Mclaughlin Gormley King Co.

Plain-English summary

Mclaughlin Gormley King Co. and other respondents in six consolidated pesticide enforcement actions submitted a study concerning Piperonyl Butoxide with a statement that the study followed EPA's Good Laboratory Practice standards. EPA alleged that the statement was false because the study deviated from four standards and charged four independently assessable violations. The Board held that the single compliance statement concerning the single study could support no more than one violation, even if it was false for four independent reasons. The Board sustained the Presiding Officer's ruling and remanded the underlying enforcement case for further proceedings consistent with the decision.

Decision snapshot

• Cited authorities: 7 U.S.C. § 136j(a)(2)(Q) and 40 C.F.R. part 160, including §§ 160.1, 160.12, 160.17, 160.35, 160.185, and 160.195.
• Outcome: The Board sustained the Presiding Officer's one-violation ruling and remanded the underlying enforcement case.
• Key point: For the facts alleged here, the unit of violation was the false compliance statement, not each alleged departure from a laboratory-practice standard.

Full text (EPA EAB public release)

MCLAUGHLIN GORMLEY KING CO. 339

IN RE MCLAUGHLIN GORMLEY KING CO.

FIFRA Appeal Nos. 95-2 through 95-7
ORDER ON INTERLOCUTORY REVIEW

Decided March 12, 1996

Syllabus

These appeals are from an interlocutory ruling by the Presiding Officer in six consolidat-
ed FIFRA enforcement actions. Respondents in these actions jointly submitted a study to EPA in
support of the registration or amended registration of each Respondent's technical grade of a
pesticide called Piperonyl Butoxide. Attached to the study was a statement stating that all aspects
of the study were conducted in accordance with EPA’s Good Laboratory Practice (“GLP”) stan-
dards at 40 C.F.R. part 160 (compliance statement”). The Toxics and Pesticides Enforcement
Division at EPA Headquarters (“Complainant”) filed a complaint against each of the
Respondents, alleging that the compliance statement was false because the study had actually
deviated from four of the GLP standards listed at part 160. Under section 12(a)(2)(Q) of FIFRA,
7 U.S.C. § 136j(a)(2)(Q), it is unlawful to “falsify all or part of any information relating to the
testing of any pesticide * * * submitted to the Administrator * * *.” In the complaint against each
Respondent, Complainant charged the Respondent with four separate falsifications of the com-
pliance statement resulting in four independently assessable violations of section 12(a)(2)(Q),
one violation for each alleged deviation from the GLP standards. Upon a motion to dismiss the
complaint submitted by Respondents, the Presiding Officer ruled that submission of the alleged-
ly false compliance statement could result in only one violation of section 12(a)(2)(Q), not four
independently assessable violations. At the request of the parties, the Presiding Officer certified
this ruling for interlocutory appeal to the Environmental Appeals Board

Held: The compliance statement in question, which covered a single study only, can give
rise to no more than a single violation of section 12(a)(2)(Q), even if, as alleged, the compli-
ance statement may be false for four independent reasons

Before Environmental Appeals Judges Ronald L. McCallum
and Edward E. Reich.

Opinion of the Board by Judge McCallum:

These appeals are from an interlocutory ruling by Senior Adminis-
trative Law Judge Gerald Harwood (“Presiding Officer”) in six consol-
idated FIFRA enforcement actions. The Respondents in these actions
are registrants of a pesticide called Piperonyl Butoxide and are mem-
bers of an organization called the Piperonyl Butoxide Task Force II
(the “Task Force”). The Task Force submitted a study to EPA in sup-
port of the registration or amended registration of each Respondent's

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340 ENVIRONMENTAL ADMINISTRATIVE DECISIONS

technical grade of Piperonyl Butoxide (the “Study”). Attached to the
Study was a statement, signed by the chairman of the Task Force, stat-
ing that all aspects of the Study were conducted in accordance with
EPA’s Good Laboratory Practice (“GLP”) standards at 40 C.F.R. part 160
(compliance statement”). The Toxics and Pesticides Enforcement
Division at EPA Headquarters (‘Complainant’) filed a complaint
against each of the Respondents, alleging that the compliance state-
ment was false because the Study had actually deviated from four of
the GLP standards listed at part 160.' Under section 12(a)(2)(Q) of
FIFRA, 7 U.S.C. § 136j(a)(2)(Q), it is unlawful to “falsify all or part of
any information relating to the testing of any pesticide * * * submitted
to the Administrator * * *.” In the complaint against each Respondent,
Complainant charged the Respondent with four separate falsifications
of the compliance statement resulting in four violations of section
12(a)(2)(Q), one for each alleged deviation from the GLP standards of
part 160. Upon a motion to dismiss the complaint submitted by
Respondents, however, the Presiding Officer ruled that submission of
the allegedly false compliance statement could only constitute one
violation of section 12(a)(2)(Q), not four independently assessable
violations. Both EPA and the Respondents requested that the Presiding
Officer certify this interlocutory ruling for appeal, and on May 1, 1995,
the Presiding Officer did so. On May 23, 1995, the Board accepted
the certification and requested further briefing, and on December 13,
1995, the Board heard oral argument on the certified issue.

For the reasons set forth below, we hold that the compliance
statement in question, which covered a single study only, can give
rise to no more than a single violation of section 12(a)(2)(Q), even

"Complainant alleges that each Respondent failed to comply with the GLP standards at 40
C.F.R. §§ 160.195, 160.185 and 160.35(b). Complainant also alleges that each Respondent failed
to comply with the compliance statement requirement at section 160.12, which Complainant
sometimes refers to as a GLP standard. See infra n.5. While it is not clear to us that the compli-
ance statement requirement is a good laboratory practice per se, it need not be distinguished
from the other three requirements for purposes of this decision. For ease of reference, therefore,
we will generally refer to all four requirements as GLP standards in this decision.

*In explaining his reasons for certifying the issue, the Presiding Officer noted that two
other Administrative Law Judges had confronted the issue and each had resolved the issue dif-
ferently than the other. In In re Bio-Tek Industries, Inc., FIFRA-92-H-06 (Order Denying Motion
to Dismiss Based on Threshold Legal Issues, April 13, 1993), the Presiding Officer ruled that the
submission of a compliance statement representing compliance with all of the GLP standards
gave rise to a single assessable violation of section 12(a)(2)(Q), despite multiple deviations from
those standards, In re Boehringer Ingleheim Animal Health, Inc, FIFRA-93- H-11 (Order
Denying Respondent's Motion to Reduce Counts in the Complaint from Four to One, Nov. 17,
1993), another Presiding Officer ruled that the submission of a compliance statement represent-
ing compliance with all of the GLP standards resulted in as many violations of section
12(a)(2)(Q) as there were deviations from the GLP standards.

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MCLAUGHLIN GORMLEY KING CO. 341

if, as alleged, the compliance statement may be false for four inde-
pendent reasons.*

I, REGULATORY BACKGROUND

All data provided to the Agency in support of a pesticide regis-
tration under FIFRA must be submitted in the form of individual stud-
ies. 40 C.F.R. § 158.32(b). A study submitted in support of a registra-
tion or re-registration of a pesticide on or after October 16, 1989, such
as the one at issue here, is subject to the GLP standards, which are
published at 40 C.F.R. part 160. 40 C.F.R. § 160.1.* The Agency does
not at present have authority to mandate compliance with the GLP
standards directly; however, it does have a powerful indirect means of
encouraging compliance with the GLP standards. Under section
160.12, it requires any person submitting a study subject to part 160
to submit a compliance statement indicating the extent to which the
study was conducted in accordance with the GLP standards. 40 C.F.R.
§ 160.12. Section 160.12 provides as follows:

Any person who submits to EPA an application for a
research or marketing permit and who, in connection
with the application, submits data from a study to
which this part applies shall include in the application
a true and correct statement, signed by the applicant,
the sponsor, and the study director, of one of the fol-
lowing types:

• For purposes of deciding the certified issue, we have assumed that Respondents’ study was
  not conducted in accordance with four GLP standards; however, this decision need not and does
  not reach the issue of whether Respondents actually did fail to comply with the GLP standards.

• Section 160.1 provides as follows:

(a) This part prescribes good laboratory practices for con-
ducting studies that support or are intended to support appli-
cations for research or marketing permits for pesticide prod-
ucts regulated by the EPA. This part is intended to assure the
quality and integrity of data submitted pursuant to sections 3,
4, 5, 8, 18 and 24(c) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended (7 U.S.C. 136a, 136c,
136 f, 136 q and 136v(c)) and sections 408 and 409 of the
Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C.
346a, 348).

(b) This part applies to any study described by paragraph (a)
of this section which any person conducts, initiates, or sup-
ports on or after October 16, 1989

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342 ENVIRONMENTAL ADMINISTRATIVE DECISIONS

(a) A statement that the study was conducted in accor-
dance with this part; or

(b) A statement describing in detail all differences
between the practices used in the study and those
required by this part; or

(c) A statement that the person was not a sponsor of
the study, did not conduct the study, and does not
know whether the study was conducted in accordance
with this part.

If the compliance statement indicates that the study was not conduct-
ed in accordance with all of the GLP standards in part 160, then the
Agency may deem the study unreliable and refuse to consider it. 40
C.F.R. § 160.17(a). This risk of rejection serves as a strong incentive to
comply with the GLP standards, since as a practical matter, studies are
ordinarily submitted to obtain necessary approvals from EPA or to
keep existing approvals in effect. The loss or denial of an approval
would represent a significant setback for an applicant or registrant.

The critical importance of accurate and truthful compliance state-
ments to the proper functioning of this scheme is obvious. EPA needs
reliable studies on which to base its decisions on whether to allow
potentially dangerous pesticide products in the market. To this end,
the Agency has a number of enforcement options at its disposal to dis-
courage registrants from submitting false compliance statements. In
the event that a registrant submits a false compliance statement, the
Agency may: (1) cancel, suspend, or modify any registration based on
the study; (2) deny or disapprove an application for such registration;
(3) bring a criminal action against the submitter under 18 U.S.C. §§ 2
or 1001 or section 14 of FIFRA; or (4) bring an action for civil penal-
ties under section 14 of FIFRA. 40 C.F.R. § 160.17(b).

Section 14 of FIFRA, 7 U.S.C. § 136l authorizes the Agency to
bring an enforcement action for civil penalties against any person who
violates a provision of FIFRA. One such provision, section 12(a)(2)(Q)
of FIFRA, makes it unlawful for any person to:

falsify all or part of any information relating to the test-
ing of any pesticide (or any ingredient, metabolite, or
degradation product thereof), including the nature of
any protocol, procedure, substance, organism, or
equipment used, observation made, or conclusion or
opinion formed, submitted to the Administrator, or that

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MCLAUGHLIN GORMLEY KING CO. 343,

the person knows will be furnished to the Adminis-
trator or will become a part of any records required to
be maintained by this Act;

Because a compliance statement contains “information relating to the
testing of any pesticide,” the submission of a false compliance state-
ment would constitute a violation of section 12(a)(2)(Q), and the
Agency would have authority under section 14 of FIFRA to bring an
enforcement action for civil penalties against the submitter.

To comply with section 160.12 in this case, Respondents relied on
the following compliance statement signed by the Chairman of
Respondents’ Task Force:

To the best of my knowledge, all aspects of this study
that were conducted by the Biological Testing Center
(BTC) were in accordance with the Environmental
Protection Agency Pesticide Program's Good Labora-
tory Practice Standards (40 C.F.R. Part 160).

Complainant contends that the submission of this compliance state-
ment resulted in four different violations of section 12(a)(2)(Q). Three
violations occurred because the Study was not conducted in confor-
mity with the following GLP standards in part 160: (1) section 160.195,
which requires the retention of documentation records, raw data, and
specimens pertaining to a study; (2) section 160.185, which requires
among other things that the final report prepared for each study be
signed and dated by the study director and include “[t]he signed and
dated reports of each of the individual scientists or other profession-
als involved in the study * * ;” and (3) section 160.35(b), which
requires that the quality assurance unit “[t]prepare and sign a statement
to be included with the final study report which shall specify the dates
inspections were made and findings reported to management and to
the study director.” As for the fourth violation, Complainant asserts
that the compliance statement itself did not comply with the require-
ments of section 160.12 and is therefore false for that reason alone.

‘The compliance statement at issue here covers work conducted at the Biological Testing
Center. It should be noted, however, that part of the Study was apparently conducted in anoth-
er laboratory. Respondents submitted a second compliance statement pertaining to the work
done by the second laboratory in an addendum to the Study, which reads as follows:

This work was carried out under the GLP protocol in place

at the Center for Advanced Food Technology (CAFT), Cook

College, Rutgers University. The work was overseen by you
Continued

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344 ENVIRONMENTAL ADMINISTRATIVE DECISIONS

II. DISCUSSION

As a preliminary matter, we must identify the precise documents
that are alleged to contain the falsified “information” in this case.
Complainant argues that Respondents falsified information in both the
compliance statement and the study itself, Oral Argument Transcript
at 9. We note, however, that the complaints that initiated these con-
solidated actions rely on the false compliance statement as the sole
basis for the charges against Respondents. The complaints do not
allege that the submission of the study itself violated section
12(a)(2)(Q). We will therefore restrict our consideration to the com-
pliance statement as the falsified “information” for purposes of apply-
ing section 12(a)(2)(Q). With the focus properly on the compliance
statement, the task before us, then, is to determine how many sepa-
rate violations resulted from the submission of the compliance state-
ment. Is it one or four?

The parties have framed the issue in terms of determining the
“unit of violation” under section 12(a)(2)(Q). Congress has authori-
ty to treat a single act of proscribed conduct as more than one vio-
lation of a statute. Bell v. United States, 349 U.S. 81, 82-83 (1955).
Determining whether Congress has exercised such authority in
enacting a particular statute requires application of traditional prin-
ciples of statutory construction.° Courts have typically framed the
issue in the criminal context as determining the “unit of prosecution”
under the statute. See United States v. C.I.T. Credit Corp., 344 U.
218, 221 (1952).

In Complainant's view, the “unit of violation is not the submission
of a false statement, but the act of falsifying information.” Com-
plainant’s Brief at 15. Complainant contends that because the study
does not conform to four separate GLP standards, “Respondents falsi-

in person (referring to Dr. Paul Lin, the first study director of
Study No, P01825),

Complainant takes the position that the first compliance statement, quoted in the text, was defi-
cient because it did not cover the work done by CAFT and that the second supplementary com-
pliance statement, quoted in this note, does not cure the deficiency because it does not indicate
the extent to which the work done at CAFT adhered to the GLP standards. Based on these con-
siderations, Complainant alleges that the original compliance statement does not fully adhere to
section 160.12,

® See U.S. v. Freisinger, 937 F.2d 383, 388 (8th Cir. 1991) (“The question of how many con-
victions can lawfully be obtained under these circumstances is a question of the appropriate unit
of prosecution, and that is the question of legislative intent."); U.S. v. Coiro, 922 F.2d 1008, 1014
(2nd Cir, 1991) (The relevant inquiry in determining the unit of prosecution under a criminal
statute is what Congress intended."); U.S. v. Evans, 854 F.2d 56, 59 (5th Cir, 1988) (same).

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MCLAUGHLIN GORMLEY KING CO. 345

fied four independent pieces of information by stating that their PBO
study complied with FIFRA GLPs.” Id. at 16.

Respondents, on the other hand, argue that “Congress has
unequivocally defined the unit of violation under FIFRA § 12(a)(2)(Q)
as the submission of a false statement in connection with a study or
test data submitted to the Agency.” Respondent’s Brief at 11.
Respondents contend further that:

Nothing in the statutory language or the legislative his-
tory suggests that there can be multiple charges for
submission of an allegedly false piece of information,
i.e., a single compliance statement. Rather, the only
logical reading of § 12(a)(2)(Q) is that a single penalty
is chargeable per piece of information, irrespective of
whether that information is false in one or more
respects.

Id. at 12.”

? The parties and two Administrative Law Judges have erroneously assumed that the stan-
dard for determining how many offenses have been committed in cases such as this one is sup-
plied by the U.S. Supreme Court decision in Blockburger v. United States, 284 U.S. 299 (1932)
‘The standard articulated in Blockburger, and applied by the parties

(Where the same act or transaction constitutes a violation of
two distinct statutory provisions, the test to be applied to
determine whether there are two offenses or only one, is
whether each provision requires proof of an additional fact
which the other does not

Note, however, that the standard quoted above refers to “two distinct statutory provisions,
whereas in the case before the Board, multiple offenses are charged under the same statutory
provision, In cases such as this one, the Blockburger standard has been held to have no appli-
cation. See Sanabria v. United States, 437 U.S. 54, 70 (1978) ("Because only a single violation of
a single statute is at issue here, we do not analyze this case under the so-called “same evidence”
test, which is frequently used to determine whether a single transaction may give rise to sepa-
rate prosecutions, convictions, and/or punishments under separate statutes. * * * Blockburger v.
United States, * * *."); United States v. Christner, 66 F.3d 922, 1995 U.S. App. LEXIS 26037 at 21,
n.7 (8th Cir. 1995) (We note that, where the double jeopardy challenge focuses on separate
punishments or prosecutions for separate acts allegedly violating the same statutory provision,
the ‘same elements’ test, as enunciated in Blockburger, does not apply. In such cases, the issue
is one of statutory intent.”); United States v. Woods, 568 F.2d 509, 513 n.1 (6th Cir. 1978) (Here
we are not concerned with whether a single act violates a multiplicity of statutes as in * **
Blockburger. Rather, we face what the Supreme Court has recognized to be a different issue:
whether a course of conduct - here possession with intent to distribute - can result in multiple
violations of the same statute.”). The Blockburger standard has no application in such cases
because it calls for a comparison of the elements that must be proved under each statutory pro-
vision (to establish a crime or prima facie case), and such a comparison is obviously meaning-
less when violations of the same statutory provision have been alleged.

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346 ENVIRONMENTAL ADMINISTRATIVE DECISIONS

For purposes of deciding this case, we need not articulate what
constitutes the “unit of violation” in every case under section
12(a)(2)(Q). For the reasons set forth below, we hold only that the
“unit of violation” under that section, as applied in this case, can be
no smaller than a false compliance statement containing a single-sen-
tence assertion that a particular study was conducted in accordance
with the GLP standards of part 160. We hold, therefore, that the sub-
mission of the compliance statement in question could have resulted
in no more than one violation of section 12(a)(2)(Q), even if, as
alleged, the study failed to conform to four independent GLP stan-
dards in part 160.

The compliance statement in question consists of a simple repre-
sentation that the study complied with the GLP standards. In other
words, the statement purports to be of the type identified in section
160.12(a), that is, “A statement that the study was conducted in accor-
dance with this part [160].” This language therefore marks the con-
tours of the unit of violation, as applied in this case; that is, the vio-
lation consists of falsifying “[a] statement that the study was conducted
in accordance with [the GLP standards].” The Complainant contends
that because several of the GLP standards were not complied with,
separate violations are attributable to each instance of noncompliance.
We are not persuaded by this argument as explained below.

It is clear that only one compliance statement was allegedly falsi-
fied, that being the single “statement that the study was conducted in
accordance with [the GLP standards].” The fact that this statement may
have been false for as many as four reasons in no way alters the fact
that only one compliance statement was the subject of the alleged fal-
sification. The compliance statement is clearly the sole item of
allegedly false “information” that was furnished to the Administrator
for purposes of section 12(a)(2)(Q).* In contrast, the study, which is
identified in the compliance statement, is not alleged to contain any
false “information;” therefore, whether the study did or did not com-
ply with the GLP standards in a single respect or a dozen, is irrelevant
to determining how many items of “information” were falsified.
Complainant’s approach of focussing on the study and the number of

• We note that merely because there is only one compliance statement does not mean that
  there can be no more than one prosecutable falsehood, or “unit of violation.” For example, let
  us suppose that instead of the compliance statement’s reference to a single study, it referred to
  more than one study, and let us suppose further that each of the several studies did not com-
  ply with the GLP standards in multiple respects. Presumably everyone would agree that such a
  compliance statement would give rise to at least as many violations as there were numbers of
  studies. Thus, if there were four studies identified, the single false compliance statement would
  give rise to four separate violations.

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MCLAUGHLIN GORMLEY KING CO. 347

instances that it did not comply with the GLP standards effectively ele-
vates the study to a level of importance that is on a par with or
exceeds the compliance statement itself. This is not a correct inter-
pretation of section 12(a)(2)(Q), for it confuses the “information” that
is falsified (here the compliance statement) with the evidence that the
Complainant intends to use to support its claim of falsification. (That
evidence consists of the study and the testimony that the Complainant
will need to adduce to show that the study did not comply with the
GLP standards.) Accordingly, for the foregoing reasons, we conclude
that, on the facts alleged in the complaint, where only a single study
is the subject of a compliance statement, no more than one violation
of the statute can occur by reason of a false assertion that the study
was conducted in conformity with the GLP standards.” We turn now
to Complainant’s specific contentions.

With respect to the specific language of section 12(a)(2)(Q), Com-
plainant raises a host of arguments in support of its position that the
“unit of violation” under section 12(a)(2)(Q) is smaller than the single
falsified compliance statement in question. In general terms, Com-
plainant argues that:

Congress’ choice of the specific terms “all or part of”
and “any information” confirm that FIFRA section
12(a)(2)(Q) was meant to have a broad scope to
encompass this concern [about inadequate data sup-
porting pesticide registrations]. “[A]ll or part of”
demonstrates that Congress understood different
pieces of information contained in a single study could
be independently true or false.

Complainant's Brief at 16. We have no quarrel with Complainant's
observations; however, they have no bearing on the issue before us.
As noted earlier, the complaints that initiated these consolidated
actions do not allege that information in the study was falsified. The
complaints allege only that the information in the compliance state-
ment was falsified.

Complainant also relies on the legislative history of section
12(a)(2)(Q), which was added to FIFRA in 1988. Complainant argues
that “[w]hen Congress enacted FIFRA section 12(a)(2)(Q), * * * it under-
stood that the integrity of the studies submitted to EPA depended on

° OF course, falsification of information in the study itself would result in an entirely sepa-
rate violation of section 12(a)(2)(Q).

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348 ENVIRONMENTAL ADMINISTRATIVE DECISIONS

the level of adherence to FIFRA GLPS.” It is unquestionably true that
Congress was concerned about the integrity of studies submitted to
EPA; however, that observation sheds little light on the issue before
us." The application of section 12(a)(2)(Q) is triggered not by the fail-
ure of a study to comply with one or more GLP standards, but by a
false statement concerning the extent to which the study complies with
those standards. Thus, if a submitter honestly represents the extent to
which a particular study deviates from the GLP standards, section
12(a)(2)(Q) has no application. See 40 C.F.R. § 160.12(b) (the compli-
ance statement may consist of a “statement describing in detail all dif-
ferences between the practices used in the study and those required
by” the FIFRA GLP standards); Oral Argument Transcript at 14-17.
Moreover, that a study was not conducted in accordance with the GLP
standards does not necessarily impugn its reliability. The regulations
clearly contemplate the possibility that the Agency might choose to
rely on a study, even if it was not performed in accordance with all of
those standards. See 40 C.F.R. § 160.17(a) (‘EPA may refuse to consider as
reliable for purposes of supporting an application for a research or
marketing permit any data from a study which was not conducted in
accordance with this part.”) (emphasis added),"' That Congress was
concerned with the integrity of studies submitted to EPA, therefore,
does not lead to the conclusion that the purpose of section 12(a)(2)(Q)
is to punish each instance of non-compliance with the GLP standards.

Complainant also believes that various statutory and regulatory
provisions, including section 6(a)(2) of FIFRA” and section 3(c)(2)(A)

We note that Respondents make a persuasive case that Congress, despite this concern,

considered and ultimately rejected legislation that would have given the Agency authority to
impose civil penalties for deviations from the GLP standards. Respondents’ Reply Brief at 5-13.

" This conclusion is implicitly acknowledged in the following statement by counsel for
Complainant at the oral argument

Had the respondents merely stated that there were some
deviations, or that they were unaware of the status of com-
pliance with the GLPS, the Office of Pesticides Programs
would have treated the study in a much different manner.
Information, perhaps, would have been examined a little
more closely, OPP may not have relied upon the study to the
extent it did.

Oral Argument Transcript at 17
11 Section 6(a)(2), 7 U.S.C. § 136d(a)(2) reads as follows:
Information. —If at any time after the registration of a pesti-

cide the registrant has additional factual information regard
Continued.

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MCLAUGHLIN GORMLEY KING CO. 349

of FIFRA,'? support the proposition that “the term ‘information’ does
not describe an indivisible whole, but instead acknowledges that there
are a variety of kinds of information that are relevant to the registra-
tion decision.” Complainant's Brief at 19. Complainant argues that
whether a particular study complies with, or deviates from, a particu-
lar GLP standard is an independent piece of information that is rele-
vant to the registration decision. Complainant's Brief at 21. That may
be true, but it is beside the point. In this case, we are concerned only
with a single assertion concerning the study as a whole. As noted
above, Complainant is confusing the false compliance statement
with the evidence that shows it is false. We find nothing in the leg-
islative history cited by Complainant that supports the argument that
the unit of violation under section 12(a)(2)(Q) is each independent
reason why a particular statement is false.

Complainant also points out that the Agency has expressed its
position on the issue before the Board in a document entitled,
“Enforcement Response Policy for the Federal Insecticide, Fungicide,
and Rodenticide Act Good Laboratory Practice (GLP) Regulations,”
issued by the Office of Compliance Monitoring, Office of Pesticides
and Toxic Substances (Sept. 30, 1991) (“GLP ERP”). In the GLP ERP,
the Agency has taken the position that each deviation from a require-
ment of the GLP standards in part 160 represents through the compli-
ance statement an independently assessable violation of section
12(a)(2)(Q)." Complainant argues, and one Administrative Law Judge
has held, that the position expressed in the GLP ERP is entitled to def-

ing unreasonable adverse effects on the environment of the
pesticide, the registrant shall submit such information to the
Administrator

'3 Section 3(¢)(2)(A) of FIFRA, 7 U.S.C. § 136a(c)(2(A), requires in pertinent part that:

The Administrator shall publish guidelines specifying the
kinds of information which will be required to support the
registration of a pesticide and shall revise such guidelines
from time to time,

"The GLP ERP provides in pertinent part as follows:

A statement, under 40 CFR 160.12, which certifies that a study
complies with the GLPs is a statement that all requirements
listed in 40 CFR Part 160 have been met. If requirements of
the GLPs have not been met, then the GLP compliance state-
ment is false. Each independent requirement of the GLPs
which has been violated, but has been represented through
the statement as in compliance, may be considered a sepa-
Continued

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350 ENVIRONMENTAL ADMINISTRATIVE DECISIONS

erence. See In re Boebringer Ingleheim Animal Health, Inc., FIFRA-93-
H-11, at 20 (Order Denying Respondent's Motion to Reduce Counts in
the Complaint from Four to One, Nov. 17, 1993). We note, however,
that the GLP ERP, which has never been put out for notice and com-
ment, is a non-binding Agency policy whose application is open to
attack in any particular case. In re James C. Lin and Lin Cubing, Inc.,
5 E.A.D. 595, 599 (EAB 1994) (While Agency penalty policies “facili-
tate application of statutory penalty criteria, they serve as guidelines
only and there is no mandate that they be rigidly followed.”). See also
In re Allied-Signal, Inc. (Frankford Plant), 4 E.A.D. 748, 760 (EAB
1993) (a non-binding Agency policy is open to attack in any particu-
lar case), Moreover, it is important to remember that the determina-
tion of whether an act of proscribed conduct constitutes multiple
offenses under a statutory provision is not a matter of enforcement
discretion; it is, rather, a matter of statutory interpretation. See supra
n.6. That the Agency has articulated its statutory interpretation within
a document that is otherwise devoted to issues committed to the
Agency's enforcement discretion does not alter this conclusion. As a
matter of statutory interpretation, the Agency's position is only enti-
ued to as much deference as is normally owed to Agency interpreta-
tions of statutes. In this regard, we note that the Presiding Officer in
the Boehringer case felt compelled to defer to the Agency's statutory
interpretation under the Chevron standard. The Board, of course, is
under no such obligation. See In re Mobil Oil Corporation, 5 E.A.D.
490, 509 n.30 (EAB 1994) (“Because the Board is the final decision
maker for the Agency, the concepts of Chevron and Skidmore defer-
ence do not apply to its deliberations.”).

Finally, Complainant argues that:

Allowing for the imposition of only one count for any
study that fails to meet the GLPS, no matter how many
deviations, would result in inequitable enforcement
against data submitters. For example, the data submit-

rate count of FIFRA section 12(a)(2)(M) or 12(a)(2)(Q), as
appropriate, and each count assessed a civil penalty up to the
statutory maximum (see July 2, 1990 FIFRA ERP, page 25, for
a discussion of independently assessable charges). For exam-
ple, a sponsor could be assessed a civil penalty for up to
$15,000 because that sponsor submitted a study with a GLP
compliance statement which failed to truthfully state that the
pesticide testing facility: (1) failed to maintain personnel
records; (2) failed to designate a study director; and (3) failed
to record raw data.

GLP ERP at7

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MCLAUGHLIN GORMLEY KING CO. 351

ter who fails to comply with some minor requirement
of the GLPS will be subject to the same penalty as the
data submitter who fails to comply with significant
portions of the GLPS.

Complainant's Brief at 24. This result, however, does not strike us as
so unusual or absurd that Congress could not have intended it under
the facts of this case. In this regard we note that section 12(a)(1)(E)
of FIFRA makes it unlawful to sell or distribute a pesticide that has
been adulterated or misbranded. The Agency has taken the position
that one sale of a misbranded pesticide constitutes a single offense
even if the pesticide has been misbranded in many different respects.
See FIFRA Enforcement Response Policy, at 26 (June 2, 1990) (“FIFRA
ERP”). Complainant’s argument concerning inequitable enforcement
could be made with equal force about section 12(a)(1)(E). We also
note that under the FIFRA ERP, the Agency has some discretion to
reflect the seriousness of the GLP standard violations in its recom-
mended penalty. /d. at Appendix A-7.'°

In conclusion, Complainant has not pointed to anything in the
language, legislative history, or statutory context of section
12(a)(2)(Q) that supports its position that the unit of violation, as
applied in this case, is smaller than the compliance statement.

II. CONCLUSION

For all the foregoing reasons, we conclude that the submission by
Respondents of a compliance statement containing a one-sentence
representation that the attached study was conducted in accordance
with the GLP standards of part 160, could result in no more than one
violation of section 12(a)(2)(Q), even if the compliance statement was
false for more than one reason, as alleged. Accordingly, we are sus-
taining the Presiding Officer's ruling that submission of the allegedly
false compliance statement could result in only one violation of sec-
tion 12(a)(2)(Q). The case is remanded to the Presiding Officer for
resolution of the issues raised in the underlying enforcement action
consistent with this opinion.

So ordered.

5 Complainant cites several federal decisions that, in its view, “tend to support a finding
that FIFRA sanctions multiple violations for multiple deviations of the FIFRA GLPS.”
Complainant's Brief at 26. The language of the statutory provisions at issue in those cases, how-
ever, is so different from the language of section 12(a)(2)(Q) that we find no useful analogies
in the cases cited

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