ML20127C252
| ML20127C252 | |
| Person / Time | |
|---|---|
| Issue date: | 09/26/1990 |
| From: | David Williams NRC OFFICE OF THE INSPECTOR GENERAL (OIG) |
| To: | Carr NRC COMMISSION (OCM) |
| Shared Package | |
| ML20127C175 | List: |
| References | |
| FOIA-92-277 NUDOCS 9301140090 | |
| Download: ML20127C252 (17) | |
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- UN11ED STATES
/ o NUCt. EAR REGULATORY COMMISSION f/S , *v. *c P( r,i WASHIN010N. O C FJ/4 4 %, h y f
' October 19, 1990
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- OFFICE OF THE INSPECTOR GENERAL MEMORANDUM FORT Chairman Carr h M C h DWilliams I &ic.o FROM: David C.
Inspector General SUID ECT! ALLEGED IMPROPER STAFF ASSISTANCE TO PETITIONERS TO AMEND 10 C. F. R. PART 35 Enclosed is an Office of the Inspector General (OIG) Report of Investigation concerning an allegation that NRC staff from the Office of Nuclear Material Safety and Safeguards (UMSS), Division of Industrial & Medical 11uclear Safety improperly solicited and assisted in preparing a petition for rulemaking to amend 10 C.F.R. Part 35 (Part 35), The American College of Nuclear Physicians and the Society of Nuclear Medicine (ACNP/SNM) submitted a petition to amend Part 35 on June 5, 1989. The on behalf of the petition was developed by f y K $ 7 M ACNP/SNM.
TheOIGinvestigationdeterminedthatNMSSstaffadvised[
to submit a petition after they concluded that the medical The OIG community had legitimate concerns with Part 35.
investigation further determined that a staff member provided with substantial assistance in draf ting the petition and PM in ren ewing subsequent revisions. This individual4 and another staf f member also reviewed the final petition for @ before it was officially submitted to the Commission.
The investigation did not substantiate wh' .her the staf f had violated criminal statutes, NRC regulations or internal policies.
!!owever, we concur with the Ofrice of the General Counsel (OGC) that the staff in an opinion obtained during the investigation, FREEDOM OF INFORMATION/ PRIVACY ACT EXEMPTION(b) ( ) (6) (7) (C) 9 'JI
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October 19, 1990 conduct raises significant policy issues and that the ptaf f needs additional guidance concerning assistance which may be provided to potential rulemaking petitioners. We also concur with.oGC, that if the staff participates in developing a petition, the assistance should be accurately acknowledged to the Commission and to the public when the petition is published for comment.
Enclosure:
Report of Investigation cc J. Taylor, EDO W. Parler, OGC
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....... 6 BASIS...............................................
6 DETAILS..................................................... 6 ALLEGATION 1........................................... 13 FINDINGS.................................................... : 14 LI S T O F E XH I B I T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P 1 s t
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(% 4 ? _%( ;;,.; 4d 9 DYNOPBIS This investigation was initiated based on information received It was from a U.S. Nuclear Regulatory Commission (liRC) employen. alleged that NBC staff, f rom the Of fice of liuclear Material Safety and Safeguards (ifMSS) , Division of Industrial ti Medical fluclear Safety improperly solicited and assisted in preparing a petition for rulemaking to amend 10 C.F.R. Part 35 (Part 35). Part 35 regulates the medical use of byproduct material. The Aner ican College of 11uclear Physicians and the Society of Nuclear Medicine ( ACNP/SNM) submitted a petition for rulemaking to amend Part 35 on June 5, 1989. The " Petition to Correct Regulatory Incompatibility and Permit the Traditional Practice of Nuclear Fedicine and liuclear fharmacy" was developed" byf; " "F 7N
] on behal f of the ACliP/SNM.
Prom August 1988 to March 1989, NMSS sta f f and y,, u m,i g had several discussions concerning problems the medical community was having with Part 25. As a result of these discussions, llMSS staff advised []} to submit a petition af ter they concluded The that the redical conmunity had legitmate concerns with Part 35. investigation determined that a staff morber provided substantial assistance in drafting the petition and in reviewing subsequent revisions. This individual and another staf f member also reviewed the final petition before it was officially submitted to the Commission. The Office of the General Counsel (OGC) was requested to review the extent of assistance that staf f may provide to a prospective retitioner in cor.nection with a petition for rulemaking. OGC advised that rejevant statutes do not address whether it is appropriate for agency staff to assist petitioners and do not define the nature of such assistance. OGC noted that 10 C.F.R. Part 2.80e encourages petitioners to confer with the staf f. llowever, OGC advised that neither NRC regulations nor NRC internal policies define the staf f role or level of assistance that may be provided to potential pe t it ione rs . OGC stated that if the staf f participates in draf ting a petition, their role should be brought to the Commission's attention. Moreover, NRC should acknowledge the staff role when the petition is published. The investigation did not substantiate whether the staf f had violated criminal statutes, NRC regulations or internal policies. However, we concur with OGC that the conduct of the staff raises significant policy issues and that the staff needs additional guidance concerning assistance which may be provided to potential rulemaking petitioners. The investigation determined that while the staff maintained that the assistance provided to petitioners was in accordance with Part 2 rules, the extent of staf f assistance was never fully disclosed to the Commission. q p c,s n mmw: vp y o k ,d-',, b w k ;_ (#g,
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' 6 DA818 This investigation was initlated It was basedthat alleged on information NRC staff received from the from an NBC employee. Division of Industrial & Medical Nuclear Saf ety (NMSS/IMNS), iaproperly solicited and assisted in preparing a petition for 35). The employee rulemaking to amend 10 C.F.R. Part 35 (Part noted that the petition stated in part, that it resulted from an Part 35 regulates the NRC staf f determination to change Part 35.11 MSS is charged with medical use of byproduct material. advising and reviewing proposed rule changes and for preparing,The office of Nucicar providing information to the Commission.has lead rosponsibility in reviewing Regulatory Research (RES) petitions (Exhibit 1). DETAILS (ACNP) and the Society The American College of 11uulear Physicianssubmitted a petition for rulemaking to of Nuclear Medicine (SNM), A letter to Chairman ZECH, dated amend Part 35 on June 5, 1989. It stated May 19, 1989, advised him of the forthcoming petition. yhat theyt f ign, re91ted a f ter extensivpAloc,unq m< n c , c' { pnp w with . v
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According to C ' <~ii;wic i _knd i .i g,E% R M b
$;23 the petition was requested liy NRC af ter the NRC staftf 35.
r etermined that the best course of action was to change Par g M stated that the petition was written, with equal participation, byThis the most knowledgeable individual on the individual was assigned to help write the subject at NRC. document by the NRC of ficial who initially requested the petition (Exhibits 1, 2, and 3). to March 1989, NRC staf f and from a, proximately August 1988 p Q had several telephone conversations and meetings to31sc after NRC made changes to with Part 35. According to h Z dl Part 35 in 1987, nuclear physicians and pharmacists were effectively precluded from practicing nuclear medicine. impact C Cl39 of the rdle commented that NRC may not have understood the changes and may not have intended the resultant of fect (Exhibits 4, 5, 6, 7 and 8). NRC staff mecbers indicated that the idea of a petition evolved during the courne of several meetings with the medical community. They further indicated that the issues vere complex and the staff did not initially understand the medical community's problems concerning Part 35 regulations (Exhibits 9, 10 and 11). stated that durin an Au t 1988 conference call with pdere Q dshoddG Uand Q E J L( E told [ ] that NRC had decided be a petition because the on1y way to address the oe r W '"a WTC** m, e ". P, .7 3r M MyG% M
. .F f i 74 'M.EJ Q,_bd6:,g;g %f5 7 i problem and take care of the needs of,the med)ical community wasAccording through a rule change.
think 11RC could provide the medical communit9~with Further,O Twhat Z ht toy wanted wanted with the current regulations. f 1 M to submit a p. tition,,which ytold "N would be endo 7 Bed by the that it was customary for li AUi4H/SMM. JC( k with petitior$5N]and that{""J"would assist {llCd statf to wor (Exhibit 4 at 2). 2$5kstatedthat[iddidnotspecificallyrecallghenh
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.JQJor$ " N ER ( W T advised that
[ ]although 1,t' Tmay ~l r a have~ been[n~TEToldf' bjg}otitionto write a."dtosuB and/orp sAccordint t o RE/ J / ];y Mtold h
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d Lgj .j would'assint [ { calDothchoice h"E f or M assi~ and sting J' ,]< - @ was the log and stated that ti [isti f amiliar with todical regulations anddwas tecauce Q F 5s most lugoly responsible for rewriting Part 35 in 1987 (ExhibiLD 9, 10, 12 and 12a). g,~ n ,, n {- ,y k.. lanned andfto Qwork d met ohwith[n n .ddl)inSeptember1988. petitlop'1ssues~ with [ "W% during)[ g
'had p;q of p"etings, l s ta but finsteaft f to as i i ,3} s assigned i s t E C" } ' Aoff discussiong t 6'r sev e ra l hou f4.j Q concludedT thjt Q could not work with dQ. PDnuclear medicine and would 1ommehted that[E N$] wanted to maketo controljudgmental decisions. ( $ stated not allow phygi that pd and QiZ had several conversations concerning the petition (Exhibits , 6, and 11).
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j l Y. m MlZ 42 myl,andh2 t hrFatened to seek a court injunction L7 gainst flRC,1f it c?ntintied to irpede the practice of nuclear tedicine, f 7C"T % notes, dated llovember 8, 1988, reflect that among the optil6n IUelng discussed were " injunction, petition,
.padger Conrress, work it out." The notes also reflect that M L i l wanted the medical community to define the problem and that "if the rulemaking was flawed we can republish (if it we accidently dropped the scope of permission)According to f g ar 4 fMte that ceabers of won't enforce until clarified." with flRC the ACliM/ Stim subcequent ly formed a corunittee to wor staff to develop a petition (Exhibits 4, 8 and 10).
my m conducted a radiopharmacy workshop with the medical
'Qai community, food and Drug Administration representatives and llRC staff on January 25, 1989. A notice of the meeting was published in the Federal Register. Part 35 and changes that thg egdig,al community wanted in the regulations were discussed. PS M U5 advised that the staff was still identifying and reviewing the
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8 : problems with Part 35 and had not yet made a decision to amend the regulations (Exhibits 10 and 13). Several memorandums reflect the ongoing discussions On December 2, 1988,between the gedical c yo, unity and NHSS staff. Division of Radiation yj E 3 3 advised the Regional Directors,that because of several questions safety and Safeguards,concerning the human applicationFurther, of by-product HMSS material, HMSS reexamining the regulations and policy statements. was considering exemptions and the advisability of amending "EDOthe regulations. Subsequently, a staf f memorandum entitled: Problem Issues," dated March 3, 1989, reflected that amendment of the regulations was "one of the least restrictive alternatives." a March 17, 1989, memorandum delegated MfM to assist aining the [Also,jfi,)in preparing a letter to the commission ex[ E aTssistance medical community's regulatory concerns. letter to ChiOrman ZECH. (Exhibits resulted in the May 19, 1989, 14, 15, 16, 17 and 17a). During March 20-26, 1969, h b M was in California on official business. After attending scheduled conferences [ f M met % fstated with that on {Md at theMarch saturday, UCIA25, Harbor 1989, OMedical a ss is ted Center,f;DIejMinpreparing ihtroddctory a detailed outline of the petition Kiid part of.kncv what &$ wanted in the text. stated that @ M assistance in drafting the petitio[gMlD n and provided teckd ca 3c prifled the issues, document. According to C d e of explained NRC regulations and ad sedgM Q @ on the t travel language and informatio.n 3 had to prNide. QTEM conducted official government business voucher reflected that on March 25, 1989. Review of M time and attendance records indicated thatf $ did not request compensation for working on Saturday with { f @ (Exhibits 12, 18 and 19).
- hstated that 1etition af ter the experience with[M' it was clear
[Mbdlthatifa to be done b was goin be wrntten, stated that (it would have reparh g a deta ed cutline of the 74 $seTNion. [Uf;d g%y assisted u ed - M in and h%M.
. through NRC regulationsi told M to provide ens background information and spec,1fic xamples of the }did not cine.
confronting nuclear write the petition andia medj/$ was careful not to offerQ M '~ stated personal thatE . opinion. [jZ$ asked "what J f" questions concerning the language to use, andE 3 told M how to state the information without contrad cting other sections of NRC rules. QQ ave written the petition wit 1out could not lacked familiarity with NRC's hgyngylgedthat2E Q assi tance because regulatory language (Exhibit . five or six drafts of the petition NEM owing their lchadvised that there werefinalized during the six f,.week period was Throughout this period, @ had numerous March 1989 meeting. w IddM$g$Mdh
%C ?--whme- w e -y .. _ _
8 4 conversations with M either discussed the petition changes during telepione conversations, in corresponde e or sent [ g pages of the draft acsimile transmission for. comments and advice. stated that the ACNM/sNM committee reviewed the petition er making revisions to ensu e that it was legally correct, forvarded the petition to 3 provided i the completed draft petition on April 18, and additional revisions on June 5, 1989. A letter dated 989, 1989 forwarded the completed draft etition to ril 9, was returning l $ ortginal, stated n es in so@the lottersee could thatthe cha es'that had een made &nd that--- might rest easier knowingl had the notes.
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advised the OIG that the letter had been written n est d was not intended,, b,0 serious. $ 3Astated that. ~ has always acknowledgedf"! Ilf M assistance and never considered
@,be viewed a improper. According to that the assis ance h mplied that d lassistance was improper.
inover [yEQIhe ActlH/S11M of ficially submitted the petition to NRC on June 5, 1989 (Exhibits 4, 4a, 4b, 20, 21, 22, and 23). According to 10 C.T.R. Part 2.802(b), a petitioner is encouraged to confer with the staff prior to filing a petition. Questions regarding regulations, procedures and requests for meetings are to be addressed to the Director, Division of Freedom of Information and Publications Service (Exhibits 24). that they did n know the BothT3" M andh 2 provided to ) However, a exters of the a'ssisti nce 1989,.noted that the, staff.had staff memorandum, dated une 8, provided technical assistance to ACNP/SNM during the development of the petition pursuant to 10 C.T.R. Part 2.802(b) (Exhibits 9, 10 and 25). petition Ti1@j M>rsaid that id not recall when o old him in s Vas written. ' F M " , stated iowever, that ihad met witTi iand they the spring /sumhier of 198 , that had worked on the petition; tha it "had been deT/ eloped," and hat it was 'something we (NRC) could deal with." Acco i to may have indicated that met vit w ille atten a conference in alifornia, stated that he asked whether was assisting in 3ccordance vi C rulemakin regulations. A cor ng to
} TEE 5_: he may have told @ ith t
the lawyers to do this"M i o " check with or asked }"is this okay w (Exhibit ). . stated that was aware that was assisting'
) petitio an 'that reg mmunications with i stated tlat told a "pa ts or
-somo" of ti pot lon, but did not ask what meant by this. [g@ F M ais ' state that after returned
l wgNNg$/ Ji"Mk-QgwLaf 10 m from California, {l ect " alluded to something about writing orAccording to 8 M ] of the petition." rnrking Ed Z d,uy soce gg.gtpidiglMjo pe careful about the amount ofshould n interactionrdhad with SUI) that O,lim ited the amount of petition for p # d and that Part 2 assistance staH could8).provide to pel [dstated thathdid not recall reviewing changes According to to the [ tit idf) pfter it was_ drafted in March 1989. rafting assistance, (peZ21\C3 provided QQJ with t echn,1 cal [ME stated that G3 never In accordance with uRC regulacions. received guidance concerning careful about the anount of assistance given to{C$. Ci further stated attorneys and never thathM% said tIIe" never toldlimited regulations $ to Eli8cx withofNRC the amount assistance staff could provide to petitioners (Exhibit 12a). [(]istedthestaffinanalGzngandclarifyingthepetitionM ass issues. In January 1990, fad recused himself f romAlthough actively
@partici ating in the, resolution involvep of the petition.Q A in the stated th meetings,Q did not recalbi. waded'atTCFT Mreviewed
(($dstargdth petition review process.the staf f's work on the petition, e d, further stated that
%F12iGdirected several changeliYich the of fice of thedisagre Cenoral counsel (OGC) adequate checks and balances (Exhibits 11, 12 and 12a),
on May 17, 1990, oIG requested Icgal advice from oGC concerning the extent of assistance that staf f may provide to a prospective oGC reviewed the isrue of whether the assistance, provided by the staff, tainted the NRC rulemaking process petitioner. contrary to the Administrative Precedures Act, NRC regulations and internal policies. Also addressed was whether the staff engaged in conduct that violated acceptable standards of conduct. oGC concluded that the rulemaking process was not However, oGCtainted stated by thatthe staff participation in the petition.the "staf f conduct raised significant po additional guidance needs to be provided to the NRC staf f on what constitutes appropriate assistance to potential rulemaking petitioners." OGC also concluded thac if the staf f is permitted to participate in drafting petitions, the participation should be acknowledged and should be a matter of public record. OGC advised that the Administrat'ive P'rocedures'Act,'which established the procedures governing the rulemaking process, does not address whether staff may assist potential rulemaking Additionally, according to oGC, neither NRC's regulations, 10 C.F.R. Part 2.802, nor agency policy define petitioners.
@d?G{TRQ p g.gwungr W:MS&RQQ
- 11 the staff's role or level of assistance that may be given.to prospective petitioners.
oGC concluded the law did not require that the staf f be disqualified from further advising NRC on the Part 35 rulemaking petition. OCC advised that disqualification had to be established on clear and convincing evidence that the staff providing the assistance had an "OGC unalterably doubtedclosed mind" that such on the a high issues raised in the petition. threshold could be met. Moreover, OGC noted that the staff involved were not in a position of authority to commit the agency and were not the agency's decision makers. Concerning whether the staff violated acceptable standards of conduct, OGC stated that employees are generally to refrain from conduct that adversely affects the efficiency of the agency. Employees accordingly, may not engage in conduct that has an effect on the credibility of the employee and/or the agency, Part 2.802 encouraged prospective oGC noted that while 10 C.F.R. petitioners to confer with staff, it provided that requests to meet with staff be channeled through the Director, Division of Freedom of Information and Publication Services (DFIPS). Similarly, the NRC Resulbilons_Ilandho_qh indicates that any of fice receiving a request to meet with prospective petitioners The handbook should also provides coordinate with the DFIPS Director. that meetings are to be summarized by DFIPS and included in the official file on the petition. OGC advised that the handbook is not a mandatory directive, however, the staff is obliged to comply with the regulations (Exhibit 26). Interviews conducted and documents reviewed did not disclose any evidence that the staf f informed DFIPS of the ongoing meetings between staf f and the medical community concerning problems with Part 35; or that the staf f channeled requests for meetings through DFIPS. Hugh THOMPSON, Deputy Executive Director, Nuclear ~ Saf ety Saf eguards & Operations Support stated that program offices typically work with licensees, or in this instance, the medical community, to resolve problems within their area of responsibility. THOMPSON advised that he would not expect the staff to be familiar with Part 2 rulemaking provisions. According to THOMPSON, he would not have expected the staf f to advise the DFIPS of the staff's effort to assist the medical community in developing a petition to amend Part 35 (Exhibit 27). t.d that most rulu changes have been
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Several staff members p initiated by NRC. MO said that in the past, M reviewed a '. draf t petition subm'ltted by a pharmaceutical manuf acturer left and pointed out items in the petition that had been omitted, unclear or were repetitive. The company subsequently submitted the final petition and NRC revised the regulatory language that the petitioners had objected to (Exhibits 9, 10 and 12). L
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;g3pp%:sqw @:=cenkym 12 m-w e . stated chat licensees are typically
{ ifirected Qdhand (IE a petition to su S q mwhen they have problems with NRC regulations. staff receive (d concerning assistance to a license applicant,f the M D Q st issue of how much assistance may be provided to a petitioner has not b addressed by management. Further M G M $ stated that{L has never requested assistance or ahvice concerning this issue rom OGC (Exhibits 9 and 10). y According tohpnymhahis there are no prohibitions on the staf f in assisting petitioners. % ET j 3 stated that the type of assistance given to a petitione would va depending on the complexity of the pejition. I ^ YS d i d . while D opinion, the was in california assistance given to p W h b 5tated that if the staff assisted notinappropriate.gje[1gjd .t not view the assistance as a in writing the petition, significant problem because final the document approval by would the be reviewed by Commicsioners many individuals before (Exhibit 9). n the Administrative Procedures Act dictatedthat honced stated that process tic rulemaking is initiated, all communications may influence Accordingly, k 1he contents of a petition must be on [3M record.would not have app petition before it was of ficially submitted to NRC. stated that the branch because it could lose some objectivity and would not be able to review the petition from an independent perspective (Exhibit 10). In providing their opinion, OGC inquired whethcr the Part 35 petition was a joint petition betveen the staf f and petitioners; or whether the staf f may have used petitioners as the vehicle to submit a petition, bypassing the customary process for staf f generated rulemaking proposals. Interviews with staff members determined that the petition was submitted af ter the staf f concluded the medical community had legitimate problems with the regulations. According to one staff member, the medical would not community was best equipped to amend Part 35 andM. have known how to change Part 35 to accomplish what they wanted (Exhibits 9, 10 11 and 12). y 4 ,.- - m % NRC had QMdiaigradvised not that when Part 35 was changed in 1987, intended to mak practice of medicine. Further, if the medical community was correct that the regulations impeded patient health care, NRC was obligated to deal with the issues as quickly as possible. According to@Jjyf h- the staf f would have initiated a petition given the sa e y issues raised by the medical community.M However,[i received d hifijZ51 " sk[2M to define practice of med, practice of pharm, keep to the 5 ingle issue, the greater'the K97WRWwR why gg;g meqe
. OF C At USE OLY j 13 support, ex AC SilM...the better the chances have S!!M submit" (Exhibits 9, 12a and 12b).
N S M stated that the staff recognized the need a rule doing for justify ihange, but whether the staf f could initigt; it and so, was another matter. According to(( % n the Commissioners clearly wanted strong oversight of the medical community. In % view, a staf f initiated rule change would have lacked the necessary consensus and would have been a long protracted ef fort. During the January 1989 workshop, p,f 3 advised the medical community that a petition submitted by them would have a better chance of succeeding because it would be viewed as having a broad consensus. Also, the Commission would have to respond to the petition (Exhibit 10). FINDINGS The investigation determined that there was insufficient evidence the staff had violated criminal statutes, llRC regulations or internal policies. However, we concur with OGC that the staff conduct raises significant policy issues. We also concur that the staff needs additional guidance concerning assistance which may be provided to potential rulemaking petitioners. The investigation determined that while the staff maintained the assistance to petitioners was in accordance with Part 2 rules, the level of staff assistance provided was never fully disclosed to the Commission. According to THOMPSON, the assistance provided to f,TS*$ would not have changed the outcome of the staff's review of the petition. However, THOMPS0!i stated that if the staff participated in developing the petition, their role should have been disclosed. In addition, % % 2 % [and}CLE T 3 statements thatf i M was cautioned regarding tile amount, of appgj QDM,is not consistent with(@QmM;ancecontention being provided that thereto are no' prohibitions concerning what staff may do in assisting petitioners (i.e., why caution someone if there are no restrictions on their level of assistance). NMSS management was aware that G N D was, working with the medical community to_dovelop a petition, fgft7kh stated that of the E((l:$%ndf2Q assis ance Q (ad were givenIna Marchf air descript:,o 1989, e ported orally to? % 4 @ provided.7after. returning from ass stl . dM in California. AccordIng to E" F N was not iven "an signal tha was doing too mucti" I6"$$s st t and had the opportunity to ask quos ons~regardin {F partic pation in the petition but did not. Also,c advised that Qwould not have devoted that much time to a pro 9ect knowledge. Therefore, it without @351pT[?[ appears that g , assume andQy (Qg' actions 1 were in accordance with 0"CL US! 0s 'l
'
- 14 ,
the wishes.of NHSS ruanagement, especially.-in view of ' declarations- that there are no prohibitions on staff participation. . The investigation revealed that the staff requested the medical community to submit the petition to amend Part-T)$ and that the ACrlP/SNM may not- have otherwise done so. ' Staff members advised that the medical community was most--familiar.with the relevant. issues they confronted on_a day to day basis and knew what changes they wanted in the rules. Accordingly, the medical-community was better able than the NRC to. initiate the rule change. i a e
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