Document jm0dYbm9EkeoomR2O6daYw2KO

R&S 113834 BIO-MEDICAL-RESEARCH DOCUMENT DESCRIPTION FORM 63 68 69 76 Duplicate.in all cards: --> noo'om year as-1961- File number [Right justify [Numeric only] Author (s), as Last Name FS (No Punctuation) and coden for journal as JAMA preceeded by one blank space -r/rejrtnse*/. t/L 304?/ 77 78 Sub-Index Code 51 62 11 12 13 Title of Report; end with space-hyphen-hyphen-space. Follow with Index Terms > separated from each other with comma-space. Avoid other punctuation; do not abbreviate. 21 22 23 24 S urce (Journal* Vol., Number, Pages,Date ) 12 U'S'rfi0fi-tSzr& Jz/A/f 61 62 31 32 Brief Summary 12 10 SUMMARY: 61 62 61 62 63 64 -J PREPARED DISCUSSION BY T. R. TORKELSON 0000426 FOR SOEH WORKING CONFERENCE ON OSHA PROPOSAL ON CARCINOGEN REGULATION - WASHINGTON, D.C. - JUNE 2, 1977 In the few minutes alloted, I don't intend to comment much on the legal implications of this standard. That will be left to the lawyers who can make each other miserable and lay off the b&rsrAHd scientist for a while. The circuitous^logic used to rephrase the 17 Principles of Carcinogenisis into this document hopefully will not stand legal tests just as they do not stand tests of scientific logic. I would rather direct your attention to some other considerations* R&s 113835 The first one is the obvious disregard for dose. Are we so naive as to believe that in practice all carcinogens are equally potent and the same controls will be needed for all? Qar we ignore thresholds of response and changes in metabolism with dosage? How, for example, can we continue to operate breweries, distilleries, and pharmaceutical plants when no i//* exposure to ethyl alcohol will be permitted for this acknow- Y" ledged human (Category I) carcinogen. I presume we substitute a I other compounds. This is not meant to be facetious; ethanol " ------ er is a documented human carcinogen and will require all the controls of Category I, although we all recognize or accept nv(ftv *7 r -rTf'ir no practical carcinogenic hazard at low levels of exposure. Are we hypocritically going to ignore this proven human carcinogen as we do tobacco which so dominates the cancer 2- - R&S 113836 problem in the U.S. that it makes occupational problems pale in comparison? Lung cancer, to a large extent due to tobacco, is the only form of cancer to show an increase in the U.S. according to the American Cancer Society. If OSHA is really concerned about cancer in the workplace, shouldn't there be a 200 page document restricting smoking to protect non-smokers. It is my understanding that this issue was raised at a recent NACOSH meeting. Apparently no legal opinion has yet been given on whether an employer can restrict smoking to protect . his non-smoking employees under the general duty clause of OSHA. This is not meant to suggest that excessive exposures to vinyl chloride, asbestos, arsenic, and other compounds have not caused cancer? obviously they require control and I certainly support proper regulations, as does all concerned industry. But it does indicate where society (and industry) might most effectively spend its resources if it is .sincere about reducing cancer. Secondr the rigid simplistic frame work contemplated in the draft document removes all judgement and flexibility and precludes the use of future . OSHA must seriously consider other possible criteria such as measurement of the amount of DNA to which a material or its metabolite (s) are attached. Research in areas of immunology and hormonal regulation of natural defense mechanisms may also provide additional useful, measurab1e-parameters in the future, but -3- knowledge. It appears particularly inappropriate at this time to place so much emphasis on in vitro mutagenic tests. As stated by OSHA in the proposed rulemaking, methodology is rapidly developing in this field and to lock-in and for practical purposes render ^irreversible the relative role of in vitro testing at this time is not justified. I understand that as recently as two weeks ago, the Science Advisory Panel to the EPA noted that mutagenic studies are got at this time sufficiently d^yglopc-cL to be standardized, and questioned the*Kcorrelation to long term studies. Third, Category I or II presumptions should not be raised by animal tests alone. Further tests should be performed to demonstrate: (1) that at least one of the species showing a positive result ma-fcahnligeg the material as does man; (2) that the dose, levftl at which a positive finding occurs is one: which does not overwhelm^the animals' ability to detoxify as demonstrated by metabolic and pharmacokinetic data; and, (3) that the dosage at which a positive finding occurs does not cause other significant adverse effects as judged by the most recent NCI criteria (growth, pathologic effects, etc.). The last two are particularly applicable to ethyl alcohol, just as they are to many of the other inappropriate animal studies at unrealistic dosages Fourth, with respect to human evidence of carcinogenicity, the proposal should take into account the principles of R&S 113837 R&S 113838 -4- dose/dependency in epidemiology studies. It must be recognized that epidemiology can never prove a cause and effect/ at most it might show an association. However, when done properly and objectively retrospective epidemiological investigation can be a good and valuable tool and the results must not be ignored. Provision must be made, however, to avoid poorly designed and improperly conducted studies. Case report and inadequately controlled studies must particularly be avoided. in regard to substitutes, it is well and good for someone to say "ban a material and use a substitute." Unfortunately, those who glibly make such statements are often unaware of what is entailed in finding a suitable and asaak^e substitute. Compositions must generally be tested for stability and func tionality. Processing equipment, shipping containers, and users' processes must also be evaluated. In addition, before any substitution is made, extensive testing is necessary to insure that the substitute is jsajfer than the original products Such testing would generally include an evaluation of carcino genic potential and other toxic potentialities, and such physical/chemical properties as reactivity and flammability. All this takes time, ranging from months to years. Thus, while it may be easy to say substitute, it may be difficult to accomplish. It must always be remembered that banning a product does more than just remove a cancer problem; it may also introduce other problems which in fact may be worse, or at least as serious, as the real or imagined risk for cancer. R&S 113839 -5- Finally, I'd like to suggest that if generic regulation is to become realistic, then an additional Category IV should be established for substances that are not considered suspect carcinogens. Let's hope a few materials will be left for societies use. We all have learned a lot from the recent strong reaction of the public to the Delaney clause. What we are talking about here appears to be merely a take-off on the Delaney t mentality. It is clear the public expects their regulators to be able to show some discretion and true Tinderstanding of all the facts. The public (and I might add, most employees) are not so naive ns to believe that simplistic, all or nothing, laws are really the answer. They expect that as in any situation all information about a material is to be evaluated if it is to be given a fair shake. Let's not lock into law that which attempts to fully regulate an area which is still a very active area of research, and let's be careful not to lock out new methods, new information, and new insights into the causes, cures, and reductions in exposure to environmental carcinogens. PRELIMINARY PROGRAM SOCIETY FOR OCCUPATIONAL AND ENVIRONMENTAL HEALTH 1714 Massachusetts Avenue, N.W., Washington DC 20036 (202) 785-8177 IMPLICATIONS OF THE OSHA PROPOSAL ON CARCINOGEN REGULATION A WORKING CONFERENCE June 2, 1977 Hotel Washington Washington, D.C. 8:15 A.M. 8:45 A.M. 9:00 A.M. 10:45 A.M. REGISTRATION INTRODUCTORY REMARKS Greetings from SOEH - Dr. Joseph Wagoner, SOEH President Conference Overview - Mr, John C. Kolojeski Conference Chairperson THE OSHA PROPOSAL - Mr. Grover C. Wrenn, Deputy Director, Directorate of Health Standards, OSHA Discussants: Director of the Toxicology Research Laboratory, Dow Chemical Corporation -Dr. J. William Lloyd, Epidemiologist, United Steelworkers of America - Dr. William J. Nicholson, Environmental Sciences Laboratory, Mt. Sinai School of Medicine Open Discussion IMPACT OF THE NATIONAL CANCER INSTITUTE AND ITS BIOASSAY PROGRAM ON THE OSHA POLICY - Dr. Robert Squire, Associate Professor of Pathology and Comparative Medicine, Johns Hopkins University School of Medicine (former Acting Chief, NCI Carcinogenesis Bioassay Program) Discussants: - Dr. Umberto Saffiotti, Chief, Experimental Pathology Branch, Carcln genesis Program, NCI - (To Be Confirmed) Open Discussion --over-- 7J 9<?/> 'r;- , ^!:|;5'.HpteX: ReservationsT^ffi'b^^ been?*reserved1; atf' Hotel Washington. .Contact the hotel; directly: for your own. tllS ' * "!-h* R&S 113842 * * 1 \ '1 -I SOCIETY FOR OCCUPATIONAL AND ENVIRONMENTAL HEALTH 1714 Massachusetts Avenue, N.W., Washington DC 20036 (202) 785-8177 April 26, 1977 Dear SOEH Members.* The Society will hold a working conference on the implications of the proposed Occupational Safety and Health Administration policy on carcinogen regulation on June 2, 1977, at the Hotel Washington in Washington, D.C. In March you received a letter regarding the con ference from Mr. John C. Kolojeski, Conference Chair person, asking you to reserve the date on your calendars. Enclosed are a preliminary program and a registration form. Since attendance will be limited, please return the registration form with your check as soon as possible. Also, if you wish to receive a copy of the draft proposal prior to the conference, we need to mail it before May 23, 1977. The one-day conference will highlight the draft pro posal itself, and also how it will interface with other federal agencies. Major presentations will be made on the impact of the National Cancer Institute and its bioassay program on the OSHA policy and on the interface between the Environmental Protection Agency authority on carcinogens and OSHA. Other governmental components, including the National Institute for Occupational Safety and Health, the National Institute for Environmental Health Sciences, the Council on Environmental Quality, the Commerce Department, the Government Accounting Office, the Office of Technology Assessment, and the Food and Drug Administration, are being asked to designate representatives to the conference to pro vide substantive comments from the floor on the ramifica tions of the policy from their perspectives. Open parti cipation, questions, and comments will take precedence over formal presentations. This conference will deal with significant policy decisions. Plan to attend. Enclosures (2) banay ZMnmerman Executive/Director REG I ST RANT S SQEH Working Conference: IMPLICATIONS OF THE OSHA PROPOSAL ON CARCINOGEN REGULATION June 2, 1977 The Hotel Washington Washington, D.C. LAWRENCE J. AHERN International Chemical Workers Union 1655 West Market Street Akron OH 44313 ROY ALBERT Environmental Protection Agency 401 M Street, SW Washington DC 20460 MATHEW K. AMBERG International Union of Electrical, Radio & Machine Workers, AFL-CIO, 1126 - 16th Street, NW Washington DC 20036 ELIZABETH ANDERSON Environmental Protection Agency UOOL M Street, SW' Washington DC 20460 NICHOLAS ASHFORD Center for Policy Alternatives MIT, Bldg. E40-250 Cambridge MA 02139 JEROME I. BARANCHC Case-Western Reserve Medical School 2319 Ablngton Road Cleveland. OH 44106 E. M. BEAVERS Rohm and. Haas Company Independence Mall West Philadelphia PA 19105 VIRGINIA BEHRENS NIOSH, CPC, USPHS 4676 Columbia Parkway Cincinnati OH 45226 . EULA BINGHAM Assistant Secretary of Labor for OSHA U.S. Department of Labor Washington DC 20210 MARVIN W. BLACHMAN American' Insurance Association 85 John Street New York NY IOO38 R. J. BLACK International Harvester Company 1707 L Street, NW Washington DC 20036 RICHARD BOGGS NIOSH WANDA BOLLENTIN 1526 - 17th Street, NW Washington DC 20036 SHIRLEY A. BRIGGS Rachel Carson Trust for the Living Environment, Inc. 94o Jones Mill Road Washington DC 20015 WAYNE T. BROOKS Organization Resources Counselors 1625 Eye Street, NW Washington DC 20006 PAUL E. BRUBAKER Mobil Oil Corporation BilUngsport Road Paulsboro NJ 08066 ROBERT E. BRUBAKER United. Nuclear Corporation 67 Sandy Desert Road. Uhcasvllle CT 06328 EVELYN G. BUHTIS Exxon Corporation P.0. Box 45 Linden NJ 07036 FLORA LU-TAI HUANG CHANG Stanford Research Institute l6ll North Kent Street Arlington VA 22209 R&S 113843 R&S 113844 Registrants SOEH W rking Conference Jane 2, 1977 Page Two WILLIAM T. CHEN D.C. Government, Suite 810 1875 Connecticut Avenue, NW Washington 1X7 20009 F,, W. CLAYTON 19116 Rhodes Way Gaithersburg MD 20760 GEORGE COLING Urban Environment Conference 1714 Massachusetts Avenue, NW Washington DC 20036 MICHAEL CONNORS OSHA - U.S. DOL 550 Main, Room 4028 Cincinnati OH 45202 RICHARD J. COOMES The Procter & Gamble Company Ivorydale Technical Center Cincinnati OH.45217 HARVEY DAVIS Velsicol Company RONALD D. DOBBIN NIOSH 4676 Columbia Parkway Cincinnati OH 45226 J- FIELDING DOUGLAS National Cancer Institute Landov Building, Room C325 Bethesda MD 20014 R. V. DURHAM International Brotherhood of Teamsters 25 Louisiana Avenue, NW Washington DC 20001 JOHN F. EGE, JR* General Electric Company Fairfield CT 06606 LOIS R. EMBER American Chemical Society 1155 - 16th Street, NW Washington DC 20036 LARRY E. EVANS Occupational Safety and Health Reporter 1231 - 25th Street, NW Washington DC 20037 SERGIO E. FABRO George Washington university Medical Center 2425 L Street, NW Washington DC 20037 KELVIN H. FERBER Allied Chemical Corporation Box IO69 Buffalo NY 14240 WARREN S. FERGUSON Allied Chemical Corporation P.0. Box 1057 R Morristown NJ 07960 W. GARY FLAMM National! Cancer Institute Building 31, Roan 11-A05 Bethesda MD 20014 D. L. FLCMERS 9 Eton Overlook Rockville MD 20850 JOHN FQDERARO E. I* DuPont de Nemours Haskell Laboratory Newark DE 197U- G. FREEMAN Allied. Chemical Corporation P.0. Box 1057 R Morristown NJ 07690 MILTON FRETFELD Manufacturing Chemists Association 1825 Connecticut Avenue, NW Washington DC 20009 WILLIAM L. GADD National Steel Corporation 2800 Grant Building Pittsburgh pa 15219 SIDNEY K GALLER U.S. Department of Comraere Washington DC 20230 Registrants SOEH Working Conference June 2, 1977 Page Three ADRIEN L. GAUDREAU Olin Corporation 91 Shelton Avenue New Haven CT 06504 HARVEY S. GOLD Velalcol Company MICHAEL L. GOLDBERG Senate Labor Subcommittee G-237 Dirksen Senate Office Bldg. Washington DC 20510 HAROLD M. GORDON D.C, Government U99 Pennsylvania Avenue, HW Washington DC 20001 BRUCE GRAHAM ITT Research Institute 1825 K Street, NW, Suite 6l0 Washington DC 20006 RICHARD E. GRAWEY Manpower and. Housing Subcommittee B-349-A Rayburn House Office Bldg. Washington DC 20915 BERNARD GREIFER U.S. Department of Commerce Washington DC 20230 ROBERT J. HALER Jones & Laughlin Steel Corporation 3 Gateway Center Pittsiibrgh PA 15263 JAMES S. HANSON Dow Chemical U.S.A. 2030 Dow Center Midland MI 48640 WILLIAM V. HARTWELL U.S. Department of Commerce Washington DC 20230 ROBERT HAYDEN United Steelworkers of America 815 - l6th Street, NW Washington DC 20006 CARL HAYES Environmental Protection Agency North Carolina ILENE R. HELLER Job Safety and Health Report P.0. Box 1067 Blair Station Silver Spring MD 20910 JOSEPH HIGHLAND Environmental Defense Fund 1525 - 18th Street, NW Washington DC 20036 PETER P. INFANTE NIOSH U.S. Post Office Building Cincinnati OH 45202 ROBERT S. JACKSON Virginia Department of Health 109 Governor Street James Madison Building Richmond VA 23219 DAVID B. JOHNS Dow Chemical U.S.A. P.0. Box 1693 Midland MI 4664o NATHAN J. KARCH Environmental Studies Board National Research Council Room JH820, 2101 Constitution Ave., NW Washington DC 204l8 MYRA KARSTADT U.S. General Accounting Office U4l G Street, NW Washington DC 20548 STANLEY S. KATZ School of Allied Health and Natural Sciences Quinnipiac College Mt. Carmel Avenue Hamden CT 06518 ANSON KELLER OSHA Washington DC 20210 R&S 113845 R&S 113846 Registrants SOEH Working Conference June 2, 1977 Page Four JAMES B. KENLEY Virginia Department of Health 109 Governor Street James Madison Building Richmond VA 23219 JANIE KINNEY House Subcommittee on Consumer Protection and Finance Room 3161, HOB #2 Washington DC 20515 JOHN C. KOLOJESKT Clement Associates, Inc. 1055 Thomas Jefferson Street, NW Washington DC 20007 SAMUEL P. KORHER Office of Congressman Andrew Maguire 1314 Longworth HOB Washington DC 20515 * GENE X. KDRTSHA General Motors Corporation General Motors Technical Center Warren MI 48090 PAUL KOTIN Jobns-Manville Corporation Ken-Caryl Ranch Denver CO 80217 HARVEY KRASNEY ANDREW F. KULANKO U.S. General Accounting Office N-1649 New Department of Labor Bldg. Washington DC 20210 MARGUERITE L. LENG Dow Chemical U-.S.A. P.0 Box 1706 Midland MI 48640 LINDA SUSAN LEWIS U.S. Department of Labor 200 Constitution Avenue, Rm* S4014 Washington DC 20210 RUTH LILTS Mt. Sinai School of Medicine 100th Street & Fifth Avenue New York NY 10029 J. WILLIAM LLOYD United Steelworkers of America 815 - 16th Street, NW Washington DC 20006 MARS T. LONGLEY ' The Standard OH Company1550 Midland Building Cleveland OH 44115 DAVID L. MALLINO House Education and Labor Committee Subcommittee on Labor' Standards Room 2104 Rayburn House Office Building Washington DC 20515 JOHN F. MARCHAND Memorial-Sloan Kettering 445 East 65th Street New York NY 10021 RONALD J. MC CANN OSEA - U.S. DOL 550 Main, Room 4028 Cincinnati OH 45202 JANE A. MC NEW OSHA - U.S. DOL 2700 Virginia Avenue, NW Washington DC 20037 ROBERT H. MERENESS Asbestos Information Association 1835 K Street, NW, Suite 402 Washington DC 20006 MARSHALL L. MILLER 7H7 Devonshire Alexandria VA 22307 A. E. MOFFPTT Bethlehem Steel Corporation Martin Tower, B-252 Bethlehem PA 18016 WARREN MUIR Council oh Environmental Quality 722 Jackson Place, NW Washington DC 20006 JOHN PATRICK MURPHY Stauffer Chemical Company Nyala Farms Road Westport CT 06880 I Uf. R&S 113847 Registrants SOEH Working Conference June 2, 1977 Page Five AHMED NASR Eastman Kodak Company Health, Safety & Human Factors Lab., B-320* KP Rochester NY 14650 GREGORY OLAF NESS NIOSH - Industry Wide Studies 28l8 Strafford, Apt. 2 Cincinnati OH 45220 WILLIAM J. NICHOLSON Mt. Sinai School of Medicine 100th street & Fifth Avenue New York NY 10029 NORBERT PAGE NIOSH Rockville MD 20857 MARY WAGNER PALSHAW Stauffer Chemical Company Nyala Farm Road Westport CT 06880 MARRION A. PARSONS Laborers International Union f North America 905 - 16th Street, NW Washington DC 20006 JAMES A. PETERS National Cancer Institute Building 31, Room 11A03 Bethesda MD 20014 LAWRENCE A. PLUMLEE Environmental Protection Agency 4*01 M Street, SW Washington DC 20460 REWARD RADFORD Department of Environmental Medicine School of Hygiene & Public Health 615 North Wolfe Street Baltimore MD 21205 L. S. RKNZONI INCO Limited P.0. Box 4h Toronto Ontario CANADA M5X 1C4 THOMAS ROBERTSON Vulcan Materials Company P.0. Box 5^5 Wichita KS 67201 CYNTHIA ROBINSON NIOSH, Industry-Wide Studies 4676 Columbia Parkway Cincinnati OH 45226 ISADORE ROSENTHAL Rohm and Haas Company Independence Mall West Philadelphia PA 19105 UMBERTO SAFFIOTTI National Cancer Institute Building 37> Room 3A19 Bethesda MD 20014 SHELDON W. SAMUELS Industrial Union Department, AFL-UIO 815 - 16th Street, NW Washington DC 20006 ERIC B. SANSONE Frederick Cancer Research Center P.0. Box B Frederick MD 21701 LOUIS SCHLOSSBERG Detrex Chemical Industries, Inc* 14331 Woodrow Wilson Avenue Detroit MI 48232 MARVIN A. SCHNEIDERMAN National Cancer Institute Landow Building, Room C403 Bethesda MD 20014 DENNIS SCHUETZLE Fond Motor Company JOHN J. SHEEHAN United Steelworkers of America 815 - 16th Street, NW Washington DC 20006 HARRY LEO SLATIN 1001 Wilson Boulevard Arlington VA 22209 R&S 113848 Registrants SOEH Working Conference June 2, 1977 Page Six WARREN J. SMITH AFL-CIO 271 East State Street Columbus OH 43215 EDITH SNETHAN U.S. Department of Labor Washington DC 20210 ROBERT SQUIRE Johns Hopkins university School of Medicine Traylor Building, Room G-52 720 Rutland Avenue Baltimore MD 21205 FRANCES STEPHENSON NIOSH 944 Ellison Cincinnati OH 45226 NANCY STROUD Stanford Research Institute l6ll`North Kent Street Arlington VA 22209 ALICE SITTER 3901 Cathedral Avenue, NW. Washlngton DC 20016 CAROLYN SUTHERLAND Organization Resources Counselors . 1625 Eye Street, NW, Suite 802 Washington DC 20006 D. G. TALENTYRE British mbassy 3100 Massachusetts Avenue, NW Washington DC 20008 GEORGE TAYLOR Research Department, AFL-CIO 815 - 16th Street, NW Washington DC 200Q6 Peggy taylor osha 2334 - 19th Syreet, NW Washington DC 20009 JOHN T. THIsLKE economics Laboratory, Inc. k Corporate Park Drive White Plains NY 10604 FREDERICK M. TOCA Texmeco Chemicals Inc. Park 80 Plaza West One Saddle Brook NJ C7662 T. R. TORKELSON Dov Chemical U.S.A. P.0. Box 1706 Midland MI 48640 JAY TUKEM Clement Associates Inc. 1055 Thomas Jefferson Street, NW Washington DC 20007 MARY ELLEN URANN E. I. DuPont de Nemours 1007 Market Street Wilmington DE 19898 H. MICHAEL D. OTIDJIAH Equitable Environmental Health, Inc. 6000 Executive Boulevard, Suite #308 Rockville MD 20852 MARK D. VAN ERT Occupational Health Studies Group Suite 32, NCNB Placa Chapel Hill NC 27514 Dr. Joseph Wagoner NIOSH, Room 523 U. S. Post Office Building Cincinnati OH 45202 RALPH WANDS National Academy of Sciences 2101 Constitution Avenue, NW Washington DC 20413 DAVID H. WEGMAN Harvard School of Public Health 665 Huntington Avenue Boston MA 02174 Registrants SOEH Working Conference June 2, 1977 Rage Seven . PATRICIA WESTUEUJ Occupational Safety and Health Reporter 1231 - 25th Street, NW Washington DC 20037 STEVEN WITT Stanford Research Institute 333 Ravenswood Avenue Menlo Park CA 95139 STEVE WQDKA Oil, Chemical & Atomic Workers International Union 1126 - l6th Street, NW Washington DC 20036 ANNA WOIGAST Oil, Chemical & Atomic Workers International union 1126 - 16th Street, HW Washington DC 20036 GROVER C. WRERN OSHA - U.S. DOL 200 Constitution Avenue, NW Washington DC 20210 SANDY ZIMMERMAN Society for Occupational and Environmental Health 17lU Massachusetts Avenue, NW Washington DC 20036 R&S 113851 ` i'rjf > > R&S 113852 v'. IblilLsiMlUliD Detailed coverage amt in-depth analyses, every week, of key developments regarding the laws and^regulations governing pesticides and toxic chemicals .< h,u 'U<P%Vb -** ' . n^.1 h** \| S160 a year Additional subscriptions $105 r*: w Volume 5, Number 28 June 8, 1977 CHEMICAL PROCESSORS must report for TSCA Inventory; premarket notification probably won't start on time. OSHA CANCER APPROACH assailed on toxicology, rigidity and likely effect. Labor unions say OSHA is too timid. EPA TRADE SECRET AMENDMENT for pesticide data "wide open." PESTICIDE DATA requirements may stop being "ever moving targets." MUTATION TESTS for pesticides approved; Dow exec says no. OTS "TIERED" TESTING PROPOSAL bogs down at SAB: Delay likely. VINYL CHLORIDE "secret deal" denounced by plastics industry. PESTICIDE STANDARDS implications queried by EPA planning group. * PESTICIDE STANDARDS approach explained by OPP; 1,300 likely. REGISTRATION/REREGISTRATION replaces classification as top priority. CANCELLATION of 300 products requested by 90 firms. NCI LINDANE STUDY may be useless; RPAR comments noted. MIREX money set aside by Appropriations Committee; use defended. 50 P.P.M. DIOXIN in Michigan cow livers linked to PCP. SODIUM AZIDE hazard figuring into DOT decision on auto airbags. PESTICIDES IN DRINKING WATER advice from NAS "unusable:" EPA staff. FISH AND WILDLIFE data to gq into RPARs thanks to Interior. PESTICIDE REPORTS policy set by ALT in civil penalty case. THOMPSON-HAYWOOD hit with big civil penalty, others noted. NORTELL LABS accuses EPA of playing favorites on product. PESTICIDE PRICES in Canada unchanged by import registration. GUTHION, DINOSEB get Section 18 exemptions for carrots, lentils. Page 9 Page 12 Page32 Page 30 Page 3 Page33 Page27 Page23 Page25 Page 17 Page28 Page 21 Page lo Page20 Page34 Page 28 Page 5 Page 6 Page 5 Page10 Page10 Page24 Published Weekly by FOOD CHEMICAL NEWS, Inc., 420 Colorado Bldg., 1341 G St./N.W., Washington. D.C. 20005 For subscribers only-copyrighted ' FOOD CHEMICAL NEWS, Inc. 1977 STerling 3-7472 Second-Class Postage Paid at Washington, D.C. 20013 Parge 2 * June 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS PESTICIDE ADVERTISING TRR which has been under consideration by the Federal Trade Commission may not be issued because FTC now thinks it already has enough authority to enforce against advertising abusers, according to an EPA official. A Commission official said no decision had been made on TRR issuance, but admitted that the option of not'issuing it would be considered at a public meeting set for today, June 8. EPA-ers noted that FTC may be worried about the time and expense of preparing a final TRR and said that there is some feeling that the problem of false advertising has abated (See Nov. 17, Page 5). E PA DEN IAL of 100 p.p.m. tolerance petition for Captan on seed com (See June. 1, Page 2) could result in review by an NAS advisory committee. Some EPA officials expect an appeal to an NAS committee to be filed (See Nov. 3, Page 5 and Nov. 24, Page 5). CAPTAN RPAR decision is expected to be made about Oct. 15 (See June 1, Page 2). ETHYLENE OXIDE RPAR decision is expected this month (See May 18, Page 27). The RPAR, if issued, would be based on`mutagenicity and/or oncogenicity, Edtoin L. Johnson, Deputy Assistant Administrator for Pesticide Programs, EPA, has indicated. MALEIC HYDRA ZIDE RPAR notice is now scheduled to be issued June 24 (See May 25, Page 2). PRONAMIDE RPAR rebuttal time extension to August 26 has been requested by Rohm and Haas, sole manufacturer of the technical grade product and the 50% wettable powder marketed under the name "Kerb- 50-W." The firm said EPA raised some points it had not considered of concern and noted that additional time was needed to evaluatethe RPAR notice (See May 11, Page 11). KE PONE CAN CELLATION hearing parties who have yet to file formal objections and labeling have been given until June 17 to do so by EPA Administrative Law Judge Bernard D. Levinson (See Junel, Page 2). TSCA TESTING Committee, when it submits its list of no more than 50 chemicals for which EPA should require tests under TSCA, also will list chemicals for which information appears to be sufficient to make further testing unnecessary. Whether such information justifies regulation will be up to EPA (See June 1, Page 14). GENERIC STANDARDS FOR PESTICIDES are being discussed at OSHA (See June 1, Page 24). MINOR USE TOLERANCES may be issued for RPAR candidates, if RPAR criteria triggers are not relevant to petitioned tolerances (See June 1, Page 2), an EPA official said last week. These tolerance decisions will be made case-by-case, according to the agency official. STATE REGISTRATIONS under Section 24(c) received to date by the Registration Division, OPP, EPA, total 850, according to OPP. R&S 113853 r / PESTICIDE & TOXIC @ ;sion .id Editors: CATHY COOPER, Gary Robinson, Gail Tapscott Circulation Dept.: Director, ` Shirley Gaiant; Assistant Director, Alice Wilkes Production Manager: Dorothy Hill i/th Publisher: Louis Rothschild, Jr. Managing Editor: Raymond Gaiant Associate Editors: Ron Grandon, Natalie Pargas <. DOW EXECUTIVE MISSTATES CASE ON MUTATION TESTING; EPA TO PROCEED Despite allegations to the contrary made by a Dow Chemlcal^^n^f^e^cutlve 4* at a meetingof the Society for (Occupational and Environmental Health (S<6EtlJ, the Environmental Protection Agency's Science Advisory Board (SAB) has not determined that the state of the art of mutagenicity testing (See June 1, Page 2) is so primitive as to preclude use of mutagenicity data to support regulatory actions against pesticide chemicals. The ^jjggytivg, Dr^^^^Torkelson of Dow's medical department, told last week's SOEH symposium on a cancer proposal from the Occupational Safety & Health Administration (OSHA) that OSHA should not depend on mutation tests at all for purposes of defining a chemical as a Category I carcinogen. Such a definition would trigger issuance of an OSHA emergency temporary standard entailing monitoring for the chemical in workplaces where it's produced, used, or packaged, as well as medical surveillance of exposed workers, "good housekeeping" requirements and other steps (See May* 25, Page 20). Placement of a chemical into Category I could be "rebutted" in a rulemaking proceeding. If the rebuttal were unsuccessful, the rulemaking would determine what the "lowest feasible" exposure level is, and workplaces would have to reach it. It would become the OSHA permanent standard. In the rulemaking, OSHA also could say that there are suitable substitutes for the chemical and attempt to promulgate a permanent standard requiring zero exposure. OSHA has proposed to allow a positive bioassay result in a single mammalian species to trigger Category I classification if the bioassay has been "replicated" by a test on the same or a different species, or, if there exists "multi-test evidence of mutagenicity." /C Torkelson epa's SAB, two weeks prior to the June 2 SOEH meeting, had 1, ' v decided that mutagenicity testing "wasn't ready yet" for regulatory use, and, Torkelsot said, itwould be "inappropriate" for OSHA to use mutation data if EPA wasn't going to. However, the SAB Environmental Health Advisory Committee met June 1 to discuss EPA's proposed mutagenicity testing requirements for pesticides (See April 13, Page 14 and May 18, Page 2) and Indicated that, in fact, the types of tests which EPA has proposed are sufficiently validated to require them for pesticide registration actions. Nelson. Woqan and Abrahamson Sav Mutation Tests are Ready At the June 1 SAB meeting, another Dow executive, )r\_y_. K. Rowe, said EPA should not Impose the mutagenicity battery because th tests whicn comprise it have not been validated and because their relevance to man is questionable. Page 4 June 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS Dr. John W. Drak , a memoer of tne study group which helped EPA draft the Section 3 guidelines, disagreed, saying that EPA and the study group had chosen only the best validated tests -out of a possible total of 30. Dr. Norton Nelson, Chairman of the Environmental Health Advisory Committee, said that based on "a wide variety of studies in the animal kingdom, we do know that heritable mutations are a severe threat. The jump from that to the human population is, to my mind, miniscule.'' His arguments on validity and relevance to man discarded, Rowe then maintained that SAB should advise EPA to delay adoption of the testing requirements until the Agency had better defined what would be a "statistically significant" result in each test and until EPA had spelled out how it would interpret "mixed results" from the component tests in the eight-test battery. Dr. Gerald Wogan, Chairman of Drake's study group, said that nothing in the upcoming criteria document, which will address "mixed" results, will change the requirements which EPA has set forth. On statistical significance, EPA's final guidelines will provide "more acceptable biometric wording" regarding what constitutes a significant finding in each test, according to EPA's Dr. Ruth Pertel, a principle author of the mutagenicity guide lines. This change comes about largely as a result of urgings from Dr. Lincoln E. Moses, professor of statistics at Stanford University and a member of SAB. R&S 113855 With respect to maintaining flexibility and not putting mutagenicity testing requirem nts "in bronze," Nelson said, "Sure things are in a major state of flux, but that state of flux Is going to lead to alternative ways of doing very much the same kind of things weVe doing now, but doing them in a more efficient way." The document will say that the battery shall be reviewed every three years for possible changes. Drake held that some of the eight test "could fall by the wayside" not because they're invalid, but.because "a more rapid or less expensive test may come along." In probably the most telling argument against bacterial tests not being relevant to man, Dr. SeymourAbrahamson gave some history on how, with respect to radiation, a-human risk estimate per Roentgen per gene using the mouse as a model has turned out to be "almost identical" to the human risk estimate which can be computed by using Drosophila (bacteria). Abrahamson said there is "good evidence" that man responds very closely to the mouse in terms of radiation sensitivity.* He said the U. S. spent over $50 million establishing the mouse as an appropriate model when it turns out that bacteria would have been just as good an indicator. He said the argument against the mutagenicity testing battery on economic grounds was untenable, since, by Abrahamson*s calculations, the battery would cost no more than $45,000 per compound. June 8, 1977 v Page 5 PESTICIDE & TOXIC CHEMICAL NEWS He said the most expensive test other than the mouse specific locus test (which is included among the 13 from which eight will be chosen because it's valid, despite its cost) is the Drosophila test, which would cost around $10,000 if the experimenter was trying to detect a doubling of the spontaneous mutation rate. Abrahamson said the Drosophila test could cost as little as $1,000 if the experimenter were looking for a more drastic response, such as a five-fold increase over the spontaneous rate. Abrahamson is based at the University of Wisconsin. The Wogan-Drake study group will meet June 15 to discuss the criteria document which will describe how EPA will interpret "mixed" mutagenicity testing results. r &S 113856 USDI LABORATORY TO pJPUT RPAR PROCESS WITH FISH, WILDLIFE EFFECTS DATA Fish-Pesticide Research Laboratory (FPRL), U. S. Fish and Wildlife Service, Interior Department, under an intragency agreement with the Environmental Protection Abency, will provide data on the effects of pesticides on fish and wildlife for use in the risk assessment portion of the rebuttable presumption against registration (HPAR) process. The agreeme/1, signed June 2 by Edwin L. Johnson, Deputy Assistant Administrator for Pesticide programs, EPA, stated that the FPRL, located in Columbia, Mo., would suppw apples of published and notification of unpublished results of research on thaeffects of about 150 pesticides --.RPAR candidates and alternatives -- on fish and wildlife. In the firsrt montk, the Laboratory would provide reprints and research results on about 60jpesticlaes, according to the agreement which has not yet been signed by the Flshiand Wildlife Service. After the first month, the agreement noted, research results and reprints would be required on 10 to 20 compounds a month. The Laboratory would aJLso supplv negative responses, the agreement provided. The agreement would expire Sept. 30, 1977. EPA would pay the Fish and Wildlife Serv^e about $10,1)00 for supplying the effects data. EPAjwlll list and assign priorities to the pesticides for which the Laboratory will poovide effects data'. W.8SQ CIVIL\ENA/TY AGREED TO BY THOMPSON-HAYWARD HEADS EPA ENFORCEMENT An agreementslgned by Thompson-Hayward Chemical Co. of Fayetteville, N. C., to * pay a $5,85$ civil penalty assessed by Environmental Protection Agency officials in Region y! \lghlighted recent pesticide enforcement activity. Page 12 June-8, 19 77 PESTICIDE & TOXIC CHEMICAL NEWS F ' that the "important thing Is how much product (grams? volume?) Is put on the plate to form colonies." He said that these data are critical to evaluate the potential f environmental hazard of this product. Correction: Notice of receipt of the new active ingredient registration application was published in the April 29 not April 30 Federal Register. OSHA CANCER PROPOSAL HIT; SEEN AS FAILING TO SPEED RULEMAKING The as-yet unproposed regulation under which .the Occupational Safety & Health Administration (OSHA) would regulate carcinogens and suspect carcinogens (See Feb. 16 Page 33) was ridiculed by a Dow Chemical Corp. executive last week at a public forum in Washington, D.C., as being an example^^SooFstrap logic" which could leave industry with no chemicals left to work with. At the same forum, which was sponsored by the Society for Occupational & Environ mental Health (SOEH), labor union officials criticized the proposal for not mandating that employers pay for employee protective clothing and equipment and medical examinations which OSHA carcinogen regulations do and will require. Jack Sheehan, Legislative Director of United Steelworkers of America and Chairman of the Policy Subgroup of the National Advisory Committee on Occupational Safety & Health (NACOSH), criticized the cancer proposal for not solving the problem of "rate retnetion" i.e. "mandatory relocation." As explained by Anson Keller, co-author of the OSHA proposal, the rate retention/ mandatory relocation dilemma pertains to an employer moving an employee to an area of a business operation where exposure to a regulated chemical is less. Such a change often results in a lower salary for the employee, since less hazardous work usually pays less. In short, Keller said, an employee could work for a firm for 30 years, get cancer, [and because of the detection, lose his high salary. The phenomenon:could prove to be an incentive for employees to avoid the medical examinations which OSHA wants employers to perform and make available. OSHA Administrator Elva Bingham is assembling an advisory group to study the problem. Unionists such as Sheehan derided the document one moment and commended it the next. OSHA was commended for attempting to improve Its performance in carcinogen regulation but was derided for not taking an even deeper plunge into labor-management relations. Grover Wrenn, a Deputy in OSHA's Health Standards Division, and defender of the proposal throughout the all-day symposium, said OSHA's health-protecting plunge was inadvertant and the extent of it was unforeseen, but Wrenn defended it as necessary. R&S 113857 June 8, 1977 VS Page 13 PESTICIDE & TOXIC CHEMICAL NEWS The Dow executive. Dr. T. R. Torkelson (See Page 3) hit the proposal for what he called "an obvious disregard for dose" when using laboratory animal tests to Dial determine whether a chemical is a carcinogen. Torkelson.got support from Dr. Roy Albert, Chairman of the Environmental Protection Agency's Carcinogen Assessment Group (CAG) (See May 18, Page 31), who asked if it "makes sense" to not consider i dose for purposes of classification. According to the proposal, a substance could be classified as a Category I carcinogen if it has been shown "at any dose level to cause the formation of malignant or benign neoplasms, or a combination thereof, in (a) man, or (b) two mammalian test species, or (c) a single mammalian test species if those results have been replicated1 in another experiment or by multi-test evidence for mutagenicity, or (d) upon the basis of any other evidence that the Secretary (of Labor) finds sufficient." A Category II classification would be triggered by "suggestive" evidence Of carcinogenicity from a single experiment on a single mammalian species, regardless of dose. Category I classification would prompt Issuance by OSHAof an emergency temporary standard which would be followed in 60 days by a proposed permanent standard. The proposed permanent standard would embellish the emergency standard and impose medical surveillance, workplace monitoring and other "model" require ments which OSHA wants to Impose "across the board" for all Category I chemicals. Engineering controls would be proposed to bring exposure to the Category I chemical down to the "lowest feasible" level, and if OSHA believed that "suitable" substitutes were available, a "zero" exposure level could be set. R&S 113858 \ ">rk lem. According to the proposal, issues at the hearing on the proposed permanent standard would be limited to: "(1) Whether the Secretary correctly classified the toxic material into Category I; (2) whether the Secretary was correct in his determination that the Category I classification should not be rebutted; (3) whether the Secretary correctly determined the lowest feasible occupational exposure, or whether there are suitable substitutes that are less hazardous to humans; (4) the appropriateness of the specific protective means of the proposed standard and (5) the environmental impact caused by such regulation." Issues also would be limited In hearings on Category II classifications. John Kolojeskl, moderator of the conference and President of Clement Associates (See June`1, Page 14) said that the proposed limitation on Issues, which is central to OSHA's . effort to speed rulemaking, could be construed as an abridgement of due "process, while Sheehan held that these very issues probably would be litigated every time OSHA proposed a standard. Therefore, Sheehan said, OSHA rulemaking is likely to remain largely a substanc -by-substance affair, characteriz d by delay. Page 16 June" 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS ` These cancer principles are essentially the same as those which have stretched out EPA cancellation proceedings on heptachlor and chlordane (See 33 June 1, Page 25). fCioO Once such review is completed, Wrenn contended, rulemaking would go faster. The speed argument appears to have been rebutted by Sheehan, but Kolojeski S argued in favor of making the document a regulation as opposed to a policy because the document's publication as a policy would not carry with it the mandatory timetables under which OSHA would be forced to propose permanent standards and take other actions . The document could be abandoned by the next Administration if it were simply a policy, Kolojeski said. Sheehan, on the other hand, argued that Federal Register publication of the proposal as a regulation would bog down OSHA in rulemaking on it and prevent OSHA from taking action on known problem chemicals. As an alternative, Sheehan suggested testing the policy on some real problems. Pointing to the recent OSHA activity on benzene (See June 1, Page 11), Wrenn denied that Federal Register publication of the proposal as a regulation would hamper OSHA in its efforts to deal with current problems.. As a remedy to industry delaying tactics, NCI's Schneiderman suggested that for any chemical tied up in litigation, all profits should be placed in a closed fund unavailable to the manufacturer. Richard Boggs of the National Institute for Occupational Safety & Health (NIOSH) asked how OSHA would handle chemicals which are similar in structure to those placed in Category I or II. He also asked for better definitions of the terms "feasible" and "detectable." As an indication of just how complicated these issues are and how deep emotions run, a labor,union official, misconstruing remarks made by Torkelson. said Dow is interested in DNA research because the firm wants to create a "super race" of chemical workers who are immune to cancer. Over 140 people from government, industry and academia attended the SOEH conference HOUSE COMMITTEE WANTS EPA TO ALLOW MIREX FOR FIRE ANT ERADICATION "In the hope that the Environmental Protection Agency will rescind its ruling on mlrex" the House Appropriations Committee has reserved $4,460,000 for a fire ant eradication program, (See March 30, Page 33). Page 14. Jane 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS Category II classification would prompt no emergency standard and no engineering controls, but an exposure limit would be set, as would medical surveillance and other "model" requirements. Rather than engineering controls, housekeeping practices and personnel protective equipment and clothing would be prescribed for Category II chemicals. Keller explained that Category II is needed to "gear up" in case in formation becomes available indicating that the chemical belongs in Category I. Jorkelson maintained that imposition of such requirements without consideration of the dose used in the animal experiment(s) would be irresponsible in light of the possibility that human metabolism could eliminate the threat which the chemical may pose. Dose in Backup Animal Studies "Irrelevant." Says OSHA's Wrenn Wrenn, however, responded that d<$e^was "largely irrelevant," since OSHA does not consider a threshold level to exist for carcinogens. Marshall Miller, a legal expert and a former Deputy Assistant Secretary of Labor for OSHA, said that potency i.e. dose would be factored into OSHA deliberations "subjectively" when OSHA, taking economics into account, sets its lowest "feasible"or "zero" exposure level. Wrenn also was supported by Dr. Marviti Schneiderman of the National Cancer Institute (NCI), who said that "cancer is bad," regardless of potency. Koloieskt said nmry>Hurps set out in thfi OSHA nrnnnsal eatery i and II classifications "take care" of Torkelson's concerns. St Justification for rebuttals on toxicological grounds are spelled out twice in the OSHA proposal, once for Category I chemicals and once for Category II. According to Section 1990.11 of the proposal, the Secretary of Labor may rebut the presumption of a Category I classification if he determines: "(a) that the alleged carcinogenic effect based on animal data clearly resulted from gon-spec^''' rather than chemical induction, or (b) that the route of exposure was grossly inappropriate relative to the . tional routes of human exposure, or (c) that the animal or human studies submitted for review were only suggestive or not adequate to establish any conclusion with respect to the carcinogenicity or noncarcinogenicity of the toxic materials or (d) that for some_otherbioloaicaj_reasonJ_ the positive results in experimental mammals are not scientifically relevant to man." u CO oo0c>0o Justifications are similar for a successful rebuttal of a Category II classification. A successful rebuttal places a chemical at least one category below the proposed one. I t nrr*- - - WS g other / 30 e June 8, 1977 Page 15 PESTICIDE & TOXIC CHEMICAL NEWS CAG's Albert Raises Sticky Regulatory Issue Just what constitutes "replication" of an animal test, however, is a particularly difficult issue, according to CAG Chairman Albert. At the SOEH meeting, Albert cited a "not uncommon" example he has run across at CAG where a pesticide now up for a rebuttable presumption against registration (RPAR) notice was found to produce tumors in a long-term study conducted by the Food and Drug Administration (FDA), but the tumors were found only at the lowest dose level, which is "strange in itself," Albert said. A long-term study by NCI was negative, Albert stated, as were two others. Another study on the same chemical, however, was found to be positive in one sex at one dose level, but the tumors which appeared in the dosed animals appeared later than spontaneous tumors observed in controls. Since tumors in dosed groups usually occur sooner than tumors in controls, this "replication" of an already "suspicious" FDA study is questionable, Albert said. Nevertheless, the finding could conceiveably trigger a Category I classification if the OSHA proposal is allowed to stand as is (Albert would not reveal the identity of the pesticide in question). Albert asked if positive findings in two dose groups in the same experiment would constitute "replication," aS suggested by Dr. David Clayson of the National Cancer Advisory Board. He also asked whether observation of a dose-response relationship could be considered "replication." No one answered his rhetorical questions. Generally, Albert expressed fears that OSHA's "black and white" proposal would give too much power to scientists. ; Squire Fears "Over interpretation" of "Suggestive" Bioassay Results Dr. Robert Squire , former Chief of the NCI Bioassay Program (See March 2, Page 22) tg and now at Johns Hopkins University and an Associate Scientist with Clement on Associates, Inc. , warned against linking "suggestive" NCI bioassay results to OSHA regulation under Category II. He said "overinterpretation of uncertain results has done more harm to toxicology than anything else." He held that NCI's research mission should be allowed to continue unencumbered by OSHA's regulatory mission. With respect to Category I classification. Squire said "results in a single mammalian species supported by incriminating in vitro data would be most con vincing if either both sexes or more than one dosage group were affected." There was considerable discussion on whether OSHA should simply adopt the proposal as an administrative policy, once it has been revised or, as an alternative, whether OSHA should publish it as a proposed regulation and subject it to judicial review. f' The argument for the latter procedur , as stated by Wrenn, would be that to spe " OSHA rulemaking, judicial r vi w is needed on the basic regulatory principles ; ,'r which OSHA follows every time it proposes a rule, on carcinog ns. v*' ll^l NOTICES 27053 j>V ment areas on the map. There are Testing of the Science Advisory Board's (FILL 733-3 PP7G1883/T1051 twenty-three counties where strychnine V:_,baits may be applied following establishEp}-: ment of the presence of rabid skunks near areas of human habitation; Environmental Health Advisory Com mittee will be hr!d at 9:00 am. on June 15. 1977. In Conference Room A (Uoinl xllUJ, Crystal Mall Building No. N-CHLOROACETYL'N-(2,6DIETHYLPHENYLJGLYCINE ETHYL ESTER Establishment of Temporary Tolerances ' 4. Exposure of any bait station within 2.1921 Jefferson Davis Highway, Arling Hercules. Inc.. Wilmington, DE 19899, !v a live (5) mile radius circle (to survey for ton. Virginia. lias submitted a pesticide petition (PP presence of rabid or suppress rabid skunk The purpose of tire meeting will be 7G1883) to the Environmental Protec 1/ populations) may not exceed thirty (30) to continue the discussion of Agency ap tion Agency (EPA). This petition re days; proaches to the evaluation of test data quests that temporary tolerances be es 5; Each strychnine lard bait will con- relating to mutagenicity In the context tablished for combined residues of the tain approximately 0.012 grams of actual of section 3, Registration, of Pesticides, herbicide lY-chloroacetyl-AM2,6-diethyl- *2? strychnine alkaloid. Each strychnine egg of the Federal insecticide. Fungicide, phcnyl) glycine ethyl ester and its major p/ bait will contain approximately 0.035 and Rodentlcide Act fFIFRA), as metabolites N-chloroacetyl-W-(2.6-di- ^-..grains of actual strychnine alkaloid; amended. cthylphcnyl) glycine ethyl ester gluta 6. The Applicant's personnel are re- The meeting will be open to the public. thione conjugate and JV-chloroacetyl-W- sponsible for preparing the strychnine Any member of the public wishing to (2.6-dlcthylphcnyl) glycine ethyl ester baits.' selecting bait stations, posting attend or submit a paper should contact cysteine conjugate in or on the raw agri X warning signs, securing premise entry the Secretariat. Science Advisory Board cultural commodities soybeans and soy f * agreements, checking bait stations pe- (A-101), trs. Environmental Protection bean forage at 0.2 part per million rlodlcally for kills, and retrieving all un- Agency, Washington, p.C. 20450. by (ppm) and sugar beet roots and tops at l S3?*- consumed bolts at the termination of thec.o.b. June 10. 1977. Please call Ms. Bar 0.05 ppm. control program; bara Robinson on (703) 557-7720. Establishment of these temporary tol 7. A maximum of two strychnine lard or egg baits per setting will be plnccd in Dated May 19. 1977. erances will permit the marketing of the abovo raw agricultural commodities Mi the following skunk habitats; skunk dens, Lloyd t. Taylor, when treted In accordance with an ex holes, garbage dumps, road culverts, junk Acting Staff Director. perimental use permit that is being is piles, and unoccupied buildings; Science Advisory Board. sued concurrently under the Federal In ggthi 8. Strychnine-treated lard or egg baits J,( will be placed only on those lands where JPR Doe.77-14948 Filed 5-35-77;8:45 am] secticide, Fungicide, and Rodenticide Act . (FIFRA), as amended (86 Stat 973, 89 premise entry agreements have been Stat. 751; 7 U.S.C. 136(a) et seq.k signed by the landowner, lessee, or ad (OPF-43009B; FRL 733-7] An evaluation of the scientific data re ministrator; 9. Warning signs will be posted at en WASHINGTON ported and other relevant material has shown that the requested tolerances are tries to all premises and other visible po Extension of Contingent Approval of State adequate to cover residues resulting from sitions near locations where treated bolts Plan for Certification of Pesticide Appli tho proposed experimental use. and it . | have been placed; 10. Each bait station will be cheeked as often as possible for kills, but. In any case, no less than once a week; 11. All retrieved or excess strychnine baits will be disposed of by burial at least 18 inches deep in an approved sanitary landfill. Containers to be destroyed will be handled In a similar manner; 12. Animals poisoned in the control v program will be submitted for laboratory !$? analysis for presence of, rnblcs virus If possible. Otherwise, they will be burled on cators In accordance with the provisions of section 4(a) (2) of the Federal Insecti cide, Fungicide, and Rodcnticldc Act (FIFRA) as amended (86 Stat. 973 ; 7 T7.S.C. 136 et seq.) and 40 CFR Part 171 (39 FR 36445 (October 9. 1974) and 40 FR 11698 (March 12.1975)). the Honor able Daniel J. Evans, Governor of the State .of Washington, submitted a State Flan/for Certification of Commercial and Private Applicators of Restricted Use Pesticides to the Environmental protec has been determined that the temporary tolerances will protect the public health. The temporary tolerances are established for the pesticide, therefore, with the folr lowing provisions: 1. The total amount of the pesticide to bo used must not exceed the quantity authorised by the experimental use per mit. 2. Hercules, -Ine,, must immediately notify the EPA of any findings from the 33 99 0) COaroD>D ir-g the premises to prevent possible sec- tion Agency (EPA) for approval on a experimental use that have a bearing on jjjaondary non-target species poisonings; contingent basis, pending promulgation safety. The firm must also keep records "Tv'. 13, The Applicant must follow any more stringent requirements imposed by State law or regulation or applied by the State pesticide regulatory authority; and ^ *% 14. The specific exemption expires on of Implementing regulations. On Jan uary 7. 1976. the Regional Administra tor, EPA Region, X, approved the plan on a contingent basis for a fifteen month period. Notice of the approval was of production, distribution, and per formance and on request make the rec ords available to any authorized ofllcer or employee of the EPA or the Food and -T/iV;i M' satracthuto31ry, 1978. authority: Section 18 of the published in the Federal Register on February 18, 1976 (41 FR 7449). Legal w.b Federal Insecticide, Fungicide, and Roden-' authority for the program is contained ticide Act (FIFRA). as amended (86 Stat. in the Washington Pesticide Control 973; 89 Stat. 751; 7 VS.C. 136(a) et seq.). Act, Washington Pesticide Application Dated: May 19. 1977. Act, and Washington Regulations. __ James M. Conlon. On April 7, 1977. the State Of Wash , Acting Deputy Assistant Ad ministrator for Pesticide Pro grams. ington requested an extension of the Washington contingent approval pend ing promulgation of the regulations as (FR Doc.77-14950 Filed 5-25-77;8:45 am) described in the State Plan. The Agen cy finds that there Is good cause for IFILL 734-1] ' approving the request, and has granted an extension until September 1, 1977. Drug Administration. These temporary tolerances expire April 11, 197B, Residues not in excess of 0.2 ppm remaining in or on soybeans and ,t. soybean forage and 0.05 ppm In or on sugar beet roots and tops after this ex- piratlon date will not be considered ac tionable if the pesticide is legally applied during the term of and in accordance . % with the provisions of the experimental * use permit and temporary tolerances.These, temporary tolerances may be re- . voked if the experimental use permit is * revoked or if any scientific data or ex Dated; May 16,1977. perience with this pesticide Indicates;, - LV"S TEE study group on mutagenicity V*-.JESTING * Donald P. Dubois. Regional Administrator. U.S. such revocation is necessary to protect. the public health. Inquiries concerning .. - Open Meeting ( Notice is hereby given that a meeting Environmental Protection Agency, Region X. this notice may be directed to Libby /. Zink, Registration Division (WH-567), - the Study Croup on Mutagenicity JFR Doc.77-14049 Fllod 6-26-77:8:45 am] Office of Pesticide Programs, Room 315, '.' FEDERAL-REGISTER, VOL 42,. NO. 102--THURSDAY, MAY 26, 1977 f V i., 4. A '-*1 2SS72 NOTICES * procedure (1% neutral buffered potas ticol to the analyzer, described In the sium iodide standardized with arsenlous designation. In many cases, such ana oxide) specified in Appendix D of 40 lyzers may be upgraded (e.g,, by minor CFR Part 50, as amended on February modification or by substitution of new 18,1975 (40 FR 7042), This method is: operation or instruction manual) so as RFOA-0577-020, "Beckman Model to be identical to the designated method 950A Ozone Analyzer," operated on a and thus achieve designated status at range of 0-0.5 ppm and with the modest cost. The manufacturer should "SLOW" <60 second) response time; be consulted to determine the necessity with or without any of the following and feasibility of such upgrading. options: Part 53 requires that sellers of desig Internal Ozone Oenerolor Computer Adaptor Kit. nated methods comply with certain con ditions. These conditions arc given in 40 CFR Part 53.9 and are summarized This method Is available from Beckman below: Instruments, Inc., Process Instruments (1)A copy of the approved operation Division, 2500 Harbor Boulevard, Fuller or instruction manual must accompany ton, California 92634. A notice of receipt the analyzer when It Is delivered to the of application for this method, submit ultimate purchaser. ted by Beckman Instruments, Inc., ap (2) The analyzer must not generate peared in the Federal Register, Volume any unrcasonablehazard,to operators or 41, October 19,1976, page 46019. to the environment. A test analyzer representative of the (3) The analyzer must function within first method has been tested by the State the limits of the performance specifica of California Air Resources Board in ac tions given in Table B-l of Part 53 for cordance with the test procedures speci at least 1 year after delivery when main fied in 40 CFR Part 53. In addition, cer tained and operated in accordance with tain supplemental tests were also conducted by EPA. After reviewing the the operation manual. (4> Any analyzer offered for sale ns a results of all these tests as well as other reference or equivalent method must information submitted by the applicants, bear a label or sticker indicating tliat it EPA has determined, in accordance with Part 53, that this method should be des has been designated as a reference or equivalent method in accordance with ignated as on equivalent method. Simi larly, a test analyzer representative of the second method has been tested by the applicant, also in accordance with the test procedures specified in Part 53. After reviewing the test results and In formation submitted, EPA has deter mined, in accordance with Part 53, thattills method should be designated as a Part 53. (51 If such an analyzer has one or more selectable ranges, the label or sticker must be placed in close proxim ity to the range selector and Indicate which range or ranges have been desig nated as reference or equivalent meth ods. <6) An applicant who offers analyzers reference method. The information sub mitted by the applicants will be kept on file at the address shown below and will be available for Inspection to the extent consistent with 40 CFR Part 2 (EPA's regulations implementing the Freedom of Information Act). As reference and equivalent methods, these methods are acceptable for use by States and other control agencies for purposes of section 51.17(a) of 40 CFR Part 51 ("Requirements for Preparation. Adoption, and Submittal of Implementa tion Plans") os amended on February 18, 1975 (40 FR 7042) . For such use, a method must be used in strict accordance with the operation or instruction manual provided with the method and subject to any limitations <e.g,, operating range) specified in the applicable designation (see description of the methods above). Vendor modifications of a designated method used for purposes of { 51.17(a) are permitted only with prior approval of EPA. as provided in Part S3. Provisions concerning modification of such meth ods by users were promulgated on March 17, 1976 (Federal Register, Vol. 41, page 11255). In general, each designation applies to any analyzer which Is Identical to the analyzer described' in the designation. However, similar analyzers manufac tured prior to the designation and bear for sale as reference or equivalent meth ods Is required to maintain a list of ul timate purchasers of such analyzers and to notify them within 30 days if a re ference or equivalent method designa tion applicable to the analyzer has been cancelled or if adjustment of the ana lyzers is necessary under 40 CFR 53.11 (b) to avoid a cancellation. (7) An applicant who modifies an ana lyzer previously designated as a refer ence or equivalent method is not per mitted to sell the analyzer (as modi fied) as a reference or equivalent method (although he may choose to sell it with out such representations), nor to at tach a label or sticker to the analyzer (us modified) under the provisions de scribed above, until he has received no tice under 40 CFR 53.14(c) that the ori ginal designation or a new designation applies to the method as modified or un til he has applied for and received no tice of a new reference or equivalent method determination for the analyzer ns modified. Aside from occasional breakdowns or malfunctions, consistent or repeated non-compliance with any of these condi tions should be reported to: Director, Environmental Monitoring and Support Laboratory, Department E (MD-70), U.S. Environmental Protection Agency, ing the same model number as the des Research Triangle Park, North Carolina ignated method are not necessarily ldcn- 27711. Ja 'ij Designation of these references and e [Uivalent methods will provide assistr ace to the States in establishing and o aerating their air quality surveillance systems under 40 CFR 51.17(a). Addlt onal Information concerning this' act on may be obtained by writing to the undress given above. Wilsoh K. Talley, Assistant Administrator for Research nad Development. IFR Dnc.77-18077 Filed 0-3-T7;fl:45 *mf 1OPP-OOOS3 FRL 741-11 FEDERAL INSECtlCIDE, FUNGICIDE, AND RODENTtCIDE ACT SCIENTIFIC AD VISORY PANEL -- Meeting AGENCY: Office of Pesticide Pro grams. Environmental Protection Agency iEPA>, ,; ACTION: Notice of meeting. SUMMARY: There will be a two-day l ' meeting of the Federal insecticide. Fun- ^ giclde. and Rodcntlclde Act (FIFRA) . t Scientific Advisory Panel from 9:30 ajn.' to 4:30 pm. dally on Monday, June 20, and Tuesday, June 21, 1977. The meeting will be held in Room 1112A, Crystal Mall, Building Number 2. 1921 Jefferson Davis Highway, Arlington, Virginia. FOR FURTHER INFORMATION CON TACT: ; Dr. H. Wade Fowler. Jr.. Executive Secretary, FIFRA Scientific Advisory j Panel, Office of Pesticide Programs! (WH-567), Em, E-316, EPA, 401 M St. SW.. Washington D.C. 20460, tele phone 202-755-4851. SUPPLEMENTARY INFORMATION: In accordance with Section 25(d) of the amended FIFRA, the Scientific Advisory Panel will comment on the impact on health and the environment of regula tory actions under section 6(b) and 25(a) prior to implementation. The pur pose of this meeting is to discuss the following topics: <1) Continued review of the advanced draft of the subpart on Hazard Evalua tion: Humans and Domestic Animals of the Guidelines for Registering Pesticides in the United States. 2. Continued'review of the proposed regulations for1 2cl3assification of pesti cides os required under Section 3(d) of FIFRA, amended. (Note: This will be. discussed only If needed. The proposed document was- reviewed on May 26-27, 1977). 3. The Agency may present back ground Information on changes antici pated in its basic regulatory approach to pesticides. Such a presentation would involve a discussion of a genericchcmical-standnrds approach to reg ulation. The meeting will be open to the public. Any member of the public wishing to attend or submit a paper should contact Dr. H. Wade Fowler, Jr., Executive Sec retary, FIFRA Scientific Advisory Panel, FEDERAL REGISTER, VOL 42, NO. 107--- FRIDAY, JUNE 3, 1977 'A / R&S 113863 I i ifffflfttfiy** .1 * NOTICES 2S573 Office of Pesticide Programs (WH-567), Room E-315, EPA, 401 M St SW.. Wash ington D.C. 20460, telephone; 202-755; 4851). Interested persons arc permitted 1 to hie written statements before or after other than those listed under Part 21, the cut-off date for filing a mutually exclu sive application is the close of business one business day preceding the day on which the previously filed application is 3123G-CD-P-77 Susquehanna Mobllo Com munications, Inc. (new). Resubmitted. C.P. for a new l-Way station to operate on 15234 MHz to be located at Holly Pike. Route 34. approximately 1.1 mllea south ofCnrlLilc, Pennsylvania. the meeting, and may upon advance no designated for hearing. With limited ex 2I391-CD-F--(2)--77 Statesboro Telephone tice to tire Executive Secretary, present ceptions, an application which is subse Company (KWA654). C.P. to change an oral statements to the extent that time permits. Written or oral statemens will be taken into consideration by Uie Panel in formulating comments or in deciding to waive comments. Persons desirous of quently amended by a major change will be considered as a newly filed application for purposes of flie cut-off rule. (See { 1.227(b) (3) and 2U0(b> of the Com mission's Rules.) tenna system operating on 163.09 MHz; add 152.61 MHz to bo located at 76 E. Grady St, Statesboro, Georgia. 2]302-CD-P-(2)-77 Mobllfone Communica tions, Inc. (HICX714), C.P. to change an tenna system and relocate faculties operat making oral statements must notify the ' Executive Secretary and submit four copies of a summary, no later than June 18, 1977. Individuals who wish to flic written statements are advised to submit ten copies of statements to the Executive Sly , Secretary in a timely manner to appropriate consideration by the ensure Panel. Dated: June 1,1977. James M. Conlon. Deputy Assistant Administrator. /or Pesticide Programs. (Pit Doc.77--16877 Piled 6-2-77:8:48 am] FEDERAL COMMUNICATIONS COMMISSION 1 (Report No. 8601 COMMON CARRIER SERVICES y," INFORMATION ... ' Applications Accepted for Filing May 31. 1977. L- The applications listed herein have ^3* been found, upon initial review, to be ac- ceptable for filing. The Commission ie' serves the right to return any of these Federal Communications Commission. Vincent J. Mullins. Secretary. Applications Accepted rot Filing DOMESTIC PVSL1C.LSND MOBILE RADIO SERVICE 31380-CD-P-77 Mobile Radio System or Ventura, Inc. (KSVD76), CJ>. for additional faculties to operate on 16334 MHz to be lo cated at a new site described as location No. 3; At Red Mountain. Approx. 6.0 miles NtV. of Ventura. California. 313SI-CD-P-77 Calhoun City Telephone Company (KUS373). CJ*. to change anten na system operating on 158.10 MHz located 0.4 mile cnat of Derma, Mississippi. 31382-CD-P-T7 DPRS. Inc. t/a Zip-Call (KCS8DO), CP. for additional facilities to operate on 43-58 MHz to be located at a new site described as location No. 33; Oh Alpine Rond, H mile JT. of Fitchburg, Massachu setts. 213S3-C-P-(4)-77 Adirondack Mobile Tel ephone Co, Inc. (new), c.P. for a new 2Way station to operate on 163.00 163.18 MHs at location No. 1 to be located at Beekman Court; and location No. 3 to operate on 162.06 162.18 MHs to be located at WGFM-FM Tower; Rand Bill, Platts burgh. New York. 21384-CD-P-77 Marc Weber Tobias and ing on 152.03 153.31 MHz from location No.' 3 to a new site described as location No. 3 to be located 13 miles south of Intersection of Highway 3344 nnd Highway 300, approxi mately 3 miles west of Austin. Texas. 21393-CD-P-77 Jackson Mobllphone, Inc. (new) . C.P. for n now 1-way station to op erate on 152.34 MHz to be locatod on VS. Highway 43, Intersection of No. 3. Jackson, Alabama. 21394-CD-P-T7 Jackson MobUephone. ine. (new). C.P. for a new 3-way station to op erate on 152.06 MHz to bo located on High way 43, Intersection of No. 3, Jackson, Alabama. 3139$-CD-p-(3)-77 The Mountain State Telephone and Telegraph Company (KOK345). C.P. to change antenna system and replace transmitter operating on 1G3.75 MHz; Add 15344 Mils to be located at 3.0 miles west southwest of Pocatello, and Test facilities to operate on 157.80 MHz located at 455 West Lewis Street. Pocatello. Idaho. 313!>6-CD-IW0)-77 South Central Bell Telephone Company (KTC343), C.P. to re locate facilities operating on 454.375. 454 450. 454.475, 454425. 454.600. 454.025 MHz to be located approximately 4 miles northeast of Pogrom. Tennessee. MAJOR AMENDMENT 3101l-CD-P-(3>-77 E. P. Mitchell, Jr. d,b os Douglas Radio (BRMQ67), Amend base frequency 454.135 MHz to read 454.200 y applications, if- upon further examine- Michael Charles Tobias d/b os MT Systems. MHz. All other particulars are to remain >*: tlon. it is determined they are defective Inc. (new). C-P. for a new 3-Way station to 'v and not In conformance with the Commission's Rules and Regulations or its l policies. t Final action will not be taken on any operation on 15331 MHz to be located North, of Rt. 34 at the SW. corner of Wes- sington Springs; South Dakota. 31365--CD-p-3-77 Mount View Communica tions (new), CP. for a new station to op T-; of these applications earlier than 31 days erate on 163.09 (base) and 460.075 (Re '. following the date of this notice, except peater) MBs to be located at Aqua.Ramon v for radio applications not requiring a Mountain. 6.1 miles NB. of South Pork;, 30-day notice period (See l 309(c) of the 1 Communications Act), applications filed `under Part 88. applications filed under 'Part 63 relative to small projects, or as and 464.076 MHz (Control) at location No. 2 to be located 716 let Avenue, Monte Vista. Colorado. 31380-CD-P-77 RCC of Virginia, Inc. (new), C.P. for a new 1-Way station to operate on otherwise noted. Unless specified to the * 1S234 MHz to be located at Rt. 47, ap > contrary, comments or petitions may bo proximately 600 feet east of the western tho same ns reported on PN No. 853 dated AprU 4,1977. INrOSMATIVZ It appeals that the following applications may bo mutually exclusive and subject to the Commission's Rule regarding Ex Parte pre sentations by reason at economic competition or potential electrical Interference. CALIFORNIA Tadlock's Radio Dispatch (KMA359) Bald Mountain, 0991-CD-P-1-77. SUvcradla Communications (Hew) Napa, . 21392-CD-P-2-77. filled concerning radio and Section 214 city limits. South Hill, Virginia. RURAL RADIO SERVICE applications within 30 days of the date of v this notice and within 20 days for Part 68 vr applications. 7 ' % In order for an application filed under Part 21 of the Commission's Rules (Do mestic Public Radio Services) to be con sidered ' mutually exclusive with anyt >other such application appearing herein* it must be substantially complete and i- tendered for filing by whichever date Is .v, earlier: (a) The close of business one . business day preceding the day on which . the Commission takes action on the pre- 31387-CD-P-77 Citizens Telephone Com pany. Inc. (new), CP. for a new 2-Way sta tion to operate on 152.76 MHz to be lo cated Union Street, Vienna, Georgia. 213B&-CD-P-77 Citizens Telephone Com pany, Inc. (new), CP. for a new 1-Way sta tion to operate on 152.84 MHz to be lo cated at Bond and. Washington Streets. Plains. Georgia. 21380-CD-P--77 Digital Paging Systems of Pittsburgh, Inc. (KWB370). CP. to change antenna system operating on 15234 MHz located 1715 Grandview Avenue, Pitts 60277-CR-P/L-77 Tucrto Rico Communica tions Authority (new), CJP. and License for a new Rural Subscriber station to oper ate on 454.375, 454.400, 454.425. 454.450. 45-1.475, 454.600, 454.526. and 454.650 MHz to be located at Bo. Anancs, Carr. 162 Ramal 813 Km 1.4, Naranijlto, Puerto Rico. 80278-CR-P/L-77 Same as abovo located at Bo. Quebradilla Carr. 900 Km. 9.7, Yabueoa, Puerto Rico. 60279-CH-P/L-77 Same as above to bo lo cated at Bo. Qucbnvda Grande Carr. 902 Km. 4.4, Snn Lorenzo. Puerto Rleo. 60270-CR-P/L-77 Same rs above to be lo cated at Bo. Tcjns auayabal Carr. 931 Km. viously filed application; or (b) Within burgh, Pennsylvania. 3.3, Humacao, Puerto Rico. -60 days after the date of the public notice 21390-CD-P-77 R.C.S, Inc. (KRM971), C.P. 60280-CR-F/L-77 Samo as above to be lo listing the first prior filed application for additional faculties to operate on cated at Bo. Aguacaeo Comuncs Ramal 9904, (with which the subsequent application Is in conflict) as having been accepted for filing. In common carrier radio services JTfc - 15334 MBZ to be located at a new site de scribed as location No. 6; 933 North I (1 Km. do Carr. 903), Yabueoa, Puerto Rico. 60281-CR--P/L-T7 Same as above to bo lo cated at Calle Pedro Marquez Dsq. William Street, Lompoc, California. Font. Culebra, Puerto Rleo. R&S 113864 , 1977FEDERAL REGISTER, VOL 42, NO. 10P--FRIDAY, JUNE //mss*' i SOCIETY FOR OCCUPATIONAL AND ENVIRONMENTAL HEALTH 1714 Massachusetts Avenue, N.W. Washington, D.C. 20036 (202)785-8177 R&S 113865 December 16, 1977 Dr. T. R. Ttarkelson Corporate Medical Department The Dow1 Chemical Company Bennett Building 2030 Dow Center Midland, Michigan 48640 Dear Dr. Ttarkelsan: This letter is written in response to ycur inquiry of November 16, 1977. There is neither a transcript nor a tape recording of proceedings of the SGEH working conference, "Inp.1 ications of the OSHA Proposal on Carcinogen Regulation". sPtticKcT*TCfoIpf*mU c-4ice 5 *. o THE DOW CHEMICAL COMPANY 33 CCO 03 CO ccnn | SOCIETY FOR OCCUPATIONAL AND ENVIRONMENTAL HEALTH 171^ Massachusetts Avenue, N.W., Washington DC 20036 (202) 783-8177 TO: Discussants, SOEH Working Conference: Implications of the OSEA proposal on Carcinogen Regulation DATE: April 27, 1977 FROM: Sandy Zimmerman Executive Director SUBJECT: Additional Information for June 2 Conference As promised, a copy of the draft OSHA proposal on carcinogen regulation is enclosed. We have also prepared and enclosed a Table of Contents for the proposal to facilitate easy reference to specific sections. The preliminary program was mailed to all SOEE members on April 26, 1977 < A copy is.enclosed. As soon as I receive copies of the presentations by the primary speaker.?, I will let you know. Please cell if you have eny questions. Enclosures (2) R&S 113867 TABLE OP CONTENTS Regulation of Certain Toxic Materials Identification, Classification and Regulation of Toxic Materials Posing a Potential Occupational Cancer Risk to Workers Page Notice of Proposed Rulemaking...................................................................... 1 I. The Regulatory Dilemma........................................... A. Nature of the Disease -...............................................................* B. The Increase in Cancer and Its Massive EconomicImpact .... 6 6 7 C. The Recognition that the Development of Cancer is In fluenced by Environmental and Occupational Factors...................10 D. Most Agents Appear Not to Be Carcinogens even at HighDoses . 12 E* Latency and Irreversibility of Effect................................. ... . 16 1. Irreversibility............................ l6 2. Long Latent Period...................... ............................................ 17 F. Known Human Carcinogens Are also CarcinogensinAnimals ... 18 G. Regulatory Approach....................................... 20 II. Identification of Toxic Materials that Pose a Carcinogenic Risk to Man......................... 26 A. Human Studies .................................................................. ..... 27 R&S 113868 B. Animal Studies.............................................................. 31 C. Short-Term or In Vitro Tests for Carcinogens............................83 D. Rate Retention or Mandatory Relocation............... .........................85 III. Classification and Regulations: The Proposal.............................. ... 87 A. General ................................................................................................... 87 B. Provisions of the Uniform Standards.......................................... 92 1. The emergency temporary standard for a Category I Toxic Material. (1990.40) 92 2. The permanent standard for a Category I Toxic Material. (1990.50)................................................................................ 93 a. Scope and application ............................................ ... . 93 ____ -y- .. .......... ------ ------------^ * TABLE OF CONTESTS Regulation f C rtaln Toxic Mat rials Page Two b. Exposure limit . . ................................................................93 c. Measurement of exposure......................... 94 d. Methods of measurement ............................................................99 e. Methods of compliance............................................ 93 f. Regulated area......................................................................... 97 g. Housekeeping and waste disposal................................. . . 9? h. Medical surveillance ................................................................98 i* Qnployee Information and training.....................................99 j. Recordkeeping........................................................................ 100 k. Observation of monitoring .................................................. 100 l. Appendixes......................... 101 3. The permanent standard for a Category IX Toxic Material. (1990.60)..................................... `1...........................................101 IV. Environmental Impact Assessment............................................................103- 1. Introduction....................................................... ... ..................... . . 103 2. Pertinent Legal Authority........................................... 10U 3. Public Participation............................................................................ 107 Proposed Addition to Title 29 of Code of Federal Regulations as Part 1990 ...................... -..................... ................................. Appendix A: Textile Workers Union of America and North Carolina Public Interest Research Group (Plaintiffs) v. Wm. J. Usery, Jr., Secretary, Department of Labor (Defendant) ...... Ill 176 R&S 113869 1200 'J&3& CHEMICAL REGULATION REPORTER by any toxic substances to which they are exposed in the He called "horrendous" the. timetable OSHA has devised workplace. for comments and hearings on the proposal. Public hearings The bill would provide protection to employees so that they are scheduled for March 14. 1978, and the deadline for could not be discharged or discriminated against because written comments is set for December 8. Lang said SOCMA they applied for compensation, participated in a claim would ask the agency for an extension. proceeding, or participated in any other action to carry out the purposes of the Act. Under the bill, victims of toxic substance pollution would be eligible for compensation, medical benefits, rehabilita Guidelines tion services, and other benefits for disability or death as claimed by the victim or the survivors of the victim and ap proved by the Administrative Board. The compensation would be equal to the victim's actual lost wages or equal to 100 percent of the statewide average weekly wage of the state in which the victim lives. Brodhead's spokesman said this compensation system would not affect benefits paid to coal miners disabled by black lung, state workmen's compensation programs, or any other workmens' compensation program. The spokesman explained that the congressman considers the bill he introduced to be a "discussion draft." He could not speculate what action the House might be inclined to take op the measure. The bill was referred jointly to the House Commerce and Ways and Means Committees. EPA ADVISORS CRITICIZE PROPOSALS - FOR MUTAGENICITY TESTING PROTOCOLS Revised guidelines for mutagenicity testing came under fire from the Federal Insecticide, Fungicide, and Rodenticide Act Science Advisory Panel during an October 25-26 meeting at the Environmental Protection Agency. According to a statement supported unanimously by the panel, although not formally adopted, there is a need for a more critical survey for mutational events and for a survey of those events capable of producing mutations in test systems. The statement continues: "A more prudent course would require that mutagenicity assays be carried out on all new products. We would suggest that the selection of tests be chosen to maximize their reproducibility and that cross species responses be surveyed. We have reservations about the testing system that has been proposed" (Current Report, October 21, p. 1175). Carcinogens "The document presents a protocol that is largely in vestigational rather than practical," the statement says, and SCCMA DIRECTOR CRITICIZES adds "concern centers upon practicality of these test PROPOSED GENERIC CARCINOGEN RULE protocols for mutagens of different chemical structure, in NEW YORK -- (By a Chemical Regulation Reporter staff correspondent) -- A proposed generic policy for regulating carcinogens is an over-simplified approach terlaboratory reproducibility, and ease of performance by available laboratory personnel. Unsolvable legal argument arising from this testing may obscure the intent of the and will result in "fill in the blank" standards, the exe program itself." cutive director of the Synthetic Organic Chemical Manu According to the statement, the panel agreed to establish a facturers Association said October 18. critical review committee, constituted of outside experts, to Konald Lang told a press briefing that the proposal by the consult with the panel in evaluating the proposed tests and Occupational Safety and Health Administration represents possibly suggest an alternative and more practical protocol. the first regulatory effort to set a national cancer policy The statement also says that the panel concurs with the (Current Report. October 7. p. 1049). Other federal agencies conclusion reached at a mutagenesis meeting held last year already have expressed interest in the proposal, he said. in Great Britain that "Overall, the general feeling was that W'hile the rule would provide a much easier way for OSHA as yet no single test or panel of tests can accurately predict to deal with substances with potential carcinogenic risk, potential hazards to man." Lang explained, he does not believe it is the correct ap During a presentation to the committee on the revised proach. He said that OSHA's starting point will be the list of guidelines, John W. Drake. National Institute of En suspected carcinogens drawn up by the National Institute for vironmental Health Sciences, told the panel that tests for Occupational Safety and Health. The proposal makes it mutagenicity have to be able to assess mutagen specificity, possible for a substance to be categorized as a Class I car should concentrate on heritability. should evoke a positive cinogen if in simple tests it causes tumors or shows signs of response, should have qualitative sensitivity, and should being mutagenic. Lang said. Once a substance has been so have to be validated. categorized, he noted, a mechanism is triggered for develop Drake said that a battery of tests was selected because no ment of an emergency standard. If there is a substitute single point-mutation test is available at this time for mam chemical available, exposure for the original substance is mals and testers have to fall back on sub-mammalian sub set at zero, which amounts to "an effective ban," he added. jects. If positive results occur in one mammalian test, the According to Lang, OSHA Administrator Eula Bingham compound tested is a mutagen and a potential human |i has said that the agency can halt the triggering mechanism if it feels such a move is warranted. Bingham has called mutagen, Drake said, but he added that in using sub-mammalian^subjects, a minimum of two tests should be used. these options "escape hatches," Lang said. However, he ex pressed doubt that once a substance has been linked with cancer Bingham would be able to say it would not be regulated. Public pressure would be too great, he said. Water Pollution SOCMA has not yet determined what it will propose as an alternative. Lang said, but he stressed that the association believes there should be sound scientific evidence for EARLY MOMENTUM SLOWS IN WATER ACT CONFERENCE regulatory action. It should take more than a benign tumor Congressional conferees attempting to amend the Federal ii to have a substance labeled a carcinogen, he added. Water Pollution Control Act are encountering delays in Chemical Regulation Reporter R&S 113870 f ( iV / Qiom tli& cUdi of... Marguerite L. Long 4//V/77 fiMZJLud s&ueZZ^j t **Z*z*+ a*U- Z& $**# ^ s&tu /U* ***** #r JGU& . T* *** ff - . _ /}eLv*****^ ^ & *^G otVi.* ru /3&ms**C si&ZZju* 7*** '~9n*U'c * /pnttJfe-y /f^0t&.^u*** J 7rt- n c&o 0CN0O v ~i i R&S 113872 '-* -1---- **2. *a*&*m*.7 *' Detailed coverage and in-depth analyses, every week, of key developments regarding the laws and. regulations governing pesticides and toxic chemicals /w..- S160 a year Additional subscriptions $105 Volume 5, Number 28 June 8, 1977 l CHEMICAL PROCESSORS must report for TSCA inventory; premarket notification probably won't start on time. Page 9 l OSHA CANCER APPROACH assailed on toxicology, rigidity and likely effect. Labor unions say OSHA is too timid. Page 12 EPA TRADE SECRET AMENDMENT for pesticide data "wide open." Page 32 PESTICIDE DATA requirements may stop being "ever moving targets." Page 30 MUTATION TESTS for pesticides approved; Dow exec says no. OTS "TIERED" TESTING PROPOSAL bogs down at SAB: Delay likely. Page 3 Page 33 VINYL CHLORIDE "secret deal" denounced by plastics industry. Page 27 PESTICIDE STANDARDS implications queried by EPA planning group. Page 23 PESTICIDE STANDARDS approach explained by OPP; lf3G0 likely. Page 2S REGISTRATION/REREGISTRATION replaces classification as top priority. Pag 17 CANCELLATION of 300 products requested by 90 firms. Page 28 NCI LINDANE STUDY may be useless; RPAR comments noted. Page 21 MIREX money set aside by Appropriations Committee; use defended. Page 16 50 P.P.M. DIOXIN in Michigan cow livers linked to PCP. Page 20 SODIUM AZIDE hazard figuring into DOT decision on auto airbags. Page 34 PESTICIDES IN DRINKING WATER advice from NAS "unusable*." EPA staff. Page 28 FISH AND WILDLIFE data to go into RPARs thanks to Interior. Page 5 PESTICIDE REPORTS policy set by ALJ in civil penalty case. Page S THOMPSON-HAYWOOD hit with big civil penalty, others noted. Page S NORTELL LABS accuses EPA of playing favorites on product. Page 10 PESTICIDE PRICES in Canada unchanged by import registration. Page 10 GUTHION, DINOSEB get Section 18 exemptions for carrots, lentils. Page 24 Published Weekly by FOOD CHEMICAL NEWS. Inc-. 420 Colorado Bldg.. T341 G St..N.W., Washingto.-r. D.C. 20005 For subscribers only--copyrighted * FOOD CHEMICAL NEWS, Inc. 1977 STerling3-7472 Page 2 June 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS i PESTICIDE ADVERTISING TRR which has been under consideration by the Federal Trade Commission may not be issued because FTC now thinks it already has enough authority to enforce against advertising abusers, according to an EPA official. A Commission official said no decision had been made on TRR issuance, but admitted that the option of not issuing it would be considered at a public meeting set for today, June 8. EPA-ers noted that FTC may be worried about the time and expense of preparing a final TRR and said that there is some feeling that the problem of false advertising has abated (See Nov. 17 Page 5). ' E PA DEN IA L of 100 p.p.m. tolerance petition for Captan on seed corn (See June 1, Page 2) could result in review by an NAS advisory committee. Some EPA officials expect an appeal to an NAS committee to be filed (See Nov. 3, Page 5 and Nov. 24, Page 5). CAPTAN RPAR decision is expected to be made about Oct. 15 (See June 1, Page 2). ETHYLENE OXIDE RPAR decision is expected this month (See May 18, Page 27}. The RPAR, if issued, would be based on'mutagenicity and/or oncogenicity, Edtoin L. Johnson, Deputy Assistant Administrator for Pesticide Programs, EPA, has indicated. 1,:. MALEIC HYDRAZIDE RPAR notice is now scheduled to be Issued June 24 (See May 25, Page 2). PRO NA MIDE R PAR rebuttal time extension to August 26 has been requested by Rohm and Haas, sole manufacturer of the technical grade product and the 50% wettable powder marketed under the name "Kerb- 50-W." The firm said EPA raised some points it had not considered of concern and noted that additional time was needed to evaluatethe RPAR notice (See May 11, Page 11). ( KE PO NE CAN CELLATION hearing parties who have yet to file formal objections and labeling have been given'until June 17 to do so by EPA Administrative Law Judge Bernard D. Levinson (See Junel, Page 2). TSCA TESTING Committee, when it submits its list of no more than 50 chemicals for which EPA should require tests under TSCA, also will list chemicals for which information appears to be sufficient to make further testing unnecessary. Whether such information justifies regulation will be up to EPA (See June 1, Page 14). GENERIC STANDARDS FOR PESTICIDES are being discussed atOSHA (See June 1, Page 24). MINOR USE TOLERANCES may be issued for RPAR candidates if RPAR criteria triggers are not relevant to petitioned tolerances (See June 1, Page 2), an EPA official said last week. These tolerance decisions will be made case-by-case, according to the agency official. STATE REGISTRATIONS under Section 24(c) rec ived to date by the Registration Division, OPP, EPA, total 850, according to OPP. R&S 113873 PESTICIDE & TOXIC nn uu Sion - Editors: CA THY COOPER, Gary Robinson, Gail Tapscott Circulation Dept.: Director, ' Publisher: Louis Rothschild, Jr, Shirley Gatant;Assistant Managing Editor: Raymond Galant Director, Alice Wilkes Associate Editors: Ron Grandon, -id Production Manager: Dorothy Hill Natalie Pargas i/r/r DOW EXECUTIVE MISSTATES CASE ON MUTATION TESTING; EPA TO PROCEED Despite allegations to the contrary made by a Dow Chemlcal^d^fffif*e^ecutlve pS# at a meeting of the"Society ior (Occupational and Environmental Health (SOEH)7 the Environmental Protection Agency's Science Advisory Board (SAB) has not determined that the state of the art of mutagenicity testing (See June 1, Page 2) is so primitive as to preclude use of mutagenicity data to support regulatory actions against pesticide chemicals. The ^jggijtivg, Dr^T^IV^Torkelson of Dow's medical department, told last week's SOEH symposium on a cancer proposal from the Occupational Safety & Health Administration (OSHA) that OSHA should not depend on mutation tests at all for purposes of defining a chemical as a Category I carcinogen. Such a definition would trigger Issuance of an OSHA emergency.temporary standard entailing monitoring for the chemical in workplaces where it's produced, used, or packaged, as well as medical surveillance of exposed workers, "good housekeeping" requirements and other steps (See May 25, Page 20). Placement of a chemical into Category I could be "rebutted" in a rulemaking proceeding. If the rebuttal were unsuccessful, the rulemaking would determine what the "lowest feasible" exposure level is, and workplaces would hav to reach it. It would become the OSHA permanent standard. In the rulemaking, OSHA also could say that there are suitable substitutes for the chemical and attempt to promulgate a permanent standard requiring zero exposure. 1 OSHA has proposed to allow a positive bioassay result in a single mammalian sp cies j to trigger Category I classification If the bloassay has been "replicated" by a test on the same or a different species, or. If there exists "multi-test evidence'of mutagenicity." Tnrkf*isfn said EPA*s SAB, two weeks prior to the June 2 SOEH meeting, had I, decided that mutagenicity testing "wasn't ready yet" for regulatory use, and, Torkelsot said, it would be "Inappropriate" for OSHA to use mutation data if EPA wasn't going to. However, the SAB Environmental Health Advisory Committee met June 1 to discuss' EPA's proposed mutagenicity testing requirements for pesticides (See April 13, Page 14 and May 18, Page 2) and Indicated that, in fact, the types of tests which EPA has proposed are sufficiently validated to require them for pesticide registration actions. Prke. Nelson. Wooan and Abrahamson Sav Mutation Tests are Ready At the June 1 SAB me ting, another Dow ex cutive, Dr^_V. K. Rowe, said EPA should not Impose the mutagenicity battery because th tests wnicn comprise it have not k" Kn^aiieo fhotr rolowanrp to man is Questionable. 35 Pa ye 4 June 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS Dr. John W. Drake, a memoer of tne study group which helped EPA draft the Section 3 guidelines, disagreed, saying that EPA and the study group had chosen onl the best validated tests out of a possible total of 30. Dr. Norton Nelson, Chairman of the Environmental Health Advisory Committee, said that based on "a wide variety of studies in the animal kingdom, we do know that heritable mutations are a severe threat. The jump from that to the human population is, to my mind, miniscule." His arguments on validity and relevance to man discarded, Rowe then maintained that SAB should advise EPA to delay adoption of the testing requirements until the Agency had better defined what would be a "statistically significant" result in each test and until EPA had spelled out how it would interpret "mixed results" from the component tests in the eight-test battery. Dr. Gerald Wogan, Chairman of Drake's study group, said that nothing in the upcoming criteria document, which will address "mixed" results, will change the requirements which EPA has set forth. R&S 113875 On statistical significance, EPA's final guidelines will provide "more acceptable biometric wording" regarding what constitutes a significant finding in each test, according to EPA's Dr, Ruth Pertel, a principle author of the mutagenicity guide lines. This change comes about largely as a result of urgings from Dr. Lincoln E. Moses, professor of statistics at Stanford University and a member of SAB. With respect to maintaining flexibility and not putting mutagenicity testing require ments "in bronze," Nelson said, "Sure things are in a major state of flux, but that state of flux is going to lead to alternative ways of doing very much the same kind of things we're doing now, but doing them in a more efficient way." The document will say that the battery shall be reviewed every three years for possible changes. Drake held that some of the eight test "could fall by the wayside" not because they're invalid, but because "a more rapid or less expensive test may come along." In probably the most telling argument against bacterial tests not being relevant to man. Dr. Seymour Abrahamson gave some history on how, with respect to radiation, a-human risk estimate per Roentgen per gene using the mouse as a model has turned out to be "almost identical" to the human risk estimate which can be computed by using Drosophila (bacteria). Abrahamson said there is "good evidence" that man responds very closely to the mouse in terms of radiation sensitivity.* He said the U. S. spent over $50 million establishing the mouse as an appropriate model when it turns out that bacteria would have been just as good an indicator. He said the argument against the mutagenicity testing battery on economic grounds was untenable, since, by Abrahamson's calculations, the battery would cost no more than $45,000 per compound. f^-..^.-*~---V. 1 <` iTii ni^a-ry.*i June 8, 1977 ' Page 5 PESTICIDE & TOXIC CHEMICAL NEWS He said the most expensive test other than the mouse specific locus test (which is included among the 13 from which eightwill be chosen because it's valid, despite its cost) is the Drosophila test, which would cost around $10,000 if the experimenter was trying to detect a doubling of the spontaneous mutation rate. Abrahamson said the Drosophila test could cost as little as $1,000 if the experimenter were looking for a more drastic response, such as a five-fold increase over the spontaneous rate. Abrahamson is based-at the University of Wisconsin. The Wogan-Drake study group will meet June 15 to discuss the criteria document 3J which will describe how EPA will interpret `mixed" mutagenicity testing results. <0*>) USDI LABORATORY TO INPUT RPAR PROCESS WITH FISH, WILDLIFE EFFECTS DATA cooo -o4> Fish-Pesticide Rfesearch Laboratory (FPRL), U. S. Fish and Wildlife Service, Interior Department, under an intragency agreement with the Environmental Protection Agency, will provide data on the effects of pesticides on fish and wildlife for use in the risk assessment portion of the rebuttable presumption against registration CgfPAR) process. The agreemeAft, signed June 2 by Edwin L. Johnson, Deputy Assistant Administrator for Pesticide Programs, EPA, stated that the FPRL, located in Columbia, Mo., would supply qppies of published and notification of unpublished results of research orf thdeffects of about 150 pesticides --.RPAR candidates and alternatives -- on fish anq wildlife. In the firsfc month, the Laboratory would provide reprints and research results on about 60 jpesticlaes, according to the agreement which has not yet been signed by the Fish.bnd Wildlife Service. After the first month, the agreement noted, r search results and reprints would be required on 10 to 20 compounds a month. .The Laboratory would aflso supply negative responses, the agreement provided. The ac/reement wotild expire Sept. 30, 1977. EPA would pay the Fish and Wildlife Service about $10,000 for supplying the effects data. EPAnviiriist and assign priorities to the pesticides for which the Laboratory will vide effects data\ IS.BSO CIVIL\eNA/TY AGREED TO BY THOMPSON-HAYWARD HEADS EPA ENFORCEMENT An agreemeWsigned by Thompson-Hayward Chemical Co. of Fayetteville, N. C., to pay a $5,85b civil penalty assessed by Environmental Protection Agency officials in Rcgt n IV Mghlighted r cent pesticide enforcement activity. Page 12 June 8, 1977 TO* r PESTICIDE & TOXIC CHEMICAL NEWS that the "important thing is how much product (grams? volume?) is put on the plate to form colonies." He said that these data are critical to evaluate the potential f environmental hazard of this product. t Correction: Notice of receipt of the new active ingredient registration application was published in the April 29 not April 30 Federal Register. R&S 113877 OSHA CANCER PROPOSAL HIT; SEEN AS FAILING TO SPEED RULEMAKING The as-yet unproposed regulation under which .the Occupational Safety & Health Administration (OSHA) would regulate carcinogens and suspect carcinogens (See Feb. 16 Page 33) was ridiculed by a Dow Chemical Corp; executive last week, at a public forum in Washington, D.C., as being an example ot^EooTstrap logic" which could leave industry with no chemicals left to work with. At the same forum, which was sponsored by the Society for Occupational & Environ mental Health (SOEH), labor union officials criticized the proposal for not mandating that employers pay for employee protective clothing and equipment and medical xaminations which OSHA carcinogen regulations dp and will require. Jack Sheehan, Legislative Director of United Steelworkers of America and Chairman of the Policy Subgroup of the National Advisory Committee on Occupational Safety' & Health (NACOSH), criticized the cancer proposal for not solving the problem of "rate retnetion" i.e. "mandatory relocation." As explained by Anson Keller, co-author of the OSHA proposal, the rate retention/ mandatory relocation dilemma pertains to an employer moving an employee to an area of a business operation where exposure to a regulated chemical is less. Such a change often results in a lower salary for the employee, since less hazardous work usually pays less. fin short, Keller said, an employee could work for a firm for 30 years-, get cancer, and because of the detection, lose his high salary. The phenomenon could prove to be an incentive for employees to avoid the medical examinations which OSHA wants employers to perform and make available. OSHA Administrator Elva Bingham is assembling an advisory group to study the problem. Unionists such as Sheehan derided the document one moment and,commended it the next. OSHA was commended for attempting to improve its performance in carcinogen r gulation but was derided for not taking an even deeper plunge into labor-management relations. Grover Wrenn, a Deputy in OSHA's Health Standards Division, and defender of the proposal throughout the all-day symposium, said OSHA's health-protecting plunge was inadvertant and th extent of it was unforeseen, but Wrenn defended it as n cessary. June 8, 1977 , , Page 13 PESTICIDE & TOXIC CHEMICAL NEWS The Dow executive. Dr. T. R. Torkelson (See Page 3) hit the proposal for what he called "an obvious disregard for dose" when using laboratory animal tests to determine whether a chemical is a carcinogen. Torkelson got support from Dr. Roy Albert, Chairman of the Environmental Protection Agency's Carcinogen Assessment Group (CAG) (See May 18, Page 31), who asked if it "makes sense" to not consid r dose for purposes of classification. According to the proposal, a substance could be classified as a Category I carcinogen if it has been shown "at any dose level to cause the formation of malignant or benign neoplasms, or a combination thereof, in (a) man, or (b) two mammalian test species, or (c) a single mammalian test species if those results have been replicated in another experiment or by multi-test evidence for mutagenicity, or (d) upon the basis of any other evidence that the Secretary (of Labor) finds sufficient." A Category II classification would be triggered by "suggestive" evidence of carcinogenicity horn a single experiment on a single mammalian species, regardless of dose. Category I classification would prompt issuance by OSHA of an emergency temporary standard which would be followed in 60 days by a proposed permanent standard. The proposed permanent standard would embellish the emergency standard and impose medical surveillance, workplace monitoring and other "model" r quirements which OSHA wants to impose "across the board" for all Category I chemicals. Engineering controls would be proposed to bring exposure to the Category I chemical down to the "lowest feasible" level, and if OSHA believed that "suitable" substitutes were available, a "zero" exposure level could be set. According to the proposal, issues at the hearing on the proposed permanent standard would be limited to: 3) "(1) Whether the Secretary correctly classified the toxic material into Category I; (2) whether the Secretary was correct in his determination that the Category I classification should not be rebutted; (3) whether the Secretary correctly determined the lowest feasible occupational exposure, or whether there are suitable substitutes that are less hazardous to humans; v (4) the appropriateness of the specific protective means of the proposed standard and (5) the environmental impact caused by such regulation." o-oooooj Issues also would be limited In hearings on Category II classifications. John Kolojeski', moderator of the conference and President of Clement Associates (See June`1, Page 14) said that the proposed limitation on issues, which is central to OSHA's effort to speed rulemaking, could be construed as an abridgement of due process, while Sheehan held that these very issu s probably would be litigated every time OSHA proposed a standard. Therefore, Sh ehan said, OSHA rulemaking is likely to remain largely a substance-by-substance affair, characterized by delay. Page 14 June 8. 1977 Pesticide & toxic chemical new Category II classification would prompt no emergency standard and no engineering controls, but an exposure limit would be set, as would medical surveillance and other "model" requirements. Rather than engineering controls, housekeeping practices and personnel protective equipment and clothing would be prescribed for Category II chemicals. Keller explained that Category II is needed to "gear up" in case in formation becomes available indicating that the chemical belongs in Category I. R&S 113879 .Torkelson maintained that imposition of such requirements without consideration of the dose used in the animal experiment(s) would be irresponsible in light of the possibility that human'metabolism could eliminate the threat which the chemical may pose. Dose in Backup Animal Studies "Irrelevant." Says OSHA's Wrenn Wrenn, however, responded that dcOfi/was "largely irrelevant," since OSHA does not consider a threshold level to exist for carcinogens. Marshall Miller, a legal expert and a former Deputy Assistant Secretary of Labor for OSHA, said that potency i.e. dose would be factored into OSHA deliberations "subjectively" when OSHA, taking economics into account, sets its iowest "feasible"or "zero" exposure level. Wrenn also was supported by Dr. Marvfri Schneiderman of the National Cancer Institute (NCI), who said that "cancer Is bad," regardless of potency. Kololeski said nmceriitres set out in the OSWA proposal category i and II classifications "take care" of Torkelson's concerns. Justification for rebuttals on toxicological grounds are spelled out twice in the OSHA proposal, once for Category I chemicals and once for Category II. According to Section 1990.11 of the proposal, the Secretary of Labor may rebut the presumption of a Category I classification if he determines: "(a) that the alleged carcinogenic effect based on animal data clearly resulted from pon-specff<c nhvalval rather than chemical induction, or (b) that the route of exposure was grossly inappropriate relative to the potenuaroccupationa1 routes of human exposure, or (c) that the animal or human studies submitted for review were only suggestive or not adequate to establish- any conclusion with respect to the carcinogenicity or noncarcinogenicity of the toxic materials or fd) that for some other biological reason, the positive results in experimental mammals are not scientifically relevant to man." 1-+ 1 Justifications are similar for a successful rebuttal of a Category II classification. A successful rebuttal places a chemical at least one category below the proposed one. l { ; ; kt --- failUdla, June 8, 1977 Page IS PESTICIDE & TOXIC CHEMICAL NEWS g other / l- CAG's Albert Raises Sticky Regulatory Issue Just what constitutes "replication'* of an animal test, however, is a particularly difficult issue, according to CAG Chairman Albert. At the SOEH meeting, Albert cited a "not uncommon" example he has run across at CAG where a p sticide now up for a rebuttable presumption against registration (RPAR) notice was found to produce tumors in a long-term study conducted by the Food and Drug Administration (FDA), but the tumors were found only at the lowest dose level, which is "strange in itself," Albert said. A long-term study by NCI was negative, Albert stated, as were two others. Another study on the same chemical, however, was found to be positive in one sex at one dose level, but the tumors which appeared in the dosed animals appeared later than spontaneous tumors observed in controlsSince tumors in dosed groups usually occur sooner than tumors in controls, this "replication" of an already "suspicious" FDA study is questionable, Albert said. Nevertheless, the finding could conceiveably trigger a Category I classification if the OSHA proposal is allowed to stand as is (Albert would not reveal the identity of the pesticide in question). Albert asked if positive findings in two dose groups in the same .experiment would constitute "replication," as suggested by Dr. David Clayson of the National Cancer Advisory Board. He also asked whether observation of a dose-response 30 relationship could be considered "replicatiohi" No one answered his rhetorical questions. S(/> Generally, Albert expressed fears that OSHA's "black and white" proposal woulc c0o0 give too much power to scientists. 0o0 Squire Fears. "Over interpretation" of "Suggestive" Bioassay Results Dr. Robert Squire., former Chief of the NCI Bioassay Program (See March 2, Page 22) ig and now at Johns Hopkins University and an Associate Scientist with Clement on Associates, Inc., warned against linking "suggestive" NCI bioassav results to OSHA regulation under Category II. He said "overinterpretation of uncertain results has done more harm to toxicology than anything else." He held that NCI's research mission should be allowed to continue unencumbered by OSHA's regulatory mission. i With respect to Category I classification. Squire said "results in a single mammalian species supported by incriminating in vitro data would be most con vincing if either both sexes or more than one dosage group were affected." There was considerable discussion on whether OSHA should simply adopt the proposal as an administrative policy, once it has been revised or, as an alternative, whether OSHA should publish it as a proposed regulation and subject it to judicial review. V The argument for the latter procedur , as stated by Wrenn, would be that to speed OSHA rulemaking, judicial review is needed on the basic regulatory principles r which OSHA follows every time it proposes a rule.on carcinogens. R&S 113881 Page 16 June 8, 1977 * PESTICIDE & TOXIC CHEMICAL NEWS These cancer principles are essentially the same as those which have stretched out EPA cancellation proceedings on heptachlor and chlordane (See June 1, Page 25). Once such review is completed, Wrenn contended, rulemaking would go faster. The speed argument appears to have been rebutted by Sheehan, but Kolojeski argued in favor of making the document a regulation as opposed to a policy because the document's publication as a policy would not carry with it the mandatory timetables under which OSHA would be forced to propose permanent standards and take other actions. The document could be abandoned by the next Administration if it were simply a policy, Kolojeski said. Sheehan, on the other hand, argued that Federal Register publication of the proposal as a regulation would bog down OSHA in rulemaking on it and prevent OSHA from taking action on known problem chemicals. As an alternative, Sheehan suggested testing the policy on some real problems. Pointing to the recent OSHA activity on benzene (See June I, Page 11), Wrenn deni d that Federal Register publication of the proposal as a regulation would hamper OSHA in its efforts to deal with current problems. As a remedy to industry delaying tactics, NCI's Schneiderman suggested that for any chemical tied up in litigation, all profits should be placed in a closed fund unavailable to the manufacturer. Richard Boggs of the National Institute for Occupational Safety & Health (NIOSH) asked how OSHA would handle chemicals which are similar in structure to those placed in Category I or II. He also asked for better definitions of the terms "feasible" and "detectable.'' As an indication of just how complicated these issues are and how deep emotions run, a labor union official, misconstruing remarks made by Torkelson. said Dow is interested in DNA research because the firm wants to create a "super race" of chemical workers who are immune to cancer. Over 140 people from government, industry and academia attended the SOEH conference HOUSE COMMITTEE WANTS EPA TO ALLOW MIREX FOR FIRE ANT ERADICATION "In the hope that the Environmental Protection Agency will rescind its ruling on mirex" the House Appropriations Committee has reserved $4,460,000 for a fire ant eradication program, (S e March 30, Page 33). . 1 r^aw 71 Mil* * irnm R&S 113882 NOTICES 27033 it* mcnt areas on the map. There arc Testing of the Science Advisory Board's (FRL 733-3 PF7O1883/TX051 j5 twenty-three counties where strychnine .bolts may be applied following establish- meat of the presence of rabid skunks near areas of human habitation; Environmental llcaith Advisory Com mittee will be lir'.d at 9:00 a.m. on June 15. 1977. in Conference Room A UAoont fililJ, Crystal Mall Building No. N-CHL0R0ACETYL-N*(2.6DIETHYLPHENYUGLYC1NE ETHYL ESTER Establishment of Temporary Tolerances 4. Exposure of any bolt station within 2,1921 Jefiersou Davis Highway, Arling Hercules. Inc. Wilmington, DE 19899. a five (5) mile radius circle (to survey for ton, Virginia. has submitted a pesticide petition (PP - J; presence of rabid or suppress rabid skunk The purpose of the meeting will be 7G1883) to the Environmental Protec populations) may not exceed thirty (30) to continue the discussion of Agency ap tion Agency (EPA). This petition re days; proaches to the evaluation of test data quests tiiat temporary tolerances be es 'ijjs; \ 5. Each strychnine lord bait will con- relating to mutagenicity in the context tablished for combined residues of the f; tain approximately 0.012 grams of actual of section 3. Registration of Pesticides, herbicide N-chloroacctyl-N-(2.G-dictiiylI strychnine alkaloid. Each strychnine egg of the Federal Insecticide. Fungicide, pbcnyl) glycine ethyl ester and Us major i* bait will contain approximately 0.035 and Rodenttclde Act (FIFRA), as metabolites N-chloroaeetyl-JY-(2.6-di- >* 7 grams of actual strychnine alkaloid: amended. cthylphenyl) glycine ethyl ester gluta W 74 6. The Applicant's personnel are rc- The meeting will be open to Uie public. thione conjugate and W-chloroaectyl-Wsponsible lor preparing the stryclminc Any member of the public wishing to (2,6-dicthylphaiyl) glycine ethyl ester baits.* selecting bait stations, posting attend or submit a paper should contact cysteine conjugate in or on the raw agri earning signs, securing premise entry the Secretariat, Science Advisory Board cultural commodities soybeans and soy - agreements, cheeking bolt stations pc- (A-101), U.S. Environmental Protection bean forage at 0.2 part per million }:wJ&rS- radically for kills, and retrieving all un- Agency, Washington, ,D.C. 204GO, by (ppm) and sugar beet roots and tops at consumed baits at the termination of the c.o.b. June 10.1977. Please call Ms. Bar 0.05 ppm. i .gSfSjJ control program: bara Robinson on (703) 557-7720. Establishment of these temporary tol ^tvEStJErirajL"*f' oi r7e.gAg maximum of two strychnine lard baits per setting will be placed In Dated May 19. 1977. erances will permit the marketing of the abovo 1 raw agricultural commodities 5? the following skunk habitats: skunk dens, Lloyd T. Taylor. when treted In accordance with an ex holes, garbage dumps, road culverts. Junk Acting Staff Director. perimental use permit that is -being is- Jjj&L piles, and unoccupied buildings; Science Advisory Board. sued concurrently under theFederal In ' a$s>- 8. Strychnine-treated lard or egg baits will be placed only on those lands where (Fit DOC.77--14948 Filed 6-25-77:8:45 >m] secticide. Fungicide, and Rodentlcide Act .(FIFRA), as amended (88 Stat. 973. 89 premise entry agreements have been -Stat. 751; 7 U.S.C. 136(a) et scq.K __signed by the landowner, lessee, or od- [OPF-42009B; FRL 733-7] An evaluation of the scientific data re ministrator; a, 9. Warning signs will be posted at en- WASHINGTON ported and other relevant-material has shown that the requested tolerances are tries to all premises and other visible po- Extension of Contingent Approval of State adequate to cover residues resulting from ri. sitions near locations where treated bolts * Plan for Certification of Pesticide Appli tho proposed experimental use: and it Kft have been placed; cators has been determined that the temporary T - 10. Each bait station will be checked as often as possible for kills, but. In any -<$*? c*se> no k* once a week; .11, All retrieved or excess strychnine baits will be disposed of by burial at least 18 Inches deep In an approved sanitary In accordance with tire provisions of section 4(a)(2) of the Federal Insecti cide, Fungicide, and Rodcnticide Act (FIFRA) as amended (88 Stat, 973; 7 U.S.C. 136 et seq.) and 40 CFR Part 171 (39 FR 36445 (October 9, 1974) and 40 tolerances will protect tho public health. Tho temporary tolerances arc established for the pesticide, therefore; with the tolIowing provisions: 1. The total amount of the pesticide S raMl/ landfill. Containers to be destroyed will FR 11698 (March 12.1975)), the Honor to bo used must not exceed the quantity . b* handled In a similar manner; able Daniel J. Evans, Governor of the authorized by the experimental use per sSaff. 12. Animals poisoned In the control State,of Washington, submitted a State mit. "slfrV program will be submitted for laboratory Plantor Certification of Commercial and 1^3 analysis for presence of rabies virus If Private Applicators of Restricted XJsc 2. Hercules. .Inc. must Immediately * Jgrtf possible. Otherwise, they will be buried on Pesticides to the Environmental Protec notify Uie EPA of any findings from the I&gii- the. premises to prevent possible sec- tion Agency (EPA) for approval on a experimental use that have a bearing on V j&SjSif ondary non-target species poisonings; contingent basis, pending promulgation safety. The firm must also keep records . - 13> T7>e Applicant must follow any j&sjfe more stringent requirements imposed by state law or regulation or applied by the State pesticide regulatory authority; and of Implementing regulations. On Jan uary 7, 1976. the Regional Administra tor. EPA Region, X approved the plan on a contingent basis for a fifteen of production, distribution, and per formance and on request make the rec ords available to any authorized officer . f t, 14. The specific exemption expires on month period. Notice of the approval was or employee of the EPA or the Food and ' published in the Federal Register on Drag Administration. Section IS of the February 18, 1976 (41 FR 7449). Legal ____ Fungicide, and Roden- authority for the program is contained tlelde Act (FIFRA), 7aa amended (BS stat. In the Washington Pesticide Control 89 Stat, 751: 7 U.S.G. 136(a) et aeq.). Act, Washington Pesticide Application >i~- *Dated: May 19.'1977. __ JAMTS M. CoNLON, Act, and Washington Regulations. On April 7, 1977, the State of Wash " , Acting Deputy Assistant Ad ministrator /or Pesticide Pro grams. ington requested an extension of the Washington contingent approval pend ing promulgation of the regulations as |FR DOC.77-14DS0 Filed 5-35-77;B:4S am] described In the State Plan. The Agen cy finds that there Is good cause for (FRL 734-1] approving the request, and lias granted v!=:1SORY an extension until September 1, 1977. Dated: May 16.1977. * Tliesc temporary tolerances expire April 11, 1978. Residues not in excess of 0.2 ppm remaining in or on soybeans and soybean forage and 0.05 ppm in or on 7' sugar beet roots and tops after this ex- plration date will not be considered acUonoblc If the pesticide is legally applied ' '* during tho term of and* in accordance . 7with the provisions of the experimental ;** use permit and temporary tolerances.'-* These temporary-tolerances may be re- .voked if the experimental use permit is ' revoked or if any scientific data or cxpcrience with this pesticide indicates;. '^,JETSEETISNTGUDY- GROUP ON MUTAGENICITY OpenMeeting t Notice is hereby given that a meeting the Study Group on Mutagenicity Donald P. Dubois. Regional Administrator. UB. Environmental Protection Agency, Region X. |FR Doe.77--14040 Filed 6-35-77:8:45 fun] such revocation is necessary to protect. the public health. Inquiries concerning;--.* .. this notice may be directed to Libby V; Zink. Registration Division iwh-567),-;.. Offlc of Pesticide Programs. Room 315. - . > - >'H federal REGISTER. VOL 43,. NO. T02--THURSDAY. MAY 36, 1977 , /- . . At VAr .r. R&S 113883 S?5TZ NOTICES procedure (1% neutral buffered potas tical to the analyzer described in the L __ Designation of these reference.' and sium iodide standardized with nrsenlous designation. In many cases, such ana Vuivalent methods will provide assist-___ oxide) specified In Appendix D of 40 lyzers may be upgraded <e.g,, by minor r tiice to the States in establishing and ; CFR Pnrt SO. (is emended on February modification or by substitution of new r >crating their air quality surveillance .$0. 18.1975 (40 Fit 7042). This method-Is: operation or instruction manual) so os systems under 40 CFR 51.17(a). Addi- '.'3= RFOA-0577-020. "Beckman Model to be identical to the designated method tjonal information concerning this- ac- ' .`.*S 9S0A Ozone Analyzer." operated on a and thus achieve designated status at on may be obtained by writing to the range of 0-0.5 ppm and wltli the modest cost. The manufacturer should ldrcss given above. "SLOW" (60 second) response time; with or without any of the following options:' Internal Ozone Generator Computer Adaptor Kit. This method Js avallablo from Beckman . Instruments, Inc., Process Instruments Division. 2500 Harbor Boulevard, Fuller bo consulted to determine the necessity and feasibility of such upgrading. Part 53 requires that sellers of desig nated methods comply with certain con ditions. These conditions arc given in 40 CFR Part 53.9 and are summarized below: (1>A copy of the approved operation or instruction manual must accompany WilsonK.Tallet, * i-*- Assistant Administrator for Research nod Development. 1 FR Doc.77-lSC77 Piled 0-2-77:8:45 Km) * V. IOPIMJOOS3 FRL 741-1J ' FEDERAL INSECTICIDE, FUNGICIDE, AND ton. California 92634. A notice of receipt the analyzer when It is delivered to the ROOENTICIOE ACT SCIENTIFIC AD ' of application for this method, submit ultimate purchaser. ted by Beckman Instruments. Inc., ap- (2) The analyzer must not generate . peared in the Federal Register. Volume any unreasonable hazard to operators or 41. October 19,1976, page 46019. to the environment. . A test analyzer representative of tlie- (3) The analyzer must function within flrst method has been tested by the State the limits of the performance specifica _V_I_S_O_R_Y__P_A_N_E_L__ 1 , Meeting ' AGENCY: Ofllce of Pesticide Pro-^ grains. Environmental Protection Agency Xp- (EPA). . NJJj ' of California Air Resources Board in nc- tions given in Table B-l of Part 53 for ACTION: Notice of meeting. i * cordance with the test procedures spccifled in 40 CFR Fart 53. In addition, cer tain supplemental tests were also conducted by BPA. After reviewing the results of all these tests as well as other Information submitted by the applicants, EPA has determined, in accordance with Part S3, that tills method should be des ignated as an equivalent method. Simi larly, a test analyzer representative of the second method lias been tested by the applicant, also in accordance with at least l year after delivery when main tained and operated in accordance with the operation manual. (4) Any analyzer offered for sole ns a reference or equivalent method must bear a label or sticker indicating that it lias been designated as a reference or equivalent method in accordance with Port 53. (5> If such an analyzer has one or more selectable ranges, the label or sticker must be placed In dose proxim SUMMARY: There will bo a two-day j./ meeting of the Federal Insecticide, Fun- gicidc. and Rodcnticide Scientific Advisory Panel Act from (FIFRA) 9:30 tun. * >`-i t j. > to 4:30 pan. daily on Monday. June 20, and Tuesday, June 21,1977. The meeting VI will be held in Room 1112A, Crystal Mall, Building Number 2, 1921 Jefferson Davis *1jt**. Highway. Arlington, Virginia. FOR FURTHER INFORMATION CON TACT: the test procedures specified in Part S3. After reviewing the test results and in formation submitted, EPA lias deter mined, In accordance'with Part 53, that* this method should be designated as a reference method. The information sub mitted by the applicants will be kept on file at the address shown below and will be available for inspection to the extent consistent with 40 CFR Part 2 (CPA's regulations implementing the Freedom of information Act). As reference and equivalent methods, these methods are acceptable for use by ity to the range selector* and indicate which range or ranges have been desig nated as reference or equivalent meth ods. <6) An applicant who ofTcrs analyzers for sale as reference or equivalent meth ods te required to maintain a list of ul timate purchasers of such analyzers and to notify them within 39 days if a re ference or equivalent method designa tion applicable to the analyzer has been earicellcd or if adjustment of the ana lyzers is necessary under 40 CFR 53.11 (b) to avoid a cancellation. Dr. H. Wade Fowler, Jr, Executl Secretary, FIFRA Scientific Advisory Pnncl, Office of Pesticide Programs (WH-567). Rm. E-31S. EPA. 401 M St. SW., Washington D.C. 20460. tele. phone 202-755-4851. SUPPLEMENTARY INFORMATION: In accordance with Section 25(d) of the amended FIFRA. the Scientifl Advisory Panel will comment on file Impact on health and the environment of regula tory actions under section 6(b) and 25(a) prior to implementation. The pur l ' 1. 'M X 4 States and other control agencies for purposes of section 51.17(a) of 40 CFR , Part 51 ("Requirements for Preparation, * Adoption, and Submittal of Implementa tion Plans") ns amended on February 18, 1975 (40 FR 7042V. For such use, a method must be used in strict accordance with the operation or Instruction manual provided with the method and subject to any limitations (e.g,, operating range) specified in the applicable designation (see description of the methods above). Vendor modifications of a designated method used for purposes of { 51.17(a) are permitted only with prior approval of EPA, as provided in Part- 53. Provisions concerning modification of such meth ods by users were promulgated ou March 17, 1976 (Federal Register. Vot. 41. page 11255). ` In general, each designation applies to any analyzer which is Identical to tiie analyzer described' In the designation. However, similar analyzers manufac tured prior to the designation and bear (7> An applicant who modifies an ana lyzer previously designated as a refer ence or equivalent method is not per mitted to sell the analyzer (as modi fied) as a reference or equivalent method (although he may choose to sell It with out such representations), nor to at tach a label or sticker to the analyzer (os modified) under the provisions de scribed above, until he has received no tice under 40 CFR 53.14(c) that the ori ginal designation or a new designation applies to the method as modified or un til he has applied for and received no tice of a new reference or equivalent method determination for the analyzer ns modified. Aside from occasional breakdowns or malfunctions, consistent or repeated iion-comptlancc with any of these condi tions should be reported to: Director, Environmental Monitoring and Support Laboratory, Department E (MD-7G). UjS. Environmental Protection Agency. pose of this meeting is to discuss the following topics: U) Continued review of the advanced draft of the subpart on Hazard Evalua tion: Humans and Domestic Animals of the Guidelines for Registering Pesticides In the United States. 2. Continued review of the proposed regulations ror classification of pesti cides as required under Section 3(d) of FIFRA. amended. (Note: Tills will be. discussed only if needed. The proposed document was. reviewed on May 25-27, 1977). 3. The Agency may present back-. ground Information on changes antici pated In its basic regulatory approach to pesticides. Such a presentation would involve a discussion of a gcnerlcclictnical-standnrds approach to reg ulation. The meeting will be open to the public.. Any member of the public wishing attend or submit a paper should contai '-.f I!. i'**'i ;* ing the same model number as the des Research Triangle Pork, North Carolina Dr. H. Wade Fowler. Jr, Executive Sec ignated method are not necessarily Iden- 27711. retary. FIFRA Scientific Advisory Panel, // /' FEOERAL REGISTER, VOL 42, NO. 107--FRIDAY, JUNE 3. 1977 ..t,.t *>t /;. NOTICES 28573 Office of Pesticide Programs fWH-567), Room -315, EPA. 401 M St. SW.. Wash ington D.C. 20460, telephone: 202-7554851), Interested persons are permitted to Ale written statements before or after the meeting, and may upon advance no tice to the Executive Secretary, present oral statements to tire extent that time permits. Written or oral statemens will be taken into consideration by the Panel In formulating' comments or in deciding to waive comments. Persons desirous of making oral statements must notify the rStf*} ` Executive Secretary and submit four ,-vil,r?'' Jcoupniees18o,1f 97a7.sununary.no later titan other than those listed under Part 21. the cut-off date for filing a mutually exclu sive application Is the close of business one business day preceding the day on which the previously filed application Is designated for hearing. With limited ex ceptions. an application which is subse quently amended by a major change will be considered os a newly filed application for purposes of the cut-off rule. (See { 12227(b) (3) and 21JO (b) of the Com mission's Rules.) Federal Communications Commission, Vincent J. Mullins. Secretary, 3123G-CD-P-77 Susquehanna Mobllo Com munications. Inc. (new). Resubmitted. C.P. for a new I-Way station to operate on 153.24 MHz to be located at Holly Pike. Route 34, approximately l.l miles south ofCarlisle, Pennsylvania. 21301-CD-P--(3) -77 Statesboro Telepho e Company (KWAG54), C.P. to change an tenna system operating on 153.69 MHz; add 153.81 MHz to bo located at 70 E. Grady St.. Statesboro. Georgia. . 2|31)2-CD-P-(2)-7T Mobltfone Communica tions, Inc. (KKX714). C.P. to change an tenna system and relocate facilities operat ing on 152.03 152.21 MHz from location No.' 3 to a new site described as location No. 3 to be located U miles south of InteractUoo of Highway 3344 and Highway 300. approxi mately 3 milefl west of Austin, Texas. Individuals who wish to flic written statements are advised to submit ten Aptucations Accents to* Prune 21393-CD-P--TT Jackson Mobilphone, Inc. (new). C.P. for a new 1-vay station to op copies of statements to the Executive DOMESTIC PUBLIC LAND SlOotLZ AAOIO SOtVICK erate on 152.24 MHz to be located on UJ5. Secretary in a timely manner to ensure appropriate consideration by the Panel. Mg* Dated: June 1,1977. &%. James M. Conloh, [safe?. Deputy Assistant Administrator. for Pesticide Programs. wr. [PTt Doc.77-16877 Piled 0-2-77:8:48 amj 213B0-CD-P--77 Mobile Radio System of Ventura. Inc. (KSV978), CP. (or additional (Acuities to operate on 182214 Mils to be lo cales! at a new site described as location No. 3; At xted Mountain. Approx. 8.0 mllrs NW. of Ventura. California. 21381-CD-P-77 Calhoun City Telephone Company (XUS373), CP. to change anten na system operating on 158.10 MHz located Highway 43. Intersection of Na 3. Jackson, Alabama. 21334-CD-P-77 Jackson MobUephone, Inc. (new), C.P. for a new 3-way station to op erate oft 153.06 MHz to ba located on High way 43, Intersection, of No. 3, Jackson. Alabama. 31395-CD-P-(3)-77 The Mountain State Telephone and Telegraph Company (KOK- 345), CP. to change antenna system and FEDERAL COMMUNICATIONS COMMISSION (Report No. 8601 COMMON CARRIER SERVICES 0.4 mile east o( Senna. Mississippi. 213S2-CD-PL77 DFRS, Inc. t/a Zip-Call (KCB890). C.P. (or additional facilities to operate on 43.88 MHz to be located at a new alto described os locaUon No. 33; On Alpine Rood, V, mile N. of Fitchburg, Massachu setts. replace transmitter operating on IG2.7S MHz; Add 152.54 Mils to be located at 3D miles west southwest of Pocatello, and Test facilities to opcrato'on 157.80 MHz located at 455 West Lewis Street. Pocatello. Idaho. 3130G-CD-P--(0)--77 South Central Dell Telephone Company (KIC343), C.P. to re * INFORMATION Applications Accepted for Filing Mat 31, 1977. The applications listed herein have 2l383-CD-P-(4>-77 Adirondack Mobile Tel ephone Co, Inc. (new), CLP. tor a new 2Way station to operate on 152.00 162,(8 Mils at location No. 1 to be located at Beckman court; and location No. 2 to operate on 162.06 183.18 Agfa to be located locate facilities operating on 454.378. 454.4SO. 484.475, 454.62S. 454.600, 454.823 At Hz to be located approximately 4 miles northeast of Pcgram. Tennessee- mazor AMZNOMerrr been found, upon initial review, to be ac- at WGFM-FM Tower; Rand Hill. Platts 210U-CD-P-(2>-TT E. P. Mitchell. Jr. d,b - fVAip'C ccptable for filing. The Commission ro il serves the right to return any of these applications, if upon further examinajt is determined they are defective and not in conformance with the Com- Vv' mission's Rules and Regulations or Its burgh, New York. 31384-CD-P-TI Mnrc Weber Tobins and os Douglas Radio (KRM3G7). Amend base frequency 454.125 MIIz to read 454.200 Michael Charles Tobias d/b as MT Systems, MHz. All other particulars ore to remain Inc. (new), C.P. tor a new 3-Way station to the same os reported on. PN No. 653 dated operation on UUI Mils to be located . April 4.10TT. North of Rt. 34 at the SW. comer ot Wesslngton Springs, South Dakota. mroiuAmr % policies. 21385-CD-P-2-T7 Mount View Communica It appears that tire following applications jjb,- Final action will not be taken on any tions (new), CP. (or a new station to op may be mutually exclusive and subject to the Jftjs of these applications earlier than 31 days &&& following the date of this notice, except lea: radio applications not requiring a 30-day notice period (See 5 309<c) of the Communications Act), applications hied erate on 182.08 (base) and 459.013 (Re peater) MHz to be located at Aqu& Kamoa Mountain. 6.1 miles NS. of South Fork; and 454.075 MHz (Control) at location No. 2 to be located 71S 1st Avenue, Monte Vista, Colorado. Commission's Rule regarding Ex parte pre sentations by reason of economic competition or potential electrical Interference. CALIFORNIA Tadlock'o Radio Dispatch (KMA25Q) Bold GSr?- under Part 68. applications filed under 2138G-CD-P-77 RCC of Virginia. Inc. (new). Mountain. 009 l-CD-P-1-77. Part 63 relative to small projects, or as C.P. for a new 1-Way station to operate on Sllvcmdio Communications (New) Hops, '^l-' othcrwlse noted. Unless specified to the contrary, comments or petitions may be filed concerning radio and Section 214 OTSsapplications within 30 days of the date of this notice and within 20 days for Part 68 i Srgjt applications. 7 152.24 MHz to be located at Rt, 47, ap proximately 800 feet coat of the western city limits. South Hill. Virginia. 2I387-GD-P-77 Citizens Telephone Com pany. Inc. (new), CJP. lor a new 2-Way sta tion to operate on 152.78 MHz to be lo cated Union Street, Vienna. Georgia. . 21202-CO-P-2-77. avast. RAuto ramee 6027T-CJV-P/L-T7 Puerto Rico Communica tions Authority (new). CP. and License (or a new Rural Sulrseriber station to oper ate on 454.375, 454.400. 454.425. 454.450. t-wfcl In order for an application filed under fcfgMr Part 21 of the Commission's Rules <Doi\ IjKjfc mestlc Public Radio Services) to be con'-Ifi'jvK-. 6idered mutually exclusive with any ix'&r other such application appearing herein,* lipsT it must be substantially complete and IM,- tendered for filing by whichever date Is earlier: <n) Tlie close of business one business day preceding the day on which [fera the Commission takes action on the preFfWjviou3ly flJed application: or (b) Within 60 days after the date of the public notice listing the first prior filed application u (with which the subsequent application 21388-CD-F-77 Citizens Telephone Com pany, Inc. (new). Cl*, (or a new 1-Way sta tion to operate on 1!U4 MHz to be lo cated at Bond and Washington Streets, Plains, Georgia. 21369-CD-F-77 Digital Paging Systems o( Pittsburgh, Inc. (RWD370), C.P. to change antenna system operating on 152.24 MIIz located 1715 Grandview Avenue, Pitts burgh. Pennsylvania. 21390-CD-P-7T R.C.S, Inc. (KHM871), C.P. (or additional (acuities to operate' on 182.34 MHz to be located at a new site de 454.475, 454,500, 454.625. and 454.560 MIIz to be located at Do. Anoncs. Carr. 152 Ramal 813 Km 1.4, Namnljlto, Puerto Rico. 6027B-CR-P/L-77 Same as above located at So. Guebradllta Carr. 900 Km. 8.7. Tsbucoa, Puerto Rico. 60279-CR-P/L-7T Same ns above to bo lo cated at Do. Quebrada Grande, Carr. 902 Km. 4.4, San Lorenzo, Puerto Rico. 6027G-CIL-P/L-77 Same ns above to be lo cated at Do. Tejna Onnynhnl Carr. 921 Km. 3,3. Humocoo. Puerto Rico. 6O2B0-CR-P/L-7T Same as above to be lo cated at Bo. Aguacato Comuncs Ramal 9004. (1 Km. de Carr. 903). Yabucoa, Puerto Rico. 80281-CR-P/L-77 Some oa above to be lo Sl in conflict) as having been accepted for scribed ss location No. 8; 023 North I cated at Cnlle Pedro Marquez Esq. William lifiltng. In common carrier radio services Street,- Lompoc, Californio. Font, cuiebra, Puerto Rica. FEDERAL REGISTER. VOL 42, NO. 107--FRIDAY, JUNE 3. 1*7/ Page J.2 June 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS that the "important thing is how much product (grams? volume?) is put on the - plate to form colonies." He said that these data are critical to evaluate the potential environmental hazard of this product. Correction: Notice of receipt of the new active ingredient registration application was published in the April 29 not April 30 Federal Register. R&S 113885 OSHA CANCER PROPOSAL HIT; SEEN AS FAILING TO SPEED RULEMAKING The as-yet unproposed regulation under which the Occupational Safety & Health Administration (OSHA) would regulate carcinogens and suspect carcinogens (See Feb. 16 Page 33) was ridiculed by a Dow Chemical Corp.' executive last week at a public forum in Washington, D.C.,as being an example of "bootstrap logic" which could leave industry with no chemicals left to work with. At the same forum, which was sponsored by the Society for Occupational & Environ mental Health (SOEH), labor union officials criticized the proposal for not mandating that employers pay for employee protective clothing and equipment and medical examinations which OSHA carcinogen regulations do and will require. Jack Sheehan, Legislative Director of United Steelworkers of America and Chairman of the Policy Subgroup of the National Advisory Committee on Occupational Safety & Health (NACOSH), criticized the cancer proposal for not solving the problem of "rate retnetion" i.e. "mandatory relocation." As explained by Anson Keller, co-author of the OSHA proposal, the rate retention/ mandatory relocation dilemma pertains to an employer moving an employee to an area of a business operation where exposure to a regulated chemical is less. Such a change often results in a lower salary for the employee, since less hazardous work usually pays less. In short, Keller said, an employee could work for a firm for 30 years, get cancer, and because of the detection, lose his high salary. The phenomenon could prove to be an incentive for employees to avoid the medical examinations which OSHA wants employers to perform and make available. OSHA Administrator Elva Bingham is assembling an advisory group to study the problem. Unionists such as Sheehan derided the document one moment and commended it the next. OSHA was commended for attempting to improve its performance in carcinogen regulation but was derided for not taking an even deeper plunge into labor-management relations. Grover Wrenn, a Deputy in OSHA's Health Standards Division, and defender of the proposal throughout the all-day symposium, said OSHA's health-protecting plunge was inadvertant and the extent of it was unforeseen, but Wrenn defended it as necessary. L'-^*-* ^-^ n 11 it1 AflOb n une 8, 1977 . Page 13 PESTICIDE & TOXIC CHEMICAL NEWS * The Dow executive, Dr. T. R. Torkelson (See Page 3) hit the proposal for what 9 he called "an obvious disregard for dose" when using laboratory animal tests to determine whether a chemical is a carcinogen. Torkelson got support from Dr. Roy Albert, Chairman of the Environmental Protection Agency's Carcinogen Assessment Group (CAG) (See May 18, Page 31), who asked if it "makes sense" to not consider dose for purposes of classification. According to the proposal, a substance could be classified as a Category I carcinogen if it has been shown "at any dose level to cause the formation of malignant or benign neoplasms, or a combination thereof, in (a) man, or (b) two mammalian test species, or (c) a single mammalian test species if those results have been replicated in another experiment or by multi-test evidence for mutagenicity, or (d) upon the basis of any other evidence that the Secretary (of Labor) finds sufficient." A Category II classification would be triggered by "suggestive" evidence of carcinogenicity from a single experiment on a single mammalian species, regardless of dose. Category I classification would prompt issuance by OSHAof an emergency temporary standard which would be followed in 60 days by a proposed permanent standard. The proposed permanent standard would embellish the emergency standard and impose medical surveillance, workplace monitoring and other "model" require ments which OSHA wants to impose "across the board" for all Category I chemicals. Engineering controls would be proposed to bring exposure- to the Category I chemical down to the "lowest feasible" level, and if OSHA believed that "suitable" substitutes were available, a "zero" exposure level could be set. I According to the proposal, issues at the hearing on the proposed permanent standard would be limited to: "(1) Whether the Secretary correctly classified the toxic material into Category I; (2) whether the Secretary was correct in his determination that the Category I classification should not be rebutted; (3) whether the Secretary correctly determined the lowest feasible occupational exposure, or whether there are suitable substitutes that are less hazardous to humans; (4) the appropriateness of the specific protective means of the proposed standard and (5) the environmental impact caused by such regulation." Issues also would be limited in hearings on Category II classifications. John Kolojeski, moderator of the conference and President of Clement Associates (See June 1, Page 14) said that the proposed limitation on issues, which is central to OSHA's effort to speed rulemaking, could be construed as an abridgement of due process, while Sheehan held that these very issues probably would be litigated every time OSHA proposed a standard. Th refore, Sheehan said, OSHA rulemaking is likely to remain largely a substance-by-substance affair, characterized by delay. R&S 113886  Page "14 June 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS . Category II classification would prompt no emergency standard and no engineering controls, but an exposure limit would be set, as would medical surveillance and other "model" requirements. Rather than engineering controls, housekeeping practices * and personnel protective equipment and clothing would be prescribed for Category II chemicals. Keller explained that Category II is needed to "gear up" in case in formation becomes available indicating that the chemical belongs in Category I. Torkelson maintained that imposition of such requirements without consideration of th dose used in the animal experiment(s) would be irresponsible in light of the possibility that human metabolism could eliminate the threat which the chemical may pose. Dose in Backup Animal Studies "Irrelevant," Says OSHA's Wrenn Wrenn, however, responded that does was "largely irrelevant," since OSHA does not consider a threshold level to exist for carcinogens. R&S 113887 Marshall Miller, a legal expert and a former Deputy Assistant Secretary of Labor for OSHA, said that potency i.e. dose would be factored into OSHA deliberations "subjectively" when OSHA, taking economics into account, sets its lowest "feasible"or "zero" exposure level. Wrenn also was supported by Dr. Marvin Schneiderman of the National Cancer Institute (NCI), who said that "cancer is bad," regardless of potency. Kolojeski said procedures set out in the OSHA proposal for rebutting both Category I and II classifications "take care" of Torkelson's concerns. Justification for rebuttals on toxicological grounds are spelled out twice in the OSHA proposal, once for Category I chemicals and once for Category II. According to Section 1990.11 of the proposal, the Secretary of Labor may rebut the presumption of a Category I classification if he determines: "(a) that the alleged carcinogenic effect based on animal data clearly resulted from non-specific physical, rather than chemical induction, or (b) that the route of exposure was grossly inappropriate relative to the potential occupational routes of human exposure, or (c) that the animal or human studies submitted for review were only suggestive or not adequate to establish any conclusion with respect to the carcinogenicity or noncarcinogenicity of the toxic materials or (d) that for some other biological reason, the positive results in experimental mammals are not scientifically relevant to man." Justifications are similar for a successful rebuttal of a Category II classification. A successful rebuttal places a chemical at least one category below the proposed one. June 8, 1977 Page 15 PESTICIDE & TOXIC CHEMICAL NEWS 's Albert Raises Sticky Regulatory Issue just what constitutes "replication" of an animal test, however, is a particularly difficult issue, according to CAG Chairman Albert. At the SOEH meeting, Albert cited a "not uncommon" example he has run across at CAG where a pesticide now up for a rebuttable presumption against registration (RPAR) notice was found to produce tumors in a long-term study conducted by the Food and Drug Administration (FDA), but the tumors were found only at the lowest dose level, which is "strange in itself," Albert said. A long-term study by NCI was negative, Albert stated, as were two others. Another study on the same chemical, however, was found to b positive in one sex at one dose level, but the tumors which appeared in the dosed animals appeared later than spontaneous tumors observed in controls. Since tumors in dosed groups usually occur sooner than tumors in controls, this "replication" of an already "suspicious" FDA study is questionable, Albert said. Nevertheless, . the finding could conceiveably trigger a Category I classification if the OSHA proposal is allowed to stand as is (Albert would not reveal the identity of the pesticide in question). Albert asked if positive findings in two dose groups in the same experiment would constitute "replication," as suggested by Dr. David Clayson of the National Cancer Advisory Board. He also asked whether observation of a dose-response relationship could be considered "replication." No one answered his rhetorical questions. Generally, Albert expressed fears that OSHA's "black and white" proposal would give too much power to scientists. Squire Fears "Over interpretation" of "Suggestive" Bioassay Results Dr. Robert Squire, former Chief of the NCI Bioassay Program (See March 2, Page 22) and now at Johns Hopkins University and an Associate Scientist with Clement Associates, Inc., warned against linking "suggestive" NCI bioassay results to OSHA regulation under Category II. He said "overinterpretation of uncertain results has done more harm to toxicology than anything else." He held that NCI's research mission should be allowed to continue unencumbered by OSHA's regulatory mission. R&S 113888 With respect to Category I classification. Squire said "results in a single mammalian species supported by incriminating in vitro data would be most con vincing if either both sexes or more than one dosage group were affected." There was considerable discussion on whether OSHA should simply adopt the proposal as an administrative policy, once it has been revised or, as an alternative, whether OSHA should publish it as a proposed regulation and subject it to judicial review. ) The argument for th latter proc dur , as stated by Wrenn, would be that to speed OSHA rulemaking, judicial review is needed on the basic regulatory principles which OSHA follows v ry time It proposes a rule on carcinogens. Page 416 June 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS These cancer principles are essentially the same as those which have stretched out EPA cancellation proceedings on heptachlor and chlordane (See ~ po June 1, Page 25). CO ^ -Once such review is completed, Wrenn contended, rulemaking would go faster. co 0o0o The speed argument appears to have been rebutted by Sheehan, but Kolojeski argued in favor of making the document a regulation as opposed to a policy because the document's publication as a policy would not carry with it the mandatory timetables under which OSHA would be forced to propose permanent standards and take other actions. The document could be abandoned by the next Administration if it were simply a policy, Kolojeski said. Sheehan, on the other hand, argued that Federal Register publication of the proposal as a regulation would bog down OSHA in rulemaking on it and prevent OSHA from taking action on known problem chemicals. As an alternative, Sheehan suggested testing the policy on some real problems. Pointing to the recent OSHA activity on benzene (See June 1, Page 11), Wrenn denied that Federal Register publication of the proposal as a regulation would hamper OSHA in its efforts to deal with current problems. As a remedy to industry delaying tactics, NCI's Schneiderman suggested that for any chemical tied up in litigation, all profits should be placed in a closed fund unavailable to the manufacturer. Richard Boggs of the National Institute for Occupational Safety & Health (NIOSH) asked how OSHA would handle chemicals which are similar in structure to those placed in Category I or IT. He also asked for better definitions of the terms "feasible" and "detectable." As an indication of just how complicated these issues are and how deep emotions run, a labor union official, misconstruing remarks made by Torkelson, said Dow is interested in DNA research because the firm wants to create a "super race" of chemical workers who are immune to cancer. # Over 140 people from government, industry and academia attended the SOEH conference HOUSE COMMITTEE WANTS EPA TO ALLOW MIREX FOR FIRE ANT ERADICATION "In the hope that the Environmental Protection Agency will rescind its ruling on mirex" the House Appropriations Committee has reserved $4,460,000 for a fire ant eradication program, (See March 30, Page 33). PESTICIDE & TOXIC g Editors: CATHY COOPER, Gary Robinson, Gail Tapscott Circulation Dept.: Director, * Publisher: Louis Rothschild, Jr, Shirley Gaiant; Assistant Managing Editor: Raymond Gaiant Director, A ifce Wilkes Associate Editors: Ron Grandon, Production Manager: Dorothy Hill Natalie Pargas DOW EXECUTIVE MISSTATES CASE ON MUTATION TESTING; EPA TO PROCEED R&S 113890 Despite allegations to the contrary made by a Dow Chemical Corp. executive at a meeting of the Society for Occupational and Environmental Health,(SOEH), the Environmental Protection Agency's Science Advisory Board (SAB) has not determined that the state of the art of mutagenicity testing (See June 1, Page 2) is so primitive as to preclude use of mutagenicity data to support regulatory actions against pesticide chemicals. The executive. Dr. T. R. Torkelson of Dow's medical department, told last week's SOEH symposium on a cancer proposal from the Occupational Safety & Health Administration (OSHA) that OSHA should not depend on mutation tests at all for purposes of defining a chemical as a Category I carcinogen. Such a definition would trigger issuance of an OSHA emergency temporary standard entailing monitoring for the chemical in workplaces where it's producejd, used, or packaged, as w 11 as medical surveillance of exposed workers, "good housekeeping" requirements and other steps (See May 25, Page 20). Placement of a chemical into Category I could be "rebutted" in a rulemaking proceeding. If the rebuttal were unsuccessful, the rulemaking would determine what the "lowest feasible" exposure level is, and workplaces would have to reach it. It would become the OSHA permanent standard. In the rulemaking, OSHA also could say that there are suitable substitutes for the chemical and attempt to promulgate a permanent standard requiring zero exposure. F* OSHA has proposed to allow a positive bioassay result in a single mammalian species to trigger Category I classification if the bioassay has been "replicated" by a test on the same or a different species, or, if there exists "multi-test evidence of mutagenicity." Torkelson said EPA's SAB, two weeks prior to the June 2 SOEH meeting, had decided that mutagenicity testing "wasn't ready yet" for regulatory use, and, Torkelson said, it would be "inappropriate" for OSHA to use mutation data if EPA wasn't going to. However, the SAB Environmental Health Advisory Committee met June 1 to discuss EPA's proposed mutagenicity testing requirements for pesticides (See April 13, Page 14 and May 18, Page 2) and indicated that, in fact, the types of tests which EPA has proposed are sufficiently validated to require them for pesticide registration actions. Drake. Nelson. Wogan and Abrahamson Say Mutation Tests are Ready At the June 1 SAB meeting, another Dow executiv , Dr. V. K. Rowe, said EPA should not Impos the mutagenicity battery b caus the tests which compris it have not been validated and because their relevance to man is questionable. ' c* ^ Vli f - Page 4 June 8, 1977 PESTICIDE & TOXIC CHEMICAL NEWS C* Dr. John W. Drake, a memner of tne study group which helped EPA draft the Section 3 guidelinesf disagreed, saying that EPA and the study group had chosen only the best validated tests out of a possible total of 30. Dr. Norton Nelson, Chairman of the Environmental Health Advisory Committee, said that based on "a wide variety of studies in the animal kingdom, we do know that heritable mutations are a severe threat. The jump from that to the human I population is, to my mind, miniscule." I His arguments on validity and relevance to man discarded, Rowe then maintained that SAB should advise EPA to delay adoption of the testing requirements until the Agency had better defined what would-be a "statistically significant" result in each test and until EPA had spelled out how it would interpret "mixed results" from the component tests in the eight-test battery. I Dr. Gerald Wogan, Chairman of Drake's study group, said that nothing in the ; upcoming criteria document, which will address "mixed" results, will change the requirements which EPA has set forth. i Qn statistical significance, EPA's final guidelines will provide "more acceptable 1 biometric wording" regarding what constitutes a significant finding in each test, according to EPA's Dr. Ruth Pertel, a principle: author of the mutagenicity guide lines , This change comes about largely as a result of urgings from Dr. Lincoln E ! Moses, professor of statistics at Stanford University and a member of SAB. , With respect to maintaining flexibility and not putting mutagenicity testing require ments "in bronze," Nelson said, "Sure things are in a-major state of flux, but that state of flux is going to lead to alternative ways of doing very much the same kind 30 of things we're doing now, but doing them in a more efficient way." The document will say that the battery shall be reviewed every three years for possible changes. Drake held that some of the eight test "could fall by the wayside" not because they're invalid, but because "a more rapid or less expensive test may come along." 113891 In probably the most-telling argument against bacterial tests not being relevant to man. Dr, Seymour Abrahamson gave some history on how, with respect to radiation, a human risk estimate per Roentgen per gene using the mouse as a model has turned out to be "almost identical" to the human risk estimate which can be computed by using Drosophila (bacteria). Abrahamson said there is "good evidence" that man responds very closely to the mouse in terms of radiation sensitivity.* He said, the U. S. spent over $50 million establishing the mouse as an appropriate model when it turns out that bacteria would have been just as good an indicator. He said the argument against the mutagenicity testing battery on economic ground*^ was untenable, since, by Abrahamson*s calculations, the battery would cost no more than $45,000 per compound. i June 8, 1977 Page 5 PESTICIDE & TOXIC CHEMICAL NEWS He said the most expensive test other than the mouse specific locus test (which is included among the 13 from which eight will be chosen because it's valid, despite its cost) is the Drosophila test, which would cost around $10,000 if the experimenter was trying to detect a doubling of the spontaneous mutation rate. Abrahamson said the Drosophila test could cost as little as $1,000 if the experimenter were looking for a more drastic response, such as a five-fold increase over the spontaneous rate. Abrahamson is based at the University of Wisconsin. The Wogan-Drake study group will meet June 15 to discuss the criteria document which will describe how EPA will interpret "mixed" mutagenicity testing results. R&S 113892 USDI LABORATORY TO INPUT RPAR PROCESS WITH FISH, WILDLIFE EFFECTS DATA Fish-Pesticide Research Laboratory (FPRL), U. S. Fish and Wildlife Service, Interior Department, under an intragency agreement with the Environmental Protection Agency, will provide data on the effects of pesticides on fish and wildlife for use in the risk assessment portion of the rebuttable presumption against registration (RPAR) process. The agreement, signed June 2 by Edwin L. Johnson, Deputy Assistant Administrator for Pesticide Programs, EPA, stated that the FPRL, located in Columbia, Mo., would supply copies of published and notification of unpublished results of research on the effects of about 150 pesticides -- RPAR candidates and alternatives -- on fish apd wildlife. In the first month, the Laboratory would provide reprints and research results on about 60 pesticides, according to the agreement which.has not yet been signed by . the Fish and Wildlife Service. After the first month, the agreement noted, research results and reprints would be required on 10 to 20 compounds a month. The Laboratory would also supply negative responses, the agreement provided. The agreement would expire Sept. 30, 1977. EPA would pay the Fish and Wildlife Service about $10,000 for supplying the effects data. EPA will list and assign priorities to the pesticides for which the Laboratory will provide effects data. $5,850 CIVIL PENALTY AGREED TO BY THOMPSON-HAYWARD HEADS EPA ENFORCEMENT An agreement signed by Thompson-Hayward Chemical Co. of Fayetteville, N. C., to pay a $5,850 civil penalty assessed by Environmental Protection Agency officials in Region IV highlighted recent pesticide enforcement activity. \m). -r _ > UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 August 18, 1977 Jirssrr R&S 113893 Mr. T. R. Torkelson Corporate Medical The Dow Chemical Company Bennett Building 2030 Dow Center Midland, Michigan 48640 --7^ Dear Mr. Torkelson: Please be advised that formal minutes, per se, of the subcommittee meeting of the FIFRA Scientific Advisory Panel held on May 16-17, 1977 are not contemplated. We do plan to publish a topical outline and summary of the meeting, but it is our current policy to concentrate our limited secretariat resources on formal meetings. Due to our extremely heavy schedule for meetings and two unscheduled moves of our office (another one since you wrote), we are considerably behind in our minutes. However, I expect to be current again in about two weeks. The Panel plans another subcommittee meeting in September on Subpart F of the Guidelines, entitled "Hazard Evaluation: Humans and Domestic Animals." Mutagenic Test requirements will be discussed at great length. Should you desire to attend, the meeting is currently planned for the period September 28 to 29, 1977 In Room 2117, Waterside Mall, EPA Head quarters, Washington, D.C. Approximately 15 days prior to the meeting we will Issue an official notice in the Federal Register. The Panel is still evaluating the proposed mutagenic testing procedures, and It is premature at this stage to Indicate the opinion of the Panel on this issue. Following the September meeting, the Panel will eventually conduct a formal review of Subpart F of the Guidelines. This is expected to take place prior to Christmas. I hope that you will attend our meeting In September. This Is the best vtayibf keep current on the status of the Guidelines. Thank you for your interest. T Harland Wade Fowler, Executive Secretary FIFRA Scientific Advisory Panel 1921 Jefferson Davis Highway Room 803, CM#2 Arlington, Virginia August 10, 1977 To All Interested Parties, The Secretariat for the FIFRA Scientific Advisory Panel has been relocated in Room 803, Crystal Mall, Building No. 2, 1921 Jefferson Davis Highway, Arlington, Virginia. All correspondence for this office should be addressed as follows: t Dr. H. Wade Fowler, Jr., Executive Secretary FIFRA Scientific Advisory Panel (WH-566) CM-2 Room 803 Environmental Protection Agency Washington, D.C. 20460 The phone number is Area Code 703- H. Wade Fowler, Jr.