procymidone (Sumilex) Pesticide Tolerance 8/94
40 CFR Part 180
[PP 0E3859/R2077; FRL-4907-3]
Procymidone; Pesticide Tolerance for Wine Grapes
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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,
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
I. Commments on the Proposal
In response to the March 31, 1994 proposed rule, seven comments
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
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
4. Sumitomo suggested that two errors appeared in the proposed
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
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
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
1,2 dicarboximide, in or on the following raw agricultural commodity:
Commodity Parts per
[FR Doc. 94-20327 Filed 8-17-94; 8:45 am]