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United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued March 17, 2003 Decided June 3, 2003
No. 02-1057
CROPLIFE AMERICA, ET AL.,
PETITIONERS
v.
ENVIRONMENTAL PROTECTION AGENCY,
RESPONDENT
NATURAL RESOURCES DEFENSE COUNCIL AND
AMERICAN CHEMISTRY COUNCIL,
INTERVENORS
On Petition for Review of an Order of the
Environmental Protection Agency
Kenneth W. Weinstein argued the cause for petitioners.
With him on the brief was Alexandra A. E. Shapiro.
Bills of costs must be filed within 14 days after entry of judgment.
The court looks with disfavor upon motions to file bills of costs out
of time.
2
Seth A. Goldberg argued the cause for intervenor American
Chemistry Council. With him on the briefs was Cynthia L.
Taub.
Daniel M. Flores, Attorney, U.S. Environmental Protection
Agency, argued the cause for respondent. Christopher S.
Vaden and Kent E. Hanson, Attorneys, entered appearances.
Aaron Colangelo argued the cause for intervenor Natural
Resources Defense Council. With him on the brief was Erik
D. Olson.
Joseph W. Hatchett, Lee Davis Thames and Jerry C. Hill
were on the brief for amicus curiae Florida Citrus Mutual, et
al., in support of petitioners.
Benjamin S. Sharp was on the brief for amicus curiae
Washington State Potato Commission in support of petition-
ers.
Before: GINSBURG, Chief Judge, and EDWARDS and GARLAND,
Circuit Judges.
Opinion for the Court filed by Circuit Judge EDWARDS.
EDWARDS, Circuit Judge: This case concerns an Environ-
mental Protection Agency (‘‘EPA’’ or ‘‘the agency’’) directive
banning agency consideration of ‘‘third-party’’ human studies
in evaluating the safety of pesticides. In the late 1990s, EPA
began reevaluating its practice of relying on data from third-
party human studies, and began considering such data on a
case-by-case basis only. In October 2001, the agency made
this case-by-case practice clear to the regulated community.
Then, however, the agency abruptly reversed its position. On
December 14, 2001, EPA issued a directive in a Press Re-
lease, announcing that, pending review by the National Acad-
emy of Sciences (‘‘NAS’’ or ‘‘Academy’’) of the ethical issues
posed by EPA’s use of third-party human studies, ‘‘the Agen-
cy will not consider or rely on any such human studies in its
regulatory decision making, whether previously or newly
submitted.’’ Environmental Protection Agency, Press Re-
lease, Agency Requests National Academy of Sciences Input
on Consideration of Certain Human Toxicity Studies; An-
3
nounces Interim Policy, Dec. 14, 2001, Appendix (‘‘App.’’) 120
(‘‘Press Release’’).
Petitioners CropLife America, et al. – pesticide manufac-
turers and a trade association that claims that its members
will be adversely affected by the announced moratorium –
seek review of the directive in the December 14 Press Re-
lease. Petitioners contend that the EPA directive is unlaw-
ful, because it constitutes a binding regulation that was issued
without the notice of proposed rulemaking and period for
public comment mandated by the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. § 301 et seq. (‘‘FFDCA’’). See 21
U.S.C. §§ 346a(e)(1)(C) & (e)(2); see also 5 U.S.C. § 553.
Petitioners also argue that the policy violates the rule, enunci-
ated in both the Federal Insecticide, Fungicide and Rodenti-
cide Act, 7 U.S.C. § 136-136y (‘‘FIFRA’’), and FFDCA, re-
quiring EPA to consider all relevant reliable data. See 7
U.S.C. § 136a-1(g)(1); 21 U.S.C. § 346a(b)(2)(D). Finally,
petitioners assert that the policy is arbitrary and capricious in
violation of the Administrative Procedure Act, 5 U.S.C.
§§ 701-706. See 5 U.S.C. § 706(2)(A) (‘‘The reviewing court
shall TTT hold unlawful and set aside agency action, findings,
and conclusions found to be TTT arbitrary, capricious, an
abuse of discretion, or otherwise not in accordance with
lawTTTT’’).
We hold that EPA’s directive constitutes a binding regula-
tion issued without notice and the opportunity for comment.
We therefore grant the petition for review and vacate the new
rule. As a consequence, the agency’s previous practice of
considering third-party human studies on a case-by-case ba-
sis, applying statutory requirements, the Common Rule, and
high ethical standards as a guide, is reinstated and remains in
effect unless and until it is replaced by a lawfully promulgat-
ed regulation.
I. BACKGROUND
EPA oversees a comprehensive scheme of pesticide regula-
tion under FIFRA and FFDCA. While FIFRA governs
pesticide registration, FFDCA regulates pesticide residues in
the food supply. Originally enacted in 1947, FIFRA estab-
4
lishes a registration system allowing EPA to prescribe the
conditions under which a pesticide may be sold or distributed.
In determining whether to register a pesticide under FIFRA,
EPA considers whether the pesticide would cause ‘‘unreason-
able adverse effects on the environment.’’ 7 U.S.C.
§ 136a(c)(5)(C). To determine whether the pesticide would
cause such unreasonable environmental effects, the agency
determines whether it would produce an ‘‘unreasonable risk
to man’’ or any ‘‘human dietary risk.’’ 7 U.S.C. § 136(bb).
Under FFDCA, EPA regulates the amount of pesticide that
may remain on food products, establishing ‘‘tolerance levels’’
for pesticide residues on raw and processed food products.
21 U.S.C. § 346a(b)(1).
The FFDCA provision dealing with the method of setting
tolerances for pesticides was substantially revised by the
Food Quality Protection Act of 1996, Pub. L. No. 104-170, 110
Stat. 1489 (‘‘FQPA’’). See 21 U.S.C. § 346a (governing toler-
ances for pesticide chemical residues); see also Andrew J.
Miller, Note, The Food Quality Protection Act of 1996: Sci-
ence and Law at a Crossroads, 7 DUKE ENVTL. L. & POL’Y F.
393, 403 (1997) (‘‘The FQPA rewrites most of section 408 of
the FFDCA.’’). The revised provision defines pesticide toler-
ances as ‘‘safe’’ when there is ‘‘a reasonable certainty that no
harm will result from aggregate exposure to the pesticide
chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable informa-
tion.’’ 21 U.S.C. § 346a(b)(2)(A)(ii). In determining whether
pesticide tolerances are safe, EPA may consider the validity
of the available data from studies, anticipated and actual
residue levels of the pesticide in or on foods, the percent of
food actually treated with the pesticide, and international
standards. See 21 U.S.C. § 346a(b)(2)(D)-(F), (b)(4).
In 1988, Congress amended FIFRA to require that every
pesticide registered before 1984 be reregistered under pres-
ent-day standards. Pub. L. No. 100-532, 102 Stat. 2654
(codified as amended in scattered sections of 7 U.S.C.). In
1996, Congress also set deadlines for EPA to review all
existing tolerances against the new standard established by
the FQPA. 21 U.S.C. § 346a(q). As a result, the agency is
5
currently in the process of reexamining thousands of regulat-
ed pesticides. This process involves years of preliminary
action and evaluation under both FIFRA and FFDCA, culmi-
nating in public pronouncements of the agency’s position on
the safety of a given pesticide.
For decades, EPA accepted and relied upon third-party
human data in evaluating pesticide safety. However, the
agency’s position shifted in 1998. On July 27, 1998, EPA
stated publicly that it would ask an internal review board to
reevaluate the agency’s use of third-party human studies.
EPA Statement, July 27, 1998, App. 11. EPA’s statement
also indicated that ‘‘[n]o human test data has been used by
EPA for any final decisions about acceptable levels of pesti-
cide use under the [1996 FQPA].’’ Id. An October 1998
internal EPA memorandum amplified this statement, indicat-
ing that EPA’s policy was to consider only third-party human
data that meets ‘‘the highest ethical standards.’’ Memoran-
dum from Peter D. Robertson, Acting Deputy Administrator,
EPA, to EPA Assistant Administrators 3 (Oct. 9, 1998), App.
14. Although the July 1998 statement signaled the beginning
of EPA’s reconsideration of the role of human testing, the
agency’s Office of Pesticide Programs continued to review
human test data and to discuss the results of such reviews in
the public record of regulatory decisions. See OFFICE OF
PESTICIDE PROGRAMS, ENVTL. PROT. AGENCY, ROLE OF HUMAN
STUDIES IN THE OFFICE OF PESTICIDE PROGRAMS 3 (2001), App.
118.
As part of its policy development process, EPA appointed a
Joint Subcommittee of its Science Advisory Board and
FIFRA Scientific Advisory Panel (‘‘the Joint Subcommittee’’)
to evaluate the circumstances under which third-party human
data should be considered. In September 2000, the Joint
Subcommittee issued a report addressing the ethical and
scientific acceptability of utilizing such data. The report
‘‘envision[ed] particular circumstances under which such dos-
ing of humans could be scientifically and ethically acceptable,’’
but found such circumstances ‘‘very difficult’’ to define.
ENVTL. PROT. AGENCY, COMMENTS ON THE USE OF DATA FROM THE
TESTING OF HUMAN SUBJECTS: A REPORT BY THE SCIENCE ADVISORY
6
BOARD AND THE FIFRA SCIENTIFIC ADVISORY PANEL 2 (2000),
App. 34. Sixteen panel members recommended that the
agency continue to consider human studies under strict stan-
dards, while two members advocated a blanket ban on such
tests. Id. at 1-4, App. 33-36.
Thereafter, in October 2001, EPA made clear that it would
consider data from third-party human studies on a case-by-
case basis. See John Heilprin, EPA Using Human Testing
Data from Manufacturers in Evaluating Pesticide Regula-
tions, Exposure Levels, ASSOCIATED PRESS, Nov. 27, 2001,
LEXIS, News Library, News Group File; Shogren, supra;
Shankar Vedantam, EPA Used Data from Human Pesticide
Tests, WASH. POST, Nov. 29, 2001, at A6. In several pesticide
regulatory decisions issued around the time of the announce-
ment, EPA in fact considered available human data. See, e.g.,
Interim Reregistration Eligibility Decision for Azinphos-
Methyl, Case No. 0235, at 10-11 (EPA Oct. 30, 2001), App. 88-
89; Interim Reregistration Eligibility Decision for Phosmet,
Case No. 0242, at 8 (EPA Oct. 30, 2001), App. 92; Interim
Reregistration Eligibility Decision for Chlorpyrifos, Case
No. 0100, at 16 (EPA Sept. 28, 2001), App. 85. However, the
agency’s decision to resume consideration of such data pro-
voked criticism, primarily from environmental groups. See,
e.g., Katharine Q. Seelye, E.P.A. Reconsiders Human Tests
of Pesticides, N.Y. TIMES, Dec. 15, 2001, at A14 (quoting
Richard Wiles, senior vice president of the Environmental
Working Group, as saying that ‘‘[t]he administration would be
in an awkward position if it was against stem-cell research
but for dosing people up directly with pesticides’’).
On December 14, 2001, EPA announced a broad moratori-
um on the use of third-party human test data. EPA publicly
released a letter to the NAS in which the agency sought the
Academy’s recommendations regarding the ethical and scien-
tific acceptability of third-party human pesticide tests. See
Letter from Stephen L. Johnson, Assistant Administrator,
EPA, to Dr. Bruce Alberts, President, National Academy of
Scientists 1-3 (Dec. 14, 2001), App. 121-23. In a Press
Release accompanying the letter’s release, the agency issued
the following directive covering third-party human studies:
7
During the Academy’s consideration of the issues
and until a policy is in place, the Agency will not
consider or rely on any such human studies in its
regulatory decision making, whether previously or
newly submitted. Should EPA be legally required
to consider or rely on any such human study during
this interim period, the Agency will assemble a
Science Advisory Board subpanel to review and com-
ment on scientific appropriateness and ethical ac-
ceptability of the study in question, and the Agency
will provide an opportunity for public involvement.
Press Release, App. 120-21.
Petitioners now challenge this directive. The American
Chemistry Council intervenes on petitioners’ behalf, while the
Natural Resources Defense Council (‘‘NRDC’’) intervenes on
EPA’s behalf.
II. ANALYSIS
The principal issue in this case is whether the EPA di-
rective that is included in the December 14 Press Release
constitutes a binding regulation. In defending against the
petition for review, most of EPA’s arguments are predicated
on the assumption that the directive in the Press Release is
not a binding regulation, primarily because of the language
allowing EPA to consider third-party human studies if the
agency is ‘‘legally required to consider or rely on any such
human study.’’ EPA thus argues that the matter in dispute
is not subject to judicial review, that petitioners lack standing,
and that the challenge is not ripe for review. EPA also
questions the timeliness of the petition. We have little
trouble determining that the directive announced in the De-
cember 14 Press Release is indeed a binding regulation. This
being the case, the agency’s other arguments rapidly fall by
the wayside.
The disputed directive constitutes a binding regulation that
is directly aimed at and enforceable against petitioners. It
provides that ‘‘the Agency will not consider or rely on any
[third-party] human studies in its regulatory decision mak-
8
ing.’’ This clear and unequivocal language, which reflects an
obvious change in established agency practice, creates a
‘‘‘binding norm’’’ that is ‘‘‘finally determinative of the issues or
rights to which it is addressed.’’’ Chamber of Commerce v.
United States Dep’t of Labor, 174 F.3d 206, 212 (D.C. Cir.
1999) (quoting Pacific Gas & Elec. Co. v. FPC, 506 F.2d 33,
38 (D.C. Cir. 1974)); see also Gen. Elec. Co. v. EPA, 290 F.3d
377, 383 (D.C. Cir. 2002) (‘‘[A]n agency pronouncement will be
considered binding as a practical matter if it either appears
on its face to be binding, or is applied by the agency in a way
that indicates it is binding.’’) (citations omitted). EPA’s
stated rule is binding on petitioners, who are now barred
from relying on third-party human studies (even in cases
where such studies formerly were approved), and is binding
on the agency because EPA has made it clear that it simply
‘‘will not consider’’ human studies.
The fact that the directive also notes that third-party
human test data can be considered if the agency is ‘‘legally
required to consider or rely on such human study’’ does not at
all alter our conclusion. This language merely contemplates
the possibility of a successful court challenge to the disputed
rule; it suggests that if an Article III court were to require
the agency to consider a third-party human study, the agency
will then ‘‘assemble a Science Advisory Board subpanel to
review and comment on scientific appropriateness and ethical
acceptability of the study in question.’’
In its argument to this court, EPA claims that the ‘‘legally
required’’ language could be read to mean that Administrative
Law Judges are authorized to rule on particular third-party
human studies after EPA completes its review of a pesticide
without the agency considering that data. The directive says
no such thing. Indeed, the reality of agency operations
makes it clear that ALJs cannot independently rule on the
legality of third-party human studies, because they may not
ignore the Administrator’s unequivocal statement prohibiting
the agency from considering such studies. See, e.g., Iran Air
v. Kugelman, 996 F.2d 1253, 1260 (D.C. Cir. 1993) (‘‘It is
commonly recognized that ALJs are entirely subject to the
agency on matters of law.’’) (internal quotations omitted);
9
Mullen v. Bowen, 800 F.2d 535, 540 n.5 (6th Cir. 1986);
Antonin Scalia, The ALJ Fiasco – A Reprise, 47 U. CHI. L.
REV. 57, 62 (1979); see also Ass’n of Admin. Law Judges, Inc.
v. Heckler, 594 F. Supp. 1132, 1141 (D.D.C. 1984) (‘‘Although
an ALJ may dispute the validity of agency policy, the agency
may impose its policy through the administrative appeals
process.’’).
The agency attempts to bolster its argument that the
directive is non-binding by pointing to Reliable Automatic
Sprinkler Co. v. Consumer Product Safety Commission, 324
F.3d 726 (D.C. Cir. 2003) (‘‘Reliable’’). This case is inappo-
site. In Reliable, we determined that the District Court
lacked jurisdiction to review the Consumer Product Safety
Commission’s (‘‘CPSC’’) process absent final agency action.
Id. at 729, 732-35; see also 5 U.S.C. § 704 (limiting the
District Court’s review of administrative agencies to cases
that challenge ‘‘final agency action’’). CPSC officials had sent
the Reliable Automatic Sprinkler Company a letter stating
that the agency intended ‘‘to make the preliminary determi-
nation that [Reliable’s] sprinklers present a substantial prod-
uct safety hazard.’’ Reliable, 324 F.3d at 730 (internal quota-
tions omitted). However, before making that determination,
CPSC officials requested that Reliable undertake ‘‘voluntary
corrective action.’’ Id. (internal quotations omitted). Reli-
able’s suit against CPSC sought a declaratory judgment that
its sprinkler heads should not be considered consumer prod-
ucts under the Consumer Product Safety Act, 15 U.S.C.
§ 2051 et seq. See 15 U.S.C. § 2052(a)(1) (defining ‘‘consum-
er products’’). The court held that there was no final agency
action in Reliable, because ‘‘[n]o legal consequences flow from
the agency’s conduct to date, for there has been no order
compelling Reliable to do anything.’’ Reliable, 324 F.3d at
732. If CPSC wished to make a formal determination that
Reliable’s sprinklers presented a substantial product safety
hazard, it was required by the Consumer Product Safety Act
to afford Reliable ‘‘an opportunity for a hearing in accordance
with the formal, on-the-record adjudication requirements of
the Administrative Procedure Act (‘APA’), 5 U.S.C. § 554.’’
Id. at 729; see also 15 U.S.C. § 2064(c), (d), (f). In that
10
hearing, Reliable would have the chance to present the very
arguments that it attempted to advance before this court. In
this case, by contrast, EPA has enacted a firm rule with legal
consequences that are binding on both petitioners and the
agency, and petitioners will be afforded no additional opportu-
nity to make the arguments to the agency that they now
present in this petition.
After oral argument in this case, in an attempt to advance
the argument that the directive does not bar consideration of
third-party human studies, NRDC submitted a copy of an
EPA decision, Interim Reregistration Eligibility Decision for
Atrazine, Case No. 0062 (EPA Jan. 31, 2003) (‘‘Atrazine
IRED’’), recently published for public comment at 68 Fed.
Reg. 9652 (Feb. 28, 2003). NRDC asserts that EPA relied on
an industry human study in Atrazine IRED to measure the
extent to which the pesticide is absorbed into human skin,
thus showing that the disputed directive does not foreclose
consideration of such data. NRDC’s argument is unavailing,
for the decision sheds no light whatsoever on the disputed
directive. Atrazine IRED does not purport to enunciate or
apply any policy at all. Indeed, EPA does not suggest
otherwise.
EPA and NRDC also argue that the directive in the Press
Release is nothing more than a ‘‘policy statement,’’ and thus
is not subject to judicial review. See 21 U.S.C. § 346a(h)(1)
(limiting the court’s jurisdiction to cases of ‘‘actual controver-
sy as to the validity of any regulation issued under subsection
(e)(1)(C)’’) (emphasis added). We reject this argument. As a
general matter, the case law reflects two related formulations
for determining whether a challenged action constitutes a
regulation or merely a statement of policy. One line of
analysis focuses on the effects of the agency action. See,
Cmty. Nutrition Inst. v. Young, 818 F.2d 943, 946 (D.C. Cir.
1987) (stating that the court should consider whether the
agency action (1) ‘‘impose[s] any rights and obligations,’’ or
(2) ‘‘genuinely leaves the agency and its decisionmakers free
to exercise discretion’’) (internal quotations omitted); See
also, e.g., Troy Corp. v. Browner, 120 F.3d 277, 287 (D.C. Cir.
1997); Am. Bus. Ass’n v. United States, 627 F.2d 525, 529
11
(D.C. Cir. 1980). The second line of analysis focuses on the
agency’s expressed intentions. See Molycorp., Inc. v. EPA,
197 F.3d 543, 545 (D.C. Cir. 1999) (stating that the court
should consider ‘‘(1) the Agency’s own characterization of the
action; (2) whether the action was published in the Federal
Register or the Code of Federal Regulations; and (3) wheth-
er the action has binding effects on private parties or on the
agency’’); see also, e.g., Am. Portland Cement Alliance v.
EPA, 101 F.3d 772, 776 (D.C. Cir. 1996). However, as we
recently noted in General Electric v. EPA, 290 F.3d 377,
these two lines of analysis overlap at step three of the
Molycorp formulation, ‘‘in which the court determines wheth-
er the agency action binds private parties or the agency itself
with the ‘force of law.’’’ Id. at 382. General Electric and
other cases also make it clear that the agency’s characteriza-
tion of its own action is not controlling if it self-servingly
disclaims any intention to create a rule with the ‘‘force of
law,’’ but the record indicates otherwise. See Gen. Elec., 290
F.3d at 383-85; see also, e.g., Sugar Cane Growers Coop. of
Fla. v. Veneman, 289 F.3d 89, 95-96 (D.C. Cir. 2002).
In the instant case, there is little doubt that the directive in
the December 14 Press Release ‘‘binds private parties [and]
the agency itself with the ‘force of law,’’’ Gen. Elec., 290 F.3d
at 382, and thus constitutes a regulation rather than a policy
statement. The directive clearly establishes a substantive
rule declaring that third-party human studies are now
deemed immaterial in EPA regulatory decisionmaking under
FFDCA and FIFRA.
The agency’s arguments that petitioners’ claims should be
dismissed for want of standing and ripeness are also without
merit. EPA asserts that petitioners lack standing because
the agency may consider third-party human studies after a
determination that it is legally required to do so, and because
setting aside the directive would leave in place a practice that
may still result in the rejection of petitioners’ third-party
human studies. See, e.g., Lujan v. Defenders of Wildlife, 504
U.S. 555, 560-61 (1992) (noting that injury-in-fact, causation,
and redressability are requirements for Article III standing);
Util. Air Regulatory Group v. EPA, 320 F.3d 272, 277 (D.C.
12
Cir. 2003) (same). EPA’s argument is meritless. The disput-
ed directive concretely injures petitioners, because it unam-
biguously precludes the agency’s consideration of all third-
party human studies, i.e., studies that petitioners previously
have been permitted to use to verify the safety of their
products. There is no doubt that the injury is caused by the
new rule, nor is there any doubt that this injury can be
redressed if the court vacates the new rule and reinstates the
agency’s previous practice of considering third-party human
studies on a case-by-case basis. Petitioners do not seek to
require the agency to consider any particular human study.
Instead, they simply ask the court to enjoin the agency’s
blanket refusal to consider any third-party human studies.
Petitioners’ standing to pursue this lawsuit is clear.
As to ripeness, EPA argues that petitioners’ claim is unripe
‘‘because an ALJ, the Administrator or the EAB may allow a
third-party study into evidence in a hearing process, or the
Administrator may make a ‘legal requirement’ determination
in a rulemaking.’’ Br. of Respondent at 27. This argument
is plainly wrong, because the EPA directive states unequivo-
cally that the agency will not consider any third-party human
studies unless a court orders it to do so. Thus, because it
presents a purely legal question that does not ‘‘depend upon
consideration of TTT particularized facts,’’ Mountain States
Tel. & Tel. Co. v. FCC, 939 F.2d 1035, 1041 (D.C. Cir. 1991),
petitioners’ claim is ripe for review.
Finally, EPA argues that petitioners’ claim is time-barred,
‘‘because EPA has made similar statements in the past.’’ Br.
of Respondent at 29. In particular, EPA contends that, ‘‘[i]f
there were a challenge to bring TTT it should have been
brought within 60 days’’ of one of the earlier EPA statements
on human test subjects. Id. at 30; see also 21 U.S.C.
§ 346a(h)(1). This argument is meritless. The directive in
the Press Release differs markedly from the agency’s past
statements, because the new rule clearly represents the first
time that the agency has adopted an unequivocal, wholesale
ban on the consideration of third-party human studies.
Moreover, the agency indisputably opened the issue anew in
2001 by first announcing that it would consider third-party
13
human studies on a case-by-case basis and then stating that it
would not consider any such studies. See Ass’n of Am. R.R.
v. ICC, 846 F.2d 1465, 1473 (D.C. Cir. 1988) (‘‘[I]f the agency
has opened the issue up anew, even though not explicitly, its
renewed adherence is substantively reviewable.’’).
Because the new rule effects a dramatic change in the
agency’s established regulatory regime, EPA was required to
follow notice and comment procedures under 21 U.S.C.
§ 346a(e)(1)(C) & (e)(2). This was not done. Therefore, we
vacate EPA’s rule for failure to comply with FFDCA’s notice
and comment requirements. See, e.g., Gen. Elec., 290 F.3d at
385; Appalachian Power Co. v. EPA, 208 F.3d 1015, 1028
(D.C. Cir. 2000).
III. CONCLUSION
For the reasons enumerated above, we vacate the directive
articulated in EPA’s December 14, 2001 Press Release for a
failure to engage in the requisite notice and comment rule-
making. The consequence is that the agency’s previous
practice of considering third-party human studies on a case-
by-case basis, applying statutory requirements, the Common
Rule, and high ethical standards as a guide, is reinstated and
remains in effect unless and until it is replaced by a lawfully
promulgated regulation.