# Unite d States Court of Appe als

F O R T H E D I S T R

I C T O F C O L U M B I A

C I R C U I T

Arg ued Apr il 23, 2012 Dec ided Aug ust 24, 2012

No. 11-5241

J A M E S L

. S H E R

L E Y , D R

. A

N D T H E R

E S A D E I S H E R , D R ., A P P E L L A N TS

v.

K A TH L E E N S E B E L I U S , I

N H E R O F F I C I A L

C A P A C I TY

A S S E C R E TA R Y O F T H E D E P A R

TM E N T O F H E A L TH

A N D H U M

A N S E R V I C E S , E T A L ., A P P E L L E E S

Appea l from the United States District Court for the D istrict of Columbia (No. 1:09-c v-01575)

Ryan J. W

atson arg ued the cause for appellants. Wit h him

on the briefs wer e Thomas G. Hungar
, Thomas M. Johnson Jr.
, Samuel B. Casey
, Steve n H. Aden , and Blaine H. Evanson

.

Adam J. W

hite was on the brief for ami ci curi ae Robert Geor g e, et a l. in support of appellants.

Beth S. Brinkma n n , Deputy Assistant Attorney Gene ral, U.S. Depa

rtment o f J ustice, arg ued the cause for appellee s. Wit h h er on the briefs wer e Tony W est , Assistant Attorney Gene ra l
, R o n ald C. Mache n Jr.
, U.S. Attorney
, and Mark B. Stern
, Steph a n i e R. Marcus
, Abby C. W right
, and Helen L.2

Gilbert
, Attorney s. R. Craig Lawrence
, Assist a nt U.S. Attorney
, enter ed an a

ppear ance

.

Neal Goldfarb and Andrew T. Karron wer e on the brief for amici curiae Coalition for the Advanc ement of Medica l Resear ch, et a l. in support of appellee s.

Be fore : S E

N TE L L E , Chief J

udge
, H E

N D E R S O N and B R

O W N , Circuit Judges

. Opinion for the Court filed by Chief Judge S E N TE L L E

. Concurring opinion filed by Circuit Judge H E N D E R S O N

. Concurring opinion filed by Circuit Judge B R O W N

.

S E N TE L L E , Chi ef Judge : Appellants are resear cher s in the field of adult stem cells wh o oppose t he use of federa l funding for the development of embry onic stem-ce ll rese arc h. I n district
court t h ey filed a complaint seeking decla ratory and inj unctive relief ag ainst appellee Secre tary of Hea lth and Human Service s’ implementation of reg ulations allowing fede ral funding of such

rese arc h. T hey appea l from a district court order enter ing
summary judgme nt in favor of the defe ndant. Be ca u se we conclude that the district court comm i t ted no err or, we aff irm the orde r and judg ment under r eview.

I. The Current Litigation

I n Aug ust of 2009, appellants and others filed the complaint commencing this action ag ainst the S ec re tary of Hea lth and Human Service s and the Direc tor of the National I nstitut es of Hea lth (NI H), seeking decla ratory relief that NI H Guidelines authorizing the funding of rese arc h involving human embry onic
stem cells was unlawful under 5 U.S.C. § 706(2)( A). I n addition3

to this and other decla

ratory relief

, the complaint soug ht to have the court enjoin the defe ndants and their agencies from implementing, apply ing, or taking any action pursuant to the
g uidelines, or otherwise funding any rese arc h involving human

em bry onic s tem cells. The dist rict court ruled that none o f t h e

sever al plaintiffs had standing to bring the ac tion and there fore dismiss ed it. See Sherley v. Sebelius
, 686 F. Supp. 2d 1 (D.D.C. 2 009). We reve rsed as to the two appellants now befor e t h e court, rese arc hers in the field of adult stem cells, concluding that they have standing as competitors to bring these claims. Sherley

v. Sebelius
, 610 F.3d 69, 72-74 (D.C. Cir. 2010). We rema nded the case to the district court for further pro ce ed i n gs

. Id. at 75. On remand, the di stri ct co urt deter mined that Congr ess had, in

an Appropria tion s Act rider called the Dickey -Wicker Amendment, cl ea rl y “provide [d] that no fede ral funds shall be used for ‘re sear ch in which a human embry o or embry os are destroy ed, discarde d, or knowing ly subjected to risk of injury or death g rea ter than that allowed for rese arc h on fetuses in utero ’” under other regul at o ry and statutory reg imes. Sherley v. Sebelius
, 704 F. Supp. 2d 63, 70 (D.D.C. 2010) (quoting Pub. L

. No. 111-8, § 508(a) (2))

. The district court further conclude d that the g uidelines under litigation violated th at s t atutory prohibition, that the plaintiffs demonstrated a strong likelihood of succe ss on the merits, that the plainti ffs would suffe r irrepa rable h ar m in the absenc e of preliminary injunction, that the balan ce of hardships weig hed in favor of preliminary injunction, and that pu b l i c interest weig hed in favor of the issuance of a preliminary injunction. T h e court there fore
enter ed the prelim inary injunction soug ht by plaintiffs. Def endants a ppeale d.

On appea l, we deter

mined that NI H had rea sonably interpre ted the Dickey -Wicker Amen dment and vacated the preliminary injunction entered b y t he district court. Sherley v. Sebelius
, 644 F.3d 388, 390 (D.C. Cir. 2011). After the second4

rema nd, t h e district court enter ed the summary judgme nt in favor of def endant now unde r re view.

II. Backgroun d

The rele vant fac ts are set forth in our opinion revie wing the preliminary

injunction, see Sherley
, 644 F.3d at 389-92, and in the two op i n i o ns of the district court, so we shall revie w them but briefly

. Be g inning in 1996, Congr ess has reg ularly included in appropr iation bills a rid er called the Dickey -Wicker Amendment, see, e.g. , Consolidated A ppropriations Act, 2012, Pub. L

. No. 112-74, § 508. The Dickey -W i cker Amendment prohibits NI H from funding “(1) the cre ation of a human embry o

or embry os for rese arc h purpo s es ; o r (2) rese arc h in which a human embry o or embry os are d es t roy ed, discarde d, or knowing ly subjected to risk of i njury or d ea t h g rea ter than that allowed for rese arc h on fetuses in ut er o u n d er 45 C.F.R. 46.204(b) a

nd [42 U.S .C. § 289g( b)].” Id.

At the time of the adoption of the first Dickey -Wicker rider, scientists had not y et isolated embry onic stem ce lls (ESC), and the orig inal enac tment was appar ently direc ted at another ty pe of rese arc h perf

ormed on human embry os in the field of in vitro fer tiliz ation. Sherley
, 644 F.3d at 390. By 1998, rese arc hers had g ener ated a stabl e line of ESCs available for further

rese ar ch

. Although more mature stem cells wer e and rema in available
, many rese arc hers consider the ESCs far more valuable beca use they are pluripotent—that is, they can be develope d into
any of near ly 200 differ ent ty pes of h u m an cells for use in a broad r ang e of me dical re sear ch.

I solating ESCs for rese arc h requires that the cells be removed from a human embry o, cultured, and stabiliz ed i n t o a “stem cell line.” This proce ss of “der ivation” d estroy s the embry o. The cells from this line may then be use d for y ear s by5

rese arc hers, who differ en t iate the cells into whateve r kinds of cells they need for a particula r rese arc h projec t. Thus, the initial deriva tion pr ocess require s the destruction of a human embry o. The particula

r rese arc h projec ts using the ear lier deri v ed stem cells, howeve r, does not involve the destruc t i o n o f any further embry os.

I t is this distinction betwee n funding rese arc h projec ts direc tly invo l v i ng the destruction of a human embry o and projec ts using embry onic stem cells derive d from an earlier destruction that underlies the controve rsy g iving rise to the
prese nt litigation. I n 2001, President Geor ge W. Bush, for ethical rea sons, decla

red t h at fede ral funds would be used in

rese arc h on embry onic stem cells only if such cells wer e draw n from one of the six ty or so stem cell lines alre ady exis ting at the time of President Bush’ s decla ration. Addre ss to the Nation on Stem Cell Resear ch from Crawf ord, Texas, 37 W E E K L Y C O M P

. P R E S

. D O C

. 1149, 1151 (Aug

. 9
, 2 0 01). President Bush later formalized this policy

in an Executive Orde r. Exec. Orde r No. 13,435, 72 Fe d. Reg . 34,591 (June 20, 2007).

So matters stood until 2009, when President Obama issued

an Ex ecutive Orde r revoking Ex ecutive Or d er No. 13,433. Ex ec. Order No. 13,505, 74 Fe d. Reg

. 1 0
, 667 (Mar

. 11, 2009). The Orde r stated that NI H “may support and co n d u ct responsible, scientifica lly wo rt hy human stem cell rese arc h, i n cl uding human embry onic stem cell rese arc h, to the extent permitted by

law.” Id.

As require d by the E x ecutive Orde r and afte r notice and comment, NI H issued new “G uidelines for Human Stem Cell Resear ch,” 74 Fe d. Reg

. 32,170 (Jul y 7, 2009 ) (G u idelines). The Guidelines “re cog nize the distinction, acc epted by Congr ess, betwee n the deriva tion of stem cells from an embry o that results in the embry o’s destruc t i on, for which Fe dera l6

fundi n g i s prohibited, and resear ch invol ving [ ESCs] that does
not involve an embryo nor result in an embry o’s destruction, for which Feder al funding i s permitted.” Id. at 32,173. Under the Guidelines, an E SC rese arc h projec t may rec eive NI H funding

as long as it utiliz es cells from lines (1) cr ea ted by in vitro fer tiliz ation for repr oductive purposes, (2) no longe r neede d for that purpose, and (3) voluntarily donated by the individuals who owned them—even if that line was derive d afte r 2001. Id. at 32,174.

During the notice and comment proce eding s, the cur rent appellants filed comments opposing the use of fede ral funds for
any embry onic stem-ce ll rese arc h. NI H did not respond to their
comments. After the adoption of the g u idelines, appellants broug ht the prese nt action.

III. Analysi s

We note at the outset that our revie w of the district c ourt’s
g rant of summary judgme nt in favor of the g over n m ent is de

novo

. See, e.g. , Calhoun v. Johnson
, 632 F.3d 1259, 1261 (D.C. Cir. 2011). Therefo re , our duty is to underta ke the same examination as d i d the district court. On summary judgme nt revie w in gen eral, that require s the court to g rant summary judgme nt in favor of the moving pa rty if that party

“shows that ther e i s n o g enuine dispute as to any materia l fac t and the
movant is entitled to judgme nt as a matter of law.” Fe d. R. Civ. P. 56. I n this court, as in the district court, the APA g overns the
scope of administrative revie ws such as the one befor e us. That Act require s a revie wing court to “hold unlawful and s et aside
ag ency action, finding s, and conclus i ons found to be

. . . arbitra ry , capr icious, an abuse of discretion, or otherwise not in

acc ordanc e with law.” 5 U.S.C. § 706(2)( A). Thus, we, a s did the di strict court, must allow summary judgme nt for appellees, unless appellants have produce d in the rec ord at least en o ug h7

sup port for their position to establish “a ge nuine di spute” as to

some materia l fac t from which we could disc er n t h at the adoption or implementation of the gu idelines by the appellee s was “ar b i t ra ry , capr icious, an abuse of di scre tion, or ot herw ise
not in acc ordanc e with law.” There is no serious dispute of fac t in this case

. Appellants advanc e three arg uments for inv al i d ati ng the NI H g uidelines, eac h of which relies upon a proposition of law.

1. Dickey-Wic ker

Appellants’ first and principal arg ument is that the NI H
g uidelines violate the Dickey -Wicker ban on fede ral funding of “re sear ch in which a human embry o or embry os are destroy ed.” On this issue, the law of the c ase is esta blished ag ainst them.

The purpose of the law-of -the-c ase doctrine is to ensure that “the same issue prese nted a second time in the same case in the

same court should lead to the same result .” LaShawn A. v. B a r r y , 87 F.3d 1389, 1393 (D.C. Cir. 1996). The courts ar e appropr iatel y “‘loa

the’ to rec onsider issues alre ady decide d,” except in the case of “extraordinar y circ ums t an ce s such as wher e the in i t i al decision was ‘cle arly err oneous and would work a manifest injusti ce

. ’” Id. (quoting Christ ianson v. Colt Indus. Operating Corp

. , 486 U.S. 800, 817 (1988) (quoting Arizona v. Calif

ornia
, 460 U.S. 605, 618 n.8 (1983)) ). Appellants’ arg ument bef o re us in the preliminary -injunction revie w was the same as now. Specifica lly
, t h ey asser ted then and asser t now that the Di ck ey -Wicker ban “unambig uously ” extends to any rese arc h project that uses ESCs. Sherley
, 644 F.3d at 395. Their arg ument, now and befor e, is that if a funded

rese arc h projec t involves the use of an ESC, then an embry o

nece ssarily has been destroy ed, and the ban of Dickey -Wicker has been violated. See generally id. at 393-94. Br iefly put, appellants contend that all ESC re sear ch is “ rese arc h” in w hich8

a human embry o or embry os are destroy ed and, there fore
, NI H’s
g uidelines vio la

te D ic k e y

- Wicke r by authorizing fede ral funding

o f s uch rese arc h. This is prec isely the same arg ument we reje cted in our r eview of

the pre liminary

injunction order.

Apply ing Chevron analy sis, see Chevron U.S.A., Inc., v. NRDC
, 467 U.S

. 837, 842-43 (1984), we held that NI H had

rea sonably interpre ted Dickey -Wicker’ s b an on funding “re sear ch in w hich

. . . embry os are destroy ed” to a llow fede ral fu n d ing of ESC rese arc h. Sherley
, 644 F.3d at 393-96. W e explained that “re s ea rch” as used in Dickey -Wicker was a “fle x ible” ( i.e.
, ambig uous) term. Id. at 3 9 4. I t could be understood as the plaintiffs const rued the term—an “extended
proce ss” t hat would i nclude the initial der ivation of st em cells. Or “re sear ch” could take o n NI H’s narr ow interpre tation as a “discr ete projec t” separ ate from deriva tion. Id. Given that ambig uity
, we d eferre d under Chevron to NI H’s permissible construction of Dickey -Wicker: “re sear ch” as used in Dickey

Wicker may rea sonab ly be understood to mean a “discre te endeav o r” that excludes the initial deriva tion of ESCs. Id. at 396 n.*. Under that interpre tation, Dickey -W i ck er permits fede ral funding of rese arc h projec ts tha t utilize a lrea dy -der ived ESCs—which are not themselves embry os— b e c a u s e n o “ h u ma n embry o or embry os are destroy ed” in such projec ts. Id. at 393- 96 (e mphasis added)

. Plaintiffs’ arg ument on this theory for relief is no differ ent than it wa s in our prior revie w. There fore
, u n le s s th ey have established some “extraordinar y circ u ms ta n c e , ” LaShawn A. , 87 F.3d a t 1393, the law of the case is established and we will not revisit the issue.

Appellants have offe red an exception to the law-of -the-c ase doctrine which they arg ue should permit us to revisit the i ssue. As they point o u t , we have held that “the decision of a trial or appellate court whether to g rant or deny a preliminary injunction does not co n s t itute law of the case for the purpose of further9

proce eding s and does n o t limit or prec lude the parties from l i t i g ating the merits.” Berrigan v. Sigler
, 499 F.2d 514, 5 1 8 (D.C. Cir. 1974); see also Belbacha v. Bush
, 520 F.3d 452, 458 (D.C. Cir. 2 0 0 8 ). There fore
, appellants rea son, we are not bound by our prior deter

minatio n i n t h e revie w of the g rant of preliminary injunction. Howeve r, on the fact s o f t his case , the exception to the law-of- the-c ase doc trine is inapplicable.

The g ener ally rec og nized prec edent fo r the preliminary injunction exception to the law-of -the-c ase doctrine arises from the nature of a preliminary injunction. That equitable reme dy is

a stopga p measure , g ener ally limit ed as to time, and intended to maintain a status quo or “to prese rve the rela tive positions of the parties until a trial on the merits can be held.” Univ. of Texas v. Camenisch
, 451 U.S. 390, 395 (1981). I n trial court, this would mean that a deter

mination ha d been made without discover y or the other ful l rang e of exploratory and prepa ratory pretria l
proce dures and wi t h o u t a full trial on the merits. I n appellate revie w, the court of appea ls must o ft en consider such preliminary relief without the benef it of a fully develope d rec ord and often on briefing and arg ument abbre viated or eliminated by time considera

tions. See, e.g. , Cohen v. Brown Univ.
, 101 F.3d 155, 169 (1st Cir. 1996). Thus arose the exception to the lawof-the- case doctrine. An appellate court in a l at er p h as e of the litigat i o n with a fully develope d rec ord, full briefing and
arg ument, and fully develope d consideration of the issue n ee d not bind its elf to the time-pr essure d decision it ear lier made on a less ade quate r ecor d.

Fur thermore
, independ ent of the preliminary -injunction exception, a decision in the preliminary -injunction context may fail to g arne r law-of

-the-case eff

ect simply beca

use it fails to satisfy an element of the law-of -t h e- ca se rule itself: the require ment that a court must “af firmatively decide [ ]” an issue, expli citly or by nece ssary i m p l ication, to establish law of the10

case

. Crocker v. P i ed

mo n t Aviation, Inc.
, 49 F.3d 735, 739 (D.C. C i r. 1995). The standard for g ranting a preliminary injunction essentially asks—in part—whe ther a plaintiff is “likely to suc cee d on the merits” of his claim. See, e.g. , W inter

v. NRDC, Inc.
, 555 U.S. 7, 20 (2008). To the extent an appellate
court predic ts, without making a definitive leg al conclusion, that the plaintiffs probably or likely will or wi l l n o t succe ed on the merits, it cannot b e said that the court “af firmatively decide d”
t h e i s s u e such that it would bind an appellate court at a later stag e of the litigation.

The question raised by this appea l is wh et h er we should apply the preliminary -injunction exception to the law-of-thecase prec lusion wher e the rea sons for its application are absent. That is, whe re t he ear lier ruling
, though on preliminary

injunction review, was established in a definitive, fully considere d leg al decision based on a fully develope d fac tual

rec ord and a decisionmaking proce ss tha t inc luded full briefing and arg ument without unusual time constraints, why should we not follow the usual law-of -the-c ase j urisprudenc e? Whil e we have not previously provided a definitive answe r to that question, sever al other c ircuits and commenta tors have.

For ex ampl e, in Naser Jewe lers, Inc. v. City of Concord
, 538 F.3d 17 (1st Cir. 2008), the Fi rs t C ircuit considere d an ap peal from summary judgme nt upholding a city ordinanc e ag ainst a First Amendment challeng e. The circ uit had previously aff

irmed the denial of prelimin ar y injunction in the

same case

. I n holding that the law-of -the-c ase doctrine applied,

even though the first decision was in the denial of a preliminary injunction and the second appea l was from the entry of summary judgme nt, that circ uit noted that “the doctrine applies when [t he]
court has previously ruled on a motion for preliminary injunction and ‘the rec ord befor e the prior panel was sufficie ntly develope d and the fac ts nece ssary to shape the prior leg al matrix11

wer e sufficie ntly clea

r.’” Id. at 20 (quoting Co h en v. Brown Univ.
, 1 01 F.3d 155, 169 (1st Cir. 1996) (other citations, quotation marks, and a lterations omitted)).

I n This That and The Other Gift and Tobacco, Inc. v. Cobb County
, 439 F.3d 1275, 1284-85 (11th Cir. 2006), the Eleventh Circuit rea ched a sim i l ar decision, citing its own prec edent to t h e eff ect that prior clea

r leg al conclusions rea ched at t h e preliminary injunction stag e would be aff orded law-of

-the-c ase status. I n Entergy, Arkansas, Inc. v. Nebraska
, 241 F.3d 979, 987 (8th Cir. 2001), the Eig hth Circuit aff orded law-of

-the-c ase status to an Eleventh Amendment is sue “c ar efully considere d” in deciding the course of the preliminary injunction appea l. And in Royal Insurance Co. of America v. Quinn-L Capital Corp.
, 3 F.3d 877, 880-81 (5th Cir. 1993), the Fifth Circuit rul ed to the

same eff ect. One of the leading co m m entators on fede ral jurisprudenc e has stated, “A fully considere d appellate ruling on

an issue of law made on a preliminary in j u n cti on appea l, howeve r, does become t h e law of the case for further
proce eding s in the trial cour t on remand a

nd in any subsequent
appea l.” 18B Charles A. Wright et al., Fe d. Prac. & Proc. J uris. § 4478.5 (2d ed.)

. Appellants insist application of the preliminary injunction exception is mandated by circ uit p rec edent. For this proposition, they rely on Berrigan and Belbacha

. They note that in Berrigan
, we stated, “The decision of a trial or appellate court whether to g rant or deny a preliminary injunction does not constitute the law of the case for the purposes of further
proce eding s and does not limit or prec lude the part i es from litigating the merits, unless there has been an order of consolidation pursuant to Rule 65(a) (2), not the case here .” 499 F.2d at 518. I n Belbacha
, we stated, “An order deny ing
p re liminary relief

, howeve r, ‘does not constitute the l aw of the

case ,’ althoug h it can be ‘per suasive.’” 520 F.3d at 458 (quoting12

Berrigan ). No doubt thes e ca s es state t he gene rally applicable rule for preliminary -injunction decisions. Howeve r, the case befor e us is fac tually distinguishable. The time c onstraints and limit ed rec ord avai l ab l e to the court in those case s are not p re s en t here

. We there fore follow the other circ uits in concluding that the exception is not prese nt either. Appellants’ first arg ument fails.

2. Sub jec ted to Risk

Appellants make a second arg ument that is intertwined with their first. They note that Dickey -Wicker also bans “re sear ch in which a human embry o or embry os are

. . . knowing ly subjected
to risk of injury or death.” § 508(a) (2 ). E ven if the NI H
g uidelines do not violate the Dickey -Wicker ban on fu n d i ng “re sear ch in which a human embry o or embry os are destroy ed” (bec ause law of the c ase a ccor ded Chevron defe renc e to NI H’s in t erpr etation), appellants maintain that the g uidelines still run afoul of the “subjec ted to ri s k ” l an g uag e. They theorize that

co n ducting a fede rally funded ESC rese arc h projec t incre ase s the demand for more ESC lines, wh i ch i n turn incentivizes the destruction of more embry os to cre ate those lines, thus subjecting those embryos to risk. NI H responds that no embry os

are subjected to risk of injury or death in any ESC rese arc h projec t using alre ady derive d ESCs and not otherwise involving the use of e mbry os.

Although appellants can cre dibly arg ue that this prec ise question of statutory interpre tation i s n o t wi thin the law of the

case , our result is nonetheless c ontrolled by that doctrine. L aw of the case has established that Chevron defe renc e applies. I t is established that “re sear ch” as used in Dickey -Wicker is an ambig uous term, and that NI H’s interpre tation of the term “re sear ch” as a discrete projec t r ather than an extended proce ss is rea sonable. Under that definiti on of “re sear ch,” the13

destruction of embry os that occur s in the ESC deriva tion proce ss is not a part o f i n d ividual ESC rese arc h projec ts using alre ady derive d ESCs. There fore
, ESC rese arc h is no more “re sear ch in which

. . . embry o s are

. . . subjected to risk” than it was “re sear ch in which

. . . embry os are

. . . destroy ed.” Appellants’ theory s hifts focus from the embry o destroy ed in the past to embry os for which an E SC rese arc h projec t “ince ntiviz es” future d estruction. But none of those embry os are “destroy ed” or “subjec ted to risk” in an ESC rese arc h projec t. The lang uag e of Dickey -Wicker does not ban funding for, e.g. , “re sear ch which provides an incentive to harm, destroy
, o r place at risk human embry os.” As we have held befor e, the NIH interpre tation of the statute’s a ctual lang uag e is rea sonable.

3. F ailure to Re ply to Com m ents

The plaintiffs finally contend that NI H violated the APA by i s s u i n g t h e Gu i delines without addre ss i n g co m m en t s cate g orica lly objecting to ESC rese arc h, which the plaintiffs consider rele vant to NI H’s decision to expand the availability of ESC rese arc h funding

. Whil e this contention rema ins unfetter ed by decisions made in Sherley II
, it far es no bett er than the Dickey -Wicker a

rg uments.

APA Section 553 require s ag encie s to provide the p u blic wi t h notice of a proposed rulemaking
, an opportunity t o comment, and, “[a]fter consideration of the rele vant matter prese nted,” a “conc ise g ener al statement” of the rule’s basis and
purpose. 5 U.S.C. § 553. We have said befor e that “the opportunity to comm en t is meaning less unless the ag ency responds to sig nificant points ra ised by the public.” Home Box Office, Inc. v. FCC
, 567 F.2d 9, 35-3 6 (D

. C

. Cir. 1977). That said, an ag ency ’s failure to addre ss a particula r comment or cate g ory of comments is not an APA violation per se

. See, e.g. , Thompson v. Clark
, 741 F.2d 401, 408 (D.C. Cir. 1984) (“[APA14

§ 553] h as never been interpre ted to require the ag ency to respond to ever

y comment, or to analy ze ev ery issue or alterna tive raised by t h e comments, no matter how insubstantial.”). We revie w an ag ency ’s response to comments under the sam e arbitra

ry -and- capr icious standard to which we hold the rest of its actions. See Home Box Office
, 567 F.2d at 35 n.58. Put simply
, “The failure to respond to comments is

s i g nificant only insofar as it demonstrates that the ag ency ’s decisi o n wa s not based on a consideration of the rele vant fac tor s

. ” Covad Commc’ns v. FCC
, 450 F.3d 528, 550 (D.C. Cir. 2006) (quoting Thompson , 741 F.2d a t 409).

The c omments identified by appellants cited scie ntific and ethical problems wi t h ESC rese arc h and categ orica lly objected
to funding any ESC rese arc h at all. They advocated funding other ty pes of stem-ce ll rese arc h instead. Cruci al l y , howeve r, this rec ommended course of action is diametrica lly opposed to the direction of Ex ecutive Orde r 13,505, which NI H soug ht to “implement” by issuing the Guidelines, see 74 Fe d

. Reg

. at 32,170. That Orde r makes it quite plain that i t s d o m i nant purpose was to “rem o ve” President Bush’ s 2001 “limitations”

on funding human E S C rese arc h and to “expand” NI H s upport for human stem-ce ll r e s e a

r c h
, “ including human embry onic stem cell resear ch

. ” See 74 Fe d. Reg

. at 10,667, §§ 1-2 (titled “Removing Ba

rrier s to Responsible S cientific Resear ch I nvolvin g Hu man Stem Cells”). Yet the comments at issue advoca te ending all ESC rese arc h fundin g— ev en for rese arc h that has b ee n el i g ible for funding for a deca de under the 2001

re s trictions. Following these commenters’ lead would direc tly
oppose the clea

r import of the Ex ecutive Orde r, which soug ht to

remove limit ations on ESC rese arc h and to expand NI H support for stem-c ell rese arc h.

NI H may not simply disreg ard an Ex ecutive Orde r. To the
contra ry , as an ag ency under the di rection of the executive15

branch
, i t must implement the President’s policy direc tives to the extent permitted by law. See Bldg. & C onst. Trades Dept.

v. Allbaugh
, 295 F.3d 2 8
, 32-33 (D.C. Cir. 2002) (citing T H E F E D E R A L I S T N O

. 72, at 463 (Alexander Hamilton) (B enjamin F. W ri g ht ed., 1961)). Bound as it is to car ry out the Presi d en t ’s directives, NI H thus rea sonably limit ed the scope of its Guidelines to implement the Ex ecutive Orde r. And beca use the Ex ecutive Orde r’s entire thrust was aimed at expanding support of stem-ce ll r esea

rch, it wa s not a

rbitrar y or capr icious for NI H to disre g ard comments that instead ca lled for termination of all ESC re sear ch (inc luding rese arc h that the executive branc h has permitted since 2001). Such comments simply did not address
any fac tor rele vant to implementing the E x ecutive O rder

.

Whil e the district court also reje cted the plaintif fs ’ AP A claim, it did so by rely

ing in part on its holding that NI H’s interpre tation of the Ex ecutive Orde r deser ved defe renc e under Udall v. Tallman
, 380 U.S. 1, 16-17 (1965). The p laintiffs claim that such d ef

er ence is unwar

rante d for a varie ty of

rea sons. We have no rea son to resolve this arg ument here

. We need not rely on defe renc e to NI H’s interpre tation of Ex ecutive Orde r 13,505 to conclude that NI H’s choice to disreg ard the
comments at issue was not arbitra ry or capr icious. NI H s t at ed that the scope of its Guidelines was t o “i mplement Ex ecutive Orde r 13505,” 74 Fe d. Reg

. at 32, 1 7 4
, and that Orde r plainly
starts from the premise that NI H should continue to fund at least

s ome ESC rese arc h. NI H’s decision to dismiss comments seeking to reope n that premise for debate there fore did n ot demonstrate a

failure to consider r eleva nt fac tors.

Conclusion

For the above rea sons, we aff irm the dist ri ct co urt’s g rant of summary

judgme nt in favor of

the g overnme nt. So ordered.K AREN L E C RAFT H ENDERSON , Circuit Judge , concurring: My colleagues correctly note that Sherley v. Sebelius , 644 F.3d 388 (D.C. Cir. 2011) ( Sherley I ), applied Chevron to uphold the National Institute of Health (NIH) Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009) (Guidelines). See Maj. Op. at 8. Although the law of the case prevents us from reconsidering that holding, I write separately for the record to point out that Chevron review is inapplicable to the Guidelines. “Not every agency interpretation of a statute is appropriately analyzed under Chevron .” Ala. Educ. Ass’n v. Chao , 455 F.3d 386, 392-93 (D.C. Cir. 2006). Chevron applies only “when it appears that Congress delegated authority to the agency generally to make rules carrying the force of law, and that the agency interpretation claiming deference was promulgated in the exercise of that authority.’ ” United States v. Mead Corp. , 533 U.S. 218, 226-27 (2001)). In short, we accord Chevron deference only when reviewing an agency’s “construction of a statutory scheme it is entrusted to administer .” Id . at 227-28 (quoting Chevron, 467 U.S. at 844) (emphasis added). “[W]hen an ag ency interprets a statute other than that which it has been entrusted to administer, its interpretation is not entitled to [ Chevron ] deference.” Dep’t of Treasury v. FLRA , 837 F.2d 1163, 1167 (D.C. Cir. 1988). NIH’s construction of the Dickey-Wicker Amendment falls outside the Chevron ambit because NIH was not charged with administering the Amendment, as is obvious from both its language and its substance. First, the Amendment’s language makes clear its administration is not within the exclusive province of NIH or its parent agency, the Department of Health and Human Services. It has been enacted annually as a rider to an omnibus appropriations act, in a division governing “Departments of Labor , Health and Human Services, and Education, and Related Agencies Appropriations .” Consolidated Appropriations Act of 2012, Pub. L. No. 112-74, div. F ., § 508(a), 125 Stat. 786, 11122

(2011) (emphasis added); see also, e.g., Consolidated Appropriations Act of 2011, Pub. L. No. 111-117, div. D, § 509(a), 123 Stat. 3034, 3280-81 (2010) (same division title); Omnibus Appropriations Act of 2010, Pub. L. No. 111-8, § 509(a), div. F, 123 Stat. 524, 803 (2009) (same). Because each annual rider by its terms applies generally to multiple agencies, Chevron deference is not due any one agency’s interpretation of its language. See Proffitt v. FDIC , 200 F.3d 855, 860 (D.C. Cir. 2000) (“When a statute is administered by more than one agency, a particular agency’s interpretation is not entitled to Chevron deference.”). In the past, we have “declined to defer to an agency’s interp retation of a statute when more than one agency is granted authority to interpret the same statute,” reasoning that “[i]n such cases, it cannot be said that Congress implicitly delegated to one agency authority to reconcile ambiguities or to fill gaps, because more than one agency will independently interpret the statute.” Salleh v. Christopher , 85 F.3d 689, 692 (D.C. Cir. 1996) (citing, e.g. , Rapaport v. U.S. Dep’t of Treasury , 59 F.3d 212, 216-17 (D.C. Cir. 1995), cert. denied , 516 U.S. 1073 (1996); Benavides v. U.S. Bureau of Prisons , 995 F.2d 269, 272 n.2 (D.C. Cir. 1993); Prof’l Reactor Operator Soc’y v. U.S. Nuclear Regulatory Comm’n , 939 F.2d 1047, 1051 (D.C. Cir. 1991)). Sherley I therefore erred in applying Chevron to NIH’s interpretation.
Second, the Amendment, as a rider to a federal appropriations statute, is “not within [any agency’s] area of expertise” and therefore a particular agency’s interpretation thereof “receives no deference.” U.S. Dep’t of Navy v. FLRA

, 665 F.3d 1339, 1348 (D.C. Cir. 2012); see, e.g. , Ass’n of Civilian Technicians, Tony Ke mpenich Mem’l Ch. 21 v. FLRA

, 269 F.3d 1119, 1121 (D.C. Cir. 2001) (court does not defer to FLRA’s “interpretation of the Department of Defense Appropriations Act, a statute not committed to the Authority's administration” but “reviews such purely legal questions de novo”). Indeed the rider’s language reveals no express3

delegation of authority—implicit or explicit—to any agency to administer its provisions—which is unsurprising given that the rider itself confers no substantive authority on any agency to do anything; it simply—and plainl y—prohibits the Departments of Labor, Health and Human Services and Education, as well as “[r]elated [a]gencies,” from using the appropriated funds for the specifically enumerated purposes. Because the Dickey-Wicker Amendment does not delegate administrative authority to the Department of Health and Human Services or to NIH, I believe that Sherley I incorrectly applied the Chevron framework. See 644 F.3d at 392 (D.C. Cir. 2011) (“We approach this issue under the familiar two-step framework of Chevron . . . .”). The court should instead have interpreted the statute de novo, according no deference to NIH’s interpretation. * See Ass’n of Civilian Technicians , 269 F.3d at 1121; Proffitt , 200 F.3d at 860; see also Dep’t of Treasury , 837 F.3d at 1167 (“Because the FLRA’s refusal to award back pay did not rest on an interpretation of its organic statute, but rather on its reading of the Back Pay Act—a general statute—the FLRA’s interpretation is entitled to respect before this court, but we are not bound by its construction of the statute even if reasonable.”). Had we done so, I believe we would have invalidated the Guidelines as contrary to the Amendment’s plain and unambiguous text. See Sherley I , 644 F.3d at 400-02 (Henderson, J., dissenting) ( Sherley I Dissent ).

* Even so-called Skidmore deference is not available because it also applies only to an agency in terpretation of a statute the agency administers. See United States v. Mead Corp. , 533 U.S. at 228 (under Skidmore v. Swift & Co. , 323 U.S. 134 (1944), “[t]he fair measure of deference to an agency admini stering its own statute has been understood to vary with circumstances, and courts have looked to the degree of the agency’s care, its c onsistency, formality, and relative expertness, and to the persuasiveness of the agency’s position”) (footnotes omitted).4

The Amendment prohibits federal funding of ‘‘research in which a human embryo or embryos are destroyed.” Pub. L. No. 112-74 § 508(a)(1). Contrary to the holding in Sherley I , this ban plainly prohibits federal funding that the Guidelines expressly permit —namely, the funding of human embryonic stem cell (hESC) research that is conducted after the destruction of the embryo. See 74 Fed. Reg. at 32,174. This conclusion is compelled by the dictionary de finition of “research” as a “systematic inquiry or investiga tion,” which necessarily includes not only “the first sequence of hESC research [involving ] the derivation of stem cells from the human embryo” but also “the succeeding sequences of hESC research.” Sherley I Dissent , 644 F.3d at 401. The Sherley I majority, however, ignored the Amendment’s plain meaning, manufacturing ambiguity where there was none. Sherley I Dissent , 644 F.3d at 399, 402-05. Nevertheless, Sherley I ’s Chevron step-two analysis is the law of the case and we are bound thereby. See Maj. Op. at 7-12.BROWN, Circuit Judge , concurring: D espite many points of agreement with my colleagues, I write separately because we converge from different paths and there are aspects of this

case that

— NIH’s insouciance notwithstanding

— should trouble the heart. E ven Dr. James Thompson, the researcher credited with being the first to successfully derive human embryonic stem cells, has admitted : “If human embryonic stem cell research does not make you at least a bit uncomfortable, you have not thought about it enoug h.” Gina Kolata, Man Who Helped Start Stem Cell War May End It

, N.Y. T IMES , Nov. 22, 2007.

I. Chevron Deference

If this was ever a simple case it long ago ceased to be one. The judiciary, the executive branch, the scientific community, and numerous legal commentators have put forth disparate interpretations of the Congressional prohibition on the use of federa l funds for stem cell research. 1 Legislators, too, express

1 See, e.g.

, Sherley v. Sebelius , 704 F. Supp. 2d 6 3 (D.D.C. 2009); Jenny Shum, Moral Disharmony: Human Embryonic Stem Cell Patent Laws, W ARF , and Public Policy , 33 B.C. I NT ’ L & C OMP

. L. R EV

. 153, 163 (2010) (“Essentially, the amendment rendered any scientific research on hESCs ineligible for federal fundi ng.”); Ronald Green, Political Interventions in U.S. Human Embryo Research: An Ethical Assessment , 38 J.L. M ED

. & E THICS 220, 224 (2010) (“Dickey

- Wicker not only prohibits research t hat risks or destroys an embryo

— applying to embryos whether in vitro or in utero the same protections applied to fetuses and even more stringent protectio ns than those afforded children

— but it defines the embryo as any organism produced by fertilization, parthenogenesis, cloning, or any other means from one or more human gamet es”) ; Maite S. Kollmann, Taking the Moral High Road: Why Embryonic Stem Cell Research Should Be Strictly2
conflicting views. 2 D isagreement is inevitable when what lies at the core of the di spute is a profound question ab out the boundaries of science

— one that is irreducibly controversial because the slippery slope is p recipitous in both directions. Ours, though, is not the legislative burden of bringing considered resolution to this contested question. We ponder a much narrower, much more prosaic query that serves only as

a rough proxy for the metaphysics : does the Dickey

- Wicker Amendment’s prohibition on federal funding of “research in which a human embryo or embryos are destroyed” or “knowin gly subjected to the risk of death or injury, ” Pub. L. No.112

- 74 , sec. 508(a)(1

– 2 ) , preclude federal funding for all human embryonic stem cell research? And how much deference, if any, shou ld be accorded to the agency’s view that stem cell research can be decoupled from the derivation of the stem cell line ?

Regulated

, 2 F AULKNER L. R EV

. 145, 155 (2010) (“[NIH] General Counsel Rabb concluded that the Dickey

- Wicker Amendment, which prohibited the use of fund s allocated to the HHS for human embryo research, would not be applicable to research using hESCs ‘because such cells are not a human embryo within the statutory definition.’”).
2 In the Senate hearing convened to respond to the district court’s initial i njunction in this case, Senator Wicker maintained that “if human embryonic stem cell research is to be done at all, it should be paid for with nontaxpayer funds.” The Promise of Human Embryonic Stem Cell Research: Hearing before S. Subcomm. on Appropriatio ns , Statement of Sen. Roger Wicker, 111th Cong. 3

– 4 (2010). In the same hearing, Senator Feinstein excoriated the District court’s “alarming” decision as “an unprecedented and highly restrictive interpretation of the Dickey

- Wicker amendment.” The Promise o f Human Embryonic Stem Cell Research: Hearing before S. Subcomm. on Appropriations

, Statement of Sen. Dianne Feinstein, 111th Cong. 33 (2010).3
Every substantive decision in this case’s checkered past has proceeded under the assumption that Che vron U.S.A. Inc. v. Natural Resources Defense Council, Inc.

, 467 U.S. 837 (1984), controls the statuto ry interpretation. I thus welcome

— and heartily concur with

— the portion of Judge Henderson’s concurring opinion dealing wit h this threshold determination. Like her, I conclude Chevron does not apply and the court should have accorded no deference to NIH’s interpretation. See AKM LLC dba Volks Constructors v. Sec. of Labor, 675 F.3d 752, 764

– 69 (D.C. 2012) (Brown, J., concurring). But in this case, deference is not dispositive. Judge Henderson finds the Amendment’s ban “plainly prohibits federal funding th at the Guidelines expressly permit

— namely, the funding of human embryonic stem cell (hESC) research that is conducted aft er destruction of the embryo.” Conc urrence at 4 ( Henderson, J.)

. I am not so sanguine. Judge Henderson’s readi ng is certainly plausibl e and undoubtedly consistent with the initial conclusion of the trial court that the language “reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in whic h a human embryo is destroyed.” Sherley v. Sebelius

, 704 F. Supp. 2d 63, 70

– 71 (D.D.C. 2010)

. But it still does not tell us how to define “ research ” in light of the many layers of executive orders, agency interpretation

, and legislative acquiescence with which we must now deal

. Congressional efforts to grapp le with the ethical challenges arising from the extraordinary advances in biomedicine and biotechnology date back at least to the passage of the National Research Act in 1974. See Pub. L. No. 93

- 348, 88 Stat. 342. Since then, there has been no shortage of committees, boards, and panels all dedicated to the study and consideration of the moral, legal, and ethical dimensions of using human subjects, or human cellular or4
genetic materials

, in scientific experimen ts. 3 More recently, Congress passed the NIH R evitalization Act of 1993, Pub. L. 103

- 43, under which NIH established the Human Embryo Research Panel (“HERP”). While the bill’s focus was human reproductive biology, HERP concluded that “[r]esearch involving the development of embryonic stem cells [done ] with embryos resulting from IVF treatment for infertility or clinical research that have been donated” was “acceptable” and could receive federal funding. Human Embryo Research Panel, Volume I of the Report of the Human Emb ryo Research Panel, 75

– 76 (Sep tember 1994). 4

Congress passed the Dickey

- Wicker Amendment in 1996 partially in response to some of HERP’s bolder recommendation s , perhaps agreeing with the Washington Post that the Panel had gone “a step too far.” See Green, supra , at 224. The Amendment was not directed at the precise research at issue here, 5 but whatever the Amendment’s original purpose, President Clinton’s decision in 1999 to announce a policy of federal funding for embryonic stem cell research

— and Congress’s decision to pass the Amendment unchanged

3 The Ethics Advisory Board (“EAB”), for example, came into being in the late 1970s around the time scientists produced the first
test

- tube baby. The EAB focused on federal support for in vitro fertilization (“IVF”) and embryo transfer. See Ethics Advisory Board, Report and Conclusions: HEW Support of Research Involving Human In Vitro Fertilization and Embryo Trans fer 1

– 7 (May 4, 1979), available at http://bioethics.georgetown.edu/pcbe/reports/past_commissions/HE W_IVF_report.pdf . For a list of other prominent past commissions, see O. Carter Snead, Science, Public Bioethics, and the Problem of Integration , 43 U.C. D AVIS L. R EV

. 1529, 1539 n. 32 (2010).
4 The panelists were foresighted as scientists had not yet derived human embryonic stem cells.
5 See 142 C ONG

. R EC

. S429

- 01 (1996).5
the following year

— altered the interpretive calculus

. See Joint Appendix at 523. In the same vein, Congress’s decision to pass the Amendment unchanged for all eight years of the Bush Administration se ems to confirm its acquiesce nce to

some federal funding of research invol ving human embryonic stem cells. 6 Indeed, Congress supplemented t his implicit approval of funding for embryonic stem cell research with contemporaneous Senate and House reports explic itly stating that the amendment “should not be construed to limit federal support for research involving human embryonic stem cells listed on an NIH registry and carried out in accordance with the policy outlined by the President.” NIH Br. at 14 (quoting H.R. Rep. No. 107

- 229, at 180 (Oct. 9, 2001)).

For this reason, I am of the view that de novo revi ew would not change the outcome of the prior decision to affirm NIH’s interpretation of the act. I thus join in the judgment of the majority opinion though I would reach the decision using the more familiar clear error standard of review under which we must vacate the logic of the prior holding and supply our own should we find that the prior decision was “clearly erroneous and would work a manifest injustice

. ” LaShawn v. Barry , 87 F.3d 1389, 1395 (D.C. Cir. 1996) (referencing Christianson v. Colt Indus. Operating Corp.

, 486 U

. S

. 800

, 817 (1988) )

. The facts in the record before us do not, however, rise to the level of these “extraordinary circumstances.” Id. That we have only now, some four

- years and multiple opinions later, questioned the propriety of Chevron strongly suggests that the decisions of the reasonable

6 President Bush’s policy was decidedly narrower than that of President Clinton, but it still authorized funding. Consequently, it must be said to violate the appellants’ reading of the Dickey

Wicker A mendment.6
jurists considering these matters were not “clearly erroneous.” 7
II. Failure to Reply to Comments

Although it is difficult to take issue with any part of the majority’s catechism on the agency’s refusal to re spond to thousands of comments, the whole seems somewhat problematic . Obviously, t he opportunity to comment is meaningless unless the agency responds substantively to significant points raised by the public

. But the law of this Circuit is clear: an agency is only required to respond to
comment s if, for example, it can be established that the comment is “relevant to the agency’s decision and wh ich, if adopted, would require a change in [the] agency’s proposed rule, Home Box Office, Inc. v. FCC, 567 F.2 d 9, 35 n. 58 (D.C. Cir. 1977), or that a failure to respond would “demonstrate[] that the agency’s decision was not based on a consideration of the relevant factors, ” Covad Comm c’ns Co. v. FCC, 450 F.2d 186, 197 (D.C. Cir. 1993). In applying this test, however, the majority defines “relevance” as coextensive with the President’s Executive Order and does so without imposing any clear limits on an a gency’s ability to ignore comments that contravene the executive’s policy goals. I fear that without such boundaries there remains the distinct possibility that the executive power will expand at the expense of the APA’s regulatory scheme and judicial rev iew will be reduced to rubberstamping preordained result s

.

7 When the dust settles and the votes are talli ed, a majority of this panel supports two seemingly conflicting positions: (1) that law of the case doctrine prevents us from reconsidering the earlier ruling that applied Chevron and (2) that Chevron does not apply. Thus, the majority opinion stands only for the proposition that the earlie r result need not be overturned

— not that the decision was correct in all respects.7
Clearly, if the Dickey

- Wicker Amendment’s prohibition was unambiguous, NIH could not ignore an entire class of interpretive vie w s because a broad reading of “research” would run counter to the e xecutive’s agenda. Similarly, I do not think the agency could attempt to implement an expansive program Congress had explicitly rejected by deeming challenges to its authority irrelevant. But this is not the case here

. As an initial matter, the comments Appellants argue were wrongfully ignored focus not on the text of Dickey

Wicker or the question of legislative authorization, but on the Executive Order’s (and the Guidelines ’ ) requirement that only “responsible” and “scientifically worthy” re search s hould be eligible for funding. Appellant Br. at 45. This is fundamentally a policy question and we must respect the Executive’s ability to reasonably define the contours of the proposed rulemaking. Nor is there a conflict between branches i n NIH’s decision to couch their rejection in more absolute terms, i.e. , declaring all comments “ advocating a blanket ban on all funding for hES C research . . . not relevant.’” See J oint App’x at 479

– 80. The NIH cannot be said to have acted arbitrarily and capricio usly by refusing to

re

- open a debate that, as a practical matter, has been foreclosed for more than a decade. Because I ultimately reach the same result, I thus concur with the majority’s conclusion and leave the more technical questions of Executive Orde rs and deference for a later day.

The challenging

— and constantly evolving

— issues presented by bioethics are critical and complex

. Striking the right balance is not easy and not, in the first instance, a task for judges

. What must be defended is “the integrity of science, the legitimacy of government, and the continuing vitality” of concepts like human dignity. 8 Given the weighty interests at

8 Snead, supra n. 3, at 1604.8

stake in this encounter between science and ethics, r elying on an increasingly Delphic, decade

- old single paragraph rider on an appropriations b ill hardly seems adequate

.