E.I. du Pont de Nemours and Company
In re E.I. du Pont de Nemours and Company (EAB FIFRA Appeal No. 98-2): appeal partly reversed and remanded
Apply this precedent to your situation
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Plain-English summary
E.I. du Pont de Nemours and Company appealed an Initial Decision finding that it made 379 shipments of misbranded pesticides in April 1994 and assessing a total civil penalty of $1,895,000. The Board held that EPA's Worker Protection Standard labeling rules establish a misbranding standard under FIFRA, and that DuPont's admission resolved whether the shipments used the WPS labeling at issue. The Board also held that EPA's November 1993 approval of the labeling was prima facie evidence of compliance, and that DuPont should have been allowed to submit evidence that its products were toxicity category III rather than category II. The Board affirmed in part, reversed in part, and remanded for the Presiding Officer to consider that evidence and other evidence about compliance with the WPS labeling rules.
Decision snapshot
- Cited authorities: FIFRA §§ 2, 3, 6, 12, and 25; 7 U.S.C. §§ 136, 136a, 136j, and 136w; 40 C.F.R. §§ 152, 156, 164, and 170.
- Outcome: The Board affirmed in part, reversed in part, and remanded for further proceedings.
- Key point: After EPA rebutted the prima facie effect of its labeling approval, DuPont was entitled to present toxicity evidence relevant to the Worker Protection Standard labeling requirements.
Full text (EPA EAB public release)
32 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
IN RE E.I. DU PONT DE NEMOURS
AND COMPANY
FIFRA Appeal No. 98-2
DECISION AND REMAND ORDER
Decided April 3, 2000
Syllabus
This is an appeal by E.I. du Pont de Nemours and Company (“DuPont”) from an
Initial Decision arising out of an administrative enforcement action by the Director of Tox-
ics and Pesticides Enforcement Division, Office of Regulatory Enforcement, Office of En-
forcement and Compliance Assurance, U.S. Environmental Protection Agency (“Pesticide
Enforcement”). The enforcement action was filed against DuPont for numerous alleged vi-
olations of section 12 of the Federal Insecticide, Fungicide, and Rodenticide Act, as
amended (“FIFRA”), 7 U.S.C. § 136j. By the Initial Decision, the Presiding Officer found
that, in April 1994, DuPont made a total of 379 shipments of pesticides that were mis-
branded as defined in FIFRA section 2(q)(1)(F) and (G).
Central to this case and DuPont’s arguments on appeal is the fact that EPA promul-
gated new pesticide labeling requirements in 1992 as part of the so-called Worker Protec-
tion Standard (“WPS”) regulations. The WPS regulations require the labeling for certain
pesticide products be modified so as to contain additional warning or caution statements
for the protection of pesticide applicators and handlers and so-called early-entry agricul-
tural workers who enter fields within a short time after pesticide application. At issue in
this case is the WPS requirement that pesticide products with a potential to cause eye irrita-
tion, identified as toxicity category II under the WPS regulations, must bear a protective
eyewear warning, but products with a lower eye irritation toxicity level — that of toxicity
category III — have no such protective eyewear warning requirement. The Presiding Of-
ficer found that the pesticide products at issue in this case are toxicity category II for eye
irritation potential but that the labeling used by DuPont failed to contain a protective
eyewear warning in the section of the label governing the warnings for early-entry agricul-
tural workers.
DuPont raised four primary arguments on appeal: (1) that the labeling allegedly used
by DuPont in April 1994 had been approved by EPA in November 1993; (2) that the WPS
labeling requirements do not establish a misbranding standard under FIFRA section
2(q)(1)(F) and (G); (3) the Presiding Officer erred by precluding DuPont from submitting
certain evidence proffered to establish that the pesticide products at issue in this case are, in
fact, toxicity category III for which the protective eyewear warning is not required by the
WPS regulations; and (4) that Pesticide Enforcement failed to submit evidence showing
that each of the 379 shipments of pesticide products was in fact sold or distributed bearing
the new WPS-modified labeling as alleged in the complaint, rather than the old, previously
approved non-WPS labeling.
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E.I. DU PONT DE NEMOURS AND COMPANY 33
Held: Affirmed in part, reversed in part and remanded for further proceedings.
1) The Presiding Officer erred on the question of whether DuPont had received ap-
proval for its labeling in November 1993. The determination as to whether approval had
been granted must be based on the terms of EPA’s official letters granting amended regis-
tration, which in this case facially granted unqualified approval of the entire labeling and
did not indicate that the proposed WPS modifications included in the label were not re-
viewed or approved. Such approval, however, is not a defense to the misbranding charge;
instead it serves as prima facie evidence that the pesticide, its labeling and packaging com-
ply with the registration provisions of FIFRA.
2) The Presiding Officer did not err in holding that the WPS regulations establish a
misbranding standard under FIFRA section 2(q)(1)(F) and (G). EPA satisfied the substan-
tive standard for misbranding under FIFRA section 2(q)(1)(F) and (G) when it promulgated
the WPS labeling requirements. Therefore, proof that a pesticide product’s label does not
contain a warning or use statement that complies with the specific language required by the
WPS rule is sufficient to establish that the product is misbranded under FIFRA section
2(q)(1)(F) or (G).
3) The WPS regulations establish different labeling requirements for different cate-
gories of pesticide products, based on the product’s toxicity through different routes of
exposure. Thus, the regulations require, for each pesticide product, that a factual determi-
nation of the product’s toxicity be made as a predicate to determining the labeling language
required by the regulations. The November 1993 approval of the labeling at issue in this
case established DuPont’s prima facie evidence that such labeling complies with FIFRA’s
registration requirements and is not misbranded under FIFRA section 2(q)(1)(F) and (G).
However, Pesticide Enforcement submitted sufficient evidence to rebut that prima facie
case by showing that EPA had mistakenly approved labeling that did not contain a caution
or warning statement required by the WPS regulations for pesticide products with eye irri-
tation toxicity category II, which is the toxicity category of DuPont’s products as stated in
DuPont’s own applications for amended registration. However, once Pesticide Enforcement
rebutted DuPont’s prima facie evidence of compliance, DuPont should have been allowed
to submit its additional evidence on toxicity, which DuPont alleges would show that these
products are toxicity category III, not toxicity category II as DuPont claims it stated by
mistake in its applications for amended registration. This case is remanded to allow DuPont
to submit its toxicity evidence and for the Presiding Officer to consider other evidence as
to whether the labeling at issue complies with the WPS regulations.
4) DuPont admitted in its answer that the 379 shipments of pesticides identified in
the complaint were shipped bearing “WPS language identical to that submitted to EPA on
July 14, 1993.” This admission removed from controversy in this case any question as to
whether the 379 shipments were actually made bearing the WPS-labeling language set
forth in DuPont’s July 1993 applications for amended registration.
Before Environmental Appeals Judges Scott C. Fulton, Ronald L.
McCallum, and Kathie A. Stein.
Opinion of the Board by Judge McCallum:
This is an appeal by E.I. du Pont de Nemours and Company (“DuPont”)
from an Initial Decision by Administrative Law Judge Edward J. Kuhlmann (“Pre-
siding Officer”) arising out of an administrative enforcement action by the Direc-
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34 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
tor of Toxics and Pesticides Enforcement Division, Office of Regulatory Enforce-
ment, Office of Enforcement and Compliance Assurance, U.S. Environmental
Protection Agency (“Pesticide Enforcement”). The enforcement action was filed
against DuPont for numerous alleged violations of section 12 of the Federal Insec-
ticide, Fungicide, and Rodenticide Act, as amended (“FIFRA”), 7 U.S.C. § 136j.
By the Initial Decision, the Presiding Officer found that DuPont made a total of
379 shipments of misbranded pesticides in April 1994 as alleged in Pesticide En-
forcement’s complaint (Count I of the complaint alleged 32 shipments of mis-
branded Bladex 4L; Count II alleged 10 shipments of misbranded Bladex 90 DF;
Count III alleged 325 shipments of misbranded Extrazine II 4L; and Count IV
alleged 12 shipments of misbranded Extrazine II DF). The Presiding Officer as-
sessed a penalty of $5,000 for each of the 379 shipments made in violation of
FIFRA, resulting in an aggregate penalty of $1,895,000.
DuPont has appealed from both the finding of liability and the penalty as-
sessment. Central to this case and DuPont’s arguments on appeal is the fact that
EPA promulgated new pesticide labeling requirements in 1992 as part of the so-
called Worker Protection Standard (“WPS”) regulations. As explained in greater
detail below, the WPS regulations require the labeling for certain pesticide prod-
ucts to be modified so as to contain additional warning or caution statements for
the protection of pesticide applicators and handlers and so-called early-entry agri-
cultural workers who enter fields within a short time after pesticide application.
At issue in this case is the WPS requirement that pesticide products with a poten-
tial to cause eye irritation, identified as toxicity category II under the WPS regula-
tions, must bear a protective eyewear warning, but products with a lower eye irri-
tation toxicity level — that of toxicity category III — have no such protective
eyewear warning requirement. The Presiding Officer found that the pesticide
products at issue in this case are toxicity category II for eye irritation potential but
that the labeling used by DuPont failed to contain a protective eyewear warning in
the section of the label governing the warnings for early-entry agricultural
workers.1
DuPont’s appeal from the Presiding Officer’s finding that DuPont is liable
for the sale or distribution of pesticides that were misbranded, as defined in
FIFRA section 2(q)(1)(F) and (G), is based on four primary arguments:
(1) that in November 1993, EPA approved the labeling allegedly used
by DuPont in April 1994 on the 379 shipments of the Bladex and
Extrazine pesticide products;
1 As will be discussed below, the labels used by DuPont did contain a protective eyewear
warning in the section of the label governing the warnings for pesticide applicators and handlers.
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E.I. DU PONT DE NEMOURS AND COMPANY 35
(2) that the WPS labeling requirements do not establish a misbranding
standard under the statutory definition of misbranding identified in the
complaint, FIFRA section 2(q)(1)(F) and (G);
(3) the Presiding Officer erred by precluding DuPont from submitting
certain evidence proffered to establish that the pesticide products at
issue in this case are, in fact, toxicity category III for which the pro-
tective eyewear warning is not required by the WPS regulations; and
(4) that Pesticide Enforcement failed to submit evidence showing that
each of the 379 shipments of pesticide products was in fact sold or
distributed bearing the new WPS-modified labeling as alleged in the
complaint, rather than the old, previously approved non-WPS
labeling.2
Brief of Respondent E.I. Du Pont De Nemours and Company (“DuPont’s Appeal
Brief”) at 1.
For the following reasons, we conclude that the Presiding Officer did not err
in holding that the WPS regulations established a misbranding standard and in
holding that all of the 379 shipments at issue in this case were made bearing the
new, WPS-modified labeling, rather than the old, non-WPS labeling. However,
we conclude that the Presiding Officer did err on the question of whether DuPont
had received approval for its labeling in November 1993 — we conclude that ap-
proval was granted and that such approval is prima facie evidence that the label-
ing complies with the WPS regulations. We also conclude that once Pesticide En-
forcement had submitted sufficient evidence to overcome the prima facie
evidence of compliance with the WPS labeling requirements, DuPont should have
been allowed to submit its additional evidence on the question of toxicity. Thus,
for the following reasons, we affirm in part and reverse in part the Initial Decision
and remand for further proceedings.
I. BACKGROUND
A. Statutory Background
FIFRA establishes an elaborate architecture for the regulation of pesticide
use in the United States. That architecture, as relevant here, consists primarily of
registration of pesticide products under section 3, cancellation of registration
2 DuPont also argues that EPA guidance allowed the sale or distribution of products bearing
non-WPS labels after April 21, 1994, if those products were “released for shipment” prior to January 1,
1994.
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36 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
under section 6, and the prohibition under section 12 of certain acts relating to use
and sale of pesticides.
Pursuant to sections 3 and 12 of FIFRA, no pesticide may lawfully be sold
or distributed unless it is registered with the EPA. FIFRA §§ 3(a), 12(a)(1)(A),
7 U.S.C.A. §§ 136a(a), 136j(a)(1)(A).3 Section 3 of FIFRA establishes stringent
requirements for registration of a pesticide. In particular, an applicant for registra-
tion must file a copy of the labeling of the pesticide and data supporting the prod-
uct’s safety and efficacy, and the applicant must demonstrate based on scientific
evidence that, “its labeling and other material required to be submitted comply
with the requirements of this subchapter.” FIFRA § 3(c)(5)(B),
7 U.S.C. § 136a(c)(5)(B). EPA will register a pesticide only if it determines that,
when considered with any restrictions imposed on it, the pesticide warrants the
proposed claims made for it; its labeling and other materials comply with FIFRA’s
requirements; it will perform its intended purpose without unreasonable adverse
effects on the environment; and when used in accordance with common practice,
it will not generally cause unreasonable adverse effects on the environment.
FIFRA § 3(c)(5), 7 U.S.C.A. § 136a(c)(5).
FIFRA contemplates that a determination made under section 3 may later be
reexamined on the grounds that the registered pesticide product does not comply
with the applicable registration standards. In particular, section 6 allows EPA to
seek to cancel a pesticide products’ registration “[i]f it appears to the Administra-
tor that a pesticide or its labeling or other material required to be submitted does
not comply with the provisions of this subchapter or * * * generally causes un-
reasonable adverse effects on the environment[.]” FIFRA § 6(b); see also CIBA-
GEIGY Corp. v. EPA, 801 F.2d 430, 431 (D.C. Cir. 1986) (noting that EPA may
seek to cancel a registration “[w]hen it appears that a registered pesticide no
longer conforms to [the registration] standards”).4 Section 3 itself provides that
“[a]s long as no cancellation proceedings are in effect registration of a pesticide
shall be prima facie evidence that the pesticide, its labeling and packaging comply
with the registration provisions of the subchapter.” Id. Section 3 further states that
“[i]n no event shall registration of an article be construed as a defense for the
3 There are certain exceptions to this general rule that are not relevant here. See, e.g., FIFRA
§§ 5, 18, 19 (requirements for experimental use pesticides, exceptions for federal and state agencies
and certain storage and transport exceptions).
4 Although a cancellation proceeding may be initiated by EPA, the proponent of registration
has the burden of proof that the registration of the pesticide product should not be cancelled.
40 C.F.R. § 164.80(b); see also Stearns Elect. Paste Co. v. EPA., 461 F.2d 293, 304-05 (7th Cir.
1972); Dow Chem. Co.v. Ruckelshaus, 477 F.2d 1317, 1324-25 (8th Cir. 1973) (“Since the registrant
has a continuing burden of proof to establish that its product is entitled to registration, Southern Nat’l
Mfg. Co. v. EPA, 470 F.2d 194 (8th Cir. 1972), if the Administrator has a substantial doubt as to
safety, it is his duty * * * to issue the cancellation order. And the cancellation order will remain in
effect until the registrant satisfies the Agency that registration is warranted.”).
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E.I. DU PONT DE NEMOURS AND COMPANY 37
commission of any offense under this subchapter.” FIFRA § 3(f)(2). In terms of
actionable offenses, section 12 of FIFRA makes it unlawful, among other things,
for any person to “distribute or sell” to any person (1) a pesticide that is not regis-
tered, (2) any registered pesticide with claims made for it that are substantially
different than were approved as part of the pesticide’s registration, and (3) any
pesticide that has been adulterated or misbranded. FIFRA § 12(a)(1)(A), (B), (E),
7 U.S.C. § 136j(a)(1)(A), (B), (E). A pesticide is “misbranded” if, among other
things, its labeling does not contain necessary warning or caution statements or
directions for use that, if complied with together with other requirements of
FIFRA, are “adequate to protect health and the environment.” FIFRA § 2(q)(1)(F)-
(G), 7 U.S.C. § 136(q)(1)(F)-(G).
Congress has specifically authorized EPA “to prescribe regulations to carry
out the provisions of [FIFRA].” FIFRA § 25(a)(1), 7 U.S.C. § 136w(a)(1). EPA
has used this authority to promulgate detailed regulations governing, among other
things, (1) the process for pesticide registration and amended-registration, see 40
C.F.R. part 152; (2) language that must be included on pesticide labeling, includ-
ing warning and caution statements and statements regarding use of pesticides,
see 40 C.F.R. part 156; and (3) procedures governing formal, on-the-record, adju-
dicatory proceedings for registrants to challenge EPA determinations denying re-
gistration or canceling or suspending registration. See 40 C.F.R. part 164. Al-
though all of these regulations underlie our decision today (the specific provisions
are described in greater detail below), this case initially arises out of EPA’s pro-
mulgation in 1992 of the WPS regulations.
B. Worker Protection Standard (WPS) Regulations and Their
Implementation
In August 1992, EPA promulgated the WPS regulations because it deter-
mined that the existing regulations promulgated under FIFRA were not adequate
to protect agricultural workers from exposure to pesticides. See Worker Protection
Standard, 57 Fed. Reg. 38,102 (Aug. 21, 1992) (codified at 40 C.F.R. parts 156
and 170). EPA estimated “that at least tens of thousands of acute illnesses and
injuries * * * occur annually to agricultural employees as the result of occupa-
tional exposures to pesticides.” Id. at 38,105. By the WPS regulations, the EPA
established requirements that it determined are “likely to reduce substantially the
number of pesticide-related illnesses and injuries to agricultural employees as the
result of occupational exposures to pesticides.” Id.
The WPS regulations require pesticide registrants, such as DuPont, to “add
appropriate labeling statements referencing the [] regulations and specifying ap-
plication restrictions, restricted-entry intervals (REIs), personal protective equip-
ment (PPE), and notification to workers of pesticide applications,” all to reduce
the risk of pesticide poisonings and injuries among agricultural workers and pesti-
cide handlers. Id. at 38,102. At issue in this case are the personal protective equip-
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38 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
ment requirements for early-entry agricultural workers, codified at
40 C.F.R. § 156.212(e) and (j), requiring that the label include a protective
eyewear warning for pesticides classified as “toxicity category II” for eye irritation
potential. No such warning is required or needed for pesticides classified as “tox-
icity category III,” the category to which DuPont alleges its products properly
belong.
The labeling requirements of the WPS regulations are central to accom-
plishing the goals of protecting human health and the environment. Indeed, it is
not an exaggeration to state that, without compliance by registrants with the label-
ing requirements, the ability to enforce the measures designed to protect human
health and the environment is significantly impaired. For example, an agricultural
employer must “[a]ssure that any [applicable] pesticide is used in a manner con-
sistent with the labeling of the pesticide.” 40 C.F.R. § 170.7. FIFRA further pro-
vides that it is unlawful for any person “to use any registered pesticide in a
manner inconsistent with its labeling.” FIFRA § 12(a)(2)(G),
7 U.S.C. § 136j(a)(2)(G). Obviously, if the labeling does not accurately state the
applicable requirements, then the applicable requirements cannot be effectively
implemented by pesticide users such as agricultural employers and workers.5
The WPS regulations contemplated a phase-in of the new labeling require-
ments in that the new WPS labeling was allowed, but not required, on affected
pesticide products sold or distributed between April 21, 1993 and April 21, 1994,
and was required for all affected products sold or distributed after April 21, 1994.
40 C.F.R. § 156.200(c)(2)-(3).6 Because regulations promulgated under FIFRA
only allow the sale or distribution of pesticide products bearing labeling that has
been approved by the EPA, during the transition period of April 21, 1993, through
April 21, 1994, registrants were allowed to sell or distribute pesticides bearing
either non-WPS labeling that had been approved as part of the product’s earlier
registration or new WPS compliant labeling that had been approved by EPA or
was otherwise authorized to be used.
The WPS regulations are designed to augment the existing FIFRA regula-
tions, which provide a comprehensive system for the registration of pesticide
products and the labeling of those products. Specifically, the new WPS labeling
5 It is important to note that negative consequences may flow from both over-protective and
under-protective labeling: for example, labeling with instructions for too little protection may increase
worker injuries and, conversely, labeling with instructions for protection greater, or different, than that
required by the regulations may result in employers bearing possibly inappropriate costs, as well as
causing confusion in the minds of users over the significance and meaning of label warning and cau-
tion statements.
6
The labeling provisions of the WPS regulations became effective on October 20, 1992.
40 C.F.R. § 156.200(c)(1).
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E.I. DU PONT DE NEMOURS AND COMPANY 39
requirements amend 40 C.F.R. part 156, which contains general provisions gov-
erning pesticide label content and requires use of specific label language. Al-
though the WPS regulations require pesticide registrants to add appropriate lan-
guage to pesticide labels, the WPS regulations did not modify the previously
existing requirements for registration of pesticides and pesticide labels set forth in
40 C.F.R. part 152.7 Significantly, those existing regulations prohibit the use of
modified labeling prior to EPA approval of an application to amend the pesticide’s
registration:
Except as provided by § 152.46, any modification in the composition,
labeling, or packaging of a registered product must be submitted with
an application for amended registration * * *. If an application for
amended registration is required, the application must be approved by
the Agency before the product, as modified, may legally be distrib-
uted or sold.
40 C.F.R. § 152.44(a).8 Because these regulations only allow the sale or distribu-
tion of pesticide products bearing labeling that has been approved by EPA as part
of the product’s registration, the only products that were allowed to be sold during
the transition period contemplated by the WPS regulations of April 21, 1993
through April 21, 1994, were products bearing non-WPS labeling that had been
approved as part of the product’s earlier registration or products bearing new
WPS-compliant labeling that had been approved as a registration amendment.
Nevertheless, in the implementation of the WPS labeling requirements,
EPA recognized that prior review of all labeling amendments would prevent rapid
implementation of the new WPS labeling requirements. EPA recognized that a
“large number of products will be affected by the new requirements,” 57 Fed. Reg.
at 38,105, and that it could not quickly perform product-by-product reviews of all
pesticides subject to the WPS regulations. EPA was expecting between 6,000 and
7 The WPS regulations did add a specific provision applicable to the WPS labeling require-
ments for “modification on special review,” which is otherwise generally governed by 40 C.F.R.
part 154. See 40 C.F.R. § 156.204(a). In addition, the WPS regulations specifically state that other
modifications, waivers, or alternative labeling statements may be approved by the Agency under the
authorities granted by FIFRA §§ 3, 6, and 12, and that “[a] registrant who wishes to modify any of the
statements required in §§ 156.206, 156.208, 156.210, or 156.212 must submit an application for
amended registration unless specifically directed otherwise by the Agency.” Id. § 156.204(b).
8 This restriction is consistent with the legislative policy underlying FIFRA that the question
of a product’s compliance with the Act be resolved before the pesticide can be marketed by the regis-
trant. This policy was first established by the 1964 amendments to FIFRA (as enacted in 1947), which
amendments shifted the burden of proof on the question of compliance to the applicant by eliminating
the option for registration “under protest,” see H. Rep. 88-1125 (1964), and was carried over into the
present version of FIFRA as part of the overhaul of FIFRA in 1972, see H. Rep. No. 92-511 at 20
(1971) (noting that the burden of proof remains with the applicant as existed under the old FIFRA).
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40 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
8,000 WPS label amendment applications. Transcript of Hearing (Aug. 20-26,
1997) (“Hearing Tr.”), vol. II at 45. Stated simply, EPA noted that it could not
“through a product-by-product review, quickly or adequately reduce the incidence
of pesticide-related injuries and illnesses.” 57 Fed. Reg. at 38,106. Accordingly,
EPA issued a series of guidance documents to aid in the efficient and expeditious
implementation of the new labeling requirements. See 57 Fed. Reg. at 38,141-42;
PR-Notice 93-7 (April, 1993); PR-Notice 93-11 (August, 1993).
The initial source of guidance appeared in the preamble to the final WPS
rule and provided an overview of the options available to registrants for coming
into compliance with the new labeling requirements. It also advised that a “PR-
Notice” would be issued to provide more detailed guidance. 57 Fed. Reg. at
38,141-142.9 Subsequently, PR-Notice 93-7, issued in April 1993, provided gui-
dance as to the exact language to be added to pesticide labeling and other options
for compliance.10 PR-Notice 93-11, issued a few months later, in August 1993,
provided supplemental guidance regarding issues that had arisen after the issuance
of PR-Notice 93-7, and offered a “registrant-verification” option for registrants to
use modified labeling prior to obtaining EPA approval. As is relevant to the pre-
sent case, in order to qualify for the “registrant-verification” option under PR-No-
tice 93-11, “the registrant [had to] certif[y] in the WPS amendment application
submitted to EPA that the labeling instructions in PR-Notice 93-7 are followed
exactly.” PR-Notice 93-11, supp. A at 1.
The registrant-verification option as implemented by PR-Notice 93-11 does
not fit within any of the authorized exceptions to the regulatory prohibition under
40 C.F.R. § 152.44(a) against the sale or distribution of products bearing modi-
fied labeling prior to the approval of an application for amended registration.11
Thus, the guidance in PR-Notice 93-11 regarding registrant-verification would ap-
pear to have been a statement by EPA regarding its intention to use its discretion
not to enforce technical violations of section 152.44(a) where the guidance of PR-
9 To the extent any conflict exists among these documents, we would generally interpret the
subsequent, more detailed guidance as controlling.
10 Other options included deletion of uses for which WPS compliance is required and cancella-
tion of registration. PR-Notice 93-7 at 8.
11 The exceptions to the regulatory prohibition established in section 152.44(a) that are set
forth in section 152.44(b) would appear not to be applicable. Those exceptions allow EPA in its dis-
cretion not to require the submission of an application for amended registration. In contrast, the exer-
cise of the registrant-verification option as contemplated by PR-Notice 93-11 was premised upon the
prior submission of an application for amended registration, which would still be reviewed by EPA,
albeit after the registrant was permitted to begin using the modified labeling.
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E.I. DU PONT DE NEMOURS AND COMPANY 41
Notice 93-7 is “followed exactly.” PR-Notice 93-11, supp. A at 1.12
Both the preamble and PR-Notice 93-7 stated that the registrant is required
to file an application for amended registration. 57 Fed. Reg. at 38,143-144;
PR-Notice 93-7 at 8. Because the new WPS labeling requirements may prescribe
multiple statements on an individual product depending upon a pesticide’s toxicity
level and the various potential routes of exposure, PR-Notice 93-7 required each
applicant to specifically state in the application the toxicity category applicable
for the pesticide through each route of exposure. PR-Notice 93-7, supp. II at 4,
5-6, supp. III at 7.13 This case, however, concerns a single route of exposure, re-
ferred to as “eye irritation potential.” PR-Notice 93-7 set forth detailed guidance
specifying the exact language required in the amended labels for each toxicity
category indicated by the applicant for each route of exposure. For toxicity cate-
gory II for eye irritation potential, PR-Notice 93-7 stated that the label must con-
tain in the Agricultural Use Requirements Box (for the protection of early-entry
agricultural workers) and in the “Hazards to Humans (and Domestic Animals)”
section of the label (for the protection of handlers and applicators, among others)
a statement requiring use of protective eyewear. Protective eyewear is not re-
quired in either section of the label for pesticides with toxicity category III for eye
irritation potential.14
Registrants who elected to add WPS-compliant language to their labels (in
contrast to those who elected to delete agricultural uses from their labels to escape
WPS coverage) were required to submit a copy of their proposed amended label
and were allowed to elect between two different types of certification statements
to include with the application. The first certification statement included the fol-
lowing key language:
I certify that the revised labeling being submitted for this product is in
complete accordance with the labeling requirements of PR-Notice
93-7 * * *. Where exact language is specified in the PR-Notice I
have used that language exactly, in the location specified.
12 Similarly, EPA’s guidance discussed in the following paragraph (which advised applicants
to state in their amendment applications the toxicity of their products through the different routes of
exposure, without providing studies to support the toxicity statement) would appear to have been an
exercise of discretion in implementing the registration regulations.
13 PR-Notice 93-7 directed the registrant to “[u]se data in your files to determine the Toxicity
Category of your end-use product for each route of entry.” PR-Notice 93-7, supp. III at 7. It also
advised where a registrant might obtain data if the registrant did not have the data in its files. Id.
14 This guidance provided in PR-Notice 93-7 as to the exact language for each toxicity cate-
gory simply restates the exact language requirements of the regulations. 40 C.F.R. § 156.212(e).
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42 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
PR-Notice 93-7, supp. II at 5. (As discussed below, DuPont submitted this certifi-
cation statement for each of its four products.) PR-Notice 93-11, which was is-
sued several months after PR-Notice 93-7, stated that applicants who had pro-
vided this certification statement of having followed the labeling requirements in
PR-Notice 93-7 exactly may elect to use the self-verification option.
The second certification statement allowed the pesticide registrant to indi-
cate that deviations from the language required by PR-Notice 93-7 were being
requested. PR-Notice 93-7 stated that applications certifying exact compliance
with the language requirements of PR-Notice 93-7 would be reviewed on an expe-
dited basis. It also specifically warned that “[m]ost label changes require Agency
approval before product may be sold or distributed bearing the new label. If any
changes to your label are neither reviewed nor accepted, sale or distribution of
product bearing a label including such changes will probably be in violation of
FIFRA, and could subject you to enforcement action.” PR-Notice 93-7, supp. II at
6-7. PR-Notice 93-11 stated that prior approval would not be required if the appli-
cant elected the self-verification option. In addition to the warning in PR-Notice
93-7, the preamble to the WPS regulation also warned that “[i]f, after a certifica-
tion is reviewed, the Agency determines that the registrant has incorrectly labeled
the product, the product may be deemed to be misbranded in violation of FIFRA
section 12(a)(1)(E) * * *.” 57 Fed. Reg. at 38,144.
C. Factual and Procedural Background
As of the effective date of the WPS regulations, October 20, 1992, the four
pesticide products at issue in this case (Bladex 4L, Bladex 90 DF, Extrazine II 4L,
and Extrazine II DF) were registered with the EPA, and DuPont had been selling
and distributing those pesticides with EPA-approved labels. After receiving PR-
Notice 93-7, DuPont acknowledged that these pesticides were subject to the new
WPS requirements. To come into compliance, DuPont filed registration-amend-
ment applications, dated July 14, 1993. Each of DuPont’s applications for
amended registration indicated that the pesticide had an eye irritation potential of
toxicity category II.15 Each application also contained a certification statement,
15 The applications for Bladex 4L and Bladex 90 DF specifically stated category II for eye
irritation potential. Although the applications for Extrazine II DF and Extrazine II 4L failed to state a
toxicity category for eye irritation potential, PR-Notice 93-7 clearly stated that treatment equivalent to
toxicity category II would be required if the toxicity category for eye irritation potential is left blank
and the product’s “signal” word is “warning.” PR-Notice 93-7, supp. III at 9-10 (guidance for work-
sheet Blocks 6, 8 and 10); see also 40 C.F.R. § 156.212(d). As part of the original registration of the
product, a signal word is assigned under 40 C.F.R. § 156.10(h) based on the highest hazard through
any of the identified routes of exposure. The signal word for the Extrazine products is “warning” and,
therefore, DuPont’s applications, which certified exact compliance with PR-Notice 93-7, necessarily
contemplated treatment equivalent to toxicity category II for eye irritation potential. For ease of refer-
ence, we will refer to DuPont’s applications as having specified toxicity category II for eye irritation
potential for all four pesticides.
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E.I. DU PONT DE NEMOURS AND COMPANY 43
certifying that the revised labeling being submitted was in complete compliance
with PR-Notice 93-7. Complainant’s Exhibits (“CX”) 6 through 9. However, de-
spite DuPont having specified toxicity category II for eye irritation potential for
all four pesticides, it is undisputed that DuPont’s proposed amended labels did not
state in the Agricultural Use Requirements Box that use of protective eyewear is
required.
At approximately the same time that DuPont submitted its applications for
amended registration seeking approval of label modifications to comply with the
WPS regulations, DuPont also submitted separate applications for amended regis-
tration in order to participate in an unrelated voluntary label amendment program
run by the EPA, known as the voluntary cyanazine-exposure reduction program.
Hearing Tr. vol. III at 58-85. DuPont had originally submitted its applications for
approval of wording changes required for the cyanazine-reduction program and
certain other changes in June 1993. Id. at 58-59. After receiving comments on the
draft cyanazine-reduction amendments and after submitting revised drafts during
August through October 1993, DuPont received preliminary approval from EPA’s
Special Review and Reregistration Division for DuPont’s proposed cyanazine-re-
duction modifications. Id. at 59-67; Respondent’s Exhibit (“RX”) 92 (letter from
Peter Caulkins, Acting Director of EPA’s Special Review and Reregistration Divi-
sion, to Tony Catka (Oct. 19, 1993)). The preliminary approval included instruc-
tions that DuPont should submit the proposed cyanazine-reduction label changes
to EPA’s Registration Division for final approval. Id. On October 28, 1993, after
receiving this preliminary approval, DuPont submitted to EPA’s Registration Di-
vision for final approval, its proposed amended labels containing both the cy-
anazine-reduction modifications and the proposed WPS modifications. Hearing
Tr. vol. III at 67-68. Five business days later on November 4, 1993, the Registra-
tion Division issued letters for each amended label stating that approval had been
granted and providing copies of the modified labeling stamped as approved (the
“November 1993 Letters”). Id. at 84-85. (The exact scope of the approval granted
by the November 1993 Letters was a matter of dispute early in this case and will
be considered as the first issue in our discussion below.)
Subsequently, on March 11, 1994 and March 14, 1994, EPA’s Registration
Division sent Notices of Serious Error to DuPont, which were received by DuPont
in mid-March 1994. CX 22 through 25. Those notices stated that EPA had re-
viewed DuPont’s July 14, 1993 registration-amendment applications, i.e., the ones
by which DuPont had requested approval of the proposed WPS label amendments
and had certified were in complete compliance with PR-Notice 93-7. Id. The No-
tices of Serious Error, among other things, stated that DuPont’s proposed label
amendments were not in compliance with PR-Notice 93-7. Id. at 1. In particular,
the Notices of Serious Error stated that “EPA has determined that one or more of
the errors on the labeling you submitted to the Agency is categorized as ‘serious’
as defined in PR-Notice 93-11.” Id. The Notices of Serious Error also stated in
bold letters that “YOU MUST NOT SELL OR DISTRIBUTE (INCLUDING RE-
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44 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
LEASE FOR SHIPMENT) ANY PRODUCT BEARING THE SUBMITTED LA-
BELING.” Id.
Notwithstanding its receipt of the March Notices of Serious Error, DuPont
thereafter between April 1, 1994, and April 26, 1994,16 proceeded to sell or dis-
tribute pesticides bearing the WPS label modifications that DuPont had submitted
with its July 1993 applications for amended registration.17
EPA’s investigation of DuPont’s sales began after DuPont informed EPA
that notwithstanding the Notices of Serious Error, it had continued to sell and
distribute pesticides bearing the modified labels. Pesticide Enforcement ultimately
filed the complaint commencing this action in October 1994. The complaint al-
leged that DuPont made the 379 shipments between April 1, 1994, and April 26,
1994, bearing the July 14, 1993 proposed amended WPS labels. The complaint
further alleged (1) that the Notices of Serious Error had informed DuPont that its
proposed amended labels were not approved; (2) that the proposed amended la-
bels were not adequate to protect health and the environment; (3) that a pesticide
is misbranded if its label does not contain a caution or warning statement of the
kind described in FIFRA section 2(q)(1)(F)-(G); (4) that DuPont sold and distrib-
uted pesticides bearing the proposed amended labels; and (5) that such conduct
violated FIFRA section 12(a)(1)(E), which prohibits the distribution or sale of
misbranded pesticides.
DuPont’s answer acknowledged that the 379 shipments were made on or
about the dates alleged in the complaint and that the WPS language in the labels
of those shipments was “identical to that submitted to EPA on July 14, 1993.”
Affirmative Defenses ¶ 2; accord Answer ¶¶ 13, 23, 33, 43. DuPont nevertheless
denied that its conduct amounted to the distribution or sale of a misbranded pesti-
cide, and, among other things, DuPont alleged that its July 1993 applications for
amended registration covering the proposed WPS changes to its labels had been
approved by the November 1993 Letters.
16
In point of fact, it appears DuPont may have begun to sell and distribute all four pesticide
products bearing amended labels earlier — sometime after DuPont submitted its applications for
amended registration. Thus, Pesticide Enforcement has stated that it could have brought more than 379
counts in this case, but that it “chose to limit its action to those shipments made after March 31, 1994,
the date of [DuPont’s] response to the Notices of Serious error.” Complainant’s Brief in Support of
Proposed Findings of Fact, Conclusions of Law, and Order (Nov. 14, 1997) at 42 n.64.
We also note that the last day of the alleged violations corresponds to when DuPont and EPA’s
Registration Division reached agreement on a procedure for DuPont to use stickers and brochures to
correct the labeling on future sales of existing product. Post-Hearing Brief of Respondent at 29-30.
17 On appeal, DuPont argues, however, that Pesticide Enforcement failed to prove that all of
the 379 shipments at issue in this case were made actually bearing the WPS label modifications that
DuPont had submitted with its July 1993 applications. This issue will be considered in the last part of
our discussion below.
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E.I. DU PONT DE NEMOURS AND COMPANY 45
In February 1995, DuPont filed a motion seeking dismissal of the complaint
on the grounds of the alleged approval of its WPS label amendment applications
by the November 1993 Letters. DuPont argued that because the WPS label
changes had been approved by the November 1993 Letters, the subsequent No-
tices of Serious Error were “null and void” as improper attempts to change the
terms and conditions of the Bladex and Extrazine products’ registrations without
following the procedures required for cancellation of the approved registration.
Respondent’s Motion to Dismiss Based on Threshold Legal Issues (Feb. 27,
1995). The Presiding Officer denied DuPont’s motion to dismiss by order dated
March 6, 1997 (the “March 1997 Order”).
Thereafter, an evidentiary hearing was held, at which time DuPont sought to
submit both documentary evidence and witness testimony to show that the Bladex
and Extrazine pesticide products should not be categorized as toxicity category II
for eye irritation potential, but instead should be categorized as toxicity category
III. This evidence would have provided DuPont with the factual foundation neces-
sary to argue that the WPS regulations do not require these pesticide products to
bear a protective eyewear warning in the Agricultural Use Requirements box of
the label. However, the Presiding Officer would not admit DuPont’s proffered evi-
dence, holding that because the proffered evidence had not been submitted in con-
nection with DuPont’s applications for amended registration, it is not relevant to
this proceeding. Thereafter, the Presiding Officer issued the Initial Decision find-
ing DuPont liable for 379 sales or distributions of misbranded pesticides and as-
sessing a penalty of $5,000 for each such sale or distribution, resulting in an ag-
gregate penalty of $1,895,000.
II. DISCUSSION
Pesticide Enforcement’s complaint alleged that DuPont violated the prohibi-
tion in FIFRA section 12(a)(1)(E)18 against the sale or distribution19 of pesticides
that are “misbranded,” as that term is defined in FIFRA section 2(q)(1)(F) and
(G),20 which provide as follows:
18 Section 12(a)(1)(E) provides that “it shall be unlawful for any person in any State to dis-
tribute or sell * * * any pesticide which is * * * misbranded.” FIFRA § 12(a)(1)(E),
7 U.S.C. § 136j(a)(1)(E).
19 The phrase “distribute or sell,” and other grammatical variations thereof including “distrib-
uted or sold,” are defined by the regulations to mean, among other things, “shipping.”
40 C.F.R. § 152.3(j). Accordingly, DuPont’s admission that it made the 379 “shipments” as alleged in
the complaint (Affirmative Defenses ¶ 2; accord Answer ¶¶ 13, 23, 33, 43) establishes that it distrib-
uted or sold those pesticides.
20 The term “misbranded” is defined in FIFRA section 2(q), 7 U.S.C. § 136(q), which sets
forth numerous provisions that define compliant and noncompliant pesticide labeling and packaging.
Continued
VOLUME 9
46 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
(F) the labeling accompanying [the pesticide] does not contain direc-
tions for use which are necessary for effecting the purpose for which
the product is intended and if complied with * * * are adequate to
protect health and the environment;
(G) the labeling accompanying it does not contain a warning or cau-
tion statement which may be necessary and if complied with * * * is
adequate to protect health and the environment[.]
FIFRA § 2(q)(1)(F)-(G), 7 U.S.C. § 136(q)(1)(F)-(G).21
The complaint alleged that the Bladex and Extrazine products were mis-
branded because the labeling omitted a protective eyewear warning in the Agri-
cultural Use Requirements box of the label. As explained earlier, statements spec-
ifying personal protective equipment must be added to a pesticide’s label as a
result of the WPS rulemaking and for pesticides with a toxicity category II for eye
irritation potential, the WPS regulations require that a protective eyewear warning
be included in both the Hazards to Humans (and Domestic Animals) section and
the Agricultural Use Requirements box of the label. Id. § 156.212(e). A protec-
tive eyewear statement, however, shall not be used for pesticides with a toxicity
category III for eye irritation potential. Id.
The issues raised by DuPont on appeal primarily concern the proper bur-
dens or presumptions governing proof in a penalty action as to whether a particu-
lar warning or direction for use is required under the definition of “misbranded”
set forth in FIFRA section 2(q)(1)(F) and (G). The principal issues argued by the
parties concern whether DuPont was properly precluded from introducing its prof-
fered evidence regarding whether the Bladex and Extrazine pesticide products are,
in fact, toxicity category II for eye irritation potential or whether they should be
categorized in the lower toxicity category III, for which EPA concedes there is no
requirement for the products’ label to contain a protective eyewear warning.
DuPont’s arguments concerning evidentiary burdens and presumptions,
stated very briefly, are as follows: (1) it was denied due process when the Presid-
ing Officer would not consider its toxicity evidence; and (2) the Presiding Officer
erroneously treated DuPont’s application for amended registration (which, as
noted, identified these pesticides as toxicity category II) as “conclusive and ir-
rebuttable” proof of the pesticides’ toxicity category. DuPont also argues that EPA
(continued)
The complaint, however, specifically identified only section 2(q)(1)(F) and (G) as implicated in this
case.
21 Although the complaint cites the misbranding definition in FIFRA section 2(q)(1)(F), both
Pesticide Enforcement and the Presiding Officer relied primarily on FIFRA section 2(q)(1)(G).
VOLUME 9
E.I. DU PONT DE NEMOURS AND COMPANY 47
guidance permitted it to use non-complying labels if the products were “released
for shipment” prior to January 1, 1994, and that Pesticide Enforcement failed to
show that these products were released for shipment after that date.
However, before we discuss these arguments, we must first consider two
additional arguments raised by DuPont that are logically antecedent to the toxicity
question and the “released for shipment” argument. DuPont contends in its pro-
posed alternative findings of fact that the Presiding Officer erred in holding that
the WPS label modifications proposed by DuPont were not approved by the No-
vember 1993 Letters. Notice of Appeal of Appellant E.I. du Pont de Nemours and
Company at 3. DuPont also argues that the Presiding Officer erred in relying upon
the WPS labeling requirements as establishing a misbranding standard under
FIFRA section 2(q)(1)(F) and (G). DuPont’s Appeal Brief at 33-35.22
In the following discussion, we consider the issues in this order: in Part A,
we consider the scope of approval granted by the November 1993 Letters; in Part
B, we consider whether the WPS regulations established misbranding standards
that implement the statutory definition; in Part C, we consider the evidence of
misbranding submitted by Pesticide Enforcement and whether DuPont was prop-
erly precluded from submitting its toxicity studies; finally, in Part D, we consider
DuPont’s arguments regarding the alleged failure of proof as to the labeling actu-
ally used on the 379 shipments and DuPont’s “release for shipment” argument. For
the following reasons, we affirm the Presiding Officer’s determination that the
WPS regulations establish a misbranding standard and his rejection of DuPont’s
failure-of-proof and “release for shipment” arguments. However, we reverse the
Presiding Officer’s conclusion that the approval granted by the November 1993
Letters did not encompass the proposed WPS label modifications and we con-
clude that DuPont is entitled to submit its toxicity studies. We therefore remand
this matter for consideration of DuPont’s toxicity evidence and for consideration
of an additional issue discussed below as to an internal inconsistency in the use of
protective eyewear warnings that is apparent on the face of DuPont’s labels.
22 DuPont has argued that “[t]he record * * * reveals bias on the ALJ’s part in EPA’s favor.”
DuPont’s Appeal Brief at 8 n.4, 14. This argument is rejected first because DuPont did not raise the
issue of bias before the Presiding Officer, see In re Woodcrest Mfg, Inc., 7 E.A.D. 757 (EAB July 23,
1998), aff’d Woodcrest Mfg., Inc. v. EPA, No. 3:98 CV 0456 AS (N.D. Ind. Dec. 14, 1999), and
second, none of the parts of the transcript cited by DuPont reflect anything other than the Presiding
Officer’s efforts at courtroom administration and diligent discharging of his fact finding responsibili-
ties. What DuPont characterizes as “coaching” of witnesses appears instead to be proper effort to ob-
tain clarification from witnesses of what otherwise would have been ambiguous answers.
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48 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
A. Whether the November 1993 Letters Approving DuPont’s Amended
Registration Authorized Use of the Labels as Approved
In its list of Proposed Alternative Findings of Facts, DuPont has requested
that we find that “[f]or each of the Bladex and Extrazine products, Respondent
received letters dated November 4, 1993 from EPA stating that the proposed la-
beling — which did not include protective eyewear warnings in the Agricultural
Use Requirements box — was ‘acceptable.’” DuPont’s Notice of Appeal at 3. In its
appeal brief, DuPont states further that “[t]he letters containing EPA’s approval
were unconditional.” DuPont’s Appeal Brief at 10. Thus, although not specifically
identified in its listing of issues on appeal and discussed only in passing in Du-
Pont’s appeal briefs,23 DuPont nevertheless seeks to challenge the Presiding Of-
ficer’s determination that the November 1993 Letters did not authorize DuPont’s
use of the WPS portions of the labels.
As noted in our summary of the procedural background, DuPont originally
raised the question of approval in the form of a motion to dismiss. DuPont argued
that the November 1993 Letters approved the WPS label amendments and that the
“approval was unconditional and unqualified and did not indicate in any way that
any additional approval would be required by the Agency.” Respondent’s Motion
to Dismiss Based on Threshold Legal Issues at 26 (Feb. 27, 1995). DuPont also
argued that “Once EPA has approved the terms and conditions of registra-
tion — i.e., the label — it cannot change the terms and conditions without follow-
ing the procedures for canceling the registration pursuant to FIFRA § 6(b).” Id. at
-
DuPont also asserted that “The Agency’s unconditional approval of DuPont’s
WPS labeling on November 4, 1993 bars the Agency from bringing this enforce-
ment action because an EPA-approved label cannot be misbranded.” Id.Pesticide Enforcement responded to DuPont’s request for dismissal based
on the November 1993 Letters by filing the affidavit of Robert J. Taylor (“Mr.
Taylor”), who stated that his responsibilities included both final review of the cy-
anazine-reduction amendments to the Bladex and Extrazine labels submitted on
October 28, 1993, and issuance of the November 1993 Letters. Taylor Aff. ¶¶ 1,
6, 9. Mr. Taylor stated that he did not review the proposed WPS label modifica-23 In its October 27, 1999 supplemental brief on appeal, DuPont asserts without any additional
explanation that EPA unconditionally approved DuPont’s label amendment applications on “November
29, 1993.” Supplemental Brief of Respondent E.I. Du Pont De Nemours and Company at 8 n.5, and
11-13 (Oct. 27, 1999). The assertion of an approval on November 29, 1993, appears to be a typograph-
ical error as an allegation of approval on that date does not appear anywhere in DuPont’s prior briefs to
this Board and does not appear in DuPont’s post-hearing briefs before the Presiding Officer. See e.g.,
Post-Hearing Brief of Respondent at 19-21, 59-62 (Nov. 14, 1997); Respondent’s Proposed Findings
of Fact and Conclusions of Law ¶¶ 135-151. However, to the extent that DuPont is seeking to raise a
new argument on appeal, it must be rejected on the grounds that it was not first argued to the Presiding
Officer and therefore has been waived.
VOLUME 9
E.I. DU PONT DE NEMOURS AND COMPANY 49
tions. Id. ¶ 8. With respect to the allegation that the November 1993 Letters stated
unconditional approval of the proposed labeling, Mr. Taylor stated that “it was
neither necessary nor required to specify that my acceptance did not apply to [Du-
Pont’s] verified WPS statements.” Id. ¶ 9. Mr. Taylor also stated that he discussed
the proposed amendments with Tony E. Catka, DuPont’s Product Registration
Manager, and that “Mr. Catka also stated that he understood I would not review
WPS statements for the four cyanazine-reduction pesticide label amendments that
DuPont submitted in October 1993.” Id. ¶ 10.
DuPont did not respond to the Taylor Affidavit by filing any affidavit or by
providing any reference to EPA’s guidance documents or any other information in
the record of this case to show any error in Mr. Taylor’s statements. Instead, it
argued that any discussions between Mr. Taylor and Mr. Catka “are irrelevant
since they were merged into the Agency’s formal approval of DuPont’s labels on
November 4, 1993 without qualification, and the terms of the Agency’s official
written registration approval speak for themselves.” Respondent’s Reply In Sup-
port of Its Motion to Dismiss at 8 n.2 (Apr. 25, 1995).
In the March 1997 Order, the Presiding Officer concluded that “The filings
submitted on this issue establish that respondent was aware that the process which
considered its amendments for cyanazine containing products did not approve the
WPS amendment that was self-certified in July 1993.” March 1997 Order at 7.
Further, the Presiding Officer concluded that “The evidence does not support a
claim that complainant changed the conditions of respondent’s registration with-
out a hearing.” Id. Thus, in the March 1997 Order, the Presiding Officer rejected
DuPont’s argument that its proposed WPS label modifications had been approved
by the November 1993 Letters.
Upon review, we conclude that the Presiding Officer erred when he deter-
mined in the March 1997 Order that the November 1993 Letters did not stand as
approval of DuPont’s proposed label modifications, including their WPS compo-
nents. We also conclude, however, that denial of DuPont’s motion to dismiss was
nevertheless proper.
The Taylor Affidavit established that EPA’s Registration Division did not,
in fact, perform a review of the WPS label modifications in connection with the
issuance of the November 1993 Letters. The Taylor Affidavit also established that
Tony E. Catka “stated that he understood [Mr. Taylor] would not review [the]
WPS statements for the four cyanazine-reduction pesticide label amendments that
DuPont submitted in October 1993.” Taylor Affidavit ¶ 10.24 The Presiding Of-
24 The Taylor Affidavit also set forth Mr. Taylor’s testimony that DuPont was aware that EPA
did not intend the November 1993 Letters to grant approval of DuPont’s proposed WPS modifications.
Continued
VOLUME 9
50 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
ficer’s March 1997 Order, in effect, concluded that Mr. Taylor’s uncontroverted
testimony on these matters would be sufficient to entitle Pesticide Enforcement to
judgment that the November 1993 Letters did not approve DuPont’s proposed
WPS labeling modifications. We disagree. Communications by EPA registration
personnel, or other factual circumstances, not referenced on the face of EPA’s
formal letters granting amended registration, cannot modify or alter the clear, un-
ambiguous terms of EPA’s formal approval.
The November 1993 Letters, on their face, approved DuPont’s applications
for amended registration and stamped as approved DuPont’s modified labels with-
out comment.25 Those modified labels contained the proposed WPS language that
is at issue in this proceeding. Nothing on the face of the November 1993 Letters
or any of the enclosures gave any indication that the approval was less than full
approval of the entire labeling. Specifically, the November 1993 Letters stated in
full as follows:
The labeling referred to above submitted in connection with registra-
tion under the Federal Insecticide, Fungicide, and Rodenticide Act, as
amended is acceptable. Please submit five (5) copies of your final
printed labeling before you release the product for shipment. A
stamped copy of labeling is enclosed for your records.
Each of the four letters contained a copy of the specific product’s labeling with an
official EPA stamp marked “ACCEPTED” and identified the EPA registration
number for the product.
While the Taylor Affidavit was sufficient to establish that EPA did not in-
tend to grant approval of the proposed WPS modifications to DuPont’s labels and
that EPA had not yet performed a review of the WPS portions of the labeling,
such facts cannot change the unqualified approval granted by the November 1993
Letters. A program that is responsible for the issuance of thousands of li-
censes — in this case, testimony established that EPA’s pesticide program was
expecting more than 8,000 WPS amendment applications — cannot be operated
based on recollections of conversations and other circumstances that are not re-
corded on the face of the official license or registration. If we were to allow such
evidence to modify the otherwise clear terms of a registration approval, it would
create an unacceptable level of uncertainty potentially undermining reliance by
(continued)
As discussed in the text, these facts cannot change the terms of the formal approval granted by the
November 1993 Letters. However, these facts may be relevant to the penalty assessed for any violation
found on remand (but we do not decide this issue at this stage of this case).
25 Where an approval is qualified, EPA’s registration division stamps the labeling as “accepted
with comments.” See, e.g., Notices of Serious Error, att. II.
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E.I. DU PONT DE NEMOURS AND COMPANY 51
both registrants and EPA on the requirements incorporated in the registrations of
numerous other products. Therefore, we hold that the question of whether the re-
gistrations for DuPont’s Bladex and Extrazine pesticide products had been
amended to include DuPont’s proposed WPS modifications must be based on the
terms of EPA’s official correspondence. Here, the November 1993 Letters on their
face granted unqualified approval of the entire labeling and did not indicate that
the proposed WPS modifications were not reviewed or approved. Accordingly,
we hold that, although EPA may not have intended to grant approval of DuPont’s
proposed WPS label modifications, nevertheless, it did in fact grant that approval
when it sent the November 1993 Letters.
DuPont argued in its motion to dismiss that since its proposed WPS labeling
was approved in November 1993, it was entitled to dismissal of this action. Spe-
cifically, DuPont argued that “[t]he Agency’s unconditional approval of DuPont’s
WPS labeling on November 4, 1993 bars the Agency from bringing this enforce-
ment action because an EPA-approved label cannot be misbranded.” Respondent’s
Motion to Dismiss Based on Threshold Legal Issues at 26 (Feb. 27, 1995). Du-
Pont’s argument in its motion to dismiss, however, is mistaken as to the effect that
the November 1993 approval has on this action. FIFRA specifically states that
“[i]n no event shall registration of an article be construed as a defense for the
commission of any offense under this subchapter.” FIFRA § 3(f)(2). Instead, “re-
gistration of a pesticide shall be prima facie evidence that the pesticide, its label-
ing and packaging comply with the registration provisions of the subchapter.” Id.
More generally, as noted in our discussion of the statutory background, FIFRA
contemplates that a determination made under FIFRA section 3 may later be reex-
amined on the grounds that the product does not comply with the registration
standards.
Notwithstanding its arguments in its motion to dismiss, during oral argu-
ment DuPont conceded that registration approval may be challenged in a mis-
branding enforcement action. In particular, during oral argument Judge McCallum
posed the following hypothetical and DuPont’s counsel responded as follows:
JUDGE McCALLUM: * * * [I]f the Agency granted the application
and it contained what EPA later thought was a toxicity characteriza-
tion that * * * minimized the toxicity of the product, then the statute
clearly provides a process for the Agency to come back in and make a
determination that [the product] causes unreasonable adverse effects
on the environment. * * * [I]t is a cancellation proceeding.
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52 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
MR. BARRETT: Or it is a misbranding proceeding.
* * * * * * *
[I]n Ciba-Geigy Corporation v. EPA, * * * the Agency itself took
the position that it could take action against products that met your
description of being unsafe because it didn’t have the correct warn-
ings, under either the misbranding provisions or the registration provi-
sions. There are two separate enforcement tracks.
Transcript of Oral Argument at 15-16 (Sept. 29, 1999) (discussing CIBA-GEIGY
Corp. v. EPA, 801 F.2d 430 (D.C. Cir. 1986)); see also Supplemental Brief of
Respondent E.I. Du Pont De Nemours and Company at 10 (Oct. 27, 1999) (“This
construction makes sense as a matter of public policy * * *.”). Accordingly, as
DuPont concedes, even if particular labeling has been approved during the regis-
tration process, the registration approval does not bar EPA from charging that the
labeling is misbranded. We agree.
For the foregoing reasons, DuPont was not entitled to rely on the registra-
tion approval granted by the November 1993 Letters as a defense to this mis-
branding enforcement action. DuPont, nevertheless, was entitled under FIFRA
section 3(f)(2) to rely on the approval granted by the November 1993 Letters as
prima facie evidence that its labeling complies with the applicable requirements.
However, the evidence submitted at the evidentiary hearing showing that Du-
Pont’s own applications for amended registration characterized these products as
toxicity category II was sufficient, in the circumstances of this case, to overcome
the prima facie evidence of compliance established by the November 1993 Let-
ters. Accordingly, while we conclude that the Presiding Officer erred in finding
that DuPont’s proposed WPS label modifications had not been approved by the
November 1993 Letters, we also conclude that denial of DuPont’s motion to dis-
miss was proper.
B. Whether the WPS Regulations Establish a Misbranding Standard
Next, we turn to the standards for proof of “misbranding” that governs this
enforcement action and DuPont’s argument that the Presiding Officer erred when
he concluded that “‘the WPS rule establishes a standard for misbranding under
[FIFRA] section 2(q)(1)(G) [and that] [p]roof that Respondent failed to include a
warning or caution statement required by the WPS rule on the labels of the Bladex
and Extrazine products is sufficient to establish that the labels were misbranded
under FIFRA § 2(q)(1)(G).’” DuPont’s Appeal Brief at 33, quoting Init. Dec. at 14
(modifications made by DuPont).
DuPont correctly notes that the analysis must begin with the statutory stan-
dard set forth in the definition of “misbranded.” For the violations at issue here the
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E.I. DU PONT DE NEMOURS AND COMPANY 53
substantive standard is found in the requirement that the directions for use and
warning or caution statements must be adequate to “protect health and the envi-
ronment.” FIFRA § 2(q)(1)(F)-(G), 7 U.S.C. § 136(q)(1)(F)-(G).26 The Presiding
Officer correctly held that EPA satisfied the substantive standard for misbranding
under FIFRA section 2(q)(1)(F) and (G) when it promulgated the WPS labeling
requirements. Init. Dec. at 11-14. EPA’s intent to establish such a standard is evi-
dent from the following excerpt from the notice of proposed WPS rulemaking:
FIFRA section 2(q)(1) provides that pesticide labeling must contain
both necessary directions for use and warnings or caution statements
which, if complied with, are adequate to protect health and the envi-
ronment. The Agency proposes to find that worker protection stan-
dards are necessary to protect health of agricultural workers and pesti-
cide handlers, and therefore should be required to be placed on
pesticide labeling.
53 Fed. Reg. 25,970, 25,998 (July 8, 1988).
In its appeal brief, DuPont also argues that EPA did not have the authority
to issue a misbranding standard by regulation. Specifically, DuPont argues that
“The ALJ’s conclusion is based on the flawed supposition that EPA is authorized
under FIFRA to make a generalized — rather than a product-specific — risk de-
termination of the warning labels that are required to protect human health.” Du-
Pont’s Appeal Brief at 33. DuPont, thus, argues that the question of whether par-
ticular labeling language “is adequate to protect health and the environment”
within the meaning of FIFRA section 2(q)(1)(F) and (G) must be made on a prod-
uct-specific basis without reference to regulations specifying labeling require-
ments for toxicity categories. This argument was stated in greater detail in Du-
Pont’s post-hearing brief, where DuPont argued that “Complainant cannot rely on
the WPS rule to establish misbranding because nothing in that rule sets a standard
for misbranding.” See Post-Hearing Brief of Respondent at 36. DuPont argued
further that the EPA did not provide notice that the WPS regulations would define
conduct that would constitute misbranding. Id. at 36-41. These arguments must be
rejected.
As noted by the Presiding Officer, DuPont primarily relies upon the opinion
of the Administrator in In re Stevens Industries, Inc., 1 E.A.D. 9 (Adm’r 1972),
for its argument that EPA cannot make a generalized risk determination, but in-
stead that a product-specific finding is required under FIFRA section 2(q)(1)(F)
26 The phrase “protect health and the environment” is defined to mean “protection against any
unreasonable adverse effects on the environment,” id. § 2(x); and that phrase is further defined as “any
unreasonable risk to man or the environment, taking into account the economic, social, and environ-
mental costs and benefits of the use of any pesticide.” Id. § 2(bb).
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54 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
and (G). Init. Dec. at 11. The Presiding Officer held, at pages 11-13 of the Initial
Decision, that DuPont’s reliance on Stevens Industries is misplaced. First, the Pre-
siding Officer correctly observed that Stevens Industries was decided before Con-
gress enacted FIFRA section 25(a), which authorizes the Administrator to pro-
mulgate regulations under FIFRA, and that Stevens Industries did not purport to
apply a duly promulgated regulation.27 Second, the Presiding Officer also noted
that the Agency specifically determined as part of the WPS rulemaking, at 57 Fed.
Reg. at 38,105, that it has the authority to promulgate regulations establishing
disclosure and warning requirements, including the warning regarding protective
eyewear at issue here, based on “a generalized risk determination * * * where
reaching individualized risk determinations would unnecessarily impair the
Agency’s ability to carry out its statutory duty to protect agricultural workers.”
Init. Dec. at 12 (noting that the Agency relied upon Associated Builders and Con-
tractors, Inc. v. Brock, 862 F.2d 63, 68 (3d Cir. 1988), in making this rulemaking
determination). The Presiding Officer also held that nothing in the statutory text
of FIFRA section 2(q)(1)(F) or (G) precludes the establishment of misbranding
standards by regulation. Upon review, we find no error in the Presiding Officer’s
analysis of these issues and hereby reject DuPont’s arguments to the contrary.
DuPont’s argument that it did not have notice that the WPS regulations cre-
ated a misbranding standard is also rejected. This contention fails to recognize
that the regulatory labeling requirements in the WPS were promulgated to inter-
pret and implement the statutory misbranding definition and, therefore, establish
the standard for compliance with the statute. The Presiding Officer correctly ob-
served that both the proposed rulemaking and notice of final rulemaking gave
specific notice to registrants that a failure to comply with the WPS rule could
result in a misbranding charge. Init. Dec. at 10, citing 53 Fed. Reg. 25,970, 26,001
(July 8, 1988) (proposed), 57 Fed. Reg. 38,102, 38,144 (April 21, 1992) (final). In
addition, we note that notice of the fact that the Part 156 regulations establish
misbranding standards is given by the registration regulations, see
40 C.F.R. § 152.112(f) (referencing Part 156 as a misbranding standard), by the
notice of proposed rulemaking that resulted in the creation of Part 156, 49 Fed.
Reg. 37,960 (Sept. 26, 1984) (stating that “[t]he statutory standard that is the basis
27 For the same reasons, we reject as inapplicable two cases cited by DuPont for the first time
on appeal. DuPont’s Appeal Brief at 16-17 (citing Continental Chemiste Corp. v. Ruckelshaus, 461
F.2d 331 (7th Cir. 1972), and Stearns Elec. Paste Co. v. EPA, 461 F.2d 293, 306 (7th Cir. 1972)).
Both cases, like the Stevens Industries case, did not involve application of regulations promulgated,
pursuant to FIFRA § 25(a)(1), interpreting and elaborating upon the definition of “misbranded.” In
addition, the Continental Chemiste case is inapplicable because it involved a question of the relation-
ship between two different statutory schemes, not the relationship between FIFRA and regulations
promulgated under FIFRA. Continental Chemiste addressed the question of whether a pesticide could
be found to be misbranded under FIFRA if it may cause certain foods to become “adulterated” within
the meaning of the Food, Drug and Cosmetic Act. It is also worth noting that the Stearns Electric court
specifically stated that the issue being considered did not involve interpretation or application of a
regulation. Stearns Elec., 461 F.2d at 304.
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E.I. DU PONT DE NEMOURS AND COMPANY 55
for Agency regulation of pesticide labeling is contained in section 2(q) of
FIFRA”), and the notice of proposed WPS rulemaking. 53 Fed. Reg. 25,970,
25,998 (July 8, 1988) (“FIFRA section 2(q)(1) provides that pesticide labeling
must contain both necessary directions for use and warnings or caution statements
which, if complied with, are adequate to protect health and the environment. The
Agency proposes to find that worker protection standards are necessary to protect
health of agricultural workers and pesticide handlers, and therefore should be re-
quired to be placed on pesticide labeling.”).
For all of these reasons, we hold that the Presiding Officer did not err when
he concluded that “the WPS rule establishes a standard for misbranding under
[FIFRA] section 2(q)(1)(G).” Init. Dec. at 14. We therefore hold that proof that a
pesticide product’s label does not contain a warning or use statement that com-
plies with the specific language required by the WPS rule is sufficient to establish
that the product is misbranded under FIFRA section 2(q)(1)(F) or (G). Next, we
turn to the question of whether Pesticide Enforcement’s evidence proves that the
labels at issue in this case failed to comply with the specific labeling requirements
of the WPS rule and whether DuPont should have been allowed to submit its
toxicity evidence to contradict Pesticide Enforcement’s evidence.
C. Compliance with the WPS Rule: Toxicity Issue and Related Matters
As noted in the foregoing discussion, the WPS labeling regulations specify
the particular label language that may be necessary to protect health and the envi-
ronment and which EPA has determined must be included on the labeling of pes-
ticide products intended for agricultural uses. The regulations, however, do not
require the same label language for all pesticide products falling within the scope
of the WPS regulations. Instead, the regulations establish different labeling re-
quirements for different categories of pesticide products, based on the product’s
toxicity through different routes of exposure. Thus, the regulations require, for
each pesticide product, that a factual determination of the product’s toxicity be
made as a predicate to determining the labeling language required by the regula-
tions. In particular, the regulations state as follows:
The requirement for personal protective equipment is based on the
acute toxicity category of the end-use product for each route of expo-
sure as defined by § 156.10(h)(1). * * * If data to determine the
acute toxicity of the product by a specific route of exposure * * * are
not obtainable, the toxicity category corresponding to the signal word
of the end-use product shall be used to determine personal protective
equipment requirements for that route of exposure.
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56 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
40.C.F.R. § 156.212(d)(2).28 Thus, whether a particular label warning is required
under the WPS regulations is dependent upon the toxicity of the pesticide product
determined first by “obtainable” data and, only if data is not obtainable, then by
the signal word assigned to the product as part of its original registration.29
The particular warning at issue in this case concerns protection against eye
irritation. For pesticides with a toxicity category II for eye irritation potential, the
WPS regulations require that a protective eyewear warning be included in two
different sections of the label: (1) the Hazards to Humans (and Domestic Ani-
mals) section for warning to handlers and applicators; and (2) the Agricultural
Use Requirements box for warning to agricultural and early entry workers.
40 C.F.R. § 156.212(e), (j). Protective eyewear statements, however, are not to
be used in either section of the label for pesticides with a toxicity category III for
eye irritation potential. Id.
As noted above in Part I.A of our discussion, DuPont was entitled to rely
upon the November 1993 Letters, which granted registration approval of its la-
bels, as prima facie evidence that its labels comply with the applicable registration
requirements, including the subsidiary issue of compliance with the WPS labeling
standards. However, the unrebutted Taylor Affidavit raised initial questions re-
garding the weight that should be given the November 1993 approval — it estab-
lished that the approval was the result of a mistake; EPA had not performed a
sufficient review of the WPS portions of the labels as of November 1993. More
significantly, at the evidentiary hearing, Pesticide Enforcement sought to establish
a prima facie case of non-compliance with the WPS labeling standards by intro-
ducing into the record DuPont’s July 1993 applications for amended registration
and the related EPA guidance which, collectively, show that DuPont characterized
these products as being toxicity category II for eye irritation potential.30 In partic-
ular, EPA’s guidance required the applicant to “[u]se data in your files to deter-
mine the toxicity category of your end-use product for each route of entry.” PR-
Notice 93-7, supp. III, at 7. Therefore, DuPont’s applications set forth its state-
ment regarding the eye irritation toxicity category of the Bladex and Extrazine
28
Section 156.212(d)(2) defines the personal protective equipment requirements for pesticide
applicators and handlers. Section 156.212(j)(1) states, with limited exceptions, that the personal pro-
tective equipment required for early-entry workers shall be the same personal protective equipment
listed for applicators and handlers. Section 156.212(c) states that the list of personal protective equip-
ment for applicators and handlers shall appear in the “Hazards to Humans (and Domestic Animals)”
section of the labeling and the list of personal protective equipment for early-entry workers shall ap-
pear in the Directions for Use section of the labeling under the heading Agricultural Use
Requirements.
29 The product’s signal word is assigned under 40 C.F.R. § 156.10(h) based on the highest
hazard through any of the identified routes of exposure.
30 See supra n.15.
VOLUME 9
E.I. DU PONT DE NEMOURS AND COMPANY 57
products. At a minimum, this evidence would generally constitute an admission
by DuPont that its pesticide products are toxicity category II and must bear pro-
tective eyewear warnings under the WPS regulations. See LWT, Inc. v. Childers,
19 F.3d 539 (10th Cir. 1994) (admission made by party in pleadings in one action
is admissible as evidence in another case).31 As such, this evidence, which was
admitted without objection, established Pesticide Enforcement’s prima facie case
that the products are toxicity category II (the evidence of this fact also established
a prima facie case under the WPS labeling requirements that a protective eyewear
warning was required in both sections of the label).
It is undisputed that DuPont’s WPS label modifications submitted with its
July 1993 applications for amended registration (which are in the record of this
case, See CX 6, CX 7, CX 8, CX 9) do not contain a protective eyewear warning
in the Agricultural Use Requirements box. Thus, Pesticide Enforcement’s evi-
dence established a prima facie case of misbranding based on non-compliance
with the WPS regulations. (The labels, however, do contain a protective eyewear
warning in the Hazards to Humans section of the label, which creates an internal
inconsistency on the face of the labeling. We will return to this issue at the end of
our discussion in this part.)
The question presented by the parties in this case, however, is whether Du-
Pont is permitted to introduce other evidence to rebut Pesticide Enforcement’s
prima facie case by showing that DuPont’s own statements in its applications for
amended registration are, in fact, incorrect. At the evidentiary hearing, DuPont
sought to rebut Pesticide Enforcement’s prima facie case by proffering evidence,
in the form of both testimony and toxicity studies, which it contended would
prove that its pesticides belong in toxicity category III for eye irritation potential,
rather than category II. DuPont’s proffered evidence, thus, would provide DuPont
with a factual predicate for arguing that a protective eyewear warning is not re-
quired on the pesticides’ labels. The Presiding Officer, however, refused to admit
this evidence. Init. Dec. at 21-22. Upon review, we conclude that the Presiding
Officer erred by excluding DuPont’s proffered evidence.
As discussed above, EPA issued the November 1993 Letters approving Du-
Pont’s proposed labels, including the WPS modifications, without comment.32
31 Under the Administrative Procedure Act, a licensing proceeding is an adjudicative proceed-
ing. 5 U.S.C. § 551(6), (7). FIFRA registration proceedings are licensing proceedings commenced by
the submission of an application.
32 Pesticide Enforcement argues that “the Agency classified each of Respondent’s four prod-
ucts as Toxicity Category II for eye irritation.” Pesticide Enforcement’s Brief at 10. However, the
Taylor Affidavit shows that EPA had not reviewed DuPont’s WPS label modifications as of November
1993. Indeed, in this case, it is Pesticide Enforcement, not DuPont, that seeks to challenge the conclu-
sion produced by the registration process.
VOLUME 9
58 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
Once EPA discovered that the approval granted in November 1993 was based on
an insufficient review and that a more complete review would have led to the
conclusion that DuPont’s proposed modifications did not conform to the WPS la-
beling standards based on the toxicity identified in DuPont’s applications, EPA
was entitled to proceed under either of the two enforcement tracks identified in
Part I.A of our discussion: cancellation under FIFRA section 6, or misbranding
enforcement under FIFRA section 12.33 Had EPA elected to enforce the WPS la-
beling standards by cancellation, DuPont would have been entitled to full due
process, including a formal evidentiary hearing pursuant to FIFRA section 6 and
40 C.F.R. part 164. There is nothing in the statute or regulations that would re-
quire DuPont, in such a cancellation proceeding, to defend the terms of its prod-
uct’s registration solely based on information it submitted in connection with its
application for registration or amended registration. To the contrary, subsequently
developed data regarding both adverse effects and benefits are considered as a
matter of course in cancellation proceedings. See, e.g., In re CIBA-GEIGY Corp.,
3 E.A.D. 232 (Adm’r 1990) (cancellation of certain diazinon registrations); In re
Stevens Indus., Inc., 1 E.A.D. 9 (Adm’r 1972) (cancellation of certain DDT
registrations).
In this case, EPA did not elect to proceed by cancellation of the registration
approval it had granted in November 1993, but instead it chose to commence this
misbranding enforcement action under FIFRA section 12. The choice of this pro-
cedural vehicle for enforcing the registration standards, however, should
not — absent clear indications to the contrary — limit the evidence that DuPont
may submit to demonstrate compliance with those standards. Indeed, we have
found nothing to suggest the contrary in this case. In a case like this where Pesti-
cide Enforcement is alleging misbranding notwithstanding the registrant’s use of
an approved label, the statute contemplates a showing that the label is not protec-
tive of health and the environment. The submission of the applications for
amended registration, while instructive and sufficient to meet Pesticide Enforce-
ment’s prima facie burden on this point, is not dispositive where the respondent
has sought to introduce other evidence relevant to the inquiry contemplated by the
statute and implementing regulations.34 Accordingly, we hold that the Presiding
33 FIFRA contains a third enforcement option: issuance of a “stop sale, use, or removal” order
under FIFRA section 13. This enforcement vehicle is not at issue in this case because, among other
things, DuPont was not charged with violation of any such order under FIFRA section 12(a)(1)(I),
7 U.S.C. § 136j(a)(1)(I).
34 Pesticide Enforcement argues that the toxicity determination in this case was made by the
WPS rule based on the Bladex and Extrazine products’ signal word because “Respondent did not pro-
pose an alternative classification” in its applications for amended registration. Pesticide Enforcement’s
Brief at 10. Here, however, registration approval was granted upon insufficient review and Pesticide
Enforcement has challenged DuPont’s labels in a separate enforcement proceeding. The WPS rule
simply does not limit the data that DuPont may use in defense of the registrations that were approved
in November 1993.
VOLUME 9
E.I. DU PONT DE NEMOURS AND COMPANY 59
Officer erred when he precluded DuPont from submitting its toxicity evidence,
which was proffered by DuPont to show that its products, in fact, are toxicity
category III for eye irritation potential. We therefore remand this case for further
proceedings to consider DuPont’s proffered evidence and any admissible rebuttal
evidence that may be submitted by Pesticide Enforcement.
In addition, on remand, the Presiding Officer may consider, as part of the
questions of the evidence bearing upon the labels’ alleged compliance with the
WPS-labeling standards, whether the labels at issue in this case show a facial non-
compliance with the language requirements of the WPS regulations in that the
labels contain an internal inconsistency. As noted above, DuPont’s proposed
amended labels submitted with its July 1993 applications for amended registration
are in the record of this case. See CX 6, CX 7, CX 8, CX 9. It is undisputed that
these labels do not contain a protective eyewear warning in the Agricultural Use
Requirements box. It is also apparent from a review of the labels that they do
contain such a warning in the Hazards to Humans (and Domestic Animals) sec-
tion. Thus, the labels contain an internal inconsistency in that a protective
eyewear warning is used in one part of the label and omitted in another. This is
facially inconsistent with the specific language required by the WPS regulations,
which require the same level of eye protection warning in both parts of the label.
40 C.F.R. § 156.212(e), (j). DuPont has not shown that it had approval for this
deviation from the regulation’s exact language requirements as required by
40 C.F.R. § 156.204(b). DuPont should be afforded an opportunity to address
this issue, which arises directly from the same facts and circumstances and legal
standards identified in the complaint and the evidence established at trial.
D. DuPont’s “Released for Shipment” Argument
DuPont argues that Pesticide Enforcement failed to prove that the 379 ship-
ments were made bearing the unapproved amended labels, and it argues that Pes-
ticide Enforcement failed to prove that use of those labels was unauthorized be-
cause PR-Notice 93-11 allowed DuPont to sell pesticide products with “non-
complying” labels if those products were “released for shipment” prior to January
1, 1994. The Presiding Officer correctly rejected both of these arguments. We
hereby adopt the Presiding Officer’s analysis and conclusions set forth at pages 25
through 27 of the Initial Decision. In particular, we note that DuPont admitted in
its answer that the 379 shipments of pesticides identified in the complaint were
shipped bearing “WPS language identical to that submitted to EPA on July 14,
1993.” DuPont’s Affirmative Defenses ¶ 2. This admission removed from contro-
versy in this case any question as to whether the 379 shipments were actually
made bearing the WPS-labeling language set forth in DuPont’s July 1993 applica-
tions for amended registration. Thus, because DuPont’s answer admitted that the
379 shipments were made bearing the WPS language that DuPont had submitted
with its July 1993 applications, Pesticide Enforcement was not required to make
any further proof at trial. The trial exhibits consisting of DuPont’s July 1993 ap-
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60 ENVIRONMENTAL ADMINISTRATIVE DECISIONS
plications and proposed modified labeling were sufficient to establish the label
language used by DuPont on the 379 shipments at issue in this case.
DuPont’s “release for shipment” argument also must be rejected both for the
reasons stated in the Initial Decision and for the additional reason that the release
for shipment option under PR-Notice 93-11 only authorized continued use, after
April 21, 1994, of previously approved, non-WPS labeling, and only if the pesti-
cides bearing that non-WPS labeling had been released for shipment prior to Janu-
ary 1, 1994. The released for shipment option set forth in Supplement C to PR-
Notice 93-11 did not purport to change the requirement under
40 C.F.R. § 152.44(a) that labeling modifications be approved before the modi-
fied product may legally be sold. Instead, by the “released for shipment” option,
EPA sought to provide manufacturers assurance that they could continue produc-
tion until January 1, 1994, of products bearing previously approved, although not
WPS compliant, labeling and be able to sell those products even if the sales had
not occurred prior to April 21, 1994. Thus, the released for shipment option did
not authorize use of modified labeling that was only partially, but not fully, com-
pliant with the new WPS standards as argued by DuPont.35 Accordingly, we reject
DuPont’s argument that Pesticide Enforcement was required to show when the
products in the 379 shipments were released for shipment.
III. CONCLUSION
For the foregoing reasons, we hereby remand this case for further proceed-
ings consistent with this decision.
So ordered.
35 In essence, DuPont’s argument, if accepted, would mean that EPA granted DuPont the right
to use any misbranded labeling, including false and misleading labeling, so long as the products bear-
ing that labeling were released for shipment prior to January 1, 1994. That result is absurd and was not
intended.
VOLUME 9
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