[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