40 CFR Part 180

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:

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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