Document mB66D7m9dqMV35N53BR7Qpx5O

A mm m Vinyl W m Institute A Division of The Society of The Plastics Industry, Inc. October 16, 1996 Robert Venezia, Dr. P.H, Chemical Manufacturers Association 1300 Wilson Blvd. Arlington, VA 22209 Dear Dr. Venezia: Enclosed is background information on the OHSA interpreta tion for medical surveillance of workers potentially exposed to VCM. Also, as I mentioned, we plan to monitor the EPA Integrated Air Toxics Strategy through an SPI task group and will carry this on our HSE committee agenda for periodic updates. I have also enclosed a letter from a student who is request ing information about angiosarcoma and VCM. I would appreciate if you could forward related published studies to Ms. Martin. Thank you. Sincerely, FEB:kc enclosures Frank E. Borrelli Technical Director CMA 121806 65 Madison Avenue Morristown, NJ 07960 (201) 898-6699 Fax # (201) 898-6633 The onpnv copy ot vim ooaimint onnM) on mcy&e ptfi# minutes HEALTH/ SAFETY AND ENVIRONMENT COMMITTEE THE VINYL INSTITUTE The westin Hotel Copley Place 10 Huntington Ave. Boston/ MA (617) 262-9600 Wednesday/ October 2, 1996 9:00 a.m. *2:00 p.m. Attendees: Kenny Akins, CONDEA Vista Frank Borrelli, The Vinyl Institute Bruce Brocka, CertainTeed Corp. Peter de la Cruz, Keller & Heckman Connie Deford, Dow Chemical Bob Garner, Borden Chemicals & Plastics Dave Goldsmith, Georgia Gulf Christopher Hendrix, Westlake Group Jim Kachtick, Oxychem Gerry Miller, Elf Atochem Ernie Parsons, PPG Industries Herman Waltemate, The Geon Co. I. OPENING OF MEETING, SELF-INTRODUCTIONS, ANTI-TRUST REMINDER AND APPROVAL OF MINUTES-April 23, 1996 Jim Kachtick opened the meeting with a round of introductions. The Committee approved minutes of the April 23, 1996 meeting. Peter de la Cruz provided an anti-trust reminder. Jim Kachtick provided a short overview of the HSE Committee and relationship with the CMA VCNET and VCM Panel (attached). II. ERPG SURVEY The Committee reviewed the results of the survey (attached). Based on the results, it was decided to hold any action by the VI until the recommendations of the AIHA are finalized. Frank Borrelli was asked to inquire on possible participation in an upcoming December meeting of the AIHA when VCM will be discussed. III. OSHA EDC PEL RULEMAKING The Committee discussed the history of this rulemaking and possi ble action by OSHA to propose an EDC exposure limit in 1997 based on the NIOSH REL of lppm. Since there was interest in partici pating in the rulemaking process, Peter de la Cruz and Frank Borrelli were asked to convene a task group of individuals CMA 121807 The Vinyl Institute. A Division of The Society of the Plastics Industry, Inc 65 Madison Avenue Morristown. NJ 07960 (201) 898-6699 Fax It (201) 898-6633 F--t6 or Recvoec Paoe 2 identified on the survey forms to develop a work plan. Connie Deford offered to provide background information. The task group was asked to coordinate with other interested panels at CMA and the Chlorine institute. IV OSHA MEDICAL SURVEILLANCE PROVISION The Committee was updated on a recent letter of interpretation by OSHA on requirements for medical surveillance provisions of the OSHA VCM standard. V. RESPONSIBLE CARE ACTIVITY The Committee reviewed the proposed responsible care self-audit surveys. Jim Kachtick provided background on the development of the survey forms and accompanying guidance documents. The Committee agreed to provide Peter de la Cruz with comments on the forms by October 15 with the intention that the modified forms will be issued with an expected completion date of January 15. Peter was asked to continue efforts to review the survey format with John Brigance at CMA. VI. 8ITE SPECIFIC TRI REPORT Peter de la Cruz advised that the data request forms are expected back by November 1. Dave Goldsmith advised that there was interest in surveying members for information on reportable releases. Dave was asked to prepare a proposal for discussion at the next HSG committee. VII. WORKING WITH PVC BROCHURE The Committee reviewed a copy of the new Working with PVC pam phlet. It was suggested that the pamphlet could be used for Community Advisory Panels. A printing of 2000 copies for these and other stewardship activities was recommended. VIII. OSHA EMERGENCY ENTRY PROPOSED RULE Peter de la Cruz provided background information on actions taken by CMA to secure clarification from OSHA on the rule applied to the entry into unknown concentrations of VCM for emergency response purposes. VI supported the position proposed by OSHA to remove rulemaking from the VCM standard and to clarify the appli cation of the HAZWOPER rulemaking. Herm Waltemate informed the committee of a recent citing of a railroad response team for alleged violation of the HAZWOPER rule. IX. VINYL 2020 Bob Garner was asked to serve as liaison for the HSE with the 2020 task group. CMA 121808 3 X. BASEL CONVENTION ON THE TRANSPORTING OF HAZARDOUS WASTES Frank Borrelli provided a summary of the recent meeting of the Technical Working Group to the Basel Convention. Frank advised that a task group at SPI will be working with CEFIC to prepare hazard classification documentation for various polymer wastes, including PVC, for the March meeting of the Technical Working Group. Frank advised that the use of the Global PVC network to communicate the position on PVC wastes in the various countries party to the convention will be considered. XI. ISO 14000 The Committee shared information on their company's review and evaluation of certification of ISO 14000 Environmental Management Systems. The committee was advised that, based on discussions at a recent ANSI meeting, there was no U.S. interest in the develop ment of a health and safety standard. A summary of the various ISO 14000 committee activities is attached. Staff was asked to invite Jim Griffin to the next HSE committee to report on his activities of ISO 14020 on eco-labeling, XII. VI COMMENT ON F024 WASTES The Committee reviewed the background to this rulemaking and anticipated action by EPA by the end of 1996. XIII. EPA ACCIDENTAL RELEASE PREVENTION AND PLANNING RULE The Committee discussed their Risk Management Planning involve ment and that worst case scenarios will consider VCM as a flamma ble hazard. It was agreed to discuss which dispersion models are being considered and used for VCM in various LEPC districts at the next HSE meeting. XIV. VCM RQ FOR SARA CERCLA REPORTING The Committee discussed possible request to EPA to raise the RQ value to 10 pounds for VCM. There is precedent for industry to provide justification for correcting RQ's from the default value of 1 pound, peter de la Cruz indicated that EPA had originally proposed a 10 pound value for VCM. A small workgroup including Frank Borrelli, Connie Deford, Ken Akins, and Jim Lewis, will convene to recommend a VI position on this topic. The workgroup was asked to first look at the past five-year reporting experi ences. XV. OTHER BUSINESS Frank Borrelli advised of a proposed ACGIH action to recommend a .5 ppm TLV for VCM. The Committee agreed to prepare a correspon CMA 121809 4 dence suggesting a delay in action by the ACGIH until completion of related industry studies on VCM. Frank also advised the group that he had provided a recent AIHA Journal article on Occupational Reproductive Health Risk Screen ing Methods (attached),to the VCM Panel for their review. Frank also reported on the upcoming APC LCI workshops, informa tion attached. The Committee was queried on the distribution to the Committee of information received by the VI on developing waste management and environmental abatement technologies. Although much of this information is most likely received by member companies though other commercial channels, the Committee members advised they would like to be informed of any related information. The Committee reviewed the list of VI literature and agreed to review four on the environmental and health related documents. Connie Deford and Ernie Parsons agreed to coordinate activities on the review of these documents. The Committee discussed the EPA Integrated Air Toxics Strategy and were advised that this activity will be monitored through an SPI task group. XVI. NEXT MEETING AMD ADJOURNMENT Peter provided the Committee with an update on the VCM litiga tions. The Committee agreed to meet in Houston on January 23. Frank was requested -to'notify the Technical Committee which will be meeting at the same location the previous day. There being no other business, the meeting was adjourned at 2:15 pm. R spectfully submitted, Frank E. Borrelli Technical Director FEB:kc attachments CMA 121810 OxyChem Corporate Environmental Affaire Health, Safety and Environment Committee S' - MEMO The HS&E Committee has not met since the meeting in April held in conjunction with the 1996 annual meeting. The next committee meeting is scheduled for October 2, just prior to the annual meeting of the international Vinyl Chloride Safety Association in Boston. Representatives from VI affiliates group will be invited since (as foreign producers) they could be attending the VCSA meeting. An update of VI activities will be presented by staff at the VCSA meeting. A continuing concern of the HS&E committee is lack of participation by all foil member companies. Efforts are continuing to address this concern at the upcoming meeting. Responsible Care Partnership with the Chemical Manufacturers Association is a primary focus of the HS&E Committee. To that end, a survey to determine the implementation status of the eight Responsible Care Principles/Practices for VI member company facilities is being developed. This survey will be sent to all VI full member companies in August, both CMA members and non-CMA members. Plans are to have the results of the survey available for the October committee meeting. The objective is to be able to document adherence to the Responsible Care principles by all VI full member companies in accordance with the organization's bylaws. A second focus of the HS&E Committee is the establishment of an Emergency Response Planning Guideline (ERPG) range of values for emergency VCM releases that could impact the public. If agreed to by the membership, these ranges of values for ERPG 1, 2 and 3 would serve as voluntary guidelines for each company to use as it saw fit in planning for road closings, evacuations, sheltering - in - place instructions, etc. relative to a significant emergency release of VCM. To that end, a strawman survey along with background information on ERPG's was sent to all full member companies in July. Plans are to have the results of the survey available for the October committee meeting. The objective is for the VI members to be able to "speak with one voice" when addressing planning for protection of the general public from significant emergency releases of VCM from our facilities. Approval for a voluntary ERPG system would be sought from the Executive Board via the Operating Committee. Other HS & E activities include compilation of TRI data for VCM, EDC and chlorine releases from member company facilities and a review of the new proposed OSHA rule as it addresses entry into a VCM vapor cloud for emergency/rescue activities. Jim Kachtick, OxyChem Clhair HS&E Committee Occidental Chemical Corporation CMA 121811 MEMORANDUM TO: FROM: DATE: RE: Jim Kachtiek Pater da la Cruz October 1, 1996 Results of ERPG Strawman Survey Keller and Heckman Following is a summary of the results of the Vinyl Institute (VI) Health Safety and Environment (HS&E) Committee's Emergency Response planning Guideline (ERPG) Strawman Proposal. The overall results are summarized in the following table and a summary of the comments appears below. Number of Companies Supporting the Proposal Number of Companies Opposing the Proposal 54 One company objected to the proposal because the company expressed an interest in involving its scientists in a discussion regarding the guidelines developed by the Radian study. Another company felt that the proposal was not practically feasible. According to the company, because a company cannot model all foreseeable releases, off-site concentrations are unpredictable. By the time a release can be estimated, it is generally too late for action in a community. The company felt that this issue would be best addressed on a case-by-case basis. Two companies noted that the American Industrial Hygiene Association (AIHA) is in the midst of developing an ERPG for vinyl chloride and preferred to await and adopt AIHA's ERPG, rather than adopt the proposed levels and risk having to subsequently change. One of these companies further indicated that the ERPG's should be single points, not ranges, and expressed uncertainty as to the defensibility of the proposed values. CMA 121812 O O Q filQ S ! pocwr ISO 14014 initial saviews ISO 14015 Bnrrlr--ntal Sit ISO 14020 Om1 and Principle# of All torirnwniul UMLinf ISO 14021 wiimwitd Caabala and Daclantlom - Self Declaration Snviro--tel Clal-- - thh and Definitions ISO 14022 ovir--nsntal talwl* and Declarations - Syebol* ISO 14023 avir--ntal Labels and Declarations IMtlagf and Verification Matbodologl-- ISO 14024 Kmiranauital Labels and Ooelaratio-- Bnvironmsatal Labeling Type I, Quldlng KinoiflM and Procedures ISO 14025 , Type XII Labeling ISO 14031 Evaluation of laviromental ISO 14040 Life Cycle Ae--ant principles and guidelines ISO 14041 Life Cycle Assess--wt - Life Cycle Inventory Analysis uspamsxau/snxuM SC 2 NS4 ox SC2 *M --I SCI 003 CD for oonoant SC3 MB2 CD.2 for ballot SC3 M02 Marking Draft SC3 MB Preliminary SCI SOI CD for ca--eat SC 3 SBl MOT SC4 OBsl MD.3 SC5 MU CD. 3 for ballot SC5 DQM2-3 CD for eaaaente only rnninri Si agreed in Oslo that 8C2 MD4 muat justify aw mark it-- four months before Aet TC 207 tweeting. us TM ballot dietrelbuted march 12, UH to determine US position oa Ml. US 7*0 --ben encouraged to opp--e SMI. i 2 u US DIO ballot distributed March 12, UH to dateraiue need for Internet! one1 KSAs. Agreed In Oslo that SC2 MM oaiet justify new work it-- four aonthe before Jim TC 207 easting. Cth draft approved La Oslo -- CD for oo--wit, coements due beck by end of the year. Mill be discussed in M0 meeting la Macah UM. CD for ballot end on--nf ieeuad in fell 1995. US W eutaeitted e disapproval vote -- 12-20-95. Tim Secretariat proposes that following the HS2 meeting, the revised draft will be ready for DIS ballot. However, tbe DIS ballot will only -- forward wh-- SCI ie satisfied that sufficient progress has be-- nsde with 14022 and 14023. Morking draft revissd at 11/95 SC easting has be-- diatribeted for additional review and cnawrwnt. (Inofficial Jape--ae draft prweented at 11/95 SC meeting baa been distributed far additional reel-- aed ua--nit. 1 new draft will be distributed to SC 3 ae a CD for fineemnl prior to the next meeting of SC 3. A CD ballot sbould be iaaued after tbe Ante meeting MN1 -- Type XXI labeling approved at 12/95 8C3 wasting. 4th draft released fr-- February 9t editing oa--ittee meeting with CD Cor ballot/aosoMvat expected by June 1*9*. Pilot project using CD . scheduled far Jtms 1994-Pebereery 1998. US Sub 1M agreed where ie one substantial lseue (i.e. cooperative assertiaol with 14040.3 CD. If ocncern re overall superiority claias is resolved, UB will vote for elevation to DIS status. SIS expected Spring/Su--er 1994. 03 for co--ta distributed 1/9* to 8T 5. Coements due to AMOK by 3/1/9*- >EPA What is ISO? What An ISO's Envlronmantal Managamant Standards? Unnad Statu Environmental Protection Agenev Office ot Pollution Prevention ano Toxics Washington DC 20460 EPA Standards Network Fact Sheet May 1995 EPV742-F-95-006 ISO 14000: International Environmental Management Standards [n recent yean, there has been heightened international interest in and commitment to improved environmen tal management practices by both the public and private sectors. This interest is reflected in the tucoeu of collaborative international efforts to address environmental problems and in the global "Mg""TM of trade- related environmental issues. The Montreal Protocol, the environmental side agreements of the North American Free Trade Agreement and the mandates resulting trom the 1992 Earth Summit of the United National Conference on Environment and Development in Rio de Janeiro are some of the Another indication of the interest in improved environmental practices is the emergence of votanry environ mental management standards developed by national standards bodies throughout the world. To address the growing need for an international consensus approach. ISO. the International Oigamzaooo for Sandatdiimion. has urtenaken the development of international voluntary environmental management standard through ISO Technical Committee 207. ISO's 14000 senes Environmental Management Standards are expaaed to have a significant impact on trade in the same way that the ISO 9000 senes Quality Management Sandredi have The U.S. EPA has a long-standing interest ui promoting improved environmental managemea practices from its 1986 environmental auditing Policy Statement to its recent Environmental Leadership and Common Sense Initiatives. ISO is a private sector, international standards body based in Geneva. Switzerland. Founded in 1947, ISO promotes the international harmonization and development of manufacturing, product and coroaunganocs standards. ISO has promulgated more than 8.000 imemiooniily accepted standards for everything hum paper sizes to film speeds. More thin 120 countries belong to ISO as mil voting members, while several other countries serve as observer members. The United States is a full voting member and is officially represented by the American National Standards Institute i ANSI). ISO produces internationally harmonized standards through a structure of Technical Cotimutiers (TCs). The TCs usually divide into Subcommittees which are further subdivided in Working Groups where the actual standards wnhn| occurs. ISO's Environmental Management Standards (EMS) are a series of voluntary standards and guideline reference documents which include environmental management systems, eco-labeling, environmental audit ing. life cycle assessment, environmental performance evaluation. and environmental aspects in product standards. The focus on "management'' distinguishes these standards from ''performance'' standards. EMS help an organization to establish and meet ns own policy goals through objectives and targets, organizational structures and accountability, management controls and review functions all with top management oventghL EMS do not set requirements for environmental compliance nor do these standards establish requirements for specific levels of pollution prevennon or performance. The Environmental Management Systems specification document calls for environmental policies which include a commitment to both cnmpftincr with environmental laws and prevention of pollution. CMA 121815 tm SteydtS Pn*r How Doom ISO 14000 Rolato to TC-207? When Will the ISO Standards Be Completed? ISO assigns a oocument numocnnt system to eacn Technical Committee. Standards produced by TC-207 are assigned the J-aOOO designation. For esamoie. tr.e Environmental Management Svstems 1EMS1 Guidance Standard will become ISO 14000. The EMS soeciricanon document will become ISO 14001. Each subsequently comoieted ISO stanaara trom mis TC will have a i4000destgnauon. The following are targeted completion dates: * The EMS specification and guidance standards Principles ot Environmental Auditing Eco-labeling Principles and Practices * Environmental Performance Evaiuauon Life Cycle Assessment May 1996 July 1996 End of 1996 I99T 1997-1998 Amican Rational Standards Inrttnta (ANSI) ' i west 42nd Street Hew rorK New York 10036 "eieonone 212-642-4900 US TAB ts ISO/TC 207 Chairman: Joe Cascto Tel: 914-766-2734 EPA Reor'esentative. Mary McKie: Office oi Pollu;.:r, Prevention ano T:x:cs Teletmone 202-260-3584 m - --vironmentai Management System Chairman uoei Charm Tel. 201-455-4057 EPA Pec.. Jim Home Tef. 202-260-5602 Office oi Water TB1 - ipecmcation T82 - General Guidelines STl - Environmental Auoiting Chairman: Cornelius (Burt) Smith Tel 509-243-9692 EPA Pee. Cheryi Wasserman Tel: 202-2604797 Office ot Enforcement ano Comoinnce Assurance TB1 - Auoiting Pnnctoias Tt* - Auditing Procedures m - Auditor Otaiitications STl - Environmental La&eung Chaiman Goroon Beilen Tel: 617-733-6050 EPAPeo. Julie Lynch Tel: 202-260-4000 Office of Pollution t-tvennon ano Toxics TS1 - juioing PnnciDies :cr ^-aaicioner Programs TIB - iiil-Declaration C; -s TB - C- jioing Pnncioies :r f-vironmentai Labeling Programs ST4 - -"vironmenai Pertorra*:e Evaluation Chairman jonn Mister Ttt 610-359-4810 EPA Pec. Jonn Hamm Tel. 202-260-6395 ________ Office ot Pollution P'rmnon ano Tones______ STB - ue Cyoe Assessment Chairman: James A Fata Tel 610-344-3636 EPA flee Mary Ann Curran Tel 513-569-2637 Office oi Research ir.j Qeyeiooment ST> - Vms ano Definitions Chairman Christooner Bell Tel 202-736-8118 SM - Environmental Asoeca n Proouc Stanoaros Chairman Stanley Rhoaes Tel 510-632-1415 EPA Pec.. Mary McKiel Tel 202-260-3564 ______ Office ot Pollution 3syennon ana Tonics Figure 2. US. TAG Structure CMA 121816 A Division of The Society of The Plastics Industry, Inc. August 12, 1996 Dr. H. Shah Chemical Manufacturers Association 1300 Wilson Blvd. Arlington, VA 22209 Dear Hass: Attached is a recent article from the American Industrial Hygiene Association Journal, "A Screening Method for Occupational Reproductive Health Risk", which I thought might be of interest to the VCM Panel. I understand the panel will undertake a study on the reproductive toxicology of VCM and we will be interested in the results of your work. As we discussed, I plan to provide you with a copy of the minutes of our Health, Safety and Environmental Committee (HSE) meetings and understand you plan to provide me with the minutes of the panel meetings. . This should provide both of us with an understanding of the issues of interest to our respective groups. Sincerely FEB:kc ends. c: R. Burnett J. Kachtick F. Krause Frank E. Borrelli Technical Director 65 Madison Avenue Morristown, NJ 07960 (201) 898-6699 Fax If (201) 898-6633 Ttm0pMleafyat9m ttxmmu omm dfi eeyOedpefim CMA 121817 m merican industrial hygiene association journal 57 641-649 < iw6i xaten and Health Technical 'upport. Oak Ridge National l.aboratorv, p O Box 2008, Oak Ridge, TN 37831-6292; A Screening Method for Occupational Reproductive Health Risk Most currently recognized occupational exposure limits do not consider reproductive toxicological end points consistently when establishing recommended exposure limits. In many cases the information is not available, but perhaps as often, existing data is not emoloyed. Further, many manufacturer's material safety data sheets omit reproductive hazard information. A method for identifying potential reproductive toxins and screening levels for associated health risks useful for hazard communication and exposure control is presented. To date, the Registry of Toxic Effects of Chemical Substances lists between 5000 and 6000 cnemicals, drugs, and natural substances that show a positive outcome m at least 1 reproductive effects study. This reproductive health risk assessment began with these substances. Using elements of the Environmental Protection Agency's health risk assessment process, the list was reduced to 213 chemicals during the hazard identification step. Occupational reproductive guidelines (ORGs) were developed m the dose-response evaluation step. At the time of this writing, 85% of the chemicals identified m the hazard identification step have had a screening level dose-response assessment completed. Of these, 13% are greater than or equal to a threshold limit value (TLV).The remaining 87% do not have aTLV or ORGs below theTLVThe reproductive toxins list, along with- the corresponding dose-response-derived ORGs that have been completed, appears at the-end of the text. Keywords: exposure limits, hazard communication, material safety data sheets, reproductive hazards, reproductive toxins method for identifying potential rcproduc- point, cstablishing/adiustmg occupational expo- A tive toxins is presented in Figure 1. This sure guidelines, and controlling exposures below method is useful tor hazard communica- these levels, the need for a special reproductive tion and in establishing guidelines for ex- healrh program is eliminated, posure control. The objectives are to provide in- Based on the current state of health protec- formaoon on potential reproductive hazards that non legislation and scientific know ledge, such a safety and health professionals can use to cstab- method is timeh and justifiable. The Occupa- lish a healthful workplace for all employees, re- tional Safety and Health Administration i OS HA; gardless of gender, and to protect all workers re- requirements for empiovec hazard communica- gardless of reproductive status. By treating repro* tion include reproductive toxins in the definition duccivc toxicity as any other toxicological end of `health hazard,yet according to a 1991 Government Accounting Office report,'1 work ers, as well as the general public, remain inade Note: The ne *reproduarvt" ndudes dnvSapmcnaJ efteu. A reproductive ooocaar is one dna ioorfeits with itproductiro or nnl funaioning of the ntak or female from puberty through adufchood- A dcvtkviim ' sAkcs as dka m the uflgujng ftam eoocep- oon to puberty-Tiedbur poncgiel tfdevetopmool ratiry ne(t) dath of the I.______- i--~T*) em-n--u--d1 -Aih--iiminlu- j /(?*\) il um-- l giiinr4ti will I(AII\ fiinnfnral jr-lr*tl-ri.e_i_w_j, quately protected from reproductive hazards un der federal regulations. Although material safeev data sheets are required for employee health pro tection in the workplace, these sheets generally do not provide reproductive hazard informa tion.'4' Established occupational exposure limits Copyright 1996, American Industrial Hygiene Association AIHA JOURNAL (57) July 1996 641 CMA 121818 A P P L IE D S T -i The hazard identification process included the develop ment of the reproduenve toxins list that was denved from the Registry of Toxic Effects of Chemical Substances i RTECS) database. RTECS, developed bv NIOSH, has toxicity informa tion on approximately 250.000 chemical substances. A search of the database for any substance with a positive outcome in at least one reproduenve effects study yielded more than 5500 substances. The list was nar rowed by a search for substances with positive outcomes m hu mans or more than one mam malian species via dermal expo sure, ingestion, or inhalation. The query refined the list to ap proximately 1000 drugs, chemi cals, and natural substances. This list was further reduced to only those substances believed to be important in an occupa tional setting, omitting sub stances used exclusively as drugs or hormones. The final repro ductive toxins list consists of 213 potential toxins. These were entered into a FoxPro data base (Table I). Dose-response assessment involved several assumptions. First was che assumption that reproductive effects have thres frequently do not take into consideration reproductive end points holds.'71 The assumption of a threshold underestimates the risk for that are clearly below the thresholds established for other toxic ef a toxin that docs not have a threshold. An adjustment for this con fects. J' cern was made in the case of transplacental carcinogens by che use There is a growing legal imperative for nondiscriminatory gen of an additional uncertainty factor of 10. der-neutral occupational health policy51 that is contrary to tradi The second assumption was that animal data is a reasonable hu tional reproductive health policy, which relies solely on pregnancy man predictor. This is based on the evidence from known human reporting and job reassignment as a means of fetal protection. Such developmental toxicity, which in most cases demonstrates that an limited policy tails short of presenting harmful parental exposures imal data are predictive of human developmental effects. ` An un that mav adversely impact the health of the unborn child or che re certainty factor of 10 was used for animai-to-human extrapolation. productive capacity of adults. For all of these reasons, this effort is Using a single positive animal study for miaul inclusion in the data considered necessary. base is designed to minimize che possibility of missing a true hu man reproductive toxin, i.e,, a false negaove. Requiring positive ef fects in two or more species is an attempt to limit the number of Methods pocenoal false positives. The third major assumption was that absorption of dose is com Creation of the reproductive toxins database required identifica tion of potential reproductive toxicants, searching the literature piece regardless of the route of entry, and that the toxicity is unal tered.'*1 This assumption frequently leads to an overestimation of for reproductive no-observed-adverse-effect levels (NOAL) and che risk at a particular exposure level, and no uncertainty factor is lowest-obscrvcd-adverse-effect levels (LOAEL) for the reproduc applied for rouie-to-route extrapolation. Taken in total it is likely tive toxicants, and determining corresponding occupational repro that these assumptions provide a reasonable margin of safety. ductive guidelines /ORG). Aspects of the Environmental Protec The dose-response evaluation began with an cxaminaoon ot cur tion Agency's i EPA's) procedure for risk assessment were used for hazard identification and dose-response assessment as applied in the National Institute for Occupational Safety and Health rent occupational exposure guides for established limits reported as protective of reproduenve health. If an exposure limit inclusive ot reproduenve health was found, it was adopted as che ORG for that I NIOSH) glycol ether critena document. ' ORGs were calculated substance and entered into the database. The references (or occu using the uncertainty factor method.'71 pational limits included the .American Conference of Governmental CMA 121819 IT A 111 t t. Reproductive Toxin Guidelines* Otemical Name Caslt*. 2.4'-DDO 2.4,5-T 2.4,s-T, N-butyl ester 2.4-0 2,4-0 butyl ester 2.4-0. isooctyl ester2-MePA Acetaldehyde Acetic acid, indolylAcetonitrile Acrolein Acrylamide Aflatoxin-B Alcohol. 2-ethylhexyl Alcohol, ethyl- Alcohol, methyl Aldrin Allyl chloride Aluminum-chlorideAmmonicotinamide Ammopteridine Amitrole Amudane Arodor 1016 Aroclor 12S4 Arodor 1260 Arsenic (elmtl/organic) Atrazine 8APN BAPN Fumarate Saygon Benomyl Benzene Benzene, (epoxy ethyl)- Benzimidazolecarbamic Benzo(A)pyrene Bisphenol A"^^ Uonc adT'B" Butadiene. 1.3Butyl alcohol, tert- Butyronitrile, Cacodylic acid Cadmium Cadmium chloride Captan Carbaryl Carbofuran Carbon dioxide Carbon disulfide Carbon monoxide Cartap Chlorhydnn Chlorine dioxide Chloroamphenicol Chlorobenzene Chloroform ^Chloromethyl mercury 53-19-0 93-76-5 93-79-8 94-75-7 94-80-4 25168-26-7 706:./-70-4 75-07-0 87-51-4 75-05-8 107-02-8 79-06-1 1162-65-8 104-76-7 64-17-5 67-56-1 309-00-2 107-05-1 7446-70-0 329-89-5 54-62-6 61-82-5 126-07-8 12674-11-2 11097-69-1 11096-82-5 7440-38-2 1912-24-9 151-18-8 2079-89-2 114-26-1 17804-35-2 71-43-2 96-09-3 10605-21-7 50-32-8 80-05-7 10043-35-3 106-99-0 75-65-0 10232-92-5 75-60-5 7440-43-9 10108-64-2 133-06-2 63-25-2 1563-66-2 124-38-9 75-15-0 630-08-0 15263-52-2 96-24-2 10049-04-4 56-75-7 108-90-7 67-66-3 115-09-3 OM* incomplete 0.18 mg/m1 0.18 mg/m1 1.50 mg/if 6.0 mg/m1 ` incomplete 7.06 mg/m1 14.4 mg/m1 6 mg/m1 22.7 mg/m1 0.12 mg/m1 0.03 mg/m1 incomplete 97.7 mg/m1 1880 mg/m1 262 mg/m1 0.012 mg/m1 3 mg/m1 0.36 mg/m1 0.02 mg/m1 1.2 ng/m1 0.2 mg/m1 0.75 mg/m1 1.4 (ig/m1 1.4 ng/m1 1.4 (ig/m1 0.5 ng/m1 2.1 mg/m1 0.68 mg/m1 0.68 mg/m1 0.5 mg/m1 0.30 ng/m1 0.05 mg/m1 0.78 mg/m1 incomplete QJ75 iio/m1 GU^/mp 1.5 mg/m' 0.26 mg/m1 106 mg/m1 incomplete 0.18 mg/m1 2 ug/m1 2 ug/m1 0.75 mg/m1 5 mg/m1 0.03 mg/m1 1800 mg/m1 8.4 mg/m1 14 mg/m1 incomplete incomplete 0.28 mg/m1 12 mg/m1 46 mg/m1 2.6 mg/m1 LOD UF 100 100 100 100 . _ _.___ , too 100 100 100 100 NA 100 NA NA 1000 NA 100 1000 100 NA 1000 30 30 30 1000 100 1000 1000 NA 1000 1000 100 NA 1000 100 1000 100 1000 NA NA 100 NA 100 10 100 NA NA 100 NA 100 NA cx R NA R NA R NA 0 NA D NA D NA 0 NA 0 NA 0 NA NA 220 0 NA NA NA NA NA 0 3.4 NA NA R NA 0 NA 0 NA NA NA D NA 0 3.3 D 3.3 D 3.3 D 4.7 R NA D NA 0 NA NA NA R NA D 1.4 D NA TC 1 D NA R NA 0 400 D NA 0 NA NA 8 NA NA 0 NA NA NA R NA D/R NA 0 NA D/R NA D NA D NA NA NA D 200 NA NA continual CMA 121820 rA TILL I. Reproductive Toxin Guidelines* (continued) Chemical Naim CasNe. 0M* Coil-derived complex Cyclohexanone Cydohexylamine Cyclophosphamide Cydophosphoramide DOT Diaminotoluene, 2,4PiaTin-jf1 Oibenzofuran, Dibromochloropropane Dichlorobenzene, p- Dichlorvos Dicumarol Dieldrin Diethylene glycol Diethyistilbesterol Difolatan Dimethoate Dimethyl-2-thiourea, Dimethylbenzanthracene Dimethylformamide Dimethylurea. 1,3Dinocap Dinoseb _ Cioctylphthalate 3 dfct~--------Disulfiram EGDME EGEE EGMBE EGME EGME, diEGMEA EGMEEA EGPE Endrin Enflurane __ (-'fpichlorhydrin ) Ergocalciferol Ethyl methane sulfonate Ethylene dibromide Ethylene glycol Ethylene glycol diethyl Ethylene oxide Ethylene thiourea Ferbam Firemaster BP-6 Folpet Formamide Fungaflor Furlfuramide Gallium-arsenide C'Slycidol 3 Glycol ether Gossypol Halothane Hexachlorobenzene None 108-94-1 108-91-8 SO-18-0 51-18-0 SO-29-3 95-80-7 333-41-r 57117-31 -4 96-12-8 106-46-7 62-73-7 66-76-2 60-57-1 111-96-6 56-53-1 2425-06-1 60-51-5 534-13-4 57-97-6 68-12-2 96-31-1 39300-45-3 88-85-7 117-81-7 74-31-7 97-77-8 110-71-4 110-80-5 111-76-2 109-86-4 111-77-3 110-49-6 111-15-9' 2807-30-9 72-20-8 13838-16-9 106-89-8 SO-14-6 62-50-0 106-93-4 107-21-1 629-14-1 75-21-8 96-45-7 14484-64-1 59536-65-1 133-07-3 75-12-7 35554-44-0 3688-53-7 1303-00-0 556-52-5 111-46-6 303-45-7 151-67-7 118-74-1 3 mg/m1 100 mg/m1 4.3 mg/m1 6 pg/m1 incomplete 0.01 -g/m1 0.11 mg/m1 1 08 pg'm1 incomplete 4 pg/m1 60 mg/m1 0.03 mg/m1 0.01 mg/m1 0.012 mg/m1 0.75 mg/m1 2 ng/m1 incomplete 0.36 mg/m1 incomplete 0.1 mg/m1 1.35 mg/m1 120 mg/m1 0.03 mg/m1 0.01 mg/m1 3 mg/m1 0.08 mg/m1 0.06 mg/m1 0.18 mg/m1 1.8 mg/m1 3.6 mg/m1 0.3 mg/m1 9 mg/m1 0.5 mg/m1 2.7 mg/m1 25.6 mg/m1 0.012 mg/m1 incomplete ( 0.38 mg/m^ 1 pg/m' 0.03 mg/m1 8 pg/m1 26 mg/m1 incomplete 1.8 mg/m1 0.30 mg/m1 6.84 mg/m1 1.4 pg/m1 6 mg/m1 5.22 mg/m1 0.60 mg/m1 1.8 mg/m1 incomplete <''(3.09 mo/m'j 75 mg/m' 0.02 mg/m1 0.16 mg/m1 0.025 mg/m.1 c,44 aiha Journal 157) July 1996 UF 1000 NA 25 1000 1000 1000 1000 1000 NA 1000 10 1000 1000 NA 100 10000 100 100 1000 1000 100 1000 100 1000 100 100 100 100 NA 100 100 1000 NA NA 10000 100 100 NA 100 100 30 10 100 100 10000 1000 10 100 1000 NA M*efctt` 0 NA R D/R R R 0 R NA D D R D TC 0 R D D D D R D D D D D D D D D D R NA D/R R R R D D D D D R D R R D R D NA at 6300 NA NA NA 3 300 NA 74 NA NA NA 3.4 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 5.6 NA 600 10 NA NA NA NA NA NA NA NA NA NA 40 continued CMA 121821 BBlii Reproductive Toxin Guidelintr (continued) Owfnial Name CasNe. 0M* Hexachlorphene Hexane Hexanedione. 2,5Hydrazine Hydroxymethyl mercury Iodine Isocyanate, MethylKanechlor 500 Kepone lead Lead acetate Lead, tetraethyl Lewisite Lindane Maneb Melamine, hexamethyl* Mercury (II) chloride Mercury (II) oxide Mercury and compounds Methanesulfomc acid, Methotrexate Methoxychlor Methoxyflurane Methyl benzimidazole .''Methyl chloride ^ Methyl ethyl ketone ) ^Methyl mercury Methyl metiram ("Methylene chloride "s Methylformamide, NMethylpyrrolidone, NMIBKO Mintezol Mirex Molybdenum Morpholine Mustard gas Nickel (II) chloride Nickel and compunds Nickel carbonyl Nicotine Nitrofen Nitrofurazone Nitrogen dioxide Nitrosamine, diethylNitrosamine, dimethylNitrosomethylurea Nitrotoluene, oNitrous oxide Oxygen Perchloroethylene Petroleum naphtha Phenol Phenylalanine nitrogen Phenylmercuric acetate Phosmet phosphate, tnmethyl- 70-30-4 110-54-3 110-13-4 302-01*2 1184-57-2 7553-56-2 624-83-* 61788-33-8 143-50-0 7439-92-1 301-04-2 78-00-2 541-25-3 58-89-9 12427-38-2 645-05-6 7487-94-7 21908-53-2 7439-97-6 66-27-3 59-05-2 72-43*5 76-38-0 1065-21-7 74-87-3 78-93-3 22967-92-6 8064-35-5 75-09-2 123-39-7 872-50-4 108-10-2 148-79-8 2385-85-5 7439-98-7 24602-86-6 505-60-2 7718-54-9 7440-02-0 13463-39-3 54-11-5 1836-75-5 59-87-0 10102-44-0 55-18-5 62-75-9 684-93-5 88-72-2 10024-97-2 7782-44-7 127-18-4 64742-95-6 108-95-2 148-82-3 62-38-4 732-1 1-6 512-56-1 0.6 mg/m1 176 mg/m1 incomplete 0.006 mg/m1 LOD incomplete 0.002 mg/m' 1.4 ug/m1 incomplete 0.01 mg/m1 0.01 mg/m1 0.01 mg/m1 0.5 ug/m1 0.003 mg/m1 3 mg/m1 incomplete 0.01 mg/m1 0.01 mg/m1 0.01 mg/m1 incomplete 0.15 mg/m1 3.01 mg/m1 8.1 mg/m1 incomplete 4.65 mg/m1 590 mg/m1 LOD incomplete iL 2.4 mg/m1 J 5.4 mg/m1 0.91 mg/m1 205 mg/m1 0.6 mg/m1 incomplete incomplete incomplete 0.003 mg/m1 0.01 mg/m1 0.01 mg/m1 0.01 mg/m1 0.01 ug/m1 10 ug/m1 0.09 mg/m1 0.18 mg/m1 7 ng/m1 0.02 ug/m1 0.4 ug/m1 incomplete 90 mg/m1 ppO, 148 mm Hg 11.87 mg/m1 12 mg/m1 3.6 mg/m1 incomplete LOO 0.01 mg/m1 0.60 mg/m1 UF 100 NA 1000 NA 1000 30 1000 1000 1000 1000 1000 NA NA NA NA 100 10 100 100 NA NA 100 10 1000 NA 100 Eadpeint1 0 NA 0 NA D 0 0 D D 0 R 0 NA NA NA 0 R 0 R NA NA R 0 0 NA D CD NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 14 NA NA NA NA 1000 100 100 100 100 100 1000 10 NA NA 10000 NA NA 100 100 100 NA 1000 1000 AIUA lAiiflliai R NA R NA R8 R NA D NA 0 NA R NA R NA TC 1 TC 1 TC NA NA NA 0 NA R 20 0 NA 0 NA NA NA D NA R NA continued CMA 121822 r,.l.i t niiA TABl t I. ReproduttivtToiinGuidtlinti* (continued) Chemical Nam* CasNe, OK* ur (adpoim1 a Phthalatc, dibutyl- 84-74-2 0.72 mg/m1 1000 0 NA Piperonyl butoxide SI-03-6 0.90 mg/m1 1000 R NA Polybrominated biphenyl 67774-32-7 1.4 jig/m1 30 D NA Polychlorinated biphenyl 1336-36-3 1.4(ig/m3 30 0 3.3 Potassium iodide 7681-11-0 1.0 mg/m3 NA NA NA Propionic acid. 120-36-5 incomplete Resorcinol methyl ether ISO-19-6 incomplete ^0- ! w e- w 08 i G'vX* 0 NA Sodium arsenite 7784-46-5 0.01 mg/m1 NA NA 100 Sodium chlorite 7758-19-2 6.84 mg/m3 1000 D NA Sodium fluoride 7681-49-4 2.5 mg/m3 NA NA NA Sodium iodide 7681-82-5 1 mg/m3 NA NA NA Sodium nitrite 7632-00-0 incomplete Sodium selenate 13410-01-0 incomplete Sodium selenite 10102-18-8 incomplete L Styrene "--------- 10CM2-5 81 mq/mJ 'N NA D 0.3 Sulfur dioxide -------- 7448-3975----------------- 2.3 mg/m* 100 D NA TCDD 1746-01-6 incomplete TIG 112-27-6 338 mg/m3 100 D NA TEGDiME 112-49-2 75 mg/m1 10 D NA Tetraglyme 143-24-8 3.6 mg/m1 NA NA NA Tetrahydrofuran 109-99-9 590 mg/m1 NA D NA Thiadiazole, 26907-37-9 4 pg/m1 100 D NA Thiourea 62-56-6 6 mg/m1 1000 D NA Thiram 137-26-8 0.16 mg/m1 1000 D NA Toluene 108-88-3 9.6 mg/m1 10 D NA Toluenediamme, o- 95-80-7 1.8 mg/m1 100 D NA Toluenesulfonamide. o- 88-19-7 2.4 mg/m1 100 D NA Toxaphene 8001-35-2 0.02 mg/m1 1000 D 20 Tributyl tin oxide 56-35-9 incomplete Trichlorfon 52-68-6 0.48 mg/m1 100 D NA Trichloroethylene 79-01-6 5.5 mg/m1 100 D NA Tridiphane 58138-08-2 0.02 mg/m1 500 R NA Triethylenemelamine 51-18-3 60 ng/m1 10000 R NA Triethylenetetramine 112-24-3 * 2.9 mg/m1 10 D NA Trifluralin 1582-09-8 3 mg/m1 1000 D NA Urethane 51-79-6 6 mg/m1 1000 D NA Vinyl chloride 75-01-4 4(ig/mJ`'N. NA TC 1 ^ Vinylidene Chloride 75-35-4 14 mg/m1 ) 10 D NA Warfarin-- -- 81-81-2 iOpg/m* 10 D NA Xylene, o-, m-, p- 1330-20-7 1.5 mg/m1 10 D NA Zinc sulfate 7733-02-0 2 mg/m1 1000 D NA ` These exposure guidelines hive been derived from i screening level of risk assessment and should not be construed as unequivocally safe exposure limits ' ORGs represent 8 hour time-weighted averages unless otherwise noted. 0 = Developmental, R - reproductive; TC transplacental carcinogen; CR - cancer risk/10,000; UF uncertainty factor; <S TLV believed to be adequate to protect reproductive health; LOO limit of detection Industrial Hvgienists' Documentation of Threshold Limit Values, OSH.A, substance-specific standards permissible exposure limits, i PELsi, the German Maximum Concentrations in the Workplace4 iMAKsi, and NIOSH recommended exposure limits (RELs). If an exposure limit was not found, the literature was searched for a NOAEL or LOAEL with a reproductive end point. The search for information on the NOAL/LOAL consisted ot' studies from peer-reviewed literature found in the following databases: Hazardous Substances Database,1'*' TOXLINE,1'0' NIOSHTIC. " REPROTOX,131 and IRIS. ,3` Human data were preferred for the NOAEL/LOAEL, but in the majontv of cases quantitative human exposure data were not available. If human data were not found, NOAELs/LOAELs obtained from animal studies were used, typically employing the most sensitive end point from the most sensitive mammalian species. If inhalation data were unavailable, ingestion studies or dermal studies were used. The NOAEL or LOAEL was converted to a value for hu mans using the calculations employed bv NIOSH'*' and IRIS, i.e., scaling the NOAEL or LOAEL to a human equivalent 646 AIHA JOURNAL!37) July 1996 CMA121823 dose and dividing.bv j combined uncertainty (actor, including a 10 (or variability in human susceptibility. For inhalation data the absorbed animal dose was determined using the average animal bodv weights and inhalation rates described in EPA's Toxicology Handbook.141 Absorbed animal dose (inhalation) tor reproductive end points: (mgkg'day) * NOAL(mg/m3) inhalatio|Un1|1 |r|IUaI te. .'m^'_'d_i_v_i ____*_ ourJ animal body weight I kg; 24 hours The absorbed animal dose was converted to an equivalent hu man concentration by assuming a 60-kg body weight (average fe male weight14 ) and a 10-m4 inhalation rate tor an 8-hour work day. iJ The average female body weight was used, as it results in a more conservative ORG. Equivalent exposure tor humans: The lifetime cancer risk was included to provide a companson between the reproductive guideline and the cancer nsk at that level. For substances listed by the World Health Organization^0' as transplacental carcinogens in animals, the ORG was established based on the exposure corresponding to an occupauonal lifetime nsk of 1 in 10,000 when an EPA slope factor was available. This nsk was chosen to represent a level equated with the nsk of mor tality from work in rhe retail clothing sector '* If a dntv firm; -a unavailable, the ORG was calculated using the uncertainty factor method with an added uncertainty factor of 10 for the nonthresh old possibility extant with transplacental carcinogenesis. Unit risk per pg/m3 ,, slope factor per mg/kg/dav x 10 m'/day body weight (60 kg) x 1000 pg/mg , 3 (10"1) x (70 vrs.) pg/m =-----------------------------------------------r (40 vrs) x urut nsk per pg/mJ absorbed dose for animals (mgrkg/day) x 60 kg (mg'm ) -- 10 nvVdav When oral or dermal animal data was used, it was converted to an equivalent human airborne concentration by assuming a 60-kg bodv weight and a 10-m4 inhaladon rate. Equivalent exposure for humans loral and dermal): j, , , 60 kg (mg/m ) = mg/kg/dav x ----j--* 10 mvday The equivalent exposure for humans was then divided by an un certainty factor to obtain the ORG: ORG - e<3ulv^cnc exposure for humans uncertainty factor An example of a reproductive toxins database record is depicted in Figure 2. Fields includes chemical name, CAS number, update code, class of chemical compound, animal species wich positive re productive studies, ORG, UF, end point, and the cancer risk asso ciated svith the ORG (if an EPA unit risk was available). A memo field containing descriptive information on human and animal re productive/developmental data along with the information used for establishing the ORG (including the uncertainty factors) was also included. Substances may be added, selected for a screening assessment, or deleted from the database on the basis of new in formation. A copy of the database including the ORG list and the descrip tive memo field is available by sending two floppy disks and a selfaddressed envelope to the authors. The multiplicative uncertainty factors'included 10 for most sensitive human, 10 for animal to human extrapolation, 10 for use of a LO.AEL, 10 for inadequate study design and a possible modi(sing factor of 0.1 for a high animal dose (>1000 mg/kg/day),1171 and 0.1 for an animal study svith effects seen only at maternally toxic doses. The modifying factor for studies reporting develop mental effects onlv at maternally toxic doses was included since "ad verse effects on development that occur only with maternal toxicity mav not indicate a specific hazard to the concepcus" and thus are not as great a concern.1,1 The uncertainty (actors (UF) applied in each ORG determination are included in the list at the end of this article. For carcinogens with slope factors published by EPA,1,1 an up per bound csdmatc of the cancer nsk expected over a lifetime of occupational exposure at the ORG was determined using the fol lowing calculations. Unit nsk per Ug/m3 * slope factor per mg/kg/dav x inhalation rate (10 m3/day) body weight 160 kg) x 1000 ug/mg Lifetime cancer nsk * exposure at ORG (pg/m3) X 40 vrs x unit risk per pg/m3 70 vrs Discussion The purpose of this study was to provide a frame of reference for reproductive health protection in the workplace regardless ofgen der or reproductive status. The safety of the workplace depends on hazard identification followed by exposure control below an estab lished limit, and these limits should protect workers from all adverse effects, including reproductive effects. While ORGs do not represent consensus standards or limits, they are based on reproductive end points. ORGs can be used to flag potential reproductive toxicity concerns for workers at the levels listed. As stated earlier, where a TLV is believed to be protective of reproduenve effects, it is used as the ORG. The assumption that other nonreproductive effects are automatically safeguarded at a particular ORG or TLV is not justi fied. As a case in point, consider carcinogens. Of 23 substances tor which cancer risk could be estimated, 84% (26/31) of the corre sponding ORGs equated to a cancer risk in excess of 1 in 10,000: some consider nsk above this level unacceptable. The study has generated a database consisting of 213 poten tial reproductive toxins. The majority of the substances have as sociated ORGs based on animal reproductive NOAELs or LOAELs. As expected, there are differences between the ORGs and existing TLVs. At this time 85% (180/213) of the dose/rcsponsc determinations have been completed; of these, 47% (85/180) do not have established TLVs. For substances with TLVs, 25% (24/95) have established limits equal to or lower CMA 121824 CAS NO: 67-56-1 Ud: 9509 Chem type: ACDMST Species: Rat Mus I ORO: 262 mg/m*1 2 3 4 5 6 7 8 j UF: NA--TLV believed to be protective CA-RISK/1E4: NA j ENDPOINT: D I j '-'ilO/ILF :ViL :'Hyl t'J.X I'HIO.-, PHYSICAL DATA: MW: 32.04; Physical State: liquid: VP: 96 mm Hg at 20C. OCCUPATIONAL STANDARDS: ACGIH 262 mg/m1; NIOSH 260 mg/m1: MAK 260 mg/m1. Group D, j 'Classification in a pregnancy group is not yet possible.* ! PPE: Material is toxic via skin absorption. Therefore, skin contact must be prohibited or else the ORC is invalidated. Buryi Rubber and Saranex are best PPE materials. Natural Rubber. Nitrile Rubber. PVAL, and PVC are not recommended. ANIMAL DATA: Rogers, et al., reported two studies in mice with inhalation doses of MeOH at 5000 and 10,000 ppm (study 1) and 2000 and 5000 ppm (study 2) for 7 hours a day on days 6 through 16 of gestation. In both studies the 5000 ppm exposure produced exencephaly in one-third of the fetuses. At 2000 ppm, 1 of 220 fetuses had exencephaly. Controls had no incidence of exencephaly in the offspring. (Rogers, Toxicologist. 11(1):344, 1991). In a more recent study, Rogers exposed mice to 1000, 2000, 5000, 7500, 10,000. or 15.000 ppm methanol for 7 hrs/day on days 6-15 of gestation. The NOAEL for developmental toxicity was reported at 1000 ppm (1310 mg/m1). A dose-related increase in cervical ribs was significant at the 2000 ppm level. Increased exencephaly and cleft palate were reported at 5000 ppm, and increased embryo/fetal death at 7500 ppm (Rogers, et al.. Teratology, Mar: 47(3), pp: 175-88. 1993). Rats have been found to be less sensitive than mice to the developmental effects of methanol, with effects seen only at 10.000 ppm and above (Rogers, Toxicologist. Mar; 13(1), pp:13. 1993). ORG RECOMMENDATION: Using the NOAEL of 1000 ppm (1310 mg/m1), the ORG is 458.5 mj/m when an uncertainty factor of 10 is applied (10 for most sensitive | human. 10 for animal extrapolation, and 0.1 as a modifying | factor for the high dose). Since the calculated ORG is above | the TLV, the TLV of 262 mg/m1 is accepted as the ORG as protective of reproductive effects. FIGURE 2. Eiimplt <f a SatabaM rwert than the calculated ORG and were assumed adequate for protec tion of reproductive effects, leaving 75)6 that have established limits greater than the ORG. Overall. 87% (156/180) of the sub stances identified bv the Jose/response portion of this assess ment method have inadequate reproductive exposure limits, .As expeeted, animal data make up the mu|onry of the available toxi cological information, although 9% I 17/180) of the ORGs are based on human data Several limitations to this method must be recognized. The two major categories of limitations are lack of information on specific chemicals and inadequate mechanistic models useful in extrapolating from animals to humans. The identification process of potential reproductive toxins is limited by the amount of currently available toxicological data on repro ductive effects. If, during the literature search, insufficient data is found on the reproductive effects of a substance, this is reported in the memo field. RTECS is used as a primary data source due to its comprehensive inclusion of positive data. However, RTECS does not report, negative studies, whvh hm/s do. eint<.e./uti;hi available for a weight of evidence approach to substance selection or elimination. .Another problem frequently encountered is the difficulty in finding certain citations, especially foreign citations. Less frequently encountered, but just as limiting, a citation is lo cated that does not include a dose level from which to calculate an ORG. The ORGs presented are based on the most sensitive (lowest) reproductive NOAEL/LOAEl discovered using the sources referenced earlier. A reasonable effort was made to locate the best available information. Beyond this no claim of veracity is made. The majority of the available reproductive data used in es tablishing human inhalation ORGs is from oral studies in ani mals. The difficulties with extrapolation between species and routes of exposure are frequently discussed in the literature. In the absence of human data or mechanistic models the usual al ternative is to apply uncertainty (actors for the various assump tions inherent m the assessment. Conclusion This study presents information on reproductive exposure guides on which to base hazard assessment and make in formed decisions on the need for exposure control. In most cases, the ORGs have been derived from a screening level of risk assessment and should not be construed as uncquivocallv safe exposure limits. It is hoped that they will serve as a catalyst and forum for further debate resulting in refinements that "ill en hance occupational health without being unnecessarily burden some. References 1 Office of Technology Assessment Task Force: Reproductive Health Hazards in tin Workplace. Philadelphia, PA. I 8 Lippmeort Co . 1988 pp 6, 55 2 "Ijbor," Code 9/Federal Regulation: Tide 29, Pc, 1910 1200 1989 pp 354-355, 3 United States General Accounting Office: Reproductive And Di vdup* mental Toxicant:, Regulatory Action: Provide Uncertain protection (GAO/PEMD`92-3) Washington DC. October 1991 pp 2-3 4 Paul, M. and S. Kurtz: Aruivjw of reproductive health hazard infornu non on material ulerv data sheets tor lead and the ethvletic glvcol ethers Am. J tnd Med 25:40J-U 5 l1994). 5 Headapohl, Dana M.: Sex. gender, biology, and work In Occupational Medicine. Stare 9/eke Are Rentm, vol. 8, no 4, D M, Headapohl. ed Philadelphia, PA- Hanlcv and Beltiu, Inc.. 1993 p 693 6 National Institute for Occupational Safety and Health (NIOSH): Criteria For a Recommended Standard. Occupational Expmurt Ethvhnc Glycol Monometfad Ether, Ethylene (Ihcol Monoethtl Etiter and Tlmr A\(tatcitpub no. 9M 19). Cincinnati* OH: NIOSH. 1991 pp 115-113 7 'Guidelines tor Developmental Toxiutv Bask Assessment" Federal Rianter 56234 15 December 1991) p 63801. 8 Calabroc. E-I- and E.M- Kenyon: Air Huff) and Rt*L- AMrtutmt < hclsca. MI. Lewis Publishers, Inc 1991 p 613 CMA 121825 V SilverPlatter Information: Hazardous Substances Database i(.'D R.OM). Norwood. MV U.S. National Library of Medicine. 1995. 10 SilverPlatttr Information; TDJfl/VElCD-ROM) Norwood. MA: U.S. National bbrarv ot Medicine. 1995. 11 SilverPlatter Information: TOXLINE iCD-ROMi Norwood, MA. Na tional Imorutc tor (Xcupaoonal Safety and Health. 1995. 12 Reproductive Toxicology Center. Columbia Hospital for Women: REPROTOX|Computer Darabaiel Washington, DC. 1995, 13 Silvcrriatter Information: SlOsHTIC iCD-ROMl Norwood. NLA National Institute tor Occupational Safetv and Health. 1995 14 Environmental Protection Agency (EisA): Toxicology Handbook Rocltulle. MIX (Jo'crnmenf Institutes. Inc.. 1987 pp 0-7. 15 Hailcnbcck. W.H. and K.M. Cunningham: Qiiaucisnnve Rttk .issenuteiit For Environmental itnd Occupational Health. Chelsea. MI Lewis Publishers. Inc.. 1987. p 45. 16. National Academy of Sciences: Risk Assessment in the Federal Covenmtnr Managing the Proem, Washington. DC: National Academe Press 1983. pp. 17-83. 17. European Community Council: Clamficneion and Ijtbellina of Damtuoat Snbitaneet. .Annex VI, 67/548/EEC. 1967. 18. Khcra, K.S.: Maternal toxicitv: A possible etiological (actor m embrvo te tal deaths and fetal malformations of rodent rabbit species Tiraeoiunv 3/ 129-15311985). 19 U.S. Environmental Protection Agency : Health Effects Assessment sum mary TablesiOERR 9200,6-303), Springfield, VA National Technical In formation Service, 1991. pp. P, . . E 19 20 World Health Organization (WHO): principles tor Evaluating Huiith Risks to Progeny Associated tetris Exposure to Utcmicals During Pngname Geneva. Switzerland: WHO, Emironmcntal Health Criteria 30, 1984 pp 79-80. CMA 121826 Ronald N. Liesemer, Ph.D. Vice President Technology September 16, 1996 American Plastics Council Mr, pnink Rorrelli, Technical Director iiic unyl lnstiLuit Newark, DE 19711 Dear Frank: Earlier this year, the American Plastics Council's Board of Directors adopted a resolution concerning the release of the plastics industry's first life cycle inventory (LCI). In part, that resolution required that all participating companies and trade associations attend a workshop prior to receiving the final data report and related software model. In December 1996, the APC and the Environment and Plastics Institute of Canada (EPIC) will host workshops for companies wishing to receive the LCI data. For the convenience of the attendees, we will be holding the workshop in two locations (the program will be identical in each city): 8:00 a.m. - 5:00 p.m. 8:00 a.m. - 5:00 p.m. December 3, 1996 December 5, 1996 Toronto, Ontario Houston, Texas The workshops are being carefully structured to address the information needs of business, communication, and technical personnel within the participating companies. We strongly encourage you to send as many individuals from your company as necessary to ensure that all of the appropriate people are fully briefed concerning not only the technical aspects of this-LCI, but also the policy, communications, and marketplace implications of its use. Please complete the attached fax response form and provide us with the names of each of the representatives who will be attending these workshops. We will provide advance materials and background information to them directly. Data is being fully released only to those companies which send one or more representatives for workshop training. Speakers at the Life Cycle Workshops will include: Scott Noesen (Manager, Environmental Performance, Dow Plastics) will provide attendees with an historical overview of the plastics industry's involvement in LCI and the value of this research. Dr. Ronald Liesemer (Vice President, Technology, APC) will address the limitations of the study, appropriate and inappropriate uses of the data, and public policy implementations. CMA 121827 A Joint Initiative with The Society of the Plastics Industry, Inc. 1275 K Street NW Suite 400 Washington, DC 2000S Fax 202.371.5679 202.371.5315 LCI Workshops September 16, 1996 Page 2 Nancy Russotto (Association of Plastics Manufacturers in Europe) will offer realworld insight on the expectations generated by the plastics industry's LCI data. As head of APME, APC's counterpart organization in Europe, Nancy will report on what has transpired since the release of APME member company LCI data in 1993 and offer words of wisdom for those involved in the communication of LCI data to i ustonw pr,fj thf-- Tom Rattray (formerly of Procter & Gamble) will offer a customer's perspective and discuss the ways packaging and consumer product industries are already using LCI/LCA and the effect on customer-supplier relationships. Don Bari (Chem Systems, Inc., LCI contractor) will summarize the processes involved in data compilation and results analysis and include a review of the deliverables, including details about the software license agreement needed to acquire the data and software. Don will give a two-hour training session on the use of the software containing company-specific LCI data. Susan Moore (Vice President of Communications, APC) will share details of APC's life cycle communication plan - target audiences, messages, tactics, media - as well as potential scenarios for issues management. Her presentation will be particularly helpful to those on the front line serving customer groups, communicating to employees, dealing with activist groups and answering to members of the public. Susan will also address the limits of APC communication on LCI. Scott Ferguson (Vice President and General Counsel, APC) will provide a primer on the do's and don'ts surrounding antitrust, copyright and data ownership involving the LCI. Throughout the day, there will be ample opportunity for discussion and Q&A, as well as one-on-one interaction with the speakers and your plastics industry peers from around the country. The demonstration of the Chem Systems LCI modeling software is planned for mid-aftemoon. A preliminary agenda for the workshop is attached. A final agenda and a short questionnaire will be mailed to each prospective attendee in the coming weeks to help us gauge more accurately the LCI knowledge-base within your company and your company's ongoing interests in this area. If you have questions, please contact Kathleen McBride of APC at (202) 371-5362. Sincerely, Enclosures Ronald N. Liesemer CMA 121828 American Plastics Council Environment and Plastics Institute of Canada Life Cycle Workshop December 3,1996 Toronto December 5,1996 Houston American Plastics Council Please complete the form below and fax bv September 2^1996_to: Michelle Addison American Plastics Council FAX: (202)371-5679 Workshop Location Choice Name __ Tide Company Address City, State, Zip Phone and Fax Numbers Name Tide Company Address City, State, Zip Phone and Fax Numbers Please copy and complete additumal pages as requiredfor more attendees A joint Initiative with The Society of the Plastics Industry, Inc. CMA 121829 __ Toro PRELIMINARY AGENDA APC/EPIC Life Cycle Workshop December 3,1996 -- Toronto December 5,1996 -- Houston e American Plastics Council Breakfast Welcome, Introduction and Strategy Overview Toronto: Dr. Fred Edgecombe (EPIC Vice President, Technical) Housum: Red Cavaney (APC President & CEO) The Value of Life Cycle Inventory Scott Noesen--Manager Environmental Performance--Dow Plastics Define LCI and distinguish from LCA. APC/EPIC efforts in context of worldwide LCA activity. Historical overview and participant involvement in LCI. Brief overview of research conducted. Value of LCI to industry (benchmarking and resource conservation, starting point for cradle-to-grave analyses, challenge reports based on old data, credibility), and customers (reliable up-to-date data for use in life cycle analysis). Q&A Session Limitations of Life Cycle Inventory Dr, Ron Liesemer--Vice President, Technology--APC Cradle to pellet vs. cradle to grave and disposal LCi is not LCA (conclusions that shouldn't be drawn from the data) ISO standards on impact assessment methodology in development What others might do with the data and potential responses LCA as a policy tool Q&A Session Break The European LCI Experience Nancy Russotto--President---APME The rationale for European LCI in 1990s. Specifics on approach, methodology results, distribution and use. The changing nature of customer & government requests for data. ... more A joint Initiative with The Society of the Plastics Industry, Inc. CMA 121830 10:40 11:20 Noon 12:45 -2- European Industry's policy on LCI/LCA, particularly as a policy tool. Additional research underway or planned, including updates. What APME has learned and future course. 0 & A Session The Research Don Bari--Chem Systems, Inc. Methodology overview Data compilation process and data gaps Study results, contents of report Capabilities and contents of LiMS Review of license agreement Q & A Session Legal Issues Scott Ferguson--Vice President and General Counsel--APC Do's and Don'ts (Scenarios for Communicators, Marketers & Technical Staff) Issues related to FTC and AGs Copyright Antitrust Review the LiMS License agreement Q & A Session Lunch LCI as a Guide to Material Choice: The Customer Perspective Tom Rattray--Former Associate Director Environmental Quality, Procter & Gamble How the packaging and consumer product industries have been used and are using LCI/LCA Can true life cycle analysis (including impact assessment) be done? Is it already being done by consumer product companies and other customer industries? Expectations of customer industries: What kinds of data do they want/need from the various materials industries? What do they expect from individual suppliers/manufacturers? ... more CMA 121831 1:35 2:00 2:30 5:00 -3- What data are available from other materials industries (e.g., steel, aluminum, paper, glass) and how are they being used? APC/EPIC data: How do you expect the plastics industry LCI will be used? The future of LCI/LCA: Its role in customer decision-making and its e*Sfcum the*u$tomersupplier relationship. Q & A Session The APC Communication Strategy Susan Moore--Vice President, Communications--APC Outline APC's timeline for communication. Define target audiences, messages (including issues management), media and goals. "What do I tell the public and my customers?" APC's role as a "Resource Center" Q & A Session Workshop Evaluation Questionnaire Completion Break Technical Training on LiMS Computer Software Chem Systems, Inc. Adjourn CMA 121832 ANTITRUST TIPS Do not discuss current or future prices. Be very careful of discussions of past prices. Do not discuss what is a fair return or profit level. Do not discuss raising, lowering, standardizing or stabilizing prices. Do not discuss costs of production or marketing. Do not discuss allocating markets. Do not discuss refusing to deal with a company because of its pricing, distribution or other business practices. Do not attend rump sessions. CMA 121833 A ## Vinyl v # Institute A Division at The Society of The Plastics Industry, Inc. Available from the Vinyl Institute Last revised: July 1995 This revision: September 1996 Denotes new or newly revised since last update Note: Individual copies of all items are available bee of charge to employees of Vinyl member companies unless otherwise noted. There may be a nominal charge for multiple copies or large quantities of some items. For more information, or to order materials, contact the Vinyl Environmental Resource Center (VERCE) by phone at (800) 969-VINYL (8469) or by fax at (330) 376-9379. 1. "Vinyl: Serving More People, In More Products, Made By More Industries, Than Almost Any Other Material Today" - 16-pagefour-color brochure describing how vinyl is made and used. Highlightsfive major markets with testimonialsfrom industry customers. VI Members: Up to 5 copies free, each additional copy is $1. Non-members: First copy free, each additional copy is SI. 2. "Polyvinyl Chloride: An Overview of die Role Chlorine Plays in this Plastic Material" - Ten-page white paper with references. Discusses the major topics associated with the mamfacture and use ofvinyl. July 1991. 3. "We're Glad You Asked: Answers to the Most Commonly Asked Questions About Vinyl" Eight-panel wallet card. A condensed version of the white paperfor use with customers, suppliers, community residents, etc. Available in English, Spanish and French. May 1995. VI Members: Up to 10 copies free, each additional copy is $.40. Non-members: Up to 5 copies free, each additional copy is $.40. 4. "Vinyl the Versatile Plastic" -A series offour videos thatfocuses on different segments of the vinyl industry: construction, electrical applications andpackaging. The tapes also discuss some of the current issuesfacing vinyl: recycling, incineration, its overall environmental "friendliness," cost-effectiveness, etc. One ofthe tapes, subtitled "Issues and Answers," provides more detail on these subjects. Each tape is VHSformat and runs approximately eight minutes. March 1992. Members/Non-members: The tapes are available separately for $15 or as a complete set for $50. 5. "Some Common Misperceptions About Vinyl"--Afour-page Q<LA piece designed to answer questionsfrom customers, prepare letters to the editor, extract materialfromforpresentations, and as a quick reference. July 1993. 6. "Vinyl 2020: Progress, Challenges, Prospects" - A 44-page document which takes a look at the future of vinylfor the next quarter century. April 1996. VI Members: Up to 10 copies free, each additional copy is $10 or $7.50 for 50 or more copies. Non-members: First copy free, each additional copy is $10 or $7JO for SO or more copies. 65 Madison Avenue Morristown, NJ 07960 (201) 898-6699 * Fax It (201) 898-6633 CMA 121834 2 7. `The Vinyl Institute: A Voice For the Vinyl Industry" - General Vinyl Institute brochure describing the mission of the VI and VERCE. April 1994. Currently undergoing revision. 8. Vinyl Environmental Resource Center Rolodex Card - Promotes VI 800-number and hotline. Health & Saffty: *, ; ; 9. "Facts About Working with PVC" - 12-page pamphlet designedfor PVCplant workers and converters. 1988. Currently undergoing revision. 10. "Facts About Vinyl Chloride Monomer" - 12-page pamphlet designedfor VCMJPVC plant workers and plant community residents. 1988. 11. "Community Health Effects of Vinyl Chloride" -13-page Vinyl Institute technical paper with references. August 1986. 12. "Potential Effects of Vinyl Chloride at Human Offspring" - 10-page VI technical paper with references. December 1987. 13. "Recommended Guidelines for Vinyl Chloride: Storage, Shipping and Handling" - 10-page VI technical paper. August 1986. 14. "On Potential Sources of Vinyl Chloride in landfills and Groundwater" - 13-page technical paper. March 1990. 15. "Effects of Vinyl Products on Indoor Air Quality" - A two-page technicalpaper with references. January 1990. Environmental Issues: Environmental Fact Kit - Pocketfolder containing twelvefact sheets (see below) dealing with vinyl's environmental performance. Also includes an overview ofthe vinyl industry and its economic impact on society. "About the Vinyl Institute" "About PVC and the PVC Industry" March 199S. "Environmental Profile: Facts About PVC's Fire Performance" March 1993. "Estimating the Incremental Cost to Replace PVC" April 1993. "Facts About the Safety of PVC Additives" July 1993. "Facts About Chlorine, the Material Used to Make PVC" March 1993. "Facts About the Economics, Life Cycle Efficiencies and Performance Benefits of PVC" July 1993. "Facts About die Safety of Incinerating PVC Wastes" March 1995. "Facts About die Safe Manufacture of PVC" March 1995. "Facts About Recycling PVC" March 1995. "Facts About the PVC Industry's Record of Transportation Safety" March 1993, "PVC's Environmental Profile: Fallacy vs. Fact" July 1993. VI Members: Up to 5 irire free, each additional kit is $3. Non-members: First kit free, each additional lot is $3. CMA 121835 3 11. "The Truth About Vinyl" - A detailed rebuttal to the allegations made by Greenpeace in its document, "No Future for PVC." This 23-page document examines a range ofenvironmental questions and provides concise answers withfootnoted references. August 1994. VI Members: Up to 5 copies free, each additional copy is $2. Non-members: First copy is free, each additional copy is $2. 12. Grassroots Mobilization Fact Sheets - Five one-pagefact sheets (see below) designedfor use by VI members and their customers when conducting outreach activities with legislators and other opinion leaders. With references. "Vinyl Plastics: Dioxin Production in Perspective" December 1995. "Vinyl Plastics: An Environmental Profile" July 1994. "Vinyl Is A Small, Manageable Part of the Solid Waste Stream" July 1995. "The Economic Impact of the U.S. Vinyl Industry" July 1994. "Vinyl Plastics: Part of Everyday Life" July 1994. 13. "The Relationship Between Chlorine in Waste Streams and Dioxin Emissions from Waste Combustor Stacks" - Study performed by the American Society ofMechanical Engineers which found no statistical relationship between chlorine in waste streams and dioxin emissions from waste combustors. October 1995. Executive summary is available by calling VERGE;full study can be orderedfrom the ASME at (800) 843-2763. 14. "Vinyl Plastics and Incineration: ASME Study Confirms No Relationship to Dioxin" - Onepage fact sheet detailing the results of the incineration study performed by the ASME. May 1996. 15. "The Vinyl Industry's Dioxin Testing Program: Background and Status Report" - One-page fact sheet which reports the initial results of the vinyl industry's voluntary dioxin testing program. August 1996. 16. Communications and Community'Mobilization Plan-A tabbed, three-ring binder containing guidelinesfor industry plant personnel charged with preparingfacilitiesfor activist protests or dealing with community-based concerns related to the presence ofvinyl productionfacilities. Also contains guidelinesfor building relationships with the local media, community leaders and government officials. June 1995. Members/Non-members: First copy is free, each additional copy is $30. 17. `Telling the Vinyl Story: It's Eco-logical!" -A training programfor VI members to use with employees and customers designed to give them an overview ofthe issuesfacing the vinyl industry, then arm them with thefacts to become industry advocates. Contains a teacher's manual andfour news-progrcun-style video interviews with industry experts. Running time: two hours. August 1995. Members/Non-members: First copy is free, each additional copy is $30. 18. "Environmental Briefs"--A quarterly newsletter which provides news about vinyl and the environment. Currently distributed to more than 17jOOO people worldwide. Members/Non-members: Subscriptions are free of charge. 19. "Vinyl Voice" - A quarterly newsletterfor vinyl processors updating them on issuesfacing the vinyl industry. Members/Non-members: Subscriptions are free of charge. CMA 121836 4 Recycling/Solid Waste: 26. "Directory of U.S. and Canadian Companies Manufacturing Products from Recycled Vinyl" - Listing of US. and Canadian companies that recycle post-industrial, and pre- and post-consumer vinyl into compounds or second-generation products. Updated quarterly. VI Members; Up to ten copies free, each atifiiljonal copy is SI. ......... , . ........... Non-members: First copy free, each additional copy is $1. 27. "Directory of U.S. and Canadian Companies Involved in the Recycling of Vinyl (PVC) Plastics" - Listing of US. and Canadian companies involved with vinyl recycling as well as processing capabilities, and the type andform ofscrap accepted. Includes contact information. Updated quarterly. VI Members: Up to ten copies free, each additional copy is $2. Non-members: First copy is free, each additional copy is $2. 28. `Tool Pool" Program Brochure - Irformational brochure about the VPsfunding programfor companies who want to develop a new recycled vinyl product. December 1995. 29. Bioreef Video News Release -A 90-second VNR distributed to television stations nationwide. Highlights the use ofrecycled-content vinyl sheet in the mamfacture of "Bioreef," an artificial reefproduct deployed in off-shore waters to help rebuild coastal reefsfor smallfish. Contains extra footage and interviews, underwater photography. June 1995. Members/Non-members: Each copy $3. 30. `Today's Environment" News Segment -A three-minute segmentproducedfor the Discovery Channel and aired over that network whichfeatures the use ofrecycled-content PVC pipe to recover methane gasfrom landfills. January 1995. Members/Non-members: Each copy $5. 31. "Post-Consumer Vinyl Recycling in the U.S." - State-by-state listing of US. communities with access to vinyl recycling. May 1992. 32. "Vinyl Plastics and Solid Waste: Some Basic Facts" - Two-page fact sheet. November 1992. 33. "End Use Markets for Recycled Polyvinyl Chloride" - Executive summary ofstudy preparedfor the Vinyl Institute by the University ofToledo. July 1990. Vinyl and Construction: 34. Habitat for Humanity Video News Release ~A 90-second VNR distributed to television stations nationwide in June 1995featuring the vinyl industry's participation in the 1995 Habitatfor Humanity Jimmy Carter Work Project. Contains extrafootage of the project and several interviews with industry experts and HFH officials. Members/Non-members: Each copy $3. 35. "Vinyl Builds America Better" - A more in-depth 10-minute video describing the vinyl industry's participation in the HFH Jimmy Carter Work Project. June 1995. Members/Non-members: Each copy $10. CMA 121837 5 36. "Affordable Housing: Meeting the Need With Vinyl" - A four-color brochure which describes in words and photographs the vinyl industry's ongoing partnership with Habitatfor Humanity. Documents industry involvement in HFH builds in Los Angeles and Washington, D.C., and highlights the benefits vinyl products bring to various construction applications. VI Members: Up to 5 copies free, each additional copy is $1. Non-membm: First copy is free, each additional copy is $1 Vinyl and Packaging: 37. "Vinyl: A World of Packaging Solutions" - Eight-page,four-color brochure showing the advantages ofvinyl in bottles, rigidfilm andflexiblefilm packaging implications. Pocketfolder holdsfourfact sheets (see below). 1992. "About Vinyl Packaging and the Environment" August 1993. "Vinyl: Still the Leader in Plastic Packaging Films" August 1993. "Vinyl is a Small, Manageable Part of the Solid Waste Stream" July 1995. "VI Member Company List" June 1996. VI Members: Up to 5 copies free, each additional copy is $1. Non-members: Erst copy is free, each additional copy is $1. . Vinyl In Electrical Applications: 38. "Wired for Safety With Vinyl Electrical Materials" - Eight-page brochure describing uses and properties of vinyl electrical implications. 1988. 39. "PVC Electrical Non-Metallic Tubing vs. Electrical Metallic Tubing: A Cost/Beoefii Comparison" - Four-page executive summary ofa study conducted on behalfof the Vinyl Institute. July 1990. 40. `Ten Reasons to Rely on Vinyl, the World's T parting Electrical Material" - Six-panel pamphlet (printed on recycled rigid vinyl sheet). Fire Performance: 41. "Fire and Polyvinyl Chloride" - Twenty-page Vinyl Institute technicalpaper with references describing variousfire tests and resultsfor vinyl and other materials. 1996. VI Members: Up to 10 copies free, each additional copy is $1. Non-members: First copy is free, each additional copy is $1. 42. "Combustion Products of Vinyl and Other Building Materials"--Layman's overview of the role that variousfire gases, including hydrogen chloride and other vinyl combustion products, play in creating a hazardousfire environment. August 1995. 43. "PVC On the Fireground: What You Should Know About Vinyl" --A brochureforfirefighters which gives them thefacts about vinyl'sfire performance. 44. "Vinyl's Fire Performance: The Perception and the Reality" -Article by Roy T. Gottesman reprintedfrom the August 1990 issue ofElectrical Construction and Maintenance. CMA 121838 Vinyl in Pipe Applications: 6 45. "PVC Drain, Waste and Vent Pipe vs. Cast lion Soil Pipe: A Cosi/Benefit Comparison" Four-page executive summary of a study conducted on behalfofthe Vinyl Institute. July 1990. 46. "PVC vs. Copper Domestic Hot & Cold Water Systems: A Cost/Benefii Comparison" 1 out -page executive summary ofa study conducted on behalfofthe VBiyTInstitute. July 1990. 47. "PVC Pipe and Drinking Water Safety" - Technicalpaper summarizing Vl-sponsored research on pipe permeation and leaching, with references. July 1991, 48. "Is PVC Piping Fire Safe?" --Article authored by Joseph B. Zicherman, PhD. reprintedfrom the November/December 1990 issue ofFire Journal. Partners Program Materials 49. Partners Handbook - Three-ring binder thatprovides how-to informationfor members of the Vi's "Partners Program" outreach effort. One copy available free of charge to all Partners. 50. "Partnerships" -Monthly newsletter mailed to members of the "Partners Program." Subscriptions free of charge to all Partners. GfCUMXXT^UENTTMNfoCMFiAVABJlMLDQC 9tWM CMA 121839 'TVE of your book," she said, "is that no large-scale population studies in the United States have been done on the drop in sperm counts. However, I understand one is coming up in May [1996] that has studied three U.S. cities over the last 25 years HAD and finds no decline in sperm counts. Is that not enough rime?" Twice more she asked variations on the question, until finally one of the scien tists conceded he would be "delighted" to learn that there are places in the world where sperm counts are not declining. Bailey, who covers a variety of scientific, MY by Kenneth Smith medical, and educational issues, says she re searched the scientific controversy over "en docrine-disrupting compounds" in advance of the press conference. She put together news stories to alert listeners to the "hype" sur- rounding the release of the book, which SAY T T Vice-President A1 Gore promoted in a * * foreword as the sequel to Silent Spring, the 1962 classic by Rachel Canon. After pub lication of Owr Stolen Future, Bailey report ed its findings, offering as well the scientific criticism. "The widely publicized book warns The release of Our Stolen Future set the stagefor a major scare story on decreasingfertility. But in balanced reporting of the book's claims, journalists distinguished between value judgments and science. Becky Bailey wasn't trying to be contennous. She said as much to the formidable group of scientists arrayed in a semicircle before her. But the veteran NBC Radio correspondent wasn't en tirely satisfied with the answers she was getting. The scientists, gathered at a Vfcshington, D.C. press conference on March 13, 1996, had charged that exposure to man-made chemicals in items includ ing plastic wrap, breast milk, and detergents threat ens human beings with sexual and reproductive problems, among them declining sperm counts. Two of the researchers, Theo Colborn and John Peterson Myers, aided by Dianne Dumanoski (a science reporter for The Boston Globe), had gone so far as to write a book with the provocative tide, Our Siolen Future: Are We Threatening Our Fertility, Intelligence, and Survival?--A Scientific Detective Story. How, Bailey asked the scientists, did such al legations square with studies showing rising Reprinted Bj Permission of AMERICAN HERITAGE Magazine, a division of Forbes, Inc. Forbes, Inc______ ARE WE THREATENING OUR FERlJlTY, INTELLIGENCE. AND SURVIVAL?--A SCIENTIFIC DETECTIVE STORY |n1ili.in mu iiiiii :j ;i In n] r i 3 if j 3 ^ in l 4I u U i 01 i.! i THEO COLBORN. DIANNE DUMANOSKI, AND JDHN PETERSON MYERS that synthetic chemicals such as dioxin in the ers could hardly be blamed for believing there environment may harm the endocrine system was no such scientist. (In a June 1993 article for by mimicking hormones," she said. "The re Eco magazine, Keith Schneider, then a science sult, says the theory, is a drop in male fertil writer for The New York Times, reported that ity and more cases of breast and prostate Bradley's conclusions had "since been described cancer. But research by Columbia Universi as completely specious by university, federal, and ty's Harold Fisch reportedly has found no drop state health experts across the country.'') in sperm counts among men in three U.S. The media's coverage of what Lawrence cities the last quarter century." Listeners got Wright's article in the January 15, 1996 New both sid^s of the story. Yorker called die "Silent Sperm" controversy has Bailey's reporting is one more sign that the yet to become "Son of Alar." "To some ex media, badly burned by scare stories that tent-times have changed," says NBC corre weren't1--killer apples, exploding trucks, and spondent Robert Hager. "The public and the deadly breast implants--are press have become more not quite so credulous this time around. The chemical "The press have educated and have learned to deal with these issues in compounds under fire in a calmer manner." Dr. Our Stolen Future may turn out to be sperm-blighting, become more Lorenz Rhomberg, a for mer EPA official who is hormone-disrupting, re production-crippling kill educated and have now an assistant professor at the Harvard Center for ers--or they may not. Sci entific opinion remains learned to deal Risk Analysis, tentatively agrees: "It seems the press is with these issues insharply divided. But fewer reporters seem willing to returning to a bit of skep ticism compared to [the take either side's word for it. That has not always been a calmer manner. " way it covered the apple panic). I'm not sure, but it's the case in science reporting. appropriate." A one-sided 60 Minutes And timely. The arrival of piece in 1989 ignited a panic over the chemical Our Stolen Future in spring 1996 appeared to set Alar, an allegedly carcinogenic growth regula the stage, as one industry consultant put it, for tor sprayed on apples. "The most potent cancer- "a major scare story." Not only was a public- causing agent in our food supply," correspondent relations group with ties to PR whiz David Fen Ed Bradley said in the opening segment, "is a ton, who dreamt up the Alar scare, brought in substance sprayed on apples to keep them on the to promote the book, but coverage of a 1992 trees longer and make them look better. That's Danish study, which found declining sperm the conclusion of a number of scientific experts." counts and was used to hypothesize a link to en Not all the experts, or even a majority, shared vironmental chemicals, suggested that the press that conclusion. But, his mind made up, Bradley might embrace the book's conclusions. spent the rest of the piece trying to find out why But something important had happened m the Alar was still on the market. He interviewed an Environmental Protection Agency (EPA) reg ulator, an environmentalist, a lawmaker, and two scientists sympathetic to stricter regulation of Alar. He also sought comment from the chemical's manufacturer, even though it would have no standing in a scientific dispute. No scientist who challenged the program's premise appeared, view- four years between the publication of the Dan ish study and Our Stolen Future. Several scientists set out to test the Danish hypothesis and found it wanting. A reanalysis of the study published in the April 1995 issue of the scientific journal Fertility and Sterility reported that there was a paucity of data from 1940 to 1970, and that from 1970 to 1990 there was "no decrease m sperm it H M I III A I It II I ( CMA 121841 counts--in tact, sperm counts were observed to Not all the journalism has been so balanced. have increased'' A 1995 study published in The Bryant Gumbel of NBC's Today had time to talk New EnglandJournal ofMedicine by Dr. Richard about the alleged hazards of plastic wrap dur Sherins, a male infertility specialist, found "lit ing a March 12 interview with Theo Colbom, tle evidence that male fertility is declining.'' A one of the authors of Our Stolen Future, but 1995 study by Dr. Stephen Safe published in made only passing reference to scientific crit Environmental Health Perspectives found that "the icism. Even this was diminished by Gumbel's hypothesized linkage between dietary/environ characterization of the critic as an "industry" mental estrogens and the increased incidence of source: "The president of the American Coun breast cancer is unproven....The hypothesis that cil on Science and Health--which is partially male reproductive problems and reduced sperm funded, I should note, by industry--has said counts are related to increased exposure to en your book is quote, `innuendo on top of hy vironmental and dietary estrogens is also un pothesis on top of theory,' and they've prepared proven." And Dr. Fisch, whose research Bailey a lengthy refutation ofyour work. Did you ex dted at the D.C. press conference, found "no de pect that kind ofbacklash from industry?" (More cline in sperm counts over a 25-year period in than a month passed before Gumbel interviewed 1,283 men who banked sperm before vasec Fisch on April 30.) A January 1996 Esquire tomies at three distinct geographical sites in the story, "Downward Motility," followed the United States." Bradley model: green scientists, regulators, in Remarkable, at least by the standards of Ed dustry spokespersons, and no scientific critics. Bradley, is that many journalists actually called A March 11, 1996 U.S.News & World Report ar these scientists in an attempt to provide bal ticle allocated just one of 18 paragraphs to sci anced coverage of the controversy over Our entific criticism. And a March 18 Newsweek Stolen Future. Two stories in the March 7 Wall story waited until the last paragraph to mention Street Journal--one by Cynthia Crossen, the the views of Safe and Fisch. other by Michael Waldholz--quoted critics of Still, we are not witnessing a replay ofthe one the theory. Diane Rehm included fertility spe sided coverage of the 1992 work of the Danish cialist Sherins in a panel discussion of the book researchers, who concluded, "There has been on her March 14 radio show. And Fisch told a genuine decline in semen quality over the past the NBC Nightly News on April 1 that there 50 years." One of the study's two authors, Niels "is a hysteria concerning the sperm counts, and E. Skakkebaek, a researcher at the University of it's unwarranted." Copenhagen, and Richard M. Sharpe, who is But it was Gina Kolata of The New York Times with the Medical Research Council in Edin who set the standard for in-depth, even- burgh, speculated in a 1993 article for the med handed reporting on the issue with rwo stories ical journal Lancet that environmental chemicals on March 19 and a third on May 5. Her March that act like the female hormone estrogen might 19 articles gave equal billing to scientific crit impair fetal development and contribute to such ics, including Safe, Sherins, and Fisch. Also problems. The researchers had a model for their quoted was Berkeley scientist Bruce Ames, then hypothesis. Between 1945 and 1971, doctors had a National Academy of Sciences panel member, prescribed a synthetic estrogen, diethylstilbestrol, CMA 121842 who challenged the scientific credibility of those promoting theories about endocrine disrupters. "It's a political movement," he told Kolata, "and it's not based on science." Her May 5 arncle ex ploring spermology, a field "fraught with con flicts and confusion," was packed with nuanced reporting about the complexity of research in this area. for several million pregnant women to prevent miscarriages. Some of their sons suffered low sperm counts as well as problems like undescended testicles and testicular cancer. According to the article, human beings "now live in an environ ment that can be viewed as a virtual sea of es trogens" These estrogen sources range from the natural variety found in plants to the synthetic M [ I M A ( K I TIC A*> w ut un. un-nmiu; wiuj wiuLu wc nave con taminated our environment in the past 50 yean." The link between the health problems and chemical contamination "is not unlikely," they said, using words suggesting something less than scientific certainty. Skakkebaek and Sharpe cited in particular such controversial chemicals to tzye reached tne airwaves additional scientif ic information had appeared to suggest that maybe the world wasn't quite so bad off after all. On July 2,1994, the British MedicalJournal, which had published the original Danish study showing declining sperm counts, published a second study describing numerous method as dioxin, a class of industry byproducts asso ological problems with the first. It concluded: ciated with the 1982 evacuation of Times "The original evidence does not support the hy Beach, Missouri, and polychlorinated biphe pothesis that the sperm count declined signif- nyls, or PCBs, a class of chemicals--often used icandy between 1940 and 1990." An editorial to cool and lubricate elec in the same issue warned trical equipment--that was largely banned in the 1970s for fear that even trace "I think environ that such controversies pose special problems for "the non-medical press" and the amounts were carcinogenic. The researchers were care mental journalism "armchair epidemiologist," who lack access to scientific ful not to exaggerate what could be extrapolated from today...is much literature that might high light data collection and the Danish data. For exam ple, they did not say that the more detached other methodological prob lems. In the case of Eye to human race was exposed more often to these chem from the Eye that warning proved prophetic. icals chan they were 50 yean ago; they simply said this was advocacy groups. " To its credit, Eye to Eye differed in one key respect the "most reasonable (and from "Assault on the Male." safest) assumption." As for It actually allowed a single whether increased exposures could lead to the scientific critic to challenge, however briefly, the ktnds of sexual and reproductive problems they theory of the declining sperm counts. "I think were seeing, the researchers simply concluded it's hogwash," said male infertility specialist that this "is not known." Sherins, "I believe that there are technical prob Such uncertainty didn't translate well in the lems in how that information was collected." October 31, 1993 BBC documentary, "Assault A month after the Eye to Eye segment, William on the Male," whose gnm title, occasionally eerie Stevens of The New York Times wrote "Industrial background music, and anecdotal treatment of Chemicals May Disrupt Reproduction of deformed animals and humans left little doubt Wildlife," an article heavily weighted toward that the world was on the verge of a chemical those who believed endocrine disrupters affect apocalypse. A July 28, 1994 CBS report on Eye reproductive health. On September 1, 1994, USA to Eye with Connie Cluing, which included in Today ran a similar account headlined, "Toxins' terviews with some of the same researchers and `Assault' on Reproductive Systems." The Times some of the same anecdotes from the BBC' doc devoted just three paragraphs to scientific critics. umentary, left a similar impression. Colborn USA Today devoted just one out of 23, but did warned Eye to Eye reporter Roberta Baskin that include one revealing remark from a researcher if chemicals weren't tested for their effects on at the National Institute of Environmental Health reproductive capability, "we are headed for extinction " l\ye to Eye was actually less evenhanded m its Sciences. "Fart of the problem," said Dr. John McLachlan, "is that it's all very new to us. So the concern that's expressed sometimes in the reporting than the BBC because by the time Eye media and by groups is ahead of the data " 7 0 M I I> I A ( k I I I ( CMA 121843 it may be subtler, but McLachlan is saying in tact, the authors were quite straightforward much the same thing that Bruce Ames of in explaining that their book was about more Berkeley told The New York Times's Kolata than just science. "When confronted with a about the hype and political agendas that sur troubling environmental problem, the first im round the endocrine-disrupters story. Take, for pulse has been to appoint a panel of experts in instance, Greenpeace's involvement in the con hopes that they can give us the right answer," troversy. The environmental group had em the authors wrote. "Scientists can certainly pro vide invaluable guidance, as the work described in this book amply demonstrates. But science barked on a campaign to ban the use of alone does not always have the answer. Decid chlorine, which had been linked to cancer and ing on a wise course involves a host of consid ozone destruction, among other things. As a erations and, most ofall, value judgments." Greenpeace spokesperson said in the July 9, Value judgments are perfectly acceptable in 1993 issue of Science, "There are no uses of books, but they are not science. The fact that so chlorine which we regard as safe." But when many reporters, particularly Kolata, cited sci chlorine was implicated as an endocrine-dis entific skeptics in their reporting shows thatjour rupting compound, Greenpeace shifted its at nalists are increasingly capable ofdistinguishing tack. "You're not half the man your father was," between value judgments and science. its ads said The group also suggested the chem There is a "new, more detached attitude by re ical was causing "willies," i.e., penises, "to porters," says Scott Allen, who has been reporting shrink in size." on health and science issues for The Boston Globe The Independent ofBritain reported on June 7, for three years, "and I think that environmen 1995, that the authors of the 1992 Danish study tal journalism today, at least at leading oudets, is were not amused by the liberties being taken much more detached from the environmental with their work. Sharpe and Skakkebaek and re advocacy groups and scientists aligned with the searcher John Larsen of the Danish National environmental movement than it used to be. I Food Agency issued a statement accusing Green think there is more effort to bring in dissident peace members of "misrepresenting this research. views." They are taking something which is a clearly Scientific opinion on Allen's comment ap stated hypothetical link and calling it fact." pears divided. Fisch says press coverage of the Matt Labash of The Weekly Standard reported on controversy, though not "terrible," has surprised April 29, 1996, that in a telephone conversation, him. Journalists seem to want short answers in Sharpe told him that "we still say that the link be black and white, he says. They are less inter tween environmental chemicals and adverse ef ested in reporting on the "gray," which may be fects on human health is still hypothetical." the only appropriate hue for a controversy as That comment is important because since complex as this one. He says that some re Sharpe, Skakkebaek, and Larsen issued that state porters approach him with preconceived an ment, Our Stolen Future, whose apocalyptic tone swers to their questions, seeking, in effect, relies in part on the Danish study, has been re corroboration. leased. Although the authors hedged their own Sherins, who has given more than a dozen in conclusions linking man-made chemicals to health terviews on the subject in recent months, de problems in humans, they didn't hesitate to rec clined comment for this article. "He feels he has ommend sweeping changes in individual lifestyle had his say," notes an aide. The media as a whole and government regulation: Everyone should should take that statement as a compliment. Giv avoid consumption of animal fat--where such ing both sides their scientific say means better- chemicals are said to collect--especially women, informed media and consumers and maybe, just from birth to the end of their childbearing years. maybe, fewer scare stories. All people should minimize contact between food and plastic. Government should consider chem Kenneth Smith is an editorial writerfor The icals guilty until proved innocent. Washington Times. CMA 121844 MEDiaCIUTIC 7 1