
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
