at a level at
which the effects are unknown. EPA used averages to calculate exposure.
Procymidone residues may concentrate when grapes are processed into
wine. Finally, EPA should have considered individuals and groups who
consume greater than ``average'' amounts of wine and individuals who
are more sensitive to pesticide exposures.
EPA's Responses. A residue level of 2.4 ppm was used to estimate
chronic dietary and cancer risks. Since imported wine grapes will not
be directly consumed, and study data indicate that residues of
procymidone are significantly reduced upon processing to wine, use of
the tolerance level of 5.0 ppm would have produced unrealistic
estimates. Therefore, a typical, or anticipated, residue level of 2.4
ppm supported by the field trial data on wine grapes was used to
estimate dietary risks. Some data on levels in wine were submitted, but
were fewer in quantity, in comparison to the field trial data. EPA
routinely performs chronic and cancer risk estimates using anticipated
residues since tolerance levels do not reflect actual or typical
residue levels found in foods. Averaging of residue levels (here, an
average from field trials using maximum application rates) is
appropriate for estimating chronic risks because with chronic risks,
EPA is concerned with exposure over a person's lifetime. Over a
lifetime, exposure will likely be an average of the range of residue
values, not the high end residue value. Moreover, averaging is
particularly appropriate where the food through which most exposure
will occur (here, wine) results from the blending of the commodity.
In addition to the study data submitted for the Agency's
consideration, FDA monitoring data also suggest that the actual residue
levels in wine will be even lower. During 1990, when procymidone
residues were first detected in wine, FDA analyzed approximately 1,100
imported wine samples. The highest level found was 0.6 ppm. The
incidence of positive samples (greater than 0.02 ppm) was 9%, and the
average positive finding was 0.06 ppm. A time-limited tolerance of 7
ppm was established on April 26, 1991 (56 FR 19518) for wine grapes
grown in 1989 or before. FDA continued to monitor wine for procymidone
residues in 1991. A total of 501 samples was analyzed. Of the 501
samples, 51 were compliance and 450 were surveillance. Of the
compliance samples, 37% had no detectable residues and 12% had
violative residues (likely due to having been tested prior to the April
1991 establishment of the time-limited tolerance). The remaining 51%
had residues below the tolerance level. The highest residue in any 1991
compliance sample was 0.06 ppm. The 450 surveillance samples included
75% with no detectable residues and 3% with violative residues up to
0.10 ppm (again, violative residues were likely to have resulted from
sampling performed prior to the April 1991 establishment of the time-
limited tolerance). The remaining 22% had residues below the tolerance
level. Using the highest average residues from all the monitoring data
(0.6 ppm) and estimating that 3,5-dichloroaniline (DCA, a procymidone
metabolite potentially of toxic concern) levels will be approximately
20% of the levels of procymidone found, typical residue levels of
procymidone and DCA in wine are expected to be less than 1 ppm.
Therefore, the risk estimates provided using 2.4 ppm are actually
overestimates and adequately consider the toxicity of both procymidone
and DCA.
A number of field trials were held in which procymidone was applied
to grapes, which were then made into wine. In general, procymidone
levels in wine were found to be much lower than corresponding
procymidone levels in grapes. The average concentration factor when
grapes were processed into wine was found to be 0.35 from field trials
held during 1990 in Bulgaria, Hungary, Italy (2), and Spain (2). The
average concentration factor from field trials held during 1991 in
France (2), Spain (2), Italy (2), and Hungary was found to be 0.19.
The proposed tolerance level of 5 ppm was used to estimate the risk
of developmental toxicity, which is presently considered an acute
effect. The estimated margin of exposure (MOE) was 370, even with use
of this unrealistically high exposure value. A MOE of 100 is typically
acceptable.
EPA did consider more than the average wine consumer. The
carcinogenic risk for high consumers was addressed in the March 31,
1994 proposed rule (59 FR 15145). As for individuals who are more
sensitive to pesticide exposures, EPA uses conservative risk assessment
assumptions to protect such individuals. For example, when
extrapolating from animal data, EPA generally uses an uncertainty
factor of 10 for inter-species differences and an additional
uncertainty factor of 10 in establishing an RfD to account for
different sensitivities in humans.
NCAMP Comment 4. We also question the efficacy of EPA's residue
tolerance-setting procedure in general and request clarification
thereof, with references to applicable regulations and policy
documents. The EPA process in this case, which appears to be a
conflation of product residues and human exposure, raises the concern
that EPA itself is not clear on its own tolerance-setting procedures.
This internal confusion raises the concern that EPA's tolerance-setting
mechanisms are disjointed, inadequately understood, and poorly managed
and, therefore, the EPA is unable to protect public health and the
environment.
EPA's Response. The sole basis stated for the allegation that EPA's
tolerance-setting process is ``unable to protect the public health'' is
the claim that for this tolerance EPA has ``conflat[ed] product
residues and human exposure.'' In the case of procymidone, as well as
all other pesticides, the Agency attempted to make reasonable estimates
of dietary exposure for risk assessment purposes. As explained above,
there was ample data to support EPA's assumption concerning residue
levels in wine. Further, EPA did not only consider average consumers of
wine in its risk estimates.
NCAMP Comment 5. NCAMP is concerned that the true reason for
setting the tolerance at 5.0 ppm is unrelated to health or
environmental concerns, but rather is designed to appease international
trading partners by using the Codex Alimentarius Commission's
international standard.
EPA's Response. In determining appropriate tolerance levels to be
used by FDA and United States Department of Agriculture (USDA) in their
enforcement programs, the Agency evaluates data from controlled field
trials, metabolism studies, and processing studies. These data are also
used, in conjunction with food consumption and toxicology data, to
estimate dietary exposure and risk. Any consideration of Codex
standards occurs within this context. In other words, international
harmonization is not a primary consideration and is only done in those
instances where dietary risk and tolerance enforcement capability will
not be compromised. The proposal to establish a wine grape tolerance at
a level (5 ppm) that is compatible with the corresponding Codex Maximum
Residue Limit (MRL) was no exception to this practice. EPA did receive
several comments from foreign governments and growers in support of the
procymidone tolerance. However, the reason EPA is establishing this
tolerance is the reason set forth in the preamble to the proposed rule:
EPA believes that exposure to procymidone residues under this tolerance
poses no greater than a negligible risk.
3. Following closure of the comment period, EPA received
supplemental comments from Sumitomo responding to comments filed by
NCAMP.
4. Sumitomo suggested that two errors appeared in the proposed
rule.
No comments were received in response to the June 30, 1994 notice
announcing the reopening and extension for an additional 30 days of the
comment period for the procymidone proposed rule.
II. Corrections to the Preamble to the Proposed Rule
1. Sumitomo suggested that two errors appeared in the March 31,
1994 preamble to the proposed rule.
The Agency concurs with Sumitomo that the supplementary
reproductive toxicity from the rat developmental (teratology) study was
observed at 125 mg/kg/day (rather than the published value of 12.5 mg/
kg/day).
The Agency maintains that the second value questioned by Sumitomo
is correct as published. A multigeneration reproduction study in rats
indicates that the NOEL for systemic/reproductive toxicity is 50 ppm
(2.5 mg/kg).
2. In addition, the Agency identified and hereby corrects two
errors to the following values for a reproductive toxicity study in
rats: The reproductive NOEL = 50 ppm, and the reproductive LOEL = 250
ppm (rather than the published values of 250 ppm and 750 ppm,
respectively).
III. Final Decision
The data submitted on the proposal and other relevant material have
been evaluated and discussed in the proposed rule. Based on the data
and information considered, the Agency concludes that the permanent
tolerance will protect the public health. Therefore, the tolerance is
established as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing with the Hearing Clerk, at
the address given above (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). If a hearing is
requested, the objections must include a statement of the factual
issue(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). 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 issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule (1) having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive Order.
Pursuant to the terms of the Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 12, 1994.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C 346a and 371.
2. By revising Sec. 180.455, to read as follows:
Sec. 180.455 Procymidone; tolerances for residues.
A tolerance is established for the residues of the fungicide
procymidone, N-(3,5-dichlorophenyl)-1,2-dimethylcyclopropane-1,2
dicarboximide, in or on the following raw agricultural commodity:
------------------------------------------------------------------------
Parts per
Commodity million
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Wine grapes................................................ 5.0
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[FR Doc. 94-20327 Filed 8-17-94; 8:45 am]
BILLING CODE 6560-50-F
