ML19308A548
| ML19308A548 | |
| Person / Time | |
|---|---|
| Site: | Crane  |
| Issue date: | 05/17/1979 |
| From: | Villforth J FOOD & DRUG ADMINISTRATION, PRESIDENT'S COMMISSION ON THE ACCIDENT AT THREE MILE |
| To: | |
| References | |
| TASK-TF, TASK-TMR NUDOCS 7910310298 | |
| Download: ML19308A548 (16) | |
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STATEMENT BY JOHN C. VILLFORTH i
DIRECTOR BUREAU OF RADIOLOGICAL HEALTH FOOD AND DRUG ADMINISTRATION AND HEW THREE MILE ISLAND INCIDENT COORDINATOR BEFORE HIE:
PRESIDENT'S COMMISSION ON THE ACCIDENT AT THREE MILE ISLAND O
MAY 17, 1979 S
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INTRODUCTION Mr. Chairman and Members of the Commission:
I am very pleased to have the opportunity to appear before you this morning to discuss the activities of the Food and Drug Administration in connection with the accident at the Three Mile Island nuclear power station.
By way of introduction, let me say that under normal circumstances I serve as Director of the FDA's Bureau of Radiological Health. In that capacity
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I oversee the administration of the Radiation Control for Health and Safety Act of 1968 (P.L.90-602). Under this Act, the Agency is charged with the responsibility of controlling unnecessary exposure from radiation-emitting electronic products, such as x-ray machines, microwave ovens, and lasers.
However, on April 1. Secretary Califano asked me to serve as coordinator of l
EEW activities relating to the Three Mile Island accident, and asked Mr.
Charles Cox, an Assistant to the Director in BRH, to serve as the EEW "on-l site" coordinator.
- I have been gratified by the cooperation and commitment which the various EEW agencies have demons *trated in helping to cope with this accident, each bringing to bear its own particular expertise.
1 It is from this perspective that I want to discuss with you the specific actions instituted in response to the incident that has occurred here.
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w FDA'S RADIOLOGICAL INCIDENT RESPONSIBILITIES In his testimony before this Commission several weeks ago, Under Secretary Champion outlined the various legal responsibilities governing the Depart-ment's role regarding radiological emergency response planning for fixed nuclear facilities. I would like to spend a few minutes re-stating and briefly elaborating on each of these, and then concentrate on a discussion of specific FDA activities.
The role of the Department of Health, Education, and Welfare in the control of radioactive contamination of food and in other emergency actions was formalized in an interagency agreement issued by the Federal Preparedness Agency (now part of the Federal Emergency Management Agency) in December of 1975 (Federal Register, Vol.
- 0, No. 248, pp. 59494-59495). This overall plan, drafted collaboratively by GSA, HEW, NRC, EPA, the former ERDA (now DOE) and otheas, identified the respective functions of those Federal agencies associated with radiological emergencies. The agreement charged HEW with:
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Assisting State health d,epartments, State hospital associations, and other professional organi=ations and ambulance services in the development of plans for the prevention of adverse effects from exposure to radiation, including the use of prophylactic drugs to reduce radiation dose to specific organs. This includes health and medical es**e responses to radiological incidents, consistent with guidelines issued by NRC.
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Issuance of guidance on appropriate planning actions necessary for evaluating and preventing radioactive contamination of foods and animal feeds, and the control and use of such products should they become contaminated.
3 Issuance of guidance on emergency radiation doses related to the health and safety of ambulance services, hospital, and other health care personnel, in cooperation with EPA.
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Establishing and issuing guidelines for radiation detection and measurement systems for use by ambulance services and hospital emergency departments, in cooperation with NRC."
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Formal responsibility under the terms of this agreement for emergency nuclear incident planning was delegated by the Department to the Food and Drug Administration in a November 1976 memorandum, and within FDA, specifically to the Bureau of Radiological Health. Certain aspects of these responsibilities are part of the regular activities of the Department and FDA. For example, the Department's planning and organizing of systems for emergency medical services, or.the FDA's traditional role in insuring the safety of food, derived from authority contained in the Food, Drug, and Cosmet'ic Act, required only redirection or expansion of ongoing activities to function under emergency conditions.
In addition to the Food, Drug and Cosmetic Act, the Public Health Service Act, as amended, authorizes the Surgeon General to assist the States 4
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through the assignment of personnel and the rendering of assistance in the conduct of prevention of disease.
t$ith the foregoing information as a backdrop, let me now focus on the Three Mile Island accident and on the tasks delegated by Secretary Califano to
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Specifically, he 'irected the Agency
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FDA in his memorandum of March 31.
d to:
. :nn-o Conduct and process an adequr.ca number of food and water inspections E
and communicate the results to the NRC Consnand Center as rapidly as I_.
possible; o Arrange for a sufficient supply of potassium iodide for emergency use by residents within a ten mile radius of the plant; o Provide for FDA coverage at the NRC Command Center to facilitate the exchange of environmental and food and water monitoring data; and, o Finally, the Secretary asked that daily reports on all FDA activities be submitted to his office fpr relay to appropriate government personnel.
FDA ACTIONS
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FDA activities relating to the Three Mile Island incident fall into four
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major categories:
(1) monitoring of milk, food, and certain environmental t
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samples for levels of radiation; (2) establishment of radiation standards that can help determine when to initiate protective actions; (3) protective actions to minimize radiation exposure; and (4) training of emergency medical personnel.
o Monitoring Milk, Food, Water, and Animal Feeds: As part of its normal duties, the FDA monitors radioactivity in selected samples of foods and focdstuffs through the collection and anlysis of composite samples obtained within a ten-mile radius feca eight nuclear power plants in the United States. This ongoing sampling program -- which did not include the Three Mile Island site - was expanded during the accident to include that area. It began the day after announcement of the
- accident, i.e., March 29 By May 11, FDA had analyzed 1,666 samples for iodine-131 (I-131), and cesium-137 (Cs-137), and other gamma-emitting radionuclides. The samples collected included food, milk, fish, water, and animal thyroids. *hese samples were collected within a 20-mile radius of the Three Mile Island nuclear power plant. The samples were collected by FDA/EDRO Region III inspectors and sent to the Agency's Winchester Engineering and Analytical Center (WEAC) for analysis.
Forty-nine of the 1,066 milk samples analyzed through May 11 (primarily collected from seventeen sites) showed trace amounts of iodine-131. The levels ranged from 13 to 36 picoeuries per liter (pCi/1) with a minimum level of detection of about 10 pCi/1. Note B
that the maximum concentration measured was 300 times lower than the level of concentration at which FDA would recommend that cows be removed from contaminated pastures (i.e.,12,000 pCi/1). I should note that iodine-131 levels in the range of 300-400 pCi/1 of milk have been reported in milk previously, due to fallout from Chinese atomic tests.
l The dose to the thyroid of an infant drinking one liter of milk daily (during this period) which had a peak concentration of 36 pCi/1 would be five millirem over the lifetime of the individual. Estimates of the probability of developing radiation-induced thyroid cancer is about one in ten thousand for one rem dose to the thyroid gland.
Hence, the thyroid dose of 5 millires, assuming no further releases of radiciodine, is associated with a probability of developing thrycid cancer of one in two million. Note that this is a worst case situation, and assumes an infant drinking a liter of milk daily over the entire time period from the farm with the highest radiciodine concentration Cesium-137 was also detected 1.,14 of the milk samples. Levels,
ranged from 11 to 36 pCi/1 with only four samples above the level of 26 pCi/1. Cesium-137 can be eted to be present in milk, especially in the spring, when residual radioactivity from weapons testing enters the lower atmosphere. Cesium-137 in the milk around Three Mile Island is attributed to this source because of its detection in milk samples at points distant from the accident site.
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With respect to food, the Agency as of May 11, had analyzed 450 samples for evidence of I-131 and cs-137, and other gamma-emitting radioisotopes. These samples were obtained primarily from food processing plant sites within a twenty-mile radius of the plant. The products samples consisted primarily of candy, bread, cheese, pastries, and ice cream. None of the samples collected revealed any detectable amounts of radioactivity.
FDA also surveyed water sources and stored animal feed supplies in the vicinity of the facility. Of the 135 fresh, river, and tap water samples and the thirteen feed samples, none showed concentrations of radioactivity above minimum detectable limits.
External Desimetry: Since there was ccacern over potential exposure of the population near the reactor to external as well as internal radiation, FDA contributed to the effort to measure external radiatica doses by placing 237 dosimeter packages at 173 sites within a twenty-mile radius around the esactor. FDA had a large supply of these thermoluminescent dosimeters (TLD's) available as a result,of our program to assist the States in monitoring medical and dental x-ray machines. A quantity of these were diverted from the x-ray programs and modified for use in Pennsylvania. These particular dosimeters, which use lithium fluoride, are not as sensitive to very low-level radiation as the calcina sulfate dosimeters used by Metropolitan Edison and NRC; they were deployed as a precautionary 8
measure, to provide exposure data in the event that external radiation levels were to become high.
When possible, two dosimeter packages were placed at a site, one inside and one outside the building.
In choosing sites, preference was given to public buildings in order to facilitate retrieval, but
.some private residences were also used. Do.mimeters were exchanged by April 18.
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Exposures slightly above limits of detectabilit.y were found at nineteen of the 173 sites. However, given the lack of precision at low doses for these dosimeters, and lack of knowledge of natural background radiation levels around the site, no significance can be attached to this finding. Nonetheless, our external dosimetry monitoring will continue during the cleanup period in the event that high external exposures occur or until such time as they are supplemented by more sensitive dosimeters from other agencies.
Survey of Photographie Film:, In order to provide an independent, check on th? various dosimeter programs which measured the accumulated external dose to the population, FDA decided to investigate the possible fogging of commercially available photographic film in the area which might have been due to external radiation. We consulted with the Eastman Kodak Company, which offered to develop the film under controlled conditions and perform
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the fog measurement. Samples of Kodacolor-400 film (the most sensitive type for x-ray exposure) were obtained from the only retailers in the area who had it in stock at the time of the accident. These stores were located in Middleton, Elizabethtown, New Cumberland, Steelton and Manchester. Under laboratory conditions,
.==.= = i Kodacolor ';00 film is sensitive to several millirem.
(One confounding variable in this tethod is that factors other than
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radiation, e.g., heat, can also produce similar fogging of the film.)
The analysis showed three rol s of film from a store near Middleton
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with a fog reading equivalent to slightly less than ten millirem. On one of these, the fog pattern on the roll suggests that the cause was yr
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radiation. These exposure levels, if they were radiation induced, are compatible with the external exposure estimates obtained from the
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dosimeter program. More detailed studies of commercially available film are presently being conducted, but the absence of any significant fog at the other four locations suggests that they were not exposed to levels much above natural background.
o Protective Action Guides (PAG's)
For a monitoring program to be useful, guidance must be available which relates the amount of radioactivity or radiation exposure to specific public health actions. In this case, this guidance takes the form of proposed recommendations for " Accidental Radioactive
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Contamination of Human Foods and Animm1 Feeds In A Radiation Emergency" (43 FR 58790) published in December 1978 by EEW, prior to
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O the accident.
The proposed PAG's provide guidelines for action to be taken in the 1
event of a radiological incident resulting in the contamination of l
human food or animal feeds. This guidance is for general use by State and local agencies responsible for constructing response plans
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in the event cf a radiological incident, and is applicable to the l
uncontrolled releases of radioactivity which occurred at Three Mile
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Island. The proposal establishes a set of guidelines that can be used to determine whether levels of radiation encountered in food j
after a radiological incident warrant protective action and suggests l
appropriate actions that may be taken if action is warranted.
The point at which action is taken to prevent further introduction of radiciodine into milk is an an:icipated concentration of iodine-131 which could give a lifetime dose of 1 5 rem to an infant's thyroid.
T!.is level need not be reached, merely anticipated in order to take action. It is equivalent to a peak concentration of 12,000
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picocuries of iodine-131 per liter of milk. The iodine-131 levels
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reported to date for the Three Mile Island accident, were one three-thousandth of the preventive. action levels.
i o Protective Action In the event that it might have been needed, potassium iodide was made available by FDA for use as a thyroid blocking agent, i.e.,
to prevent the uptake of radiciodine by the thyroid gland. As delineated in the December 1975 Federsl Register announcement that I 11 l
alluded to earlier in my testimony, HEW is responsible for assisting State health agencies in developing " plans for preventing adverse effects from exposure to radiation, including prophylactic drugs..."
Potassium iodide is neraally not available in large quantities in a form suitable for mass use as a blocking agent. Thus, on December 15, 1978, FDA asked manufacturers to submit New Drug Applications (NDA's) to manufacture potassium iodide as a thyroid blocking agent for radiatic.7 emergencies.
At the time of the accident there was still no readily available large supply of potassium iodide in a form suitable for use as a thyroid blocking agent. On an emergency basis, FDA's Bureau of Drugs was able to obtain several shipments of a saturated solution of potassium iodide packaged in four-ounce dropper bottles, each with a sufficient quantity to accommodate the needs of a family of four for the duration of the incident. By April 4, there were 237,013 bottles of potassium iodide, enough for at least ene million persons, in the custody of the State Health Department in Harrisburg. The material Will be left there for as long as radiciodine remains a potential problem, but after that, FDA. plans to retrieve it and store it at FDA headquarters as a national emergency stockpile.
o Emergency Monitoring Procedures In accordance with our responsibility to provide guidance to State and local medical care teams en handling radiation emergencies, we prepared an instructional leaflet giving guidance on monitoriing and 12 I
decontaminating personnel and vehicles, estimating emergency protective action guides, and measuring radiciodine in milk. On April 2, 300 copies were provided to the State.
Shortly after the accident, we trained approximately 30 medical and allied health staff members at the Public Health Service Hospital in Baltimore (the PHS facility closest to the accident) in emergency radiation procedures, in the event they might have to be deployed to the Harrisburg ares.
o Interagency Coooeration Cooperation between HEW, EPA, and NRC was developed immediately after, the accident at an Incident Center established at NRC headquarters.
This permitted a free exchange of information among the three agencies.
This intra-agency cooperation is best exemplified by the joint effort to assess the population dose and health effects to residents within 50 miles of the Three Mile Island Nuclear Station. A report has been prepared by an Ad Hoc Population Dose Assessment Group, comprised of technical staff representatives from HEW, NRC, and EPA which provides
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an assessment of the health impact on the approximately 2 million offsite residents within 50 miles of the Three Mile Island Nuclear
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Station, from the dose received by the entire population. The Ad Hoc Group has examined in detail the available data for the period up to and including April 7,1979 Based on a preliminary l
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review of data from periods beyond April 7, it appears that the collective dose will not be significantly increased by extending the period past April 7 On April 13, 1979, the White House assigned to EPA the lead agency responsibility for coordinating the collection and documentation of
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the environmental radiation data obtained by all of the Federal agencies involved. The EPA requested that data collected through April 15 be forwarded to it by May 7,1979 The FDA complied with
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EPA's request by forwarding sample analysis data on focd, milk, external dosimetry, and bioassay. In addition, information from FDA milk and food monitoring has been placed in the computer and the results shared with the State, EPA laboratories, and FDA field stations. This provides a rapid link between the various agencies interested in the results.
COMMrlMENT OF HEW /FDA RESOURCES I want to briefly highlight the level of resources that have been required to sustain our activities, both at headquarters and in the field. As of May 11, the FDA had expended approximately 14.5 persons-years of the total HEW investment of 15 5 person-years. Of the 1415 person-years assumed by FDA, 10.5 were in support of field operations at the site, i.e., sampling and laboratory analysis. The reamining 4.0 person-years served to support O command post at Bureau headquarters, coordination of intra-Agency i
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responsibilites, and to provide round-the-clock respresentation at the hRC's command center in Bethesda.
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Considerable costs have also been incurred by the Agency. As of May 11, FDA had allocated about $720,000, approximately $400,000 of which was spend to obtain a sufficient supply of potassium iodide for the Three Mile Island l
resident population should circumstances have warranted its distribution.
FDA'S FUTURE RESPONSIBILITIES In conclusion, Mr. Chairman, I think it important to stress that FDA and its sister agencies in the Department will continue to maintain a vigilant eye over the Three Mile Island area throughout the aftermath period. This is sspecially important during the cleanup operation when the potential exists for further radiation release.
For example, our food surveillance plan has been r.odified to account for the long-term cooling status of the plant and the protracted cleanup phase.
r Such alterations are necessary now and in the coming weeks and months to reflect the changes in the radionuelides, released to the environment and on-site due to decay. It is expected that iodine-131 in milk will continue to be the principal food contaminant of concern for the next 60 to 90 days and possibly until the cows are taken off pasture in t M fall. In light of this and in keeping with our authority over food in interstate commerce, FDA will continue to monitor market milk. Although our samples of this milk will largely be obtained from processing plants, we do intend to 15 l
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provide coverage of essentially all milk produced within seven miles of the i
Three Mile Island facility.
Insofar as food is concerned, we have initiated a sampling program for locally grown fresh produce to provide early indications of contamination.
W3 have suspended the collection and analysis of all processed foods; nevertheless, we stand ready to reinstitute this activity should it become warranted.
These ongoing efforts are being conducted in accordance with the terms of the April 13 directive from the Executive Office of the President. They cre of critical igortance in assuring that the health and welfare of the essidents and workces in the vicinity of the plant are being adequately safeguarded. We are committed to doing whatever else may be required to cchieve that end.
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This completes my formal statement, Mr. Chairman. I would like to note that a document sunnarizing the chronology of the FDA's involvement in the Three Mile Island incident is appended to my testimony which I believe may be htlpful to you. I would be pleased to respond to any questions you or,the Members of the Commission may have.
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