80_FR_60805 80 FR 60611 - Adoption of Statement

80 FR 60611 - Adoption of Statement

ADMINISTRATIVE CONFERENCE OF THE UNITED STATES

Federal Register Volume 80, Issue 194 (October 7, 2015)

Page Range60611-60613
FR Document2015-25570

The Administrative Conference of the United States adopted one formal statement at its Sixty-Third Plenary Session. The appended statement addresses ``Issue Exhaustion in Preenforcement Judicial Review of Administrative Rulemaking.''

Federal Register, Volume 80 Issue 194 (Wednesday, October 7, 2015)
[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60611-60613]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25570]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

========================================================================


Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / 
Notices

[[Page 60611]]



ADMINISTRATIVE CONFERENCE OF THE UNITED STATES


Adoption of Statement

AGENCY: Administrative Conference of the United States.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Administrative Conference of the United States adopted one 
formal statement at its Sixty-Third Plenary Session. The appended 
statement addresses ``Issue Exhaustion in Preenforcement Judicial 
Review of Administrative Rulemaking.''

FOR FURTHER INFORMATION CONTACT: Gisselle Bourns, Administrative 
Conference of the United States, Suite 706 South, 1120 20th Street NW., 
Washington, DC 20036; Telephone 202-480-2080.

SUPPLEMENTARY INFORMATION: The Administrative Conference Act, 5 U.S.C. 
591-596, established the Administrative Conference of the United 
States. The Conference studies the efficiency, adequacy, and fairness 
of the administrative procedures used by Federal agencies and makes 
recommendations for improvements to agencies, the President, Congress, 
and the Judicial Conference of the United States (5 U.S.C. 594(1)). For 
further information about the Conference and its activities, see 
www.acus.gov.
    The Conference's Sixty-Third Plenary Session was conducted, for the 
first time, as a virtual meeting, held via the Internet, in accordance 
with the Conference's earlier Recommendation, 2011-7, The Federal 
Advisory Committee Act--Issues and Proposed Reforms. The plenary 
session was open for participation by Conference members and the public 
for the period of September 18 through September 25, 2015. The Assembly 
of the Conference adopted one formal statement. Statement #19, ``Issue 
Exhaustion in Preenforcement Judicial Review of Administrative 
Rulemaking,'' examines judicial application of an issue exhaustion 
requirement in preenforcement review of administrative rulemaking. It 
invites courts to consider a series of factors when examining the 
doctrine of issue exhaustion in the context of preenforcement review of 
agency rules.
    The Appendix below sets forth the full text of this statement. The 
Conference will transmit the statement to federal agencies, relevant 
committees of Congress, and the Judicial Conference of the United 
States, as appropriate, for their consideration. The statement is not 
binding, but it represents the collective views of the membership of 
the Administrative Conference of the United States. The research report 
prepared for the Conference on this subject is posted at: www.acus.gov/63rd.

    Dated: October 2, 2015.
Shawne C. McGibbon,
General Counsel.

Appendix--Statement of the Administrative Conference of the United 
States

Administrative Conference Statement #19

Issue Exhaustion in Preenforcement Judicial Review of Administrative 
Rulemaking

Adopted September 25, 2015

    The doctrine of issue exhaustion generally bars a litigant 
challenging agency action from raising issues in court that were not 
raised first with the agency. Although the doctrine originated in 
the context of agency adjudication, it has been extended to judicial 
review of challenges to agency rulemakings. Scholars have observed 
that issue exhaustion cases ``conspicuously lack discussion of 
whether, when, why, or how [the issue] exhaustion doctrine developed 
in the context of adjudication should be applied to rulemaking.'' 
\1\ The Administrative Conference has studied the issue exhaustion 
doctrine in an effort to bring greater clarity to its application in 
the context of preenforcement review of agency rules. The Conference 
believes that this Statement may be useful by setting forth a series 
of factors that it invites courts to consider when examining issue 
exhaustion in that context.\2\
---------------------------------------------------------------------------

    \1\ Jeffrey S. Lubbers, Fail to Comment at Your Own Risk: Does 
Issue Exhaustion Have a Place in Judicial Review of Rules: 11 (May 
5, 2015) (Report to the Administrative Conference of the U.S.) 
[hereinafter Lubbers Report] (citing Peter L. Strauss, et al. 
Gellhorn and Byse's Administrative Law 1246 (10th ed. 2003)); see 
also Koretoff v. Vilsach, 707 F.3d 394, 399 (D.C. Cir. 2013) 
(Williams, J., concurring) (joining a decision to preclude 
preenforcement review of new issues but writing separately 
``primarily to note that in the realm of judicial review of agency 
rules, much of the language of our opinions on `waiver' has been a 
good deal broader than the actual pattern of our holdings'').
    \2\ This Statement does not address the application of the 
doctrine in the context of a challenge to a rule in an agency 
enforcement action, where the passage of time and new entrants may 
complicate the inquiry. The Conference has previously identified 
issues that Congress should not ordinarily preclude courts from 
considering when rules are challenged in enforcement proceedings. 
See Admin. Conf. of the U.S., Recommendation 82-7, Judicial Review 
of Rules in Enforcement Proceedings (Dec. 17, 1982), http://www.acus.gov/82-7.
---------------------------------------------------------------------------

Evolution of the Issue Exhaustion Doctrine

    The requirement that parties exhaust their administrative 
remedies (``remedy exhaustion'') is a familiar feature of U.S. 
administrative law. This doctrine generally bars a party from 
appealing a final agency action to a court unless the party exhausts 
prescribed avenues for relief before the agency.\3\
---------------------------------------------------------------------------

    \3\Myers v. Bethlehem Shipbuilding Corp., 303 U.S. 41, 50-51 
(1958).
---------------------------------------------------------------------------

    The related but distinct concept of ``issue exhaustion'' 
prevents a party from raising issues in litigation that were not 
first raised before the agency, even if the petitioner participated 
in the administrative process.\4\ As with remedy exhaustion, the 
issue exhaustion doctrine initially arose in the context of agency 
adjudications.\5\
---------------------------------------------------------------------------

    \4\ See Fiber Tower Spectrum Holdings, LLC v. FCC, No. 14-1039, 
slip. op. at 9 (D.C. Cir. Apr. 3, 2015), Issue exhaustion statutes 
may not always be jurisdictional. E.g., EPA v. EME Homer City 
Generation, L.P., 134 S. Ct. 1584, 1602-03 (2014) (``A rule may be 
`jurisdictional,' we have explained. Section7607(d)(7)(B), we hold, 
is of that character. It does not speak to a court's authority, but 
only to a party's procedural obligations.'') (citations omitted); 
see also Advocates for Highway and Auto Safety v. FMSCA, 429 F.3d 
1136, 1148 (D.C. Cir. 2005) (``as a general matter, a party's 
presentation of issues during a rulemaking proceeding is not a 
jurisdicional matter'') (emphasis in original).
    \5\ See Lubbers Report, supra note 1, at 2-3.
---------------------------------------------------------------------------

    As the Supreme Court has recognized, ``administrative issue-
exhaustion requirements are largely creatures of statute.'' \6\ In 
several judicial review provisions adopted during the 1930s, prior 
to the advent of the Administrative Procedure Act of 1946, Congress 
expressly required parties to raise all their objections to agency 
action before adjudicatory agencies. Since that time, Congress has 
included issue exhaustion provisions in many statutes governing 
review of agency orders.\7\ The typical statute contains an 
exception for ``reasonable grounds'' or ``extraordinary 
circumstances'' and permits the court to

[[Page 60612]]

require an agency to take new evidence under certain conditions.\8\
---------------------------------------------------------------------------

    \6\ Sims v. Apfel, 530 U.S. 103, 107 (2000) (plurality opinion).
    \7\ See Lubbers Report, supra note 1, at 4-6.
    \8\ E.g., 15 U.S.C. Sec.  77i(a); 29 U.S.C. Sec.  160(e); 42 
U.S.C. Sec.  1320a-8(d)(1).
---------------------------------------------------------------------------

    Courts have also imposed issue exhaustion requirements in the 
adjudication context in the absence of an underlying statute or 
regulation requiring it. The Supreme Court early on characterized 
the ``general rule that courts should not topple over administrative 
decisions unless the administrative body not only has erred but has 
erred against objection made at the time appropriate under its 
practice'' as one of ``simple fairness,'' emphasizing that issue 
exhaustion promotes orderly procedure and good administration by 
offering the agency an opportunity to act on objections to its 
proceedings.\9\ But questions about the common law application of 
the doctrine were later raised in Sims v. Apfel, where the Court 
held that a judicial issue exhaustion requirement was inappropriate 
on review of the Social Security Administration's informal, non-
adversarial adjudicatory benefit determinations, reasoning that 
``the desirability of a court imposing a requirement of issue 
exhaustion depends on the degree to which the analogy to normal 
adversarial litigation applies in a particular administrative 
proceeding.'' \10\
---------------------------------------------------------------------------

    \9\ United States v. L.A. Tucker Truck Lines, Inc., 344 U.S. 33, 
37 (1952) (reviewing an adjudicative order issued by the Interstate 
Commerce Commission after an adversarial hearing); see also 
Advocates for Highway and Auto Safety v. FMSCA, 429 F.3d 1136, 1149 
(D.C. Cir. 2005) (applying the same rationale to rulemaking).
    \10\ Sims v. Apfel, 530 U.S. 103, 108-12 (2000) (plurality 
opinion).
---------------------------------------------------------------------------

    Although the issue exhaustion doctrine originated in the 
adjudication context, it has been extended to preenforcement review 
of agency rulemakings. Two statutes have been identified by the 
Conference as explicitly requiring issue exhaustion for review of 
agency rules--the Clean Air Act and the Securities Exchange Act of 
1934.\11\ Both statutes were amended to incorporate issue exhaustion 
provisions in the 1970s, when Congress enacted numerous regulatory 
statutes with significant rulemaking provisions. \12\
---------------------------------------------------------------------------

    \11\ 42 U.S.C. 7607(d)(7)(B); 15 U.S.C. 78y(c)(1). However, 
provisions governing some agencies' ``orders'' have been held to 
apply to judicial review of rules. See Citizens Awareness Network v. 
U.S., 391 F.3d 338, 345-47 (1st Cir. 2004); see also Inv. Co. Inst. 
v. Bd. of Govs., 551 F.2d 1270, 1276-77 (D.C. Cir. 1977); American 
Public Gas Ass'n v. Fed. Power Comm'n, 546 F.2d 983, 986-88 (D.C. 
Cir. 1976).
    \12\ Lubbers Report, supra note 1, at 4, 11, 13.
---------------------------------------------------------------------------

    The doctrine has also been extended to the rulemaking context 
through common law. Despite Sims' focus in the adjudication context 
on the extent to which the underlying administrative proceeding 
resembled adversarial litigation for purposes of determining whether 
the doctrine applied, appellate courts have increasingly applied the 
doctrine in the absence of a statute requiring it when reviewing 
preenforcement challenges to agency rules enacted via notice-and-
comment proceedings.\13\ And at least two appellate courts have 
applied the doctrine to review of administrative rulemaking after 
specifically considering Sims,\14\ although Sims was recently cited 
by the Ninth Circuit as militating against issue exhaustion in an 
informal rulemaking issued without notice-and-comment 
procedures.\15\
---------------------------------------------------------------------------

    \13\ E.g., Koretoff v. Vilsack, 707 F.3d 394, 401 (D.C. Cir. 
2013) (Williams, J., concurring) (``[g]enerally speaking, then, the 
price for a ticket to facial review is to raise objections in the 
rulemaking''); City of Portland, Or. v. EPA, 507 F.3d 706, 710 (D.C. 
Cir. 2007); Military Toxics Project v. EPA, 146 F.3d 948, 956-57 
(D.C. Cir. 1998); see also Lubbers Report, supra note 1, at 27-30 
(describing application of the doctrine as well as varied precedent 
in appellate courts other than the U.S. Court of Appeals for the 
D.C. Circuit). No cases were identified that applied the issue 
exhaustion doctrine in the context of new issues raised during 
enforcement challenges to rules.
    \14\ Advocates for Highway and Auto Safety v. FMSCA, 429 F.3d 
1136, 1148-49 (D.C. Cir. 2005); Universal Health Servs., Inc. v. 
Thompson, 363 F.3d 1013, 1020 (9th Cir. 2004).
    \15\ See Alaska Survival v. Surface Transp. Bd., 705 F.3d 1073, 
1080 (9th Cir. 2013) (describing a Surface Transportation Board 
(STB) exemption proceeding as a rulemaking but applying the Sims 
rationale to it because the STB's procedures were informal and 
public comments were not sought).
---------------------------------------------------------------------------

    Relying on their equitable authority, courts have also fashioned 
exceptions to the issue exhaustion doctrine.\16\ The Conference 
commissioned a consultant's report to identify and articulate the 
scope of these exceptions in federal appellate case law, as well as 
to examine the general arguments for or against the doctrine in the 
rulemaking context.\17\ Without endorsing every conclusion expressed 
therein, the Conference believes that the report of its consultant 
can provide guidance to courts considering the application of the 
doctrine as it pertains to preenforcement review of administrative 
rulemaking.
---------------------------------------------------------------------------

    \16\ E.g., Washington Ass'n for Television and Children 
(``WATCH'') v. FCC, 712 F.2d 677, 681-82 (D.C. Cir. 1983) (``[Our] 
cases assume that Sec.  405 contains implied exceptions without 
explaining why. We understand these cases, however, as implicitly 
interpreting Sec.  405 to codify the judicially-created doctrine of 
exhaustion of administrative remedies, which permits courts some 
discretion to waive exhaustion.'') (footnotes omitted).
    \17\ See generally Lubbers Report, supra note 1.
---------------------------------------------------------------------------

Factors for Courts To Consider in Applying the Issue Exhaustion 
Doctrine

    The Administrative Conference believes that stakeholders, 
agencies, and courts benefit when issues are raised during 
rulemaking proceedings with sufficient specificity to give the 
agency notice and a fair opportunity to address them prior to 
judicial review.\18\ Many of the justifications for applying the 
doctrine in judicial review of agency adjudicatory decisions apply 
squarely to review of rulemakings. The doctrine promotes active 
public participation, creates orderly processes for resolution of 
important legal and policy issues raised in agency proceedings, 
ensures fully informed decisionmaking by administrative agencies, 
provides a robust record for judicial review, and lends certainty 
and finality to agency decisionmaking. Issue exhaustion also avoids 
the potential for significant disruption to extensive work by the 
agency, which can result if an issue is raised only during judicial 
review, after the rule has been developed. Application of the 
doctrine spares courts from hearing objections that could have been 
cured at the administrative level and reduces the need for agencies 
to create post-hoc rationalizations.\19\
---------------------------------------------------------------------------

    \18\ Nat'l Ass'n of Mfrs. v. U.S. Dep't of the Interior, 134 
F.3d 1095, 1111 (D.C. Cir. 1998); see also Ctr. for Sustainable 
Econ. v. Jewell, 779 F.3d 588, 602 (D.C. Cir. 2015) (holding on 
review of an agency adjudicatory decision that ``the question in 
determining whether an issue was preserved, however, is not simply 
whether it was raised in some fashion, but whether it was raised 
with sufficient precision, clarity, and emphasis to give the agency 
a fair opportunity to address it'').
    \19\ The argument for judicial application of the doctrine may 
be especially strong where the challenged issue concerns the factual 
basis of a rule, the agency's evaluation of alternatives, or the 
agency's failure to exercise its discretion in a particular manner. 
Judicial evaluation of the reasonableness of an agency's action in 
such cases under an arbitrary and capricious standard of review may 
depend heavily on the administrative record and on the agency's 
analysis of those issues. See generally Gage v. Atomic Energy 
Comm'n, 479 F.2d 1214, 1217-19 (D.C. Cir. 1973).
---------------------------------------------------------------------------

    On the other hand, the Conference also recognizes some practical 
and doctrinal concerns with uncritically applying issue exhaustion 
principles developed in the context of formal adversarial agency 
adjudications to the context of preenforcement rulemaking 
review.\20\ Overbroad application of the doctrine to rulemaking 
proceedings could serve as a barrier to judicial review for persons 
or firms who reasonably did not engage in continuous monitoring of 
the agency in question.\21\ Issue exhaustion requirements may also 
contribute to the burdens of participating in a rulemaking 
proceeding, by exerting pressure on commenters to raise at the 
administrative level every issue that they might conceivably invoke 
on judicial review.\22\ Also, an overbroad exhaustion requirement 
may result in unnecessary uncertainty and inefficiencies by leaving 
unaddressed fundamental legal questions--such as a rule's 
constitutionality or validity under a substantive federal statute. 
These and other concerns have led some observers to question the 
value of the doctrine as applied to rulemaking, or at least to call 
for limitations on its scope.
---------------------------------------------------------------------------

    \20\ See William Funk, Exhaustion of Administrative Remedies--
New Dimensions Since Darby, 18 Pace Envtl. L. Rev. 1, 17 (2000) 
(``[u]nfortunately, some courts have ignored the specific statutory 
origin for [issue exhaustion] and have applied a similar exhaustion 
requirement in cases totally unrelated to that statute, while citing 
cases involving application of that statute'').
    \21\ The impact of such barriers can fall most heavily on 
persons or entities whose interests are not in close alignment with 
the interests that have been advanced most forcefully by other 
participants in a given proceeding. See Koretoff v. Vilsack, 707 
F.3d 394, 401 (D.C. Cir. 2013) (Williams, J., concurring).
    \22\ See Wendy E. Wagner, Administrative Law, Filter Failure, 
and Information Capture, 59 Duke L.J. 1321, 1363-64 (2010); Lubbers 
Report, supra note 1, at 38-40.
---------------------------------------------------------------------------

    The Conference has compiled a list of factors--some of which may 
be dispositive in particular cases--that it invites courts to 
consider when deciding whether to preclude a litigant from raising 
issues for the first time

[[Page 60613]]

during preenforcement review of an agency rule. The list should be 
understood as a checklist of potentially relevant factors, not a 
fixed doctrinal formula, and as inapplicable where a statute directs 
otherwise. Specifically, the list includes consideration of whether:
     The issue was raised by a participant in the rulemaking 
other than the litigant.\23\
---------------------------------------------------------------------------

    \23\ See Portland Gen. Elec. Co. v. Bonneville Power Admin., 501 
F.3d 1009, 1024 (9th Cir. 2007) (``In general, we will not invoke 
the waiver rule in our review of a notice-and-comment proceeding if 
an agency has had an opportunity to consider the issue. This is true 
even if the issue was considered sua sponte by the agency or was 
raised by someone other than the petitioning party.'').
---------------------------------------------------------------------------

     The issue was addressed by the agency on its own 
initiative in the rulemaking.\24\
---------------------------------------------------------------------------

    \24\ Id.
---------------------------------------------------------------------------

     The agency failed to address an issue that was so 
fundamental to the rulemaking proceeding or to the rule's basis and 
purpose that the agency had an affirmative responsibility to address 
it.\25\
---------------------------------------------------------------------------

    \25\ See NRDC v. EPA, 755 F.3d 1010, 1023 (D.C. Cir. 2014) 
(``EPA retains a duty to examine key assumptions as part of its 
affirmative burden of promulgating and explaining a nonarbitrary, 
non-capricious rule . . .'') (internal quotation marks omitted). 
This factor may include issues arising under the applicable 
substantive statute or the APA.
---------------------------------------------------------------------------

     The issue involves an objection that the rule violates 
the U.S. Constitution.\26\
---------------------------------------------------------------------------

    \26\ Cf., Noel Canning v. NLRB, 705 F.3d 490, 497 (D.C. Cir. 
2013), aff'd NLRB v. Noel Canning, 134 S. Ct. 2550 (2014) (invoking 
``extraordinary circumstances'' exception in statutory provision 
requiring issue exhaustion to address constitutional issue not 
raised with the NLRB because the issue went to the very power of the 
agency to act and implicated fundamental separation of powers 
concerns). It is worth emphasizing that regardless of whether the 
issue exhaustion doctrine would apply, participants in a rulemaking 
should raise constitutional issues during the rulemaking proceeding 
to give the agency an opportunity to adjust its rule to eliminate 
the constitutional objection or at least to explain in the 
administrative record why its rule does not raise constitutional 
concerns.
---------------------------------------------------------------------------

     It would have been futile to raise the issue during the 
rulemaking proceeding because the agency clearly indicated that it 
would not entertain comments on or objections regarding that 
issue.\27\
---------------------------------------------------------------------------

    \27\ See Comite De Apoyo A Los Trabajadores Agricolas v. Solis, 
No. 09-240, 2010 WL 3431761, at *18 (E.D. Pa. Aug. 31, 2010); cf. 
WATCH v. FCC, 712 F.2d 677, 682 (D.C. Cir. 1983) (remarking that 
``[a] reviewing court . . . may in some cases consider arguments 
that it would have been futile to raise before the agency,'' but 
cautioning that ``[f]utility should not lightly be presumed'').
---------------------------------------------------------------------------

     The issue could not reasonably be expected to have been 
raised during the rulemaking proceeding because of the procedures 
used by the agency.\28\
---------------------------------------------------------------------------

    \28\ See Alaska Survival v. Surface Transp. Bd., 705 F.3d 1073 
(9th Cir. 2013) (declining to apply issue exhaustion because the 
agency's procedures were informal and ``never provided direct notice 
of or requested public comment'' on challenged issue).
---------------------------------------------------------------------------

     The basis for the objection did not exist at a time 
when rulemaking participants could raise it in a timely comment.\29\
---------------------------------------------------------------------------

    \29\ Cf. CSX Transp., Inc., v. Surface Transp. Bd., 584 F.3d 
1076, 1079-81 (D.C. Cir. 2009) (declining to apply issue exhaustion 
to a litigant's argument that the final rule was not a logical 
outgrowth of the noticed rule).
---------------------------------------------------------------------------

    If an issue exhaustion question arises in litigation, litigants 
should be given an opportunity to demonstrate that some participant 
adequately raised the issue during the rulemaking or that 
circumstances exist to justify not requiring issue exhaustion. And 
if a court declines to apply issue exhaustion principles to preclude 
review of new issues, the agency should be given an opportunity to 
respond to new objections on the merits.\30\ Where application of 
the issue exhaustion doctrine forecloses judicial review, the 
Administrative Procedure Act, 5 U.S.C. 553(e), can provide a 
procedural mechanism for the public to raise new issues that were 
not presented to the agency during a rulemaking proceeding: The 
right to petition agencies for amendment or repeal of rules.
---------------------------------------------------------------------------

    \30\ Courts have a variety of options for soliciting the 
agency's views that should vary depending on the circumstances. 
These options include permitting the agency to brief the issue or 
supplement the administrative record, or ordering a remand for the 
limited purpose of soliciting the agency's views.

[FR Doc. 2015-25570 Filed 10-6-15; 8:45 am]
BILLING CODE 6110-1-P



                                                                                                                                                                                                                60611

                                                    Notices                                                                                                          Federal Register
                                                                                                                                                                     Vol. 80, No. 194

                                                                                                                                                                     Wednesday, October 7, 2015



                                                    This section of the FEDERAL REGISTER                    judicial application of an issue                         be useful by setting forth a series of factors
                                                    contains documents other than rules or                  exhaustion requirement in                                that it invites courts to consider when
                                                    proposed rules that are applicable to the               preenforcement review of                                 examining issue exhaustion in that context.2
                                                    public. Notices of hearings and investigations,         administrative rulemaking. It invites
                                                    committee meetings, agency decisions and                                                                         Evolution of the Issue Exhaustion Doctrine
                                                                                                            courts to consider a series of factors
                                                    rulings, delegations of authority, filing of                                                                        The requirement that parties exhaust their
                                                                                                            when examining the doctrine of issue
                                                    petitions and applications and agency                                                                            administrative remedies (‘‘remedy
                                                    statements of organization and functions are            exhaustion in the context of
                                                                                                                                                                     exhaustion’’) is a familiar feature of U.S.
                                                    examples of documents appearing in this                 preenforcement review of agency rules.
                                                                                                              The Appendix below sets forth the                      administrative law. This doctrine generally
                                                    section.                                                                                                         bars a party from appealing a final agency
                                                                                                            full text of this statement. The
                                                                                                                                                                     action to a court unless the party exhausts
                                                                                                            Conference will transmit the statement
                                                                                                                                                                     prescribed avenues for relief before the
                                                    ADMINISTRATIVE CONFERENCE OF                            to federal agencies, relevant committees
                                                                                                                                                                     agency.3
                                                    THE UNITED STATES                                       of Congress, and the Judicial Conference
                                                                                                                                                                        The related but distinct concept of ‘‘issue
                                                                                                            of the United States, as appropriate, for
                                                                                                                                                                     exhaustion’’ prevents a party from raising
                                                    Adoption of Statement                                   their consideration. The statement is not
                                                                                                                                                                     issues in litigation that were not first raised
                                                                                                            binding, but it represents the collective
                                                    AGENCY:  Administrative Conference of                                                                            before the agency, even if the petitioner
                                                                                                            views of the membership of the
                                                    the United States.                                                                                               participated in the administrative process.4
                                                                                                            Administrative Conference of the                         As with remedy exhaustion, the issue
                                                    ACTION: Notice.                                         United States. The research report                       exhaustion doctrine initially arose in the
                                                    SUMMARY:    The Administrative                          prepared for the Conference on this                      context of agency adjudications.5
                                                    Conference of the United States adopted                 subject is posted at: www.acus.gov/63rd.                    As the Supreme Court has recognized,
                                                    one formal statement at its Sixty-Third                   Dated: October 2, 2015.                                ‘‘administrative issue-exhaustion
                                                    Plenary Session. The appended                           Shawne C. McGibbon,                                      requirements are largely creatures of
                                                    statement addresses ‘‘Issue Exhaustion                  General Counsel.                                         statute.’’ 6 In several judicial review
                                                    in Preenforcement Judicial Review of                                                                             provisions adopted during the 1930s, prior to
                                                    Administrative Rulemaking.’’                            Appendix—Statement of the                                the advent of the Administrative Procedure
                                                    FOR FURTHER INFORMATION CONTACT:
                                                                                                            Administrative Conference of the                         Act of 1946, Congress expressly required
                                                    Gisselle Bourns, Administrative                         United States                                            parties to raise all their objections to agency
                                                    Conference of the United States, Suite                  Administrative Conference Statement #19                  action before adjudicatory agencies. Since
                                                    706 South, 1120 20th Street NW.,                                                                                 that time, Congress has included issue
                                                                                                            Issue Exhaustion in Preenforcement Judicial              exhaustion provisions in many statutes
                                                    Washington, DC 20036; Telephone 202–                    Review of Administrative Rulemaking
                                                    480–2080.                                                                                                        governing review of agency orders.7 The
                                                                                                            Adopted September 25, 2015                               typical statute contains an exception for
                                                    SUPPLEMENTARY INFORMATION: The
                                                                                                               The doctrine of issue exhaustion generally            ‘‘reasonable grounds’’ or ‘‘extraordinary
                                                    Administrative Conference Act, 5 U.S.C.                                                                          circumstances’’ and permits the court to
                                                    591–596, established the Administrative                 bars a litigant challenging agency action from
                                                                                                            raising issues in court that were not raised
                                                    Conference of the United States. The                    first with the agency. Although the doctrine                2 This Statement does not address the application
                                                    Conference studies the efficiency,                      originated in the context of agency                      of the doctrine in the context of a challenge to a
                                                    adequacy, and fairness of the                           adjudication, it has been extended to judicial           rule in an agency enforcement action, where the
                                                    administrative procedures used by                       review of challenges to agency rulemakings.              passage of time and new entrants may complicate
                                                    Federal agencies and makes                              Scholars have observed that issue exhaustion             the inquiry. The Conference has previously
                                                                                                            cases ‘‘conspicuously lack discussion of                 identified issues that Congress should not
                                                    recommendations for improvements to                                                                              ordinarily preclude courts from considering when
                                                    agencies, the President, Congress, and                  whether, when, why, or how [the issue]
                                                                                                                                                                     rules are challenged in enforcement proceedings.
                                                    the Judicial Conference of the United                   exhaustion doctrine developed in the context
                                                                                                                                                                     See Admin. Conf. of the U.S., Recommendation 82–
                                                                                                            of adjudication should be applied to                     7, Judicial Review of Rules in Enforcement
                                                    States (5 U.S.C. 594(1)). For further                   rulemaking.’’ 1 The Administrative                       Proceedings (Dec. 17, 1982), http://www.acus.gov/
                                                    information about the Conference and                    Conference has studied the issue exhaustion              82-7.
                                                    its activities, see www.acus.gov.                       doctrine in an effort to bring greater clarity              3Myers v. Bethlehem Shipbuilding Corp., 303 U.S.
                                                       The Conference’s Sixty-Third Plenary                 to its application in the context of                     41, 50-51 (1958).
                                                    Session was conducted, for the first                    preenforcement review of agency rules. The                  4 See Fiber Tower Spectrum Holdings, LLC v.

                                                    time, as a virtual meeting, held via the                Conference believes that this Statement may              FCC, No. 14–1039, slip. op. at 9 (D.C. Cir. Apr. 3,
                                                    Internet, in accordance with the                                                                                 2015), Issue exhaustion statutes may not always be
                                                                                                               1 Jeffrey S. Lubbers, Fail to Comment at Your         jurisdictional. E.g., EPA v. EME Homer City
                                                    Conference’s earlier Recommendation,                                                                             Generation, L.P., 134 S. Ct. 1584, 1602-03 (2014)
                                                                                                            Own Risk: Does Issue Exhaustion Have a Place in
                                                    2011–7, The Federal Advisory                            Judicial Review of Rules: 11 (May 5, 2015) (Report       (‘‘A rule may be ‘jurisdictional,’ we have explained.
                                                    Committee Act—Issues and Proposed                       to the Administrative Conference of the U.S.)            Section7607(d)(7)(B), we hold, is of that character.
                                                    Reforms. The plenary session was open                                                                            It does not speak to a court’s authority, but only to
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                            [hereinafter Lubbers Report] (citing Peter L. Strauss,
                                                                                                            et al. Gellhorn and Byse’s Administrative Law 1246       a party’s procedural obligations.’’) (citations
                                                    for participation by Conference                                                                                  omitted); see also Advocates for Highway and Auto
                                                                                                            (10th ed. 2003)); see also Koretoff v. Vilsach, 707
                                                    members and the public for the period                   F.3d 394, 399 (D.C. Cir. 2013) (Williams, J.,            Safety v. FMSCA, 429 F.3d 1136, 1148 (D.C. Cir.
                                                    of September 18 through September 25,                   concurring) (joining a decision to preclude              2005) (‘‘as a general matter, a party’s presentation
                                                    2015. The Assembly of the Conference                    preenforcement review of new issues but writing          of issues during a rulemaking proceeding is not a
                                                                                                            separately ‘‘primarily to note that in the realm of      jurisdicional matter’’) (emphasis in original).
                                                    adopted one formal statement.                                                                                       5 See Lubbers Report, supra note 1, at 2-3.
                                                                                                            judicial review of agency rules, much of the
                                                    Statement #19, ‘‘Issue Exhaustion in                    language of our opinions on ‘waiver’ has been a             6 Sims v. Apfel, 530 U.S. 103, 107 (2000)
                                                    Preenforcement Judicial Review of                       good deal broader than the actual pattern of our         (plurality opinion).
                                                    Administrative Rulemaking,’’ examines                   holdings’’).                                                7 See Lubbers Report, supra note 1, at 4-6.




                                               VerDate Sep<11>2014   18:12 Oct 06, 2015   Jkt 238001   PO 00000   Frm 00001   Fmt 4703   Sfmt 4703   E:\FR\FM\07OCN1.SGM     07OCN1


                                                    60612                       Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices

                                                    require an agency to take new evidence                  two appellate courts have applied the                       legal and policy issues raised in agency
                                                    under certain conditions.8                              doctrine to review of administrative                        proceedings, ensures fully informed
                                                       Courts have also imposed issue exhaustion            rulemaking after specifically considering                   decisionmaking by administrative agencies,
                                                    requirements in the adjudication context in             Sims,14 although Sims was recently cited by                 provides a robust record for judicial review,
                                                    the absence of an underlying statute or                 the Ninth Circuit as militating against issue               and lends certainty and finality to agency
                                                    regulation requiring it. The Supreme Court              exhaustion in an informal rulemaking issued                 decisionmaking. Issue exhaustion also avoids
                                                    early on characterized the ‘‘general rule that          without notice-and-comment procedures.15                    the potential for significant disruption to
                                                    courts should not topple over administrative              Relying on their equitable authority, courts              extensive work by the agency, which can
                                                    decisions unless the administrative body not            have also fashioned exceptions to the issue                 result if an issue is raised only during
                                                    only has erred but has erred against objection          exhaustion doctrine.16 The Conference                       judicial review, after the rule has been
                                                    made at the time appropriate under its                  commissioned a consultant’s report to                       developed. Application of the doctrine spares
                                                    practice’’ as one of ‘‘simple fairness,’’               identify and articulate the scope of these                  courts from hearing objections that could
                                                    emphasizing that issue exhaustion promotes              exceptions in federal appellate case law, as                have been cured at the administrative level
                                                    orderly procedure and good administration               well as to examine the general arguments for                and reduces the need for agencies to create
                                                    by offering the agency an opportunity to act            or against the doctrine in the rulemaking                   post-hoc rationalizations.19
                                                    on objections to its proceedings.9 But                  context.17 Without endorsing every                             On the other hand, the Conference also
                                                    questions about the common law application              conclusion expressed therein, the Conference                recognizes some practical and doctrinal
                                                    of the doctrine were later raised in Sims v.            believes that the report of its consultant can              concerns with uncritically applying issue
                                                    Apfel, where the Court held that a judicial             provide guidance to courts considering the                  exhaustion principles developed in the
                                                    issue exhaustion requirement was                        application of the doctrine as it pertains to               context of formal adversarial agency
                                                    inappropriate on review of the Social                   preenforcement review of administrative                     adjudications to the context of
                                                    Security Administration’s informal, non-                rulemaking.                                                 preenforcement rulemaking review.20
                                                    adversarial adjudicatory benefit                                                                                    Overbroad application of the doctrine to
                                                    determinations, reasoning that ‘‘the                    Factors for Courts To Consider in Applying                  rulemaking proceedings could serve as a
                                                    desirability of a court imposing a                      the Issue Exhaustion Doctrine                               barrier to judicial review for persons or firms
                                                    requirement of issue exhaustion depends on                The Administrative Conference believes                    who reasonably did not engage in continuous
                                                    the degree to which the analogy to normal               that stakeholders, agencies, and courts                     monitoring of the agency in question.21 Issue
                                                    adversarial litigation applies in a particular          benefit when issues are raised during                       exhaustion requirements may also contribute
                                                    administrative proceeding.’’ 10                         rulemaking proceedings with sufficient                      to the burdens of participating in a
                                                       Although the issue exhaustion doctrine               specificity to give the agency notice and a fair            rulemaking proceeding, by exerting pressure
                                                    originated in the adjudication context, it has          opportunity to address them prior to judicial               on commenters to raise at the administrative
                                                    been extended to preenforcement review of               review.18 Many of the justifications for                    level every issue that they might conceivably
                                                    agency rulemakings. Two statutes have been              applying the doctrine in judicial review of                 invoke on judicial review.22 Also, an
                                                    identified by the Conference as explicitly              agency adjudicatory decisions apply squarely                overbroad exhaustion requirement may result
                                                    requiring issue exhaustion for review of                to review of rulemakings. The doctrine                      in unnecessary uncertainty and inefficiencies
                                                    agency rules—the Clean Air Act and the                  promotes active public participation, creates               by leaving unaddressed fundamental legal
                                                    Securities Exchange Act of 1934.11 Both                 orderly processes for resolution of important               questions—such as a rule’s constitutionality
                                                    statutes were amended to incorporate issue                                                                          or validity under a substantive federal
                                                    exhaustion provisions in the 1970s, when                (‘‘[g]enerally speaking, then, the price for a ticket       statute. These and other concerns have led
                                                    Congress enacted numerous regulatory                    to facial review is to raise objections in the              some observers to question the value of the
                                                    statutes with significant rulemaking                    rulemaking’’); City of Portland, Or. v. EPA, 507 F.3d       doctrine as applied to rulemaking, or at least
                                                    provisions. 12                                          706, 710 (D.C. Cir. 2007); Military Toxics Project v.       to call for limitations on its scope.
                                                       The doctrine has also been extended to the           EPA, 146 F.3d 948, 956–57 (D.C. Cir. 1998); see also           The Conference has compiled a list of
                                                    rulemaking context through common law.                  Lubbers Report, supra note 1, at 27–30 (describing
                                                                                                                                                                        factors—some of which may be dispositive in
                                                                                                            application of the doctrine as well as varied
                                                    Despite Sims’ focus in the adjudication                 precedent in appellate courts other than the U.S.           particular cases—that it invites courts to
                                                    context on the extent to which the                      Court of Appeals for the D.C. Circuit). No cases            consider when deciding whether to preclude
                                                    underlying administrative proceeding                    were identified that applied the issue exhaustion           a litigant from raising issues for the first time
                                                    resembled adversarial litigation for purposes           doctrine in the context of new issues raised during
                                                    of determining whether the doctrine applied,            enforcement challenges to rules.                               19 The argument for judicial application of the
                                                    appellate courts have increasingly applied                 14 Advocates for Highway and Auto Safety v.
                                                                                                                                                                        doctrine may be especially strong where the
                                                    the doctrine in the absence of a statute                FMSCA, 429 F.3d 1136, 1148–49 (D.C. Cir. 2005);             challenged issue concerns the factual basis of a rule,
                                                    requiring it when reviewing preenforcement              Universal Health Servs., Inc. v. Thompson, 363 F.3d         the agency’s evaluation of alternatives, or the
                                                    challenges to agency rules enacted via notice-          1013, 1020 (9th Cir. 2004).                                 agency’s failure to exercise its discretion in a
                                                                                                               15 See Alaska Survival v. Surface Transp. Bd.,           particular manner. Judicial evaluation of the
                                                    and-comment proceedings.13 And at least
                                                                                                            705 F.3d 1073, 1080 (9th Cir. 2013) (describing a           reasonableness of an agency’s action in such cases
                                                                                                            Surface Transportation Board (STB) exemption                under an arbitrary and capricious standard of
                                                       8 E.g., 15 U.S.C. § 77i(a); 29 U.S.C. § 160(e); 42
                                                                                                            proceeding as a rulemaking but applying the Sims            review may depend heavily on the administrative
                                                    U.S.C. § 1320a-8(d)(1).                                 rationale to it because the STB’s procedures were           record and on the agency’s analysis of those issues.
                                                       9 United States v. L.A. Tucker Truck Lines, Inc.,
                                                                                                            informal and public comments were not sought).              See generally Gage v. Atomic Energy Comm’n, 479
                                                    344 U.S. 33, 37 (1952) (reviewing an adjudicative          16 E.g., Washington Ass’n for Television and             F.2d 1214, 1217–19 (D.C. Cir. 1973).
                                                    order issued by the Interstate Commerce                 Children (‘‘WATCH’’) v. FCC, 712 F.2d 677, 681–82              20 See William Funk, Exhaustion of
                                                    Commission after an adversarial hearing); see also      (D.C. Cir. 1983) (‘‘[Our] cases assume that § 405           Administrative Remedies—New Dimensions Since
                                                    Advocates for Highway and Auto Safety v. FMSCA,         contains implied exceptions without explaining              Darby, 18 Pace Envtl. L. Rev. 1, 17 (2000)
                                                    429 F.3d 1136, 1149 (D.C. Cir. 2005) (applying the      why. We understand these cases, however, as                 (‘‘[u]nfortunately, some courts have ignored the
                                                    same rationale to rulemaking).                          implicitly interpreting § 405 to codify the judicially-     specific statutory origin for [issue exhaustion] and
                                                       10 Sims v. Apfel, 530 U.S. 103, 108–12 (2000)
                                                                                                            created doctrine of exhaustion of administrative            have applied a similar exhaustion requirement in
                                                    (plurality opinion).                                    remedies, which permits courts some discretion to           cases totally unrelated to that statute, while citing
                                                       11 42 U.S.C. 7607(d)(7)(B); 15 U.S.C. 78y(c)(1).     waive exhaustion.’’) (footnotes omitted).                   cases involving application of that statute’’).
                                                    However, provisions governing some agencies’               17 See generally Lubbers Report, supra note 1.              21 The impact of such barriers can fall most
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    ‘‘orders’’ have been held to apply to judicial review      18 Nat’l Ass’n of Mfrs. v. U.S. Dep’t of the Interior,   heavily on persons or entities whose interests are
                                                    of rules. See Citizens Awareness Network v. U.S.,       134 F.3d 1095, 1111 (D.C. Cir. 1998); see also Ctr.         not in close alignment with the interests that have
                                                    391 F.3d 338, 345–47 (1st Cir. 2004); see also Inv.     for Sustainable Econ. v. Jewell, 779 F.3d 588, 602          been advanced most forcefully by other participants
                                                    Co. Inst. v. Bd. of Govs., 551 F.2d 1270, 1276–77       (D.C. Cir. 2015) (holding on review of an agency            in a given proceeding. See Koretoff v. Vilsack, 707
                                                    (D.C. Cir. 1977); American Public Gas Ass’n v. Fed.     adjudicatory decision that ‘‘the question in                F.3d 394, 401 (D.C. Cir. 2013) (Williams, J.,
                                                    Power Comm’n, 546 F.2d 983, 986–88 (D.C. Cir.           determining whether an issue was preserved,                 concurring).
                                                    1976).                                                  however, is not simply whether it was raised in                22 See Wendy E. Wagner, Administrative Law,
                                                       12 Lubbers Report, supra note 1, at 4, 11, 13.
                                                                                                            some fashion, but whether it was raised with                Filter Failure, and Information Capture, 59 Duke
                                                       13 E.g., Koretoff v. Vilsack, 707 F.3d 394, 401      sufficient precision, clarity, and emphasis to give         L.J. 1321, 1363–64 (2010); Lubbers Report, supra
                                                    (D.C. Cir. 2013) (Williams, J., concurring)             the agency a fair opportunity to address it’’).             note 1, at 38–40.



                                               VerDate Sep<11>2014   18:12 Oct 06, 2015   Jkt 238001   PO 00000   Frm 00002   Fmt 4703    Sfmt 4703   E:\FR\FM\07OCN1.SGM       07OCN1


                                                                                Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices                                            60613

                                                    during preenforcement review of an agency                   If an issue exhaustion question arises in            DATES:  We will consider all comments
                                                    rule. The list should be understood as a                 litigation, litigants should be given an                that we receive on or before November
                                                    checklist of potentially relevant factors, not           opportunity to demonstrate that some                    6, 2015.
                                                    a fixed doctrinal formula, and as inapplicable           participant adequately raised the issue
                                                    where a statute directs otherwise.                       during the rulemaking or that circumstances             ADDRESSES: You may submit comments
                                                    Specifically, the list includes consideration            exist to justify not requiring issue exhaustion.        by either of the following methods:
                                                    of whether:                                              And if a court declines to apply issue                     • Federal eRulemaking Portal: Go to
                                                       • The issue was raised by a participant in            exhaustion principles to preclude review of             http://www.regulations.gov/
                                                    the rulemaking other than the litigant.23                new issues, the agency should be given an               #!docketDetail;D=APHIS-2015-0062.
                                                       • The issue was addressed by the agency               opportunity to respond to new objections on                • Postal Mail/Commercial Delivery:
                                                    on its own initiative in the rulemaking.24               the merits.30 Where application of the issue            Send your comment to Docket No.
                                                       • The agency failed to address an issue               exhaustion doctrine forecloses judicial
                                                    that was so fundamental to the rulemaking
                                                                                                                                                                     APHIS–2015–0062, Regulatory Analysis
                                                                                                             review, the Administrative Procedure Act, 5             and Development, PPD, APHIS, Station
                                                    proceeding or to the rule’s basis and purpose            U.S.C. 553(e), can provide a procedural
                                                    that the agency had an affirmative                       mechanism for the public to raise new issues
                                                                                                                                                                     3A–03.8, 4700 River Road Unit 118,
                                                    responsibility to address it.25                          that were not presented to the agency during            Riverdale, MD 20737–1238.
                                                       • The issue involves an objection that the            a rulemaking proceeding: The right to                      Supporting documents and any
                                                    rule violates the U.S. Constitution.26                   petition agencies for amendment or repeal of            comments we receive on this docket
                                                       • It would have been futile to raise the              rules.                                                  may be viewed at http://
                                                    issue during the rulemaking proceeding                                                                           www.regulations.gov/
                                                    because the agency clearly indicated that it             [FR Doc. 2015–25570 Filed 10–6–15; 8:45 am]
                                                    would not entertain comments on or                       BILLING CODE 6110–1–P
                                                                                                                                                                     #!docketDetail;D=APHIS-2015-0062 or
                                                    objections regarding that issue.27                                                                               in our reading room, which is located in
                                                       • The issue could not reasonably be                                                                           room 1141 of the USDA South Building,
                                                    expected to have been raised during the                                                                          14th Street and Independence Avenue
                                                    rulemaking proceeding because of the                     DEPARTMENT OF AGRICULTURE                               SW., Washington, DC. Normal reading
                                                    procedures used by the agency.28                                                                                 room hours are 8 a.m. to 4:30 p.m.,
                                                       • The basis for the objection did not exist           Animal and Plant Health Inspection
                                                                                                                                                                     Monday through Friday, except
                                                    at a time when rulemaking participants could             Service
                                                    raise it in a timely comment.29
                                                                                                                                                                     holidays. To be sure someone is there to
                                                                                                             [Docket No. APHIS–2015–0062]                            help you, please call (202) 799–7039
                                                      23 See   Portland Gen. Elec. Co. v. Bonneville Power
                                                                                                                                                                     before coming.
                                                    Admin., 501 F.3d 1009, 1024 (9th Cir. 2007) (‘‘In        Availability of an Environmental                        FOR FURTHER INFORMATION CONTACT: Dr.
                                                    general, we will not invoke the waiver rule in our       Assessment and Finding of No                            Donna Malloy, Operational Support
                                                    review of a notice-and-comment proceeding if an          Significant Impact for Field Use of
                                                    agency has had an opportunity to consider the                                                                    Section, Center for Veterinary Biologics,
                                                    issue. This is true even if the issue was considered
                                                                                                             Vaccines Against Avian Influenza H5                     Policy, Evaluation, and Licensing, VS,
                                                    sua sponte by the agency or was raised by someone        Virus Strains                                           APHIS, 4700 River Road Unit 148,
                                                    other than the petitioning party.’’).                                                                            Riverdale, MD 20737–1231; (301) 851–
                                                       24 Id.                                                AGENCY:  Animal and Plant Health
                                                       25 See NRDC v. EPA, 755 F.3d 1010, 1023 (D.C.         Inspection Service, USDA.                               3426, fax (301) 734–4314.
                                                    Cir. 2014) (‘‘EPA retains a duty to examine key          ACTION: Notice of availability and                      SUPPLEMENTARY INFORMATION: Under the
                                                    assumptions as part of its affirmative burden of                                                                 Virus-Serum-Toxin Act (21 U.S.C. 151
                                                    promulgating and explaining a nonarbitrary, non-         request for comments.
                                                    capricious rule . . .’’) (internal quotation marks
                                                                                                                                                                     et seq.), the Animal and Plant Health
                                                    omitted). This factor may include issues arising         SUMMARY:   We are advising the public                   Inspection Service (APHIS) is
                                                    under the applicable substantive statute or the APA.     that an environmental assessment has                    authorized to promulgate regulations
                                                       26 Cf., Noel Canning v. NLRB, 705 F.3d 490, 497
                                                                                                             been prepared by the Animal and Plant                   designed to ensure that veterinary
                                                    (D.C. Cir. 2013), aff’d NLRB v. Noel Canning, 134
                                                    S. Ct. 2550 (2014) (invoking ‘‘extraordinary             Health Inspection Service relative to the               biological products are pure, safe,
                                                    circumstances’’ exception in statutory provision         use of one or more veterinary biological                potent, and efficacious. Veterinary
                                                    requiring issue exhaustion to address constitutional     products as a treatment for and as an aid               biological products include viruses,
                                                    issue not raised with the NLRB because the issue         in the reduction of highly pathogenic                   serums, toxins, and analogous products
                                                    went to the very power of the agency to act and
                                                    implicated fundamental separation of powers              avian influenza (HPAI) incidence                        of natural or synthetic origin, such as
                                                    concerns). It is worth emphasizing that regardless       caused by strains such as Eurasian H5                   vaccines, antitoxins, or the immunizing
                                                    of whether the issue exhaustion doctrine would           viruses of clade 2.3.4.4 lineage. Any                   components of microorganisms
                                                    apply, participants in a rulemaking should raise
                                                    constitutional issues during the rulemaking              biological products would become part                   intended for the diagnosis, treatment, or
                                                    proceeding to give the agency an opportunity to          of the measures to reduce the incidence                 prevention of diseases in domestic
                                                    adjust its rule to eliminate the constitutional          of HPAI in the nation’s commercial                      animals.
                                                    objection or at least to explain in the administrative   poultry flocks. Based on the                               APHIS issues licenses to qualified
                                                    record why its rule does not raise constitutional
                                                    concerns.                                                environmental assessment, we have                       establishments that produce veterinary
                                                       27 See Comite De Apoyo A Los Trabajadores             concluded that the use of vaccines as                   biological products and issues permits
                                                    Agricolas v. Solis, No. 09–240, 2010 WL 3431761,         described in the environmental                          to importers of such products. APHIS
                                                    at *18 (E.D. Pa. Aug. 31, 2010); cf. WATCH v. FCC,       assessment will not have a significant                  also enforces requirements concerning
                                                    712 F.2d 677, 682 (D.C. Cir. 1983) (remarking that                                                               production, packaging, labeling, and
                                                    ‘‘[a] reviewing court . . . may in some cases            impact on the human environment. We
                                                    consider arguments that it would have been futile        are making this environmental                           shipping of these products and sets
                                                    to raise before the agency,’’ but cautioning that        assessment and finding of no significant                standards for the testing of these
                                                    ‘‘[f]utility should not lightly be presumed’’).                                                                  products. Regulations concerning
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                       28 See Alaska Survival v. Surface Transp. Bd., 705
                                                                                                             impact available to the public for review
                                                                                                             and comment.                                            veterinary biological products are
                                                    F.3d 1073 (9th Cir. 2013) (declining to apply issue
                                                    exhaustion because the agency’s procedures were                                                                  contained in 9 CFR parts 101 to 124.
                                                    informal and ‘‘never provided direct notice of or           30 Courts have a variety of options for soliciting      Veterinary biological products
                                                    requested public comment’’ on challenged issue).         the agency’s views that should vary depending on        meeting the requirements of the
                                                       29 Cf. CSX Transp., Inc., v. Surface Transp. Bd.,     the circumstances. These options include                regulations may be considered for
                                                    584 F.3d 1076, 1079–81 (D.C. Cir. 2009) (declining       permitting the agency to brief the issue or
                                                    to apply issue exhaustion to a litigant’s argument       supplement the administrative record, or ordering
                                                                                                                                                                     addition to the U.S. National Veterinary
                                                    that the final rule was not a logical outgrowth of       a remand for the limited purpose of soliciting the      Stockpile (NVS). The NVS is the
                                                    the noticed rule).                                       agency’s views.                                         nation’s repository of vaccines and other


                                               VerDate Sep<11>2014   18:12 Oct 06, 2015   Jkt 238001   PO 00000   Frm 00003   Fmt 4703    Sfmt 4703   E:\FR\FM\07OCN1.SGM   07OCN1



Document Created: 2015-12-15 08:48:34
Document Modified: 2015-12-15 08:48:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactGisselle Bourns, Administrative Conference of the United States, Suite 706 South, 1120 20th Street NW., Washington, DC 20036; Telephone 202-480-2080.
FR Citation80 FR 60611 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR