ML20207E144
| ML20207E144 | |
| Person / Time | |
|---|---|
| Issue date: | 05/07/1986 |
| From: | Senseney R NRC |
| To: | Magnusson S ICELAND |
| Shared Package | |
| ML20207D960 | List: |
| References | |
| FOIA-86-335 NUDOCS 8701020073 | |
| Download: ML20207E144 (15) | |
Text
'
NRC '7PERATIONS ENTER
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G j W I NO. OF PAGES INCLUDING COVER PAGE '
/5 PDR LORO --335 ,
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4 I Rsoponse levels for 2/ 1 34 -4/ 137 Cs 4/
- 90 Sr 89 sr
- Prcvsntive PAG 1 31 7 Cs -
1
!Initici Activity
- Area Deposition j (oic rocuries/aquare 8 0.13 2 3 0.5 estor) l Forege Concentration3 / 0.18 3
- (cierocuries/ kilogram) 0.05 0.8 1.3 Pack Hilk Activity - .
0.009 0.14 0.015 0.15 0.24
- (cierocuries/ liter)
- Total intake 7 0.2 2.6 0.09 4 4 (cierocuries) l l
I -
l 2/ From fallout, iodine-131 is the only radiolodine of significance with respect to milk l contemination beyond the first day. In case of a reactor accident, the cumulative intake of
' icdine-133 via milk is about 2 percent of iodine-131 essuming equivalent deposition.
2/ Fresh weight. .
bI Intake of cesium via the' meat / person pathway 'for adults may exceed that of the milk pathway;-
therefore, such levels in milk should cause surveillance and protective actions for meat as l appropriate. If both cesium-134 and cesium-137 are equally present as might be expected for i reactor accidents, the response levels should be reduced by a factor of two.
(
!, Fm4-86-33r E/ 7 l
l .
j 1
1 l l j scponse levels for .
acrgency PAC 1311 2/ 134g ,EI 903 , 893 , .
137g ,J/ ,
i Infant 1/ Adult Infant 2/ Adult 2 In fant_/ Adult Infant2,/ Adult In fan t2,/ '
. Adult iltial Activity-Arco Deposition (oicrocuries/ square .
j metor) 1.3 18 20 40 30 50 5 20 80 1600 Forcge Concentrationk!
! (cierocuries/
kilegram) 0.5 7 8 17 l 13 19 1.8 8 30 7s,)
- mak Milk Activity l (cierocuries/ liter) 0.15 2 1.5 3 2.4 4 0.09 0.4 '
'! 1.4 30 i stol intake j (oicrocuries) 0.9 10 40 70 70 80 2 26 7 400 Al "
Newborn infant includes fetus (pregnant women) as critical segment of, population for iodine-131.
2_/ " Infant" refers to child less than 1 year of age.
Sl !
From fallout intcmination beyond, the iodine-131 first day.is the only radioiodine of significance with respect to milk In case of a reactor accident the cumulative intake of idira-133 via milk in about 2 percent of iodine-131 asguming equivalent deposition ~.-
bI Fresh weight. ,
5I Intake of cesium via the meat / person pathway for adults may exceed that of the milk .
ithway; therefore, such levels in milk should cause surveillance and ' protective actions for ,
i eat co appropriate.
If both cesium-134 and cesium-137 are aquelly present ' as might be
! <pected for reactor accidents, the response levels should be reduced by.a lactor of two.
i j yor A 33.fr 4
i - /7 l -
, . . ,, s
, Average consumption for the general population Food ,
(kilogram / day) 1 Milk, cream, cheese, ice cream / .570 Fats, oils .
.~055 Flour, cereal . .091 Bakery products .150-Meat .220 .
Poultry -
.055 Fish and shellfish ,
.023 Eggs .055 Sugar, sirups, honey, molasses, inte. .073 _, _
Pocatoes, sweet potatoes
,.105 Vegetables, fresh (excluding potatoes)
.145 Vegetables, canned, frozen, dried .077 Vege, tables, juice (single strength) .009 Fruit, fresh .165 Fruit, canned, frozen, dried .036 .
Fruit, juice (single strength) .045 1
other beverages (soft drinks, coffee, alcoholic) .180 Soup and gravies (mostly condensed) .036 Nuts and peanut butter .009 f TOTAL 2.099 2
1/
Expresdad as calcium equivalent, that is, the quantity of l
whole fluid milk to which dairy products are equivalent in I calcium content.
i 9/ A 335 g /7 1
L
Federal Register / Vol 47. Ns. 205 / Frid:y. Octob:r 22. 1982 / Notic s 47073 l
I ,
I i
f DEPARTMENTOFHEAL7N ANO HUMAN SERVICES Food and Drug Administratlove
- (Deeket No. 79fM0001 1
A=' _ -.. ; Radioeceve ContanWietion j
- of Human Food and Animed %
Recommendatione for State and Local Agencies Asasecr. Food andDrug Administration.
Ac71osc Notica.
suasesAsm The Food and Drug Administra tion (FDAl is- publishme this
' notice to provide to State sad local agendes responsible for emergency response planning for radiological incidents recommendationalfor taking protective actionrin the event that an '
i incident causes the contamination of human food or animal feeds. '!hese recommendatione can be used to determme whetherlevels of radiation .
encountered in food after a radlological incident warrant protective action and to suggest appropriate actions that may be taken if action la warranted. FDA has a responalbility to issue guidance on
. -/7 w---y.ame-,-en-< - . , - - - , . _ _ , _ , _ _ _ _ _ _ _ . . , _ _ , _ . , . . _ , _ _ _ . , . - , . . . _ , _ . _ - - , _ , , _ . _ - , . _ . _ . _ _ . _ _ .. _, ,.n_ .
4 l .
e 4'10'74 Federal Reglsi.e / Vd. 47. W. 205 / Fridsy. October 22. 1982 / Ncticzs i
, appropriate planning actions necessary during the development of these final for evaluating and preventing sufficient time to avoid most of the recommendations. Although EPA's proiected radiation dose. Ms. the i contamination of human food and formal comments are reponded to in PAG *s define the numencal value of !
animal feeds and on the control and use this notice. EPA staf reviewed a draft of projected radiados doses for which r i of these products should they become the Anal recommendadons, and FDA protective actions are recommended.
contaminated. '
has considered their additionalinformal
- pon runneen issponesanoes costracyt FDA has reviewed the recent mport of i comments. These contacts were the Nadonal Academy of Sciences /
- Gail D. Schmidt. Bureau of Radiological considered appropnate because EPA Health (HFX-1). Food and Drug has indicated that it intends to use the Nadonal Research Councd (Ref.3) on I radiation risks and biotopcal effects Administration. 3000 Fishers Lane, mcommendations as the basis for !
- Rockville. MD 20087. 301-443-2a80, data that became available after j revisms its guidance to Federal agendes publication of the FRC guidance and has
- 3,y,,,,,,,,,, on protecdve acdon
- radioactivity la food, guides for reviewed the impact of taking action in
- Background the pastum/ cow /mik/ person pathway Protective Action Guidance .
- In light of the current concerns in This guidance on accidental radiadon protecdon Based on these radioacdve cont'andnadon of food from I "8h 88' MI88d 8
- 88888 " 88 mceind. DA has noidend its considerations and the comments Axed nuclear facilities, transportation- received on the proposed accidents, and fallout is part of a propmal to confy Federallateragency efort coordinated "* ' ' et recommendadons. FDA has concluded Becaum s se iira do that tective actions oflow impact
- by the Federal Emergency Management Agucy (FEMA). FEMA issued a Anal voluntary guidance to State and local sho d be undertaken at prow regulation in the Federal Register of agencies (not regulations). FDA has radiadon doses lower than those dedded not to codify the recommended by FRC (Refs.1 and 2)..
March 11.1982 (47 FR 10758), which recommendadons; rether. It is issuing Accordingly. FDA is recommending low.
reflected governmental reorganizatime spect pmucou acdas (tenned me and reassigned agency responsibilities them in this notica. Elsewhere in this issue of the Federal Register.FDA is Pmvudu PAC) at projected reesdon for radiologicalinddent emersucy withdrawing the December 15.1978 doses of 0.8 rem whole body and IJ rem l response planning. A responsibility thyroid. FDA intends that such 4
assigned to the Department of Health p$ g, reco==aadadons contain basic protective actions be implemented to 4
and Human Services (HHS)(and in turn criteria, deAned as protective action prevent the appearance of radioecdvity i delegated to FDA)is the responsibilitF guides (PAG *s), for establishing the level in food at levens that would regare its
- to develop and specify to State and local ofradioecove contandmedan of human mada==adon. Preventive PAG's governments protective actions and incimie se transfer of dairy cowe frons aseodated guidance for human food and food or animal feeds at which sedan l huh forage (pasnire) to unceitaniinated animalInd. should be taken to promet the public !
l -
In the Federal Register of December health and assure the safety of food, ne stored feed and the diversion of whole l 8de poundauy commaninead wis 15.1978 (43 FR 587901. FDA published recommendadons also contain specific guidance on what emergency protective short lind radionuclides to products proposed reconimandations for State wie aimig sheme to aHow l aedons should be taken to prevent i and local agenctee regarding acddental ,
further contaminaden of food or feeds or radioacdve decay of the radioactive !
I radioactive contamtantion of human to restrict the use of food, as well as maurial.
food and animal feeds. Interested more general guidance on the
! fa those situations whom the only Persons was given until February 13. development and implementados of l
, 1973 to comment on the proposal. Protecdve actions that are fossible em action. The PAG *s have been present high dietary and social costs or
- Twenty.one comments were receival devel on the bests of impacts (termed the Emergency PAC)
! 'from State agencies. Federal agencies. consideredans of acceptable risk to I nuclear utilities, and others.Two of the acdon is recomniended at projected idendfy that level of contamination at radiation doses of 5 rem whole body conuments from environmentally which acdon is necessary to protect the concerned organizations were received and 13 rem thyroid. At the Emergency public health. PAC level respoamble offidals should after the March 28.1973 acddent at In preparing these recomunendations, isolate food to prevent its introduction i i
Three Mue Island. which increased PDA has reviewed and utilized the i public awareness of protectin action into commerce and determine whether l Federal guidance on protective actions condemnation or other dispondon is guidance. Although these conuments contained in Federal Radiation Council appropriate. Acdon at the Emergency were received after the cloes of the (FBC) Reports No.S. July 1984 (Ret 1l PAG levelis most likely for the conument penod, they were considered and No. 7. May 1ses (Ret 2). 3e population that is near to the source of by the agency in developing these final Federal guidance provides that each-recomunendations. radioactive contanunation and that Federal agency, by virtue ofits. consumes home grown produce and The OfBee of Radiation Programs, lamediate knowledge or its operating milk.
Environmental Protection Agency (IPA). problems, would use the applicable fitC The PAC's represent FDA's judgment submitted a detailed and exhaustive guides as a basis for developing detailed as to that level of food contamination arttique of the proposed standards to meet the particular needs '
resulting from radiation inddents at recommendations. EPA addressed the of the agency.FDA's recommendadone dosimetry data, the agricultural models which action should be taken to protect incorporate the FRC concepts and the the public health. This is based on the used in calculating the denved response levels, and the philosophical basis for FRC guidance that protective actions in- agency's recognition that safety involves the event of a contaminating accident, the degree to which risks are judged establishing the numencal value of the should be based on esdmates of the acceptable. The nok from natural orotective action guides. FDA advises projected radiation dose that would be i hat, to be responsive to the EPA disasters (approximately a one in a received in the absence of taking
.:osunents. FDA staff met with staff of , protective actions. Similarly, protective md!!on annualindividual risk of death) the OfRee of Radiation Programs. EPA. and the risk from vanettons in natural actions should be implemented for a background radiation have provided En w,-+-.----, - . . _ _ _ --m w -
-n._ - - - -
, Federal Register / Vcl. 47. No. 205 / Friday. Octob;r 22. 1982 / Noticis 47075 perspeedve in selecting the PAC valu lower by f'actors of 3.3 and a. For use by State and local agencies in This issue is further discussed in the respectively, than values based on response planning and implementation responses to specific comments later in ICRP-28 (Ret 8). FDA advises that it of protective actions in the event of a this notice, espedaily in paragraph 8, A will make appropriate changes in contaminating inddent. Further. FDA's
.nore detailed treatment of the rationale, recommendadons for internal organ recommendations would also be used by risk factors, dosimetric and agriculfural- doses when a consensus in the United models, and methods of calculadon is FDA in implementing its authonty for States emerges-ta nedla the"Be food in interstate commerce under b d]ar Analysi, og c Federal Food. Drug, and Cosmetic Act.
Accidental Radioactive Contamination The following is a summary of the FDA's recommendations are being of Food and Anhaal Feeds"(Ref. 22). comments received on the December 18. forwarded to DA as se basis for Orgas PAG Values -
1973 proposal and the agency's response mvising Federal saidance on food-to seem accidentaHy contaminated by Current scienti8e evidence, as - 1. Several comments requested - -
radionuclides.DA has advised PDA reflected by BEIR-I(Ret 14), clart8cados of the applicability and that it intends to forward the FDA UNSCEAR-1977 (Ref. 4), and BEIR-IH , compatibility of FDA's re==-dadoesto the President under (Ref. 3). Indicates that the relative recommendadone with other Federal its authority to " advise the President importance of risk due to sped 8e organ actions, specdically the PAC guidance with respect to radiation matters exposure la quite diferent from the of EPA (Ref. 7), the FRC Reports No. 5 directly or indirectly aNeedag health, earlier assumpdons. The International (Ret 1) and No. 7 (Ret 2), and the including guidance for all Federal Commission on Radiological Protection Nuclear Regulatory Commission (NRC) agencies in the formulation of radiation (ICRP) clearly recosmzed this in its 1977 dennition of " Extraordinary Nuclear standards * * '". (This authority was recommendations (ICRP-28 (Ref s)). Occurrence
- In to CFR Part 140. A transferred to EPA in 1970 when FRC which changed the methodology for comment recommended that the term. was abolished.) -
treating external sad internal radiation " Protective Action Guide (PAG)" not be doses and the relative importance of De recomrnendations established in used because that term traditionally has this document apply only to human food spec 2Hs organ doses. ICRP-20 assigned been associated with the FRC, and the and animal feeds accidentally weighting factors to speedic organs general public would confuse FDA's based on considerations of the contaminated by radionuclides. Dey recommendadons with Federal should not be appiled to any other incidence and severity (mortality) of guidance. source of radiati exposure. EPA radiados cancerinduction. For the ne FRC Report No.s speci8cally- already has I protective action radior:aclides of concern for food PAC's, recorn-dad that the term. " protective guidance for the short term accidental ICRP-28 assigned weighting factors of action guide." be adopted for Federal exposure to airborne releasse of 0.03 for the thyroid and tL12 for red bone use.The report dennes the term as the marrow. Thus, the organ doses equal in " projected absorbed does to the radioactive materials and intends also .
risk to t rem whole body radiation dose to forward the EPA guides to the mdividuals in the general population President as Federal guidance. EPA also are 33 rem to the thyroid and a rern to which warrants protective action is considering the development of Red bone marrow.(De additional .
following a contaminating event." a ICRP-28. nonstochasdc limit, however, guidance for acidentally contaminated concept that is addressed by FDA's l water and for long term exposures due restricts the thyroid does to 30 rem or to recommendations. To use the concept times the whole body occupational limit to contaminated land property, and l with,a diferent description would in materials. Guidance for each of these of S rem.) FDA a opinion, be unnecessanly l In the Federal of January 23, confusing to State and local agencies as im ally
",poeun jg p thwa g, fo, ,
1901 (48 FR 7838). A proposed to well as Federal agencies.
revise the Federal Radiation Protection Dese recommendadons are being uposure pathway is app ste Guidance for Occupational Exposures issued to fulAll the HHS responsibilides became diNennt crHena o risk, cat, using the ICRP approach for internal under FEMA's March 11.1982 and beneSt are involved. Also, each o an radiation doses modined to reguladon. FDA fully considered FRC exposure pathway may involve different te ect s cific EPA concerns. The EPA Reports No. 3 and No. 7 and the basic sets of protective or motorative actions proposa as been subject to concepts and philosophy of the FRC and would relate to different penods of considerable controverey. Also, the guidance form the basis for these une when such acdoes would be taken.
Nauonal Council as Radiation reconunendations.De specific PAC 2. Several comunents expressed Protection and Meneurements (NCRP)- values are derived response levels soncern about radiation exposure from curently is evaluating the need to revise included in these recomunendadons are multiple radionuclides and from multiple its recommendations. FDA does not. based on current agricultural pathway pathways, e.g via inhalation, ingestion.
however, expect the protection model and radiation dose models and current and external radiation from the cloud for internal redletion doses to be estimates of risk.We FRC guidance (plume exposure) and questioned why resolved to y in the United States provided that protective actions may be Particular pathways or radionuclides and has based the relative PAC dose justifled at lower (or higher) profected and the does received before assignments in these recommendations radiation doses depending on the total assessment were not addressed in the on curmnt U.S. standards and the 1971 Impact of the protective action.Dus, recommendations. Several comrnents recommendations in NCRP49 (Ref.19). FDA's recommendation that protective recommended that the PAG's include nus, the red bone metrow is assigned actions be implemented at projected specific guidance for tap water (and the same PAC dose as the whole body radiation doses lower than those potable water). Other comments noted (0.5 rem Preventive PAC). and the recommended by FRC doses is that particular biological forms of thyroid PAC le greater by a factor of consistent with the FRC guidance. The specific radionuclides (Ls
.hree (1.3 rem Preventive PAC). His FRC guidance is applicable to Federal cyanocobalamin Co 60), would lead to results in PAC assipunents for the agencies la their radiation protection orgmficantly diNerent denved response thyroid and red bone marrow that are activides. FDA's recommendadons are levels.
En u _ _-
a-
}r 47g73 Federal Registm / Vol. 47. No. 205 / Friday. October 22 1982 / Notices 4 PDA advises that the PAC's and the models. FDA and EPA staffs agreed that protective action concepts of FRC apply further pathway studies would be 131 and 14 days for cesium or strontfum. i to actions taken to avoid or prevent Assuming that inidal contanunation by useful Elsewhere in this notice. TDA projected radiadon dose (or future references models for other these radionuclides was at the dose).Thus, by dennition, the PAG *s for radionuclides, providing a resource for Preventive PAC level. radioactive decay i
food do not consider the radiadon ddees those requiring more details, and weathenna would reduce the levels i
already incurred from the plume so that protective actions could be 4
pathway or from other sources. The The chemical form of radionuclides in ceased after 1 or 2 months.
the environment may be important when The model used to compute the population potentially exposed by considenng the denavation of an i ingestion of contaminated food can be denved response levels speciBed in
! appropriate " response level" la specinc paragraph (d) of the recommendations divided lato that population near the situadons, but would not change the
{ source of contaminados and a generally PAG's, which are in terms of projected assumes a continous or infinite ingesdon inuchlarger populados at distances does conunitments. Cyanocobalamin Ce period. i.e Intake that la limited only by where the doses from the cloud are not radioactive decay and weethenne. This I so has not been identiSed as a likely . is the approach recommended in sispuficant. He NRC reguladons provide constituent of health importance to be that State and local planning released from a nuclear reactor accident estimatmg the projected radiation dose piume exposure should extend to - (in the absence of protective acdons.).
- and, therefore, the esency regocts the miles and the ingesdon
- psthway should Further revisions have been made in the
! recommendation that it provide derived " recommendations to clanfy these extend for 50 nules (see 48 FR 55402 response levels for this radionuclide, aspects.
August 19.1900), ne total population However, after reviewmg current
- j exposed by ingesdon. however. is a 4. A ca== ant stated that aedon
! 8 agricultural and dose models the . should be initiated by notification unction of the animal feed and human. agency concludes that costum.134 would
- food production of any given area and is likely be released and has addedit to received from the facility itsell Another l not lirmted by distance from the source the tables in paragraph (d) of the comment noted the importance of timely s
I of contamination. Exposure from announcements to the public of the recommendations identifying necessity for protective acdons.
multiple pathways would not be a radionuclide concentradons equivalent concern for the more distant population to the PAC response levela.. These recommendadons on protective 1 group. Further. individuals in this larger FDA rejects the conunent sction guides for food and feed are not populadon would most likely receive intended to cover other aspects of recommending that the PAG's include doses ==.11= than that projected for guidance for water. A memorandian of- emergency plaamns for radiological continuous intakebecause the incidents. The general responsibilities of understanding between EPA and FDA
. contaminated food present in the retail NRC lleannese in radiation emergencies provides that FDA will have primary distnbudon syv..:n would be replaced responsibility over direct and indirect have been further defined in a rule
, by uncontaminated food, issued by NRC(48 FR 5840t August 13.
FRC Report No. $ states that, for additives and other substances in 1950). FDA recognissa however, that drinking water (see 44 FR 42775: July 20. noti 8 cation and public announcements
, repedtive occurrences, the total ~
projected radiadon dose and the total 1979).nua. FDA defers to EPA for are vital to effective protective actions developing guides specifically for and,in paragraph (e)(8) of the impact of protecdve actions should be drinking water, considered. Sinular considerations on a recommendadons, urges that State and 3.nroe comments requested local emergency plans should provide case-by-case basis would then appear to clari8 cation of the proposed for such notice.
- be appropnete in the case of multiple .
' recommendadons, including the time exposures from the plume and the over which the guides apply, the time of S. A comment offered clarification of ingesdon pathway. Accordingly, the proposed i 1000.400(3) regarding ingestion required to reach the PAG, and venfication of sample measurements, final reco===adadons are modified to the time that protective actions should note that, specafically in the case of the while another comment suggested that be implemented.
i population near the site that consumes Preventive PAG's should be based on
! FDA advises that the- projected levels and that Emergency locally grnwu produca !!nutadons of the recommendations are intended to PAG.s require verification.
! totaf dose should be considered (see
' provide guidance for actions to be ne litC concepts and philosophy.
I paragraph (s)(2)). The agency concludes, implemented in an emergency, and the which FDA fully endorses, use estimates however, that a single umfled PAG duration of protective action should not j r.overing ravitiple pathways, e.g. of profected radiados does as the
- externalrediaden, inhalation and exceed 1 or 2 months The agency critana for taking protective action. FDA
! ingestion is not pracdcal because believes that the scdone identiSed la believes that projected radiados dose i paragraphs (a)and(h)of the different sedons and Impacts are estimates should be based on venfled i recotomendations should be continued measurements of radioactivity in the involved. Further. FDA's responsibility for
~
a sufRcient time to avoid most of the i in radiologicalincident emergency food pathway. Such venfication might emergency radiation does and to assure include the analysis of replicate response planning extends only to that the remaining does is less than the human food and animal feeds. samples. laboratory measurements.
ne agency's primary charge is to set Preventive PAG. His period of time cun sample analysis by other sgencies, be estimated by considertne the samples of various environmental l
recommended PAG dose commitment effective half life of the radioactive . media. and descriptive data of the
!!mits for the food pathway.Thus, matenal taking lato account both i dertving response levels for only the radioactive release and has so provided radioactive decay and weathenng. Each in peregraph (g) of the radionuclides most likely to enter the case must be exammed separately food chain and deliver the highest dose recommendations.
m the population permits H)A to considenne the actuallevels of A. A comment suggested that some contamination and the effective half. life States do not have the resources to j stablish recommendations that are of the redloactive material present. For i
pectical for use in an emergency. In evaluate projected radiation doses. The i the pasture / cow / milk pathway, the rilscussms with EPA the list of definitive effective half-lives are 5 days for iodine- comment asked what regulatory agency would have control over interstate i
1 ED I
.~ .. -. .
I r.
l Fodseal Reg. m / Vcl. 4y. No. 206 / Friday, October <.2,1982 / N:ticoe 47tr/7 j ehipment of contaminated foods hem
- under " ORGAN PAC VALIJES" the use recommanded proteedve actions. Once States without sutF.cient resources and of BEIR 111 risk eedmates or the ICRP.2s I
what would be the applicable PAG. the protective ecdon is fartiated,it FEMA. as the lead agency for the recommendations would result in an shoold be executed so es to prevent as
- increase of the thyroid PAG relative to Federal effort. Is providing to States much of the calculated projected does
- the whole body PAG. For these reasons, rudance and assistance on emergency from being received as is reasonably I
response planning including evaluation FDA believes the PAG !!mits for projected does commitment to the achievable.This does not mesa.
! of projected doses. Alio. NRC requires however, that all dosee above guidance thyroid are cannaevedve when nuclear power plant licensees to have levels can be prevented.
l the capability to asseen the of.eite considered ia light of current knowledge . Further, the guides are notietsaded to of radiation to produce equal health consequences of radios ctivity releasse riska from whole body and spemSc prohibit taking actions at protested and to provide notif! cation to State and organ doses. exposureslower than the PAC velass, local agencies (4s FR 3540s: August 18, Although it may be doenreble to %ey have beso derivedforgeneret i casse and arejust what theirname 1980). FDA has authorito under the consider totalhealth efects, not fust Federal Food. Drug, and Cosmede Act to lethal efects, there is a lack of data for . Impiles, spidae. As prodded laFRC.
remove radioactively contandasted food total health efects to use in such - Reporte No. 3 and No. 7 and se I
from the channals ofinterstate comparisons. la the case of the discamed la paragraph 1 of &is noden, commerce. la this circum.itance. FDA variability of natural background as as la the absence of significent coneeuinta.
i would use t! eee PAC recomunendadons estimate of acceptable risk, responsible authosity may findit u the basis forimplementing appropriate to implement low-impact regulatory acdca. consideration of Isthal effects or total health efects is not involved because protective acdoes at projected radiation t
Rhk Esdemo the comparison is the total does over a doses less than those spoofled in the
- 7. Many commente quest,oned the risk Ilf*d"* guides. Sindarly, high W sedene may be lustiSed at higher projected 1
estimates on which MA based the a dms. name Ndgmenu mm b me pmposed PAC's. De comments s. Several comments quesdoned the according to se facts of och eiMon.
i especially suggested that risk estimater p ,,grep g ga
! todonal mA used in setting the specific anC3 have been from WASH.teco(Ref. 4) wwe of queenonable velldity. Other comunena PAC values included in the December added to se A@nal ma==)=m lampwate &is concept.
i 1975 proposeL A comuneet fbom DA argued that the proposed stated that the guidance levels should be S.Sporal commente quedoned the recommendedone used an analysis of justified as the grounde that it is not adequacy of &elevelof rish judged
! only lethal efects: that they need as practical or reasonable to take, acceptablela deriving theproposed
' absolute risk model: and that;ienstia protective actione at lower risk levela PAG velass. A comuneet stated that the efects were not i 4 cctiendered. Further. DA arseed that the protocove admated one in a atHlos annual The risk estimates tlinneelves were action concept for essergency planning alleged to be erroneone because recent ladividual risk of death hem natural and response should incorporate the disasters is extremely conservattve. DA studies show that doubling doses are taggested that comparedve dak is
- principle of keeping radiatica exposame lower than are those suggested by as low as reasonably achievable appropnete for perspective but not for i
WASH =140tL ne tensa capitis study by (ALARA). DA noted that the prin:iple establishing the limite.DA Aarther Ron and Modan, which indicater an of acceptable risk involves a percepdos sugated est de populadon. weighted increased probability of thyroid cancer of risk that may very f>om person ta average of the variability is natural
.it an estimated radiados dose of a rom person and that the implicadon that an background dose or the verjados in to the thyroid (Rat S), was cited r.e acceptable genede risk has been i dose due to the natural radioactivity la rndente that the PAG limits for t'te- established should be avoided. food should be the besie for judgmg 4
' ihyroid were too high. The comments FDA accepts and antiaroes the acceptsble risk.
requested further identification ani ALARA concept. but the extent to which l rupport for using the critical populados FDA concludes that the diferencee r
selected. a concept. which is used in occupadonal between DA's suggested appranch and settings, should be applied to emergency that employed by mA largely involve Most of these issues were addressed protective acdone is not clear. To use
- e. ;he preamble to the FDA proposal, the semanuca of the redonale the ALARA concept as the basis for descripdona. Ao ,Hwnaama la tbg The final recoounendations issued la spec Ac PAC values and also require t!de notice employ the most recent risk preamble to the proposal FDA believee ALARA during the implementados of that safety (or a safe level of risk) neede estimates (somade and genetic) of the Nanonal Academy of Sciences emergency protective actions appears to to be'deAnod as the degree to which the be redundant and may not be practical risks are judged acceptable, because it Cammittee on Biological Efects of under emergency conditions.
toniang Radistica (Ret 3). Is not posenble to schfeve zero risk from FDA advises that these guidee do not De thyroid PAC limits are based on human endeavoro. Further. !CRP (Ref. el constitute acceptable occupational recomunende that, for a given
'he relative radiation protection guide radiados doeg timste nor do they !
for thyroid compared to whole body application involving radiation, the not conatttute acceptable linnits for other i
contoined la NRC's current regulations benent to society should be positive, applicadona (e.g acceptable genede considering the total costs and impects
( 0 CFR Part 20).The derived response risk). The guides are not intended to be levels for thyroid are based on risk and the total benant (this is termed. l used to linut the radiation does that "justificadon"). FDA believes thel to factors for external x.roy irrediation, Thermicts, the criticism of the PAC people may receive but instead are to be establish a PAG. the primary concern is i compared to the calculated projected to provide adequate protection (or safe tir:ua for the thyroid is not applicable, no trel;t" having been taken for as dose. i.e. the future dose that the people. level of risk) for members of the public. '
would receive if no protective action To decide on safety or levels of
.opa ant lower radiation risk due to - j were taken in a radiation emergency. !n acceptable risk to the public from a odine 131 Irradiation of the thyroid this respect, the PAC's represent tngger ;
gland. Further, as discussed above contaminating event.FDA introduced '
levels calling for the initiation of the eettmates of acceptable risk from
{
kn -
i
C078 Fed:r:1 Regist
~
. . Vol. 47. No. 205 / Friday. Octobtr 2 982 / Notices nttur:.1 disasters and background - meds fer using either variable. Bec:use natural disteters, the variation la the 1 radiation. These values provided persons rather than geographic areas background or perspective for FDA's -
population. weighted natural background )
are the important parameter in the rudiation dose to the total population.
adgment that the proposed PAG *s i evaluation of nsk associated with these and the variation in dose due to epresent that level of food or feed- guides. FDA has used population. ingestion of food, have been used to radiation contamination at which . weighting la estimating the variability of provide the basis for the Preventive protective actions should be taken to the annual external dose from natural protect the public health: Judgment PAG. The basis for the Emergency PAG radiation. A recent EPA study (Ref. 20) involves considerations of(1) The ratio which. consistent with FRC Report No. Indicates that the average population between average and maximum
- 5. also involves consideration of the dose from external background impacts of the action and the possibility Individual radiation doses (taken as 1 to radiation dose is 53 millirem (mrem) per 10). (2) the cost of low and high impact of future events. The recommendadons year, and the variability in lifetime dose protective actions. (3) the relative risks are based on the assumption that the taken as two standard deviations is . from natural disasters. (4) health impact, occurrences of environmental about 2.000 mrom.Daproposal, which (5) the upper range of the PAG's contaminadon requiring protective indicated that the variation in external ' proposed by EPA (5 rem projected actions in a particular area is an background was about 800 mrom.
unlikely event, that nicet individuals radiation does to the whole body and 25 utilized a geographic weighting of State tem projected does to the thyroid), and will never be so exposed, and that any averages. . . (6) radiation doses from multiple individual is not likely to be exposed to Radioactivity in food contributes pathways.
projected doses at the PAC level more about 20 mrom per year to average 11. A comment citing experience with than once in his or herlifetime. , population done and about 17 mrom per other contaminanta, suggested that FDA continues to believe that the year of this dose results from potassium. further consideredos should be given to average riska from natural disasters and 40 (Ref. 8). Measurements of potassium. the problem of marketability of foods vanation of background radiation 40 (and stable potassium) indicate that containing low levels of radioactivity, provide appropriate bases for fudgmg vanability (two standard deviadons) of Marketability is not a concern for the acceptability of risk represented by the potassium.40 dose is about 28 PAC development. However, the b Preventive PAG.Dese percent or a lifetime does of 350 mrom. It publication of the PAG's should enhance recommendations incorporate the . should be noted that body levels of marketability of foods because it will philosophy that action should be taken potassium are regulated by metabolic enhance public con 8dence in food at the Preventive PAG level of processes and not distan selection or safety. Also. FEMA has been contam== tion to avoid a potential residence. De vanaden of the internal specifically directed to undertake a public health problem. Should this does is about one.ftfth of the variation public information program related to action not be wholly successful, the from external background radiadon. radiation emergencias to allay public Emergency PAG provides guidance for FDA has retained the proposed , fears and percepdone.
sking action where contaminated food revenove PAG of 500 area whole *
.s encountered. FDA expects that sedon 12. A cammant noted the difficulty in even though the newer data assessing the impacts of and the at the Emergency PAC level of indicate a greater variation in external benefits to be gained from protective contaminsuon would most likely background radiation.
aedons. Another comment suggested involve food produced for consumption
- FDA did not consider perceived risks by the population near the source of that timre were lowerimpact actions la dertving the proposed PAG values which could be implemented to keep contanunation. As discussed la because perceived risk presents paragraph 2. this is also the population food off the market until radiation levels numerous problems in its in the food approach normal which might receive radiation doses appropriatenese and application. If the background.
from muluple pathways.Thus, the factor of perception is added to the-Emergency PAG might be considered to ne recommendation that planning equation scuatific analysis is- ofBcials consider the impacts of be an upper bound for limiting the total Impossible.
protective actions in implementing radiation dose to individuals. FDA 10. Two cornments quesdoned ihe action does not imply that a i emphasizes. however, that the assumptions that the Emergency PAC . mathematical analysis is required.
Emergency PAG is not a boundary might apply to 15 million people and Rather. FDA intends that the local between safe levels and hasardous or that the Preventive PAC might apply to situation, resources, and impacts that injury levels of radiation. Individuals the entire United States. One comment
! may receive an occupational dose of 5 are important in assurms effective noted that 15 million persons are more protective actions be considered in
! rem each year over their working than that population currently within 25 lifetime with the expecta ion of mmimal selecting any actionc ci, we implemented.
I miles of any Umted States reactor sites: As discussed in paragraph 8. if the local
! increased risks to thaindividual thus, using this figure rueults in guideo Persons in high elevation areas such as constraints pernut a low impact action.
l more restrtctive than riaraamary. The this can be app sta at lower Colorado receive abeet (Los tem per other comment noted that, by reducing projected doses,
, year (or 2.s rem in a lifetimel above the the population involved, and use it is not .
j pose ble in general guidance to consider aversge background radiation dose for unacceptably high value could result. fully ail local constrainta, the PAG's the United States population as a whole. De ratio of total United States represent FDA's judgment as to when l De Emergency PAG is also consistent population to the maximum number of with the upper range of PAG's proposed protective actions are appropriate.
i people in the vicinity of an operating
- by EPA for the cloud (plume) pathway . reactor could be erroneously interpreted Agricultural and Does Models (Ref. 7). so that progressively smaller 13. Several comments noted errors
! FDA agrees that a population. populations would be subject to either in approach or calculations i eighted variable is as applicable to the progressively larger individual risks. regarding the proposed egneultural and
- isluation of comparative risks as is a Die is not the intent of the dose models, while others spec 2fically l geographic vanable. Arguments can be recommendations. Hence the risk from noted that there are newer and better I
-/7
, n ~. .. .-
1 . . - - __ _ _ . _ _ _ _ _ _ _ . . _ - - _ _ . . _ - _ - _ . _
i Federal Regist / Vol 4'7, N . 205 / Fridsy, Oct:ber 2 1982 / Naticer 47tr73 models for use in computation of the recommendation,s and are listed under i, derived response levels. 'Torage Concentration'*, Assistance Plan (IRAP) coordinatee ther FDA appreciates the careful review provision of Federal assistana and an 1
sad the suggestions as to betterdata Other &===am Offsite Instrumentadon Task Force of and rnodels. The references suggested, - b Fedwal Radiological Preparedneu
- 14. A comment addressed the as well as other curnat reports, have Coordinsung Conumttee edadmetered
' definition of the entical or senaidve by FEMA is developing spec Sc been carefully reviewed and appropriata population for the tables in proposed ones ase being used as the basis for gedance on instrumenteden and t i1000.400(d) and observed that there le computation of the derived response a greater risk per rom to the younger age methods for sempling food (Rhf.21J.
levels for the Baal PAG's.h spec:Ac groups than toadults Anothercomunant CastAasiyeis models and daam being used are ao requested father expleastion of the follows: relative ability to protect children and 17. Several comments wgued that i
Ay 'w"M =19336tgy , 8dult* FDA's cost /benant analysisused to gg ,g,g,ladtural " ' * -
FDA spees that.rd ny. the esitical establish the PAC levelswee Intake per unit depamose-Table 8 t. segment of the population should be . inadequate. Cosmeente stated thatit to j UCR14tese (ReL si, daAned la tenas of the postost risk per jnot appropriate to seeips a unique fbsod peek anik sedvity-Equados 86 UCRI,. unit intaka. However, this would douar value to se advwee heels
- stwas(Ret si.
^8** Introduce yeeter ==p3==i*y into the . efface assomand wdh one pareen-men d doom i day. Ug1e30 (ReL SI-by cow--es squam meters /
r======iations thanialusaiSed. .
j taitial reennon om formes-.4.s frecuan, because the risk sedmates are uncerteia, FDA advises that its cost /beneSt 4 UCRIA:em M n h Snal reco===adadone provide analysis was not conducted to establish Forege yield-423 kiloyam/ square meter derived response levels for infante at the the PAClevelm FDA considers such use *
(dry weight). UCRIAtese trac sg ,
' Prevendre PAC and infants and adulle 88PPmpriek la Part because dee
! wlk consumonoe ar tirer/ day (afass. for the Emergency PAG. -
inability to assess dennitively the total
, ICRP-U.19741Rel 10);-4.58 litar/ day adult. FDA has reexandned the available societal impacts (positive and negadwel i USD A.1986 (Ref. ul, I data and concludes thet taking acdon at of such actions. Rather, the cost /beneSt Does conversion factore from per yeia was used 2 demnnia wheder aucrocune mgested). the Prevendve PAC (based oe the infant as the. critical or sensatve populadon P"""U"**d"*****""*""""
wiu also pr PAG's would provule a not societal I
4 i I nee g,,, g,,providep,otecdon
,g , ,ta=daa of unk.h of the benent. bl To make such an a-, it-t
- denstion.oinewborn infant in the 18 neco88887 2 place e douanelse ce a i """s"is"t $"" poman.msa d doom camise see tables in pareyeph (d) of the PAG *e has ante -=== masus' 13. Sewal comments also q==adn=ad been revised to redest this conchsmos.
"I" '" **
me. amamuma 1S. EPA comunested that ita 6e appropriatanese of the assumption i! r
""""*"""" reguladons governing drinking weter (40 the coet/hanadIt analysis of 23 days ad I CFR Subchapter Diperrait blending of protective acdon, the need to address
- 5"M7
'1'****=== weter to meet =avi=== contasninant redimuclidae other than iodine.131. and levels. EPA suggested that FDA's abort- the need m consider the impact ormber
. ""7Al" ,'.".". tena reconamendadons should be prometive acdone,
===== ,
compatible with thelong.tenaEPA N cost assessments have been c ,,,,_.; go,, , ,a %, , , , , reguladons, extensively revised to consider alf the s a_lam amis amt =
angopi aaim As stated in pereyephs 1 and 2of this radionuclidae for which derived nodce. FDA's recomunendadons apply t, response levels are provided la t6e s es_ a am l bumen food and anhnal feed, wheroes I ==uws est recommendations and to incorporate i EPA is responsible for providing
' '" updated cost data and risk estimates i
guidance on contaminated water. Alan, (Ret 221.N cost /beneAt analysis is
- as discussed in parayaph 3 of the .
The use of the newer agncultural linuted to the condemnaden of talk and proposal, there is a long-semaniing FDA model(Ref. 91 has resulted in a 2D the use of stored feed because accident
, percent incrosse in the iodine.131 policy that blending of food is unlawful analysee indicate that the milk pathway
! denved response levels ider.nSed la under the Federal Food. Drug,and is the moet likely to require protective -
Cosamttc Act. Further, these guides are action. Further, theos two actions are paragraph (d)(tl sad (d)(2) of the irrtended for protective ectione under recommendations. Generally, sunilar the most likely protective acdons that emergency siteetions and are not for will be isnplemented.
magmtiide changes am reflected in the dertved response levels for the other continuous exposure applications.For FDA approached the coet/benent 4 these reasons. FDA concludes that the analysis by calculeting the
]
radionuclides. Newer data on todine.131 d15erences between its ' concentrados of radioactivity in milk at does conversion factore (RaL17) would have furtherincreased the dertved reco==aadattana and EPA's regulations, which the cost of taidag action equals are spyroprtate.
response levels for that radienuclide by the risk avoided by the sedan taken on l about 40 percent, but these data have te. Two ca=-ta were received on a daily milk intake basis. The the adequacy or syst! ability of assessment was done on a population not been used pending their acceptance resources for sampling and analysis of by Umted States recornmending basis and considered only the direct State. local. and Federal agencies and costs of the protective actions. h
.authorides. In addition, the proposal
, contained a systematic error in that the the adequacy procedures. of guidance on sampling - analyers indicates that. for restricting
- pasture denved response levels were feed to stored feed. the cost equale-hoe recommendations are not benent concentradons are about one.
i
- tated to be based on fresh weight but designed to provide a compendium of re in fact based on dry weight. Fresh fiftieth to one-eightfeth of the Preventive sempilns techniques, methods, or j ight values (4 of dry weight values) PAG level (dertved peak mdk resourcse. h Department of Energy concentration) for todine.131. cesium.
! re identified in the final through its Interogency Radiological i
i 134 and cesium 137 and about one third EO 4
i - -- . _ _ - - . . . - - . . _ _ _ _ - _ ~ . . _ _ . . _ _ _ _ _ _ _ _ _ . _ . _ _ - _ _ -
47000 Fedetal Regia.. t / Vel 47. Nr. 205 / Fridsy. October 1982 / Nstices 4
4 4
of the level for strontium 40 and UCRIAte3E Lawrence IJvenoore Pertinent background data and strontium-30. For condemnation of milk. taboratory Ouly is terrl.
based on value at the farm, the cost. 1E !aternaumal Comeussion os Information on the recommendations are
- d'"' ** on file in the Dockets Management equals-benent concentrations are Branch. and copies are avedable from similar fractions of the Emergency PAC . $*,, y,,,
Publicados n, paea, Pusame Prew, that office faddress above).
levels (derived peak nulk .
Oxford (terel. Based upon review of the comments concentration). If condemnation of milk 11.UI Deperament of Agnculture, received on the proposal of December i la based on retail market value. the cost. "Hoveehold F ad Consumption Survey 1988- 15.1978 (43 FR 58790), and FDA's further !
equals.benent concentratie is are 18eE" consideration of the need to provide 4
greater by a factor of two. Thus,it 13. Wehaa H. N. and R. T. Anger.
guidance to State and local agencies for l appears that protective actions at the 7'j*],*,$ D'*""**7 *"dy" 3, use in emergency response planning in
- Prevendve or PAC levels ," hidc/serMedicina t
will yield a not societal the event that an incident results in the .
St. Dhgus,h,53, pg radioacdve contaminadon of human !
, Howower. In the case of strontium-as tJ. Kinaugh. G. G. D. E. Dunnias i R. . food or man ==I feed, the agency offers
- and strondum-SIL protective action will 'Bomard, and I. C. Pleasant. " Estimates of the following reco==madations yield a bene 8t only for concentrations !aternel Does Equivalet to a Target Organs greater than about one. third the derived regarding protective action planningfor for 'ada"a= Occurries in Routtae human food and animal feeds-peak values. In the case of lodine.131. Reisease from Nacieer Fusi Cycle Facdities.
cesium.134. and cesium.137, protective Vol.1." ORNL/NUREG/D4-tet Oak Ridge -
Accis'iental Radeessive r *ans==namaana }
National Laboratory Guae 18r81 of Himaam Food and Anunal Feedet acdone could be condaued to avoid 98 14, National Cooned on Radiaties t
! percent of the pro!ected radiation does e=====madadana for State and local Proteceos and mesurements. "Casium. tar Agende, for initial peak concentrations at the From the Environsient to Maa Metabodem PAC level, and Done." NCRP Report No. sa. Wuhingtoa (8) Applicability. (1) These i
g,g,,,,,,, . (January 1s. t -
recornmendations are for use by
- 13. Internati Commission on appropriate State or local agencies in i The following informados has been placed Radiological Protecdem. !Jaits for Istakes of i on display in the Dockets Management response planning and the conduct of Redonuclidae by Workere. ICRP Publication Branch (HFA-3081. Food and Drug M Part 1. Annale of um ICRP. Pupon regation protection activities involving Adminletredes. Jim. Ma. 3000 Flahere lane' Ptuas (tsret, the production, procosmag, distribution.
Rockvule.MD 30egr. and may be seen between 9 a.m. and 4 p.m Monday through m Popwards. D. G and I. Vemmart, and use of human food and animal feeds Friday. "Retados of % is Hmas Sees at DWesus in the event of an incident resulting in
- 1. M Ages and Resulting Radaties Dessa." the lease of radioactivity to the g, P w am Myeise is Modstne end 3/etegF.18:10518e environment. The Food and Drug Candance for Federal Agencies." Federal (tek Admaistredon (FDA) raea==made that 1 tr. Kersiaken. llG., P. A. Feiler. F. A. this guidance be used on a case by-case
% August 23.1984 (a FR 120eej aEd Report No. 3 Uuly teet). AeoenL 3. R. Thomas. M. J. Celland, and E.1. - basis to determine the need for taking
- 2. Federal Radeuon Councd. Memorendum 888"88 ~P'd*'"8,, Rad , - - - - ocal appropriate protective action in the for the President / Radiation Pmtecnon ***7 8~ T =dcal
- --, Syseposiusa April au 1970' event of a diversity of contaminating .
Guidanos for Federal Agencies.* Fedesel -
"*" *"* events. such as nuclear facility y[ggs N donal accidents, transportation accidents, arid i 3. National Academy of Saences/ National National Research CeumoL "De Effects on fallout from nuclear devices.
! Research ComamL "The Effects on Population Populeuses of Exposum to Leur taseis of (2) Proteedve actions are appropriate 1 of Exposure to tow Levels of Ionamng foessang Radamen." Report of the Advisory when the health benefits associated Radisuen." Report of uw Advisory Cmanna on assiegical Effete ofIsosang with the reduction in exposure to be i Comnuttee on 5 elogical Effects of temsing Radlauen (EEIR-l)(tert),
in National Commed on Radselen achieved are sufBcient to offset the Radiation (BEDt-iH1(1 seek
- 4. Uruted States Nuclear Regulatory Pmtwuon and MoeemmenteJNQtPL " Basic undesira.ble
,ggg,,,, features Ilie Protective of the protective Action Guides i Commisence. Reector Safety Study. WASH. Radiation Protocean Cetterta. NCRP Report toca Appenda VI(October ters). No.
- Washington (19r1). (p g .eggn paragre (c) o eso
! 3. Rom. E and E. Medan. "Bem an Sogen. K. T. and A.1 Colda, recommendatione represent FDA,s
! Malignant Dyrood Neoplasme Ake,and ' Moon Esposure to External Natural judgment as to the level of food Chudhood Irredatice for T!nes Capetta.- Radation Background in the United States." contammation resulting from redletion
/ ovine / of tAe Merionel Cancer lasrituse. Vol. ORP/SEPD-et-11 Eavtrorumental Protocesa incidents at which protective acdon es No.1(July teeDb Agency. Washingese. DC (Apnl feelb should be taken to protect the public
- e laternational Cosnaiselon on 21. Federel laterogeoey Task Fosce on Radiological Proceense (ICRP), Offeite Emergemey lastrussentados fe' health. Further. as provided by Federal guidance issued by the Federal I
Recommendations of the Internauonal Nuclear Aandeem. "Ceidamos on Olhite l Cosimaaa'an se Radiological Protocoon. ICRP Emergency Radiation Measurement Systemet Radladon Councl. if. In a pardculat i
Publicasse a Ammale of the ICRP. Pergamon Phase 2. Monitortes sad Measurement of situation. and effective action with low l Press (1977), Radicouendes to Detesense Does total Impactis available. Initiation of I
- f. Enytreamental Protection Agency. Commitment la the MAD Peshway.* such action at a projected dose lower
" Manual of Protective Acnos Cuades and developed by Exzee Nuclear Idaho Co. Inc than the PAC may be justiflable. If only
! Protective Actions for Nuclear inc2 dents." Idaho Falle. ID. Dreft. july test (to be very high impact action would be i EPA Sas/1-r5-ost rewteed lune 1980 pubilshed by FEMA). effective, initiation of such acdon at a j s. Umted Natione Scientific Comrnittee on 21 Shlesen. 8 C. D. Schnudt. and R. P.
the Effects of Atomic Radiauon.1977 Report. projected dose higher than the PAC may l-Chiacchiennt. "Backsmund for Protective be justifiable. (See 29 FR 22056: August Uruled Nations. New York (1977). Acnon Recorrunendet one Accidental
- 9. N y Radioective Contaminaden of Food and 22,1964,) A basic assumpdon in the i S. E TIom. pson.C. C. S.Coefficients
" Transfer Coleher.forD. I. Quinn Ammal Feeda." and Septetsber test. Department dev*lopment of protective action I the Prediction of the Does to Man Via the of Health and Human Services. Food and . guidance is that a condition requiring i Forage-Cow. Milk Pathway from . Drug Admuustration. Sureau of Radiological protective action is unusual and should .
Radionuclides Released to it e Biosphere." Health.Rockvius MD, not be expected to occur frequently.
1 E /7 1
. __ _ _ _ _ . _ _ ~ _ _ _ _ _ . _ _ . - __.-_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _
m 3
- . . Federal RegL / Vol. 47. N2. 205 / Friday. OctabIt 1982 / Notic
- s 47031 !
3 C!rcumstances this invIlve repetitive occurrence, a substantial probability of (b) Definitions. (1) " Dose
- la a general which the responsible ofBdals should '
recurrence within a period of1 or 2 term denoting the quantity of radiation determine whether conc!emnation or
- yeare, or exposure from multiple sources or energy absorbed. For special another disposition is appropriate. At n urposes it must be appropriately
~
(such as airborne cloud and food the Emergency PAC. higher imprct -
queUfled. In these recommendstions it scdons are jusufled because of the pathway) would require special refers specifically to the term " dose consideredon. In such a esse, the total projected health hazards, equivalent.a (9)" Rad" means the unit of absorbed i projected dose from the several events and the totalimpact of the protective (2)" Dose commitment" means the dO" equal to 041 foule per kilogram in i
! radiadon does equivalent received by any medium.
actions that might be taken to avoid the an exposed ladividual to the organ cited (10)" Rem"is a special unit of dose future does from one or more of these over a lifetime from a single event. . equivalent.He dose quivalent in mas events may need to be considered. In is nunwricaDy qual to the absorbed 4
any event, the numancal values selected (3) m qu 88a 8 88 1 that expresses all radiation on dose la ends muldplied by se quauty factor, the distribution factor, and any for the PAG's are not intended to 'ctd common scale for calculating aubrise delibersto mIesaw expe other necessary modifyms factors.
efective absorbed dose. It is defined as ,
to result in absorbed doses of these he product of the absorbed dose in rede (11)"Responsa level"means the -
- N"d**' and certain modifying factore. De unit acevity M a sydSc doucHde(0 4
(3) A protecdve acdon is an action or initially deposited on pasture: or (ii) per of does equivalent is the mm. unit weight or volume of food or animal measure taken to avoid most of the (4)" Projected dose commutment" radiadon dose that would occur fkom feed: or (till in the total dietary intake future ingestion of foods contaminated means the does commitment that would which cormsponds to a pardcular PAG.
, with radioactive materials, nees. be received la the future by individuals (c) Protective action guidae (PAG's/.
In b population group from the To permit flexibility of sedan for the d recommendations are intended for contaminating event if no protective implementation within hours or days reduction of radiadon exposure to the action were taken, public via the food pathway due to the from the time sa emergency is j (5)" Protective action
- means an occurrence of a cdniaminating event, the
- reed ne ecuan recommended to action taken to avoid most of the be taken should be continued for a foDowing Preventive and Emergency exposure to radiation that would occur PAG's for an expond individualin the sufHeient time to avoid most of the froar. future lagesdon of foods projected dose. Evaluation of when to population aan adopted:
- cease a protective action should be contaminated with radioactive (1)Pieventive FAG which is (1)1J maurials. rem projected does commitment to the made on a case by. case basis considering the spec Ac incident and the (6)"Protecdve aedon guide (PAG)- thyroid, or (ii) 08 rem projected does j food supply contaminated. In the case of means the projected dose conunitment commitment to the whole body, bone
=
values to individuals in the general marrow, or any oder the pastum/ cow /nnik/ person pathway, . (2) Kneig.cy PAG
! for which derived "meponse levels" are population that warrant protecdve ch is (l)15 tem
! action following a rolesse of radioactive projected dose commitment to the provided in parograph (d) of these
! material Protective action would be thyroid, or (11) 5 rem projected dose recommendations, it is expected that warranted if the expected individual commitment to the whole body, bone l actions would not need to extend does reduction is not offset by negative marrow, w any other organm i beyond 1 or 2 months due to the
' social, economic, or health effects. De (d)/tes selevels equivalent to reduction of forege concentrations by PAG Al ough se basic PAG weathering (14-day half. life assumed). PAG does not include the dose 4 hat has
! unavoidably occurred before the mcmamendadona am ginn in tenne d la the case of fresh produce directly assesanent, protected dose equivalent. it is often l contaminated by deposition from the (7)" Preventive PAC"is the projected mon conwnfent to uduse spedSc cloud, actions would be nec'essary at the dose commitment valuh at which radionuclide concentrations upon which
! time of harvest.nis guidance is not -
' responsible ofBdals should take to initiate protective action. Denved
' intended to apply to the problems of protective actions having minimalIpect . response levels eqmvalent to the PAC's long-terra food pathway contaminadon to prevent or reduce the radioactive fw mdionucUdes Cnurnt arm where adequate time after the incident
' la evetlable to evaluate the public health feeds.
consequences of food contaminadon contamination of human food or animal (g)" Emergency PAG"is the projected Mid(Ql'$[
M d*""
l "j" y
using current recommendadone and the dose commitment value at which guidance in Feders! Radiation Comned ,
(FRC) Report No. 3. fuly teet and Report leo. 7, Msy Iges.
responsible oNidals should isolate food containing radioactivity to prevent its Introducson into commerce and at
,,s.%.no one,,
sai, Isse aan pee, #
pe,ses,,. % % %%%
a %iara., ,e,,,e i.ew
, etosa ammanu n.us er a=.=== pas
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a we e y gg gg ame eu, saamme.o ayuempus um emment to aum _ _.
_ seseis me tot asy. m esso af a sammur esmeme, me esmass.e summe af men.933 =e 3E:::"." 'lll :".". ""."P.'e"e ;"',:::l:' *"fo:" ll".""."".".*.,"*".',""::lN " - ". .""
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. 47gg3 Federal Rest. e / Vcl. 47. No. 205 / Friday. Oct:ber . 1982 / Nstices (2) llesponse lxlfor Em:rg:ncy FAC. %2 response levels equivalent to the !*.ncrgency PAG.are presented for both Infants and adults to permit use of either level and thus assure a flexible approach to taking action in cases where exposure of the most entical portion of the population (infants and pregnant women) can be prevented:
ist.* i esa.' I isms i es, sei,
- w. A.m lw *- Aas nie ' l A.m \ u
- a Aes u
- I Aed p
-o,ep.sva.9 na< A- .yp.m n
- ,s as ,., .
.,, =,s .,e 's u
a e
.e
=
,e=
=
&ls : 1J s to e 0.0e to f.4 se r as se .e m to se a r = .as y .e.e s .s n= or .e ist.
g ,.'s,, ,,,,, , y , ,= ,, g,,.y. . , . ,,,.,S'=. _ . _ a .e. ..- - i . =-
E'" ".IIEY."E." "I '" '"." ""s"E" Y *i.NY .".'."". 'E".'.' *,'".IE " Y. "*." ".".' e 'E E e'r"""E ""I I (e}lmplementation. When usingthe w ofintake* would probably be Ilmited by PAG's and associated response levels . .3" , the quantity purchased at a given time.
for response planning or protective ** For most food. especially fresh produce.
actions. the following conditions should '"'
E thiswould probably be about a 1 week be followed: cE. supply. In some cases. however. Targer (1)Specr/ic items. To obtain the quantities would be purchased forhome responseleve (microcune/ kilogram)
%l'
'*""laf or freesang. For moor foods and equtvalent to the PAG forother specific o.= ===.e a.a = =. =.e - 'as members of the public. an effective foods, it is necessary to weigh the 8.".",",,,,',,,,",",*,',a======*,, j*a " days of intake" 30 days is probably contnbution of the individual food to the conservative.
total dietary intake: thus, '" 1"'
(iiil For population groups having
.e . e 6 ,. si-=^=~iy di5eront dietary intakes. an g,,,,,,g ,, Total f atake (aucreent up 3*g,,",,,*"""**'8"""**"""""" appropriate adjusanent.of dietary consumpaos twoeremel factors should be made.
(ii) Assessment of the effective days * (2)/todianuclidemanares.If a Whers kaitatake(microcanal Airthe ofintake should consider the speciAc U ' ""d* mixture of radionuclidae is present, the 7,7,,* ph of mes food, the population involved, the food pun of all the ratioe of the conce stration recoe===danons distnbution systens and the - of each speciAc redfonulide to its and radionuclide. Whethat the food is specrfic noe level equivalent to the consumpeon is the product of the eversee distnbuted to the retailmarket or PAG sh be less than one, daily consumpoon spemfled in perssreph produced for home use will sism8cantly (3) Othernrdionudidas. De response (eM1 Nil of these recommedanons and affect the intake in most instances.
- the days oflatake of the contammated Isvel for the Preventive and Emergency Dus while assessment ofIntake should PAG for other radionuclidae should be food se specified ta pareyeph (eg1)(ti) of be on a case.by-case basis.some i *"*'***""*"d*"*"** calculated frasa dose comunitment general comments may he usefulla factors evallable in the literature (1) De daily consumption of specific specific circumstances. (Killough G. C., et al. ORNI./NUREC/
foods in kilograms per day for the (a) For short half. life radionuclides. .DI-190 (1978) (adult only). and U.S.
general population to given in the radioactive decay willlimit the Nuclear Regulatory Commission Reg.
followtng table: ingestion of radioactive materials and *
' Cuide 1.100 (1977)).
. the effective " days of intake *. De (4) Othercritica/organe. Dose -
effective " days of Intake
- in this case is commitment factors in U.S. Nuclear 1.44 times the radiological half-life. For Regulatory Comunssion Reg. Guide 1.tes lodine-131 (half. life--4.08 daysJ. the (1v77) refer to bone rether than bone
' ^'2*' eff active " days of intake" is, thua.11 marrow does comantments.For the
"",,g= days. purpose of these reconunendations, does
,, ,,, m (b) Where the food product is being oonunitment to the bone marrow is
'"."' harvested on a daily basis,it may be considered to be 0.3 of the bone does
@en reasonable to assumareduction of commitment. This is based on the totio contamination due to weathering. As an ' of does rate per unit activity in the bone initial asessement,it may be ap marrow to does rete per unit activity in
,,, t . life a small tissue. filled cavity la bone and gone('o used assume a 1kiay woethering
- 7e '""'" "' *"" '
m.w. for forage la pasture / cow / milk assumes that strontium-00 is distnbuted 7., g pathway) pending further evaluation. In aos this case, the effective " days ofintake" only in the mineral bone (Spiers. F. W.
et al.in "Blomedical Implications of
- .*-- 088 is 31 days. A combination of radioactive Radiosarontfunt Exposure." AEC
's".,',, , ,,,,., "en*decay and westhering would result In Symposium 25 (1972). De totio for a a .- as an effective half. life foriodine 131 of 5 strontium-se is the same because the y* days and reduce the " days of Intake" to mean particle energies are sinular(0.56 P_L.T.e.
- v. ,'=ise,,""* ao 7 days.
Q, .L p ws 3 (c)la the case of a food which is sold MeV (messelectronvolts)). Situstione could anse in which an orgen other than l
. o. . i on in thentail market the effective " days those discussed in this paragraph could f .
\
E /7
..~._-.,___-_____,.,______._____-m_ __ _ _ _- _ ~ _ _ __ __ .- . _ _ _ _ ~ _ _ _ . _ _ _ . - . - _ _ _ . _ - . _ _ - - - .
i ,
r,
, Federal Regl6 / Vcl. 47. No. 205 / Frid:y Oct:ber i 1982 / N: dees 47083 i
be considered to be the orgas receiving
! the highest does per unit intake,Ia the December tort andInternational milk, butter, cheese. or evaporated mdk.
i case of exposure via the food chain; AtomicEnergy Agency." Environmental Monitoring in Emergency Situations." (iii) For fruits and vegetables:(el
- i depending on the radionuclide under j ISOS. Analysia need not be !!aited to Washing, brushing, scrubbing, or peeling considereuon, the asstrointestinal tract to remove surface contaminatiqp.
3 could be the p organ exposed. these4aethodologies bat should provide '
! comparable results. Acton should not (b) Preservation by canning, freemas.
4 ne references cat la peregraph (e)(3) and dehydration or storage to pernut of these recommendations contain does be taken without vertilcation of the i'
commitment factore for the following analyets. Such verification might laclude radioactive decay of short.uved organs bone, kidneye. liver, overke. the analysis of dupucate samples. radionuclides.
I syssen, whole body, and geseeintesdael laboratory measurements. sample . (iv)For gralam (a Milling and(b) .
i poushing, tract. analysis by other agencies, sample (al Prompt notiSostion of State and analysis of various environmental (v) For other food products. processus
, local agendes regardag the oseurrence moda, and descripew data os
- to remove surface contamandon.
j of sa lacident having poteadal radioecove roleses. (vi) For meet and meet producta,
! health consequences is of mefn ==* g . M ons.Acd m
' latake of cesium.tse and cashm.137 by-value la the implementados of efecdvs sppropriate when the health beneet as adult via the meet pathway ma protec actions. noti 8cados is aseodatal with the reduedon la does exceed that of the milk pathway; y
' u g g a
' onset the undesirable health. -=i, I' enWore. levels dcasima la sulk onstofr from he approaching the " response level" should 4
i sirborne cloud but is also of value for and social factors. it is the fatent of' , cause surntuence and proteedw l food pathway contamination.
I these recomunendadons that. not only j actions for meat as appropriate.
Accordingly, this protective aedos ! the protective actione died for the '
guidance should be incorporated la Emergency PAG be fattiated when the (vn) For animalfeeds other than State / local emergency plans which i equivalent response levels are reached. pasture, acdon should be on a case.by-i provide for coordination with nuclear i but also that acdons appropriate at the case basis taking into consideradon the fadllty operatore including prompt reladonship between the radionuclide Prevendve PAG be considered.%is has notification of accidents and technical t the efect of reducing the period of time concentredos in the animal feed and the i co====ication regarding peblic health a required during which the protective concentration of the radioonallde hr I consequences and protective acdca. action with the greater economic and human food. For hay and adage fed to !
(f)Semp/htpperamerar. Generally, social!mpact needs to be.takas.FDA lactattag cowe. the concentrados should i sites for sample collection should be the not exceed that equivalent to the retad market, the processing plant. and re--la that osos one or more recommendations for pasture,
! the farm. Sample cousction at the nulk protective actions are faitiated. the processing plant may be more e5cient la
- action or sedons continue for e (2)EmerymmerMG Responsibfe 4
sufBcient time to avoid moet of the ofHciels should Isolate food containing l
deternimas the extent of the food radioecovtty to prevent its introduedoa projected dose. Dere is a longstanding ,
pathway area where contamination.The protective actions are geographic FDA poucy that the purposeful lat*blandlag
"""""*" ud detwain* *h*e ' '
- implemented should be based ce of adulterated food with usedulterated cadmanada w anoder espede is i considerations of the wind direction and food le a violados of the Federal Food, ePProprieta Bdom taking eis acdon, i
sanospherte transport, measuransats by Drug, and Cosmode Act. De following the following factore should be
) airborne and yound servey teams of the protocen accons should be considered considered:
radioecove cloud and surface for implementados when the projected (!) De avadabdity of other possible i deposition, and measurements in the . does equals or exceeds the appropriate protective acdone discussed la fadpetway. PACS i
paragraph (bM1)of these (g) Aecommendedmethoolr of (1)Froventive MG (1) Foryestura meannendad es.
one/ysis. Techniques for measurement Removal of tactating dairy cows from(el(u)Reladw propordon of the total l
of radionuclide concentredens should contaminated pasturege and diet by weight represented by the item i han detection !!auts equal to or less ' subedtudos feed.
of uncontanunated storedin queedon.
l than the response levels equivalent to ' (lu)De importance of the pardcular speci8c PAG. Some essful asethods of @ d food la nutrition and the avedabtuty of radionuclide analysis can be found is: an uncontaminated food or subeututse l (1)1.ohotoraryMethode "HASL (ii)For mine(e) Withholding of having the same autridonal properdes.
Procedure Manual." edited by John H. .
contandasted adk from the market to Harley. HASL 300 ERDA. Health and Safety Laborst aHow radioactive decay of shorouved f (iv) M De relative conertbudos of other oew red to b radionucliden. This may be schieved by. totalpmW
-Ratnd MethodNo. t Esthme New York.NY.19F3:
F!seios storage of Grosen emeh milk, trosen product Coocentredoes la " U.S. (v)De due and efon mquirmi to concentrated milk. or e,ses.
tyr ut of Health. Education, and coneantrated muk products.
efeci cor-dn .cdon.
i Welfare.Pubuc Health Service %Is nodce is Isened under the Public Publicados No. 95Nt-2. May 1963: (b) Storage for prolonged times at Health Service Act (seca. 301. 310,311.
"Evolustion of los Exchange Cartridges reduced temperatures also is feasible se Stat. est-ess as amended, se Stat. 371 t
for Fleid Sampling ofIodine-t31la provided ultrahlgh tempersfure - (42 U.S.C 241,2420. 2431) and under l Milk." Johnson. R. H. and T. C Reevy, , pasteurtsstion techniques are employed authority delegated to the Commissioner Noture. 300. (5012): 750-752. November for processing (Finley, R. D. H. 5. of Food and Drugs (21 Cm S.10).
j MLiges:and Warren. and R. F. Hargrove. " Storage ,
\
(2l PieldMethods-Kearny. C H. Stability of Conumerdel Milk."fourne/. Desed Octobw tt.19es.
ofMilk andFood Technology. A'*** H'M H*1**' l
' JRNL 48086 Nevsmber 1973: Dietenfeld. 31(12);382-Ger/ December 1980).
C and J. X!senish. Brookhaven National Commissionero/roodandDeves.
{ Laboretory, NUREG/CR4fts. (c) Diversion of fluid sulk for tru om asassa ru.e is.ase *** am production of dry whole mdk. nonfat dry s m a cose "** *
- 5.o o A -ec,,- ur E17
___ __ __