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procymidone (Sumilex) Pesticide Tolerance 8/94

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:

                                                                              
                                                                              
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Commodity                              Parts per   
                                        million    
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Wine grapes...............................5.0  
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[FR Doc. 94-20327 Filed 8-17-94; 8:45 am]