[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]


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


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.

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

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  
------------------------------------------------------------------------
Wine grapes................................................          5.0
------------------------------------------------------------------------


[FR Doc. 94-20327 Filed 8-17-94; 8:45 am]
BILLING CODE 6560-50-F