Benomyl, Trifluralin, Mancozeb, and Phosmet; Revocation of Certain Food Additive Regulations

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 185

[OPP-260053B; FRL-4896-9]

RIN 2070-AB78

Benomyl, Trifluralin, Mancozeb, and Phosmet; Revocation of

Certain Food Additive Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; Denial of Stay Petitions.

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SUMMARY: EPA is responding to objections and hearing and stay requests

filed in response to a final rule revoking certain food additive

regulations (tolerances) under section 409 of the Federal Food, Drug,

and Cosmetic Act. EPA is denying the objections and hearing and stay

requests on the following section 409 tolerances: (1) Benomyl--raisins

and processed tomato products; (2) trifluralin--peppermint and

spearmint oil; (3) mancozeb--bran of wheat; and (4) phosmet--cottonseed

oil. The denial of the objections and hearing and stay requests effect

the removal of corresponding sections from the Code of Federal

Regulations.

DATES:This regulation is effective June 30, 1994. The portion of this

rule denying the objections and hearing requests will be effective

September 28, 1994. The denial of the petitions to stay the revocation

of the food additive regulations is effective June 30, 1994. For

purposes of judicial review, this rule shall be entered 1 p.m. eastern

daylight time on July 14, 1994.

FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi or Lisa

Engstrom, Special Review and Reregistration Division (7508W),

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

Office location and telephone number: Crystal Station #1, 2800 Crystal

Drive, Arlington, VA. Telephone: (703)-308-8010.

SUPPLEMENTARY INFORMATION: This Order is one in a series of orders

issued in response to a petition filed with EPA in 1989 seeking the

revocation of 14 tolerances as violative of the Delaney anti-cancer

clause in section 409(c) of the Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 348(c). In its first Order on the petition issued in

1990, 55 FR 17560 (April 25, 1990), EPA refused to revoke several of

the tolerances on the ground that even though the pesticides involved

were animal carcinogens, the Delaney clause contains an exception for

de minimis risks. Following EPA's affirmance of that Order after an

administrative appeal (56 FR 7750, Feb. 25, 1991), EPA's decision was

set aside by a court in 1992 based on the court's finding that the

Delaney clause was not subject to an exception for de minimis cancer

risks. Les v. Reilly, 968 F.2d 985 (9th Cir. 1992), cert. denied, 113

S. Ct. 1361 (1993). Then in 1993, EPA issued a revised Order consistent

with the court's holding, stating that the pesticides are animal

carcinogens but this time revoking the tolerances as inconsistent with

the Delaney clause (58 FR 37862, July 14, 1993). Manufacturers of the

subject pesticides and a trade association filed objections to the

revised Order, as well as requests for hearings on, and stays of, the

revocation Order. This final Order addresses those objections and

requests for hearings and stays.

In summary, most of the objections submitted address the issue of

whether the subject pesticides ``induce cancer'' within the meaning of

the Delaney clause. However, EPA concludes herein that this issue was

resolved in an earlier Order and the objectors are precluded from

raising issues already finally decided. EPA finds that the objectors do

not make an adequate case for reopening that issue. Therefore,

objections and requests for hearings focused on whether the subject

pesticides induce cancer are denied by this Order. Other objections and

a request for a hearing on an issue other than whether the pesticides

induce cancer are also denied. In sum, this Order denies the objections

and hearing and stay requests pertaining to revocation of the following

section 409 tolerances: (1) Benomyl--raisins and processed tomato

products (40 CFR 185.350); (2) trifluralin--peppermint and spearmint

oil (40 CFR 185.5900); (3) mancozeb--bran of wheat (40 CFR 185.6300);

and (4) phosmet-- cottonseed oil (40 CFR 185.3950).

The July 14, 1993 final rule (58 FR 37862) is withdrawn as to the

section 409 tolerance for mancozeb on raisins because EPA has published

another final rule elsewhere in this issue of the Federal Register

revoking that tolerance on other grounds. Persons adversely affected by

that Order may file objections with EPA within the period provided by

that Order.

I. Statutory Background

The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et

seq., authorizes the establishment by regulation of maximum permissible

levels of pesticides in foods. Such regulations are commonly referred

to as ``tolerances.'' Without such a tolerance or an exemption from the

requirement of a tolerance, a food containing a pesticide residue is

``adulterated'' under section 402 of the FFDCA and may not be legally

moved in interstate commerce. 21 U.S.C. 331, 342. EPA was authorized to

establish pesticide tolerances under Reorganization Plan No. 3 of 1970.

5 U.S.C. App. at 1343 (1988). Monitoring and enforcement of pesticide

tolerances are carried out by the U.S. Food and Drug Administration

(FDA) and the United States Department of Agriculture (USDA).

The FFDCA has separate provisions for tolerances for pesticide

residues on raw agricultural commodities (RACs) and tolerances on

processed food. For pesticide residues in or on RACs, EPA establishes

tolerances, or exemptions from tolerances when appropriate, under

section 408. 21 U.S.C. 346a. EPA regulates pesticide residues in

processed foods under section 409, which pertains to ``food

additives.'' 21 U.S.C. 348. Maximum residue regulations established

under section 409 are commonly referred to as food additive tolerances

or food additive regulations. Section 409 food additive regulations are

needed, however, only for certain pesticide residues in processed food.

Under section 402(a)(2) of the FFDCA, a pesticide residue in processed

food generally will not render the food adulterated if the residue

results from application of the pesticide to a RAC and the residue in

the processed food when ready to eat is below the RAC tolerance. This

exemption in section 402(a)(2) is commonly referred to as the ``flow-

through'' provision because it allows the section 408 raw food

tolerance to flow through to the processed food form. Thus, a section

409 food additive regulation is only necessary to prevent foods from

being deemed adulterated when the concentration of the pesticide

residue in a processed food when ready-to-eat is greater than the

tolerance prescribed for the RAC, or if the processed food itself is

treated or comes in contact with a pesticide.

Prior to establishing a food additive regulation under section 409,

EPA must determine that the ``proposed use of the food additive

[pesticide], under the conditions of use to be specified in the

regulation, will be safe.'' 21 U.S.C. 348(c)(3). Section 409

specifically addresses the safety of carcinogenic substances in the so-

called Delaney clause, which provides that ``no additive shall be

deemed safe if it has been found to induce cancer when ingested by man

or animal or if it is found, after tests which are appropriate for the

evaluation of the safety of food additives, to induce cancer in man or

animal * * * .'' Id.

Section 409 food additive regulations may be established or revoked

by EPA by order in response to petitions from any person. 21 U.S.C.

348(b). Adversely affected parties may object to an order issued in

response to a petition and such parties may seek an administrative

hearing on the order. 21 U.S.C. 348(f). Only an order responding to

objections is subject to judicial review. 21 U.S.C. 348(g).

II. Regulatory Background

This proceeding was initiated on May 25, 1989, by a petition filed

by the State of California, the Natural Resources Defense Council,

Public Citizen, the AFL-CIO, and several individuals (the ``California

petition'') requesting that EPA revoke 14 food additive regulations for

the pesticides trifluralin (in spearmint and peppermint oil), 40 CFR

185.5900; benomyl (in raisins and tomato products), 40 CFR 185.350;

phosmet (in cottonseed oil), 40 CFR 185.3950; mancozeb (in raisins and

bran of barley, oats, rye, and wheat), 40 CFR 185.6300; dicofol (in

dried tea), 40 CFR 185.410; DDVP (in packaged and bagged nonperishable

processed foods and dried figs), 40 CFR 185.1900; and chlordimeform (in

dried prunes), 40 CFR 185.750. Petitioners argued that these food

additive regulations should be revoked because the seven pesticides to

which the regulations applied were animal carcinogens and thus the

regulations violated the Delaney anticancer clause in section 409 of

the FFDCA. 54 FR 27700 (June 30, 1989).

In the Federal Register of June 30, 1989 (54 FR 27700), EPA issued

the California petition in its entirety in the Federal Register and

sought comments on the action proposed by the petitioners. EPA received

numerous comments on the petitioners' proposal, including several

comments addressing the petitioners' conclusion that EPA had found that

the referenced pesticides induced cancer within the meaning of the

Delaney clause.

EPA issued an Order responding to the petition on April 25, 1990

(``April 1990 Order''). 55 FR 17560 (April 25, 1990). EPA agreed with

the petitioners that it had found that the seven pesticides were

``animal carcinogens'' within the meaning of the Delaney clause, 55 FR

17566, and rejected comments to the contrary by several commenters. 55

FR 17570, 17572-73. As required by section 409, the Order provided

adversely affected parties the right to file objections and requests

for hearings. EPA noted that ``[i]f objections and requests for

hearings are

submitted, * * * the issues of whether the chemicals listed by the

petition induce cancer * * * could be potential factual matters for

resolution at an administrative hearing.'' 55 FR 17570.

Although EPA agreed with the petitioners that all of the referenced

pesticides induce cancer within the meaning of the Delaney clause, EPA

refused to revoke most of the challenged food additive regulations

based on the determination either that: (1) that the residues allowed

by the food additive regulation pose a de minimis cancer risk; (2)

there was insufficient information to determine whether the residues

allowed by the food additive regulation pose a de minimis cancer risk,

and EPA believed that data to be submitted in the future would show

that the cancer risk is de minimis; or (3) action under FFDCA was

appropriately withheld pending completion of an ongoing FIFRA

proceeding addressing similar cancer risk issues. EPA also announced

that it had already revoked the chlordimeform food additive regulation

for dried prunes on October 25, 1989, 54 FR 43424, and agreed to revoke

the food additive regulation for residues of DDVP on dried figs, 55 FR

17567. EPA revoked the food additive regulation for DDVP on dried figs

on June 26, 1991, 56 FR 29182.

On May 22, 1990, the original submitters of the California petition

filed objections to EPA's response to their petition. The petitioners'

central objection was that EPA had incorrectly interpreted section 409

by reading a de minimis exception into the Delaney clause. Petitioners

also contended that ongoing review of a pesticide under the FIFRA did

not provide grounds for refusing to rule on their petition. EPA

received no other objections, and no party requested a hearing on any

matter, including whether any of the pesticides involved induce cancer.

In the Federal Register of February 25, 1991 (56 FR 7750), EPA

responded to the petitioners' objections by issuing an Order (1)

denying the petition to revoke the trifluralin, benomyl, mancozeb, and

phosmet food additive regulations; and (2) stating that revocations for

the DDVP and dicofol regulations would be forthcoming. (``February 1991

Order''). EPA denied the request to revoke the trifluralin and benomyl

regulations because, although it had found the pesticides to ``induce

cancer,'' it further concluded that the residues allowed by the food

additive regulations pose a de minimis cancer risk. EPA denied the

request to revoke the mancozeb regulations because the cancer risk was

being addressed in a parallel proceeding under FIFRA. Finally, EPA

denied the request to revoke the phosmet regulation because EPA's

cancer finding on phosmet was only ``tentative.''

The original petitioners sought judicial review of EPA's ruling on

their objections concerning the benomyl, trifluralin, mancozeb, and

phosmet food additive regulations. On July 8, 1992, the United States

Court of Appeals, Ninth Circuit, set aside EPA's Order. Les v. Reilly,

968 F.2d 985 (9th Cir. 1992), cert denied, 113 S. Ct. 1361 (1993).

Determinative to the court was that EPA had found that the subject

pesticides induce cancer within the meaning of the Delaney clause. The

court dismissed EPA's various arguments on why food additive

regulations for pesticides which are animal carcinogens could be

maintained. Specifically, as to benomyl and trifluralin, the court held

that the Delaney clause prohibited the establishment of food additive

regulations for pesticides which induce cancer no matter how

infinitesimal the human cancer risk. For mancozeb and phosmet, the

court held that the ongoing FIFRA cancellation action concerning

mancozeb and the EPA reevaluation of 2carcinogenicity data on phosmet

did not overcome the induce cancer findings. 968 F.2d at 990 n.3. The

Supreme Court declined to review the decision on February 22, 1993. Les

v. Reilly, 968 F.2d 985 (9th Cir. 1992), cert. denied, 113 S. Ct. 1361

(1993).

Subsequent to the Supreme Court's action, but prior to EPA's

issuance of a revised Order responding to the California petition,

DuPont Agricultural Products (``DuPont''), the producer of benomyl, the

Mancozeb Task Force (comprising DuPont, Elf Atochem North America,

Inc., and Rohm and Haas Co.), and the National Agricultural Chemicals

Association (NACA), each contacted EPA requesting that EPA respond to

the Les v. Reilly decision procedurally by issuing a proposed order

responding to the California petition. They argued that the induce

cancer issue, among others, was not ``adequately explored or raised for

comment.'' (Ref. 1 ). DuPont and NACA specifically claimed that the

``proponents of the maintenance of the section 409 regulations were

never `adversely affected' by an EPA position [in the April 1990

Order], because no change was ever made or proposed to the existing

food additive regulations.'' (Ref. 2).

DuPont, the Mancozeb Task Force, and DowElanco also took several

actions related to the challenged food additive regulations in this

time period. DuPont petitioned EPA to revoke the food additive

regulations for benomyl on processed tomato products and raisins (58 FR

29318, May 19, 1993; 58 FR 63575, Dec. 2, 1993). DuPont contended that

the food additive regulation on tomato products was not necessary

because benomyl did not concentrate during the processing of tomatoes.

DuPont sought the revocation of the raisin food additive regulation on

the ground that raisins should be classified as a ``raw agricultural

commodity,'' and thus this regulation should be repromulgated under

section 408. The Mancozeb Task Force petitioned EPA for the revocation

of the mancozeb food additive regulations on bran of wheat and raisins

on the grounds that those tolerance regulations were unnecessary based

on lack of concentration during processing (58 FR 29318, May 19, 1993).

Finally, DowElanco requested that EPA cancel DowElanco's registration

under FIFRA for the use of trifluralin on peppermint and spearmint (57

FR 7752, March 4, 1992).

III. The Order in Dispute

On July 14, 1993, EPA issued a revised Order responding to the

California petition in light of the decision in Les v. Reilly (58 FR

37862, ``July 1993 Order''). In that Order, EPA stated that the four

pesticides in question, benomyl, trifluralin, mancozeb, and phosmet,

induce cancer within the meaning of the Delaney clause, and, based on

the Ninth Circuit's interpretation of the Delaney clause, EPA ordered

that the challenged regulations for these pesticides be revoked. As

provided in section 409, any person adversely affected was given 30

days to file written objections to the Order and a written request for

an evidentiary hearing on the objections. Adversely affected parties

were also given 30 days to file a petition for a stay of the effective

date of the Order (58 FR 37865). EPA set an effective date of August

30, 1993, for the revocations. Id. EPA announced that, if it received a

request for a stay of the effective date for a particular regulation,

it would stay the effective date as to that regulation for such time as

would be necessary to review and respond to the stay petition. Id.

IV. Stay Petitions

A. Stay Petitions Filed With EPA

EPA received stay petitions from DuPont, DowElanco, the Mancozeb

Task Force, and NACA covering each of the regulations revoked by the

July 1993 Order. Because EPA determined that the stay requests were

properly filed, on September 16, 1993, it issued an Order (``the

September Stay Order'') staying the revocations announced in the July

1993 Order for such time as would be necessary to review the stay

requests. 58 FR 48456. In the September Stay Order, EPA announced that

it would accept comments on the stay requests for fifteen days from

publication of the stay. EPA received within the comment period one

comment from Gowan Inc. addressing the request for stay of the

revocation of the phosmet food additive regulation submitted by NACA.

NRDC submitted comments outside the comment period. In the September

Stay Order, EPA also announced that it would publish in the Federal

Register its determination on each stay request, and, if denying a

particular stay request, that the revocation of the affected regulation

would become effective upon publication of EPA's determination.

B. EPA Response To Petitions To Stay

This Order announces EPA's denial of each of the petitions to stay

the referenced food additive regulations. EPA's consideration of

whether to grant the requested stays for the pendency of the

administrative proceedings has been rendered moot by the fact that

elsewhere in this Order EPA has denied each of the objections filed to

the July 1993 Order, as well as the hearing requests. As a result of

EPA's denial of the requests to stay the revocations of the food

additive regulations for benomyl, mancozeb, trifluralin, and phosmet,

the July 1993 Order becomes effective June 30, 1994.

Gowan Co. and NRDC filed comments in response to the petitions to

stay the revocations announced in the July 1993 Order. Gowan Co., the

manufacturer of phosmet, submitted comments in support of a stay

arguing that phosmet was wrongly classified as an animal carcinogen. If

Gowan Co. had substantive objections to EPA's Order, it should have

filed a timely objection. Gowan Co. cannot surmount the 30-day deadline

for filing objections by couching its objections as a ``comment'' on a

stay request. NRDC commented that the stay should be denied citing the

length of these proceedings and arguing that the objectors submitted no

new evidence justifying further delay of the effective date of these

revocations.

V. Summary of Objections and Hearing Requests

EPA received objections from NACA, DuPont, DowElanco, and the

Mancozeb Task Force. NACA submitted objections to the revocation of

each of the food additive regulations affected by the July 1993 Order.

NACA asserted that the pesticides involved did not induce cancer and

that EPA's July 1993 Order was procedurally defective. EPA also

received separate objections on the revocations of the food additive

regulations for benomyl (DuPont), mancozeb (DuPont and the Mancozeb

Task Force), and trifluralin (DowElanco). DuPont objected to the July

1993 Order arguing that (1) benomyl does not induce cancer; (2) the

benomyl and mancozeb tolerances should be revoked on other grounds; and

(3) the July 1993 Order was procedurally defective. DowElanco claimed

that trifluralin does not induce cancer and that the July 1993 Order

was procedurally defective. The Mancozeb Task Force asserted that (1)

the July 1993 Order was procedurally defective; (2) EPA had failed to

promulgate criteria for making an induce cancer finding; and (3) the

mancozeb tolerances should be revoked on other grounds.

In addition, DuPont filed a request for a hearing on whether

benomyl induces cancer and on whether the benomyl regulations should be

revoked on other grounds, and DowElanco filed a request for a hearing

on whether trifluralin induces cancer.

VI. EPA Response to Hearing Requests and Objections

Most of the objections submitted challenge EPA's finding that the

subject pesticides ``induce cancer'' within the meaning of the Delaney

clause. However, EPA believes that the issue of whether the named

pesticides induce cancer is closed, and the objectors have not raised

new evidence justifying a reopening of that issue. Therefore, EPA is

denying the objections and requests for hearings relying upon the

induce cancer issue. All other objections and the remaining hearing

request are addressed and denied on other grounds.

In part VI.A. of this preamble below, EPA explains why the

objectors are precluded from raising the induce cancer issue. In part

VI.B., EPA addresses the remaining objections and hearing request and

explains its grounds for denying each.

A. The Induce Cancer Determination

Under the doctrines of res judicata, collateral estoppel, and law

of the case, issues finally resolved may not be resurrected absent

manifest injustice. These doctrines are as important in the

administrative context as in the judicial. In the interest of

administrative efficiency and economy, final determinations in

administrative proceedings deserve to be treated with finality. Based

on the procedural requirements of FFDCA section 409 and the specific

facts involved in this proceeding, EPA believes that the issue of

whether the named pesticides induce cancer under the Delaney clause was

laid to rest once the objectors failed to file objections to EPA's

April 1990 Order finding that the named pesticides induce cancer. As a

result, under these doctrines, the objectors may not now rely on that

issue to support a challenge to EPA's July 1993 Order. The following

sections discuss EPA's reasoning.

1. The Finality of FFDCA Section 409(c) Orders. The doctrines of

res judicata, collateral estoppel, and law of the case share a common

theme, finality of decisions in the interest of efficiency and economy.

Generally, these doctrines preclude a party from resurrecting issues

that were finally decided in the same or a prior case. Depending on the

circumstances, any of the three doctrines may be invoked to preclude a

party from raising an issue in an administrative setting that had been

finally decided in another or related administrative or judicial

proceeding. (Ref. 3 ). Furthermore, application of any of the three

doctrines is especially appropriate in an administrative setting when

the organic statute in question is specifically designed to ensure

finality of certain issues. The FFDCA is such a statute.

Under section 409 of the FFDCA, any person may file a petition for

the establishment, amendment, or revocation of a food additive

regulation. 21 U.S.C. 348(b) and (h). EPA must publish a summary of the

petition within 30 days of its filing. 21 U.S.C. 348(b)(5). By order

issued pursuant to section 409(c) of the FFDCA, the Administrator may

either grant or deny, in whole or in part, that petition. A section

409(c) order is effective upon publication unless EPA, in its

discretion, determines that a stay of the order is appropriate. 21

U.S.C. 348(e). In addition, any person adversely affected by a decision

issued pursuant to section 409(c) of the FFDCA may file objections,

specifying the reasons for the objections, and request an

administrative hearing on the objections. 21 U.S.C. 348(f). Section

409(f) requires the Administrator to issue an order responding to the

issues raised by any objections and, if a hearing is held, such order

must be based upon a fair evaluation of the entire record at the

hearing. Only challenges to a section 409(f) order are judicially

reviewable. 21 U.S.C. 348(f). (Ref.4).

This procedural framework is designed to further optimal public

participation while ensuring finality of issues that remain unopposed

either at the administrative or appellate level. In sum, the FFDCA

permits persons adversely affected by a section 409(c) order to

challenge that order, first at the administrative level, and then at

the appellate level. Persons adversely affected by a section 409(c)

order may challenge that order through the submission of objections and

requests for a hearing. Section 409(c) orders that are not challenged

by persons adversely affected by such orders are final. Id. Likewise,

the FFDCA permits persons adversely affected by a section 409(f) order

that responds to objections and to requests for a hearing to challenge

the Agency's findings in an appellate court. Again, if such orders are

not challenged at this stage by persons adversely affected by such

orders, they are final and no longer reviewable. Id. As noted by the

court in Nader v. EPA,

[i]n the FFDCA, Congress constructed an elaborate yet consistent

administrative design for the proposal, consideration, promulgation

and review of regulations. The Act provides a number of well defined

avenues for participation by members of the public and review by

appellate courts. These provisions permit the maximum citizen input

consistent with the Agency's need for consistency and finality.

(Ref. 5). Failure, by a person adversely affected by an Agency

determination, to follow the procedures prescribed by the FFDCA must

necessarily result in determinations that are final and no longer

reviewable. (Ref. 6).

Under the doctrines of res judicata, collateral estoppel, and law

of the case, objectors may not resurrect final decisions necessary or

essential to an ultimate decision and on which objectors had the

opportunity to be heard. (Ref. 7). EPA believes that it is appropriate

to apply these doctrines in proceedings it administers under the FFDCA.

Parts 2, 3, and 4 describe the final Order EPA issued making an

``induce cancer'' finding on all the subject pesticides, the adverse

effect experienced by the objectors, and why precluding the objectors

from raising that issue now is appropriate in this proceeding.

2. EPA's April 1990 Order Under FFDCA Section 409(c). On April 25,

1990, EPA issued a final Order (April 1990 Order) subject to objections

and requests for a hearing in response to petitioners' request to

revoke the 14 food additive regulations. In that Order, EPA concluded

that the subject pesticides induce cancer within the meaning of the

Delaney clause. EPA stated that it agreed with the petitioners ``that

the pesticides named in the petition are animal carcinogens * * * .''

55 FR 17566. EPA also responded to comments submitted on the

petitioners' proposal from the National Food Processors Association

(NFPA), 55 FR 17570, NACA, 55 FR 17570, 17571, Rohm and Haas, 55 FR

17572, and Industria Prodotti Chimici, 55 FR 17573, arguing that the

named pesticides do not induce cancer. In each case, EPA confirmed that

the named pesticides induce cancer and provided a summary of the data

supporting each finding.

For example, in the April 1990 Order, EPA summarized the NFPA

comments on the California petition as follows:

First, NFPA claims that EPA has not determined that any of the

seven pesticides listed by the petition ``induce cancer'' within the

meaning of the Delaney Clause. According to NFPA, an ``induce

cancer'' finding under section 409 must be supported by sufficient

evidence of animal or human carcinogenicity; in the view of the

commenter, limited evidence of animal carcinogenicity is not

necessarily sufficient to support such a finding. Moreover, NFPA

contends that the characterization of pesticides as probable or

possible carcinogens does not constitute a finding under the Delaney

Clause. To determine whether any of the seven pesticides ``induce

cancer'' within the meaning of the Delaney Clause would, in the view

of NFPA, involve complex and disputed factual issues that cannot be

appropriately resolved in the context of the petition. (55 FR 17570)

In its response, EPA explicitly disagreed with NFPA's conclusions that

the induce cancer determinations had not been made for the pesticides

and that the evidence did not support such a finding. Further, EPA

specifically responded to NFPA's comment regarding resolution ``in the

context of the petition,'' by inviting objections to its findings. EPA

stated,

EPA has taken a different position than that espoused by NFPA on

the carcinogenicity of the chemicals named in the petition. As

discussed [in the chemical by chemical review of the cancer data],

the available data provide at least limited evidence that the seven

pesticides induce cancer in test animals. This conclusion was

reached by a weight-of-the-evidence approach in evaluating the

potential carcinogenicity of a chemical which takes into account all

available data for the chemical (see Unit II of this notice).

If objections and request for hearing are submitted, the

Administrator will determine whether there are factual issues

appropriate for resolution at an evidentiary hearing. The issues of

whether the chemicals listed by the petition induce cancer and

whether the risks attributable to the uses identified in the

petition are de minimis could be potential factual matters for

resolution at an administrative hearing. Id.

(The phrase ``limited evidence'' in the quote above is a term of art

under EPA's Cancer Assessment Guidelines (51 FR 33992, Sept. 24, 1986)

specifying the quantum of evidence necessary to find a substance to be

a ``possible human carcinogen.'')

EPA's response to each of the other commenters was similar. Thus,

EPA left no room for doubt in its response to the commenters that it

agreed with the petitioners' conclusion that the pesticides named by

the petition induce cancer.

To support the claim that EPA did not find that the pesticides

named in the California petition induce cancer within the meaning of

the Delaney clause, the objectors cite an EPA policy statement on

emergency exemptions under FIFRA and a 1993 EPA press release. The

policy statement noted that ``EPA has not made formal induce cancer

determinations on many pesticides.'' (Ref. 8). This statement is in no

way inconsistent with EPA having made an induce cancer finding on a few

pesticides--the pesticides in the April 1990 Order. The press release,

dated February 5, 1993, listed dozens of pesticides, including the

pesticides here involved, that are potentially affected by the Delaney

clause. It stated that EPA had not made an induce cancer finding for

the listed pesticides. (Ref. 9). Thus, petitioners are correct in

pointing out an inconsistency between the press release and the April

1990 Order. However, EPA would note that press releases are informal

documents which do not have the status of an FFDCA Order or a policy

statement. Moreover, press releases cannot amend an FFDCA Order.

3. The Adversely Affected Party Requirement. As discussed above,

the FFDCA is specifically designed to ensure finality of decisions that

remain unchallenged as to all persons that were adversely affected by

those decisions. Earlier in these proceedings, EPA issued a decision

stating that the subject pesticides induce cancer. If the objectors

were adversely affected by that decision, the decision should be

accorded finality and preclusive effect.

The following sections address why EPA believes the objectors were

adversely affected by EPA's 1990 determination that the named

pesticides induce cancer.

a. The Adversely Affected Standard. The phrase ``adversely

affected'' is a fairly common statutory phrase used to describe, in

general, the standing of persons to challenge agency decisions. That

phrase is used in a number of FFDCA provisions as well as in many other

statutes, including the Administrative Procedure Act (APA). In the

preamble to the procedural rule for FFDCA actions, 40 CFR parts 177,

178, and 179, EPA states that the adversely affected standard should be

interpreted broadly and not limited to ``narrow categories of

persons.'' 55 FR 50285 (Dec. 5, 1990). This interpretation is in

accordance with the interpretation adopted by the Supreme Court in

construing the same standard under the APA and by FDA in its

implementation of the FFDCA. According to the Supreme Court, the APA

adversely affected standard ``is not meant to be especially

demanding.'' (Ref. 10) In addition, as early as 1979, FDA adopted

procedural regulations defining the adversely affected standard used in

the FFDCA. That definition states that adversely affected persons

``include any interested person.'' 21 CFR 10.3; 44 FR 22318, 22319

(April 13, 1979). FDA agreed that the result of its interpretation was

to make the phrase ``adversely affected'' in its regulation

``superfluous.'' Id. That interpretation of the adversely affected

standard continues in FDA's regulations today.

b. Were The Objectors Adversely Affected By The April 1990 Order?

In their filings on the July 1993 Order, the objectors argue that they

are injured by the stigma attached to an induce-cancer finding. They

claim that this stigma causes them not merely an adverse effect, but

irreparable harm. Moreover, the objectors do not limit this impact to

the uses that are the subject of the revocation Order; rather, they

extend this impact to all uses of the affected pesticide and, in fact,

to all products manufactured by their companies. By their own

admission, thus, the objectors have identified themselves as persons

adversely affected by the induce-cancer finding announced in the April

1990 Order.

For example, in its filings, DuPont argues that as a result of

EPA's revocation of the benomyl food additive regulations, ``the use of

benomyl on tomatoes and other crops could be dramatically curtailed

because of the `taint' of the Delaney Clause.'' (Ref. 11). DuPont

states that

[b]eyond the significant loss in sales to DuPont, this

revocation could create long-term irreparable harm to DuPont because

of the stigma attached to the unfounded allegation that benomyl

``induces cancer.'' This stigma not only has the potential to cause

ill-will against DuPont by customers and consumers, but also will

adversely affect the ability of DuPont to offer fungicide products

to meet the needs of growers, thereby creating further ill-will for

the company. Customers who abandon DuPont products as a result of

the adverse publicity caused by the ``induce cancer'' finding made

by this Order will not likely return to using DuPont products. (Ref.

12).

DowElanco admits that the revocation action itself would have no

impact. DowElanco asserts that

[s]ince DowElanco and the other U.S. registrants of trifluralin

have each independently requested the voluntary cancellation of the

use of trifluralin on peppermint and spearmint, this tolerance

revocation action will not directly effect (sic) the use of

trifluralin on peppermint and spearmint in this country. (Ref. 13).

However, DowElanco argues that it is adversely affected by the

stigma attached to EPA's induce cancer finding. According to DowElanco:

the Agency's so-called ``induce cancer'' finding for trifluralin

puts this chemical in the same league with the very small number of

chemicals found by FDA to ``induce cancer'' within the meaning of

the Delaney Clause, and constitutes a direct attack by EPA on the

safety of trifluralin in the eyes of growers, processors, and

consumers, and on the credibility of DowElanco in selling and

distributing a product which allegedly ``induces cancer.'' * * *

DowElanco will not only directly experience lost sales of

trifluralin as a result of the adverse publicity caused by the

``induce cancer'' finding made by this Order, but will also be

subject to a ``taint'' which will likely adversely effect its

reputation and entire business. (Ref. 14).

The Mancozeb Task Force makes similar admissions. The Task Force

claims that EPA's induce cancer finding

will irreparably injure the Task Force members. Such a finding

will taint the pesticide, and in all probability will lead to

substantial reduction in mancozeb's use by growers, both for those

commodities involved in this proceeding as well as for other

registered uses. (Ref. 15).

They advise that

[t]he Agency must recognize that determining that a pesticide

``induces cancer'' within the meaning of the Delaney clause has

significant adverse consequences for registrants, both in the

regulatory context and the marketplace. (Ref. 16).

Finally, NACA's submission is in the same vein. According to NACA:

NACA and its members have built an enviable reputation of

reliably providing to its customers and the public safe and

efficacious crop protection products. They have devoted significant

time, money, and effort to building the very reputation which EPA's

unfounded action will irreparably damage by suggesting that NACA's

members sell products which ``induce cancer.'' The crop protection

industry's credibility with its customers and NACA's effectiveness

in the public debate on food safety legislation and regulation will

be hurt.* * * Incorrectly designating these pesticides as

carcinogens will cast doubt and suspicion on NACA and the entire

pesticide industry such that complete recovery--when the original

determination is eventually reversed--will be unlikely. (Ref. 17).

In sum, based on these statements provided by the objectors, it is

clear that all the objectors believe that a finding that a pesticide

induces cancer, in and of itself, has an irreparable and adverse

effect. EPA believes that the objectors have overstated the size of the

impact from the induce cancer finding. EPA has regulated each of these

pesticides for years based on EPA's published conclusion that they pose

a cancer risk. (Ref. 18). Nonetheless, given the breadth of the

adversely affected standard, EPA cannot conclude that an induce cancer

finding in a rulemaking did not have some additional adverse impact.

Thus, EPA concludes that the objectors were adversely affected by EPA's

induce cancer finding announced in the April 1990 Order.

Notwithstanding the broad adversely affected standard, the

objectors apparently argue that they were not adversely affected by the

April 1990 induce cancer finding. They suggest that they could not have

been adversely affected in 1990 because EPA never proposed to change

the status quo; and because EPA's 1993 Order proposes to change the

status quo, they are now irreparably injured. According to DuPont, for

example,

[t]he proponents of the maintenance of the Sec. 409 regulations

were never ``adversely affected'' by an EPA position, because no

change was ever made or proposed to the status quo. (Ref. 19).

Several other objectors make similar assertions. (Ref. 20).

EPA finds this argument disingenuous. Having themselves made the

case in their objections that the impact of an induce cancer finding

extends far beyond the specific legal consequences resulting from the

revocation of a few tolerances, the objectors cannot then cite the lack

of direct legal consequences from the April 1990 Order on the

regulations concerned as the sole criterion for determining whether

they were adversely affected by that Order.

Moreover, EPA believes that any additional injury to objectors

based on the revocation of a food additive regulation is merely

additive to what the objectors already describe as an irreparable

injury. As is evidenced by the nature of the objections quoted herein,

none of these objectors argue injury based on the fact that farmers or

other users would cease to purchase their product because of a fear

that use of the product would result in over-tolerance residues on

processed food. The objectors link the total of their injury to a

Delaney clause taint. For example, DuPont, at one point asserts that

the revocation would cause ``confusion'' in the marketplace. But even

here, DuPont tied that to the Delaney clause taint:

The revocation of a Sec. 409 regulation under the Delaney clause

in a situation where there is no concentration necessitating a

Sec. 409 tolerance will result in unwarranted concern and confusion

among growers, food processors, consumers, and the country's

international trading partners. As a result, the use of benomyl on

tomatoes and other crops could be dramatically curtailed because of

the ``taint'' of the Delaney Clause. (Ref. 21).

Thus, the objectors' statements clearly show that the stigma

allegedly caused by an induce cancer finding is their predominant, and

possibly only, concern and thus the objectors' had sufficient incentive

to challenge the April 1990 Order. Given that fact, the potentially

greater effect linked to the more recent Orders does not excuse failure

to challenge the April 1990 Order.

4. The Essentiality of the Induce Cancer Finding in the April 1990

Order. Under the doctrines permitting preclusion of issues finally

decided, preclusion is appropriate when the resolution of an issue was

necessary or essential in the prior action and the persons being

precluded from raising that issue had a full and fair opportunity to

challenge its prior resolution. EPA's April 1990 finding that the

pesticides named in the petition induce cancer within the meaning of

the Delaney clause was necessary for the Agency to respond to the

petition and the comments raised, and EPA specifically noted the

opportunity to object to EPA's conclusions that the named pesticides

induce cancer. Thus, the objectors' failure to challenge EPA's

resolution of that issue results in a final determination, and the

objectors must be barred from relitigating that issue. EPA believes

that the objectors may not now rely on that issue to support their

challenge to EPA's July 1993 Order.

Under the preclusion doctrines, findings necessary to an ultimate

decision may be accorded finality and preclusive effect in the same

manner the ultimate decision would be if a fair and full opportunity to

challenge the findings was made available. (Ref. 22). Many of the

objectors, however, argue that EPA's 1990 finding that the named

pesticides induce cancer was not necessary for EPA to respond to the

petition and that the objectors were not afforded an opportunity to

challenge such a finding. According to DuPont,

[t]he basic issue of whether the pesticides subject to the NRDC

petition ``induce cancer'' within the meaning of the Delaney Clause

was not critical to the Agency's response to the petition, because

the regulations at issue fell within de minimis levels, whether or

not these chemicals ``induce cancer.'' (Ref. 23).

Several other objectors make similar objections. (Ref. 24).

The objectors apparently claim that EPA theoretically applied the

de minimis doctrine--that EPA applied the doctrine only in the event

that it later found any one of the named pesticides to be carcinogens.

EPA disagrees with the objectors' characterization of EPA's

actions. An induce cancer finding was essential and necessary to EPA's

decision in response to the California petition. The California

petition sought revocation of various food additive regulations

asserting that the pesticides covered by such regulations were animal

carcinogens and therefore the regulations violated the Delaney clause.

EPA denied the petition on the ground that there was an exception to

the literal terms of the Delaney clause. Of course, EPA could not have

reached the question of whether there was an exception to the literal

terms of the Delaney clause unless EPA first found that the literal

terms of the clause applied. EPA made it abundantly clear in its April

1990 Order and response to comments that EPA agreed with the

petitioners that the pesticides named in the petition are animal

carcinogens. As noted earlier in this document, at several points

throughout its April 1990 Order, EPA explicitly corrected comments that

the named pesticides do not induce cancer. 55 FR 17566-67; see also 55

FR 17570, 17572-73.

Further, it is apparent that the Ninth Circuit likewise considered

the induce cancer issue an essential element of EPA's Order when

reaching its conclusion in Les v. Reilly. Les v. Reilly, 968 F.2d 985

(9th Cir. 1992), cert denied, 113 S. Ct. 1361 (1993). In its opinion,

the Ninth Circuit recited facts found by EPA which the court adopted:

In 1988, * * * the EPA found these pesticides to be carcinogens.

Notwithstanding the Delaney clause, the EPA refused to revoke the

earlier regulations, reasoning that, although the chemicals posed a

measurable risk of causing cancer, that risk was ``de minimis.''

(Ref. 25).

Thus, the court concluded that the induce cancer determination had

been made even before the April 1990 Order. Significantly, the court

also rejected --on the ground that the induce cancer finding had

already been made--EPA's refusal to revoke the phosmet and mancozeb

food additive regulations. EPA had argued in the February 1991 Order,

that, because the carcinogenicity classification of phosmet was

tentative and because EPA's Special Review would address the cancer

risks posed by mancozeb, immediate revocation of either set of

regulations under the Delaney clause was inappropriate. The court

concluded, however, that EPA's ongoing review of data relating to the

carcinogenicity of phosmet and mancozeb ``cannot countermand the

application of the Delaney clause in light of the 1988 declaration,

never revoked, that both of these pesticides are carcinogenic.'' (Ref.

26).

The objectors also advance a somewhat circular argument to support

their claim that EPA never provided the opportunity to challenge its

1990 induce cancer finding. The objectors argue that they never had the

opportunity to challenge EPA's induce cancer findings because EPA

relied on the de minimis theory to deny the request to revoke the

regulations and EPA never proposed the revocation of the regulations.

Essentially, the objectors are suggesting that although they are

irreparably injured by the more recent induce cancer finding, they were

not adversely affected by EPA's 1990 induce cancer finding. Thus, the

right to challenge EPA's 1990 finding was never triggered.

As noted earlier, EPA believes that the objectors themselves make

the case that they were adversely affected by the 1990 induce cancer

finding and may not now create a post hoc rationalization for the

failure to challenge that finding. Moreover, EPA finds both bases for

the objectors' argument to be irrelevant given that EPA explicitly

noted the opportunity for objections on the induce cancer issue. In its

response to comments on the induce cancer issue, EPA specifically

announced that it would consider objections and requests for a hearing

on the issue of whether the named pesticides induce cancer:

[i]f objections and requests for hearing are submitted, the

Administrator will determine whether there are factual issues

appropriate for resolution at an evidentiary hearing. The issues of

whether the chemicals listed by the petition induce cancer and

whether the risks attributable to the uses identified in the

petition are de minimis could be potential factual matters for

resolution at an administrative hearing. 1055 FR 17570.

See also 55 FR 17572, 17573. (EPA references above-quoted response in

its response to other similar comments). In fact, it is clear that the

commenters understood the controversial nature of EPA's findings. As

noted by several commenters, an induce cancer finding may result in

disputed factual issues, 55 FR 17570, and involve material issues of

fact. 55 FR 17571. A strategic choice not to challenge such an

admittedly controversial finding in an FFDCA proceeding is one that

bears many risks. One obvious and pertinent risk under FFDCA section

409 is that the finding will be accorded finality and referenced in

related administrative or judicial proceedings.

Thus, EPA clearly provided the objectors the opportunity to object

and file hearing requests on the issue of whether any of the named

pesticides induce cancer. The objectors' apparently risky assumption

that EPA would prevail in a judicial setting on legal theories untested

by the Agency does not excuse them from the responsibility to challenge

findings which they believe adversely affect them when the first

opportunity to challenge arises.

5. New Evidence On the Induce Cancer Issue. As detailed above, EPA

believes that, based on the objectors' own arguments, they were

adversely affected by EPA's April 1990 Order finding that the named

pesticides induce cancer within the meaning of the Delaney clause.

Precluding the objectors from relying on the induce cancer issue to

support a challenge to the later revocation Order is appropriate

because EPA's induce cancer findings were essential to its ultimate

response to the petition and because the objectors were provided an

opportunity to challenge the Agency's conclusions. To ensure no

manifest injustice by precluding relitigation of these findings, EPA

has reviewed the objectors' submissions to determine whether the

objectors submitted any new data justifying the reopening this issue.

EPA believes that none of the submissions are sufficient to grant a

rehearing on this issue.

Only one of the objectors, DuPont, specifically argues that there

is ``new'' evidence justifying a hearing on EPA's finding that benomyl

induces cancer. DuPont's claim that it has submitted ``new'' evidence

regarding the cancer determination on benomyl does not justify

reopening this issue. DuPont's ``new'' evidence falls into four basic

categories: (1) a reexamination of the tumors from several cancer

bioassays in mice; (2) an extensive discussion of data on the

mutagenicity of benomyl and several recent mutagenicity studies; (3) a

short-term feeding study directed at determining benomyl's mechanism of

action; and (4) a literature survey concerning hepatoblastomas in Swiss

mice. Little of this evidence is new because, as discussed below,

DuPont was aware of the data before it had lost its opportunity to

challenge EPA's induce cancer finding in the April 1990 Order.

Objections and hearing requests on the April 1990 Order were required

to be submitted by May 25, 1990. What little of the evidence may be

``new'' is merely cumulative to the then existing database, or, at

best, ``further support[s]'' that database. (Ref. 27).

Reread of Tumor Slides. DuPont has submitted a report dated June

19, 1990, documenting a reexamination of the liver sections from two

benomyl cancer bioassays completed in the early 1980s. The report was

prepared by an independent pathologist. (Ref. 28). Even if it is

conceded that a reexamination of older data could be classified as

``new data,'' DuPont clearly had substantial information concerning

what that reread of the tumor slides would disclose before the

expiration of the period for objections to the April 1990 Order. The

report submitted by the independent pathologist reveals that (1) DuPont

scientists reread the tumor slides initially and presented their

conclusions to the independent pathologist for review, (Ref. 29); (2)

the independent pathologist received a ``project sheet'' for the tumor

slide review from DuPont no later than April 18, 1990 (Ref. 30); and

(3) the independent pathologist agreed for the most part with the

earlier conclusions of the DuPont scientists (Ref. 31). Additionally,

DuPont's scientists prepared a report on the reread of the tumor slides

by both the DuPont scientists and the independent pathologists. That

report explicitly states that the scientists ``findings'' were given to

``management'' on May 18, 1990. (Ref. 32). Thus, DuPont's own

submission shows that the this evidence is not ``new.'' In any event,

even assuming that DuPont somehow did not ``know'' the results of the

reread of the tumor slides until the June 19, 1990 completion date, by

the exercise of due diligence DuPont should have know by May 25, 1990.

DuPont was put on notice in June 1989 by the California petition that

the question of benomyl's carcinogenicity was at issue. When DuPont did

contract for an independent evaluation of the tumor slides that

independent evaluation appears to have been completed in roughly 2

months. (Ref. 33). Thus, there is no reason this information could not

have been prepared prior to the expiration of the objection period.

Certainly, there is no scientific reason for the delay because the

scientific justification for the reexamination of the tumor slides--

that the criteria for classifying benign and malignant tumors had

changed--had been extant since at least 1987. (Ref. 34). DuPont's delay

in reevaluating existing data cannot justify their failure to file a

timely objection to the April 1990 Order.

Mutagenicity Report. DuPont has submitted two related reports

addressing whether benomyl is mutagenic. (Ref. 35). DuPont also

submitted several mutagenicity studies for review which are dated later

than May 25, 1990. (Ref. 36). The reports discuss hundreds of

mutagenicity studies done on benomyl and similar compounds over the

last twenty years. The newly submitted studies add little to the vast

data already compiled by April 1990 on whether benomyl is mutagenic.

Thus, the major thrust of this mutagenicity report could have been

raised in objections to the April 1990 Order.

28-Day Mouse Feeding Study. DuPont has submitted a short-term

feeding study with mice, dated June 27, 1990, which attempted to assess

possible mechanisms of liver tumor induction caused by benomyl. (Ref.

37). DuPont concluded that the ``results of this study suggest that

benomyl causes induction of a normal adaptive response that results in

an increase in cell proliferation and thus acts indirectly by

modulating a high spontaneous incidence of mouse hepatic tumors through

physiological mechanisms and not as a direct acting carcinogen.'' (Ref.

38). Even assuming this information is relevant to the induce cancer

finding, this study is not so definitive as to justify reopening the

induce cancer determination. Moreover, this was a study conducted in-

house by DuPont for which the actual experimental work was completed by

March 30, 1990. (Ref. 39). If the results of this study were indeed

critical, DuPont had ample time to raise them in objections to EPA's

April 1990 Order.

Literature Review Regarding Hepatoblastomas. DuPont submitted a

review of scientific literature discussing hepatoblastomas in mice.

(Ref. ). All of the nine articles cited were published prior to May 25,

1990. Thus, this submission did not constitute new evidence.

Accordingly, all of the ``new'' evidence either could have been

raised in objections to the April 1990 Order or is merely cumulative to

evidence which could have been raised in objections to that Order.

6. Conclusion. As adversely affected parties, the objectors'

failure to file a challenge with EPA to the April 1990 Order bars them

from now challenging a finding essential to that Order--that the named

pesticides are animal carcinogens. The objectors must accept the

consequences of the decision not to object to that April 1990 Order.

B. Remaining Hearing Requests and Objections. The objectors raise

several other objections and a hearing request pertaining to issues

other than EPA's induce cancer finding that are not necessarily barred

by EPA's April 1990 Order. These objections and hearing requests are

summarized and addressed below.

1. Concentration. DuPont and the Mancozeb Task Force have objected

to the revocation of the benomyl tolerance on raisins (DuPont) and the

mancozeb tolerances on raisins and bran of wheat (DuPont and Mancozeb

Task Force) on the ground that these food additive tolerances should be

revoked because there is no concentration of residues for these

pesticides in these processed foods. Under existing EPA policy, EPA

does not consider food additive tolerances necessary unless residues of

a pesticide concentrate during processing and therefore could exceed

the raw food tolerance. DuPont and the Mancozeb Task Force, contend

that the respective benomyl and mancozeb regulations are not necessary

under this policy and EPA must make a determination on the

concentration issue prior to reaching the Delaney clause question.

DuPont has also requested a hearing on the question of whether benomyl

concentrates in tomato products. EPA disagrees with the objectors on

both legal and practical grounds.

First, these objections and hearing requests suffer from a basic

flaw: a challenge to an order under FFDCA section 409 must ``go to the

legality of the agency's order.'' (Ref. 41). Arguing that there is an

alternate ground for a revocation action based on information or claims

not resolved by EPA in the revocation does not challenge the legal

basis of the revocation. Here, EPA revoked the benomyl and mancozeb

tolerances on the ground that these tolerances are barred by the

Delaney clause. That was the sole issue addressed by the July 1993

Order. EPA did not address whether the tolerances were needed due to a

concentration of residues during processing except to mention the

irrelevancy of the issue to that Order. Unlike the induce cancer issue,

the question of whether benomyl concentrates during processing was not

an essential element of the July 1993 Order.

The objectors appear to be contending that, even when EPA finds

that a tolerance violates the core safety standard in FFDCA section

409, EPA is legally barred from acting on that finding prior to

determining whether there are some other grounds for revoking the

tolerance. DuPont claims that ``[t]he Agency must make a threshold

determination if a 409 regulation is necessary before even reaching the

question of the applicability of the Delaney clause.'' (Ref. 42).

DuPont cites three reasons why such a threshold determination is

mandated. None has merit.

DuPont first argues that ``if data demonstrate that there is no

concentration of residues in processed food, there is no reason to

retain the Sec. 409 food additive regulations.'' (Ref. 43) True, there

may be ``no reason'' under EPA's existing policy or given the flow-

through provision of section 402 to retain such a food additive

regulation, but the regulation would not be barred as a legal matter by

the flow-through provision. The flow-through provision simply creates a

safe harbor for residues in processed food which are at or below the

section 408 raw food tolerance. Thus, revocation of a food additive

regulation where the pesticide does not concentrate in the processed

food is driven by policy not legal considerations. Second, DuPont

asserts that a threshold determination on concentration must be made

because of the taint attached to the Delaney clause finding. This

reason may explain why DuPont seeks revocation on another ground;

however, as stated above, it is not legal support for requiring EPA to

first make a concentration determination. Finally, DuPont claims that

relying on the Delaney clause grounds to revoke the tolerance may cause

FDA to misallocate its enforcement resources because of public fears

about cancer. Even assuming this to be true, this reason is again

nothing more than a policy reason for relying on lack of concentration

rather than the Delaney clause.

The Mancozeb Task Force makes similar policy arguments as to why

EPA should revoke the mancozeb food additive tolerances on

concentration grounds. Like the arguments of DuPont, the Task Force's

contentions do not attack the legal basis for the revocation.

At bottom, DuPont and the Mancozeb Task Force are objecting because

EPA has not taken action on their later petitions to revoke these

tolerances on lack of concentration grounds. EPA is acting on the one

food additive tolerance (mancozeb on raisins) where EPA had data which

had already been reviewed showing that the tolerance was not needed

under existing policy. EPA, however, has not yet acted on the portions

of the petitions filed by DuPont and the Mancozeb Task Force which are

inadequately supported by data or are premised on a change in a

longestablished EPA policy. EPA sees no error in acting first on the

California petition since it was submitted nearly four years prior to

the DuPont and Mancozeb Task Force petitions.

EPA denies DuPont's and the Mancozeb Task Force's objections to

EPA's failure to revoke these tolerances on concentration grounds and

DuPont's hearing request on the same issue because they do not attack

the legal basis of the July 1993 Order. None of the policy arguments

made by the objectors convince EPA that it would be appropriate to

delay responding to the California petition until the issues

surrounding their petitions can be resolved.

2. The Classification of Raisins as a Processed Food. DuPont has

objected to the revocation of the benomyl food additive tolerance for

raisins claiming that that tolerance should be revoked because raisins

are not a processed food but a raw agricultural commodity. DuPont

argues raisin tolerances should be established under section 408, not

section 409. This objection is denied for the same reason as the

objection involving the concentration issue--proposing an alternate

ground for revocation based on information or claims not resolved in

the revocation does not attack the legal basis of the July 1993 Order.

Similarly, EPA does not believe that it is obligated to rule on

DuPont's petition to reclassify raisins prior to ruling on the

California petition, given that DuPont's petition was filed 4 years

later.

3. Procedural Objections.Several of the objectors have raised

various related procedural objections to EPA's July 1993 Order. Because

these alleged procedural errors all involve EPA's determination on the

induce cancer question and because each of the objectors are precluded

from relitigating that issue, EPA believes if it committed any error,

the error was harmless. Nevertheless, because the objections raised

call into question the operating procedures of both EPA and FDA over

the last 40 years, EPA will respond to them in some detail.

The objectors' basic complaint is that following the decision in

Les v. Reilly, EPA immediately issued a final order rather than a

proposal seeking public comment on revoking the tolerances. The

objectors claim this violated EPA's regulations and the Administrative

Procedure Act (APA). They are mistaken.

Section 409 of the FFDCA contains an elaborate procedure for the

establishment, amendment, and revocation of food additive tolerances.

21 U.S.C. 348; see Nader. It is basically a hybrid rulemaking scheme

that marries some aspects of informal rulemaking with the adjudicative

hearing requirements of formal rulemaking.

As explained above, the statute establishes a petition procedure

whereby any person may request EPA to establish a tolerance. 21 U.S.C.

348(b). It also requires EPA to establish, by regulation, the procedure

for the amendment or repeal of food additive tolerances. 21 U.S.C.

348(h). ``[S]uch procedure shall conform to the procedure provided [in

section 409] for the promulgation of such regulations.'' Id.; see 40

CFR parts 177, 178 (establishing such regulations). When a petition is

submitted, EPA is required to publish ``[n]otice of regulation proposed

by the petitioner * * * in general terms.'' 21 U.S.C. 348(b)(5); 21 CFR

177.88. EPA is commanded to act on the petition by order within 180

days either establishing a tolerance regulation or denying the

petition. 40 U.S.C. 348(c). EPA regulations allow EPA to issue a

proposal prior to issuing a final order on the petition. Once a final

order is issued, adversely affected parties are allowed 30 days to file

objections and request an adjudicative hearing. Any EPA decision on the

objections is then subject to judicial review.

The steps followed by EPA in acting on the California petition have

been described in detail above. These steps were clearly in accordance

with FFDCA section 409, and the objectors do not claim that they were

not. However, as noted above, the objectors argue that EPA violated its

own regulations and the APA. The objectors claim that EPA regulations

require EPA to issue a proposal, in addition to a notice of a petition,

prior to revoking a food additive regulation in response to a petition

from a member of the public.

EPA disagrees. EPA's regulations clearly make it discretionary with

the Administrator whether to issue a proposal where it has received a

petition. The pertinent regulation states: ``The Administrator may

publish in the Federal Register a proposal to establish a food additive

regulation or to modify or revoke an existing food additive regulation,

on his or her own initiative or in response to a petition.'' (40 CFR

177.130(a); see 40 CFR 177.125(b); 53 FR 41128). The objectors'

allegations to the contrary have no basis.

EPA also rejects the objectors' claim that the APA required a

proposal in this case. Essentially, the objectors are contending that,

despite Congress' express inclusion in the FFDCA of an intricate

procedural scheme involving both an initial notice procedure and

opportunity for a full de novo administrative hearing on the

government's action, APA notice and comment rulemaking requirements

must be followed as well. As support for this argument, DuPont relies

on the fact that EPA has generally issued proposals prior to revoking a

tolerance in the past. While this is true, it is a fact with little

effect here because previous revocation actions have nearly always been

initiated by the Administrator. In those circumstances, both section

408 and 409 of the FFDCA requires issuance of a proposal. 21 U.S.C.

346a(e) and 348(d). The more appropriate analogy for the revocations at

issue here are those procedures EPA follows generally when it receives

a petition to establish, modify, or revoke a food additive regulation.

In those cases, as stated above, in accordance with FFDCA sections 408

and 409 and EPA regulations, EPA issues a notice summarizing the

petition followed by a final order. For example, nearly all of the

roughly eight to ten thousand tolerances and exemptions from a

tolerance under section 408 and 409 were established in response to

petitions. In the overwhelming majority of cases, including the

regulations involved in this Order, (Ref. 44), EPA published a brief

summary of the petition followed by a final rule. See, e.g., 44 FR

23932 (April 23, 1979) (notice of filing of petition to establish a

food additive regulation for phosmet (imidan) on cottonseed oil).

Having taken advantage of this procedure for over 30 years, see, e.g.,

23 FR 118, and 2402 (January 7, 1958; April 12, 1958) (Rohm & Haas Co.

petition on dicofol), the objectors quite understandably do not argue

that this procedure violates the APA and have not objected to EPA using

it to establish tolerances established subsequent to the filing of

objections in this case. See, e.g., 59 FR 5108 (Feb. 3, 1994). (DuPont

petition for tolerance for hexakis.) Yet, unless they take that

position, they necessarily must be contending that industry is entitled

to more process under the rulemaking provisions of the APA on tolerance

revocation petitions than the public is on petitions seeking the

establishment of a tolerance legalizing pesticide residues in food.

Finally, the objectors are in a poor position to argue they should

have been given an additional opportunity to file written comments with

EPA. The objectors chose not to challenge EPA's April 1990 Order. A

timely and proper objection to the April 1990 Order would have entitled

them to a full de novo administrative hearing on the induce cancer

issue not merely an opportunity to file comments.

4. Substantive Due Process. DuPont argues that EPA's revocation

action violates the constitutional doctrine of substantive due process

because the revocation is without scientific basis and thus is

arbitrary. (Ref. 45). DuPont, however, already has a statutory right to

challenge the substance of EPA's action under the FFDCA. The

Constitution provides nothing further in this regard. EPA thus denies

DuPont's constitutional argument for the same reasons it has denied

DuPont's substantive challenge to EPA's induce cancer finding.

VII. References

1. Letter from Jay J. Vroom, President, NACA, to Linda J. Fisher,

Assistant Administrator, EPA, at 4 (January 12, 1993) (hereinafter

cited as ``NACA Letter''); Letter from Edward M. Ruckert, Attorney for

Mancozeb Task Force, to Carol M. Browner, Administrator, EPA at 2

(March 5, 1993); Letter from Stanley H. Abramson, Attorney for DuPont,

to Raymond B. Ludwiszewski, General Counsel, EPA at 1 (February 17,

1993) (hereinafter cited as ``DuPont Letter'').

2. DuPont letter at 8; NACA Letter at 4.

3. Nader v. EPA. 859 f.2d 747, 752-754 (9th Cir. 1988), cert.

denied, 490 U.S. 1931 (1989); Rutherford v. U.S., 806 F. 2d 1455, 1459-

60 (10th Cir. 1896); CNI V. Young, 773 F. 2d 1356 (1985); Retail Clerks

Union, Local 1401 R.C.I.A. v. N.L.R.B., (463 F.2d 316, 322 (D.C. Cir.

1972).

4. Nader, 859 F.2d 752-754.

5. Nader, 859 F.2d at 754.

6. Id.

7. Rutherford v. U.S. 806 F.2d 1455, 1459-60 (10th Cir. 1986); CNI

v. Young, 773 F.2d 1356 (1985); Retail Clerks Union, Local 1401

R.C.I.A. v. N.L.R.B., 463 F.2d 316, 322 (D.C. Cir. 1972).

8. U.S. EPA and FDA Statement of Policy, ``The Delaney Clause and

Emergency Exemptions Under FIFRA,'' p. 4 (May 7, 1993).

9. EPA, Note to Correspondents (Feb. 2, 1993). Contrary to the

calim by DuPont these lists and the language quoted by Dupont in its

objections were not published in the Federal Register. See DuPont

Agricultural Products' Objections to ``Induce Cancer'' Finding for

Benomyl and to Revocations of Section 409 Food Additive Regulations for

Benomyl in Processed Tomato Products and Raisins and Mancozeb in Bran

of Wheat and in Raisins, at 43 (August 13, 1993) (hereinafter cited as

``DuPont Objections'').

10. Clarke v. Securities Indstry Ass'n, 107 S. Ct 750, 757 (1987).

11. DuPont Agricultural Products' Request for a Hearing on Issues

Pertaining to Whether Benomyl ``Induces Cancer'' and Whether Benomyl

Concentrates in Processed Tomato Products, at 13-14 (August 13, 1993)

(hereinafter cited as ``Dupont Hearing Request''); Petition of DuPont

Agricultural Products to Stay the Effective Date of the Revocation of

the Section 409 Food Additive Regulations for Benomyl in Processed

Tomato Products and Raisisns and Mancozeb in Bran of Wheat and Raisins,

at 9 (August 13, 1993) (hereinafter cited as ``Dupont Stay Petition'').

12. DuPont Stay Request at 9.

13. DowElanco's Objections to ``Induce Cancer'' finding for

Trifluralin and to Revocation of Section 409 Food Additive Regulations

for Trifluralin in or on Peppermint Oil and Spearmint Oil, at 9-10

(August 13, 1993) (hereinafter cited as ``DowElanco Objections'').

14. DowElanco Objections at 9-10.

15. Mancozeb Task Force Petition to Stay Effective Date, at 13

9August 13, 1993) (hereinafter cited as ``MTF Stay Petition'').

16. MTF Stay Request at 11.

17. Petition of the National Agricultural Chemicals Association to

Stay the Revocation of Food Additive Regulations for Benomyl, Mancozeb,

phosmet, and Trifluralin, at 2 (August 13, 1993) (hereinafter cited as

``NACA Stay Petition'').

18. Benomyl Special Review, 47 FR 46747, 46749 (1982); ``EBDCs,

Notice of Intent to Cancel and Conclusion of Special Review,'' 57 FR

7483 (March 2, 1992); Trifluralin, Position document 4, 47 FR 33777

(July 1982); ``Guidance for the Reregistration of Pesticide Products

Containing Trifluralin as the Active Ingredient'' (April

1987);``Guidance for the Registration of Pesticide Products Containing

Trifluralin as the Active Ingredient'' (1987); ``Guidance for the

reregistration of Pesticide products Containing Phosmet as the Active

Ingredient.'' (September 1986).

19. DuPont Objections at 72.

20. See DowElanco Objections at 62 and 65; Objections of the

Mancozeb Task Force, at 10 (August 13, 1993) (hereinafter cited as

``MTF Objections'').

21. DuPont Hearing Request at 13-14.

22. Synanon Church v. U.S., 806 F.2d 1455, 1459-60 (10th Cir.

1986); CNI v. Young, 773 F.2d 1356 (1985); Retail Clerks Union, Local

1401 R.C.I.A. v. N.L.R.B., 463 F.2d 316, 322 (D.C. Cir. 1972).

23. DuPont Objections at 74.

24. See DowElanco Objections at 62 and 65; MTF Objections at 10.

25. Les 968 F.2d at 986.

26. Les, 968 F.2d at 990 n.3.

27. Letter from Ronald A. Hamen, DuPont, to Dr. Janet Anderson,

U.S. EPA, (August 17, 1990) (letter submitting mutagenicity data,

reread of tumor slides, and 28-day mouse study). (Dupont Exhibit #61).

28. Oncogenicity Studies with Benomyl and MBC in Mice, Peer Review

of Liver Neoplasms, Experimental Pathology Laboratories, Inc. (June 19,

1990) (Dupont Exhibit #57).

29. Id. at 1.

30. Id. App. Quality Assurance Final certification.

31. Id. at 3.

32. Oncogenicity Studies with Benomyl and MBC in Mice, Supplemental

Peer Review; Supplement to Haskell Laboratory Report Nos. 20-82 and 70-

82, Quality Assurance Documentation at 4 (June 28, 1990). (Dupont

Exhibit #58).

33. See Reference 31.

34. Oncogenicity Studies with Benomyl and MBC in Mice, Peer Review

of Liver Neoplasms, Experimental Pathology Laboratories, Inc., at 4

(June 19, 1990) (Dupont Exhibit #57) (citing criteria on proliferative

hepaocellular lesions, published in R.R. Maronpot, J.K. Haseman, G.A.

Boorman, S.E. Eustis, G.N. Rao, and J.E. Huff, ``Liver Lesions in

B6C3F1 Mice: The National Toxicology Program, Experience and

Position,'' Archives of Toxicology: Mouse Liver Tumors (1987)).

35. V. Reynolds, A. Sariff, ``A Review of the Genetic Toxcity

Studies on Benomyl and Carbendazim'' (January 1, 1993); and A. Sarrif,

``Assment of the Genetic Toxicological Studies on Benomyl and

Carbendazim: A Review'' (January 31, 1993). (Dupont Exhibits Nos. 64

and 65).

36. See DuPont Exhibits Nos. 105, 108, 109, 110.

37. 28-Day Feeding Study with Benomyl in Mice, Haskell Laboratory

Report No. 324-90 (August 15, 1990). (Dupont Exhibit #60).

38. Id. at 12.

39. Id. at 5.

40. Memorandum from C.S. Van Pelt, DuPont, to R.A. Hamlen, Dupont,

``Review of TNO Mouse Feeding Study and Interpretational Significance

of Hepatoblastomas in Mouse Liver,'' (August 15, 1999). (Dupont Exhibit

#59).

41. CNI v. Young, 773 F.2d at 1364.

42. DuPont objections at 59.

43. DuPont objections at 59.

44. 45 FR 8979 (February 11, 1980) (phosmet food additive

regulation established on petition of Stauffer Chemical co.); 38 FR

26447 (September 21, 1973) 9benomyl food additive regulation

established on petition of DuPont); 34 FR 531 (January 15, 1970)

(trifluralin food additive regulation established on petition of Elanco

Products Co.); and 32 FR 7523 (May 23, 1967) (mancozeb food additive

regulation established on petition of Rohm 7 Haas Co.).45. DuPont

objections at 83.

VIII. Conclusion

For the reasons detailed above, all objections and hearing requests

filed in response to the July 1993 Order are denied. All of the stay

requests are denied as well. This Order is issued under section 409(f)

of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 348(f)) and is

subject to judicial review as provided in section 409(g) of the act (21

U.S.C. 348(g)).

List of Subjects in 40 CFR Part 185

Environmental protection, Administrative practice and procedure,

Food additives, Pesticides and pests, Reporting and recordkeeping

requirements.

Dated: June 17, 1994.

Lynn R. Goldman,

Assistant Administrator for Prevention, Pesticides and Toxic

Substances.

Therefore, 40 CFR part 185 is amended as follows:

PART 185--[AMENDED]

1. The authority citation for part 185 continues to read as

follows:

Authority: 21 U.S.C. 346a and 348.

Sec. 185.350 [Removed]

2. By removing Sec. 185.350 Benomyl.

Sec. 185.3950 [Removed]

3. By removing Sec. 185.3950 N-(Mercaptomethyl)phthalimide S-(O,O-

dimethyl phosphorodithioate) and its oxygen analog.

Sec. 185.5900 [Removed]

4. By removing Sec. 185.5900 Trifluralin.

Sec. 185.6300 [Amended]

5. By amending Sec. 185.6300 Zinc ion and maneb coordination

product in the list at the end of the section by removing the words ``,

and wheat'' in the second entry.

[FR Doc. 94-15922 Filed 6-28-94; 11:46 am]

BILLING CODE 6560-50-F