Document mp3dQ823xG2Ee8R5o9K4jwkEO

OHEMICAI MANUFACTURERS ASSOCIATION June 2, 1992 Dear Vinyl Chloride Research Coordinator Members: The following items are enclosed to aid you in your discussion at the June 5, 1992 conference call: 1) Agenda for the conference call; 2) Publication entitled, "An Industry-Wide Epidemiologic Study of Vinyl Chloride Workers, 1942-1982" by Otto Wong et al; 3) A October 21, 1991 letter to Roy Gottesman from R. Hinderer expressing concerns on the Wong et al publication; 4) A November 8, 1991 letter to Roy Gottesman from J. Drumwright expressing concerns on the Wong et al publication; 5) Publication entitled, "Critical Review of Cancer Epidemiology in Petroleum Industry Employees, With a Quantitative Meta-Analysis by Cancer Site,"; 6) A copy of the CMA Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research; 7) Selected pages from the October 1991 ATSDR Draft Update of the Toxicological Profile for Vinyl Chloride; 8) A copy of the ATSDR Procedure for Conducting Voluntary Research; and, 9) March 4, 1992, EPA RM 1 Meeting Summary for Screening Level Testing of TRI Chemicals, CMA will initiate the call at 1:00 p.m. EDT. Dr. Otto Wong will be included on the call at 1:45 p.m. EDT. Items 2,3, and 4 probably were sent to you earlier; however, they are included again for your ready reference. Discussion of Dr. Wong's publication on vinyl chloride will be the major topic of discussion on June 5. Dr. Wong has sent me his publication entitled, "Critical Review of Cancer Epidemiology in Petroleum Industry Employees," (Item 5) to see if the CMA Vinyl Chloride Panel may want to publish a similar article. Item 6 is enclosed for your information only. Item 7 is selected pages from the October, 1991 Draft Toxicological Profile Update for Vinyl Chloride. The comment period on the draft profile was extended to March 2, 1992. Vinyl chloride is R&S150035 T::01 M 8l'eo! NVV Wasninoton DC 20037 202-887-'-no P.jnaiax 202-887 1X s9bi : 2m ) Vinyl Chloride Research Coordinators June 2, 1992 Page 2 number 4 on a list of 38 high priority chemicals identified by ATSDR for filling data gaps. The identified data gaps for vinyl chloride are included in the enclosed selected pages. ATSDR plans to publish revised data gaps for vinyl chloride in June, 1992, based on comments received. Item 8 is the procedure for conducting a voluntary research program under ATSDR and Is being sent to you for your information. Item 9 is EPA's intention to list vinyl chloride on its high production/release chemical list and identifies several data gaps for vinyl chloride. My cursory review of the data gaps identified by Clemment Associates in the support document attached to the EPA document indicates that these data gaps are incorrect. The Panel members may want to work with EPA now so that the new document reflects correct data gaps or may want to wait until EPA publishes the new document. We will discuss above items on our conference call on June 5. If there is sufficient interest on the part of the Vinyl Chloride Research Coordinators to pursue the above items further, we may consider a meeting in Washington, D.C., to discuss the industry's plan of action in more detail. I am looking forward to speaking with you on June 5. If you have any questions concerning the call, please call me at (202) 887-1192. Sincerely Enclosures Hasmukh C. Shah, Ph.D. Manager, Vinyl Chloride Panel" 4758 Federal Register / Vol. 57, No. 26 / Friday. February 7,1992 / Notices pursuant to th* applicable tariff, notwithstanding demand for payment This proceeding hat been atiigned to Administrative Law fudge Charles E. Morgan ("Presiding Officer"). Hearing in this matter, if any is held, shall commence within tbe time limitations prescribed in 46 CFR 502.61. The hearing shall include oral testimony and crossexamination in the discretion of the Presiding Officer only upon proper showing that there are genuine issues of material fact that cannot be resolved on the basis of sworn statements, affidavits, depositions, or other documents or that the nature of the matter in issue is such that an oral hearing and cross-examination are necessary for the development of an adequate record. Pursuant to the further terms of 46 CFR 502.61. the initial decision of the Presiding Officer in this proceeding shall be issued by February 3,1993, and the final decision of the Commission shall be issued by fune 3, 1993. Joseph C Policing, Secretary. [FR Doc. 92-2966 Filed 2-6-92: MS am] mum coot sras-ei-a FEDERAL RESERVE 8YSTEM Cartoa Salman, at U Chang* in Bank Control Notie*; Acquisition of Shares of Banka or Bank Holding Companies The notiflcant listed below has applied under the Change in Bank Control Act (12 U.S.C. 1617(j)) and | 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire a bank-or bank holding company. The factors that are considered in ecting on notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notice is available for immediate inspection at the Federal Reserve Bank indicated. Once the notice has been accepted for processing, it will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for the notice or to the offices of the Board of Governors. Comments must be received not later than March 3,1992. A. Federal Reserve Bank of Atlanta (Robert E. Heck. Vice President) 104 Marietta Street NW,, Atlanta. Georgia 30303: 7. Carlos Salman. Miami. Florida: to acquire an additional 11.30 percent of the voting shares of Terrabank Holding Corporation, Miami Florida, for a total of 20.57 percent, and thereby indirectly acquire Terrabank. N_A.. Miami. Florida. Board of Governors of tha Federal Reserve System. February X1992. (enaifar J. Johnetm. Associate Secretory ofthe Board. (FRDoc. 92-2966 Filed 2-6-92:6:45 am| HUM coos s*1-r U.S.B. Hokflng Co* Inc* at aL; Formations of. Acquisitions by; and Mergers of Bank Holding Companies The companies listed in this notice have applied for the Board's approval under section 3 of the Bank Holding Company Act (12 U.S.C. 1642) and f 225.14 of tha Board's Regulation Y (12 CFR 225.14) to become a bank holding company or to acquire a bank or bank holding company. The factors that are considered in ecting on the epplications ere set forth in section 3(c) of the Act (12 U.S.C. 1842(c)). Each application is available for immediate inspection at the Federal Reserve Bank indicated. Once the application has been accepted for processing, it will also bs available for inspection at tha offices of tha Board of Governors. Interested persons may express their view* in writing to the Reserve Bank or to the offices of the Board of Governors. Any comment on an application that requests a bearing must include a statement of why a written presentation would not suffice in lieu of e hearing, identifying specifically any questions of fact that art in dispute end summarizing tha evidence that would be presented at a hearing. Unless otherwise noted, comments regarding each of these applications must be received not later than March 3, 1902* A. Federal Reserve Bank of New York (William L Rutledge. Vice President) 33 liberty Street New York. New York 10045: 1. US.B. Holding Company. Inc.. Nanuet New York; to acquire 26 percent of tbe voting shares of New Milford Bank end Trust Company. Inc- New Milford, Connecticut B. Federal Reserve Bank of Richmond (Lloyd W. Bostian. Jr- Senior Vice President) 701 Beat Byrd Street Richmond Virginia 23261; 1. F&MNational Corporation, Winchester. Virginia; to acquire 100 percent of the voting shares of Farmers A Msrchants Bank of Keyset Kayaer, West Virginia. C Federal Reserve Bank of Atlanta (Robert E. Heck. Vice President) 104 Marietta Street N.W* Atlanta, Georgia yngryf' 7. Villages Bancorporation, Inc., Lady Lake. Florida; to become a bank holding company by acquiring 100 percent of the voting shares of First Bsnk of the Villages. Lady Lake. Florida. D. Federal Reserve Bank of Chicago (David S. Epstein. Vice President) 230 South LaSalle Street Chicago. Illinois 60690: 7. Fairmount Banking Company. Fairmount Indiana; to become e bank holding company by acquiring 100 percent of the voting shares of The Fairmount State Bank. Fairmount, Indiana. Board of Governors of tbs Federal Reserve System. February X1992. (ennifer |. fohneoa. Associate Secretary ofthe Board. (FR Doc. 92-2967 Filed 2-6-92:6:45 am| HUM coot etws> V DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Diases* Registry [ATSOft-47] Procedure for Conducting Voluntary Research AOCMCY: Agency for Toxic Substances and Disease Registry (ATSDR). Public Health Service (PHSL Department of Health and Human Services (HHS). action: Notice. summary: This notice announces the procedure for volunteering to conduct research as part of the ATSDR Substance-Specific Applied Research Program authorized by the Comprehensive Environmental Response. Compensation, tnd Liability Act (CERCLA), as amended. The voluntary research will be conducted by the private sector to All priority data needs for hazardous substance* that are the subjects of the ATSDR Toxicological Profiles. To date, the priority data needs for 38 hazardous substances have been identified and announced by ATSDR in the Federal Regieter (56 FR 52178) on October 17,1991. As part of this procedure for conducting voluntary research, the Agency has developed a model agreement Memorandum of Understanding (MOU). that will be signed by ATSDR and the interested private sector organization(s) (hereinafter referred to as the Company, although multiple companies or a consortium may be signatories to a single MOU) prior to the initiation of the voluntary research. The public is invited to comment on this procedure for conducting voluntary research, and the model MOU. R&S150037 Federal Register / Vol. 57. No. 26 / Friday. Febniaty 7, 1992 / Notices 4759 DATtS: The ATSDR considers this voluntary research effort to be of significant importance to the continuing development of the Substance-Specific Applied Research Program. Therefore, public comments concerning this Federal Register notice will be accepted throughout the Agency's involvement with voluntary research. ADONCSSCS: Comments on this notice shouid bear the docket control number ATSDR-4" and should be submitted to the Division of Toxicology. Research Implementation Branch. Agency for Toxic Substances and Disease Registry. Maiistop E-29.1600 Clifton Road NEL. Atlanta. Georgia 30333. Requests for a copy of the model Memorandum of Understanding should be addressed similarly. Comments on this notice will be available for public inspection at the Agency for Toxic Substances and Disease Registry'. Building 33. Executive Park Drive. Atlanta. Georgia (not a mailing address), from 8 a.m. until 4:30 p.m.. Monday through Friday, except for legal holidays. FOR FURTHER INFORMATION CONTACT; The Division of Toxicology. Research Implementation Branch. Agency for Toxic Substances and Disease Registry. Mailstop E-29.1600 Clifton Road NE. Atlanta. Georgia 30333. Telephone: 404639-8015 or FTS 236-6015. SUPPLEMENTARY INFORMATION: Background The Comprehensive Environmental Response. Compensation, and Liability Act (CERCLA) (42 U.S.C. 9604(i]). as amended by the Superfund Amendments and Reauthorization Act (SARA) (Pub. L 99-499), requires that ATSDR: (1) Develop jointly with the Environmental Protection Agency (EPA) a list of hazardous substances found at National Priorities List (N7L) sites, (in order of priority), (2) prepare Toxicological Profiles of these substances, and (3) assure the initiation of a research program to HU identified data needs associated with the substances. The identification of the priority data needs for 38 priority hazardous substances was described in the Federal Register (October 17.1991,56 FR 52178). public comments were invited, end Companies were invited to volunteer to conduct research (o fill specific priority data needs during the public comment period for that notice. Future Federal Register notices will announce (1) the Final list of priority data needs for the 38 hazardous substances after public comments on these priority data needs Have been addressed. (2) a second call for voluntarism to conduct research to RU priority data needs, and (3) the names of Companies that have volunteered to Rll specific priority data needs. The major purpose of this ATSDR Applied Research Program is to supplement the substance-specific informational needs of the public and scientific community; and to supply necessary information for conducting comprehensive public health assessments for populations living in the vicinity of hazardous waste sites. This program will also provide date that can be generalized to other substances or areas of science, including risk assessments of chemicals, thus creating a scientific base for filling a broader range of data needs. Procedure for Conducting Voluntary Research CERCLA. as amended in eection l04(i)(5)(D). states that it is the sense of Congress that the costs for conducting this research program be borne by the manufacturers end processors of the hazardous substances under the Toxic Substances Control Act (TSCA) and registrants under the Federal Insecticide. Fungicide, and Rodenticide Act (F1FKA). or by coat recovery from responsible parties under CERCLA. To effectuate this statutory intent the ATSDR has developed a plan whereby portions of this CERCLA SubstanceSpecific Applied Research Program will be conducted via regulatory mechanisms (TSCA/FIFRA), private sector voluntarism, and through the direct use of CERCLA funds. ATSDR intends to enter into voluntary research projects in ways that lead only to high quality scientific work. This necessitates peer review of study protocols and results consistent with CERCLA section 104(0(13). CERCLA requires the peer review panel to consist of three to seven peer reviewers who (a) are selected by the Administrator of ATSDR. (b) are disinterested scientific experts, (c) hava a reputation for scientific objectivity, and (d) who lack institutional ties with any person involved in the conduct of the study or research under review. The ATSDR is aware of concerns within some segments of the public regarding voluntary research conducted by Companies with vested Internets in the research. To this and, the Agency encourages the public to comment on ATSDR's procedure for conducting voluntary research in this nodes. Additionally, for each research project conducted voluntarily, the MOU (signed by ATSDR and the interested Company), the ATSDR approved study plan, peer reviewers' comments, and die final research report will be available for public inspection at the location and times indicated in the montim section of this notice. The ATSDR encourages Companies to volunteer to conduct research on priority data needs that ware announced in the Federal Register notice "Ident./ication of Priority Data Needs for 36 Priority Hazardous Substances'' (October 17.1991,56 FR 52178] and on priority data needs to be subsequently announced by the Agency. Interested Companies are asked to submit concept proposals (1-2 pages, not detailed -protocols) during the October 17,1991january 15,1992 public comment period for the above-mentioned notice, and for subsequent Federal Registar notices. The concept proposal should include (l) the name of the interested Company, (2) the specific priority data need(s) to be filled. (3) a summary of the Company's experience in conducting research similar to that in the concept proposal, and (4) a statement about the laboratory and other resource capabilities for conducting the proposed research. Interested Companies may submit concept proposals that address substance-specific data needs or. where appropriate, concept proposals for research that will provide information relevant to classes of chemical substances or which may be generalized to other areas of science. A tri-agency review committee comprised of scientists from ATSDR. the National Toxicology Program (NTP), and the EPA will review these concept proposals. The committee, chaired by the Director of the Divition of Toxicology. ATSDR, is charged with coordinating and assuring the - appropriate evaluation of research conducted to fill priority data needs of ATSDR's priority hazardous substances relevant to the objectives of CERCLA. as amended. The principal responsibilities of the committee are to (1) provide a forum to discuss substance-specific research activities being carried out via TSCA/FIFRA. private sector voluntarism, or CERCLA funds, (2) coordinate knowledge of research activities to avoid duplication of research being conducted in other programs and under other authorities, and (3) maintain a scheduled forum that provides an overall review of the ATSDR Superfund Applied Research Program. Bated on tha review committee's recommendations. ATSDR will determine which, end how, specific voluntary research project* will be pursued with volunteering Companies. In instances where volunteered research initiatives are considered by the tri R&S150038 4760 Federal Register / Vol. 57. No. 28 / Friday. February 7. 1992 / Notices agency committee to be more appropriate for EPA response. EPA may negotiate directly with the interested Company. If ATSDR decides to pursue a specific voluntary research project submitted in a concept proposal by a Company, the Agency will enter into a MOU with the interested Company, or where appropriate, a single MOU will be entered into with multiple Companies. ATSDR recognizes that two or more companies or a consortium of interested firms may elect to enter into collaborative efforts in pursuing one or more concept proposals. Following the signing of the MOU and prior to the initiation of the research, the interested Company will negotiate with ATSDR to agree upon an approved study plan including testing protocols. The content of the MOU is described below. (1) Identification of the party or parties comprising the Company which enters into the MOU--this section consists of the name and address of each party responsible for the conduct of the research. (2) Identification of the substance(s) subject to research requirements under the MOU--this section consists of the name and Chemical Abstract Service (CAS) Number of the chemical substance(s) that is the subject of the MOU. The chemical substance(s) to be tested shall be as pure as reasonably can be attained. AJtemate language will be substituted when the subject of the research is a human population, as in epidemiologic studies. (3) Identification of the effects or characteristics for which research is to be conducted--in this section, the health effects, environmental fate or other characteristics for which research is to be conducted under the MOU shall be listed. (4) Schedule for submission of study plans, initiation of research and submission of interim and final reports--the Company shall submit to ATSDR a study plan for each test six weeks after signing the MOU. The study plan shall include test protocols and a schedule with reasonable timetable and deadlines for initiation and completion of each test and submission of interim and final reports. The test protocols will be reviewed by an ATSDR-appointed peer review panel If ATSDR disapproves the study plan, it will inform the Company of the deficiencies of the plan. The Company may request reconsideration of the study plan, resubmit a modified study plan, or elect to terminate the MOU with no further obligation of either party under the MOU. In the event that the Company resubmits a modified study plan and ATSDR disapproves it the Agency may elect to terminate the MOU. The starting date of the research project may be negotiated depending on the type of research being conducted. However, as a general guideline, the research effort shall be initiated within eight weeks of the approval of the study plan and attendant test protocols. Written notification of the starting date of the test will be submitted to ATSDR by the Company. The completion date of the study will be established from the approved study plan. Interim progress reports shall be submitted to ATSDR within six months after the initiation of testing and thereafter within six months after submission of each previous interim report The final report on the results of testing shall be submitted to ATSDR no more than 20 weeks following the end of the study. ATSDR acceptance of the final report will be contingent upon approval by ATSDR following the peer reviewers' recommendations, consistent with CERCLA section 104(i)(13) peer review requirements. All results of research conducted pursuant to the MOU and all supporting data associated with the research report will be provided to ATSDR and made available by the Agency to the public as part of its implementation of sections 104(i) (3) and ($} of CERCLA. Final reports will not be accepted if the data is designated Confidential Business Information (CBI) or otherwise restricted from public disclosure. (5) Modifications of study plans, guidelines, and schedules--if a Company intends to modify a study plan, protocol, or schedule that was approved by ATSDR, it must notify ATSDR in writing of the proposed modifications and reasons therefor. If ATSDR approves of the modifications, the time schedule established for completion of the tests shall be re negotiated and appended to the existing MOU. If ATSDR disapproves the Company's request and the Company does not accept ATSDR's decision to disapprove the modified study plan, the Company may terminate the MOU. (8) Observance of Good Laboratory Practices--all research agreed to in die MOU shall be conducted in accordance with the Good Laboratory Practice (CLP) standards codified in 40 CFR 792, to the extent that such CLP standards apply. Should tha Company's Good Epidemiology Practices be relevant to a research project those Practices should be affixed to the study protocol. (7) Inspections--the Company shall ensure that an authorized employee of ATSDR is permitted, at reasonable times and in a reasonable manner, to (1) inspect any research or testing facility that is conducting research pursuant to the MOU. and (ii) inspect (and in the case of records, copy) any records and specimens required to be maintained in connection with research performed pursuant to the MOU. (8) Submission and publication of data--all data and reports submitted to ATSDR pursuant to the MOU shall be sent to ATSDR. in duplicate, at the address indicated in the ADOftUScs section. Acceptance of the final report is contingent upon approval by ATSDR following the peer reviewers' recommendations, consistent with CERCLA peer review requirements. The Company maintains all rights to publication of data and results, however all results of research conducted pursuant to the MOU and all supporting data associated with the final research report will be provided to ATSDR and m&de available by the Agency to the public as part of its implementation of Section 104(i)(5) of CERCLA. The final report will not be accepted by ATSDR if the data is designated Confidential Businesa Information (CBI) or is otherwise restricted from public disclosure. (9) Payments of costs and expenses-- each company shall agree to pay all costs, direct and indirect associated with the research programs and which are not considered part of ATSDR's administrative costs. (10) Events constituting a breach of the MOU--Failure by the Company to: (a) Submit a study plan that receives ATSDR's approval following the peer reviewers, recommendations: (b) Initiate any test agreed to in the MOU by the date established pursuant to the MOU: ------- (c) Adhere to CLP standards, established test procedures or accepted practices of good science to the extent that these standards and practices apply; (d) Submit any interim report required under the MOU by the date established pursuant to the MOU; or (e) Submit any final report that receives ATSDR's approval following peer review conducted by the Agency, shall constitute a breach of the MOU. In the event of a breach. ATSDR will not impose any claim to damages, but at the Agency's discretion may terminate the MOU. (11) Termination--since the MOU is entered into voluntarily by ATSDR and the Company, termination by ATSDR is not considered reviewable agency action pursuant to the Administrative Procedure Act or any other applicable Federal law. and there will be no appeal R&S150039 Federal RegUter / V 1. 57. No. 28 / Friday. February 7. 1982 / Notice* *781 process beyond that aet out in the MOU. The Company may elect to terminate the MOU at any time. (12) Statutory compliance--conaiatent with aection I04(i)(12) of CERCLA. as amended (42 U.S.C. 9612). nothing in the MOU shall be construed to delay or otherwise affect or impair the authority of the President, the Administrator of ATSDR or the Administrator of EPA to exercise any of their authority under any other provision of law. including TSCA and FIFRA. or the response and abatement authorities of CERCLA. The results of the research conducted via this ATSDR Substance-Specific Applied Research Program will be used for public health assessment purposes and to reassess ATSDR's substancespecific priority data needs. It is the intention of the Agency, at this time, to re-evaluate the priority data needs for the listed hazardous substances every three years. Dated: February 3,1902. Walter R. Dowdle. Acting Administrator. Agencyfor Toxic Substances and Disease Registry. (FR Doc. 92-2978 Filed 2-8-02:8:45 am] MiBM COOC 41*6-7*41 Alcohol, Drag Abuse, and Mental Health Administration Suspension Lifted; Laboratory Again Meets Minimum Standards To Engage In Urine Drag Testing tor Federal Agencies agency: National Institute on Drug Abuse. HHS. action: Notice. summary; The Department of Health and Human Services notifies Federal Agencies of the laboratories currently certified to meet standards of Subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11986) dated April 11.1966. The following laboratory's certification to engage in urine drug testing for Federal Agencies was suspended on October 15. 1991 (56 FR 54582, October 22.1991} and was reinstated effective February 4, 1992. HealthCare/Preferred Laboratories. 24451 Telegraph Road, Southfield. MI 48034. 800225-9414 (outside Mil. 800-328-4142 (inside MI). FOR FURTHER INFORMATION CONTACT: Mona W. Brown. Press Officer. National Institute on Drug Abuse, room 10-A-39, 5600 Fishers Lane. Rockville. Maryland 20BS7: Telephone (301>-443-6245. Richard A. Mllbtta, Acting Director. Notionalinstitute on Drug Abuse. (FR Doc. 92-3085 Filed 2-6-92:8:45 am) mum coot iea as s National Instttuts of Mental Health; Meetings Pursuant to Public Law 92-463. notice is hereby given of the meetings of the advisory committees of the National Institute of Mental Health for February/ March 1992. The initial review group* will be performing review of applications for Federal assistance: therefore, portions of these meetings will be closed to the public as determined by the Administrator. ADAMHA. in accordance with S U.S.C. 552b(c)(6) and 5 U.S.C. app. 210(d). Summaries of the meetings and rosters of committee members may be obtained from: Ms. joanna L. Kieffer. NIMH Committee Management Officer. Alcohol Drug Abuse, and Mental Health Administration, Parklawn Building, room 9-105,5600 Fishers Lane. Rockville, MD 20657 (Telephone: 301443-4333). Substantive program information may be obtained bom the contacts whose names, room numbers, and telephone number* are listed below. Committee Name: Mental Health Small Business Research Review Committee. Meeting Dote: March 2-3.1992. Place: Washington Marriott 1221 22nd Street NW, Washington. DC 20037. Open: March 2.9-1030 am. Closed: Otherwiae. Contact- Gloria Levin, room 9C-14, Parklawn Building. Telephone (301) 443-1367. Committee Name: Treatment Assessment Review Committee. Meeting Date: March 2-3,1992. Place: Embassy Suites. 4300 Military Road. NW, Washington. DC 20015. Open: March 2.630-9:30 a.m. Closed: Otherwiae. Contact Barbara CampbelL room 9C-02. Parklawn Building, Telephone (301) in fiUiUiUi< Committee Name: Child Psychopathology and Treatment Review Committee. Meeting Date: March 9*11.1992. Place: Holiday Inn Chevy Chase. 5520 Wisconsin Avenue, Chevy Chase. MD 20615. Open: March 9.9-10 am. Closed: Otherwise. Contact Dons Lee Robb, room 9C-15. Parklawn Building. Telephone (301) 443-6470. Committee Name: Behavioral, Clinical, and Psychosocial Subcommittee of the Mental Health AIDS and Immunology Review Committee. Meeting Date: March 11-12.1992. Place: Holiday Inn Chevy Chase, 5520 Wisconsin Avenue, Chevy Chase. MD 20615. Open: March 11.8:30-9:30 a.m. Closed: Otherwise. Contact Regina M. Thomas, room 9C15. Parklawn Building. Telephone (301)443-6470. Committee Name: Psychobiological. Biological and Neuroscience Subcommittee of the Mental Health AIDS and Immunology Review Committee. Meeting Date: March 11-12.1992. Place: Holiday Inn Chevy Chase, 5520 Wisconsin Avenue. Chevy Chase. MD 20615. Open: March 11.8:30-9:30 am. ' Closed: Otherwise. Contact Reliant A. Chowdhury, room 9C-15, Parklawn Building. Telephone (301)443-6470. Committee Name: Clinical Subcommittee. Mental Health Special Project Review Committee. Meeting Date: February 28,1992. Place: Holiday Inn Crowne Plaza. 66 Hale Avenue. White Plains. NY 10601. Open: February 28,830-9 am. Closed: Otherwise. Contact Cewn Artis, room 8-Cia. Parklawn Building, Telephone (301) 443-3944. Dated: February 4.1992. Peggy W. CodtriB. ------ Committee Management Officer. Alcohol. Drug Abuse, andMentalHealth Administration. [FR Doc. 91-3024 Filed 2-8-92:8:45 am| llbw cone 4ee-sMi Cantors for Disease Control National Committee on Vital and Haafffi Statistic* (NCVHS) Subcommitt## on State and Community Health Statistics: Cancellation of Moating This notice announces the cancellation of a previously announced meeting. Federal RegUter Citation ofPrevious Announcement 57 FR 3CS9. January 27, 1X2. Previously Announced times and Dotes: 1 p.m-5 p.m*. February 20,1992 a.m.-5 p.m.. February 21.1992 R&S 150040 BFGoodrich Trie BPGoodnch Company 3925 Embassy Partway Akroa Ohio 44313-1799 October 21, 1991 Dr. Roy T. Gottesman Vinyl Institute Wayne Interchange Plaza II 155 Route 46 West Wayne, NJ 07470 Dear Roy: In response to your request, you should note that there are two main problems with the study by Wong et al. 1991, entitl d An Industry-wide Epidemiology Study of Vinyl Chloride Workers, 1942-1982". First, the authors use the 7th rather than the 9th revision of the International Classification of Disease. The effect here is to lump all brain cancers together. Secondly, the authors leave the question of whether there is a relationship between VCM and brain cancer hanging without providing some logical comments and assessments. While they reference Doll's earlier review paper in the introduction, they fail to mention what is important from that paper. Specifically, they fail to note that for brain cancer, and in fact all cancers except liver, there is no consistency across studies which is an important consideration in -- assessing causal relationships in epidemiology studies. Furthermore, the effect of other potential biasing/confounding factors (eg. other exposures) are not addressed. When I obtained a copy of this publication, I quickly realized that this was the work that was sponsored by the CMA VCM Panel. Unfortunately, the authors failed to send a draft to the Panel for review prior to publication. When I discussed this with Dr. Shah at CMA, he indicated that CMA would notify them that they have violated their contract. The next step will be for the whole Panel to consider what corrective actions are necessary and/or appropriate. Hopefully, the authors will be agreeable to add some clarifying comments in a letter to the editor. Tt'-OOStSVfcl Dr. Gottesman October 21, 1991 Page 2 At present, I view this as a CMA project. However, I will keep you posted as things progress. Best regards, THE BFGOODRICH COMPANY Robert X. Hinderer,Ph.D. Manager, Health and Toxicology Environment, Health and Safety Management Systems 1021-4/jp cc: Dr. Drumwright Dr. Shah - CMA 1 rtuy i c r?.C' Vuta Chemical Company 900 Throodneedle Hourton. Texas 77224 Poll Office Box 19029 J.R. Drwmwright, M.O. Manoger-Medicol November 8, 1991 Roy T. Gottesman Vinyl Institute Wayne Interchange Plaza n 155 Route 46 West Wayne, N.J. 07470 Dear Roy: Bob Hinderer and I have discussed the Wong et al 1991 study entitled "An Industry-wide Epidemiology Study of Vinyl Chloride Workers, 1942-1982". I first heard about the updated report while attending the Denver meeting of the VCSA. The BNA report had addressed some of Wong's conclusions as they were reported in the American Journal of Industrial Medicine. My comments essentially agree with those already presented to you by Bob Hinderer. Namely, the use of the ICD-7 classification lumps all brain and other CNS cancers together; death certificate data without adequate histopathological diagnosis/review and assumptions established without specific cause/effect, consistency in latency period, etc. Bob's recognition that the authors had apparently failed to have the CMA Panel review the report prior to publication by Wong led to his discussing this with Dr. Shah. It is my understanding that CMA will be addressing this with Dr. Wong. In any event, the study has been published and we must be cognizant of this when new litigation appears. Hopefully, clarification by Wong et al will receive adequate publication as well. R&S150043 I plan to keep in contact with Bob and will keep you posted as well on any events dealing with this issue. cc: JRD Vi File T. Grumbles R. K. Hinderer, PhD Mgr. Health & Tox. B.F. Goodrich Co. 3925 Embassy Pkwy. Akron, Ohio 44313-1799 R&S 150044 Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research Th Chemical Manufacturers Association's Epidemiology Task Group The Guidelines for Good Epidemiology Practices (GEPs) for Occupation*! and Environmental Epidemiologic Research addreet the conduct of studies generally undertaken to answer queetioneabout human health in relationahip to the workplace or the environment. The GEPt propaee minimum praeticee and procedures that thouid be considered to help ensure the quality and integrity of data used in epidemiologic research mnd to provide adequate documentation of the research methods. The GEPt addreee the process of conducting individual epidemio logic studies and do not prescribe specific research methods. The Guidelines for Good Epidemiology Praeticee propose minimum practices and procedures in the following areas: I. Organisation and Personnel U. Facilities, Resource Commitment, and Contractors HI. Protocol IV. Review and Approval V. Study Conduct VI. Communication VII. Archiving VIII. Quality Assurance Duriaf th* d*v*iopm*nt of th* Guldalln** tor Good Epidemiology Practical, th* following reaearchara war* mambara of CMA't Epida- miolofy Taak Group: William J. Ballay, MFH, Chevron Corporation: Claudia Berner. BS. Exxon Blomadlcal Solano**. Inc; Jama* J. Oolllaa. PhD. Monsanto Company; Ralph B. Cook. MD. MPH. Th* Dow Chan- leal Company: Barbara J. Diets*. PhD. Taxaoo Inc; Barry E*ebanbach. MS. Orae* Specialty Chamloala Company; William X. Eayarvaatbar. PhD, MPH. X. I. du Pont da Nemours aad Oo. Ian, (Ghalraaa, Epld*mloloy Taak Group); Lorraine Lucas. PhD, American Cyaaamld Company; M. Gerald Ott. PhD, BASF Corporation; Gerhard K. Hash*. Dr PH. MS, Mobil Corporation; Robert Schnattar, PhD, Exxon Bioaadleal Science*. lam Sandra Salanaka*. PhD. Union Carbide Chemicals 4 Plaatica Company Inc; M. Jan* Tata, Dr PB. Union Carbid* Chamloal* A Plaatica Company Inc: William Thar, MD. Exxon Blomadlcal Sd- oncaa. Inc: Sandra L Tlroy. MS. Chemical Manufacturer* Association. Address correspondence to Dr William X. Fayarvaathar, L L da Pont d* Nemoura and Co. N-11S10-HR, 1007 Market Streat. WUmlnpton. DE 10608. i73/#i /ssia- laaipos.oo/o CopyrifBt C by Americas Ceil*** of Occupational Medietas Although th* Guideline* for Good Epidemiology Practice* will not guarantee good *pid*miolO(y. they do provid* a uaoful framework for ensuring that all research itauaa are adequately addmaand. Thl* framework Is propoaad as a first step in Improving spidamlologic research practices through adher ence to sound scientific raaaarch principlaa. Appandioaa proetd* an overview of etandard operating pro cedure*. a ginai*ry of term* uaed in th# Guideline*, and uggeeted rafaranoaa on oocupational apidomiology mathoda. Epidemiologic atudlon provide unique, valuable infor mation about the relationship between human health and exposure to eubatancee in the environment and the workplace. While the contributions of toxicology and epidemiology are complementary, there Is general agreement that reliable human evidence (epidemiologic studies) should take precedence over animal data (tox icological studies) in public policy and regulatory deci sion making. However, because of the nonexperimental nature of occupational and environmental epidemiologic studies, scientific controversy often surrounds the inter pretation and significance of epidemiologic study re sults. In addition, controversy frequently concerns the quality of the data used, the appropriateness of the study design, and the process used to oonduct the study. Th# nonexperimental nature of the epidemiologic stud io# cannot be changed, but the value of such research can be improved. The Guidelines for Good Epidemiology Practices address those issues--data quality, study de sign, and study oonduct--that are under the control of the investigator. Goafe for thaGukMnss for Good Epidemiology Practices The Guidelines for Good Epidemiology Practices (GEPs) address the conduct of studies generally under- Joumal f Occupational Medicine/Volume 33 No. 12/Decombor 1991 1221 R&S 150045 taken to answer questions ebout human health in rela tionship to the workplace or the environment. The OEPs propoee minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The OEPs address the process of conducting individual epi demiologic studies and do not prescribe specific research methods. Although Guidelines for Good Epidemiology Practices will not guarantee good epidemiology, they will provide a framework within which these issues might be ad dressed. The Guidelines have the following goals: 1. To provide a framework to assist researchers in adhering to good epidemiologic research princi ples. 2. To promote sound epidemiologic research by en couraging quality data collection and analysis. 3. To facilitate the continued development of im proved epidemiologic research methodology. 4. To provide a framework for evaluating epidemio logic studies. 5. To improve the acceptance of studies that use sound scientific methods. 6. To improve the utility of epidemiologic studies in the formulation of public policy. 7. To improve public confidence in epidemiology as a scientific discipline. 8. To facilitate the conservation of technical re sources by promoting careful study design and planning of study conduct. EPA's position that the study itself can be conducted and submitted to EPA in accordance with the GLP standards." The GLFs are directed primarily at experimental laboratory research, often involving the use of animal^ or cell culture systems. The GLPs address issues that confront researchers conducting experimental toxico logical research. The Guidelines for Good Epidemiology Practices were developed in part to provide an alter native to the GLPs that would appropriately address the issues confronted by epidemiology researchers con ducting nonexperimental studies. Scope and Application The Guidelines for Good Epidemiology Practices can be applied to all types of occupational and environmental epidemiologic research. Epidemiologic studies often evolve through a number of stages that might include proposals, feasibility studies, and measurement instru ment validation studies that precede the development of a protocol. The GEPs should encompass all activities that begin with protocol development. Clearly, large complex studies will benefit from the careful planning and thorough documentation implicit in these guidelines. Adherence to the spirit of the guidelinee will be beneficial for those activities preceding protocol development as well as more informal investi gations such as health hazard assessments/evaluations or small cluster Investigations. Even in circumstances of immediate public health concern, the guidelines will provide a useful framework to ensure that all research issues are adequately addressed. Alternative Guidelines A number of other organizations have also beoome interested in developing or applying guidelines to epi demiologic research.1-* The Office of Management and Budget (OMB) published "Guidelines for Federal Sta tistical Activities" in which they defined "statistics" as the quantitative results of a survey or study collected for the purposes of reporting population characteris tics.1 The Environmental Protection Agency (EPA) re cently modified both the Federal Insecticide. Fungicide, and Rodenticide Act (FIFRA) and the Toxic Subetanoee Control Act (TSCA) good laboratory practice standards (GLFs) to specifically include epidemiology.4* In re sponse to comments, EPA states that "all studies, in cluding epidemiologic studies ... [should] be performed under GLP standards. EPA recognizes that in such studies data used may not have been generated in conformance with ... GLP standards. However, it is Further Development of the Guidelines for GEPs The current document is a first stop in developing a framework for improving epidemiologic research prac tices through adherence to sound scientific research principles. The guidelines emphasize data quality and integrity and adequate documentation of research meth ods. These guidelines should evolve based on the expe riences gained through their application to studies. A Special Note to Reader*: As an aid to readers, a glossary of terms is provided in Appendix 2. These definitions reflect the use of the terms in this document. In an effort to be concise and clear, some sections of the guidelines for GEPs include examples and/or further explanation of the Issue. Examples or elaborative text appear in italic*. 1222 Guidelin s for Good Epidemiology Practices/The CMA Epidemiology Task Group R&S150046 Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research L Organization and Personnel A. Organizational Structure The organization or individual conducting the re search shall be fully responsible for the operation and performance of the research. The organization shall be a legal entity with a governing body that sets policy and that is fully responsible for the administrative aspects of the Organization and its related research activities. The relationship, roles, and responsibilities of the organizations and/or individuals sponsoring or conduct ing the study should be carefully defined in writing. For example, this should include delineating the rolee and responsibilities to be assumed by the study spon sor and the contractor(s) in communicating various aspects ot the study as well as data ownership, ar chiving, etc. B. Personnel Personnel engaged in epidemiologic research and re lated activities shall have the education, training, and/ or experience necessary to competently perform the assigned functions. The organization shall maintain a current summary of training and experience of these personnel. A job description for each individual engaged in or supervising activities shall be maintained and updated periodically. II. Facilities, Resource Commitment and Contractors A. Facilities Adequate physical facilities shall be provided to all those engaged in epidemiologic reeearch and related activities. Sufficient resources, eg, office space, relevant equipment, and ofQce/profssaional supplies, shall be available to ensure timely completion of all studies. Suitable storage facilities shall be available to maintain research materials in a safe and secure environment. B. Resource Commitment Sufficient commitment shall be made at the beginning of each study to ensure its timely and proper completion (see section III(L): Protocol). C. Contractors For the purposes of ensuring and documenting the contractor's conformance with the Guidelines for Good Epidemiology Practices, it is recommended that the study sponsor have the right during the course of the study, and for a reasonable period following completion of the study, to inspect the contractor's facilities, in cluding equipment, technical records, and records re lating to the work conducted under the sponsor's con tract. HI. Protocol Each study shall have a written protocol/ This proto col must be approved before the study begins (see section IV: Review and Approval). The protocol should include the following: A. A descriptive title. B. The names, titles, degrees, addresses, and affili ations of the study director, principal investiga tor. and all co-investigators. C. The name(s) and address(es) of the sponsor(s). D. An abstract of the protocol. E. The proposed study tasks and milestones, includ ing study approval data (date protocol signed by all signatories), study start date (first date that the protocol is implemented), periodic progress review dates, and completion date. F. A statement of research objectives, specific aims, and rationale. The statement should Identify the immediate purpose of the investigation. For example, it might also indicate whether the study will be exploratory data analysis, hypothesis testing, or a combination of both as well as whether the proposed study will address previously unan swered questions, will attempt to corroborate or confirm previous findings, or will be routine epidemiologic surveillance. G. A critical review of the relevant literature to evaluate applicable findings. For example, the literature review should en compass animal and human experiments, clini cal studies, vital statistics, and previous epi demiologic studies. The literature review should be of sufficient depth to identify poten tial oonfounders and effect modifiers and to determine areas where new knowledge is needed. H. A description of the research methods, including: 1. The overall research design and strategy and reasons for choosing the proposed study de sign. For example, case-control, cohort, cross-sec tional, nested case-control, or other hybrid designs. Journal of Occupational MsrUr.lnai/Ynlif-? 33 No. 12/Decambar 1091 1223 R&S150047 8. The data sources for exposure, health status, and risk factors. For example. queetionnaires, biologic*! measurements, exposure/work history rec ord reviews, or exposure/disesss registries. 3. Clear definitions of health outcomes, exposure, and other measured risk factors as well as selection criteria, as appropriate, for exposed and nonexposed persons, morbidity or mortal ity cases, and referent groups. 4. Projected study size and. if appropriate, statis tical power. 5. The methods to be used in assembling the study data. This should include a description of, or ref erence to, methods used to control, measure, or reduce serious forms of error--eg, bins due to selection, misciessiflcetion, inter viewer, or confounding--and its impact on the study. Pretesting procedures for re search instruments end any manuals end formal training to be provided to interview ers. abstractors, coders, or data entry per sonnel should be described or referenced. 6. Procedures for handling the data in the analy sis. This should include a description of proce dures for defining or categorising exposure and health outcome variables for purposes ofanalysis. It should also include provisions for assessing dose-response relationships and treatment of potentially confounding and effect modifying variables. 7. Methods for data analysis. This should include procedures to control, if possible, sources of bias and their influence on results and a description of planned com parisons and methods for analysing and pre senting results. 8. Major limitations of the study design, data sources, and analytic methods. 9. Criteria for interpreting the results. This should include a brief discussion of the characteristics of the proposed study design. Including limitations, that will Inlluenoe the discussion of the results. It also should state criteria fbr assessing biological plausibility, internal and external consistency ofthe find ings, and causal inference. The statistical tests to be applied to the data and proce dures for obtaining point estimates and con fidence Intervals of measures of oocurrenos or association should also be described. I. A description of plans for protecting human sub jects. This should include information about whether study subjects will be placed at risk as a result of the study, under what circumstances in formed consent will be required, and provisions for maintaining confidentiality of information on study subjects, (See section IV: Review and Approval; section V: Study Conduct; section VI: Communication: and sec tion VTL Archiving.) J. A description of. or reference to, quality assur ance and quality control procedures for all phases of the study. As appropriate, include certification and/or qualifications of any supporting labora tory or research groups (see section VIII: Quality Assurance). K. A descriptionof plans for disseminating and com municating study results (see section VI: Com munication). L. Resources required to conduct the study. Describe, for example, time, personnel, and equipment required to conduct the study, in cluding a brief description of the role of each of the personnel assigned to the research project. M. The bibliographic references. N. Addenda, as appropriate. For example, correspondence, collaborative agreements, institutional approvals, and sam ples of tbs Informed consent forma, question naires, and representative samples ofother doc uments to be used in the study. O. A dated protocol review and approval sign-off sheet for the study director, principal Investiga tor, oo-investigators, and all reviewers (see sec tion IV: Review and Approval). P. Dated amendments to the protocol. IV. Review and Approval Review of study protocols and final reports should encompass all aspects of a study outlined in the Guide lines for Good Epidemiology Practices (see section III: Protocol and section V(D): Study Conduct). All reviews should be conducted in a timely fsahion. It may be appropriate to involve worker or community represent atives in the planning and review of the protocol and study results. A Scientific Review The study protocol shall receive appropriate scientific review by qualified person(s) who are not part of the investigative team to ensure that the study is designed to address the objectives of the research and that the protocol is written according to Guidelines for Good Epidemiology Practices. The nature and circumstances of this review shall be documented (see section HI: Protocol). The scientific aspects of the completed study shall receive appropriate technical review to ensure that the 1224 Guidelines for Good Epid mk>k>gy Practices/The CMA Epid mfotogy Task Group ib*tr*ct, summary, and conclusions are supported by tbs underlying data, methods, and analyses (see section V: Study Conduct). B. Ethical Review The ethical aspects of each study protocol shall be reviewed by an institutional review board or other comparable review procedure. This review should consider: 1. Obligations to research subjects. For examp/e. protecting the welfare of atudy subjects; the need for, end content of, commu nications and informed consent; protecting pri vacy; and maintaining confidentiality. 2. Obligations to society. For example, avoiding conflicts of interest; avoiding partiality; disseminating the study's findings; data sharing; and pursuing responsi bilities with due diligence. 3. Obligations to funders and employers. For example, specifying obligations in contrac tual form ofbow research la to be conducted and how it may involve ethical, technical, adminis trative, or legal responsibilities; presenting methods and alternatives; and protecting privi leged information. 4. Obligations to colleagues. For example, promoting and preserving public confidence in epidemiologic research while not over- or underestimating the methods or results of epidemiologic inquiry; reporting methods and resuits; and disseminating the study's findings. C. Administrative Review The administrative aspects of the study protocol shall receive appropriate review and written approval by sponsors, contractors, and associated third parties to ensure that sufficient resources are available to com plete the study in a timely and proper fashion. Reports shall include a statement that the study was completed in accordance with the protoool. Including any approved modifications to the protocol, and in ac cordance with the GEPs. Any deviations from the GEPs shall be explained and documented (see section VIII: Quality Assurance). V. Study Conduct the study including periodic reporting of study progress as well as quality assurance. In some situations, the study director and the principal investigator may be the same person. To ensure the proper conduct of the study, personnel shall adhere to sound research principles and practices established according to the protocol. A protocol must be approved before the study begins. The study shall be conducted in accordance with the protocol: all deviations from the protocol shall be prop erly documented and authorized by the principal inves tigator. If a decision is made not to complete a research project, the reasons for that decision shall be put in writing, dated, and signed by the responsible party, ie, the individual who makes the decision to terminate the study. A. Protection of Human Subjects Procedures for protecting human subjects shall be followed (see section IXI(I): Protocol and section IV(B): Review and Approval). Confidential information about study subjects shall be protected using established pro cedures. If stipulated by the study protocol and/or required by an institutional review board, each study subject shall be informed about the purpose of the study and any risks associated with participating in the study. Written consent, if required, shall be obtained from each study subject before he/she participatee in the study. Written consent shall include at a minimum: 1. Purpose of the research or study. 2. Name(s), address(es). and phone number(s) of personnel available to answer questions about the research and the rights of study subjects. 3. Expected duration of subject's participation:' 4. Eligibility requirements for study participation. 5. Possible benefits to the study subject or others of study results. 6. Statement on the voluntary nature of participation in the study and the right of the study subject to discontinue participation at any time. 7. Statement of confidentiality of records idsntiiying the study subject, including reasonable exceptions to absolute confidentiality, eg, sharing of infor mation with the study subject's personal physician or as required by court order. 8- Description of any foreseeable risks or discomforts to the study subject. 9. Statement of availability of results. R&S150049 While the study director shall be responsible for the overall research program, the principal Investigator shall be responsible for the individual research project, including the day-to-day conduct of the study, interpre tation of the study data, and preparation of a final report. These responsibilities extend to all aspects of B. Data Colection and Verification All data collected for the study should be recorded directly, accurately, promptly, and legibly. The individ ual^) responsible for the Integrity of the data, comput erized and hard copy, shall be identified. Journal of Occupational Medicine/Volum* 33 No. 12/Decombor 1991 1225 f AU procedures used to veriiy and promote the quality and integrity of the data ahall be outlined in writing (aee eection VIII: Quality AMuranee). An historical file of theee procedure* shall be maintained, including all revisions and the dates of such revisions. Any changes in data entries shall be documented. C. Analysis 14. A statement describing the location where ail source data and the final report are stored, (see section VTH: Archiving). 16. A dated study report review sign-off sheet for the study director, principal investigator, oo-invsstigators, and reviewers and/or auditors (sss sec tion IV: Review and Approve! and section VIII: Quality Assurance). All data management and statistical analysis pro grams and packages used in the analyses should be documented. All dated versions used in research shall be kept with accompanying documentation (see eection VII: Archiving). 0. Study Report Completed studies shall be summarized in a final report that accurately and completely presents the study objectives, methods, results, and the principal investigator's interpretation of the findings. The final report ahall include at a minimum: 1. A descriptive title. 8. An abstract. 3. Purpose (objectives) of the research as stated in the protocol. 4. The names, titles, degrees, addresses and affilia tions of the study director, principal investigator, and all co-investigators. 5. Name(s) and address(es) of sponsor(s). 6. Dates on which the study was initiated and com pleted. 7. Introduction with background, purpose, and spe cific aims of the study. 8. A description of the reMarch methods, including: a. the Mlection of study subjects and oontroia, b. the data collection methods used, c. the transformations, calculations, or opera tions on the data, and d. statistical methods used in data analyses. 9. A description of circumstances that may have affected the quality or integrity of the data (see section VTII: Quality Assurance). 10. A summary and analyses of the data. Include #utBeient tables, graphs, and UluMtrmUodm to pnooat the portlnoat data and to re flect the analyses performed. 11. A statement of the conclusions drawn from tha analyses of the data. 12. A discussion of the implication of study results. Cite prior research in support ofand to oontrest to present findings. Discuss possible bis see and limitations in present research. 13. Reference*. VI. Communication Each organization ahall predetermine procedures un der which communications of the intent, conduct, re sults. and interpretations of an epidemiologic study will occur, including what function individuals associated with the research must fulfill. TbeM individuals should include the principal investigator, study director, and/ or the sponsor. This procedure may be documented in the form of a company standard operating procedure, in the study protocol, or through contractual agree ment. Government agencies shall be informed of study re sults in a manner that complies with applicable regula tory requirements. Scientific peers shall be informed of study results by publication in the scientific literature or presentations at scientific oonfsrenoee, workshops, or symposia, to the extent possible. All study subjects shall be informed of the study results and any interpretation of the study findings and conclusions, to the extent possible. Study subjects may be informed in person, through meetings, video tapes, letters, newsletters, summary reports, or other appro priate communication. Information about study results be provided in language appropriate for the audienoe. VI Archiving There shall be physically secure archives f r the orderly storage and expedient retrieval of all study related material. An index shall be prepared to identify the archived contents, to identity their location, and to identify by name and location any materials that by their general nature are not retained in tb study archive. Aooees to the archives shall be oontrolled and limited to authorized personnel only. Special prooeduree may be neeeeeary to ensure that aooees to confidential infor mation is limited end that the confidentiality of infor mation about study subjects is protected (see section ni(I): Protocol). At s minimum, the study archive should contain, or refer to, the following: A. Study protocol and copies of all approved modifi cations. B. A final report of the study. 1226 Guidelines for Good Epidemiology Practices/The CMA Epidemiology Task Group R&S150050 r C. All source data end. where feasible. specimens. A printed sample of the master computer data flle(s) with reference to the location of the machine readable master. It the data include any employee medical rec ords subject to the Access to Employee Medics.1 Records Regulation (29 CFR 1910.80). the rec ords shell be retsiaed according to the provi sions of this rule. D. Documentation adequate to identify and locate all computer programs and statistical procedures used, including version numbers where appropri ate (see section V(C): Study Conduct). E. Copies of computer printouts, including relevant execution code, that form the basis of any tables, graphs, discussions, or interpretations in the final report. Any manually developed calculations shall be documented on a work sheet and similarly retained. F. Correspondence pertaining to the study, standard operating procedures, informed consent releases, copies of all relevant representative material, cop ies of signed institutional review board and other external reviewer reports, and copies of all quality assurance reports and audits. Include, for example, questionnaires, name, make and model numbers of relevant measure ment instruments, calibration information and procedures. G. Original documents for the following research ma terials shall be included in the archives: 1. Laboratory/research notebooks. 2. Coder modification notebooks. 3. Signed and dated copies of the protocol and final report. research VIII. Quality Assurance Written procedures shall be established to ensure the quality of the data used in a study (see section UI(J): Protocol and section V: Study Conduct). These proce dures shall address data collection and completeness, coding and computer input, storage and retrieval, and data validation and analysis. Any deviations from the GEPs shall be explained and documented in the final report (see section FV(C): Review and Approval). An individual who is not part of the investigative team should be assigned as a study quality assurance auditor. This individual shall, no less than annually, review study compliance with the written quality assur ance procedures. The study quality assurance auditor shall prepare a written summary of the audit. The principal investigator should respond in writing to the audit report, including any remedial actions taken. Quality assurance activities shall address the preced ing sections of these guidelines as well as monitor oonformance with established standard operating proce dures (SOPs) (see Appendix 1: Standard Operating Procedures). APPENOICES Appendix 1: Standard Operating Procedures Appendix 2: Glossary of Terms Used in the Guidelines for Good Epidemiology Practices Appendix 3: Suggested References on Occupation. Epidemiology Methods Appendix 1 Standard Operating Procedures The Guidelines for Good Epidemiology Practices ad dress the conduct of epidemiologic studies rather than the management of epidemiologic research programs. Many of the suggested guideline requirements can be fulfilled by reference to standard operating procedures for the research program. Standard operating procedures (SOPs) are written, detailed descriptions of routine procedures involved in performing epidemiologic studies. Reproducibility, ac curacy, and validity are ensured when SOPs are de signed to clearly reflect each facility's research proce dures. It should be the responsibility of a designated individual to develop and continuously review and up date SOPs pertaining to his area of responsibility. Sig natures of approval from the department's managing personnel or appropriate designees should be obtained for all new and updated versions. Significant changes in established SOPs should be maintained, including all revisions and the dates of such revisions. The manual of SOPs should be readily available to all research and administrative personnel. Standard operating procedures should include: X, A statement of the purpose of the standard operating procedure. 8. A detailed description of the procedure. 3. The person responsible or the training level required to perform the procedure. 4. The date of issue (effective date). 6. The issue number/revision number. 6. Signature of preparer. 7. Authorizing/reviewing signature of manage ment. Examples of research program activities for which SOPs could be established include: 1. Procedures for collecting raw data. 2. Procedures for validating the completeness of the study population. 3. Procedures for coding death certificates. 4. Procedures for assessing error rates in data abstraction and coding. Journal of Occupational Mediclne/Voluma 33 No. 12/Dcmbor 1991 1227 R &S 150051 B. Security procedure* for ensuring the integrity of the raw data and computer record*. 6. Procedure* for archive management. 7. Procedure* for standard induetrial hygiene sam pling and analytic method*. 8. Procedures for scientific review. 9. Required composition of scientific review boards. 10. Procedures for data analysis. 11. Procedures for communications. Appendix 2 Glossary of Terms Used in the Guidelines for Good Epidemiology Practices The definitions below reflect the use of these terms in the Guidelines for Good Epidemiology Practices. These terms may have additional or different meanings in another context. Descriptive Studies--a description of the population under study and the occurrence of disease or dlsesserelated phenomena in populations. The latter may be presented as incidence or prevalence rates according to basic group characteristics such as age, sex, race, and/ r geographic area.* Epidemiologic Surveillance--periodic scrutiny of a de fined population using epidemiologic technique* to de tect changes and trends in the distribution of morbidity, mortality, or disease risk factors within that population. Exploratory Data Analysis--analysis of a data set with out a predetermined hypothesis, sometimes referred to as a descriptive study. This can be don* with or without tests for statistical significance. Exploratory data analysis can be used to generate hypotheses, to suggeet the most appropriate analytical techniques, to set prior ities for future research, and to help focus subsequent analyses. A study may be a hybrid design and combine both exploratory data analysis and tests of the null hypothesis. Hypothesis Testing Study--an analytic study that, through the use of tests of statistical significance, seeks to refute specific predetermined null hypotheses; the process of answering a specific a priori question or group of questions. A study may be a hybrid design and combine both exploratory data analysis and tests of the null hypothesis. Legs! Entity--legal existence. An entity, other than a natural person, who has sufficient existenoe in legal contemplation that it can function legally, be sued or sue, and make decisions through agents as in the law of corporations. Null Hypothesis--the study question stated in a null fashion so that it can be tested for statistical signifi cance, eg, tested to determine whether the results might occur by chance alone.7 Principal Investigator--the research Investigator who has direct responsibility for the initiation, conduct, analysis, and interpretation of a specific study or inves tigation. Quality Assurance--the overall program that ensures conformance to established performance standards. The quality assurance process encompasses all aspects of the research operation from the protocol to the final report. Scientific Review--critical evaluation of a scientific study or investigation at any stage of development by peers of the principal investigator. Standard Operating Procedure (SOP)--any standard method or process, for conducting or accomplishing a routine research procedure not unique to a specific study. Study--epidemiologic research relating to the distri bution and determinants of health-related outcomes in specified populations and the application of this research to control of health problems. Study Director--the research director, manager, or administrator who is responsible for managing the re search program and who provide* oversight of studies or investigations conducted within the research pro gram. t AppendixS Suggested BMography on Occupational Epidemiology Methods Breslow N, Day N. Statistics! Methods in Cancer Research. Volume 1: The Analysis of Case-Control Stud ies. Lyon. France: IARC; 1960. Breslow N, Day N. Statistical Methods in Cancer Research. Volume S: The Deeign and Analysis ofCohort Studies. Lyon, France: IARC; 1967. Checkoway H, Pearce N, Crawford-Brown D. Research Methods in Occupational Epidemiology. New York: Ox ford University Press; 1989. Friedman G. Primer of Epidemiology. 3rd ed. New York; McGraw-Hill Book Company; 1967. Kleinbaum D, Kupper L, Morgsnstern H. Epidemio logic Research Principles and Quantitative Methods. Belmont, Calif: Lifetime Learning Publications; 1988. Lillenfeld A, Lillenfeld D. Foundations of Epidemiol ogy. 8nd ed. New York: Oxford University Press; 1980. Mlettlaen O. Theoretical Epidemiology: Principles of Occurrence Researching in Medicine. New York: John Wiley A Sons, Inc.; 1965. Monson R- Occupational Epidemiology. 2nd ed. Boca Raton, Fla: CRC Press, Inc.; 1990. Rothman K. Modem Epidemiology. Boston: Little Brown A Co.; 1966. Schlesselman J. Case-Control Studies: Design. Con duct, Analysis. New York: Oxford University Press; 1968. R&S 150052 1228 Guidelines for Good Epid miology Practices/The CMA Epidemiology Task Group Rf*WICM t. Interagency Regulatory Liaison Group: Epidemiology Work Group- Guideline* for documentation of epidemiologic studis*. Am J Eptdoauol- 1981:114:609-618. . Federal policy for the protection of human subject*. Fodoroi RtfliUr November 10. 1988:53:46660. 3. Office of Management end Budget: guideline* for federal sta tistical activitiee. Federal Register. January 90. 1968:53:1548 4- Federal Ineectlcide. Fungicide. and Rodenticid* Act (TIFRA); good laboratory practice etaadarda. Federal Abater. August 17. 1969:54:34068. 5. Toxic Subetancee Control Act (TSCA): good laboratory practice etandarda. Federal Register Auguet 17. 1989:54:34034. 6. Friedman O. Primor of Eptdomloiogy. 3rd ed. New York: McGraw-Hill Book Company: 1987. 7. Laet JId. A Dictionary of Epidomiofafy. Bad ad. Sow York: Oxford Univeruty Preee: 1988. Manuscript Reviewers The Editor gratefully acknowledges the valuable contributions of the following individuals who served the Journal of Occupational Modicine in the review of manuscripts between October 1, 1990. and September 30, 1991. Thorns* J. Aibin. MA. MS Thome* J. Armstrong. PhD Mahmoud A- Ayoub. PhD Chari** E. Becker. MD Aaron Blair. PhD Steven N. Blair. FED Margit Bleecker. MD. PhD Gregory G. Bond. PhD. MPH Pearlie Boyd Irvin Broder. MD Stuart M. Brooks. MD C. Ralph Buncher. ScD Joseph M. Cannella. MD Ralph R. Cook. MD Robert Crape. MD Roy L. DeHart. MD Elizabeth Delzeil. ScD David C. Deubner. MD Mary V. DiGangi. MD Bertram D. Dinman. MD Kelly J. Donham. DVM Alan M. Ducatman. MD Philip A. Edelmsn. MD John Erfurt. BA William Fayerwoathor, PhD. MPH Robert G. Feldman. MD Arthur L. Frank. MD. PhD Howard Frumkin. MD David H. Garahrant. MD Jame* O Gibbe, PhD Thomas Golaazewekl. EdD Robert A. Goyer, MD Elizabeth E. Greach. MD Reginald M. Griffin. PhD Tse L. Quidotti. MD Nortln M. Hadlsr. MD Philip Harter. MD. MPH Jamas A. Hathaway. MD David Henderson. MD Gary D. Herrin. PhD C. John Hodgson. MD Richard W. Hornung. Dr PH Alan B. Jonas. PhD Meryl Karol. PhD Bruo# W. Karrh. MD W. Mooroa Keyearling. PhD Susan Kinn*. PhD Paul Kotin, MD Wayne M. Lednar. MD Richard J. Levine. MD Robert Levy, MD Jem** E. Lockey. MD Wendy D. Lynch, PhD Thomas J. Marriott C. 0. Toby Mathias, MD Melissa McDiarmid. MD. MPH Alan A. McLean. MD W. K. C. Morgan. MD Lisa Morrow. PhD Boyce Moser. Jr., MD Carolyn Neodleman. PhD Richard K. Olney, MD Gilbert 8. Omenn. MD Sidney Pell. PhD John M. Peter*. MD Robert Reger. PhD David B. Robbin*. MD Thornes 0. Robins, MD Howard E. Rockett*. PhD Linda Roaanstock. MD Julia Royster. PhD Larry H. Royster. PhD David A. Savltz. PhD Teresa Schnorr. PhD Michael SUversteia. MD Michael Smolensky. PhD 8tov*r Snook. PhD Kyi* Stsnnlaod. PhD Nancy Sussman. PhD Barbara C. Tilley, PhD Sally W. Vernon. PhD Donald M. Vickery. MD Julian A. Waller, MD W. Dixon Ward, PhD Kenneth E. Warner. PhD Donald E. Waaeennaa. MSEE. MBA Roberta F. Whit*. PhD Myron L. Wolbarebt. PhD C. Craig Wright. MD R&S150053 Journal ot Occupational Medicin /Volume 33 No. 12/December 1991 1229