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
'TE'LE'f HO NE' :
3cI-9 5l- 05 5 o TELeFAX' 30/ - '/9.2-1r 18'7 DATE
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FROM' ~ ha+ E ewseu ey, N RC.
.M4*SSAGE :._ Enclosed lS sl -h(f food ANd -l A
con v UG Adminn3 fru,%d A u'idt/ihes i$ sued Ocf 's2..
Also eneded
ARe $g ->f hblt3 (ENLA Crfb 50R THis 724NS/nts.S/o' Q\\
wAic4 x <c Ja +4s Adras/. dea &/rx A)o Aie. /?wy 8/ low up o u es d o u.s.sAoald be dibeled '-/n GAl/ bCbM/$b Y Ebb l 30/-443-2850.
on A/RC wou/d xppierejsh nectivire (via,c d Anv indamahon _
s he co//eehas
/0le/c and compos, A.,,, of vo u msv c o acc aniac AdE66 ch ut k bel nrN/ced u':
An Icf/ANW.
G j W I
NO. OF PAGES INCLUDING COVER PAGE '
/5 PDR LORO --335
t
~
j i.
4 I Rsoponse levels for 2/
1 34
-4/
4/
90 89 137
- Prcvsntive PAG 1 31 Cs Cs Sr sr 7
1
!Initici Activity Area Deposition j
(oic rocuries/aquare estor) 0.13 2
3 0.5 8
l Forege Concentration /
3 (cierocuries/ kilogram) 0.05 0.8 1.3 0.18 3
Pack Hilk Activity (cierocuries/ liter) 0.015 0.15 0.24 0.009 0.14
- Total intake (cierocuries) 0.09 4
7 0.2 2.6 4
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 131 2/
134,EI 137,J/
90,
89,.
1 g
g 3
3 Infant 1/
Adult Infant2/
Adult In fant_/
Adult Infant,/
Adult In fan t,/
Adult 2
2 2
i iltial Activity-Arco Deposition (oicrocuries/ square j
metor) 1.3 18 20 40 30 50 5
20 80 1600 l
Forcge Concentrationk!
(cierocuries/
l kilegram) 0.5 7
8 17 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
7 26 400 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, iodine-131 is the only radioiodine of significance with respect to milk intcmination beyond the first day.
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
/7 i
4 l
s Average consumption for the general population Food (kilogram / day) ice cream /
1 Milk, cream, cheese,
.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 of Human Food and Animed %
Recommendatione for State and Local j
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 incident causes the contamination of i
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
4'10'74 Federal Reglsi.e / Vd. 47. W. 205 / Fridsy. October 22. 1982 / Ncticzs e
i appropriate planning actions necessary during the development of these final sufficient time to avoid most of the for evaluating and preventing recommendations. Although EPA's proiected radiation dose. Ms. the contamination of human food and formal comments are reponded to in PAG *s define the numencal value of i
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 FDA has reviewed the recent mport of i
pon runneen issponesanoes costracyt comments. These contacts were the Nadonal Academy of Sciences /
Gail D. Schmidt. Bureau of Radiological considered appropnate because EPA Nadonal Research Councd (Ref.3) on Health (HFX-1). Food and Drug has indicated that it intends to use the radiation risks and biotopcal effects I
Administration. 3000 Fishers Lane, mcommendations as the basis for data that became available after Rockville. MD 20087. 301-443-2a80, revisms its guidance to Federal agendes publication of the FRC guidance and has j
- 3,y,,,,,,,,,,
radioactivity la food, guides for reviewed the impact of taking action in on protecdve acdon
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' ndnadon of food from I "8h 88' MI88d 8
- 88888 " 88 a
mceind. DA has noidend its considerations and the comments Axed nuclear facilities, transportation-propmal to confy received on the proposed accidents, and fallout is part of a recommendadons. FDA has concluded et Federallateragency efort coordinated that tective actions oflow impact by the Federal Emergency Management Becaum s se iira do 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 March 11.1982 (47 FR 10758), which dedded not to codify the recommended by FRC (Refs.1 and 2)..
reflected governmental reorganizatime recommendadons; rether. It is issuing Accordingly. FDA is recommending low.
and reassigned agency responsibilities them in this notica. Elsewhere in this spect pmucou acdas (tenned me for radiologicalinddent emersucy issue of the Federal Register.FDA is Pmvudu PAC) at projected reesdon 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 assigned to the Department of Health p$ g, 4
reco==aadadons contain basic protective actions be implemented to and Human Services (HHS)(and in turn criteria, deAned as protective action prevent the appearance of radioecdvity 4
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 food or animal feeds at which sedan incimie se transfer of dairy cowe frons l
aseodated guidance for human food and should be taken to promet the public huh forage (pasnire) to unceitaniinated l
animalInd.
health and assure the safety of food, ne stored feed and the diversion of whole l
In the Federal Register of December 15.1978 (43 FR 587901. FDA published recommendadons also contain specific 8de poundauy commaninead wis l
proposed reconimandations for State guidance on what emergency protective short lind radionuclides to products and local agenctee regarding acddental aedons should be taken to prevent wie aimig sheme to aHow i
radioactive contamtantion of human further contaminaden of food or feeds or radioacdve decay of the radioactive I
food and animal feeds. Interested to restrict the use of food, as well as maurial.
more general guidance on the fa those situations whom the only Persons was given until February 13.
development and implementados of Protecdve actions that are fossible l
1973 to comment on the proposal.
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 acdon is recomniended at projected I
nuclear utilities, and others.Two of the idendfy that level of contamination at radiation doses of 5 rem whole body conuments from environmentally which acdon is necessary to protect the and 13 rem thyroid. At the Emergency concerned organizations were received 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
Three Mue Island. which increased PDA has reviewed and utilized the into commerce and determine whether l
i i
public awareness of protectin action 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-radioactive contanunation and that recomunendations.
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 which action should be taken to protect dosimetry data, the agricultural models incorporate the FRC concepts and the the public health. This is based on the used in calculating the denved response FRC guidance that protective actions in-agency's recognition that safety involves levels, and the philosophical basis for 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 i
orotective action guides. FDA advises projected radiation dose that would be disasters (approximately a one in a hat, to be responsive to the EPA received in the absence of taking md!!on annualindividual risk of death)
.:osunents. FDA staff met with staff of,
protective actions. Similarly, protective and the risk from vanettons in natural the OfRee of Radiation Programs. EPA.
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' ctors of 3.3 and a.
For use by State and local agencies in a
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 FDA in implementing its authonty for models, and methods of calculadon is States emerges-food in interstate commerce under b ta nedla the"Be 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 De recomrnendations established in doses and the relative importance of 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 contaminated by radionuclides. Dey based on considerations of the 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 radioactive materials and intends also.
marrow. Thus, the organ doses equal in
" projected absorbed does to the to forward the EPA guides to the risk to t rem whole body radiation dose 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 following a contaminating event." a is considering the development of Red bone marrow.(De additional guidance for acidentally contaminated ICRP-28. nonstochasdc limit, however, concept that is addressed by FDA's restricts the thyroid does to 30 rem or to recommendations. To use the concept water and for long term exposures due l
l times the whole body occupational limit with,a diferent description would in to contaminated land property, and 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
",poeun p thwa im ally jg 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-
}
47g73 Federal Registm / Vol. 47. No. 205 / Friday. October 22 1982 / Notices 4
r 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 Assuming that inidal contanunation by to actions taken to avoid or prevent useful Elsewhere in this notice. TDA these radionuclides was at the projected radiadon dose (or future references models for other Preventive PAC level. radioactive decay dose).Thus, by dennition, the PAG *s for radionuclides, providing a resource for and weathenna would reduce the levels i
food do not consider the radiadon ddees those requiring more details, so that protective actions could be i
already incurred from the plume The chemical form of radionuclides in ceased after 1 or 2 months.
4 pathway or from other sources. The the environment may be important when The model used to compute the population potentially exposed by considenng the denavation of an denved response levels speciBed in i
ingestion of contaminated food can be appropriate " response level" la specinc paragraph (d) of the recommendations divided lato that population near the situadons, but would not change the assumes a continous or infinite ingesdon
{
source of contaminados and a generally PAG's, which are in terms of projected period. i.e Intake that la limited only by inuchlarger populados at distances does conunitments. Cyanocobalamin Ce radioactive decay and weethenne. This where the doses from the cloud are not so has not been identiSed as a likely
. is the approach recommended in I
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 -
and, therefore, the esency regocts the (in the absence of protective acdons.).
Further revisions have been made in the miles and the ingesdon:psthway should 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
- 4. A ca== ant stated that aedon j
exposed by ingesdon. however. is a agricultural and dose models the
. should be initiated by notification 8unction 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 announcements to the public of the I
of contamination. Exposure from recommendations identifying necessity for protective acdons.
s multiple pathways would not be a radionuclide concentradons equivalent concern for the more distant population to the PAC response levela..
These recommendadons on protective sction guides for food and feed are not group. Further. individuals in this larger FDA rejects the conunent 1
intended to cover other aspects of populadon would most likely receive recommending that the PAG's include emergency plaamns for radiological doses==.11= than that projected for guidance for water. A memorandian of-incidents. The general responsibilities of continuous intakebecause the understanding between EPA and FDA NRC lleannese in radiation emergencies
. contaminated food present in the retail provides that FDA will have primary have been further defined in a rule distnbudon syv..:n would be replaced responsibility over direct and indirect issued by NRC(48 FR 5840t August 13.
by uncontaminated food, additives and other substances in 1950). FDA recognissa however, that FRC Report No. $ states that, for drinking water (see 44 FR 42775: July 20.
noti 8 cation and public announcements repedtive occurrences, the total 1979).nua. FDA defers to EPA for are vital to effective protective actions
~
projected radiadon dose and the total developing guides specifically for and,in paragraph (e)(8) of the impact of protecdve actions should be drinking water, recommendadons, urges that State and considered. Sinular considerations on a 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 S. A comment offered clarification of exposures from the plume and the over which the guides apply, the time of proposed i 1000.400(3) regarding ingesdon pathway. Accordingly, the ingestion required to reach the PAG, and venfication of sample measurements, final reco===adadons are modified to the time that protective actions should while another comment suggested that note that, specafically in the case of the be implemented.
Preventive PAG's should be based on i
population near the site that consumes 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.
paragraph (s)(2)). The agency concludes, implemented in an emergency, and the which FDA fully endorses, use estimates I
however, that a single umfled PAG duration of protective action should not of profected radiados does as the j
r.overing ravitiple pathways, e.g.
exceed 1 or 2 months The agency critana for taking protective action. FDA externalrediaden, inhalation and believes that the scdone identiSed la believes that projected radiados dose ingestion is not pracdcal because paragraphs (a)and(h)of the estimates should be based on venfled i
different sedons and Impacts are recotomendations should be continued measurements of radioactivity in the i
involved. Further. FDA's responsibility for a sufRcient time to avoid most of the food pathway. Such venfication might
~
i in radiologicalincident emergency emergency radiation does and to assure include the analysis of replicate response planning extends only to that the remaining does is less than the samples. laboratory measurements.
human food and animal feeds.
Preventive PAG. His period of time cun sample analysis by other sgencies, ne agency's primary charge is to set be estimated by considertne the samples of various environmental recommended PAG dose commitment effective half life of the radioactive.
media. and descriptive data of the l
!!mits for the food pathway.Thus, matenal taking lato account both radioactive release and has so provided i
dertving response levels for only the radioactive decay and weathenng. Each in peregraph (g) of the radionuclides most likely to enter the case must be exammed separately recommendations.
food chain and deliver the highest dose considenne the actuallevels of A. A comment suggested that some m the population permits H)A to contamination and the effective half. life States do not have the resources to j
stablish recommendations that are of the redloactive material present. For evaluate projected radiation doses. The pectical for use in an emergency. In the pasture / cow / milk pathway, the i
rilscussms with EPA the list of definitive effective half-lives are 5 days for iodine-comment asked what regulatory agency i
would have control over interstate i
ED 1
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 States without sutF.cient resources and of BEIR 111 risk eedmates or the ICRP.2s recommanded proteedve actions. Once the protective ecdon is fartiated,it I
what would be the applicable PAG.
recommendations would result in an shoold be executed so es to prevent as FEMA. as the lead agency for the increase of the thyroid PAG relative to Federal effort. Is providing to States the whole body PAG. For these reasons, much of the calculated projected does rudance and assistance on emergency FDA believes the PAG !!mits for from being received as is reasonably achievable.This does not mesa.
I response planning including evaluation projected does commitment to the of projected doses. Alio. NRC requires thyroid are cannaevedve when levels can be prevented.
however, that all dosee above guidance nuclear power plant licensees to have considered ia light of current knowledge.
Further, the guides are notietsaded to l
the capability to asseen the of.eite of radiation to produce equal health prohibit taking actions at protested consequences of radios ctivity releasse riska from whole body and spemSc 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
1980). FDA has authorito under the consider totalhealth efects, not fust casse and arejust what theirname 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 from the channals ofinterstate comparisons. la the case of the discamed la paragraph 1 of &is noden, I
commerce. la this circum.itance. FDA variability of natural background as as la the absence of significent coneeuinta.
would use t! eee PAC recomunendadons estimate of acceptable risk, responsible authosity may findit i
u the basis forimplementing consideration of Isthal effects or total appropriate to implement low-impact regulatory acdca.
health efects is not involved because protective acdoes at projected radiation Rhk Esdemo the comparison is the total does over a doses less than those spoofled in the t
Ilf*d"*
guides. Sindarly, high W sedene
- 7. Many commente quest,oned the risk 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 todonal mA used in setting the specific p,,grep g ga anC3 have been added to se A@nal ma==)=m from WASH.teco(Ref. 4) wwe of PAC values included in the December queenonable velldity. Other comunena 1975 proposeL A comuneet fbom DA lampwate &is concept.
i 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.
The risk estimates tlinneelves were Further. DA arseed that the protocove admated one in a atHlos annual action concept for essergency planning ladividual risk of death hem natural alleged to be erroneone because recent and response should incorporate the disasters is extremely conservattve. DA studies show that doubling doses are lower than are those suggested by principle of keeping radiatica exposame taggested that comparedve dak is 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 dose due to the natural radioactivity la i
rndente that the PAG limits for t'te-established should be avoided.
food should be the besie for judgmg ihyroid were too high. The comments FDA accepts and antiaroes the acceptsble risk.
4' requested further identification ani ALARA concept. but the extent to which FDA concludes that the diferencee l
rupport for using the critical populados a concept. which is used in occupadonal between DA's suggested appranch and selected.
r 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 the semanuca of the redonale
- e. ;he preamble to the FDA proposal, the ALARA concept as the basis for descripdona. Ao,Hwnaama la tbg The final recoounendations issued la spec Ac PAC values and also require preamble to the proposal FDA believee t!de notice employ the most recent risk ALARA during the implementados of that safety (or a safe level of risk) neede estimates (somade and genetic) of the emergency protective actions appears to to be'deAnod as the degree to which the Nanonal Academy of Sciences be redundant and may not be practical risks are judged acceptable, because it Cammittee on Biological Efects of under emergency conditions.
Is not posenble to schfeve zero risk from toniang Radistica (Ret 3).
FDA advises that these guidee do not human endeavoro. Further. !CRP (Ref. el De thyroid PAC limits are based on constitute acceptable occupational recomunende that, for a given
'he relative radiation protection guide radiados doeg timste nor do they application involving radiation, the not for thyroid compared to whole body conatttute acceptable linnits for other benent to society should be positive, i
contoined la NRC's current regulations 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 and the total benant (this is termed.
l levels for thyroid are based on risk used to linut the radiation does that "justificadon"). FDA believes thel to factors for external x.roy irrediation, people may receive but instead are to be establish a PAG. the primary concern is i
Thermicts, the criticism of the PAC compared to the calculated projected to provide adequate protection (or safe tir:ua for the thyroid is not applicable, dose. i.e. the future dose that the people. level of risk) for members of the public.
no trel;t" having been taken for as would receive if no protective action To decide on safety or levels of j
.opa ant lower radiation risk due to 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 contaminating event.FDA introduced gland. Further, as discussed above levels calling for the initiation of the eettmates of acceptable risk from
{
kn
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 population. weighted natural background background or perspective for FDA's are the important parameter in the rudiation dose to the total population.
i adgment that the proposed PAG *s 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 PAG. The basis for the Emergency PAG protect the public health: Judgment 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 Individual radiation doses (taken as 1 to impacts of the action and the possibility 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.
radiation does to the whole body and 25 unlikely event, that nicet individuals 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
- 12. A cammant noted the difficulty in
.s encountered. FDA expects that sedon 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 that timre were lowerimpact actions by the population near the source of la dertving the proposed PAG values which could be implemented to keep contanunation. As discussed la because perceived risk presents food off the market until radiation levels paragraph 2. this is also the population 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-ne recommendation that planning Emergency PAG might be considered to 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 emphasizes. however, that the assumptions that the Emergency PAC. mathematical analysis is required.
i 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 are important in assurms effective may receive an occupational dose of 5 noted that 15 million persons are more protective actions be considered in rem each year over their working than that population currently within 25 selecting any actionc ci, we implemented.
I lifetime with the expecta ion of mmimal 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 constraints pernut a low impact action.
l Persons in high elevation areas such as 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, use it is not.
year (or 2.s rem in a lifetimel above the the population involved, and pose ble in general guidance to consider j
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 protective actions are appropriate.
i with the upper range of PAG's proposed 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 Assistance Plan (IRAP) coordinatee ther i,
derived response levels.
'Torage Concentration'*,
provision of Federal assistana and an FDA appreciates the careful review sad the suggestions as to betterdata Other &===am Offsite Instrumentadon Task Force of 1
and rnodels. The references suggested, -
- 14. A comment addressed the b Fedwal Radiological Preparedneu as well as other curnat reports, have definition of the entical or senaidve Coordinsung Conumttee edadmetered been carefully reviewed and appropriata population for the tables in proposed by FEMA is developing spec Sc ones ase being used as the basis for i1000.400(d) and observed that there le gedance on instrumenteden and t
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 gg,g,,ladtural " ' *
'w"M =19336tgy,
8dult*
FDA's cost /benant analysisused to i
Ay FDA spees that.rd ny. the esitical establish the PAC levelswee g
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 day. Ug1e30 (ReL SI-by cow--es squam meters /
r======iations thanialusaiSed..
d doom i
j taitial reennon om formes-.4.s frecuan, because the risk sedmates are uncerteia, FDA advises that its cost /beneSt 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
- 4 (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, data and concludes thet taking acdon at of such actions. Rather, the cost /beneSt I
Does conversion factore from per the Prevendve PAC (based oe the infant yeia was used 2 demnnia wheder aucrocune mgested).
as the. critical or sensatve populadon P"""U"**d"*****""*""""
g,,, g,,providep,otecdon of the bl I
i I nee wiu also pr PAG's would provule a not societal
,g,
,ta=daa of unk.h benent. To make such an a-, it-4 t
denstion.oinewborn infant in the 18 neco88887 2 place e douanelse ce a i
"""s"is"t $""
tables in pareyeph (d) of the PAG *e has poman.msa d doom camise ante see -=== masus' "I" '" **
been revised to redest this conchsmos.
- 13. Sewal comments also q==adn=ad 1S. EPA comunested that ita 6e appropriatanese of the assumption i r!
me. amamuma reguladons governing drinking weter (40 the coet/hanadIt analysis of 23 days ad 5"M7 CFR Subchapter Diperrait blending of protective acdon, the need to address I
weter to meet =avi=== contasninant redimuclidae other than iodine.131. and
'1'****===
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
,a %,,,,,
reguladons, extensively revised to consider alf the c
,,,,_.; go,,
s a_lam amt =
As stated in pereyephs 1 and 2of this radionuclidae for which derived amis angopi aaim nodce. FDA's recomunendadons apply t, response levels are provided la t6e l
bumen food and anhnal feed, wheroes recommendations and to incorporate s
es_
a am I
i
==uws est EPA is responsible for providing updated cost data and risk estimates guidance on contaminated water. Alan, (Ret 221.N cost /beneAt analysis is i
as discussed in parayaph 3 of the linuted to the condemnaden of talk and The use of the newer agncultural proposal, there is a long-semaniing FDA the use of stored feed because accident model(Ref. 91 has resulted in a 2D policy that blending of food is unlawful analysee indicate that the milk pathway percent incrosse in the iodine.131 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 the most likely protective acdons that recommendations. Generally, sunilar emergency siteetions and are not for will be isnplemented.
magmtiide changes am reflected in the continuous exposure applications.For FDA approached the coet/benent dertved response levels for the other these reasons. FDA concludes that the analysis by calculeting the radionuclides. Newer data on todine.131 d15erences between its '
4
]
does conversion factore (RaL17) would concentrados of radioactivity in milk at have furtherincreased the dertved reco==aadattana and EPA's regulations, which the cost of taidag action equals are spyroprtate.
the risk avoided by the sedan taken on response levels for that radienuclide by te. Two ca=-ta were received on a daily milk intake basis. The l
about 40 percent, but these data have the adequacy or syst! ability of assessment was done on a population not been used pending their acceptance by Umted States recornmending resources for sampling and analysis of basis and considered only the direct State. local. and Federal agencies and costs of the protective actions. h
.authorides. In addition, the proposal the adequacy of guidance on sampling - analyers indicates that. for restricting contained a systematic error in that the procedures.
feed to stored feed. the cost equale-pasture denved response levels were hoe recommendations are not benent concentradons are about one.
- tated to be based on fresh weight but designed to provide a compendium of fiftieth to one-eightfeth of the Preventive i
re in fact based on dry weight. Fresh sempilns techniques, methods, or PAG level (dertved peak mdk j
ight values (4 of dry weight values) resourcse. h Department of Energy concentration) for todine.131. cesium.
re identified in the final through its Interogency Radiological 134 and cesium 137 and about one third i
i EO 4
i -
~..
47000 Fedetal Regia.. t / Vel 47. Nr. 205 / Fridsy. October 1982 / Nstices 4
4 of the level for strontium 40 and UCRIAte3E Lawrence IJvenoore Pertinent background data and 4
strontium-30. For condemnation of milk.
taboratory Ouly is terrl.
Information on the recommendations are based on value at the farm, the cost.
1E !aternaumal Comeussion os on file in the Dockets Management similar fractions of the Emergency PAC. $*
- d'"'
equals-benent concentrations are y,,,
Branch. and copies are avedable from Publicados n, paea, Pusame Prew, that office faddress above).
levels (derived peak nulk Oxford (terel.
Based upon review of the comments concentration). If condemnation of milk 11.UI Deperament of Agnculture, received on the proposal of December i
la based on retail market value. the cost. "Hoveehold F ad Consumption Survey 1988-15.1978 (43 FR 58790), and FDA's further equals.benent concentratie is are 18eE" consideration of the need to provide greater by a factor of two. Thus,it
- 13. Wehaa H. N. and R. T. Anger.
4 guidance to State and local agencies for l
appears that protective actions at the 7'j*],*,$ D'*""**7 *"dy" use in emergency response planning in 3,
Prevendve or PAC levels
, hidc/serMedicina the event that an incident results in the Dhgus,h,53, radioacdve contaminadon of human will yield a not societal St.
t pg 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 regarding protective action planningfor greater than about one. third the derived 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 *ans==namaana
}
r acdone could be condaued to avoid 98 National Laboratory Guae 18r81 of Himaam Food and Anunal Feedet t
14, National Cooned on Radiaties e=====madadana for State and local percent of the pro!ected radiation does 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 (January 1s. t recornmendations are for use by i
g,g,,,,,,,
- 13. Internati Commission on appropriate State or local agencies in i
The following informados has been placed Radiological Protecdem. !Jaits for Istakes of response planning and the conduct of i
on display in the Dockets Management Redonuclidae by Workere. ICRP Publication Branch (HFA-3081. Food and Drug M Part 1. Annale of um ICRP. Pupon regation protection activities involving Ptuas (tsret, the production, procosmag, distribution.
Adminletredes. Jim. Ma. 3000 Flahere lane' 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 Myeise is Modstne end 3/etegF.18:10518e environment. The Food and Drug g,
P w am Candance for Federal Agencies." Federal (tek Admaistredon (FDA) raea==made that
% August 23.1984 (a FR 120eej aEd tr. Kersiaken. llG., P. A. Feiler. F. A.
this guidance be used on a case by-case 1
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 Guidanos for Federal Agencies.* Fedesel
- --, Syseposiusa April au 1970' event of a diversity of contaminating events. such as nuclear facility y[ggs N donal accidents, transportation accidents, arid
- 3. National Academy of Saences/ National National Research CeumoL "De Effects on fallout from nuclear devices.
i 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),
achieved are sufBcient to offset the Radiation (BEDt-iH1(1 seek in National Commed on Radselen
- 4. Uruted States Nuclear Regulatory Pmtwuon and MoeemmenteJNQtPL " Basic undesira.ble features of the protective i
Commisence. Reector Safety Study. WASH.
Radiation Protocean Cetterta. NCRP Report
,ggg,,,, Ilie Protective Action Guides 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 health. Further. as provided by Federal Radiological Proceense (ICRP),
Offeite Emergemey lastrussentados fe' 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 Publicasse a Ammale of the ICRP. Pergamon Phase 2. Monitortes sad Measurement of situation. and effective action with low i
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.
l the Effects of Atomic Radiauon.1977 Report.
Chiacchiennt. "Backsmund for Protective projected dose higher than the PAC may Uruled Nations. New York (1977).
Acnon Recorrunendet one Accidental be justifiable. (See 29 FR 22056: August S. E TIom. C. C. S. Coleher. D. I. Quinn and Radioective Contaminaden of Food and 22,1964,) A basic assumpdon in the
- 9. N y pson. " Transfer Coefficients for Ammal Feeda." Septetsber test. Department dev*lopment of protective action i
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
_ _ _. _ _ ~
3 m
Federal RegL
/ Vol. 47. N2. 205 / Friday. OctabIt 1982 / Notic:s 47031 C!rcumstances this invIlve repetitive 3
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 (such as airborne cloud and food
~ urposes it must be appropriately the Emergency PAC. higher imprct n
pathway) would require special queUfled. In these recommendstions it scdons are jusufled because of the consideredon. In such a esse, the total refers specifically to the term " dose 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
actions that might be taken to avoid the radiadon does equivalent received by any medium.
future does from one or more of these an exposed ladividual to the organ cited (10)" Rem"is a special unit of dose events may need to be considered. In over a lifetime from a single event.
equivalent.He dose quivalent in mas is nunwricaDy qual to the absorbed 4
any event, the numancal values selected (3) m qu 88a 8 88 that expresses all radiation on dose la ends muldplied by se quauty 1
for the PAG's are not intended to 'ctd factor, the distribution factor, and any aubrise delibersto mIesaw expe common scale for calculating to result in absorbed doses of these efective absorbed dose. It is defined as other necessary modifyms factors.
- N"d**'
he product of the absorbed dose in rede (11)"Responsa level"means the (3) A protecdve acdon is an action or and certain modifying factore. De unit acevity M a sydSc doucHde(0 initially deposited on pasture: or (ii) per 4
measure taken to avoid most of the of does equivalent is the mm.
unit weight or volume of food or animal radiadon dose that would occur fkom (4)" Projected dose commutment" 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/.
recommendations are intended for In b population group from the To permit flexibility of sedan for the implementation within hours or days contaminating event if no protective reduction of radiadon exposure to the d
action were taken, from the time sa emergency is public via the food pathway due to the j
reed ne ecuan recommended to (5)" Protective action
- means an occurrence of a cdniaminating event, the action taken to avoid most of the foDowing Preventive and Emergency be taken should be continued for a sufHeient time to avoid most of the exposure to radiation that would occur PAG's for an expond individualin the projected dose. Evaluation of when to froar. future lagesdon of foods population aan adopted:
contaminated with radioactive (1)Pieventive FAG which is (1)1J cease a protective action should be 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
=
the pastum/ cow /nnik/ person pathway, values to individuals in the general marrow, or any oder for which derived "meponse levels" are population that warrant protecdve
. (2) Kneig.cy PAG ch is (l)15 tem provided in parograph (d) of these action following a rolesse of radioactive projected dose commitment to the recommendations, it is expected that warranted if the expected individual commitment to the whole body, bone material Protective action would be thyroid, or (11) 5 rem projected dose l
actions would not need to extend beyond 1 or 2 months due to the does reduction is not offset by negative marrow, w any other organm i
social, economic, or health effects. De (d)/tes selevels equivalent to reduction of forege concentrations by PAG does not include the dose 4 hat has PAG Al ough se basic PAG weathering (14-day half. life assumed).
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 long-terra food pathway contaminadon protective actions having minimalIpect. response levels eqmvalent to the PAC's to prevent or reduce the radioactive fw mdionucUdes Cnurnt arm where adequate time after the incident contamination of human food or animal Mid(Ql'$[
"j" y
l la evetlable to evaluate the public health feeds.
consequences of food contaminadon (g)" Emergency PAG"is the projected M d*""
using current recommendadone and the dose commitment value at which guidance in Feders! Radiation Comned responsible oNidals should isolate food
,,s.%.no on % %%%
(FRC) Report No. 3. fuly teet and Report containing radioactivity to prevent its sai, pe,ses,,. %
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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.*
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e
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y
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=-
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
%l' quantities would be purchased forhome responseleve (microcune/ kilogram)
'*""laf or freesang. For moor foods and equtvalent to the PAG forother specific o.====.e a.a
=
=.
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'as members of the public. an effective foods, it is necessary to weigh the 8.".",",,,,',,,,",",*,',a======*
j* " days of intake" 30 days is probably a
contnbution of the individual food to the conservative.
1"'
total dietary intake: thus, (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.
Whers kaitatake(microcanal Airthe (ii) Assessment of the effective days (2)/todianuclidemanares.If a U
""d*
ofintake should consider the speciAc 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.
Isvel for the Preventive and Emergency the days oflatake of the contammated 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 calculated frasa dose comunitment i
- "*'***""*"d*"*"**
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 (b) Where the food product is being oonunitment to the bone marrow is m
'"."' harvested on a daily basis,it may be considered to be 0.3 of the bone does 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 en initial asessement,it may be ap marrow to does rete per unit activity in
- 7e '""'" "' *"" '
g ('o assume a 1kiay woethering t
. life a small tissue. filled cavity la bone and used for forage la pasture / cow / milk assumes that strontium-00 is distnbuted m.w.
one 7.,
g pathway) pending further evaluation. In only in the mineral bone (Spiers. F. W.
this case, the effective " days ofintake" et al.in "Blomedical Implications of aos 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.-
an effective half. life foriodine 131 of 5 strontium-se is the same because the as P_L.T.e.,'=ise,,""*
y* days and reduce the " days of Intake" to mean particle energies are sinular(0.56 v.
ao 7 days.
MeV (messelectronvolts)). Situstione Q,.L 3
(c)la the case of a food which is sold could anse in which an orgen other than l
p ws
- o..
i on in thentail market the effective " days those discussed in this paragraph could f
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~
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..~._-.,___-_____,.,______._____-m_
i r,
Federal Regl6
/ Vcl. 47. No. 205 / Frid:y Oct:ber 1982 / N: dees i
i 47083 be considered to be the orgas receiving December tort andInternational milk, butter, cheese. or evaporated mdk.
the highest does per unit intake,Ia the i
case of exposure via the food chain; AtomicEnergy Agency." Environmental i
depending on the radionuclide under Monitoring in Emergency Situations."
(iii) For fruits and vegetables:(el j
considereuon, the asstrointestinal tract ISOS. Analysia need not be !!aited to Washing, brushing, scrubbing, or peeling these4aethodologies bat should provide to remove surface contaminatiqp.
could be the p organ exposed.
3 comparable results. Acton should not (b) Preservation by canning, freemas.
ne references cat la peregraph (e)(3) be taken without vertilcation of the and dehydration or storage to pernut 4
of these recommendations contain does commitment factore for the following analyets. Such verification might laclude radioactive decay of short.uved i
I organs bone, kidneye. liver, overke.
the analysis of dupucate samples.
radionuclides.
syssen, whole body, and geseeintesdael laboratory measurements. sample (iv)For gralam (a Milling and(b) analysis by other agencies, sample
- poushing, i
tract.
(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.
of sa lacident having poteadal radioecove roleses.
j (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
' enWore. levels dcasima la sulk onstofr from he
' onset the undesirable health. -=i, I 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.
these recomunendadons that. not only j actions for meat as appropriate.
I 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 pasture, acdon should be on a case.by-State / local emergency plans which i equivalent response levels are reached.
case basis taking into consideradon the i
provide for coordination with nuclear i but also that acdons appropriate at the reladonship between the radionuclide fadllty operatore including prompt 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, i
sites for sample collection should be the social!mpact needs to be.takas.FDA lactattag cowe. the concentrados should retad market, the processing plant. and re--la that osos one or more not exceed that equivalent to the the farm. Sample cousction at the nulk protective actions are faitiated. the recommendations for pasture, processing plant may be more e5cient la
- action or sedons continue for e (2)EmerymmerMG Responsibfe deternimas the extent of the food sufBcient time to avoid moet of the ofHciels should Isolate food containing 4
projected dose. Dere is a longstanding radioecovtty to prevent its introduedoa l
pathway contamination.The geographic FDA poucy that the purposeful blandlag lat* """""*" ud detwain* *h*e
area where protective actions are 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,
)
sanospherte transport, measuransats by Drug, and Cosmode Act. De following the following factore should be i
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 PACS i
fadpetway.
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 of uncontanunated storedin queedon.
feed.
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 (iv) De relative conertbudos of other Harley. HASL 300 ERDA. Health and aHow radioactive decay of shorouved f
M oew red to b Safety Laborst
-Ratnd MethodNo. New York.NY.19F3:
radionucliden. This may be schieved by.
totalpmW t Esthme F!seios storage of Grosen emeh milk, trosen (v)De due and efon mquirmi to product Coocentredoes la
" U.S.
concentrated milk. or e,ses.
efeci cor-dn.cdon.
tyr ut of Health. Education, and coneantrated muk products.
%Is nodce is Isened under the Public i
Welfare.Pubuc Health Service 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 for Fleid Sampling ofIodine-t31la provided ultrahlgh tempersfure
- (42 U.S.C 241,2420. 2431) and under t
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.
\\
JRNL 48086 Nevsmber 1973: Dietenfeld.
ofMilk andFood Technology.
A'*** H'M H*1**' l
C and J. X!senish. Brookhaven National 31(12);382-Ger/ December 1980).
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
--