EPA-730-N-00-005
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
SEP I 5 2000
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
PESTICIDE REGISTRATION NOTICE 2000-8
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS DISTRIBUTORS AND
REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION:
SUBJECT:
Persons Responsible for Federal Registration of Pesticides
Reportability of Attorneys' Opinions and Conclusions Under 40 CFR Part
159 and FIFRA Section 6(a)(2)
EPA's regulation at 40 CFR § 159.158(a) provides that risk/benefit information subject to
reporting under FIFRA section 6(a)(2) includes opinions and conclusions of certain employees
and agents of registrants. Some registrants have objected to this provision because they believe it
requires reporting of all opinions and conclusions of attorneys. EPA is issuing this PRN to
inform registrants of EPA's opinion that an attorney's professional legal judgment is not an
opinion or conclusion that is reportable under 40 CFR part 159.
I. Opinions and conclusions rendered as the professional legal Judgment of an attorney are nnt
relevant to EPA's assessment of the risks or benefits of a pesticide and are not required to be
reported under part 159 ~
Part 159 requires reporting of toxicological and ecological studies, discontinued studies
human epidemiological and exposure studies, information on pesticides in or on food, feed or '
water, pesticide metabolites, degradates, contaminants, and impurities, toxic or adverse effect
incidents, and failures of performance. Such information must be reported only if it meets the
requirements of § 159.158, in particular, that it contains "information relevant to the assessment
of the risks or benefits" of a pesticide registration. EPA's primary purpose in assessing the risks
and benefits of a pesticide is to determine whether the pesticide meets the criteria for registration
under section 3, chiefly, that it "will perform its intended function without unreasonable adverse
effects on the environment [and] when used in accordance with commonly recognized practice it
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•will not generally cause unreasonable adverse effects on the environment."1 In contrast, the
attorney's professional judgment is defined in the Model Code of Professional Responsibility as
the attorney's "educated ability to relate the general body and philosophy of law to a specific
legal problem of a client". Model Code of Prof 1 Responsibility, EC 3-5 (1980). EPA believes
that the professional legal judgment of an attorney is sufficiently unlikely to contribute to EPA's
understanding of whether a pesticide presents unreasonable adverse effects on the environment.
Therefore, opinions and conclusions rendered as the professional legal judgment of an attorney,
as defined in the Model Code, need not be reported under part 159.
n. Opinions and conclusions of attorneys other than the attorney's professional legal judgment
can be reportable under part 159
EPA recognizes that attorneys today may perform many different types of tasks for
registrants, and these tasks may result in opinions and conclusions that are not strictly the
professional legal judgment of an attorney. Those opinions and conclusions may become
reportable under part 159. If a person is involved in "the development, testing, sale or
registration of a pesticide" or "could be reasonably expected to come into possession of
information otherwise reportable," § 159.155(d) provides that any conclusion or opinion held by
that person would be possessed or received by the registrant and must be reported - regardless of
•whether that person might also happen be an attorney.2 Collecting information about the risks
and benefits of a pesticide and obtaining reviews of data by expert consultants are activities
commonly performed by persons other than attorneys, and are also activities that are very likely
to produce information that is reportable under part 159. Registrants cannot shield themselves
from the reporting requirements of part 159 by putting attorneys in the front lines of their
information gathering apparatus.
:FIFRA section 3(c)(5)(C)&(D). FEFRA section 2 (bb) defines "unreasonable adverse
effects on the environment" to mean:
(1) any unreasonable risk to man or the environment, taking into account the economic,
social, and environmental costs and benefits of the use of any pesticide, or (2) a human
dietary risk from residues that result from a use of a pesticide in or on any food
inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 346a).
2Section 159.155(d) provides, in part, that:
[A] registrant possesses or knows of information at the time any officer, employee, agent,
or other person acting for the registrant first comes into possession of, or knows of, such
information; provided that, such person performs any activities for the registrant related
to the development, testing, sale or registration of a pesticide or the person could be
reasonably expected to come into possession of information otherwise reportable under
this part.
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it is based
III. Factual information upon which an attorney's professional legal jud
reported if it meets the criteria of part 159
Although opinions and conclusions rendered as the professional legal judgment of an
attorney need not be reported under part 159, the factual information underlying those opinions
and conclusions would be reportable if it meets the criteria of part 159. For example, while an
attorney's opinions as to the legal sufficiency of an adverse effect allegation would not be
reportable, the allegations themselves would be reportable pursuant to § 159.184. Where an
attorney engages outside experts to review and advise on the effects of a pesticide on a
registrant's behalf, the experts' opinions and conclusions may be subject to reporting.
IV. Conclusion
Opinions and conclusions rendered as the professional legal judgment of an attorney need
not be reported under part 159. To the extent that the attorney engages in activities that do not
necessarily call for the professional legal judgment of an attorney, the attorney's opinions and
conclusions may become reportable under part 159.
This Notice is intended to give notice to pesticide registrants of EPA's interpretation of
40 CFR part 159. This Notice does not increase registrants' reporting burden.
For further information regarding part 159 and FIFRA section 6(a)(2), contact Kathryn
Bouve at: telephone number (703)305-5032, facsimile number (703)305-7670, or e-mail address
bouve.kate@epa.gov.
Marcia E. Mulkey, Director
Office of Pesticide Programs
U.S. Environmental Protection Agency
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