Document Lgb8OoygxGeQ60OBekebbRyj7

>RAI CONFIDENTIAL April 1, 1981 DRAFT EPA TOXIC SUBSTANCES CONTROL ACT PLAN SPI-PVC SAFETY GROUP ALTERNATIVES COMMITTEE PURPOSE: PRESENT SITUATION To identify responses to potential EPA regu latory activity under the Toxic Substances Control Act (TSCA) affecting VCM/PVC. 1. EPA promulgates and enforces regulations which affect VCM/PVC under TSCA. 2. EPA is developing the following rules under TSCA: Section 4(a)(testing), Section 5(a) (Pre-Manufacturing Notification (PMN) and Significant New Use Regulations (SNUR)), Section 6(a) (labeling). Section 8(a) (re porting) , Section 8(c) (allegations of adverse effects), Section 8(d) (health and safety studies), and Section 8(e) (substantial risks). Each of these has a potential impact on VCM/PVC. 3. Under Section 4(a), EPA may determine whether it has insufficient data to prop erly regulate VCM/PVC. Currently, the Agency is behind schedule in evaluating Interagency Testing Committee (ITC) recom mended substances for testing. It is im probable that VCM/PVC would be subject to a Section 4(a) rule unless a correlation between VCM and a new human health hazard becomes apparent. 4. Under Section 8(b) (chemical inventory) EPA made an arbitrary two percent exemption for comonomers in a reaction formula that produces high molecular weight polymers, such as PVC. This exemption may not apply. 5. EPA has proposed PMN regulations under Section 5. SPI has commented on the pro posals, and maintained that structural GACC 00088 polymers should be considered articles even when they are in particle form. Pre sent indication is that EPA may react favorably to SPI comments on this point. Final regulations are expected to be promul' gated in mid-1981. Due to the multitude of PVC uses, it is unlikely that PVC would be subject to a SNUR under Section 5(a). Under Section 6 (a), EPA can require label ing to warn of human health and environ mental hazards. While EPA was coordinating its efforts with OSHA, in November 1980, EPA terminated its joint labeling effort with OSHA. Separate EPA rules on labeling are not currently expected. However, CMA has furnished EPA`s Office of Toxic Sub stances with a proposed rule relating to labeling and is urging EPA action on this proposal. Section 8(a) directs EPA to promulgate rules that require manufacturers or pro cessors to furnish reports on chemical substances. SPI has commented on the pro posed reporting rule, objecting to its burdensome nature and the sales and cus tomer information provisions. EPA anti cipates promulgation of a final rule in mid-1981. EPA has issued a proposed rule under 8(c) that will require recording and reporting of allegations that products are harmful to the environment or human health. SPI has commented on the burden of the proposed regulation. Guidelines under 8(e) concerning evidence of significant risk have been issued; the information that must be submitted and the mechanism of submission are described. Under 8 (d), the Agency can require manu facturers or processors to furnish avail able health safety studies. EPA promul gated final rules under Section 8(d), but withdrew them following legal action by industry. VCM/PVC were not included in the first rule; we can anticipate EPA re quiring studies to be submitted at a later date. GACC 00089 -2- ACTION UNDERWAY: WHAT IF; 1. 2. 3. 4. 1. Continued SPI participation in proposed rulemakings under 5(a), 8(a) and 8(c). 2. Health Committee continues to collect and summarize new health and safety studies. 3. Proposed labeling rules issued by OSHA in January, 1981, were withdrawn in February, 1981. They are treated under a separate contingency plan, and are currently being evaluated by SPI. EPA proposes additional toxicological testing under Section 4(a) of VCM or PVC. a. Impact on industry - high b. SPI influence - medium EPA requires a PMN for minor constituents in PVC reaction formulation, or SNUR for VCM/PVC under Section 5(a). a. Impact on industry - high b. SPI influence - medium EPA promulgates a proposed rule under Section 6(a) requiring labeling of VCM/PVC. a. Impact on industry - medium to high b. SPI influence - dependent on proposed agency action EPA requires production, sales and customer reports under Section 8(a) for VCM/PVC. a. Impact on industry - very high b. SPI influence - medium to high EPA promulgates a final rule under Section 8(c) containing the onerous reporting requirement of the proposed rule on allegations of harm. a. Impact of industry - high b. SPI influence - medium -T -- GACC 00090 6. A rule is proposed under Section 8(d) requiring submission of health and safety studies relating to VCM/PVC. a. Impact on industry - variable b. SPI influence - minimal 7. A person submits a substantial risk notice under Section 8(e) including VCM/PVC. a. Impact on industry - high TRACKING: b. SPI influence on subsequent EPA proceedings variable Direct Agency contacts Keller and Heckman Trade and associated press Speeches and announcements by EPA Public news media SPI Washington office Other trade associations Non-SPI companies Federal Register TRIGGERSi 1. EPA proposes rules which include VCM/PVC for: testing under 4(a), PMN or SNUR under 5(a), labeling under 6(a), or reporting under 8(a) or 8 (c) . 2. EPA requires health and safety studies under 8(d) . 3. A notice of substantial risk is received by EPA under 8(e). CONTINGENCY PLANS: General 1. Alert PVC Safety Group. 2. Evaluate proposal or petition, or assess new health data. GACC 00091 -4- 3. Coordinate with SPI Toxicology Committee. 4. Meet with Agency personnel. 5. Participate in administrative proceedings. 6. Seek favorable comments from OMB, other groups, and individual firms including non-SPI members. 7. Pursue court review if appropriate. For Specialized what Ifs: 1. If EPA proposes a test rule for VCM or PVC under 4(a), SPI should join forces with CMA's Subcom mittee on Testing for Improved Efficiency in formulating industry response. 2. If Agency proposes PMN's or SNUR's under 5(a), PVC Safety Group should identity SPI member companies which would be affected, and form appropriate task group to address issues raised by the proposed rule. 3. If EPA promulgates labeling rules under 6(a) which affect VCM/PVC, the appropriate SPI com mittee should share evaluations with established CMA committees that are currently tracking this activity. 4. If EPA requires volume and customer reporting under 8(a) the appropriate SPI committee should be divided, with part of the committee studying the regulations from the manufacturers point of view, and the remaining part of the committee studying the same proposed rule from a processors point of view. 5. If a notice of substantial risk is submitted under 8(e) that appears to affect other SPI members, an ad hoc committee should be formed to address the issues and industry actions re sulting from this submission. ACC 00092 -5- CONFIDENTIAL April 1, 1981 DRAFT EPA RESOURCE CONSERVATION AND RECOVERY ACT PLAN SPI-PVC SAFETY GROUP ALTERNATIVES COMMITTEE PURPOSE; PRESENT SITUATION: To identify responses to potential EPA regu latory activity under the Resource Conserva tion and Recovery Act (RCRA). 1. EPA promulgates and enforces regulations addressing chemical substances pursuant to five acts: Resource Conservation and Recovery Act (RCRA), Federal Water Pol lution Control Act, also known as the Clean Water Act (CWA), Clean Air Act (CAA), Toxic Substances Control Act (TSCA), and the Safe Drinking Water Act (SDWA). 2. RCRA regulations must not be inconsistent with requirements for substances imposed under the CWA or SDWA and their implement ing regulations. 3. EPA is intensifying regulation of toxic substances under all acts, and is focusing on chronic rather than acute toxicity. 4. In August 1979, EPA proposed to list waste PVC from the manufacture of coated fabrics and PVC sludge from the manufacture of polyvinyl chloride. SPI submitted exten sive comments on these listings. EPA has not reproposed these two listings or taken final action. 5. Present RCRA listings include: (1) heavy end from the distillation of vinyl chloride in VCM production (K020), and (2) VCM as a commercial chemical product or manufac turing chemical intermediate which would be a toxic hazardous waste if discarded or intended to be discarded in its pure or off-spec form; (3) VCM is also listed in Appendix VIII to Part 261 as a hazardous constituent. GACC 00093 WHAT IF: TRACKING: 6. Potential listings. The listing of VCM as a hazardous constituent in Appendix VIII means that additional listings of VCM-containing waste is probable. Generic listing of chlorinated hydrocarbon wastes have potential impact on the production of VCM, EDC, ethyl chloride and PVC. Potentially affected wastes include: reactor clean-up wastes, fractionation bottoms, distillation bottoms, spent cata lysts, batch residues, and solution resi dues . 7. If EPA follows past practice any new list ing will be in interim final form, effec tive in six months, but giving 60 days to comment before the listing is promul gated in final form. 8. Although not specified, the inclusion of VCM suggests that the basis will be the toxicity/carcinogencity of VCM. 9. Potential listing of chlorinated hydro carbon wastes could potentially drag a plant's entire waste water treatment system into the hazardous waste requirements. A formal rulemaking petition to delist one or all of these wastes would be re quired. Delisting would be difficult for VCM. 10. Disposal of PVC sludge on landfills pre sents both air and groundwater contamina tion concerns. 11. Recent animal studies suggest tumors for relatively low-level ingestion of VCM. 12. EPA developing national groundwater strategy. 13. The Reagan Administration is conducting a review of all RCRA regulations. EPA lists chlorinated hydrocarbon wastes as a hazardous waste. a. Impact on industry - very high b. SPI influence - medium Direct Agency contacts 2- - GACC 00094 Keller and Heckman Federal Register Other trade associations such as CMA, AIHC, Chamber of Commerce and Business Roundtable Trade and associated Press TRIGGERS; EPA lists a particular substance or class of substances related to VCM/PVC production as a hazardous waste. A RCRA "citizen petition" is filed with EPA for rulemaking of concern to the PVC industry. CONTINGENCY PLANS: 1. EPA lists VCM/PVC-related waste under Section 261.11(a)(3) (individual determination that a particular substance is hazardous waste). a. Alert PVC Group. b. Mobilize SPI membership to compile relevant data to contest listing. c. Utilize CMA comments on the May 1980 regula tions. d. Argue that more than simple presence of a substance in any quantity or form is required before a waste can be listed under Section 261.11(a)(3). e. Encourage helpful comments from other asso ciations and individual firms including non-SPI members. f. Participate in administrative proceedings. g. Consider petitioning for judicial review within 90 days from the date of the pro mulgation of the list. h. Consider petitioning EPA for amendment or repeal of the listing. 2. In the event EPA lists VCM/PVC-related wastes under authority of Section 261.11(d)(generic listings) we should follow the plan listed under GACC 00095 -3- No. 1 above. In addition, the right of EPA to generically list waste under Section 261.11(b) has been challenged in the pending RCRA litiga tion, and intervention or an amicus brief by SPI should be considered. 3. Response to a citizen petition to EPA for a rulemaking of concern to the PVC industry should be similar to that listed in 1 and 2 above. 4. Recent VCM animal studies suggest tumors at relatively low levels using ingestion as route of exposure. These studies are being reviewed by the PVC Health Committee. 5. SPI should review and consider commenting on EPA's emerging nationwide ground water strategy, which will have an important impact on disposal methods for VCM-containing wastes. -4- GACC 00096 CONFIDENTIAL April 1, 1981 DRAFT EPA SAFE DRINKING WATER ACT PLAN SPI-PVC SAFETY GROUP ALTERNATIVES COMMITTEE PURPOSE: PRESENT SITUATION: To identify possible responses to potential EPA regulatory activity under the Safe Drink ing Water Act (SDWA) that would effect VCM/PVC. 1. EPA promulgates and enforces regulations under five relevant acts: Clean Air Act (CAA), Clean Water Act (CWA), Toxic Sub stance Control Act (TSCA), Resource Con servation and Recovery Act (RCRA), and Safe Drinking Water Act (SDWA). 2. Under SDWA, EPA identifies contaminants which may have an adverse effect, and sets maximum contaminant levels for drink ing water. 3. In 1975, EPA and FDA signed a Memorandum of understanding that FDA would exercise jurisdiction over bottled drinking water under the SDWA. 4. In setting standards, EPA considers expo sure to contaminants in other media, in cluding piping. 5. Current regulations establishing maximum contaminant levels for chlorinated hydro carbons do not include VCM. 6. Ambient water quality criteria for vinyl chloride were published by EPA in October 1980. 7. Current information indicates that the quantity of VCM that migrates from PVC pipe into drinking water is well below the one in a million risk level identified in the EPA water quality criteria docu ment. GACC 00097 8. The Criteria and Standards Division of EPA's Office of Drinking Water is cur rently evaluating the need for a vinyl chloride standard under the SDWA. ACTION UNDERWAY: The National Sanitation Foundation (NSF) has established standards and test methods for PVC pipes. NSF is aware of EPA's current activity and is submitting documents and back ground information on VCM migration into drink ing water from PVC pipe. Keller and Heckman is coordinating the submission of information with NSF. WHAT IF: EPA proposes a maximum contaminant level for vinyl chloride in drinking water. TRACKING: Direct Agency contacts Keller and Heckman National Sanitation Foundation Other trade associations Federal Register Trade and associated press TRIGGERS: EPA staff recommends regulation of vinyl chloride under the SDWA. CONTINGENCY PLAN: EPA proposes regulation of vinyl chloride under the SDWA. a. Alert Group. b. Evaluate proposal; coordinate with SPI Plastics Pipe Institute and NSF. Compare proposal to known levels of VCM in PVC-piped water. c. PVC Group meets, discusses nature of comments to be presented to Agency. d. Meet with EPA personnel and submit comments. e. Seek favorable comments from OMB, other groups and individual firms including non-SPI members. GACC 00098 -2- f. If EPA adopts a regulation of VCM under the SDWA, consider judicial review. GACC 00099 -3- CONFIDENTIAL April 1, 1981 DRAFT CONSUMER PRODUCT SAFETY COMMISSION PLAN SPI-PVC SAFETY GROUP ALTERNATIVES COMMITTEE PURPOSE: SITUATION: To identify responses to potential Consumer Product Safety Commission (CPSC) regulation that may affect vinyl chloride or polyvinyl chloride. 1. CPSC is an independent regulatory commis sion with jurisdiction over consumer pro ducts. Its authority does not extend to motor vehicles, aircraft, boats, pesti cides, foods, drugs or cosmetics. 2. PVC is used in many consumer products. 3. Under CPSC regulations, PVC used in wear ing apparel is subject to a flammability standard under the Flammable Fabrics Act. 4. Self-pressurized products intended or suitable for household use may not con tain VCM as an ingredient or a propellant under CPSC regulations. 5. In 1979, CPSC announced a program to identify carcinogens in consumer products. The policy statement was subsequently withdrawn, and no further CPSC action is presently expected. 6. PVC is one of the plastics products in volved in a CPSC study that will focus on the flammability and combustion toxi city of plastics. The study might result in proposals to regulate certain uses of PVC. Regulatory action may entail the development of a flammability test method or standard in conjunction with the National Bureau of Standards (NBS). SPI has been in liaison with the CPSC through the SPI Coordinating Committee on Consumer Safety (SPI-CCCS), some of whose members represent the PVC industry. ACTIONS UNDERWAY: 1. SPI's Coordinating Committee on Consumer Safety maintains liaison with CPSC and NBS during flammability study. 2. PVC Group or outside Lawyer's Committee may collect and maintain flammability data in conjunction with pending fire litiga tion. WHAT IF: CPSC adopts a flammability test method or standard for PVC used in construction, elec trical insulation, furnishings and other con sumer products. a. Impact on industry - varies with test or standard b. SPI influence - medium to high TRACKING: Direct Agency contacts Keller and Heckman Other trade associations Federal Register Trade and associated press TRIGGERS: NBS proposes flammability test method. CPSC considers endorsement of flammability test method. CPSC considers establishment of a plastics flammability standard. CONTINGENCY PLAN: CPSC or staff proposes adoption of flammability test or standard. a. Alert Group. b. Evaluate proposal; draw on SPI-CCCS analysis and PVC litigation data. c. Coordinate with SPI-CCCS. d. Submit comments to CPSC, if appro priate. e. Seek favorable comments from OMB, other groups and individual firms including non-SPI members. GACC 00101 -2- f. Consider judicial review if regula tion is finalized. GACC 00102 -3- CONFIDENTIAL April 1, 1981 DRAFT OSHA PLAN SPI PVC SAFETY GROUP ALTERNATIVES COMMITTEE PURPOSE: PRESENT SITUATION: To identify possible responses to potential OSHA action that would effect VCM/PVC. 1. OSHA established the current workplace standard of 1 ppm 8-hour TWA (and 5 ppm 15-minute TWA) in October, 1974, on the basis that the standard was feasible, although possibly technology-forcing. 2. There is no current movement at OSHA to tighten the standard. OSHA did request information on VCM and PVC in December 1979. SPI filed voluminous comments. OSHA has taken no action stemming from this. 3. PVC respirable dust is regulated as any other dust. A British study suggests that excessive exposure may cause adverse ef fects on the lungs. 4. OSHA proposed labeling regulations for hazardous chemicals on January 16, 1981, but the proposal was withdrawn on February 12, 1981. 5. In December 1978, OSHA requested informa tion on ethylene dichloride (EDC) (1, 2dichloroethane). Since that time, EDC has appeared on OSHA's Candidate List for further review pursuant to the Generic Cancer Policy, 6. The OSHA Generic Cancer Policy is being reevaluated by the Reagan Administration. Meanwhile, review proceedings in the court of appeals have been stayed. GACC 00103 ACTION UNDERWAY: WHAT IF: TRACKING: 7. Regulation in other countries: 1977 British standard of 10 ppm 8-hour TWA; 1978 EEC alarm threshold of 15 ppm for mean values measured over a one hour period. 8. Post-1974 health data shows that the actual incidence rate for cancer in workers exposed to VCM is lower than projected rate. 9. Update of VCM Mortality Study by CMA will be underway in 1981. SPI, together with AIHC, is pursuing court review of the Generic Cancer Policy. 1. OSHA attempts to lower the vinyl chloride standard or apply the generic cancer policy to EDC or VCM through rulemaking. a. Impact on Industry - medium to high b. SPI Influence - medium to high 2. OSHA begins investigation or rulemaking regarding PVC respirable dust. a. Impact on Industry - varies with regulation b. SPI Influence - medium to high 3. OSHA reproposes labeling regulations. a. Impact on Industry - medium b. SPI Influence - medium 4. OSHA proposes additional regulations on PVC additives. a. Impact on Industry - varies with regulation b. SPI Influence - medium to high Direct agency contacts Keller & Heckman Daniel P. Boyd and Co. Federal Register -2- GACC 00104 Trade and associated press NIOSH Other associations - CMA, AIHC, Chamber of Commerce and Business Roundtable ACGIH OSHA priority lists under Generic Cancer Policy Contacts with non-SPI companies TRIGGERS: New health data produced OSHA requests information OSHA announces a proposed rulemaking OSHA amends Cancer Policy CONTINGENCY PLANSi General 1. Alert PVC Safety Group. 2. Assess health data. 3. Evaluate proposal. Assess economic and technological feasibility; prepare cost/ benefit analysis. 4. Lobbying activities as appropriate. 5. Meet with OSHA personnel. 6. Participate in administrative proceedings. 7. Seek favorable comments from OMB, other groups, and individual firms including non-SPI members. 8. Pursue court review if necessary. For Specified What Ifs; 1. a. Challenge revision to VCM standard by focusing on lack of need; support by worker health records. b. Use Maltoni data and latest information on angiosarcoma world-wide. GACC 00105 -3- Utilize Health and Lawyers Committees. Evaluate critically any health hazard allegation for PVC dust and recommend appropriate action. Verify dust exposure levels in all segments of the PVC industry. Evaluate possible dust exposure reductions. Recommend that producers advise customers. Evaluate acceptability of regulation. Coordinate with CMA on labeling proposal. Ensure protection of proprietary informa tion. Consider filing SPI comments. Enlist support of other groups, i.e., food, rubber, specialty products. Coordinate with CMA on application of Cancer Policy to EDC. Solicit more indi vidual companies to respond. Compare PVC additive regulation proposal with other standards such as lead. Build a library of information on substances such as heavy metals, phthalates, etc., to be prepared with the facts. -4GACC 00106 CONFIDENTIAL April 1, 1981 DRAFT EPA CLEAN WATER ACT PLAN SPI-PVC SAFETY GROUP ALTERNATIVES COMMITTEE PURPOSE: PRESENT SITUATION: To identify responses to potential EPA regu lation of vinyl chloride or PVC under the Clean Water Act (CWA). 1. Current effluent limitations for PVC waste water only address the pH level. 2. EPA is developing effluent guidelines under Sections 301, 304 and 307 of the CWA on an industry-by-industry basis. 3. In 1975, effluent guidelines for some plas tics manufacturing operations were pro posed, but they were withdrawn in March, 1981. The proposals included standards for TSS, BOD, COD and pH. 4. Ambient water quality criteria for vinyl chloride were published by EPA in October 1980. 5. Effluent guidelines for the chemical and plastics industries were scheduled for proposal in August 1981. However, the entire guidelines program is being criti cally evaluated by new Administration. 6. Effluent guidelines will specify best avail able technology (BAT), best conventional technology (BCT), new source performance standards (NSPS), and pre-treatment stan dards for publicly owned treatment works (POTW). 7. Ethylene dichloride (EDC) is listed as a hazardous substance under EPA rules imple menting the oil and hazardous substance spill provisions of CWA S 311. GACC 00107 WHAT IF: 1. EPA's effluent guideline document sets allowable VCM levels at unrealisticly low levels. 2. Water quality criteria issued in October 1980 are used to write water quality dis charge permits. 3. New scientific data on the health effects of vinyl chloride in ambient water is reported. TRACKING: Direct Agency contacts, including Effluent Guidelines Division Keller and Heckman Other trade associations, such as CMA and SOCMA Beveridge and Diamond Federal Register Trade and associated press Member companies having water quality criteria used in their permit negotiations TRIGGERS: EPA proposes effluent guidelines. Water quality criteria used to write permits. EPA requests information. New health data reported. CONTINGENCY PLAN: 1. EPA proposes effluent guidelines. a. Evaluate proposal b. Mobilize membership to compile rele vant data. c. Compare guidelines to actual effluent levels of vinyl chloride. d. SPI Group meets and prepares comments for the administrative proceedings. e. Meet with EPA personnel. f. Seek favorable comments fromOMB, other groups and individual firms including non-SPI members. GACC 00108 2- g. Consider ultimate judicial review plan. 2. Water quality criteria used to write dis charge permits. a. Advise Group b. Evaluate suggested discharge limit; assess economic and technological feasibility; prepare cost/benefit analysis. c. Compile relevant data through member ship and submit to permit writers. d. Consider preparing a "briefing" pack age in advance of the use of the water quality criteria in permit writing. e. Consider judicial review if permitting negotiations fail. 3. New scientific data on the health effects of vinyl chloride in ambient water reported. a. Advise Group b. Assessment of data by Health Committee. c. Group meets to consider Health Com mittee assessment and recommend course of action. GACC 00109 -3- .FT CONFIDENTIAL April 1, 1981 DRAFT FDA PLAN SPI-PVC SAFETY GROUP ALTERNATIVES COMMITTEE PURPOSE: To identify possible responses to potential FDA action that affects PVC Polymers. PRESENT SITUATION; 1. PVC polymer use presently permitted on basis of "prior sanctioned" status. 2. In 1973, based on information reported by Schenley Distillers that it was finding up to 25 ppm VCM in alcoholic beverages packed in PVC containers, BATF terminated experimental use of PVC packaging for distilled spirits. 3. In September, 1975, FDA proposed to remove the "prior sanctioned" status with respect to all rigid and semi-rigid food packaging applications, while reaffirming prior sanc tioned status for film, cap and can liner and medical applications. 4. Residual VCM content in PVC resins drama tically reduced since 1975. In February, 1979, Ethyl Corporation submitted data to support no migration of RVCM from a bottle resin with a test method sensitive to approximately 2 ppb. 5. In 1979, the United States Court of Appeals for the District of Columbia Circuit held that FDA must determine with a fair degree of confidence that a substance actually migrates into food in more than insigni ficant amounts before it becomes a food additive, and that FDA has latitude to find migration insignificant. FDA is now planning to issue a new "constituents policy" in light of this decision. 6. The uncertain status of FDA regulation of PVC food packaging has confused and bewildered food packagers. GACC 00110 7. FDA has announced intentions to: a. Withdraw the September 1975 Proposed Regulation. b. Propose a new regulation based on "constituents policy." c. Both events to occur in June 1981. d. Announcement made in Regulatory Re porter , Vol. XI, Issue II, Interagency Regulatory Liaison Group, December 1980. 8. On January 13, 1981, FDA responded to the BATF inquiry concerning the use of PVC to package distilled spirits. While the letter was apparently intended to maintain the status quo, the Agency did not find documentation indicating a prior sanction for PVC use in alcholic beverage packages. FDA stated its intention to issue a PVC regulation in the future, but indicated that none would be forthcoming prior to its reassessing its overall policies re garding indirect additives. FDA will not take administrative action against rigid and semi-rigid PVC food containers unless there is a compelling public health reason based on new information. 9. In addition to impact on food packaging, an FDA decision has the potential to affect cosmetic, toiletry and household chemical packaging based on consumer and product manufacturer reaction. FDA policy may influence other governmental agencies such as EPA and OSHA, and possibly regulation in other countries. 10. The constituents policy appears to be the preferred solution to the dilemma created by the Delaney Amendment and ever-improving analytical technology. ACTION UNDERWAY: 1. Continuing contact with FDA 2. Contact with Presidential Task Force on Regula tory Relief and OMB Director Stockman to obtain helpful reform of FDA constituents policy. 3. Participating with other leading industry law yers in drafting and pressing for passage of constructive amendments to FD&C Act. gacc oom -2- WHAT IF: TRACKING: TRIGGERS: 1. FDA finalized the 1975 proposal. a. Impact on Industry - very high b. SPI influence - high 2. FDA proposed to limit VCM extractable to non-detectable level. a. Impact on industry - varies with sensi tivity of authorized test method. Method sensitive to 5 ppb would have a positive influence on use. b. SPI influence - high 3. FDA proposes to regulate migratable VCM in food products to non-detectable levels by analytical method having sensitivity derived from dietary exposure calculations. a. Impact on industry - high/positive b. SPI influence - high 4. Legislation introduced that would modify Delaney Clause and/or remove packaging materials from preclearance as food addi tives. a. Impact on industry - high/positive b. SPI influence - high Contact with FDA officials. Federal Register Food Chemical News Keller & Heckman Trade and associated press New health data reported FDA requests information FDA issues constituents policy FDA finalizes 1975 proposal FDA proposes new regulations -3- GACC 00112 CONTINGENCY PLANS: 1. 2. General Alert Group, Evaluate proprosal; assess impact. 3. Coordinate with Food, Drug and Cosmetic Pack aging Materials Committee and other SPI groups. 4. Meet with FDA personnel. 5. Lobby if appropriate. For Specified What Ifs: 1. FDA acts on 1975 proposal. a. Inform FDA of the need to repropose the regulation given the passage of time. b. Update the record with new information on residual VCM levels. c. If FDA finalizes 1975 proposal assess legal options: stay, court review. d. Encourage participation by individual firms together with SPI. 2. FDA proposes to limit extractable VCM to nondetectable level. a. Determine sensitivity of official method of testing. b. Individual companies assess impact. c. Meet with Keller & Heckman to prepare comments. d. Encourage favorable comments from OMB, other groups and individual firms. 3. FDA proposes regulation based on risk assess ment and dietary exposure. a. Individual companies assess proposal. b. SPI Group meets with Keller & Heckman to prepare comments indicating proposed com pliance schedule if proposal is reasonable. GACC 00113 -4- 4. FDA issues constituents policy. a. Assessment by individual firms. b. SPI Group meets with Keller & Heckman to develop coordinated response and prepare comments if appropriate. c. SPI Group should establish subcommittee to prepare industry case assuming "most likely" regulatory proposal. d. If appropriate, encourage favorable com ments from OMB, other groups, and indi vidual firms including non-SPI members. e. Consider judicial review, and pursue if necessary. 5. New legislation introduced. a. Monitor legislation introduced. b. Organize industry support. GACC 00114 -5-