[Federal Register Volume 59, Number 125 (Thursday, June 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15922]


[[Page Unknown]]

[Federal Register: June 30, 1994]


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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