O'Connell v. Shalala

UNITED STATES COURT OF APPEALS
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
FOR THE FIRST CIRCUIT

No. 95-1355

FRANCIS O'CONNELL AND LISA O'CONNELL,
AS THE LEGAL REPRESENTATIVES OF THEIR MINOR DAUGHTER,
KELLIANN O'CONNELL, AND DISSATISFIED PARENTS TOGETHER,
A VIRGINIA NON-PROFIT CORPORATION,

Petitioners,

v.

DONNA E. SHALALA, SECRETARY OF THE UNITED STATES
DEPARTMENT OF HEALTH AND HUMAN SERVICES,

Respondent.

PETITION FOR REVIEW OF A FINAL RULE OF
THE SECRETARY OF HEALTH AND HUMAN SERVICES

Before

Torruella, Chief Judge,

Aldrich, Senior Circuit Judge,

and Selya, Circuit Judge.

Curtis R. Webb, with whom Michael R. Hugo and Conway,

Crowley & Hugo, P.C. were on brief, for petitioners.

Charles R. Gross, Attorney, Civil Division, United States

Department of Justice, with whom Frank W. Hunger, Assistant

Attorney General, Helene M. Goldberg, Director, Civil Division,

Barbara C. Biddle, Attorney, Civil Division, David Benor and

Deborah Harris, Office of the General Counsel, United States

Department of Health and Human Services, were on brief, for
respondent.

March 11, 1996

SELYA, Circuit Judge. This is a petition for review
SELYA, Circuit Judge.

and vacatur of a final rule promulgated by the Secretary of

Health and Human Services (the Secretary) under the National

Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10

through 300aa-34 (1994). We have jurisdiction under 42 U.S.C.

300aa-32. In the pages that follow, we explore the pertinent

statutory framework, recount the proceedings to date, and then

examine the petitioners' three-pronged challenge. When all is

said and done, we deny the petition and leave the rule intact.

I. THE STATUTORY SCHEME
I. THE STATUTORY SCHEME

The administration of childhood vaccines, though

critically important to public health, "is not always without

risk." Committee to Review the Adverse Consequences of Pertussis

and Rubella Vaccines, Institute of Medicine, Adverse Effects of

Pertussis and Rubella Vaccines 1 (1991) (IOM Report). Since

vaccines generally contain either dead bacteria or live but

weakened viruses, it is not surprising that they are capable of

causing serious adverse effects. See id. Despite the

infrequency of such episodes, Congress feared that the long

shadow of tort liability cast by vaccine-related injuries would

drive up prices and eventually force vaccine suppliers out of the

market. See H.R. Rep. No. 908, 99th Cong., 2d Sess. 1, 4, 6-7

(1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6345, 6347-48.

Congress also worried that the vagaries of litigation, coupled

with the cost, might leave many deserving victims of vaccine-

related injuries undercompensated. See id.

2

To protect the supply of vaccines while ensuring fair,

timely compensation for victims, Congress departed from the

traditional tort system and wrote the National Childhood Vaccine

Injury Act (the Act), Pub. L. No. 99-660, tit. III, 100 Stat.

3755 (1986). Among other things, the Act established a special

tribunal (the Vaccine Court), and moved vaccine-injury cases

partly outside the customary tort framework. See Schafer v.

American Cyanamid Co., 20 F.3d 1, 2 (1st Cir. 1994) (explaining

the mechanics of the Act).1 In respect to cases brought before

this tribunal, Congress eased the complainants' burdens both by

dispensing with the requirement of proving negligence and by

greatly simplifying the requisite proof of causation. See 42

U.S.C. 300aa-11. Of course, there are tradeoffs; for example,

Congress limited the damages that a victim could obtain for

vaccine-related injuries. See id. 300aa-15.

In aid of the neoteric regulatory regime, the Act

provides, in tabular format, a listing of vaccines and a parallel

listing of medical conditions commonly associated with the use of

each vaccine. See id. 300aa-14(a). These listings, known

collectively as the Vaccine Injury Table (the Table), are

accompanied by, and are to be read in light of, the

1The Act does not entirely supplant traditional tort
remedies. An injured person is required to repair first to the
Vaccine Court, but if she is not satisfied with the result she
may reject the judgment and proceed to litigate her claim in a
more conventional forum subject to certain substantive and
procedural limitations established by the Act. See Schafer, 20

F.3d at 2-3 (discussing interplay between the Act and the tort
system).

3

Qualifications and Aids to Interpretation (QAI). The QAI is a

separate subsection that provides definitions and explanations

for the terms used in the Table. See id. 300aa-14(b). To

receive compensation for a vaccine-related injury, a recipient

must simply petition the Vaccine Court and show that, within a

prescribed time span, she suffered one or more of the disorders

listed in the Table as associated with the particular vaccine

that she received. Thus, the content of the Table (a sample of

which is excerpted in the Appendix) is critical: it is only when

a vaccinated child suffers a listed condition within applicable

temporal parameters that compensation will be forthcoming without

the time, expense, proof requirements, and uncertainty of full-

blown litigation.

The Table is not intended to be static. Congress gave

the Secretary express power to promulgate regulations adding to

or subtracting from the tabular list of conditions, and changing

the delineated time periods. See 42 U.S.C. 300aa-14(c)(3).

This is a rather odd approach because it authorizes the

Secretary, in effect, to amend the statutorily enacted Table by

way of administrative rulemaking.2 This grant of power probably

reflected a congressional consensus that the first iteration of

the Table was not perfect. Driven by a sense of urgency to put

2As such, the Act may raise questions under the Presentment
Clause, which requires that all federal laws must be passed by
both houses of Congress and signed by the President. See U.S.

Const. art. 1, 7; see also INS v. Chadha, 462 U.S. 919, 954

(1983) ("Amendment and repeal of statutes, no less than
enactment, must conform with Art[icle] I."). Since this issue is
not raised in the instant petition, we take no view of it.

4

something into place, the solons knowingly used incomplete data

when forging the causal links between vaccines and associated

medical conditions. Mindful of its haste, Congress directed the

Secretary to have the Institute of Medicine (IOM) an arm of the

National Academy of Science conduct an extensive review of all

available information bearing on the relationship between

vaccines and medical conditions, and thereafter to publish

findings and revise the Table based on the IOM's study. See

Vaccine Act 312, 100 Stat. at 3779.

To assist the Secretary in updating the Table, Congress

created the Advisory Commission on Childhood Vaccines (ACCV) a

body composed of a cross-section of health professionals, legal

experts, interested citizens (including two who are parents of

children victimized by vaccine-related injuries), and federal

officials. See 42 U.S.C. 300aa-19. Congress directed the

Secretary to provide the ACCV with a copy of each contemplated

regulation before formally proposing it, and then to await the

expiration of a ninety-day comment period before moving forward.

See id. 300aa-14(d).

II. THE COURSE OF EVENTS
II. THE COURSE OF EVENTS

In 1991, the IOM completed its study and, on August 27,

issued the IOM Report. Among the many conclusions contained in

this tome the IOM found a causal relation between DPT

(diphtheria-pertussis-tetanus) vaccine, on one hand, and acute

encephalopathy and hypotonic, hyporesponse episodes (HHE), on the

5

other hand.3 See IOM Report at 118, 177. However, the IOM found

insufficient evidence to indicate a causal relationship between

DPT vaccine and residual seizure disorders (such as epilepsy).

See id. at 118 n.3. The project director gave the ACCV a full

briefing on the IOM Report in September of 1991.

In anticipation of receiving the IOM Report, the

Secretary formed a Public Health Service Task Force as a vehicle

for revising the Table. She also enlisted yet another helpmate,

the National Vaccine Advisory Committee (NVAC). Unlike the ACCV,

which by statute counsels the Secretary in respect to the injury

compensation program, see 42 U.S.C. 300aa-19, the NVAC's

statutory responsibility is to advise the director of the

separate national program for developing and administering the

public health aspects of immunization policy, see id. 300aa-5.

The Secretary transmitted the IOM Report to the Task Force, which

then recommended a number of changes to the Table (including the

removal of encephalopathy, HHE, and residual seizure disorders as

associated medical conditions vis-a-vis DPT vaccination).4 The

NVAC concurred in these recommendations.

3Encephalopathy is a general term that refers to "any
disease of the brain." Stedman's Medical Dictionary 508 (25th

ed. 1990). HHE, also known as shock, shock-like state, or shock
collapse, refers to "an unusual reaction consisting of an acute
diminution in sensory awareness or loss of consciousness
accompanied by pallor and muscle hypotonicity [reduced tension]."
IOM Report at 171-72.

4Even though the IOM Report verified a causal relation
between the first two conditions (encephalopathy and HHE) and DPT
vaccinations, the Task Force did not believe the study disclosed
credible evidence of prolonged neurological damage.

6

Despite the fact that the ACCV had not yet formally

received the Task Force's or the NVAC's recommendations, it took

up the substance of the proposed revisions at its December 1991

meeting. In lieu of the literal text of the suggested changes,

the ACCV members received what has been referred to as a "matrix"

essentially, a table comparing a synthesis of Task Force and

NVAC recommendations and summarizing the rationales advanced by

those bodies. The ACCV discussed these recommendations at length

and approved all but the one that suggested dropping

encephalopathy from the Table. As a counter-proposal, the ACCV

encouraged the Secretary to modify the QAI definition of

encephalopathy in a way that would restrict its meaning to acute

or chronic episodes of a type more likely to result in

significant harm.

In due season, the Secretary published a Notice of

Proposed Rulemaking (the Notice). See 57 Fed. Reg. 36,878

(proposed Aug. 14, 1992). The Notice included the required

scientific findings and set forth regulations designed to revise

the Table accordingly. These covered all the Task Force's

recommendations save only for the dropping of encephalopathy. On

that point the Secretary acquiesced in the ACCV's view and

proposed a new definition of the condition similar in most

respects to the definition discussed at the ACCV's December 1991

meeting. See id. at 36,880. A comment period and public hearing

ensued.

In 1993, the results of a ten-year study of acute

7

childhood neurologic illnesses became available. Recognizing the

potential importance of the study, the Secretary stayed her hand

and requested the IOM to review the newly compiled material. In

March 1994, the IOM concluded that the "balance of the evidence

is consistent with a causal relationship" between DPT vaccination

and certain forms of chronic nervous system dysfunction suffered

by children who experience an acute neurologic illness shortly

after vaccination. Committee to Study New Research on Vaccines,

Institute of Medicine, DPT Vaccine and Chronic Nervous System

Dysfunction: A New Analysis 2-3 (1994). On March 24, 1994, the

Secretary reopened the comment period for a limited time,

restricting discussion to the question whether the previously

proposed revisions should be modified in light of the

supplemental report.

At its June 1994 meeting the ACCV discussed the new

information as it concerned the proposed definition of

encephalopathy. This time, the ACCV did not achieve consensus on

the subject, and simply transmitted the minutes of its meeting to

the Secretary. On February 8, 1995, the Secretary promulgated a

final rule (under attack in this proceeding) that removed HHE and

residual seizure disorders from the Table and changed the

definition of encephalopathy in a manner very similar (but not

identical) to the manner originally suggested by the ACCV and

proposed in the Notice. See 60 Fed. Reg. 7678 (1995).

Francis and Lisa O'Connell (parents and legal

representatives of Kelliann O'Connell), joined by a parents'

8

advocacy group, now seek judicial review and vacatur of the final

rule.5

III. THE PETITIONERS' CHALLENGE
III. THE PETITIONERS' CHALLENGE

The petitioners raise three objections to the

Secretary's action. First, the petitioners assert that the Act

does not empower the Secretary to change the definitions included

in the QAI, but, rather, only authorizes the Secretary to add and

subtract entries (i.e., vaccines and associated medical

conditions) and change time periods specified in the Table

proper. Second, the petitioners contend that, even if the

Secretary otherwise had authority to effectuate the contested

change, she failed to follow the procedures mandated by the Act.

Finally, the petitioners insist that a decision to remove a

medical condition from the Table must be based on definitive

evidence refuting the existence of a causal relationship between

the vaccine in question and the condition, and that the Secretary

eliminated HHE and residual seizure disorders from the Table

notwithstanding the absence of such an evidentiary predicate. We

address each remonstrance separately.

A. Authority to Revise the QAI.
A. Authority to Revise the QAI.

The petitioners argue that the Secretary's attempt to

change the definition of encephalopathy provided in the QAI is

5When queried at oral argument as to his clients' standing,
the petitioners' attorney explained that Kelliann had suffered an
adverse reaction after vaccination that would have been included
within the original tabular definition of encephalopathy but
which fell outside the revised definition. The Secretary does
not challenge this recital, and we therefore accept counsel's
explanation at face value.

9

impuissant because it surpasses the authority granted to the

Secretary by the Act. The Act states:

A modification of the Vaccine Injury Table
under paragraph (1) [authorizing the
Secretary to "promulgate regulations to
modify" the Table] may add to, or delete

from, the list of injuries, disabilities,

illnesses, conditions, and deaths, for which
compensation may be provided or may change

the time periods for the first symptom or

manifestation of the onset or the significant
aggravation of any such injury, disability,
illness, condition, or death.

42 U.S.C. 300aa-14(c)(3) (emphasis supplied). In the

petitioners' view, the underscored phrases limit the Secretary's

powers of alteration, and hence, because the QAI provision is

distinct from the Table proper, the Secretary's revisory

authority does not extend to it. Ergo, changing the definition

of encephalopathy contained in the QAI oversteps the Secretary's

bounds. The Secretary debunks this argument. She construes the

statute more broadly, urging that it gives her authority to

rewrite the QAI.

1. Chevron Deference. Before choosing between these
1. Chevron Deference.

competing views, we must address a preliminary issue. The

Secretary, correctly observing that courts ordinarily defer to an

agency's plausible construction of a silent or ambiguous statute

as long as Congress has committed the statute to the agency for

purposes of administration, see Chevron U.S.A. Inc. v. Natural

Resources Defense Council, Inc., 467 U.S. 837, 842-43 (1984);

Strickland v. Commissioner, Me. Dep't of Human Servs., 48 F.3d

12, 16 (1st Cir.), cert. denied, 116 S. Ct. 145 (1995), asks that

10

we defer to her construction of 300aa-14(c). There may be more

to this request than meets the eye. The petitioners' objection

is arguably not directed at a regulation that purports to apply a

particular statutory directive which the Secretary is concededly

empowered to implement, but instead at a regulation that lies in

an area as to which, the petitioners say, the statute grants the

Secretary no rulemaking authority at all. In the current state

of the law, it is unclear whether deference is appropriate under

such circumstances.6

Discretion is sometimes the better part of valor.

Because we decide, as a matter of original statutory

construction, that the Act grants the Secretary authority to

revise the QAI provision, see infra, we leave the question of

deference unanswered.

2. Interpreting the Statute. We turn now to the
2. Interpreting the Statute.

disputed statute. While one can focus with Cyclopean intensity

6The Supreme Court has never taken a clear institutional
stand on the question. In Mississippi Power & Light Co. v.

Mississippi, 487 U.S. 354 (1988), the Court affirmed an agency's

interpretation of a statute in a comparable situation, but
without relying on Chevron-type deference. Justice Scalia,

writing separately, argued for deference even though the
interpretive question involved the scope of the agency's
authority under the statute. Id. at 381 (Scalia, J.,

concurring). Justice Brennan, writing for himself and two other
Justices, expressed the view that deference was inappropriate
because the scope of an administrative agency's jurisdiction is
not a decision that Congress normally entrusts to the agency.
Id. at 387 (Brennan, J., concurring). The problem is complicated

by a realization that almost any administrative action can be
described by a challenger as either exceeding an agency's
authority or overstepping the authorized application of agency
authority. See generally Thomas W. Merrill, Judicial Deference

to Executive Precedent, 101 Yale L.J. 969, 997-98 (1992).

11

on the words singled out by the petitioners and perhaps construct

a coherent argument that those words restrict the Secretary's

revisory authority to the Table proper, courts are bound to

afford statutes a practical, commonsense reading. See King v.

St. Vincent's Hosp., 502 U.S. 215, 221 (1991). Instead of

culling selected words from a statute's text and inspecting them

in an antiseptic laboratory setting, a court engaged in the task

of statutory interpretation must examine the statute as a whole,

giving due weight to design, structure, and purpose as well as to

aggregate language. See National R.R. Passenger Corp. v. Boston

& Me. Corp., 503 U.S. 407, 417 (1992); Dole v. United

Steelworkers of Am., 494 U.S. 26, 36 (1990); K mart Corp. v.

Cartier, Inc., 486 U.S. 281, 291 (1988); Riva v. Massachusetts,

61 F.3d 1003, 1007 (1st Cir. 1995).

The petitioners' reading of the Act cannot survive the

application of this global standard. Reading the statute as a

whole, we are satisfied that Congress gave the Secretary

authority to revise the QAI. In the absence of such authority

the system for updating the Act is virtually unworkable. For

instance, when the Secretary exercises her undeniable power to

include an emergent condition in the Table, she must be able to

amend the QAI to reflect the addition. Surely Congress did not

intend either to leave added conditions unexplained or itself to

edit the QAI every time the Secretary saw fit to alter the Table.

In short, the power to revise the QAI is a necessary adjunct of

12

the power to revise the Table itself.7 Elsewise, the tension

that would be created within the structure of the Act would be

intolerable and would contravene the salutary principle that

statutes should, whenever possible, be construed sensibly. See

American Tobacco Co. v. Patterson, 456 U.S. 63, 71 (1982); Riva,

61 F.3d at 1008; United States v. Meyer, 808 F.2d 912, 919 (1st

Cir. 1987); see also Norman J. Singer, Sutherland Statutory

Construction 45.12, at 61 (5th ed. 1992).

We add, moreover, that the petitioners' proffered

reading of the statute is excessively formalistic. If the

Secretary could not change the definition of encephalopathy

directly, she could certainly accomplish the same result

indirectly. She need simply delete encephalopathy from the

Table, thus rendering its definition nugatory, and then

immediately add encephalopathy, redefined, to the Table.

This reality is lethal to the petitioners' position.

We cannot imagine that Congress intended to force the Secretary

to go round and round the mulberry bush in order to revise the

Table and its accompanying explanations. The shortest distance

between two points is a straight line, and we will not lightly

presume that Congress lost sight of so abecedarian a principle.8

7In their reply brief, the petitioners seemingly concede
that this is so, but suggest that the Secretary may only revise
the QAI when she is in the process of modifying the Table itself.
The suggestion is meritless. Nothing in either the text or the
history of the statute supports such an artificial construction.

8Congress had a golden opportunity to express an intent
contrary to the Secretary's view that she possesses the power to
revise the QAI, but it chose not to do so. Originally, the Act

13

See Singer, supra, 45.12, at 61 (advocating the baseline

assumption that an enacted statute should be construed to

"achieve[] an effective and operative result"). To cinch

matters, we note that the statutory grant of a greater power

typically includes the grant of a lesser power, see, e.g., United

States v. O'Neil, 11 F.3d 292, 296 (1st Cir. 1993) (describing

this principle as "a bit of common sense that has been recognized

in virtually every legal code from time immemorial"), and the

overall structure of the Vaccine Act confirms its applicability

here: the brute power to subtract listed medical conditions from

the Table encompasses the more modest power to trim the

definitions associated with listed medical conditions.

We have said enough on this score. We hold that the

Act grants the Secretary the authority to revise the

Qualifications and Aids to Interpretation that accompany the

Vaccine Injury Table. Consequently, the petitioners' initial

remonstrance fails.

B. Notification.
B. Notification.

The petitioners accuse the Secretary of failing to

observe the required notification procedures when she promulgated

did not permit the Secretary to add vaccines to the Table. In
1993, Congress amended the law to allow the Secretary to add
vaccines without specific congressional authorization. See Pub.

L. No. 103-66, 13632(a)(2), 107 Stat. 312, 645-46 (1993).
Congress made this important modification almost a year after the
Secretary published the Notice (in which she proposed to alter
the QAI) and after a number of loud voices had been raised during
the comment period in strong opposition to the proposed action.
Despite this public clamor, Congress did not prohibit the
Secretary from altering the QAI.

14

the regulation. The accusation is unfounded.

The relevant statute provides:

Except with respect to a regulation
recommended by the [ACCV], the Secretary may
not propose a regulation under subsection (c)
of this section or any revision thereof,
unless the Secretary has first provided to
the [ACCV] a copy of the proposed regulation
or revision, requested recommendations and
comments by the [ACCV], and afforded the
[ACCV] at least 90 days to make such
recommendations.

42 U.S.C. 300aa-14(d). The petitioners contend that the

Secretary neglected to follow these procedures twice over, by

failing to provide the ACCV with (1) a copy of the Notice before

publishing it, and (2) a copy of the final rule before issuing

it. We examine each contention.

1. The Proposed Rule. We rehearse the relevant facts.
1. The Proposed Rule.

Shortly after publication of the IOM Report, the Task Force made

its initial recommendations for changing the Table. The NVAC

substantially concurred in those recommendations. The

Secretary's proposal was then circulated at the ACCV's December

1991 meeting in the form of a matrix detailing the various

recommendations. During the ensuing discussion, the principal

objection was to the Secretary's proposal, reflected in the

matrix, for removing encephalopathy from the Table. The ACCV

urged instead that encephalopathy should be retained in the Table

but that its definition should be modified in the QAI. The

Secretary accepted the ACCV's unanimous recommendation and, in

15

August 1992, published a Notice that implemented this

recommendation.9 See 57 Fed. Reg. at 36,880 (accepting ACCV

recommendation to retain encephalopathy in the Table with a new

definition).

The petitioners argue that the rule ultimately

promulgated is invalid because the matrix distributed and

discussed in December of 1991 was not literally a "copy of the

proposed regulation" as required by 300aa-14(d). Although the

matrix may not have been produced in the typical format for a

proposed administrative regulation, we think that for all intents

and purposes it was a "copy" of the regulation that the Secretary

planned to propose. The matrix contained the substance of all

the proposed changes to the Table. The only real difference

appears to have been in manner of presentation. The statute

requires the Secretary to deliver all the meat of a planned rule

to the Secretary without regard to how it is arranged on the

platter. Thus, as long as the Secretary transmits the entire

substance of her proposed regulation to the ACCV in the

9Though there appears to have been substantial consensus
among ACCV members about the definition they would recommend to
the Secretary, it is not clear whether the ACCV members
irrevocably agreed on an exact definition. This uncertainty
arises because, while no formal vote was taken, the members
approved in principle a specific definition proposed by Dr.
Gerald Fenichel. The members also agreed that some refinements
to Dr. Fenichel's proposed definition might be necessary and
apparently agreed to a mechanism for expediting action on any
such refinements. The administrative record (including the
minutes approved at the next ACCV meeting) reveals no objections
to Dr. Fenichel's final proposed definition and discloses no
suggested refinements to it. The Secretary included in the
proposed rule a definition of encephalopathy that was
substantially the same as this definition.

16

appropriate time frame, the form of the transmission is

immaterial. This principle possesses particular force where, as

here, the unorthodox format does not obfuscate or mislead.

Indeed, the matrix's tabular format increased comprehension by

allowing the ACCV to discuss the revisions in a manner

corresponding to the format of the Vaccine Injury Table itself.

We hold, therefore, that the Secretary fulfilled her statutory

pre-publication duty in regard to the proposed regulation.

If there were any room for doubt about the adequacy of

the transmittal and we do not believe that there is the

ACCV's actions would dispel it. We are particularly impressed by

two things. First, the transcript of the ACCV's December 1991

meeting makes very clear that ACCV members thought they were

discussing the Secretary's proposed revisions to the Table.

Second, after the Secretary published the proposed regulation,

the ACCV did not cry "foul" or otherwise complain that it had

been bypassed. These facts plainly show that the ACCV understood

the matrix to be a "copy of the proposed regulation" and acted

upon it as such.

2. The Final Rule. The Secretary's issuance of the
2. The Final Rule.

final rule poses a somewhat closer question. The Secretary

openly admits that she did not provide the ACCV with the text of

the final rule prior to its promulgation. She argues, however,

that the Act does not oblige her to do so, or that, if it does,

she substantially complied with that obligation.

Section 300aa-14(d) provides in material part that "the

17

Secretary may not propose a regulation . . . or any revision

thereof" without first furnishing the ACCV with a copy of "the

regulation or revision," requesting comment, and marking time for

ninety days. This aspect of the controversy between the parties

arises from the phrase "any revision thereof." In context, this

phrase is susceptible to at least two reasonable meanings. Under

one interpretation, favored by the Secretary, the phrase refers

to a revision of a regulation, so that, while the Secretary may

not propose either a new regulation or a revision to an existing

regulation without advance notice to the ACCV, she may proceed to

revise a proposed regulation without resubmitting it to the ACCV.

Under the second interpretation, favored by the petitioners, the

phrase "any revision thereof" refers to proposed regulations, so

that the Secretary may propose neither a new regulation nor any

later revision to that proposed regulation without first

informing the ACCV.

Once again our analysis begins with a nod in the

direction of Chevron. The rule of deference traditionally

applies when the agency's interpretation is a "product of

delegated authority for rulemaking," Stinson v. United States,

113 S. Ct. 1913, 1918 (1993), a sphere that ordinarily

encompasses legislative rules and agency adjudications. Here,

the Secretary's interpretation of the law is not embodied in a

legislative rule or an adjudication. The evidence of her view

about how 300aa-14(d) is supposed to operate comes exclusively

from two sources: the refusal of her subordinates to send the

18

ACCV a pre-publication copy of the final rule, and the tactical

position adopted by her counsel.

As for the first source, agency positions that are

pieced together from offhand conduct of bureaucratic fussbudgets

are entitled to little weight on judicial review, principally

because they do not reflect the kind of delegated authority for

policymaking that underlies the Chevron presumption.10 See

Stinson, 113 S. Ct. at 1918; Martin v. OSHRC, 499 U.S. 144, 157

(1991); Public Citizen v. United States Dep't of Justice, 491

U.S. 440, 463 n.12 (1989). As for the second source, courts

customarily withhold Chevron deference from agencies' litigating

positions. See, e.g., Bowen v. Georgetown Univ. Hosp., 488 U.S.

204, 212 (1988); United States v. 29 Cartons of * * * an Article

of Food, 987 F.2d 33, 38 n.6 (1st Cir. 1993); Director, OWCP v.

General Dynamics Corp., 980 F.2d 74, 79 (1st Cir. 1992). We see

no reason to take a different tack in this instance. We

therefore decline to defer to the Secretary's construction of

300aa-14(d).

Approaching the statutory question without the

Secretary's thumb on the scale, we believe that both suggested

interpretations are plausible but imperfect renditions of

problematic language. The petitioners' interpretation means that

10In point of fact, the record indicates that the
Secretary's minions were not even attempting to parse the Act's
requirements, but, rather, were simply enunciating "a matter of
procedure and policy" within the agency not to distribute final
rules prematurely. Quite obviously, this affords no basis for
deference.

19

every alteration to the text of a proposed rule even a minor

technical or grammatical alteration would have to be rerouted

through the ACCV, subject to a fresh notice-and-comment period.

This extra step would be necessary even when the Secretary

changes a proposed regulation in accordance with the ACCV's

announced wishes or to correct a syntactical bevue. Such a

construction would create a nearly endless circle and attenuate

the rulemaking process without achieving any corresponding

benefit. Because it is difficult to believe that Congress

intended to prolong the revisory process by directing the

Secretary to engage in a mindless minuet, the prospect of wasted

motion cuts against the petitioners' interpretation. See Alabama

Power Co. v. Costle, 636 F.2d 323, 360 (D.C. Cir. 1980) (stating

the obvious proposition that courts should be reluctant to

interpret the terms of a statute "to mandate pointless

expenditures of effort").

The Secretary's construction likewise presents a

problem in that it may render the phrase "any revision thereof"

superfluous to some extent. Since the Secretary would have to

issue a new regulation in order to change an existing one, see 42

U.S.C. 300aa-14(c), Congress probably did not need to add the

requirement that a revision to an existing regulation must be

reviewed by the ACCV. Because courts usually presume that every

word and phrase in a statute is pregnant with meaning, see, e.g.,

United States v. Ven-Fuel, Inc., 758 F.2d 741, 751-52 (1st Cir.

1985), the prospect of redundancy cuts against the Secretary's

20

interpretation.

Faced with no ideal choice, we conclude that Congress

more likely intended the statute to be read as the Secretary

urges. This interpretation is more plausible and better serves

the ends that the legislature sought to achieve. Though it is

possible that Congress could have accomplished its purpose

without adding the disputed phrase ("any revision thereof"), it

is not certain that it could have done so. A wily lawyer could

perhaps have argued that the unembellished word "regulation"

referred only to brand-new regulations, not to adjustments of

preexisting regulations. Cf. Public Serv. Co. v. United States

EPA, 682 F.2d 626, 633 (7th Cir. 1982), cert. denied, 459 U.S.

1127 (1983). Even more likely, Congress might have thought that

the Secretary would be able to style a revision to a preexisting

regulation as something other than a new regulation (perhaps as a

clarification), and thereby evade the statutory safeguards. See,

e,g., Detroit Edison Co. v. United States EPA, 496 F.2d 244, 249

(6th Cir. 1974) (rejecting EPA's attempt to characterize agency

action as mere "clarification" of regulation as opposed to

revision); cf. United States v. LaBonte, 70 F.3d 1396, 1411 n.13

(1st Cir. 1995) (noting Sentencing Commission's practice of

styling certain pronouncements affecting the interpretation of

extant sentencing guidelines as "clarifications" rather than

amendments). Moreover, a belt-and-suspenders approach is not

uncommon when the Legislative Branch cedes rulemaking power to

the Executive Branch. Indeed, Congress has frequently employed

21

the phrase "revision thereof" to confirm that its procedural

mandates apply both to original regulations and future revisions

of such regulations. See, e.g., 15 U.S.C. 2934(f)(1); 16

U.S.C. 410cc-32(e); 33 U.S.C. 1314(c); 42 U.S.C.

4916(a)(3)-(4), 7521(a)(2), 7571(b).

Here, the Secretary's interpretation not only is

consistent with common congressional statute-drafting practice

but also ensures the ACCV's input into the rulemaking process

without inviting the wasteful circularity of proposal, notice,

comment, changed proposal, re-notice, additional comment, and so

on and so forth, ad infinitum. The petitioners' suggested

alternative, on the other hand, creates a perverse incentive. If

the Secretary is forced to recommit a proposed regulation and

twiddle her thumbs for an additional three months every time she

responds agreeably to an ACCV suggestion, she may be less

inclined to acquiesce in the first place. Hence, the

interpretation that we adopt actually may increase the chance

that the Secretary will pay attention to, and act upon, the

ACCV's advice.

In reaching the conclusion that the statute refers to

regulations and revisions thereof (and not to revisions of

proposed regulations), we necessarily override two other concerns

anent the ACCV's place in the scheme of things. First, the

petitioners boast that the ACCV's statutorily prescribed part in

the process of revising the Table evinces Congress's distrust of

the Secretary and proves that the reference to "any revision

22

thereof" is intended to give the ACCV a more prominent presence

in the rulemaking process. This distorts the statutory alignment

by grossly underestimating the Secretary's role and aggrandizing

the ACCV's importance. In crafting the Act, Congress delegated

unusually great authority to the Secretary, including the power

to rewrite the statute by updating one of its hallmark

provisions. In contrast, Congress assigned the ACCV a purely

advisory function. See 42 U.S.C. 300aa-19; see also H.R. Rep.

No. 908, supra, 1986 U.S.C.C.A.N. at 6365. Thus, far from

bolstering the petitioners' case, a comparison of the relative

responsibilities that Congress entrusted to the Secretary and the

ACCV, respectively, undermines the petitioners' argument.

Second, the Secretary's construction of the statute

does not permit her effectively to bypass the ACCV by proposing

one regulation and then issuing something radically different as

a final rule. The Administrative Procedure Act applies here, and

it is axiomatic under that regime that a final rule must be a

lineal descendant of, and in character with, the earlier proposed

rule. See, e.g., Kooritzky v. Reich, 17 F.3d 1509, 1513 (D.C.

Cir. 1994); American Medical Ass'n v. United States, 887 F.2d

760, 767 (7th Cir. 1989). Put another way, changes must flow

logically from the prescribed notice and comment. See Natural

Resources Defense Council, Inc. v. United States EPA, 824 F.2d

1258, 1283 (1st Cir. 1987). If the final rule deviates

substantially from the proposed rule, it amounts to a new

proposal and must run the regulatory gauntlet afresh. Thus, the

23

ACCV's right to be consulted is not stunted by the reading of

300aa-14(d) that we adopt today.

To recapitulate, we believe that Congress might

reasonably have inserted the phrase "any revision thereof" to

close what it suspected were potential loopholes. We therefore

accept the Secretary's thesis that the phrase "any revision

thereof," as used in 300aa-14(d), refers exclusively to

revisions of existing regulations (not to revisions of proposed

regulations). On this understanding, we hold that the Secretary

complied with the statutory notice-and-comment requirement by

providing a pre-publication copy of her proposed regulation to

the ACCV in December of 1991.

C. Adding and Subtracting Medical Conditions.
C. Adding and Subtracting Medical Conditions.

The petitioners' final shot injects a new notion into

the case: the idea that the Act does not authorize the Secretary

to remove HHE and residual seizure disorders from the Table in

the absence of "definitive information" attesting to the lack of

any causal link between DPT vaccination and these medical

conditions. Since both the IOM and the Secretary herself found

only that there was "insufficient evidence to indicate a causal

relation" between vaccination and the kind of permanent

neurological damage reflected in HHE and residual seizure

disorders over time, see IOM Report at 118; Notice, 57 Fed. Reg.

at 36,879, they tell us that the deletions cannot survive.

The Secretary accepts the petitioners' premise the

available evidence does not flatly disprove the causal relation

24

but she vigorously disputes the petitioners' conclusion. In her

view, the criteria for revising the Table simply do not include

the requirement that the petitioners seek to impose. We agree

with the Secretary.

We need not tarry. Nothing in the text of the Act

prohibits the Secretary from eliminating a condition from the

Table if the evidence of a causal relationship between the

vaccination and that condition is equivocal. The only explicit

constraints on the Secretary are procedural. See, e.g., 42

U.S.C. 300aa-14(c) (requiring notice-and-comment period,

including public hearing); id. 300aa-14(d) (mandating referral

to the ACCV). While some other constraints may be readily

inferred from the terms, structure, and history of the Act, there

is no principled basis for the added constraint that the

petitioners would have us infer.

The petitioners' construct rests solely on a suggestion

in the committee report accompanying the Act to the effect that

the Secretary may revise the Table when "more definitive

information" is available. They read this terse reference as

superimposing on the text of the statute a requirement that the

Secretary must have definitive evidence rejecting a causal

relation between vaccination and a medical condition before she

may delete the condition from the Table.

The petitioners read the committee report through rose-

colored glasses. The passage on which they rely is reproduced in

25

its entirety in the margin.11 The passage as a whole makes it

abundantly clear that, though Congress, struggling with a lack of

information, itself used an initial presumption that the

conditions listed in the Table were caused by vaccination so long

as they occurred within the specified time period following

vaccination, it did not intend to carve this presumption into

stone. To the precise contrary, the authors of the committee

report explicitly recognized that the Table, as originally

devised, might in some cases go too far, and relied on the

Secretary to reconstitute it in light of the "more definitive

information" that would be available as a consequence of the

review, in order to reflect more accurately the causal relations

11The passage reads:

The Committee recognizes that there is public
debate over the incidence of illnesses that
coincidentally occur within a short time of
vaccination. The Committee further
recognizes that the deeming of vaccine-
relatedness adopted [in the Table] may
provide compensation to some children whose
illness is not, in fact, vaccine-related.
The Committee anticipates that the research
on vaccine injury and vaccine safety now
ongoing and mandated by this legislation will
soon provide more definitive information
about the incidence of vaccine injury and
that, when such information is available, the
Secretary or the [ACCV] may propose to revise
the Table . . . . Until such time, however,
the Committee has chosen to provide
compensation to all persons whose injuries
meet the requirements of the petition and the
Table and whose injuries cannot be
demonstrated to be caused by other factors.

H.R. Rep. No. 908, supra, 1986 U.S.C.C.A.N. at 6359.

26

between vaccines and allegedly associated medical conditions.12

Had Congress intended the Secretary to revise the Table

by removing a medical condition only after a causal link was

definitely disproven, it could quite easily have said so. It

said nothing of the sort. What is did say is that the Secretary

should update the Table in light of new and better information

about causation. The Secretary, in pursuance of this directive,

decided inter alia to remove HHE and residual seizure disorders

from the Table because the medical evidence failed to establish a

causal connection between DPT vaccines and these disorders.

Since there is nothing in the record to suggest that this

decision is arbitrary or capricious, it must stand. See, e.g.,

Strickland, 48 F.3d at 17-18; United States v. Members of the

Estate of Luis Boothby, 16 F.3d 19, 21 (1st Cir. 1994); see also

5 U.S.C. 706(2)(A).

IV. CONCLUSION
IV. CONCLUSION

We need go no further. The Secretary had authority to

issue the regulation about which the petitioners complain, and

she exercised that authority in a procedurally appropriate and

substantively permissible manner. No more is exigible.

The petition to review and vacate the final rule is
The petition to review and vacate the final rule is

denied.
denied.

12This is of a piece with the statute itself, which
indicates that the Secretary's revisions should be based on
findings about whether "each of the illnesses or conditions set
forth in [the Table] can reasonably be determined in some
circumstances to be caused or significantly aggravated by
pertussis-containing vaccines." Vaccine Act 312(b), 100 Stat.
at 3780.

27