ML20205S118
| ML20205S118 | |
| Person / Time | |
|---|---|
| Issue date: | 01/22/1999 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Vietticook A NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20205S086 | List: |
| References | |
| RULE-PRM-50-63, RULE-PRM-50-63A SECY-98-264-C, NUDOCS 9904260092 | |
| Download: ML20205S118 (18) | |
Text
.
NOTATION VOTE RESPONSE SHEET TO:
Annette Vietti-Cook, Secretary FROM:
COMMISSIONER MCGAFFIGAN
SUBJECT:
SECY-98-264 - PROPOSED AMENDMENTS TO 10 CFR 50.47; GRANTING OF PETITIONS FOR RULEMAKING (PRM 50-63 AND 50-63A) RELATING TO A RE-EVALUATION OF POLICY ON THE USE OF POTSSIUM IODIDE (KI) AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT l
Approved X
Disapproved Abs.tain Not Participating COMMENTS:
See af tached coments.
These coments also apply to COMJSM-98-002.
i a -
af SIGNATURE I '> ' s l-2, (1'l'l s
DATE.
Entered on "AS" Yes ( No Pa**ds!M 38c.22 CORRESPONDENCE PDR
o a
Commissioner McGaffigan's Comments on SECY 98-246 and COMJSM 98-2 Subject to the attached edits, I approve the draft Federal Register Notice. Note that these include some of Commissioner Dicus' edits.
Two Commissioners argue that the proposed rule is a backfit. I disagree.
Consideration of Kl has, like consideration of evacuation and sheltering, always been a part of NUREG-0654's guidance on 50.47(b)(10), the rule we are revising (see items
- e. and f. on page 63 of NUREG-0654, Rev.1 (attached)). The proposed version of (b)(10) would do nothing more than make explicit in (b)(10) itself something more of its long-existing interpretation, thereby providing greater assurance that that interpretation will be adhered to. Moreover, even if requiring someone to consider the uLa of Kl is a new interpretation of (b)(10), requiring someone to considersomething is not a backfit.
Generic letters and other requests for information under 10 CFR 50.54(f) often ask that licensees consider whether they should make some change in hardware or procedure, but the agency has long argued that such requests are not themselves backfits because they do not impose changes in hardware or procedure. It is true that licensees will be put to some trouble if state or local emergency planners opt for KI, but such conditional costs have not heretofore been considered backfits.
I support Commissioner Merrifield's proposal to an extent..I believe that we should work with FEMA to assure that FEMA's NBC anti-terrorism stockpiles could make substantial amounts of Kl available on an ad hoc basis to states that did not have stockpiles for radiological emergencies at a nuclear utility, but who elected at the last minute to use Kl in an emergency. It was clearly the Commission's understanding in June 1997 that substantial FEMA NBC stockpiles would be available in such an emergency. At our November 1997 briefing, FEMA did nothing to disabuse us of that understanding. Now we are told, however, that almost no Kl is going into FEMA's NBC stockpiles to deal with nuclear terrorism. We should try to persuade FEMA to go back to its 1997 policy in response to Presidential Decision Directive 39.
However, I also continue to support federal funding of state stockpiles. It is well established that Kl is most useful if taken early in a radiological emergency. Reliance on federal stockpiles would probably cost precious time. In June 1997 we made a unanimous decision to commit to funding of state stockpiles, and only this last summer we unanimously reaffirmed that decision, when we well knew that our budget was under great pressure. We evidently thought then that we could find the money for KI, and I see no reason to think differently now. We do not face a choice beteteen jobs for NRC people and Kl for citizens. Not all the states are going to decide in favor of Kl, and coitainly not all at once, and, as Commissioner Diaz points out, the price of K1 is likely to drop under the pressure of competition, as it has in Europe.. An argument against federal funding of state stockpiles can be made, but our commitment to funding has existed long enough now that at least one State, Ohio, has relied on it (see inside NRC, January 4,1999, p.11), and others have undertaken public processes of the sort this rulemaking would encourage, presumably partly based on our consistent statements over the past two years. At this point, the virtue of consistency, which is among our Principles of Good Regulation, outweighs the argument against funding.
(,
J.
Protective Response (continued)
Applicability and Cross Evaluation Criteria Reference to Plans Licensee State Local
.e.
Provisions for the use of radioprotective i
drugs, particularly for emergency workers and l
institutionalized persons within the plume exposure EPZ whose imediate evacuation may be infeasible or very difficult, including quantities, storage, and means of distribution.
X X
f.
State and local organizations' plans should include the method by which decisions j
by the State Health Department for administering i
radioprotective drugs to the general population I
are made during an emergency and the pre-determined conditions under which such drugs
)
may be used by offsite emergency workers;l X
X j
g.
Means of relocation; X
X h.
Relocation centers in host areas which i
I are at least 5 miles, and preferably 10 miles, beyond the boundaries of the plume exposure emergency planning zone; (See J.12).
X X
lI 1.
Projected traffic capacities of evacuation i
routes under emergency conditions; X
X l
- j. Control of access to evacuated areas and organization responsibilities for l'
such control; X
X with potential impediments (e.g., seasonal k.
Identification of and means for dealing impassability of roads) to use of evacuation routes, and contingency measures; X
X l
1.
Time estimates for evacuation of various sectors and distances based on a dynamic analysis (time-motion study under various conditions) for the plume exposure pathway emergency planning zone (See Appendix 4); and X
X 1/ See DHEW (new DHHS) Federal Register notice of December 15, 1978 (43 FR 58798) entitled " Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency.'
Other guidance concerning the storage, stockpiling, and conditions for use of this drug by the general public, is now under development by the Bureau of Drugs, DHHS.
t-
F l
l l
{7590-01-P)
NUCLEAR REGULATORY COMMISSION l
t RIN: 3150-AG11 Consideration of Potassium lodide in Emergency Plans I
AGENCY:
Nuclear Regulatory Commission.
ACTION:
Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing an amendment to its emergency planning regulations governing the domestic licensing of production and utilization facilities. The proposed rule would amend the current regulations to imheate that consideration
~
' require shall be given to including potassium iodide (KI), a eng wdisheltering and evacuation,' as a supplement & protective measure for the general publicq he proposed rule responds to T
Insert petitions for rulemaking submitted by Mr. Peter G. Crane concerning the use of Kl in emergency plans.
EFFECTIVE DATES: The comment period expires 90 days after publication in the Federal Reaister. Comments received after this date will be considered if practical to do so, but only those comments received on or before this date can be assured of consideration.
Insert that would supplement sheltering and evacuation. KI would help prevent thyroid cancers in the unlikely event of a major release of radioactivity from a nuclear power plant.
C.rscu.5eAE 3
1
~.
(7590-01 P]
ADDRESSES: Comments may be sent to the Secretary of the Commission, Attention:
Rulemaking and Adjudications Staff, U.S. Nuclear Regulatory Commission, Washington 20555, or may be hand-delivered to One White Flint North,11555 Rockville Pike, Rockville 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. Copies of comments re be exarnined at the Commission's Public Document Room at 2120 L Street NW (Lowe Washington, DC.
You may also provide comment via the NRC's interactive rulemaking web site on the NRC home page (http://www.ntc. gov). This site provides the availability to upload comments aj files in any format that the NRC web browser supports. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-6215; e mai: CAG @nrc. gov.
FOR FURTHER INFORMATION CONTACT: Michael T. Jamgochian, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
Telephone: (301) 415 3224. Internet: MTJ1 @NRC. GOV.
SUPPLEMENTARY INFORMATION:
Insert Y
By undertaking this rulemaking, the Commission is proposing to grant tec pe:...ane4er
-ru;emehini; (PP.M-50 50$nd 50-00A) from Mr. Peter Crane esbmi;;ed en Oeptembert4995,
- nd N;vember 11,1007 Considering all public comments received, the information available in the litercture, 20 years of experience gained in evaluating licensee emergency preparedness plans, and the arguments presented by the petitioner, the Commission has decided to grant the petition for rulemaking and to proceed with rulemaking to amend 10 CFR 50.47(b)(10) by inserting the following sentence, after the first sentence
- "In developing this range of actions, consideration 2-
1 has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (KI), as appropriate." In addition, the preamble for this proposed rule includes a statement to the effect that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and pruden for specific local conditions. The Commission also noted that, consistent with the Commission's i
decision on June 30,1997, the Federal government (most likely the NRC) is prepared to fund the purchase of a stockpile of Kl for the States, upon request. The NRC staff will work to ensure that the process for States to obtain funding for Kl is established.nThe NRC staff will i
Insert else work with other relevant agencies to ensure that there are established procedures to
\\
enable the national stockpile'of Kl, for terrorist activities, to be effectively and timely used by states that have not established local stockpiles and wish to make use of the national stockpiles in the event of a severe nuclear power plant accident.
On November 27,1995 (60 FR 58256), the Nuclear Regulatory Commission (NRC) published a Notice of Receipt of a petition for rulemaking (PRM-50-63) filed by Mr. Peter G.
Crane on his own behalf The petitioner requested that the NRC amend its regulations concerning emergency planning to include a requirement that emergency planning protective actions include the prophylactic use of potassium iodide (KI), which the petitioner notes prevents thyroid cancer after nuclear accidents.
On November 11,1997, the petitioner submitted a revision to his original petition (PRM-50 63A). The NRC published a Notice of Receipt of the amended petition on December 17, 1997 (62 FR 66038). In the amended petition, the petitioner requested that:
A statement [be made] clearly recomrnending stockpiling of KI as a " reasonable and prudent' measure, and; A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the 3-
l L
first sentence: "In developing this range of actions, L'
I consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (KI), as appropriate."
1 The petitioner also provided a marked up version of thgpropcsed Federal Radiologica NRC staff's Preparedness Coordinating Committee (FRPCC) Federal Register notice concerning Fede policy relating to the use of KI for the general public.
On June 26,1998 (SRM 98 061), the Commission decided to grant the petition for rulemaking PRM 50-63A by directing ths requested amendment to 10 CFR 50.47(b)(10). The Commission also directed that the preamble for the proposed rule include a statement to the effect that State and local decision makers, provided with proper information, may find that the use of KI as a protective supplement is reasonable and prudent for specific local conditions.
Petitioner's Basis for Requesting Potassium lodide The petitioner stated that potassium iodide (KI) protects the thyroid gland, which is highly sensitive to radiation from the radioactive iodine that would be released in extremely serious nuclear accidents. By saturating the gland with iodine in a harmless form, Ki prevents any inhaled or ingested radioactive iodine from lodging in the thyroid gland, where it could lead t
to thyroid cancer or other illnesses. The petitioner stated that the drug itself has a long shelf-life, at least 5 years, and causes negligible side effects.
The petitioner further stated that, in addition to preventing deaths from thyroid cancer, KI prevents radiation-caused illnesses. The petitioner notes that thyroid cancer generally means surgery, radiation treatment, and a lifetime of medication and monitoring. The petitioner assened that the changes in medication that go with periodic scans put many patients on a physiological and psychological roller coaster. The petitioner stated that hypothyroidism can l
f
' could be used in the event of a nuclear terrorist event. The NRC was a m Group which generated the recommendations and was instrumental in adding Ki to th medical supplies to be stockpiled nationally.
The Core Group concluded that as the result of recent events, significant threats over the past few years, and the increased availability and proliferation of NBC materials, there increasing concem for the potential of terrorist lacidents. NBC events, the report con may occur as a local event with pote'ntially profound national implications. In responding to these events, the first responders must be able to provide critical resources to the victim These include, but are not limited to, chemical nerve antidotes, vaccines for anthrax, and antibiotics. The Core Group identified the need to purchase and preposition stockpiles of adequate medical supplies at the Federal, State, and locallevel. While Kl was not considered as vital as chemical nerve antidotes and vaccines, the NRC staff was successful in getting I included with other medical supplies for NBC events because of the unusual characteristics of these events.
Because of the special characteristics of NBC events, the Core Group recommended a broader range of protective actions. The NRC concurred in the findings of the report in a letter
- dated September 25,1996, from the Director of NRC's Office of Analysis and Evaluation of Operational Data to FEMA's Director. The report was subsequently presented to the President l
in February 1997, and approved for distribution in May 1997.
Insert FRPCC Subcommittee on KI (1996).
l l
Along with petitioning the NRC, Mr. Crane also requested that FEMA review his petition and reconsider the Federal policy. In ear;y 1996, the FRPCC convened an Ad Hoc Subcommittee on Potassium lodide to request and review new information on this matter from general public should consult with the State to determine if these arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need to include this measure in their emergency plans.
Insert 1 Analysis of issues Raised by Public Comments On November 27,1995 (60 FR 58256), a Notice of Receipt of the Petition for Rulemaking was published in the Federal Reaister requesting public comment. A total of 63 comment letters were received, of which 20 utilities,9 State govemmental age interest organizations,1 letter signed by 12 health physicists,2 State universities and 1 member of the public were against the granting of the petition for rulemaking. Those letter favor of granting the petition came from 5 environmental groups,22 memters of the publ (including 1 from the petitioner), and the American Thyroid Association.
On December 17,1997 (62 FR 66038), the Commission published a request for public comment on the revised petition in the Federal Register. In response to several requests, the comment period was extended until February 17,1998, by a Federal Register notice published on January 21,1998 (63 FR 3052). A total of 82 comment letters were received, of which 13 utilities,3 State governmental agencies,1 utility interest association, and 1 member of the public were against granting the petition for rulemaking. The letters in favor of granting the petition came from 8 public interest groups,46 members of the public (including 1 from the petitioner),3 physicians,2 U.S. Senators, and 1 State Representative. 7.; i::c;;'.; ;w;;
4
, __2: ;;.T..T..;On ~;.7. ;n ::::I ;;/ne C:7-- '::':. :::;:n:::
r Insert 2.
4
i 11 is estimated that approximately a 40 45 percent reduction in thyroid burden was
. achieved by thyroid blocking and milk restrictions in the 11 provinces treated.' Had the Russiani authonties given prompt warning, the 24-or 48-hour gain in time might have improved the effectiveness of their response.
There were no reported serious adverse reactions except for two adults with known iodide sensitivity. About 36,000 medically significant reactions were also reported (mos nausea). Because of the low iodine concentrations in Poland it is doubtful that epidemiolog "See new footnote studies could detect excess cancers resulting from intake of radioiodine.'
international Practices - During this assessment, the NRC staff examined the current policies and practices regarding the use of thyroid blocking during Nuclear Power Plant accidents for a number of countries. The NRC staff accomplished this task primarily through 1
personal communication with colleagues in each country. In general, the countries either are following or intend to implement systems that are consistent with the guidance promulgated by the World Health Organization (WHO). Specifically, the WHO recommends predistribution of stable iodine close to the site and stockpiles further from the site. These stocks should be strategically stored at points such as schools, hospitals, pharmacies, fire stations, or police stations, thereby allowing prompt distribution. A further description of the WHO guidance is
- provided below, followed by a discussion of the guidance promulgated by lAEA and a comparison between U.S. and international practice.
7 The implementation of Short-term Countermeasures After a Nuclear Accident, Proceeding of an NEA Workshop Stockholm," Sweden,13 June 1994. OECD 1995.
' Manual on Public Health Actions in Radiation Emergencies, WHO, European Center of Environmental and Health, Rome Division,1995.
~
23 -
I Commission Response:
The commenter is correct, in that it was difficult to obtain Kl after the Three Island accident sHowever, with the limited Federal stockpile of Ki for terrorist events and the 3Insert willingness of the Federal Government to provide a-stockpile-of Ki for-any State that -
decides to use it as a supplemental protective-measure for the general public, the~
Commission believes that an adequate supply of Kl could be obtained..
issue 6 i
Even though K1 administration before any exposure is ideal, the Chernobyl experience also has shown that the exposure can continue for days. Is the institution of Ki blockade at any time in this period beneficial?
Commission Resoonse The administration of K1 is most effective if done before or immediately after (within 2 to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />) a release. Nonetheless, during a chronic exposure of several days, the administration of Kl any time during the exposure period may block some uptake of radioactive iodine. However, the benefit diminishes quickly over time and may be very smallif administered iate. If a release is expected to continue for several days, the NRC anticipates that the public would be evacuated or other protective action would be taken, depending on the level of release. K1 could nevertheless serve as a useful j
supplemental and complement to these primary protective actions.
L Commission Resoonse The Commission considers that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement to evacuation and sheltering is reasonable and prudent for specific local conditions.
The 1998 proposed Federal Policy on use of KI as an emergency preparedness measure for commercial nuclear power plant accidents is being developed by the FRPCC. FEMA plans to publish this policy in the Federal Register in early 1999, nonetheless, it currently is proposed to state that:
The revised Federal policy is that Kl should be stockpiled and distributed to emergency workers and institutionalized persons for radiological emergencies, but leaves the decision on whether to stockpile, distribute and use Kl for the general public to the discretion of State and, in some cases, local governments. Any State or local government that selects the use of KI as a protective measure for the general public may so notify the appropriate FEMA Regional Director, and may request funding for the purpose of purchasing a supply. The Federal offer to fund purchases of KI for the States represents an explicit recognition that this medicine can, under certain conditions, supplement other protection measures and thereby enhance protection of the public. State and local govemments that opt to include Kl as a protective measure for the general public will be responsible for preparing guidelines for its stockpiling, maintenance, distribution and use. State and local govemments may also contact FEMA when the shelf life of the drug has expired and the supply needs to be replenished. It should also be noted that medical supplies, including KI, will be stockpiled in 27 metropolitan areas and in three national stockpiles across the country in support of State and local govemment response to emergencies caused by acts of terrorism involving nuclear, chemical and biological agents. For radiological.
emergencies resulting from any cause, including accidents at commercial nuclear power plants, this additional stockpile can be acquired ad hoc by State or local government officials if they determine its use would be beneficial.
Commission Decision
~~
p..-
~.
p On June 26,1998, the Commission decided to grant the petition for rulemaking.
2N.
See attac Accordingly, the NRC staff was directed,to proceed with rulemaking to change 10 CFR replaceme f'/
N
N Commissio 33 -
Decision
[ Replacement for
- Commission Decision" on page 33 of FRN:]
Kl is a reasonable, prudent, and inexpensive supplement to evacuation and sheltering.
Therefore, the Commission's guidance on emergency planning has long taken Kl into consideration (NUREG-0654/ FEMA-REP-1, Rev.1, p. 63, items e and f.). However, since the last revision of that guidance, we have had experience with the mass distribution of Kl during a radiological emergency, and though the record on that distribution is not complete, the indications thus far are that mass distribution is' effective in preventing thyroid cancer and causes remarkably few threatening side effects.
Moreover, many nations in Europe and elsewhere, nations as different in their circumstances, politics, and regulatory structures as France, Canada, and Japan, have stockpiled Kl and planned for its use. So have some U.S. States. The World Health Organization and the International Atomic Energy Agency recommend its use.
Therefore, in order the acheve greater assurance that KI will receive due attention by planners, it seems reasonable to take a small further step and, continuing to recognize the authority of the States in matters of emergency planning, explicitly require that planners consider the use of Kl.
The proposed rule change should not be taken to imply that the NRC believes that the present generation of nuclear power plants is any less safe than previously thought.
On the contrary, present indications are that nuclear power plant safety has improved since the current emergency planning requirements were put in place after the Three Mile Island accident.
The use of potassium iodide is intended to complement, not to replace, other protective measures. This rule change thus represents no alteration in the NRC's view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any exposure to radiation occurs, whenever that is feasible.
(Evacuation protects the whole body, whereas potassium iodide protects only a single gland, the thyroid.) Depending on the circumstances, KI may offer additional protection if used in conjunction with evacuation and/or sheltering.
The NRC recognizes that the decision to stockpile Kl presents issues of how best to position and distribute the medicine, to ensure, e.g., that optimal distribution takes place in an emergency, with first priority given to protecting children; that persons with known allergies to iodine not take it; that members of the public understand that Kl is not a substitute for measures that protect the whole body; etc. To date, these issues have been addressed in different ways in the numerous countries that currently stockpile Kl.
The NRC is working with States and localities to develop guidance on these and other points relating to the use of Kl. The NRC believes that these implementation issues can be solved, given the level of expertise in the relevant Federal and State agencies, and the experience of numerous nations that have built KI into their emergency plans.
It is expected that States willinform FEMA and the NRC of the results of their consideration of whether to opt for stockpiling. This will enable the Federal govemment
to provide Kl as expeditiously as possible to States that desire it, to provide any further assistance that may be called for, and to allow the Federal govemment to engage in better contingency planning for States that decide against stoc,kpiling Kl 4
4 4
5
r document emphasizes that prompt evacuation is the preferred protective action for actual or projected severe core damage accidents.
D.
The Commission recognizes that in 1994 the Board of Governors of the IAEA adopted new International Basic Safety Standards. With respect to emergency plann standards provide, among other things, " intervention levels for immediate protective action including sheltering, evacuation, and iodine prophylaxis." It is important to note that each l
country bases its response plans on local and regional characteristics. For example, Italy a
' France, using the same intemational standards and guidelines, implement them differe See revised E.
The Commission agrees with the NRC staff estimate that the purchase of Kl paragraph tablets is inexpensive. KI related costs increase when the cost'of maintenance, distribution, l
and public education are considered.
See revised F.
The Commission believes that NBC medicinal stockpiles should provide paragraph assurance to States and local govemments that a limited Federal stockpile of Kl is available, if needed.
Commission aooroval to fund Kl:
On June 30,1997, the Commission voted to approve the NRC staff recommendation to endorse the FRPCC recommendations for the Federal Govemment to fund the purchase of potassium iodide (KI) for States at their request and endorsed the FRPCC recognition of the availability of the Federal stockpile of Kl to State and local govemments for purposes of mitigating the consequences of terrorist use of nuclear, biological, or chemical (NBC) weapons.
Under this endorsement, the Federal Government would fund the purchase of Kl, and State i
and local govemments would be responsible for maintenance, distribution, and subsequent costs. As part of their emergency response planning, NRC licensees should discuss this matter l
with State and local govemments that make decisions on protective measures in planning for responses to emergencies.
i 36 -
e
(b)
(10) A range of protective actions, shave been developed for the plume exposure pathway eas EPZ for emergency workers and the public. In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (KI), as appropriate. Guidelines for the choice of protective actions durin an emergency, consistent with Federal guidance, are developed and in place, and protective actions for the ingestion exposure pathway 5PZ appropriate to the locale have been developed.
Dated at Rockville, Maryland, this day of
.1998.
For the Nuclear Regulatory Commission.
I John C. Hoyle Secretary of the Commission i
n Page 2:
a petition for rulemaking (PRM 50-63A) submitted by Mr. Peter Crane on November 11,1997.
That petition is a revision of a petition (PRM 50-63) that he submitted on September 9,1995.
Page 3:
The Commission will work with FEMA to ensure that national stockpiles of Kl for terrorist activities, stockpiles created pursuant to Presidential Decision Directive 39, contain substantial amounts of Kl.
Page 15:
However, FEMA recently reported that the federal stockpiles of Kl are tew and stocked only for l
l first responders to terrorist action. As things. stand now, needs of members of the public for Ki on an ad hoc basis would have to be supplied from other sources. As stated above, the Commission intends to work to persuade FEMA to assure that these stockpiles contain adequate supplies of Kl.
Page 17, first insert:
On November 5,1997, the Commission held a p Mic meeting with its staff, FEMA representatives, and the author of the 1995 rulemaking petition to consider the petition and proposed changes to the Federal policy on the use of Kl. In part as a result of the meeting, the petitioner amended his petition to ask for a rule that would require that consideration would be given in the formulation of emergency plans to the uso of Kl as a supplement to evacuation or sheltering, and on June 26,1998, the Commission granted the amended petition, and directed the NRC staff to initiate the requested rulemaking. The Commissioners also decided that the l
FRPCC Federal Reaister notice on Federal Kl policy should include a statement to the effect that the State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions.
On September 30,1998, the Commission approved a draft Federal Reaister notice and directed that it be sent to the FRPCC.
j Page 17,2nd insert (part of Commissioner Dicus' Insert 4):
The Commission has considered the Kl policy question on numerous occasions since 1984.
The voting history of the Commission shows that reaching consensus on this policy question has been an elusive goal. An important reason for this historicallack of consensus is that this policy question is not a clear cut one. Individual Commissioners, past and present, have differed in their views with respect to the relative importance to be given to factors bearing on the KI issue. These honest differences have led to divided Commission views on how to resolve the policy question. With that background, following are the Commission's views on specific issues raised by the petition.
Page 23 footnote:
A " medically significant" reaction was one for which the person suffering the reaction consulted a physician more than once. Nauman and Wolff,"lodide Prophylaxis in Poland After the Chernobyl Reactor Accident: Benefits and Risks," The American Journal of Medicine, Vol. 94,
s May 1993, p.530. About.02% of the population that received Kl had " medically significant" adverse reactions to Kl. Id. However,"[i]t should be pointed out that control values for these side effects in a population not receiving Kl are not available." Id.
Page 28:
That is one reason why the Commission believes that planners should consider stockpiling KI, i
and why the Commission has expressed its willingness to provide a stockpile to any State that decides to use Kl. In part for the same reason, the Commission believes that the NBC stockpiles established under Presidential Directive 39 should have adequate stockpiles of KI, so that States that have chosen not to stockpile Kl could have access, albeit ad hoc and de!ayed, to an adequate supply in a radiological emergency at a nuclear power plant. As noted elsewhere in this notice, the Commission will work to persuade FEMA to assure that these stockpiles contain adequate supplies of Kl.
Page 36:
[ Item E. should read as follows (new material is redlined):]
Tthe Commission agrees with the NRC staff estima%, and other nations' experience, that the purchase of KI tablets is inexpensive. Ki-related costs increase when the cost of maintenance, distribution, and public education are considered.. However, the overall cost should not be a deterrent to stockpiling Ki for use by the general public should State and local decision makers determine that the prophylactic use of KI as a supplement to evacuation and sheltering is appropriate.
i
[ Item F. should read as follows (new material is underlined, old is struck out):]
The Commission believes will work to assure that NBC medicinal stockpiles shot,ld will provide eeeusence te 0:e:ee end ;ec. geeeininen;e :he; e l;,T. :ed redesel a:eds;le of, Kl ie ese::eble, if needed: enough Kl to enable use by States that have not established local stockpiles and wish to make use of KI in the event of a severe nuclear power plant accident.