Document ym54Jj8rNEQpGXKkYB50L7qQX

join- c. *LL JiaOHC H HCCXMAN CNAdLt* M MCCHAN WILLIAM H 0"0IWI J MALCOLM 0. MATMU wayncv Slack mahtim W IIACOV'CI JQHM S CLPflCO CARQiC c. NARRift MCMACL 9 MOMONt jOhn a. euiccK trca wa cu2 CnMlSTlNC A. MCA&HCA ft. FLJIMOTO kAwncNce * halmim CDwarq L. HO*>*i* TtAAftNCfO UONCft AOMlTTCO IN VIROINlA ONL AOM'TTCD IN ACNNSruVANI MASK FOK CV(M9 RAlRN a. simwOnS C MUOLAI JAMCTT *CTCA A ftVS9CA SM Cl LA A. MILUAA AljftSCLL H fO g*N M WAHftTCO JLENC WIMOCL MBLlCA ftUftA* T CONTI SUSAN g SLUM AftH c. HArCI SamBRa g DCNNift ATfttCK J HU*Of C. *Oam LCrfNft S. CfftAlO TAUTrcST DAVIO H. gCTT** LAW OFFICES Keller and Heckman I ISO 17T* STREET. >J. W SUITE lOOO WASHINGTON, D.C. 20036 (202) 956-5000 December 16, 1986 SCIENTIFIC STAFF danicl s Dialer OUAWARD t DODOCM CHARLES V. 9RCDCR TELEX Aft ftftSSl TElECOAiE (ROft) 2ftft.?eft2 CAOLC ADORES* KCLMAN * WRITER'S Direct dial number (202) 956-5641 Ms. Meredith Scheck The Vinyl Institute c/o Charleston Marriott Hotel 4770 Marriott Drive North Charleston. SC 29418 (803) 747-1900 FEDERAL EXPRESS Res Counsel's Report to the Health, Safety and Environment Committee Dear Meredith: As I previously discussed with you and W.C. Holbrook, I will not be able to attend the December 18 meeting of the Vinyl Institute's Health, Safety and Environment Committee so that I may attend a different Vinyl Institute meeting and help draft comments for the Food and Drug Administration (FDA) arguing against the need for an environmental impact statement before FDA finalizes its proposed rule on the food contact uses of vinyl chloride polymers and copolymers. The attached Keller and Heckman report to the Vinyl Institute Executive Board provides additional information for the Committee on the subjects addressed below. A. EPA VCM Standard On September 30, 1986, the Environmental Protection Agency (EPA) published revisions to the vinyl chloride standard promulgated under Section 112 of the Clean Air Act. 51 Fed. Reg. 34,904 (Sept. 30, 1986). With the Committee's assistance, we filed a request for reconsideration and stay of the standard with EPA on November 25, 1986. I am enclosing copies of our WV 000004435 f f Ms. Meredith Scheck December 16, 1986 Page 2 Keller and Heckman final EPA submission in case the Committee members have not seen it previously. On November 26, we filed a petition for review with the United States Court of Appeals for the District of Columbia Circuit. We also filed a motion requesting that the court stay the EPA changes. The memorandum in support of our motion tracks the pleading we filed with EPA except that it does not discuss the relief valve discharge issue. Although I have dis cussed the stay and reconsideration issues with the EPA and Justice Department attorneys, as of today, we have not received a formal response indicating whether EPA is willing to recon sider the objectionable provisions. The Justice Department should file its response with the Court of Appeals to our request for a stay this week. We anticipate that the court will issue a decision on the stay in approximately two weeks. B. Withdrawal of 1977 Proposal In a precedent-setting decision on November 4, 1986, the United States Court of Appeals for the District of Columbia Circuit rejected the National Resource Defense Council's (NRDC) challenge to the vinyl chloride standard and affirmed EPA's withdrawal of the 1977 proposal to amend the standard by lower ing permissible emissions. Natural Resource Defense Council, Inc, v. U.S. Environmental PiTotection^Agency^ No. 85-1150 (D C. Cir. Nov* 4~, 1986). On December 15, NRDC filed a petition for rehearing and a suggestion for rehearing en banc by all the active members of the court rather than a~"5-judge panel. Con sistent with their prior arguments, NRDC maintains that: (1) the appellate court decision conflicts with prior decisions of the Supreme Court and the Court of Appeals, and (2) that the legislative history and statutory language unambiguously pre clude EPA from applying economic and technological feasibility considerations in setting emission standards under Section 112. Obviously, the Court of Appeals reached a contrary decision. Petitions for rehearing and rehearing en banc are rarely granted. Under court rules, we are not permitted to submit a response unless requested to do so by the court. Based on the court's opinion and its request that other Section 112 cases involving benzene and radionuclides be rebriefed in light of the decision in the vinyl chloride case, we consider VVV 000004436 f Ms. Meredith Scheck December 16, 1986 Page 3 Keller and Heckman it unlikely that the Court of Appeals will grant NRDC's peti tion. After the petition for rehearing is denied, we antici pate that NRDC will seek Supreme Court review of the appellate decision. A copy of NRDC's pleading is enclosed. C. Leak Detection and Elimination Based on conversations with several members, the Committee may wish to discuss the leak detection and elimina tion provisions of the revised standard. A number of questions have arisen concerning how many valves should be counted. More specifically, the 200 or 90% valve count requirement applies to each "process unit" as defined in 40 C.F.R. 261.241. That definition states: 'Process unit1 means equipment assembled to produce a VHAP or its derivatives as inter mediates or final products, or equipment assembled to use a VHAP in the production of a product. A process unit can operate independently if supplied with sufficient feed or raw materials and sufficient product storage facilities. Although unclear at this time, it appears that EPA Region VI may contend that separate lines with a VCM or PVC plant, storage facilities, and loading lines are separate "process units" each requiring a 200 valve count. Region VI claims this interpretation is based on a draft guidance docu ment. We are trying to track this down. In any event, a preliminary review did not disclose any clarifying discussion in the preamble to the Subpart V rules? nor are we aware of any helpful discussion during the benzene rulemaking. From the language of the definition, it is clear that storage facilities connected with VCM or PVC production would be part of a single process unit. An anomaly has been brought to our attention concerning the uncertain position of a company that has precisely 2% of its valves leaking, for example, four valves of 200 tested. Therefore, we are recommending that some odd number of valves in excess of 200 be tested, such as 201 or 205, so that a result of exactly 2% can be avoided. VVV 000004437 f Ms. Meredith Scheck December 16, 1986 Page 4 Keller and Heckman D. OSHA PVC Labeling A discussion of the PVC labeling dispute and our October 23 meeting with the Occupational Safety and Health Administration (OSHA) can be found on pages 4 and 5 of our report to the Vinyl Institute Executive Board. OSHA has not taken a final position at this time. However, we have been requested to supply copies of any citations on this matter so that these cases can be held in abeyance pending resolution and so that everyone will be treated the same. If any of the Committee members are aware of citations, we would appreciate receiving copies of them so that we can forward them to OSHA. If companies or their customers would prefer to submit them to OSHA directly, we would be happy to provide the appropriate name and address at OSHA and would simply like to be aware of what is being submitted. E. FDA PVC Proposal A report on the environmental issues concerning the Food and Drug Administration's PVC proposal appears on pages 1 and 2 of our report to the Vinyl Institute. We are meeting with other Vinyl Institute members on December 18 to prepare, as promptly as possible, a submission on the critical environ mental issues. We intend to develop a document in support of a decision by FDA policy-making officials that no environmental impact statement is needed. The key points that we plan to cover are the small incremental increase in PVC usage that the FDA decision would make, the scientific literature demon strating that the amount of PVC in municipal solid waste is not a dispositive factor in the generation of dioxin and furans from incinerators, and that FDA approval will not have an adverse affect on recycling and solid waste streams. As for the less critical issues, if information is readily available, we will certainly include this with our submission to the Agency. FDA has requested that we provide the submission as soon as possible and we hope to do so within the next few weeks. A cover letter and outline of issues is enclosed. 0000443a Ms. Meredith Scheck December 16, 1986 Page 5 Keller and Heckman F. EPA OCPSF Effluent Guidelines On December 8, 1986, EPA published a request for comments on particular features of its proposed effluent guide lines for the organic chemicals, plastics and synthetic fibers (OCPSF) point source category. EPA was to have published final guidelines this month in accordance with a court order. But, the Agency has requested an extension of time until August 1987 for promulgation of a final rule. The court has not yet ruled on EPA's reques t. ** * I very much regret that I will be unable to attend the Committee meeting, but trust you will understand. Since I will be at another meeting in our offices on Thursday, please feel free to call me if you have any questions or if I can be of any assistance. Incidentally, if any of the Committee members are planning to stay in Charleston, I would recommend touring several of the houses in the historic district south of Broadway. In addition, a tour of one of the plantations, such as Drayton Hall, is also fun. Cordially yours, Peter L. de la Cruz Enclosures cc: Robert D. Luss, Esq. Roy T. Gottesman, Ph.D. Charles E. O'Connell Lewis R. Freeman, Jr. Margaret Rogers Hugh Patrick Toner (w/encs.) " " " " VVV 000004-439 TAB H KELLER AND HECKMAN REPORT TO THE VINYL INSTITUTE November 20,1986 vvv 000004440 F table of contents Page A. FOOD AND DRUG ADMINISTRATION.............................................. I 1. Environmental Issues Concerning FDA's PVC Proposal Resurrected ................. ........................................ 1 B. ENVIRONMENTAL PROTECTION AGENCY.................................... 2 1. Court Rules Favorably in Vinyl Chloride Standard Case................................................................. 2 2. VI To Challenge EPA Revisions to Vinyl Chloride Standard ..................................................... 3 3. EPA Hazardous Waste Proposal Draws Comments........................................................................... 3 4. Land Ban Disposal Rule Issued...................................................... 4 C. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION........ 4 1. PVC Labeling Dispute Leads to Meeting With OSHA...................................................................................... 4 2. Court Upholds Federal Law Over Right-to~Know Law in Akron, Ohio, But Not in Pennsylvania.......................................................... 5 D. FLAMMABILITY AND COMBUSTIBILITY ISSUES............................. 6 1. New York Council Adopts a Proposal Requiring Filing of Combustion Toxicity Data ..................................... 6 E. MISCELLANEOUS .............................................................................. 6 1. Hearings Held on Proposed Sacramento Pipe Ban.............................. 6 VVV 000004441 J KELLER AND HECKMAN REPORT To The VINYL INSTITUTE November 20, 1986 This report summarizes Keller and Heckman activities since the prepa ration of our last report for the August 1986 Executive Board meeting. Of particular interest are the Environmental Protection Agency's (EPA) amend ments to the vinyl chloride standard and our victory in litigation brought by the Natural Resources Defense Council (NRDC) challenging EPA's withdrawal of the 1977 proposed amendments to the vinyl chloride standard. Additionally, the Food and Drug Administration (FDA) is raising environmental concerns on disposal of vinyl chloride polymer and copolymer food packaging materials in the context of the PVC rulemaking. In a related area, our efforts to clarify the Occupational Safety and Health Administration's (OSHA) labeling requirements for vinyl chloride polymers under the hazard communication standard led to a meeting with OSHA in October; we are awaiting the Agency's responses. Matters we have pursued specifically for the Vinyl Institute as well as SPIrelated actions are discussed below. A. FOOD AND DRUG ADMINISTRATION 1. Environmental Issues Concerning FDA's PVC Proposal Resurrected State solid waste officials advised us that FDA has been requesting information on the anticipated environmental impact of the Agency's February proposal confirming the safety of vinyl chloride polymers and copolymers for food contact applications. 51 Fed. Reg. 4,173 (Feb. 3, 1986)*!!/ This prompted us to contact Dr. Buzz L. Hoffman, Chief, Environmental Impact Section, in FDA's Center for Food Safety and Applied Nutrition. Mr. Hoffman indicated that FDA was evaluating the comments, particularly the Environmental Protection Agency's (EPA) letter suggesting that FDA needed to study the environmental impact issue further, and that FDA's Finding of No Significant Impact (FONS1) needed further support. When asked how we might assist in this evaluation process, Mr. Hoffman suggested that any new or different information available to industry would be helpful. / Although the comment period in the Docket formally closed in June, 1986, we recently became aware that five comments were filed in late September and early October relating solely to the environmental impact issue. The five com mentors are: the Pennsylvania Department of Environmental Resources; the Environmental Defense Fund; the Environmental Action Coalition; Udell's Cove Preservation Committee, Inc.; and Konheim and Ketcham, an environmental consulting firm. vw 000004442 r 2- - While preparing a draft set of supplemental comments, we became aware of a growing sentiment within FDA that the environmental impact associated with clearance of PVC would not be non-significant. We responded promptly by immediately filing comments that we hope will put the environ mental impact issue in a better perspective and stem the tide that seemed to be building in favor of a full-blown Environmental Impact Statement (EIS). Briefly, these stop-gap comments observe that FDA improperly evaluated the magnitude of the impact because the Agency compared a projected food contact market for PVC in 1988 against the total market for all PVC in 1983. When 1983 data and 1988 projections are compared against appropriate reference data, the impact of FDA clearance is much less significant than FDA assumed. We plan to discuss the environmental impact issues with policy-making officials in FDA and file any supplemental comments that will help support a decision against conducting an EIS. Besides the environmental issue our draft includes suggested regulatory language concerning the basis for calculating residual vinyl chloride monomer levels. In our original comments, we were concerned with proposed language that would require determination of residual vinyl chloride monomer (RVCM) levels according to the percentage of the vinyl chloride polymer component of the food contact article. We argued vigorously that the RVCM level should be determined as a percentage of the entice food contact article rather than as a percent of the vinyl chloride component alone. Based on our assessment of the situation, we now consider it necessary to follow FDA's lead and base the vinyl chloride monomer limitation on the weight of the part of the package (e.g. a layer) that is made from vinyl chloride polymer. However, we are attempting to make clear what we believe to be FDA's intent, that is that the basis for calculating should not be the weight of the vinyl chloride resin contained in such a part but, rather, the weight of the entire part. When the RVCM test cannot be feasibly applied, an extraction test sensitive to 1 part per billion (ppb) is being suggested. We have requested member company comments on our draft langugage. B. ENVIRONMENTAL PROTECTION AGENCY 1. Court Rules Favorably in Vinyl Chloride Standard Case The Court of Appeals of the District of Columbia Circuit rejected the Natural Resources Defense Council's (NRDC) challenge to the vinyl chloride Clean Air Act standard and affirmed the Environmental Protection Agency's (EPA) withdrawal of a 1977 proposal to amend the standard by lowering permissible emissions. Natural Resources Defense Council, Inc, v. U.S. Environ mental Protection Agency, No. 85-1150 (D.C. Cir. Nov. 4. 1986). Besides this immediate and positive result, the decision is a landmark victory in the VVV 000004443 r -3- interpretation of Section 112 of the Clean Air Act which provides for the regulation of hazardous air pollutants. Specifically, the court held that EPA has discretion to consider economic and technological feasibility in regulating pollutants under Section 112. NRDC had argued that Section 112 does not permit EPA to consider any factor other than health effects in setting regulatory levels. 2. VI To Challenge EPA Revisions to Vinyl Chloride Standard The Vinyl Institute plans to challenge revisions to the vinyl chloride standard promulgated by EPA on September 30, 1986. 51 Fed. Reg. 34,904 (Sept, 30, 1986). The Vinyl Institute will file a petition for review with the United States Court of Appeals for the District of Columbia Circuit and seek a stay. The offensive provisions include several definitional changes which expand the scope of the standard, impose double or treble penalties for emissions from a single event and create new requirements. EPA also failed to implement the numerical relief valve discharge provision it had proposed in 1985. We also plan to request that EPA stay the revisions and reconsider its determinations before filing with the Court of Appeals in late November. We are coordinating our efforts with the Legal Committee and the Health, Safety and Environment Committee. 3. EPA Hazardous Waste Proposal Draws Comments Working with both the Vinyl Institute and the SPI Phenolic Molders Division, in August, we submitted comments in response to an EPA proposal to amend the manner in which certain wastes are characterized as hazardous. Under the Resource Conservation and Recovery Act (RCRA), waste is hazardous if it is specifically listed or if it exhibits one of four characteristics. The characteristics are ignitability, corrosivity, reactivity and toxicity. Toxicity had been defined as the detection of certain amounts of heavy metals or pesticides when the waste is subjected to an extraction procedure (EP) toxicity test. In June 1986, EPA proposed to substitute a new toxicity characteristic leaching procedure (TCLP) for the EP toxicity test and to expand the number of substances whose presence in the extraction solvent would cause the waste to be deemed hazardous. The comments that were submitted to EPA in August, 1986 addressed the toxicity leaching characteristic procedure itself. That was issued in final form on November 7, 1986. 51 Fed. Reg. 40,572. Additional comments were filed on EPA's other proposals relating to the proposed listing of other substances such as vinyl chloride and the assumptions on which wastes are characterized as hazardous due to toxicity. Among other things, these comments indicated that VVV 000004444 the proposed rules lack a firm basis in statutory or scientific authority. The comments were submitted on September 26, 1986 and an addendum providing more technical data was submitted on October 20, 1986. EPA is currently evaluating comments submitted on the proposal. A final rule is not expected until the Fall of 1987. 4. Land Ban Disposal Rule Issued On November 7, 1986, the EPA published a final rule implementing congressionally mandated prohibitions on land disposal of certain hazardous waste. 51 Fed. Reg. 40,572. In its notice, EPA established, among other things, procedures for setting treatment standards for hazardous wastes, for granting nationwide variances from statutory effective dates as well as evaluating petitions for a variance from the treatment standard. Specifically, EPA has promulgated treatment standards and effective dates for hazardous wastes included in the first phase of land disposal prohibi tions under the Resource Conservation and Recovery Act (RCRA). These include certain dioxin and solvent-containing hazardous wastes. This is the same document in which EPA published the Toxicity Characteristic Leaching Pro cedures (TCLP) for use in determining whether these wastes meet applicable treatment standards. The rule became effective on November 3th. C. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION 1. PVC Labeling Dispute Leads to Meeting With OSHA As part of its implementation of the Hazard Communication Standard, OSHA has been conducting compliance inspections and reviewing product label ing and material safety data sheets (MSDS). As a result of these inspections, some polyvinyl chloride (PVC) producers and compounders have received cita tions for failure to label PVC resin or compound as a carcinogen under OSHA's vinyl chloride and hazard communication standards or for failure to indicate PVC's carcinogenicity in MSDSs. We have been attempting to obtain a letter from OSHA confirming that: (1) PVC itself is not a hazardous chemical under the hazard communication standard and (2) vinyl chloride homopolymer and copolymer resins and compounds do not trigger the labeling and training provisions of the OSHA vinyl chlroide standard when no exposure to vinyl chloride monomer at or above the action level of 0.5 ppm is anticipated. In a meeting on October 23rd with Frank A. White, Deputy Assistant Secretary for Occupational Health, and other OSHA staff members,we again 0OOOOA445 VVV -5- presented our views on this issue. At the meeting, staff member Dave Smith suggested that we forward to him copies of any recent citations issued by OSHA inspectors relating to this matter for his coordinated handling. We agreed to provide the Agency with the information and are requesting that any pertinent OSHA citations be forwarded to us. We are awaiting the Agency's response on our request. *** In October, we met with the National Paint and Coatings Association (NPCA) to discuss OSHA's May directive requiring "target organ effect labeling" for hazardous materials. Apparently, in the May directive OSHA has elected to view labeling requirements under the HCS as the primary, if not the sole source of hazard information. In so doing, the Agency has moved significantly from a performance-oriented standard that incorporates all aspects of the hazard communication program to a comprehensive labeling standard. NPCA subse quently met with OSHA. The Agency was sufficiently receptive to NPCA's concerns so that the association has decided to work with OSHA to try to reach agreement. 2. Court Upholds Federal Law Over Right-To-Know Law in Akron, Ohio, But Not in Pennsylvania The extent to which the Hazard Communication Standard, 29 C.F.R. S 1910.1200 (HCS or the Standard), promulgated by the Occupational Safety and Health Administration (OSHA), preempts, inconsistent state "right-to-know" laws has previously been the subject of several court rulings. Earlier this year, however, those segments of industry which produce and utilize hazardous chemicals were startled by a federal court ruling which held that local "right-toknow" laws are not displaced by the Federal Standard. Due to the serious con sequences of this ruling, which involved the City of Akron's right-to-know law, SPI joined other industry groups in filing a brief in the appeal of that decision. As the result of these efforts, the lower court decision has been reversed. In a ruling issued on September 17, 1986, Ohio Manufacturers Association v. City of Akron, No. 86-3191 (6th Cir. 1986), the U.S. Court of Appeals for the Sixth Circuit reversed the decision of U.S. District Judge Ann Aldrich, and held that the Akron ordinance is preempted to the extent that it attempts to regulate employee safety in the manufacturing sector. Nevertheless, a judicial decision on this issue in Pennsylvania threatens to make right-to-know compliance substantially more difficult for chemical manufacturers and suppliers doing business in that state. On December 12, 1985, the U.S. District Court for the Middle District of Pennsylvania held that VVV 0000(K446 f -6- PennsylvaniaTs Worker and Community Right-to-Know Act (Act), 35 P.S. S 7301.1, et sea, is preempted by federal law to the extent that it requires employers in the manufacturing sector to identify and disclose information concerning workplace hazards. Manufacturers* Association of Tri-County, et. al. v. Knepper. 623 F. Supp. 1066 (M.D. Pa. 1985). The court ruled that the Act, however, is not preempted as it applies to employers in the non-manufacturing sector, or to the disclosing of information regarding environmental hazards, except for labeling requirements in the manufacturing sector. This decision was then appealed and partially reversed in a recent ruling. Manufacturers Associa tion of Tri-County v. Knepper, Nos. 86-5032, 86-5066 (3d Cir. 1986). But, the U.S. Court of Appeals for the Third Circuit held that significant portions of the Pennsylvania right-to-know law -- which features burdensome "universal label ing" provisions -- are not preempted by OSHA's Hazard Communication Standard. D. FLAMMABILITY AND COMBUSTIBILITY ISSUES 1* New York Council Adopts a Proposal Requiring Filing of Combustion Toxicity Data On October 23, 1986, in Albany, New York, the New York State Uniform Fire Prevention and Building Code Council (Council) voted affirmatively on the toxicity data filing proposal which has been the subject of much heated controversy. The newly adopted regulation includes a disclaimer provision, language allowing representative testing and the deletion of the "no more toxic than wood" provision in the current code. The regulations are now being sent to the Secretary of State whose approval is expected in late November. We have been working with the VI in evaluating the potential of a judicial challenge and the substitution of a less offensive testing requirement. E. MISCELLANEOUS 1. Hearings Held on Proposed Sacramento Pipe Ban On November 17, 1986, the Toxic Substances Commission of the Sacramento City Council initiated a hearing on a proposed amendment to the City Building Code to ban plastic pipe for installation in potable water distribution systems; drain, waste and vent systems; building sewers; and plastic conduit in electrical installations in buildings. Councilman Joe Serna introduced the proposal on behalf of the plumbers' and firefighters' unions. The Ad Hoc Pipe Resin Producers Committee coordinated witnesses who testified on behalf of industry. Topics that were covered include leaching, permeation, worker health Wv ^000044^7 ! -7and fire issues. Additional hearings are scheduled for December 1, 1986, at which builders, realtors and others opposed to the proposed ban are expected to testify. SPI submitted comments on September 19, 1986 and reply comments on October 13, 1986 in this proceeding. In our reply comments, we indicated that the unions have presented biased versions of scientific studies on the safety of plastic pipe. Further, the evidence they submitted does not justify the ban, including data on projected job dislocations stemming from the introduction of this new and innovative product. VW 00000444 s f