Document VKLQ7jM83Xp3mV272b893dDRp

HCHRV L. DIAMOND filCHARO M. fAtRBANKS, HI ALBERT J. BCVERIDGE.m GARY M. BAI SE A.JAMES BARNES HAROLD HIMMELMAN CHRISTOPHER H. BUCKLEY, JR. KEVIN M. FOLCY JONATHAN l CANNON ANDREW E- MISHKIN CHARLES A.PATRrZlA SCOTT W. BOWEN LAW OFFICES Beveridge, Fairbanks &. Diamond One Farragut Square South Washington, D. C. aooQ6 TELEPHONE (20 2) 636-7000 16 December 1977 CARL CAROLE OF COUNSEL CABLE AODRC3S "iNOLAV." Joseph E. Hadley, Jr., Esquire Keller & Heckman Suite 1000 1150 17 Street N.W. Washington, D.C. 20036 Dear Joe: This letter will update you regarding EPA's plans regarding the cancer policy review suggested by the Administrator of EPA in his meeting with the representatives of SPI. The Environmental Defense Fund filed a petition on November 7, 1977 requesting that EPA promulgate a new cancer policy and regula tions. This petition and the Amendments to the National Emission Standard for Vinyl Chloride have caused the staff at EPA to develop a schedule to review EPA's present cancer policy. EDF's counsel will be meeting with EPA staff in Research Triangle Park some time during December or the first part of January. After this meeting a determination will be made as to whether EDF will meet with the Administrator of EPA as requested in the November 7th petition. Within a couple of weeks after the meetings, EPA will seek public comments regarding what EPA's cancer policy should be. We are advised that EPA will not be publishing EDF's proposal. This information comes from attorneys in the EPA General Counsel's office. The Federal Register notice will call for public comment and set a public hearing date. EPA expects substantial comment because of the present OSHA action. If Mr. Costle does not issue a final decision regarding the Vinyl Chloride Amendments until a final decision is made regarding an EPA cancer policy, the PVC Safety Group could be facing a substan tial delay. This delay, and this is rank speculation, could take up most of next year. We have spoken to a number of individuals in EPA and most of them believe this process could take the Agency through July or later before a decision is final from Mr. Costle. If you have any questions, please advise GHRibdb see L 5-1630 November 9, 1977 ' Page 23 PESTICIDE & TOXIC CHEMICAL NEWS of the permits provided for an evaluation of the product on rice to repell various blac bird species feeding on heading rice. The permit allowed use of 4,406 pounds of the product and it expires Jan. 1, 1979. The other Mobay permit calls for use of 1,350 pounds of the bLrd repellent on blueberries to evaluate control of the blueberry maggot, blueberry case bettle and blueberry flea beetle and to repell various depredating bird species attacking ripening blueberries. The permit expires Sept. 12, 1978. The third Section 5 permit was issued to Uniroyal Chemical and allows the use of 171 pounds of the herbicide 2,3-dihydro-5,6-dimethyl-l, 4-dithiin 1,1,4,4-tetraoxlde on cotton and potatoes to evaluate its use as a defoliant and desiccant. The permit is effective until Sept. 29, 1978. The three DBCP documents relating to suspension, conditional suspension and cancellation of DBCP uses were published in the Nov. 3 Federal Register. A notice on the status of the rebuttable presumption against registration on three nitrosamine-contalning pesticides--Treflan, Trysben, and Benzac--appeared in the Nov. 2 Federal Register (See Oct. 19, Page 17). O EDF AIR CARCINOGENS PETITION SEEKS EPA POLICY SIMILAR TO OSHA PROPOSAL The Environmental Defense Fund (EDF) this week petitioned the Environmental Protection Agency to begin a rulemaking proceeding to establish a policy which would expedite control of airborne carcinogens. The policy was supposed to be part of EDF's petition asking EPA to control air emissions of benzene (See March 16 , Page 4). The proposal, modeled after one published for comment by the Occupational Safety and Health Administration (OSHA), would have EPA categorize substances as "confirmed," "probable," or "possible" carcinogens. Like the OSHA proposal (See Oct. 5, Page 11), placement of a substance into a certain category could be rebutted, issues open for discussion in such an administrative action would be limited, and if the rebuttal were unsuccessful, certain regulatory actions automatically would be triggered. In the case of a successful EPA classification of a substance as a "confirmed" carcinogen, EPA would be required to list the substance as a hazardous air pollutant under Section 112 of the Clean Air Act, the EDF proposal says. One hundred and eighty days after the listing, EPA would have to propose regulations which would either prohibit emissions of the substance or prescribe "best available control technology" (BAT). SCC 5-1631 ' As provided In the OSHA proposal, the EDF scheme would allow prohibitions oi emissions if there were substitutes for the substance or for whatever caused the emissions, [f BAT were prescribed, the EDF proposal says, a schedule would have to be worked out "which would ultimately eliminate emissions." This is the intent of EDF's action In the vinyl chloride case {.See Sept. 14, Page 2). Page 24 November 9 , 1977 PESTICIDE & TOXIC CHEMICAL NEWS If a substance were classified as either a "probable"or "possible'1 carcinogen, and the classification could not be rebutted, EPA would have to order additional tests under Section 4 of the Toxic Substances Control Act (TSCA) or pay for the tests itself, the EDF proposal says. The proposed policy would have EPA prescribe standards for any tests which it ordered, did itself or had done. After the tests were completed, EPA would reclassify the substance. The EDF proposal says that studies aimed at changing "possible" carcinogens to "probable" carcinogens must be completed within one year of classification of a substance as a Category III or "possible" carcinogen. Studies aimed at classifying "possible" carcinogens as "confirmed" ones would have to be completed within three years, the EDF proposal says. EDF Trigger for "Confirmed" Carcinogens is More Sensitive Than QSHAls According to the EDF proposal, a substance should be classified as a'Category I or "confirmed" carcinogen if it or one of its degradation products: "(P)roduces or induces a statistically significant increase in benign or malignant neoplasms, tumors, or a combination thereof, or causes a statistically significant decrease in the latency period between exposure and onset of benign or malignant neoplasms, tumors, or some combination of the two in (i) humans; (ii) a single experiment on one or more mammalian test species, if the results are reproducible." The classification could also be made "if the Administrator finds other evidence to be sufficiently probative of carcinogenicity," the proposal says. The EDF proposal differs from OSHA's in that OSHA's proposal says a positive result m a single test on one mammalian species is sufficient evidence if the results "have been replicated" in an Independent, separate study using the same species. EDF says only that the positive results must be "reproducible." Also, OSHA's proposal does not mention a decreased latency period as a trigger. A substance would be a "probable" carcinogen, the EDF proposal says, if it or one of its degradation products: "(1) produces or induces a suggestive Increase in benign or malignant neoplasms, tumors, or a combination thereof; or causes a suggestive decrease in the latency period between exposure and onset of benign or malignant tumors, neoplasms, or some combination of the two in humans or a single experiment > on one or more mammalian test species; or "(2) produces a positive result in one or more short term tests, including tests for: (i) mutagenicity in Salmonella typhimurium; (ii) in vitro mammalian ceil transformation; or (iil) any other short term test or tests designated by the Administrator; or see 5-1632 C November 9, 1977 Page 25 PESTICIDE & TOXIC CHEMICAL NEWS "(3) is determined by the Administrator to be a Probable Carcinogenic Substance on the basis of evidence which he finds sufficiently probative." OSHA's Justification for a Category II substance would be a positive result "in an unreplicated experiment in a single mammalian species" or other evidence "sufficient" to justify such a classification. A substance would be a Category III or "possible" carcinogen, the EDF proposal says, if it or one of its degradation products: "(1) belongs to a class of compounds that regularly displays carcinogenic activity, including (i) polycyclic aromatic hydrocarbons, (ii) chlorinated hydrocarbons, (iii) nltrosamines, (iv) aromatic amines, (v) any other class designated by the Administrator; "(2) contains an active chemical moeity that regularly displays carcinogenic activity; "(3) produces a positive result in any short term test or test designated by the Administrator; "(4) is determined by the Administrator to be a Possible Carcinogenic Substance on the basis of any evidence he finds probative." Among other differences, OSHA's proposal would not attempt to rely on structural similarities among compounds for purposes of classification. F.DF Wants NCI Opinion on Whether Positive Results are Meaningful According to the EDF proposal, a classification of a substance as either Category I or II could be rebutted if both the EPA Administrator and the Director of the National Cancer Institute (NCI) conclude that a positive result! "(1) was caused by physical induction, in that the appearance of the neoplastic effect occurred only at the site of administration, or "(2) was obtained by use of a method of exposure wholly unrelated to circumstances of expected human exposure, or "(3) is, in some demonstrable way, scientifically inadequate as proof of carcinogenicity. Such determination will be published in the Federal Register." This is similar to OSHA's proposal. see Issues to be addressed at the hearing on a substance's classification, the EDF proposal says, would be limited to: Page 26 November 9, 1977 PESTICIDE & TOXIC CHEMICAL NEWS "(a) whether the substance has been correctly classified according to the evidentiary requisites for the relevant category; "(b) the scientific adequacy of evidence upon which the Administrator is basing the classification decision; "(c) the availability, safety, and technological and economic feasibility of employing substitutes for the material or process which causes a Category I Confirmed Carcinogenic substance to be emitted into the atmosphere; "(d) the lowest level of emissions that can now be reached, using best available technology, for substances listed as Category I Confirmed Carcinogenic Substances; "(e) the lowest level of emissions that can be reached in the future using foreseeable technology for substances determined to be Category I Confirmed Carcinogenic Substances." According to EDF attorney Robert Rauch, EPA "has failed to move against even a small fraction of the chemicals which may pose a cancer risk to humans. In its seven-year history, EPA has issued regulations for only four hazardous pollutants under 112 of the Clean Air Act and has Just recently listed a fifth (benzene). The Mitre Corporation, on the other hand, has identified 600 organic air pollutants which may pose a threat to human health. Over 100 of them are suspected of causing cancer. Unless drastic changes are made, the Agency will never even get close to solving the problem." ETHYLENE DICHLORIDE APPEARS TO BE POSITIVE IN CANCER INSTITUTE BIOASSAY Ethylene dichloride (EDC), one of the twenty highest volume chemicals in the U .S, , is a carcinogen, according to preliminary results from a National Cancer Institute (NCI) bioassay. According to the National Occupational Hazard Survey conducted by the National Institute for Occupational Safety and Health (NIOSH), about two mLllion U .S. workers are exposed to EDC full or part-time, and "98.2% of the exposure are not controlled." NIOSH sources say that of the 7 .9 million pounds of EDC produced in the U .S. In 1975, 75% were used to produce vinyl chloride. Also, a March 1976 NIOSH criteria document on EDC, which did not list cancer as an effect, said at least 29 U .S. firms use EDC as an ingredient in at least 45 fumigant-insecticide products. According to NIOSH, 36 U.S. firms put EDC into mixes with ethylene dibromlde (EDB), and the combination is used as an "anti-knock" mixture for leaded gasoline. EDC also is used to formulate degreaser compounds and certain rubber cements, NIOSH sa id . November 9, 1977 Page 27 PESTICIDE & TOXIC CHEMICAL NCV-T The 78-week NCI test, conducted by Hazleton Laboratories America, Inc., was a gastric intubation test Involving rats and mice. According to an Experimental Design Group Status Report dated Nov. 8, 50 male rats exposed dally to an average of 50-75 milligrams EDC per kilogram of body weight, 20 developed malignant tumor Six of the animals had hemangiosarcomas of the spleen and three had squamous cell carcinomas of the stomach. Of 50 male rats exposed daily to 100-150 mg/kg, again, 20 developed tumors, nine of which were hemangiosarcomas of unnamed internal organs. In a group of 20 male control rats receiving corn oil by gastric intubation rather than EDC, only four were tumor-bearing, the report said, while among 20 male rats which were not treated at all, six had tumors. Female rats receiving the higher dose appeared to exhibit a statistically significant excess of adenocarcinomas of the mammary glands. According to the report, male mice in the test appeared to have a statistically significant excess of carcinomas of the liver, while female mice appeared to have excesses of mammary gland and stomach tumors. The Environmental Protection Agency, which recently got word of the preliminary NCI results, now is doing a hazard assessment on the chemical and is trying to determine if adequate monitoring data are available. An EPA official said that in terms of stomach tumors, EDC did not look to be as potent a carcinogen as EDB (See Oct. 26, Page 14). The time-to-tumor ratio for EDB was shorter than EDCs, he said, and EDB produced more stomach cancers than did EDC. % He also said that EPA's regulatory response must take into account that NCI's test used gastric intubation, while exposures to the general environmenta probably involve inhalation. The NCI test on EDC has not yet been forwarded to NCI's Clearinghouse for review. Another name for EDC is 1,2-dichloroethan; CAS number is 107062. sec 5- j-635 PEST IC IDE - NITROSA MIN E CHEMISTRY DATA FILING DATE TO BE EXTENDED BY EPA Apparently responding to numerous comments from industry asserting that the original 90 day filing time requirement for pesticide-nitrosamine analytical chemistry data was too short, the Environmental Protection Agency (See Oct. 26, Page 2) has decided to provide two compliance options: (1) submission of the analyses data within a total of 180 days of Sept. 29, the date the requirement was published in the Federal Register or (2) within the 180 days filing a plan, including an intended date for getting the analyses data to EPA. The EPA decision will alleviate one of the main worries expressed by industry representatives commenting on the requirements but they have also pointed to HENRY l. diamond RICHARD M. FAIRBANKS, HZ ALBERT J. SEVERIDGE,ni CART H.BAISE A.JAMES BARNES KAROLO HIMMELMAN CHRISTOPHER H. BUCKLEY, JR. KEVIN M- FOLEY JONATHAN Z.CANNON ANDREW E-MISHKIN CHARLES A- PATRlZIA SCOTT W. BOWEN LAW OFFICES Beveridge:, Fairbanks & Diamond One Farragut Square South Washington, D. C. 20006 TELEPHONE (202) 633- 7SOO CARL EAROLEY OF COUNSEL CABLE ADDRESS *INOLAw" 15 December 1977 Joseph E. Hadley, Jr., Esquire Keller & Heckman Suite 1000 1150 17 Street N.W. Washington, D.C. 20036 Dear Joe: Enclosed is a proposed radiation notice from the Federal Register dated November 30, 1977. Please note the risk analysis discussion on page 60957. Once again the Administrator is saying that a single risk must be viewed from the overall perspective of the costs and benefits. The Agency is continuing to adopt the approach set forth in the Vinyl Chloride Standard. If you have any questions, please advise. Cordially, Enclosure GHB:bdb see 5-1636 60956 NOTICES .ihc loss of the frult-bearlng area, the 4. Application will be made with quired to estimate dose i.itrs to per losses are not confined to one year. ground sprays ond only by' State-li sons from measured air and/or soil Loss due to fire blight is compounded censed commercial or certified private concentration levels. Based on avail by the loss of large sections of an es-. ; applicators. Applicators must (tear able environmental measurements, ;; tablished tree; In some cases, whole protective clothing and respirators; nearly all the land outside the bound f trees might be lost. Once fire blight 6. Workers may not enter orchards aries of existing contaminated sites (s ' has gotten out of the control of the . treated with terramycih until foliage . below the levels specified in the guid ' grower, several yearn are involved to is dry; ance and little or no remedial actions bring the pear orchard back Into pro 6. Applications must not be made would probably be required to achieve duction. Post-harvest sprays can be an near highly populated areas; hospitals, compliance. Important phase of fire blight control, since the bacterium overwinters on the host in cankers and attacks the blos soms in the spring. , Under epidemic conditions, 10 to 15% of the bearing surface of an or chard may be lost. Depending on the normal yield of the orchard, this could ' result in a loss ranging from V4 to 3 7. tons of pears per acre. Approximately "'Vc 6,000 to 9,000 acres of pears are .ex-' j. pected to have economic loss due to fire blight during the 1977 season. The . '7 Applicant estimated that, based on an ' average loss of one ton per acre, this represents a monetary loss of up to ' ' $900,000 (current price approximately ,, $100/ton to the grower). Failure to - - control the disease will extend this * loss to subsequent years. To this can ; be added the cost of bringing an or- chard back to normal production by . replacing dead or dying trees and cut- and areas where food or water may be contaminated; 7. A residue level of oxytetracycllne In or on pears not exceeding 0.1 ppm has been deemed adequate to protect the public health. The Food and Drug Administration, U.S, Department of Health, Education, and Welfare, has been advised of this action; 8. The EPA shall be immediately In formed of any adverse effects resulting from the use of terramycin In con nection with this exemption; and 9. The Applicant is responsible for ensuring that all provisions of this ex emption are followed, and that records ' are kept of the amount of terramycin sold to growers for the purpose of fire blight control. A final report must be submitted by October 31, 1978, which . summarizes the results of this control . program and the acreage treated. DATES: Comments must be received on or before February 2a. 1977, and should be addressed to: Director, Cri teria and Standards Division. Office of Radiation Programs AW-460/CM-2. U.S- Environmental Protection Agency, Washington. D.C. 20460. The Agency will schedule a public hearing if warranted on the basis of comments received. All written comments filed pursuant to this Notice will be available for in spection and copying in the EPA Public Information Reference Unit. Room 2922, 401 M Street SW.. Wash ington, D.C. during normal business hou^rs. TECHNICAL DESCRIPTION: A tech nical summary document explaining the proposed guidance has been pre pared by the Office of Radiation Pro grams. Single copies of this document *' ' ting out infected wood. (Section IS of the Federal Insecticide, Fun may be obtained on request from the After reviewing the application and ^ ther available Information. EPA has >I,i 7't' f determined that (a) a pest outbreak of fire blight on pears has occurred; <b> i I: ' there Is no pesticide presently regis... tered and available for use to. control 7- r fire blight In Washington State; <c) ' I . there are no alternative means of con- ,V:. trol, taking Into account the efficacy and hazard; (d) significant economic ` problems may result Jf the fire blight J':.. is not controlled; and (e) the time available for action to mitigate the problems posed is Insufficient for a gicide. and Rodentlclde Act (FIFRA). as amended <86 Stat: 973; 89 SUU 751: 7 U.S.C.-^ 136(a) elscq.U Director, Criteria and Standards Divi sion at the above address, or from any EPA Regional Office. Dated; 22 November. 1977. 1'7 , FOR FURTHER INFORMATION Edwin L. Johnson, Deputy Assistant Administrator /or Pesticide Programs, (FR Doc. 77-34277 Filed 11-29-77; 8:45 ami CONTACT: Dr. Gordon Burley. Chief. Environ mental Standards Branch, Criteria and Standards Division. Office of Radiation Programs (AW-460/CM- (6560-01] CFRL 808-51 ;.;y 2), U.S. Environmental Protection Agency, Washington, D.C. 20460. Telephone Number 703-557-8610. r pesticide to be registered for this use. PERSONS EXPOSED T04RANSURANIUM V SUPPLEMENTARY INFORMATION: ,;4.Accordingly, the Applicant has been 7 granted a specific exemption to use . i -ri i- the pesticide noted above until Octo* . i ber 31. 1977. to the extent and in the manner set forth In the application. ]- '7 The specific exemption Is also subject 7; to the following conditions; 1. The Myco Shield Brand of Pfizer `v>-7 Agricultural Terramycln. containing 7^'" the calcium complex of oxytetracy- ELEMENTS IN T% HE ENVIRONMENT Statutory Authority.--Authorities of Federal Radiation Prelection Ooldence on 0oe,' the former Federal Radiation Council., Limit* `f ' 7 which was established under Execu AGENCY: Environmental. Protection* Agency. ' tive Order 10831 and Public Law 86- 373, were transferred to the Environ mental Protection Agency by Reorga ACTION: Proposed Federal radiation nization Plan No. 3 of 1970. It is the protection guidance. Administrator's statutory responsibil SUMMARY: This proposed guidance ity (4?. U.S.<~L_2Q2Ih)_to: h- cline. Is authorized at a dosage rate of is addressed to Federal agencies and . advise the President with respect to _ 50 to 100 gallons of a 200 ppm spray would contain recommendations In radiation matters, directly or indirectly af i: solution. Up to 27,000 pounds of prod- uct may be used; . l -*r 2. Up to 9.000 acres of pears in coun ties east of the crest of the Cascade ,7 Mountains may be treated. Treatment . Is authorized only after Washington TV,-' State pathologists determine that streptomycin resistant strains of Er~ tended to assure protection of the public health by limiting the radiation doses persons may receive from tran suranium elements present In the en vironment as a result of existing or possible future unplanned contamina tion. The guidance considers both the In fecting health. Including guidance for all Federal agencies In the formulation of radi ation standards In the establishment and execution of programs of cooperation with States. Prcuiotis actions by EPA.--This Agency published a Notice of Intent to Review the Need for Establishing New uhnia amylovora are present In a halation and ingestion pathway of Rules for Plutonium and Other Tran given growing area; transuranium elements to humans and suranium Elements In the Federal > 3. Up to three post-harvest applica would establish a maximum dose rate Register, Vol. 39. page 34098 on Sep tions may be made. No application will to lung.and bone for members of the tember 23. 1974. Public Hearings to be made to any block of trees until all general population. Agencies imple gather Information were subsequently fruit in that block has been harvested; menting the guidance would be re held In Washington, D.C.. on Deccm- FEOERAl REGISTER, VOl. 42, NO. 230--WEDNESDAY, NOVEMBER 30. 1977 I see 5-1637 NOTICES 60057 ber 10-11, 1&74. and In Denver. Colo., There may be differences in reputable the guidance at the reference level on January 10. 1076. The Proceedings scientific opinions on their accuracy, would be reasonable and achievable, of these Hearings were published as but they represent the best Judgment `but that the cumulative costs Increase EPA Document ORF/CSD-75-I. of the Agency. The social Judgment of rapidly when lower guidance limits arc Rationale for guidance.--The guid whether this risk level is' gCUCbUtfiTe considered. ance Is Intended to provide recommen wili Se subject to""pubnc' comment On the basis of the above consider dations on protection of the public during the period provided. The final ations. the Agency has concluded that health from exposure to transuranium Agency recommendation may be the proposed guidance would provide elements at levels above those found higher or lower as appropriate. adequate protection of the critical seg In the environment as a result of fal Other Federal regulatory actions ment of the population and would be lout from the testing of nuclear de have considered lifetime risk levels for capable of Implementation at reason vices. Accordingly, it proposes to es other carcinogens but there Is, at this able cost. Further details are provided tablish a maximum dose rate applica time, no uniformity of approach to the in the technical summary document, ble to the general population which regulations of carcinogens, me itTc- which Is available on request. considers all possible Important path C17flB Ttex levels proposed range from Scope o/ outdance.--The proposed ways to humans. Two primary criteria one per million as "virtually safe" to guidance is not intended to supersede used In deriving the proposed guidance greater than 300 per million. Differ existing radiation protection guides, were: that any added risk to an indl- l ences In the action levels reflect differ such as the individual and population vldual from exposure to the transur ent regulatory requirements, con limits established by the Federal Radi anium elements be very small, and straints associated with remedial ac ation Council In I960, but rather to ( that any actions required by Imple tions for a particular carcinogen, un supplement these by specifying limits ' mentation of the guidance be practical, certainties in the calculations, differ for one type of source and for one tn terms of overall economic require ences In methods used to derive life group of radionuclides within these ments. The Agency has found that the time risks, and economic consider broader limits. The scope of the pro costs of remedial actions and benefits, ations. posed guidance Includes all transuran of risk reduction differ so greatly be The Agency has recognized a differ ium element contamination In the gen tween contaminated sites that generic ence between those sites presently eral environment from all sources. The guidance applicable to all sites cannot contaminated and sites that may be recommendations are applicable to in be provided by formal beneflt<ost pro accidentally contaminated in the dividuals In the general papulation cedures. future, and has considered whether outside the boundaries of a Federal fa Radiatfon Induced risks can be esti separate numerical guides should be cility. Federally licensed facility, or mated bAsed on a number of different developed for these two cases. It was other site under the direct control of a assumptions, but the most prudent Is concluded that no specific rationale is Federal agency. The limits apply spe that there Is some - finite risk. ho known that would justify, different cifically to the critical segment of the humariy flO fTl&uef-~fioW** small the guidance based on healLh risk consid exposed population, which is that amount oraDSOjhedjft^tiqfl might erations. Therefore, the Agency rec group of persons In the general popu Bfe 4h3*TTTartf7e risk^t any given low ommends that the same numerical lation who. because of residency or dose level Is directly proportional to guide be used in both cases, but that other factors, can on the average be the damage actually observed at much all future contamination be cleaned up expected to receive the highest life higher dose levels. The acceptance of as soon as possible after occurrence In time radiation dose from a specified such assumptions. In the absence of' order to .minimize radiation exposures source of transuranium elements. data to the contrary, must be consid of the general public and prevent The recommendations arc given in ered as most appropriate for a regula widespread dispersion of environmen terms of an annual limiting dose com tory or guidance function. On thl^ tal contamination. mitment to the pulmonary region of basis, there Is no level of radl^lnn The Agency has also considered the the lung or to bone. Although the pro posur_e wnlch ts aS^utciy sate Tnd costs wiiwu iniyiiL uu mgflrvmi 111 "Cm- posed guidance specifies dose rale anv radiation dose carries with it some plgmefftink tnia kuiuincfe: cased" on limits to only these organs, this also degree dlTi'fiR. Balanced agaiKsl LWs!js tHeTnfS'rmatldfr fivauaDi^. Yli limits the potential accumulation in ftttrramfiat 't^aernsocieTTalL were estfmat<9 Thtfrfl fe-OTT contamina other body organs including gonadal persoiis ^rfe exposea tojiC|Tirg.S.r?1,t*,Y>**r tion levels at existing sites of contami tissues. The annual dose rale to the or^cbmpcttn'g rfskMlncTudlng nwJnral nation. A reference level of soil con designated organs can be estimated bbckgrbuhd^dTEtt'&riTinaTnat fhp r- tamination was chosen which, with a from representative measurements of cftJIUUfl 01 A SlTVB'f&fisk musL hejdewAdU very high degree of probability would air concentrations or soil contamina Etta be expected to result in an inhalation tion levels, either by use of sitc-spccif- costs ana benefits. dose to an Individual not to exceed the Ic data or by use of calculations based ~TTfy`^r<J&nc2?"Wcommendations are guidance recommendation. The costs on reasonable procedures and assump Intended to achieve adequate health of implementing the guidance can be tions. protection for the small fraction of expected to vary by location, contami Risk perspectives.--It Is known that the total population at greatest risk nation level, and other factors. A mini exposure to radiation may increase so from exposure to transuranium nu mum cost of $500 per acre has been as matic risks, primarily that of cancer, clides In the environment, and will sumed for estimating the total costs as well as genetic risks to future gen therefore offer much greater protec which may be Incurred In bringing all erations. The proposed guidance Is tion to the vast majority of the tH>pu- areas above the designated level into based on suitable models chosen by lation at lesser risk. The risk at the proposed guidance level is estimated to be less than one chance in a million per year and less than ten chances per hundred thousand In a lifetime that an Individual would develop a cancer from continuous exposure at the stated dose rates. It must be recog nized that these estimates are not pre cise. and have an uncertainty of at least a factor of three for cancer risk. compliance. Such costs Include dilu tion or removal of contamination by plowing or scraping as required and re storative actions needed to prevent erosion and assist ecological recovery. Costs necessarily Increase as the dif ference between the existing contami nation levels and those sought be comes greater. Results are discussed below In more detail. It can be con cluded that the costs of implementing the Agency that relate environmental levels to the dose to internal organs. Health risks resulting from radiation exposure were estimated using models and recommendations of the Advisory Committee on the Biological Effects of Ionizing Radiation of the National Academy of Sciences (NAS-BEIR Committee) in its reports entitled "The Effects on Populations of Expo sure to Low Levels of Ionizing Radi- FEOERAt REGISTER, VOL 42, NO. 230--WEDNESDAY, NOVEMBER 30, 1977 see 5-1639 Si l ' 60958 ^ i NOTICES i c V * r^* alion" (1972), and "Health Effects of the Alpha-Emitting Particles In the Respiratory Tract" (1976) as well aS information In other technical reports. The radiation risk due to Inhalation of transuranium elements Is primarily through inhalation of airborne partic ulates derived from resuspension of soil particles and compliance with this dose guidance can be demonstrated by measurements of air and/or soil con centration. Air concentration may be achieve the guidance level aL any site An economic evaluation can be used to Identify the technique or combination of techniques that will attain and maintain the guidance level at the least total cost. Monetary costs, envi lung cancer. Additional risks may related to the dose guidance using do ronmental costs, and other nonmonc- result from translocation of a small simetry models that Include consider-, Lary costs should all be considered in fraction of the transuranium elements atlon of particle size distribution and the evaluation or each alternative from the lung to other body organs, other parameters appropriate to the combination of possible remedial ac especially to the liver and bone. On specific site of contamination. Soli tions. the basis of models, it was estimated contamination levels can be related to Projected impact of guidance and al- that, for a cohort of 100,000 persons a corresponding air concentration by ternatives.--Under the provisions of followed through their entire life use of a resuspension factor, which Is the National Environmental Policy times. the continuous Inhalation over obtained either by experimental deter Act of 19G9, It is required that every their lifetimes of transuranium aero mination or by calculatlonal tech major Federal action be examined in sols leadings to an average annual niques. terms of projected impacts and I hat dose rate to the pulmonary tissue of 1 For practical reasons of facilitating all available alternatives be consid mrad/ycar per person could potential implementation of the proposed guid ered. The purpose of such an analysis ly resylt in 10 prem&tUrmWcer ance, derived numerical values for is to compare the costs and benefits of 1 fleathsTFor an Average lifespan of 71 level of soil or air concentrations, the recommended action with other yCEFsTthe annual risk to each person which can reasonably be predicted to options in terms of the broad range of from lifetime exposure at this level Is result In dose rates less than the guid- - projected health, sociological, econom about one per million per year. ance recommendations, could be sub ic, and environmental Impacts. The radiation risk due to ingestion stituted for the site-specific values. On The implementation of the proposed- . of transuranium elements Is primarily the basis of limited data available for action would be site-specific. The por bone and liver cancers. In a cohort of several existing sites, the Agency sug tion of the environment affected is 100,000 persons, continuous ingestion over a lifetime of a transuranium ra dionuclide at a level causing an aver age skeletal (bone) dose rate of 3 mrad per year 70 years after the start of In gestion could potentially result In less than 6 premature deaths from such cancers. Genetic damage Is possible ns a result of assimilation of transuranium elements In gonadal tissue. There Is . considerable uncertainty In the esti mated dose to gonadal tissue and re sultant genetic risk but it can be esti mated that, for continuous Ingestion at the limits set by this proposed guid ance. the total dose to gonadal tissue over 30 years of chronic exposure would be about 10 mltlirad. Such a go nadal dose to each of the parents is es gests that a soil contamination level of 0.2 >iCl/m*, for samples collected at the surface to a depth of 1 cm and for particle sizes under 2 mm, would es tablish a reasonable "screening level" for this purpose. The Agency also sug gests that a derived Air concentration based on an activity median aerody namic particle diameter (AMAD) not to exceed 0.1 ^m, which is substantial ly smaller than observed values at all known contamination sites, could be equated to a limiting concentration of about 1 fCi/m* for alpha emitting transuranium nuclides. Use of such de rived numerical values can serve to reduce the land areas requiring evalu ation and minimize the number of measurements needed. Areas which do not exceed the "screening level" would generally be considered In compliance that where present or future transur* ' anlum nuclide concentrations may exceed guidance values. Such areas are likely to be those where the transur anium elements are prepared, fabricat ed, used, stored, or transported. A number of such areas currently exist within the limits of the continental ' United States. Most contamination Is located on lands with restricted or limited access, but a few instances exist where contamination has spread to privately owned properties. There are four Federal sites in the United States that have transuranium element contamination above ambient levels in soils beyond their boundaries., These include the Rocky Flats Plant In Jefferson County. Colo., Mound Laboratory In Miamisbure. Ohio. Nevada T6st Site In southern Nevada, timated to produce 1 to 20 genetic de with the guidance recommendations; and Trinity Test Site near Alamogor fects per 100,000 live births In the first those that qxcecd. It would require do, N. Mex. The majority of all con generation. This number can be com more intensive evaluation to deter tamination released is confined within pared to the approximately 6000 ge mine actual dose rates to exposed per areas under the direct control of the netic defects normally observed , In sons. Federal government, which imposes 100,000 live births. 1 Remedial actions and economic restrictions on the across and use of In practice, very few. If any. Individ evaluation.--Where a need for the use these areas. Relatively small amounts uals arc expected to be subjected to ' of remedial measures would arise, two of transuranium element contamina the recommended guidance limits and alternatives are available: (1) reduc tion exists outside the boundaries of /the total number of Individuals ex tion or elimination of the source term; these sites on lands generally accessi posed above levels of worldwide fallout or (2) establishing restricted access or ble to the public. will be small. The Agency also consid use of the area fn question. Remedial The following discussion is intended ered the total impact on population measures which reduce or remove ex to supply a perspective of applying the groups but. because the exposed popu isting surface contamination, in order guidance recommendations to these lation groups ake small and are .likely to remain so. It was deemed unneces sary to separately consider the total to minimize the source term and sub sequent transport of plutonium to humans, include: 6itcs in terms of the reference level of 0.2 fiCi/m*. and is based on all the in formation presently available to the populatibn radiation dose commitment In developing this guidance. Implementation.--Implementation - of this guidance would require mea 1. In-place stabilization by the application of a relatively impermeable cover, such as oil. polymerized plastics, or asphalt: 2. Dilution by plowing or other similar Agency. Use of such a reference level for soil contamination is intended solely to provide a basis for compari son and in most cases probably overes surement of the ambient concentra techniques; and timates the magnitude of the areas tion level of transuranium elements in air, soil, food, or water, and conversion through models to dose estimates. In 3. Disposal by removal of surface soils and burial either on-site or in a designated waste storage repository. subject to remedial actions. Compari sons are made in terms of areas out side the boundaries of these sites most cases the critical pathway for ex It can generally be expected that a which may exceed the derived soil ref posure to transuranium elements is variety of techniques could be used to erence level. FEOER At REGISTER, VOt. 43, MO. 230--WEDNESDAY, NOVEMBER 30, 1777 see 5-1639 NOTICES 60959 Thu Rocky Flats Plant (RFP) pro duces components for nuclear weap ons. Barrels containing plutonium con taminated cutting oil slowly corroded and some of the contents eventually leaked into the environment and were dispersed. On the basis of sol) concen tration data, all offsite areas at the Rocky Flats plant probably would be in compliance with guidance recom mendations. However, more intensive evaluation in the most highly contami nated areas east of the plant may be needed to determine the actual dose rates to the general population. The area is sparsely inhabited and there are few people living in the particular area of concern. All local water sup plies are expected to yield Ingestion dose rates well below the guidance rec ommendations. Mound Laboratory is a major re search and development site for fabri cation of radioisotopic heat sources used for space and terrestrial applica tions. In 1969 a pipeline transporting a waste Pu-238 solution ruptured, spill ing the contaminated solution. The plutonium migrated slowly Into nearby waterways. The majority of the plutonium is now sorbed and fixed on the sediments of the North and South Canals. Maximum concentra tions are 1 to 3 ft. below the sediment .surface and currently do not pose any, radiation problem, since very little of the plutonium is In soluble form and the canal w&ter is not used for drink-' Ing purposes. Banks Immediately adja cent to the canal and overflow creek, which are subject to occasional flood ing. have maximum plutonium concen trations exceeding the reference level. The amount of land In question is about 0.01 ml' and there are no people living on this land. No Immediate cleanup is Indicated for this site, but continued surveillance la warranted. The Nevada Test Site (NTS) covers an area of 1400 ml* with an additional exclusion zone extending distances of 3 6 to 48 miles. Major programs at NTS have Included nuclear weapons tests, testing tor peaceful uses of nuclear ex plosives. and nuclear .reactor engine development. These activities have re sulted in plutonium contamination In certain areas of the test site and exclu sion areas and slight contamination (above worldwide fallout levels) out side the exclusion areas. There are no known uncontrolled areas which have transuranium element contamination exceeding the reference level. The Trinity Test Site Was the loca tion of the first nuclear explosion. No other nuclear explosion tests were per formed at Trinity. A site survey was performed by EPA during 1973-74 to determine residual plutonium concen tration contours. The highest plutoni um contamination levels in uncon trolled areas ranged from .02 to .09 jiCi/m'. On the basis of limited avail able data, no major remedial actions would appear to be necessary at this site. Text of proposed guidance.--'The En vironmental Protection Agency pro poses that the following recommenda tions be submitted by the Administra tor to the President for Issuance as Federal Radiation Guidance: 1. The annual alpha radiation dose rate to members of the critical seg ment of the exposed population as the result of exposure to transuranium elements in the general environment should not exceed cither: a. 1 mlllirad per year to the pulmon ary lung, or and b. 3 mlllirad per year to the bone. 2. For newly contaminated areas, control measures should be taken to minimize both residual levels and radi ation exposures of the general public. The control measures are expected to result in levels well below those speci fied In paragraph one. Compliance with the guidance recommendations should be achieved within a reason able period of time. 3. The recommendations are to be used only for guidance on possible re medial actions for the protection of the public health In instances of pres ently existing contamination or of pos sible future unplanned releases of transuranium elements. They are not to be used by Federal agencies as limits for planned releases of transur anium elements Into the general envi ronment DeftninifioTis.--a. "Critical segment of the exposed population'* means that group of persons within the ex posed population receiving the highest radiation dose to the pulmonary region of the lung or to the bone. b. "Rad" is the unit of absorbed dose, defined as the energy Imparted to tissue due to ioqjzing radiation di vided by the mass of the tissue. One rad Is equal to'the absorption of 100 ergs of radiation energy per gram of. matter. 1 mlllirad (mrad)=10~' rad. c. "Pulmonary lung" means that region of the lung consisting of respi ratory bronchioles, alveolar ducts, atria, alveoli, and alveolar sacs. The average total weight of this tissue, In cluding the capillary blood. Is assumed to be 570 gms. d. "Mlllirad per year to the pulmon ary lung" means the equilibrium dose rate following chronic Inhalation. This dose rate is calculated by dividing the alpha energy absorbed per year In the pulmonary lung by Its mass. e. "Bone" means osseous tissue. The average total weight of this tissue Is assumed to be 5000 grams. f. "Mlllirad per year to the bone" means the dose rate attained after 70 years of chronic exposure. This dose rate Is calculated by dividing the alpha energy absorbed In the bone during the 70th year by the bone mass. g. "General environment" means the total terrestrial, atmospheric and aquatic environments outside the boundaries of Federally licensed facili ties or outside the boundaries of sites which arc under the direct control of a Federal agency, h. "Curie (Cl)" Is the basic unit to describe the intensity of radioactivity in a material. It Is equal to 37 billion disintegrations per second. I milllcurlc (mcn- io-- Cl 1 femtocurle (fCl> 10'" Cl Dated: November 22. 1977. Douglas M. Costle, Administrator. CFR Doc.77-34328 Filed 11-29-77; 8:45 ami (6712-011 FEDERAL COMMUNICATIONS COMMISSION RADIO ASTRONOMY SERVICE WORKING GROUP AND BROADCAST SATELLITE SER VICE WORKING GROUP FOR THE 1779 ITU WORLD ADMINISTRATIVE RADIO CONFER. ENCE Joint Mooting November 23, 1977. A Joint meeting of the Radio Astron omy Service Working Group and the Broadcast Satellite Service Working Group for the 1979 General World Ad ministrative Radio Conference is scheduled to be held on Thursday, De cember 15, 1977. at 1 p.m. in room 8210 of the Commission's offices located at 2025 M Street NW,. Washington, D.C. This Joint meeting will be held to discuss mutual problems and possibili ties of shared allocations in the 2670 to 2700 MHz band. The Joint advisory committee meet ing Is open to the general public and any written comments will be accepted before or after the meeting. For the Federal Communications Commission. William J. Tmcarico, Acting Secretary. [Fit Doc.77-34282 Filed 11-29-77: 8:45 Km] [6712-01] SATELLITE BROADCASTING SERVICE GROUP 1979 WORLD ADMINISTRATIVE RAOIO CON FERENCE Schdul of Moling November 25. 1977. Pursuant to Pub. L. 92-463, notice is hereby given of the following meeting. WARC-79 Satellite Broadcasting Service Group Thursday, December 15, 1977, 9:30 a.m. to 12 Noon, Room 8210, 2025 M Street NW.. Washington. D.C. FEOERAl REGISTER, VOL 42, NO. 230--WEDNESOAi, NOVEMBER 30, 1977 see 5-1640 Editor: Louis Rothschild. Jr. Managing Editor: Raymond Gatant Assistant to the Editor: Natalie Pargas Assistant Editor: Patricia Mitchell Circulation Director: Shirley Galant Production Manager: Dorothy Hi/I Associate Editors: Cathy Cooper, Gail Tapscott PVC ORDER, UNDER ACRYLONITRILE DOCTRINE, BEING DRAFTED Food and Drugs Commissioner Donald Kennedy held out little hope for continued use polyvinyl chloride food packaging materials In a Nov. 8 letter to Ethyl's Dr. C. M. Neher. Kennedy said the final rule "will necessarily reflect many of the judgments and conclusions of law reached Ln the related final decision on the status of acrylo nitrile ..." (See FOOD CHEMICAL NEWS, Sept. 26, Pages 47, 50 and 53). In the acrylonitrile matter, FDA held that if any migration of a carcinogenic lndirec additive into any food under any circumstances has been shown, there is a reason able expectation of migration of the substance into food. FDA has proposed banning use of PVC ln rigid, semi-rigid packaging (See FOOD K CHEMICAL NEWS, Sept. 1, 1975, Page 34), but the proposal would retain use in films, coatings, and cap linings. It is these uses that appear to be in jeopardy because of the acrylonitrile ruling. The FDA proposal included an interim Food Additive Order for use of PVC ln water pipes. Since the 1975 proposal, Kennedy wrote, "toxicological studies have established vinyl chloride as a carcinogen Ln both animals and man." Sending Neher a copy of "a new and as yet unpublished FDA analytical procedure for vinyl chloride detection," Kennedy said: "However, we intend to proceed as expeditiously as possible with the publication of a final rule of poly vinyl chloride copolymers. Any and all relevant scien tific data made available before publication will be ob jectively considered In formulating our final decision." The Commissioner noted that Ethyl requested "additional time to rework your study ln order to obtain convincing data which may demonstrate that the vinyl chloride monomer in your applications is not reasonably expected to migrate to food." Dis cussing a September 8 meeting of Neher with staffers of FDA's Bureau of Foods, Kennedy wrote: "I am aware that over the past ten months the Ethyl Corporation has submitted data to demonstrate decreas ing migration of vinyl chlorLde from production samples of your polyvinyl chloride copolymers. As noted Ln the Sept. 8 meetLng, our staff discovered that due to various see 5-1641 ' Page 4 December 5, 1977 FOOD CHEMICAL, NEWS deficiencies In the sensitivity and reliability of your data, they were unable to confirm at what level devia tion from the linear diffusion model actually occurs. "Our chemistry staff has attributed part of the problem to your imprecise determination of residual vinyl chloride in the copolymer itself. Of course, this uncertainty makes difficult a reliable correlation between residual monomer and any migration that may be measured." Applying the acrylonitrile doctrine to the PVC issue, Kennedy said: "The conclusions of the acrylonitrile document concern ing migration of monomer resulted from my concurrence with the decision that the linear diffusion process was confirmed by experimental data at a temperature, con centration, and storage time 'reasonably close to the values associated with normal use,' and that extrap olation of this behavior to regions below which no measurement of monomer could be made is justified. "As stated In the document, we grant the possibility that there could be deviations from the linear diffusion model in extreme conditions, and thus 'The reasonable expecta tion of migration, arrived at on the basis of the diffusion principle, Is not unalterable . . . The expectation can be rebutted, but only If an adequate showing is made that migration is not reasonably to be expected.' This is ob viously what you hope to accomplish in your proposed experiments. * "A mere deviation from the linear diffusion model, how ever, would not be sufficient to satisfy this standard. Rather the deviation must be such as to show that migra tion of vinyl chloride cannot reasonably be expected. Such a fLndtng cannot be made'if data are imprecise." The FDA acrylonitrile decision Ls being appealed in court by the Society of the Plastics Industry, Monsanto, Vistron, and The Continental Group (See FOOD CHEMICAL NEWS, Nov. 21, Page 41; and Nov. 28, Page 2). It Is anticipated that other firms In the food packaging- Industry -- and perhaps also in the food industry -- will file amicus curiae briefs in the case because of the broad implications of the acrylonitrile doctrine to all food-packaging materials. The filings of legal papers in the acrylonitrile case starts with FDA filing of a certified index of the record within 40 days of the petition for appeal, which will be followed by briefs. It is estimated that the case may not go to oral argument before next summer, and that a final decision may not come until fall of 1978. see 5-1642