Court Opinion

ID: 2964028
Source: CourtListenerOpinion
Date Created: 2015-09-21 21:19:13.60362+00
Date Added: 2024-06-11T11:37:22.906557
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USCA1 Opinion

	

                            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