ML20199F099
| ML20199F099 | |
| Person / Time | |
|---|---|
| Issue date: | 01/14/1999 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Makris J ENVIRONMENTAL PROTECTION AGENCY |
| References | |
| NUDOCS 9901210193 | |
| Download: ML20199F099 (19) | |
Text
1
'Q pQ CEC lt UNITED STATES o
e NUCLEAR REGULATORY COMMISSION a
f WASHINGTON, D.C. 20555-0001 o
,o January 14, 1999 Mr. James Makris, Director Chemical Emergency Preparedness and Prevention Office U.S. Environmental Protection Agency 401 M. Street S. W. (Mail Code 5101)
Washington, D.C. 20460
SUBJECT:
PENDING U.S. NUCLEAR REGULATORY COMMISSION REGULATIONS FOR DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL
Dear Mr. Makris:
The U.S. Nuclear Regulatory Commission (NRC) is currently in the process of developing revisions to its regulations (10 CFR Part 70) for domestic licensing of special nuclear material.
The amendments will require certain NRC-licensed facilities to develop and implement a safety program based on the performance of an integrated hazard analysis. Generally, the facilities that will be affected by these amendments are nuclear reactor fuel fabrication facilities and some uranium enrichment facilities. In addition to special nuclear material, these facilities may also possess quantities of hazardous chemicals that subject them to the U.S. Environmental Protection Agency's (EPA's) chemical accident prevention provisions (i.e.,40 CFR Part 68) and to the Occupational Safety and Health Administration's (OSHA's) process safety management regulation (i.e.,29 CFR 1910.119).
The regulatory revisions are intended to be consistent with the October 31,1988, NRC-OSHA Memorandum of Understanding (Enclosure 1). That is, NRC regulatory purview would include radiological risk, chemical risk produced by radioactive materials, and facility hazards (e.g.,
chemical, fire, electrical and mechanical) which could affect the safety of NRC-licensed materials and thus present an increased radiological risk; however, NRC would not have regulatory responsibility for facility hazards that may result in occupational risks but do not affect the safety of NRC-licensed materials. Similarly, the regulatory revisions would not place the impacts of hazardous chemicals on members of the public under NRC's regulatory purview, unless those chemicals were licensed radioactive material themselves or were produced from licensed radioactive material.
Upon its review of a previous version of the rule, the Commission directed the NRC staff to revisit the issues related to chemical safety and further discuss them with the affected agencies, to understand the respective authorities and the degree to which those authorities are implemented. In addition, the Commission directed the staff to discuss the relevant documents with stakeholders and the public and submit a proposed rulemaking package in May 1999.
(Stakeholders and the public will also have an opportunity for formal comment
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i J. Makris January 14, 1999-l once the Commission approves a rule for publication as a proposed rule.) Since September 1998, we have held two public meetings and have established a World Wide Web site (http /techconf.llnl. gov /cgi-bin / messages? dom _.lic) that contains discussion threads and a
/
library of documents related to this rulemaking. As a result of discussions at those meetings and written comments received, two sections of the rule text were developed (Enclosure 2).
These two sections are intended to implement the NRC areas of responsibility and be consistent with the respective statutory authorities of NRC, EPA, and OSHA. Accordingly, we would greatly appreciate your views on these two sections.
To facilitate submission of a proposed rule package to the Commission in May 1999, we would like to resolve in January any major issues with the draft rule language itself, particularly for the attached two rule sections. Again, your views on the attached draft rule text would be appreciated. It would be desirable if your views could be provided by January 29,1999.
Should you like to arrange a meeting or have any questions, please contact Mr. Theodore Sherr on (301) 415-7218 or Mr. Andrew Persinko on (301) 415-6522.
Sincerely, (Original signed by)
Carl. J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. NRC-OSHA Memorandum of Understanding
- 2. Draft changes to 10 CFR 70.60 and $70.62 DISTRIBUTION:
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- ETenEyck CJ a ello DATE 01/11/99 01/11/99 01/11/99 01/12/99 01/13/99 01/ / Y /99 C = COVER E = COVER & ENCLOSURE N = NO COPY OFFICIAL RECORD COPY
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J. Makris once the Commission approves a rule for publication as a proposed rule.) Since September 1998, we have held two public meetings and have established a World Wide Web site (http /techconf.llnl. gov /cgi-bin / messages? dom _lic) that contains discussion threads and a
/
library of documents related to this rulemaking. As a result of discussions at those meetings and written comments received, two sections of the rule text were developed (Enclosure 2).
These two sections are intended to implement the NRC areas of responsibility and be consistent with the respective statutory authorities of NRC, EPA, and OSHA. Accordingly, we would greatly appreciate your views on these two sections.
To facilitate submission of a proposed rule package to the Commission in May 1999, we would like to resolve in January any major issues with the draft rule language itself, particularly for the attached two rule sections. Again, your views on the attached draft rule text would be appreciated. It would be desirable if your views could be provided by January 29,1999.
Should you like to arrange a meeting or have any questions, please contact Mr. Theodore Sherr on (301) 415-7218 or Mr. Andrew Persinko on (301) 415-6522.
Sincerely, 6l L M Carl. J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. NRC-OSHA Memorandum of Understanding
- 2. Draft changes to 10 CFR 6 70.60 and 970.62 L
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43950 Fc<letal Register / Vd. !3, No. *10 / Monday. October 31. 1988 / Notices
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(DockM No. f &-491 DEPARTMENT OF LABOR tnteragency effort can ersae asaw Summer Grove Pharmacy, Shre,eport, e aam t a i d; l
LA; Hearing effort. This memorandum replace, a.
NUCLEAR REGULATORY exis! Lng procedure for interagency Not::e is hereby given that on Apnl 12.1988. the Dryt Enf orcement COMMISSJON act2vities. Genera,Gui ehnen fer interface Activit:es vetwecn the NA j
Administration. Department of justice.
Memorardum of Understanding Regional Offices and the OSilAJ issued to Summer Grove Pharmacy an Between The Nuclear Regulatory Hazards Associated w.ith Nuclear j
Order to Show Cause as to wby the ComsrdsaJon and the Occupationaj Fa s es l
Drug Enfercement Administratien Safety and Heafth Administration; should not revoke your DEA Ceruf;cate Worter Protection at NRC4icensed 3.nere are four kinds of hazards tw of Registration AS3413755 and deny any Fact!!ttes may be associated with NRC4 censed pening apphcatiens.
nuclear facilities:
ne Nuclear Regulatory Comm.ission
- a. Radiation risk produced by Thirty days having elapsed since the (NRC) and the Occupadonal Safety and ra6oactive matenals:
+
said Order to Show Cause was received Healtle Mministration (OSHA) have
- b. Chemical risk produced by by Respondent, and wntten request for entered into a Memorandum of radioacthe matuials:
a bearing having been filed with the Understanding (MOU) to provide
- c. Plant conditions which affect th, Drug Enforcement Administration.
generalguidelines for interface activities nouce is hereby given that a hearing in between the two agencies. The MOU is safety of radioact we materials and th.s this matter will be held on nursday.
destgreed to ensure that there wiu be no present an increased rad 2ation nsk to workers.For example these might November 17.1988, commencing a t 10 00 gaps ta the protection of workers at a.m.. at the Unf ted States Custom NRC.rteensed facilities where the OSHA produce a fire or an explosion, and House. 423 Canal Street. courtroom. 211.
also has heahh and safety lurisdiction.
thereby cause a release of raicactne materials or an unsafe reactor conie New Orleans. louf siana.
At the same time. the MOU is designed a nd.
t avoid dupucation of effort on the part Dated. October 24. t ora
- d. Plant codJt2ons w hich result in a, cf the two agencies in those cases where IM C L'%
lt is not always practical to sharply occupaljonal risk, but do not affect the A &insucror. Div &hmen Identify boundaries between the NRC's safety of licensed radioact:.:' matenaN j
A d:r:n.s won-responsibliit es for nuclear safety and Far example, there mi);ht be exposure :
)
1 touc nonradioactive matenals and c:rr-the OSHA's responsibiliues for Industdal hazards in the workplace IFR Doc. es-now n:ed EM.8 &45 asI industrial safety.
ne MOU. whfch replaces an existing Generally, NRC covers the Erst three procedure for interagency activities.
hazards listed in pareg-eph 3 (a, b. cad defines the general areas of c). and OSHA covers the fourth hazard (Docae No. as441 responsibuities of both egencies.
described in paragraph 3 (d). NRC an describes generaUy the efforts <,f each to OSHA responsibilities and actions a achieve worker protection at NRC.
described more fully in paragraph 4 H' #
licensed facibties, and provides general and 5 below, No H
procedures for the coordmauen of NRC Responsibuities interface activities and exchange of Notice is hereby given that on Apr-J information between the NRC and
- 4. NRC la responsible for licensing and 22.1962, the Drug Enforcernent OSHA."Ite text of the MOU le set out regulating nuclear faciliues and Administration. Department of Justice materials and for conducting research n below.
issued to Michael C. Vizcarra. M.D., an support of the bcensing and regulatory Order to Show Cause as to why the Purpose and Backgiound process, as mandated by the Atomic Drug Enforcement Administration 1.The purpose of th!s Memnrandum of Energy Act of1954, as amended; the should not deny your application for a Understanding between the U.S. Nuclear Energy Reorganization Act of 1974. as DEA Certificate of Registrabon-Regulatory Commission (NRC) and the amended; and the Nuclear n!rty days having elapsed since the Occupational Safety and Health Nonproliferation Act of 1978; and in said Order to Show Cause was received Administration (OSHA)is to delineate accordance with the National by Respondent, and written request for the general areas of responsibility of Environmental Policy Act of1909. as a hearing having been filed with the each agency: to describe generauy the amended, and other applicable statutes Drug Enforcement Administration.
efforts of the agencJes to achieve worker nese NRC responsibilities cover the notice is hereby given that a beanng in protection at faciuties licensed by the first three nuclear facility hazards this meIter will be held on Tuesday.
NRC; and to previde guidelines for identified in paragraph 3 (s. b, c). NBC November 15.1988. commencing at 1200 coordination of interf ace activities does not have statutory authority for the s.m., at the Alhambra Municipal Court, between the two agencies. lf NRC fourth hatard described in paragraph 3 licenses observe OSHA's standards and (d).
150 West Common Wealth Avenue.
Division One Courtroom. Second Floor.
$ations, this wiu help minimize NRC responsibilities include workplace her.ards, protecting public health and safety:
Alhambra. California.
- 2. Both NRC and OSHA have protecting the environment; protecting f>a ted: October 15.1968.
jurisdiction over occupatjenal safety and safeguading materials and plants Joha c. hwn, and health at NRC-licensed f acilitb.
In the interest of national secunty; and Bec.ause it is not always practical to assuring conformity with antitrust laws Adminisuntor. Drug Enforcement Adeninisuotion, sharply identify boundaries between the for certain types of facilities, e.g, nuclear and radiological safety NRC nuclear power reactors. Agency im Doc. as-25c96 hted 10-28-e# 8 45 s m) regulatee and the industrial safety functions are performed through:
ammoccos** e OSHA regulates, a :.aoMinsted Standards. setting and rulemakim
Federal Register / Vol. 53. No. 210 / M dav. Ocider 31. 1988 / Notices 4KI 3
materials facihties presents chem.ca:
technical renews and stuies, conduct facihties are conducted no=a"y as a and nuc! car operational safety hatards result of accidents, fatehties. referra's, which can best be evaluated by tomt ci pubhc heannas; issuance of authonzations, permits and licenses:
cr w orker complaints.
NRC-OSHA team assessments. Each inspection. investigataan and ace Pmcedures agency will make its best ef! orts to enforcement; evaluation of operatmg
- 6. In recoptition of the agencies' support such assenstnent: ct stout 20 expenence. and confirmatory researth.
autherities and responsibthties facihties once every five years.Of dese OSHA Respons.bilities enumerated above. the f ouowing f acihues, about one. third are in the i
- 5. OSHA is responsible for procedures will be foUowed:
OSHA Plan States. OSHA will also Althougti NRC does not conduct assist in promoting such participation by admirJstenng the requirements estabbshed under the Occupauonal inspections of industrial safety. in the State personnelin OSHA F1an States.
course of inspections of radiological and
- 10. Based upon reports of injury or Safety and Health Act (OSHA ActJ [29
!).S C. e51 el see ). which was enacted in r uclear saf try. NRC personnel may complaints at nuclear power plant sites.
1970. OSHA's authority to engage in the identify safety concerns mthin the ana OSHA will provide NRC with 1
kmds of acdvities descnbed below does of OSHA responsibibty or may receive information on those sites w here
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not apply to those workplace safety and complaints from an employee aboutincreased management attendon to health con 6tions for which other OSHA-covered workmg conditi-ns. In worker safety is needed. The NRC w tu such instances. NRC wul brms the bnng such information in6catng Federal agencies exercise statutcry matter to the attenbon of bcensee e graficant breakdown in worker safety authority to presenbe and enforce management. NRC inspectors are not to to the attention of b.censee manage =er.t standacis, rujes or reguladons.
Under the OSH Act.every empicyer perform the role of OSHA inspectors:
and monitor corrective act3ons.This wtil has a general duty to furnish each however, they are to elevate OSHA not interfere mth OSHA authonty and eciployee with a place of ernploytnent safety issues to the attenden of NRC responsibility to investrgate tndustnsi that is free from recogntzed hazards that Regional managernent when accidents and worker cociplaints.
can cause death or senous physical appropnate. lf stgnificant safety
- 11. puwer reactor sites are inspected harm and to corrply mth au OSHA concerns are identified or tf the bcensee by NRC Region-based and Rendent standards. ru!es, and regulat ons.
demonstrates a pattern of m inspectors. Personnel fmtn NRC OSt!A standards contam unresponsiveness to identified concerns, requirements designed to protect the NRC Reponal OfSoe mil mform the Regional Offices routinely conduct employees against worv place hazards.
appropriate OSHA Regional OfBce. In inspecuans at most fuel and matena!s la general safety standania are the case of cociplaints. NRC wtil licensed facilities. In order to enhance intended to protect agatnst traumatic withhcid. from the hcensee, the identity the abibty of NRC personnel to identfy injury, wbde health standards are of the employee. In addition, when safety matters under OSHA purview designed to addma potential known to NRC. NRC will encourage during nuclear and radiological safety gg overexposure to toxic substances and hcensees to report to OSHA accidents inspeedons. OSHA mil provide NRC (j
harmful physical a gents, and protect resulting rn a fatahty or multiple Regional personnel mth basic chemical
- e a
and industrial safety trammg and themselves for many years after tuitial When such instances occur within indoctnnationin OSHA safety against illnessea wh2ch do not manifest hospitalizations.
OSHA State Plan States' junediction.
standards. consistent mth ongoing exposum.
the OSHA Regional Office will refer the OSHA tralmas programs.To enhance OSHA standards cover employse exposures from all radiabou sources not matter to the State for appropriate the ability of OSHA and State Plan l
personnel to effectively participate in regulated by NRC. E.xamples include x-a ctiort-rsy equiptoent. secclerators.
- 7. OSHA Regional Offices willinform the Operational Safety Team accelerator produced matenals, electron the appropriate NRC Regional Office of Assessments. NRC wtll provide trainir,g macroscopes and betatrons, and matten which are in the purview of in basic radiation safety requirernents, natuaUy occurrms radioactave NRC. when these come to their suec4on consistent with ongoing NRC training matenals such as rad 2um.
during Federal or State safety and programa. Details of such training will
!!is estimated that the Act covers health inspections or through be as mutually agreed by the NRC nearly a milhon workplaces employing complaints. ne following are exatoples Technical Training Center and the more than 80 cullion workers. Federal of matters that would be reported to the OSHA National Trulrung Institute.
OSHA ccvers approxfmately three NRC:
n.Resciution of policy issues ft!ths, or four rtulhon of these
- a. Lax security control or work
' DC'#"E8 "8f* " sdihti"
- d workplaces States which operate practices that would effect nuclear or gg OSHA-approved job safety and health radiological health and safety.
%0, y
NR Deputy programm, cr Plans cover the
- b. Improper posting of redietion areas.
N DWctor fw Opmuom. and
- c. IJcensee employee suegations of by the OSHA Director og pngcy.
remainder.
OSHA State Plan States are NRC license or regulation violations, Appropriate Headquanets points of encourased. but not required. to
- a. ne NRC and OSHA need not contact will be established.
delineate their authonty for normally conduct loint inspections at
- 13. Resolution of issues concernirig i
occupatic'nni safety and bealth at NRC-NRC-licensed facilities. However, under inspection and enforcement actintics licensed facahties in the same manner as certain conditions, such as involving both NRC and OSHA Federal OSHA.
Investigations or inspections following furtsdict2on at NRC-licensed facihties The OSHA areas of responsibility occidents or resulting from reported desenbed in this memorandum are activities as discussed initems e and 7 will be handled between NRC's OfEce of Enforcement and OSHA's Directorate subject to all applicable requirements above.it may be mutually agreed on a of Compliance Programs.Each NRC and and authorities of the OSH Act.
case-by-case basis that joint However, the industrial safety record at investigations are in the public int'erest.
OSHA Regional Office will designate NBC licensed nuclear power plants is 9.The chemical processing of nuclear points of contact for carrymg out D
such that OSHA inspections at these materials at some NRC-licensed fuel and interface activities.
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Professor cf Man ad D w ce:neetwgtete m b A e laboratory for Molecdar Smact rcr t.te.% clear RetrJetery Car.=esan.
seccmaaodate the sde&g 7 and Bonding. Texas aim Umse.
/s victor Stella. ;r, cl the participants.
College Stauon. Texas.
Esecutae D.rectorfor Chere:.u s.
TYPE OF MI1TN Cb.se Dr. Mary L Good (Chairman). Senior October 21.196&
October *s.19es.
Vice President.Tecimoloev. Allied-For the Occupanonal Safe'y and Heshh PElip D., Wader.
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lFR Doc. 68-:.5065 Filed 1NS-oa 8 45 amJ MassourL Dr. James B. Holderman. President.
esuseocoos - w NAT10s(A1. SCIENCE FOUNDATION University of South Carchna.
Columbia. South Carolma.
NATIONAL AERONAUTICS AND Naborsed Science Board; Nom 5. stions Dr. James L Powell. President. Reed SPACE ADWIN!STRAT10N for n.ht.;p November 1,1968 College 3203 Southeest Woodstoci ne National. Science Board (NSB)!s Boulevard. Portland. Oregon.
ipsetsa so-t21 a on Dr to L T.
e sidert Sj' NASA Adytsory Councit; Meeting nd cons!sts of 24 members appointed by the Ithaca* New York.
Acencr. National Aeronautics and President, with the advice and consent Dr. Howard A. Schneiderman. Senior Vice President. Research and Space Administration.
of the Senate, for six year terms,in Development and Chief Scientist.
Acnoec Notice of meeting.
addidon to the NSF Director & officm.
suesuAnn In acco tf ance with the as follows:
Monsanto Company,800 N. Lindbem.
Boulevard. St. Loua. M;s e curi.
Federal Advisory Committee Act. Pub.
Tms &pire May 12 IN L 92-463. ae amended. the Nauona1 Dr. Perry L Adkissen. Chance :or. The Terms Opite May 10. JPM Aeronautfcs and Space Admuustration Texas A&M Umversity System.
Dr. Warren J. Baker, President.
announces a forthccming meetag of the NASA Advisory Council (NAC).
System Admmistration Buildma.
Cahfornia Polytechnic State Executive Offices. Room 219. Co!!ege Univus4 San No OWpo, Informal Executn e Subcomrmitee.
Sta tion. Te xa s.
Cahfornia.
cart Ano nasc November 18.19o8, g Dr. Annelise G. Anderson. Senior Dr. Arden L Bement. lr.. Vice President a.m' to 5 p m' Researt:h Fellow The Hoover chmo d R a e
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Dr. Craig C. Black. Dtrector. Los Angeles Nuclear Structure Laboratory. P.
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" " """* * "*"" C * *C" 900 exposition Boules ard. Los University. New Haven. Connectic Mr. Nathaniel B. Cohen. Code ADI-t.
Angeles. California.
Dr. Daniel C. Drucker. Craduate National Aeronautics and Space Dr. Rita R. Colwell. Director Maryland Research Professor. Department of Administration. Washington DC 20546.
Biotechnology Institute and Professor Aerospace Engineering Mechanics 0245F6 M of Microbiology. Microbiology and Engineering Science. University of semAn womaAmc ne Building.Unisetsity of Maryland.
Florida.231 Aerospace Building.
NAC Informal Executive Subcommittee Co!!cse Park. Maryland.
Cainesville. Florida.
was established under the N AC to assist Dr. Thomas B. Day (Vice Chairrcan).
Dr. Charles L Hooler. Senior Vice the Chair in planning the activities-President. San Diego State University.
President for Research and Dean of establishing meetmg agendas, and 5300 Campanile Dnve. San Diego.
Craduate School.114 Kern Buildms.
otherwise guiding the activities of the Cahfornia.
The Pennsylvania State University.
Council.The Councilis chaired by Dr.
Dr. lames J. Duderstadt. Prestdent. The University Park. Pennsylvania.
John L McLucas, and includes eight University of Michf gart. 2074 Fleming Dr. Miguel Rios, Jr President. ORION other members, seven of whom chalt Administration Building. Ann Arbor.
InternationalTechnology. 300 San standing committees of the Councti.
Mateo. N.E., Suite #200, Albuquert;ue ne meeting will be closed to the Dr. K. June Lindstedt.Siva. Manager.
public.The sole egenda item will be EnvironmentalSciences. Atlantic New Mexico 5 planning for the coming year of the Richfield Company. 515 South Flower Dr. Roland W. Schmitt. President, activities of the Council, the committees.
Street.Los Angeles. California.
Rensselaer Polytechnic Institute, and their task forces, with emphasis Dr. Kenneth L Nordtvedt. Jr Professor PittsburEh Building. Troy, New York throughout on prospective future of Physica. Department of Physics, (One Vacancy) membership of each of these groups and Montana State University. Boceman.
Member & Officio thelt interacuons with NASA and '
Mr. Edch Blo'ch (Chairman. NSB outside parties.Throughout the sessions, Terms &pire May 10.1992 Execudu CommmnWctor, the quahfications of these individuals will be candidly discussed and Dr. Frederick P. Brooks, Jr.. Kenan National Science Mauon.
appraised whh respect to the tasks to be Professor of Computer Science.
Washington, DC.
acccaS:ned. Because the meeting will Department of Computer Scient.e, Section 4(c) of the Netional Science be concemed throughout with coatters University of North Carolma. Chapel Foundation Act of 1950 as amended.
lisled in 5 U.S.C. 552b(c)(e!, it hee been Hill. North Carolina.
l determined that this meeting should be Dr. F. Albert Cotton. W.T. Doherty.
j closed to the public. It is imperative that Walch Foundation Distinguished NSB Norntnee.
G
p REGu For the website. December 17,1998 g
A The views expressed in this document do not necessarily represent the
- s 8 views of the U.S. Nuclear Regulatory Commission (NRC). The l
j information in this document represents NRC staff-developed draft Cd g language for possible inclusion in a package to be provided for k
6 Commission approval for publication as a proposed rule. In accordance 4
with Commission direction, NRC staff is providing this information at this time for preliminary public comment and discussion. The public will have an opportunity also for formal comment once the Commission approves a rule for publication as a proposed rule.
Contents:
- 1. Release Notes
- 2. Clarifyino Modifications to 670.60
- 3. Clarifyino Modifications to 670.62
- 4. Related Definitions from 670.4
- 1. Release notes A. We have attempted to provide annotations [in redlined-brackets] that identify parallels to the SECY 98-185 version of the rule or call attention to certain clarifying information or other changes. These annotations will be put on the website but removed in the proposed rule package language. (Appropriate parts of this information would reappear in the rule package's statement of considerations.) The following redrafts are revisions-in-total of sections @70.60 and 70.62 of the SECY 98-185 version of the rule. The SECY 98-185 version of the rule may be viewed or downloaded from this page by clicking on the highlighted link or by setting your browser to http://techconf.llnl. gov /cgi-bin / library? source =*& library = dom _lic_ lib & file =042-0035.wp and clicking on either the Wordperfect (wp) or html version of 042-0002.
B. The purpose of the following redrafts of 470.60,670.62, and related definitions was to clarify the apparent confusion regarding the rule being " consequence-driven" as opposed to " risk-informed." This confusion was a major topic of discussion at the December 3-4,1998, public meetina on the draft rule. Another purpose was to clarify the responsibilities under NRC's 1988 memorandum of understanding (MOU) with the Occupational Safety and Health Administration (OSHA) (see note D, below), and to incorporate, in part, the comments provided by the Nuclear Energy Institute (NEI), in a letter dated November 4.1998, on NRC regulation of chemical hazards. To accomplish these purposes, we combined the consequence and likelihood sections, to reflect risk, and separated the performance requirements from the descriptive requirements for integrated safety analyses (ISAs) and safety programs.
C. The fact that a topic does not appear in the following draft rule language does not indicate that the topic will not be reinserted into the draft language that the staff will submit for Commission approval for publication as a proposed rule. For example, in the draft rule language below, the annotation after section 70.62(c)(5) mentions that the staff is currently 1
l evaluating the appropriate contents and location for the requirements for preliminary integrated safety analysis. Thus, preliminary integrated safety analysis language was not included in this i
l 2
web posting even though it was in the parallel section in SECY 98-185. However, language l
regarding this subject will be included in the draft rule language. As another example, the draft l
rule below (see 70.60 bl(5) and (c)(4)) does not reference the quantitative Emergency l
Response Planning Guidelines (ERPG) and Acute Exposure Guideline Limits (AEGL) chemical consequence standards, but adopts equivalent, qualitative language. We are still considering l
the merits of this approach.
D. As mentioned above, we believe the redrafts of these two rule sections provide clearer l
treatment of the 1988 NRC-OSHA MOU on responsibilities for hazards at NRC licensed facilities. Specifically, item (c) of the NRC-OSHA MOU states that NRC has the general I
purview for regulating " plant conditions which affect the safety of radioactive materials and thus present an increased radiation risk to workers." As an example, NRC's regulatory purview l
would include the impacts of chemical system failures or fires that cause failure of a nuclear safety system, and NRC's purview would include impacts of plant conditions on the ability of operators to perform an activity (administrative control) that is relied on for nuclear safety. The draft rule addresses these responsibilities in two ways / cases, the performance requirements (70.60) and the ISA requirements (70.62(c)(1)(iii)). Language very similar to item (c) of the NRC-OSHA MOU now appears in the ISA requirements in 670.62(c)(1)(iii). Also, through
@70.60, if the failure of a "non-nuclear" system could disable a nuclear system and cause an unacceptable risk [such as the frequency of a worker dose exceeding 25 rem being greater than "unlikely"-- per 70.60(c)(1)]; then 70.60(d) would require that the non-nuclear system be designated as an " item relied on for safety" and controlled by the safety program (viz., it would be under NRC's regulatory purview). In addition,70.60(b) and (c) specify risk-based standards for " hazardous chemicals produced from licensed material," such as HF gas accidentally released from a reaction of UF, with water. Sections 70.62(c)(1)(i) and (ii) also contain statements that correspond to MOU items (a) and (b). Inclusion of this language assures that each MOU item for which NRC has general regulatory purview will be explicitly addressed by licensees in the ISA.
E. We have added two paragraphs, 70.62(c)(2) and 970.62(c)(3), that deal with integrated safety analysis (ISA) team qualifications and ISA revalidation, respectively. These sections are very similar to requirements of the OSHA process safety management rule (specifically,2_9 CFR 1910,119(e)(4) and (e)(6)). We believe that inclusion of these sections may be appropriate, not only for consistency with OSHA, but also in consideration of the further development of requirements on the submittal and contents of the ISA summary, what is "on the docket" and/or "in the license," and the process (e.g., NRC pre-approva! or not) for making changes to the plant and items relied on for safety. Revalidating the ISA will also permit an opportunity for consideration and incorporation of recent industry and facility accidents into the ISA, and possibly an opportunity to incorporate different experiences (e.g., if staff changed) into the updated ISA.
- 2. Clarifyina modifications to 70.60 70.60 Performance Reauirements for Certain Licensees Authorized to Possess Special Nuclear Material in Quantities Sufficient to Form a Critical Mass.
(a) Each applicant or licensee required to establish and maintain a safety program pursuant to 670.62 of this part shall demonstrate, in the integrated safety analysis, compliance with the
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performance requirements in paragraphs (b) and (c) of this section. [ annotation: most requirements of previous 70.60(a) and 70.60(d), dealing with the safety program and ISA contents have been moved into 70.62 (below) for clarity]
l (b) The risk of each credible high-consequence event must be limited, unless the event is highly l
unlikely, through the application of engineered controls, administrative controls, or both, that i
reduce the likelihood of occurrence of the event or (except for nuclear criticality) its consequence. Application of further controls is not required for those high-consequence events demonstrated to be highly unlikely. High-consequence events are those internally or externally initiated events that result in:
(1) a nuclear criticality; (2) an acute worker dose of 1 Sv (100 rem) or greater total effective dose equivalent; (3) an acute dose outside the controlled site boundary of 0.25 Sv (25 rem) or greater total effective dose equivalent; (4) an intake outside the controlled site boundary of 30 mg or greater of uranium in soluble form; or (5) an acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed material that: (i) could endanger the life of a worker, or (ii) outside the controlled site boundary, could lead to irreversible or other serious, long-lasting health effects. If an applicant possesses or plans to possess quantities of material capable of such chemical exposures, then the applicant shall propose appropriate quantitative standards for these health effects, as part of the application information submitted pursuant to Section @70.65 of this Part.
- [ annotation: The ERPG and AEGL would be identified as acceptable standards in the SRP. Items (b)(5) and (c)(4) cover, for example, "HF;" and rely on a new
@70.4 definition, hazardous chemicals produced from licensed materiat}
[ annotation: " acute" is defined in section 70.4 (see below)}
(c) The risk of each credible intermediate-consequence event must be limited, unless the event is unlikely, through the application of engineered controls, administrative controls, or both, that reduce the likelihood of occurrence of the event or its consequence. Application of further controls is not required for those intermediate-consequence events demonstrated to be unlikely. Intermediate-consequence events are those internally or externally initiated events, that are not high-consequence events, that result in:
(1) an acute worker dose of 0.25 Sv (25 rem) or greater total effective dose equivalent; (2) an acute dose outside the controlled site boundary of 0.05 Sv (5 rem) or greater total effective dose equivalent; (3) a 24-hour averaged release of radioactive material outside the restricted area in concentrations exceeding 5000 times the values in Table 2 of Appendix B to 10 CFR Part 20; or (4) an acute chemical exposure to an individual from licensed material or hazardous i
chemicals produced from licensed material that: (i) could lead to irreversible or other serious, long-lasting health effects to a worker, or (ii) outside the controlled site l
boundary, could cause mild transient health effects. If an applicant possesses or plans to possess quantities of material capable of such chemical exposures, then the applicant shall propose appropriate quantitative standards for these health effects, as
4 part of the application information submitted pursuant to Section 70.65 of this Part.
(d) Each engineered or administrative control necessary to comply with subsection (b) or (c) of this section shall be designated as an item relied on for safety. The safety program, established and maintained pursuant to @70.62 of this part, shall ensure that each item relied on for safety will perform its intended function when needed and in the context of the performance requirements of this section.
- 3. Clarifying modifications to 70.62 70.62 Safety Proaram. Intearated Safety Analvsis. and Filina of Intearated Safety Analysis Summarv (a) safetyprogram. (1) Each licensee engaged in enriched uranium processing, uranium fuel fabrication, uranium enrichment, enriched uranium hexafluoride conversion, plutonium processing, mixed-oxide fuel fabrication, scrap recovery, or any other activity that the Commission determines could significantly affect public health and safety, shall establish and maintain a safety program that ensures that actions taken will provide adequate protection from licensed materials, for worker and public health and safety and of the environment. The safety program may be graded such that management measures applied are commensurate with that item's reduction of the risk. Requirements for the safety program, including process safety information, integrated safety analysis, and management measures, are described in subsections (b) through (d) of this section.
[ annotation: note "may be..." - grading of safety program is permitted but not required).
[ annotation: by " management measures" we mean measures that assure that items used for safety will be available and perform their functions reliably when needed.)
(2) Each licensee shall establish records that demonstrate that the requirements of this section have been met. Each licensee shall maintain these records untillicense termination. [ annotation: (a)(1) and (a)(2) parallels 70.60(a) and 70.60(d)(6), respectively, in SECY 98-185; note change to " license termination"instead of " lifetime of the plant")
(3) If the decommissioning of a facility involves potentially hazardous activities such as chemical treatment of wastes, each licensee shall perform an ISA of the decommissioning process, demonstrate compliance with the performance requirements of section 970.60 of this part, and submit the results to NRC for approval before beginning such decommissioning activities. [ annotation: parallels 70.62(b) in SECY 98-185]
(b) process safetyinformation. Each licensee or applicant shall compile and maintain a set of process safety information to enable the performance of an integrated safety analysis. This process safety information must include information pertaining to the hazards of the materials i
used or produced in the process, information pertaining to the technology of the process, and I
information pertaining to the equipment in the process. [annotatica: parallels 70.60(d)(1) in SECY 98-185]
l
5 (c) integrated safety analysis. (1) Each licensee or applicant shall conduct an integrated safety analysis, that is of appropriate detail for the complexity of the process, that:
(i) identifies radiological hazards resulting from possessing or processing licensed material at its facility; (ii) identifies chemical hazards of licensed material or hazardous chemicals produced from licensed material resulting from possessing or processing licensed material at its facility; (iii) identifies facility hazards (e.g., chemical, fire, electrical and mechanical) which could affect the safety of licensed materials and thus present an increased radiological risk;
[ annotation: (i)-(iii) modified slightly from draft rule to explicitly address OSHA MOU)
(iv) identifies and provides the basis for potential accident sequences caused by process deviations or other events internal to the plant and credible external events, including natural phenomena; (v) identifies and provides the basis for the consequence and the likelihood of occurrence of each potential accident sequence identified pursuant to paragraph (b)(1)(iv) of this section; and (vi) identifies and provides the basis for each item relied on for safety identified pursuant to section 970.60(d) of this Part, and the characteristics of its preventive, mitigative, or other safety function.
(2) integrated safety analysis team qualifications. [ annotation: this paragraph added to match 29 CFR 1910.119(e)(411 in order to assure the adequacy of the integrated safety analysis, the integrated safety analysis shall be performed by a team with expertise in engineering and process operations, and the team shall include at least one employee who has experience and knowledge specific to each process being evaluated, and employees who have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process safety. Also, one member of the team must be knowledgeable in the specific integrated safety analysis methodology being used.
(3) integrated safety analysis revalidation. The integrated safety analysis shall be periodically revalidated by a team meeting the requirements of paragraph (c)(2) of this section, to ensure that the integrated safety analysis is consistent with the current facility.
The minimum period for such revalidation shall be at each filing of an application for renewal of a license pursuant to section 70.33 of this part [ annotation: this paragraph added to match 29 CFR 1910.119(e)(6). The wording permits a more frequent period between revalidations, e.g., every 5 years as specified in 29 CFR 1910.119(e)(6) for the process hazards analysis).
(4) integrated safety analysis summary. Each applicant or licensee shall submit an integrated safety analysis summary to NRC for approval, as appropriate: (i) in accordance with the requirements and schedule in paragraph (c)(5) of this section, if applicable; or (ii) as part of the license application contents, amendment application contents, or renewal l
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l application contents identified in 6670.21, @70.22,670.33,670.34, and 670.65.
[ annotation: this paragraph requires the submitted ISA-summary (which used to be called 'results of the ISA.' This paragraph (c)(4) parallels 70.62(a)(1)-(3) that were in i
SECY 98-185). The contents of applications section (70.65, under development) and l
the definitions (70.4) will identify the contents of the ISA summary and what is to be "in the license,""on the docket," etc. We plan to move the SECY 98-185 sentence "The process description in the integrated safety analysis summary must include information that demonstrates the licensee's compliance with the design requirements for criticality monitoring and alarms in 670.24." to 670.65 (contents of applications) since it addresses the contents of the ISA summary and license application. Note also that the correction of ' unacceptable vulnerabilities' identified by the ISA, that was in the parallel section of SECY 98-185, is now handled by 70.60(a)]
(5) filing by existing licensees. Individuals holding an NRC license on <the effective date of this rule > shall, with regard to existing licensed activities:
(i) within 6 months of <the effective date of this rule >, submit, for NRC approval, a compliance plan that describes the integrated safety analysis approach that will be used, the processes that will be analyzed, and the schedule for completing the analysis of each process. Pending the correction of unacceptable vulnerabilities identified by the integrated safety analysis, the licensee shall implement appropriate compensatory measures to ensure adequate protection.
(ii) within 4 years of <the effective date of this rule >, unless otherwise specified by the conditions of a license held on <the effectivo date of this rule >, complete an integrated safety analysis, correct all unacceptable vulnerabilities, and submit an integrated safety analysis summary in accordance with paragraph (c)(4) of this section or the approved compliance plan submitted under paragraph (c)(5)(i) of this section.
[ annotation: (c)(4) and (5) parallel 70.62(a)(1)-(3) that were in SECY 98-185. We are currently reevaluating: (1) if preliminary ISA requirements should appear here (as they did in the SECY 98-185 version), or another section (e.g.,670.64); and (2) the nature and contents of the preliminars!ISA requirements. After this reevaluation, we may reinsert language here that parallels the old 70.62(a)(3)]
[ annotation: unacceptable vulnerabilities is defined in Section 70.4 (see below)]
(d) management measures. [ annotation: except as noted, this section parallels 70.60(d)(3) in SECY 98-185) To ensure that each item relied on for safety will perform its intended function when needed, the integrated safety analysis shall be used by licensees to establish safety program management measures. The safety program management measures shall ensure that:
(1) Engineered controls that are identified as relied on for safety pursuant to section 70.60(d) of this part are designed, constructed, inspected, calibrated, tested, and l
maintained, as necessary, to ensure the ability to perform their intended functions when l
needed items subject to this requirement include but are not limited to: principal l
structures of the plant; passive barriers relied on for safety (e.g., piping, glove boxes, containers, tanks, columns, vessels); active systems, equipment, and components relied I
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on for safety; sampling and measurement systems used to convey information about the safety of plant operations; instrumentation and control systems used to monitor and control the behavior of systems relied on for safety; and utility service systems relied on for safety.
(2) Personnel are trained, tested, and retested, as necessary, to ensure that they l
understand, recognize the importance of, and are qualified to perform their duties that are identified as relied on for safety pursuant to section G70.60(d) of this part; (3) Procedures that are identified as relied on for safety pursuant to section S70.60(d) of this part are developed, reviewed, approved, and distributed to ensure that personnel are able to perform the duties relied on for safety.
(4) Human-system interfaces are designed and imnlemented to ensure that personnel relied on for safety are able to perform their dutiet th< t are identified as relied on for safety pursuant to section 70.60(d) of this part; (5) Configuration changes to site, structures, process, systems, equipment, components, l
computer programs, personnel, procedures, and documentation are managed so that such modifications are reviewed, documented, communicated, and implemented in a systematic, controlled manner.
(6) Quality assurance that is commensurate with the item's reduction of risk is applied to each item relied on for safety identified pursuant to section Q70.60(d) of this part.
l (7) Periodic audits and assessments of the safety program are performed to ensure that an adequate level of protection is maintained at the facility. [ annotation: parallels 70.60(d)(4) it) SECY 98-185]
4 (0) Abnormal events are investigated and corrective actions taken to minimize the recurrence of these events. [ annotation: parallels 70.60(d)(5) in SECY 98-185]
- 4. Related Definitions from 970.4 Acute as ushd in section 670.60 of this part means a single radiation dose or chemical exposure event oi multiple radiation dose or chemical exposure events occurring within a short time (24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less). [ Annotation: slightly modified]
Acut$ eXDosi re Guideline levels (AEGLi (Annotation: this term is not used in'the rule anymore]
Controlled site boundary means the physical barrier surrour: Jing the facility that is used by the licensee to control access, it may or may not coincide with the property boundary.
Critical mass of SNM means special nuclear material in a quantity exceeding 700 grams of contained uranium-235; 520 grams of uranium-233; 450 grams of plutonium; 1500 grams of contained uranium-235, if no uranium enriched to more than 4 percent by weight of uranium-
8 235 is present; 450 grams of any combination thereof; or one-half such quantities if massive l
moderators or reflectors made of graphite, heavy water, or beryllium may be present.
Emergency response plannino auidelines (ERPGJ [ Annotation: this term is not used in the rule anymore]
Hazardous chemicals [ Annotation: this term is not used in the rule anymore]
Hazardous chemicals oroduced from licensed materials means substances having licensed material as precursor compound (s) or substances that physically or chemically interact with licensed materials; that are toxic, explosive, flammable, corrosive, or reactive to the extent that they can endanger life or health if not adequately controlled. These include substances commingled with licensed material, and include substances such as hydrogen fluoride that is produced by the reaction of uranium hexafluoride and water, but do not include substances prior to process addition to licensed material or after process separation from licensed material.
[ Annotation: modified version of the NEl-proposed definition. The terms, process addition and process separation are used to indicate an intentional activity (as opposed to an accidental separation)]
Intearated safety analvsis (ISA) meane a systematic analysis to identify plant and external hazards and their potential for initiating accident sequences, the potential accident sequences, their likelihood and consequences, and the site, structures, systems, equipment, components, and activities of personnel that are relied on for safety. As used here, integrated means joint consideration of, and protection from, all relevant hazards, including radiological, nuclear criticality, fire, and chemical, items relied on for safety means structures, systems, equipment, components, and activities of personnel that are relied on to prevent or to mitigate potential accidents at a facility.
Results of the ISA [ Annotation: this term is not used anymore -it was replaced by inteorated safety analysis summarv1.
jntearated safety anajysis summary means the portion of the license application, license amendment application, or license renewal application that has the purpose of informing the Commission of the nature of the facility, the plans for its use, and the evaluations that have been performed to evaluate if the facility has been constructed and will be operated in accordance with NRC requirements and will provide adequate protection from licensed materials, for worker and public health and safety and of the environment. [ Annotation: new definition].
Unacceptable vulnerabilities mean deficiencies in the items relied on for safety or the measures used to assure their availability and reliability of such items when needed, that need to be corrected to ensure an adequate level of protection as defined in 10 CFR 70.60(b) or (c).
[ annotation: this term is now only used in one place - 670.62(c)(5) dealing with filing of the ISA l
summary by existing licensees].
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9 Worker means an individual whose assigned duties in the course of employment involve exposure to radiation and/or radioactive material from licensed and unlicensed sources of radiation (i.e., an individual who is subject to an occuoational dose as in 20 CFR 20.1003).
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I J. Makris
-2 January 14, 1999-once the Commission approves a rule for publication as a proposed rule.) Since September 1998, we have held two public meetings and have established a World Wide Web site (http://techconf.llnl. gov /cgi-bin /tr,essages? dom _lic) that contains discussion threads and a library of documents related to this rulemaking. As a result of discussions at those meetings and written comments received, two sections of the rule text were developed (Enclosure 2).
These two sections are intended to implement the NRC areas of responsibility and be consistent with the respective statutory authorities of NRC, EPA, and OSHA. Accordingly, we l
would greatly appreciate your views on these two sections.
l To facilitate submission of a proposed rule package to the Commission in May 1999, we would like to resolve in January any major issues with the draft rule language itself, particularly for the attached two rule sections. Again, your views on the attached draft rule text would be appreciated. It would be desirable if your views could be provided by January 29,1999.
Should you like to arrange a meeting or have any questions, please contact Mr. Theodore Sherr on (301) 415-7218 or Mr. Andrew Persinko on (301) 415-6522.
Sincerely, (Original signed by)
Carl. J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. NRC-OSHA Memorandum of Understanding
- 2. Draft changes to 10 CFR @ 70.60 and 70.62 DISTRIBUTION:
NRC File Center NMSS Dir Ofc r/f NMSS r/f FCSS r/f SPB r/f FRIB Task Force r/f PSantiago, DWM DMartin, OEDO PDR G:\\TaskForce\\epaltr.wpd 'See Previous Concurrence CP/PROOPED/.8MUARY 13.1999 OFC FCSS E
FCSS E
FRIB E
OGC E
FCSS NMSL A NAME
- RLewis:al
- APersinko
- TSherr
- KWinsberg
- ETenEyck CJ nello DATE 01/11/99 01/11/99 01/11/99 01/12/99 01/13/99 01/ / Y /99 C = COVER E = COVER & ENCLOSURE N = NO COPY OFFICIAL RECORD COPY l
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J. Makris once the Commission approves a rule for publication as a proposed rule.) Since Se ember 1998, we have held two public meetings and have established a World Wide Web ite (http://techconf.llnl. gov /cgi-bin / messages 7 dom._lic) that contains discussion thrp ds and a library of documents related to this rulemaking. As a result of discussions a and written comments received, two sections of the rule text were develop ).
)
These two sections are intended to implement the NRC areas of respon ility and be consistent with the respective statutory authorities of NRC, EPA, and - HA. Accordingly, we would greatly appreciate your views on these two sections.
To facilitate submission of a proposed rule package to the Co ission in May 1999, we would like to resolve in January any major issues with the draft rule attached two rule sections. Again, your views on the attac )d draft rule text would benguage appreciated. It would be desirable if your views could be rovided by January 29,1999.
Should you like to arrange a meeting or have any que ons, please contact Mr. Theodore Sherr on (301) 415-7218 or Mr. Andrew Persinko on (301) 15-6522.
Sinoerely, Carl. J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
Enclosures:
Enclosures:
NR -OSHA Memorandum of Understanding Draft change o 10 CFR @S70.60 and 70.62 l
DISTRIBUTION:
NRC File Center NMSS ir Ofc r/f NMSS r/f FCSS r/f SPB r/f FRIB Task Force r/f PSantiago, DWM DMartin, OEDO PDR Center G:\\TaskForce\\epaltr pd
(*See Previous Concurrence)V OFC FCSS E
FCSS E
FRIB E
OGC E. FCSS)
NMSS NAME
- R[ewis:al
- APersinko
- TSherr
- KWinsberg ETenhck CJPaperiello DATE
'01/11/99 01/11/99 01/11/99 01/12/99 01// 3 /99 01/
/99 C = COVER E = COVER & ENCLOSURE N = NO COPY OFFICIAL RECORD COPY if tt2' I
I i
l J. Makris once the Commission approves a rule for publication as a proposed rule.) Since September 1998, we have held two public meetings and have established a World Wide Web site
- nttp
- //techconf.llnl. gov /cgi-bin / messages 7 dom _lic) that contains discussion threads and a library of documents related to this rulemaking. As a result of discussions at those meetings and written comments received, two sechons of the rule text were developed (Enclosure 2).
These two sections are intended to implement the NRC areas of responsibility and be consistent with the respective statutory authorities of NRC, EPA, and OSHA. Accordingly, we would greatly appreciate your views on these two sections.
To facilitate submission of a proposed rule package to the Commission in May 1999, we would like to resolve in January any major issues with the draft rule language itself, particularly for the attached two rule sections. Again, your views on the attached draft rule text would be appreciated. It would be desirable if your views could be provided by January 29,1999.
Should you like to arrange a meeting or have any questions, please contact Mr. Theodore Sherr on (301) 415-7218 or Mr. Andrew Persinko on (301) 415-6522.
Sincerely, Cari. J. Paperiello, Director Office of Nuclear Material Safety and Safeguards l
Enclosures:
Enclosures:
NRC-OSHA Memorandum of Understanding Draft changes to 10 CFR $$70.60 and $70.62 DISTRIBUTION:
NRC File Center NMSS Dir Ofc r/f NMSS r/f FCSS r/f SPB r/f FRIB Task Force r/f PSantiago, DWM DMartin, OEDO PDR Center G:\\TaskForce\\epaltr.wpd eM dGbh FCSSd NMSS i
OFC.hCSS E
FCSS E
FRIB E
NAMEhbwis:aN kPersinko TSherrfh < Khb$fb ETenE ek CJPaperiello
,3 1 DATE 01/\\\\ /99 1 01/\\\\ /99 01/ A /99 01/12_/99 01/ Py /99 01/
/99 C = COVER E = COVER & ENCLOSURE N = NO COPY OFFICIAL RECORD COPY i
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