Document 6wvd4VOMD0yEXgjzX4bQoB0ao

jcvomc m. **ceMAtt CnAMlCB M m(|MN WM.UAM M. IOM(l*NI. J MAUCOLM o. m*CATHU> WA^Nf v ilack maMTin <m C*COviC> JOHN f. CUOMCO CANOcC C. HAM'S miCMACL * MO*AOMC JOHN . OUBCCH rrca l. i.a cux CHflltTlNC A. mCAOMCA IhiALCT t. <OjihO^O LAWMCMCC M mALMMIN maAm roi tv CM t IULM A SIMMOMS c. OOUOLAS jaaCTT "CTC* A SUIICB SHC1LA A. M'LLAM USICLL M. fox iLCNt VIMOCU HCLLCA 1UAM T CMT' SUSAN J BLUM MAMA C. NAYtS JANOMAJ M OCMNIS C. AOAM LC^CNS S. CMAlO TAuYrcST LAW OFFICES Kell er and Heckman 50 IT** STREET. N . W. SUITE lOOO 5HINGTON, D.C. 20000 (202) 50-5600 June 18, 1986 SCHNTIF1C STAFF OANUL S. OlXLtft OUBWAMO F. OOOOCM CHAMLCS V. 8MCOCM TCLCX A* BSSSI TtUCOFtCB (SOS) CASLC AOOMCSS -KCLMAN- wmreirs oimcct oal numbc* (202) 956-5641 John B. Miles, Jr., Direc tor Directorate of Field Oper at ions Occupational Safety and Ei ealth Administration U.S. Department of Labor 200 Constitution Avenue, |N.W. Washington, D.C. 20210 Re: OSHA Regulat ion of Vinyl Chloride Polymers and Copolymers Dear Mr. Miles: Thank you for you): letter of April 30, 1986 to Peter Susser of our firm regard Lng the regulatory status of polyvinyl chloride (PVC) under the Hazard Communication Standard (HCS), 29 C.F.R. 1910.1200, and OSHA1s vinyl chloride standard, 29 C.F.R. 1910.1017. Following receipt of your letter, we met with Mr. Gail M. Brinkerhoff in the Office of Health Standards on May 20, 1986. He resolved our question concerning the Registry of Toxic Effects of Chemical Substances (RTECS) and helped us to better frame the remaining issues. As explained belovp and based on OSHA's current compliance instructions a id prior letters and litigating position, we request an opini q>n letter confirming that: (1) PVC itself is not a hazardous chemical under the Hazard Communication Standard, and (2) viri yl chloride homopolymer and copolymer resins and compounds do n cbt trigger the labeling and training provisions of the vinyl chloride standard when no exposure to vinyl chloride monomer (VC M) at or above the action level is anticipat ed. SP1-01422 John B. Miles, Jr., Director June 18, 1986 Page 2 Keller and Heckman While such an opinion letter is plainly consistent with Agency policy, the advent of the HCS has created a real need for the clear articulatic n of OSHA's current position. We would like the opportunit y to meet with you and your staff after you have had an opp ortunity to consider these materials. We have also taken the liberty of attaching a draft opinion letter of the type we are seeking from your office. We have found the preparation of such draft letters to be helpful in focusing discussion and clearly articulating our request. We will contact your office shortly to schedule a meeting. A. Current Status of PVZ Polyvinyl chlorid (Chemical Abstract Services Registry No. 9002-86-2) is the sec and most widely used plastic resin in the United States. It is produced from vinyl chloride monomer (CAS No. 75-01-4) by a prp cess called polymerization. Vinyl chloride polymers and copi slymers are fabricated into a wide variety of consumer and i idustrial products including pipe and conduit, floor tile, curt ins, shoes, food packaging, records, medical devices, blood tr insfusion bags and a myriad of other items. While there is con cern about possible adverse health effects relating to VCM e:c posure, PVC itself is quite inert from a toxicity standpoint For example. Environmental Protection Agency (EPA) r Agulations under a variety of statutes minimize the release of VC M into the environment, while PVC itself is not deemed hazaf dous and is not regulated per se. See, e.g., 40 C.F.R. 60 61 (VCM regulated as hazardous air pollut ant). The food contact Applications for vinyl chloride polymers and copolymers ar e extensive. While PVC is "priorsanctioned" for current fo od contact uses, earlier this year the Food and Drug Administ ration (FDA) published a long-awaited proposal rea ffirming the Safety of PVC for all food contact applications . 51 Fed. Rec 4,173-4,188 (Feb. 3, 1986) (copy enclosed) . The key speci ication in the proposal is a limitation on the amount of res dual vinyl chloride monomer (RVCM) permitted in various viny chloride polymers. In the preamble t the proposal, FDA reported on "vastly improved producti c n technology that has made it possible for manufacturer to succeed in reducing the level of residual vinyl chloride me nomer in vinyl chloride polymer by a SPI-01423 John B. Miles, Jr., Direqtor June 18, 1986 Page 3 Keller and Heckman factor of nearly of 1 mil ion." 51 Fed. Reg. at 4173. As the Agency noted, before 1975 residual VCM levels of 1,000 parts per million (ppm) were com mon. Since then, improved manufacturing procedures have lowered the RVCM level by more than five orders of magnitude, Id. at 4,178. A review of the FDA proposal indicates that t i e Agency had no toxicological concerns with PVC polymer it elf. FDA conduct ed a r isk assessment in light of probable exposure to any unwanted inyl chloride monomer constituent, The Agency concluded that "there is a reasonable certainty of no harm from the exposure to vinyl chloride monomer that may result from the use of vi yl chloride polymers in food packag- ing complying with the vi ;iyl chloride monomer limitations set forth in" the proposal. [d. at 4,183. As pertinent here, the FDA proposal constitutes formal finding that PVC is safe for the intimate personal use involved in food contact applica- tions. We also note that PVC is cleared for use in a wide variety of drug and devi Ci applications also subject to FDA's jurisdiction. For exampl PVC may be used to package pharma- ceutical products and is bleared for use in medical devices such as blood bags, in di lysis machine tubing, and in other critical uses. B. Status of PVC as a H<i zardous Chemical Under Hazard Communic:at ion Standard Our review of EPA and FDA regulation as well as the discussion below on OSHA egulation, indicates a uniform position that, apart from the question of RVCM levels, PVC does not present any health concerr s. We recognize that OSHA has a legitimate interest in mi imizing worker exposure to vinyl chloride monomer. Howevei , it would be very helpful if OSHA provided a clear statement that PVC itself is not a hazardous chemical under the HCS. Tfhe question of RVCM and its effect on PVC's status is discussed below. As for PVC itself, however, we do not believe that th re is any basis for characterizing it as a hazardous chemical as that term is defined under the HCS. As discussed more fully in our letter of February 26, 1986 to you (copy enclosed ), PVC is not listed as a carcinogen or possible potential care inogen by the National Toxicology Program (NTP). Similarly PVC itself is not regulated as a carcinogen by OSHA. No mounograph by the International Agency SPI-01424 John B. Miles, Jr June 18, 1986 Page 4 Direct or Keller and Heckman for Research on Cancer ( ARC) concludes that PVC is a carcinogen or potential (farcinogen. IARC's summary classification of the carcinogenic risk of chemicals does not include PVC under Category 1 or 2. Thus, consistent with OSHA Instruction CPL 2-2.38A (May 16, 198$ ), PVC is not considered a carcinogen under the HCS. Your letter of April 30, 1986 correctly stated that characterizations of IARC studies reported in the Registry of Toxic Effects of Chemical Substances (RTECS) published by the National Institute for Occupational Safety and Health (NIOSH) are the interpretation by the contractor used by NIOSH. Mr. Brinkerhoff further confirmed that interpretations con tained in the NIOSH Registry (RTECS) are not necessarily bind ing. Rather, manufacturers assessing the carcinogenic status of substances should consult the studies themselves to reach a definitive conclusion. In this instance, it is quite clear that the NIOSH contractor erred in characterizing the IARC studies on PVC. Because of the confusion that may be generated by the contractor's interpretation, a letter from your office indicating that PVC itsel f is not hazardous would help resolve any lingering confusion on this issue. C. Status of PVC Resin and Compound Under the OSHA Vinyl Chlori de Standard Beginning in Janup ry 1974, OSHA worked quickly to publish a final vinyl chlori 3e standard on October 4, 1974. The standard sets a permissibL e exposure limit (PEL) of 1 part per million (ppm) averaged ov r any 8-hour period and an action level of 0.5 ppm averaged over an 8-hour work day. Other pro visions establish monitor ng, medical surveillance, sign and label, and reporting requ rement s. The standard appl es to the "manufacture, reaction, packaging, repackaging, s': orage, handling or use of vinyl chloride or polyvinyl chlo ride, but does not apply to the handling or use of fabric ated products made of polyvinyl chloride." 29 C.F.R. 1 ?10.1017(a)(2). Because "fabricated products" are exempt, the r definition has been of particular significance to the regul ted community. Under Section 191$ .1017(b)(6), a fabricated product is defined as "a product mad wholly or partly from polyvinyl SPI-01425 Keller and Heckman John B. Miles, June 18, 1986 Page 5 Jr. , Direct or chloride, and which does not require further processing at temperatures, and for ti es, sufficient to cause mass melting of the polyvinyl chlorid resulting in the release of vinyl chloride." Slightly rest ated, PVC is a fabricated product not subject to the standard i.nless it is mass melted and that melting results in the releas e of vinyl chloride. Although the con gept of mass melting is easily understood, at the time the st andard was issued it was unclear what the phrase "resulting in the release of vinyl chloride" meant, In the attached 1975 opir ion letters, OSHA stated that "release of vinyl chloride" means the release of an amount of vinyl chloride which would be 1 ikely to result in employee exposure at or above the action 1<= vel without regard to the use of engineering controls. IT us, low residual monomer resins which would not release vinyl c hloride in excess of the action level during further processing such as mass melting, are fabricated products not subject to t he Act . As FDA noted in l ts February 1986 proposal, residual vinyl chloride levels hav e been reduced from the 1,000 ppm level found in 1975 by or ders of magnitude. Thus, when manufacturers of PVC resin an d compound can conclude that exposure at or above the action le vel is not likely, the training, labeling, and similar prc visions of the standard are not applicable. The continuing va lidity of the 1975 opinion letters was confirmed in a letter fro m the Secretary of Labor filed with the Occupational Safety a nd Health Review Commission (OSHRC). In Secretary of Labor v. Hooker Chemical Company, (OSHRC Docket No. 78-4862) (decision en closed), an OSHA inspector issued a citation to Hooker Chemic al Company for allegedly failing to provide training under th e vinyl chloride standard for employees who worked in t he calendering, compounding and warehouse areas of a Hooker f acility. Hooker contested the citation on the basis that en ployees working in these areas were not subject to OSHA's vin yl chloride standard because they were not exposed to vinyl chlo ride monomer above the action level, Both Hooker and OSHA's mo nitoring for vinyl chloride in the calendering and compoundi ng facilities indicated concentrations below the 0.5 ppm action level. In May 1979, Judg e Charles K. Chaplin issued a decision that adopted Hooker's pos it ion and vacated the OSHA citation. SPI-01426 John B. Miles, Jr., Director June 13, 1986 Page 6 Keller and Heckman He held that the training provisions of the standard do not apply to areas where the vinyl chloride level in the ambient air is below the action evel. Although not requested to do so by any party, a Commissi <|>ner on the Occupational Safety and Health Review Commission directed that the case be reviewed, In responding to the rev ew proceedings, OSHA changed its position and filed the lette stating that the Judge's decision should be affirmed. Sigr(i ificantly, the Secretary of Labor's letter stated that: "Tr ining requirements are not applicable in this case because res jJ>ondent ' s cited compounding and calendering operations s: mply are not processes which could result in hazardous expo ^ure to vinyl chloride by the nature of the operations themselve ." Because OSHA indicated that it did not wish to pursue the a. se, the Review Commission left the Judge's decision intact. The training pro visions of the vinyl chloride standard provide that "each employ ee engaged in vinyl chloride or polyvinyl chloride operations shall be provided training in a program relating to the 1 azards of vinyl chloride and precautions for its safe us ." Section 1910.1017(j). Literally interpreted, any "polyvir yl chloride operation" would require training. However, OSHA s consistent position has been that when exposure is below tl e action level, the standard is largely inapplicable. A similar conclu ion pertains to labeling. For example, PVC is literally required to be labeled with an indication that it conta ins vinyl chloride,, a cancer-suspect agent. However, where e jposure to vinyl chloride will not reach or exceed the actic n level, labeling is not required. We would appreci alt e your confirmation that low RVCM resins which are not exp qcted to result in exposure above the action level are not sub: ect to the training and labeling requirements of the stand ard because such materials would not result in hazardous expo ure to vinyl chloride. Again, this is simply a confirmation of the Secretary of Labor's letter and the Hooker case. D. Conclusion Based on your let ter of April 30, if the mass melting of PVC resin and compound will result in employee exposure at SPI-01427 Keller and Heckman John 3. Miles, Jr., Director June 13, 1986 Page 7 or above the action leve[L of 0.5 ppm, the labeling requirements of both the vinyl c'nlori e standard and the Hazard Communication Standard apply. A1 ernatively, if PVC resin or compound will not result in expos jre to vinyl chloride monomer at or above the action level, he labeling and training requirements of the vinyl chloride st indard do not apply and the provisions of the Hazard Communicat Lon Standard do not apply because there would be no hazardous ex oosure. For purposes of expository clarity, our discussion has focused on PVC. However the same reasoning is also applicable to vinyl chloride copolyi|i ers, such as vinyl chloride-vinyl acetate. If the RVCM le yel is sufficiently low the labeling and training requirement of the vinyl chloride standard are not applicable. Similar:, y, the HCS would not apply due to the presence of VCM in the c dpolymer. Naturally manufacturers must determine whether the pr esence of substances other than VCM would subject vinyl chloi ide polymers or copolymers to the Hazard Communication St a ridard. As noted at the dut set, we have attached a draft letter summarizing the items we wish to confirm. We would like to meet to discuss this matt er with you and will contact you in the near future to arran gle a mutually convenient meeting time, In the interim, if you should have any immediate comments or questions, please feel free to contact us. Cordially yours, cc: Barry J. White Enclosures _ (st4*Z. Peter L. de la Cruz SPl-01428 DRAFT -1- Peter L. de la Cruz, Esqi lire Keller and Heckman 1150 17th Street, N.W. Washington, D.C. 20036 Re: Regulatory tatus of Vinyl Chloride Polymers anc Copolymers Dear Mr. de la Cruz: This is in respor se to your letter of June 2, 1986, and our subsequent meeting or , 1986, concerning the regulatory status of polj/vinyl chloride (PVC). The first issue you raised was whether P\1C itself was a hazardous chemical or carcinogen under the pro\visions of the Hazard Communications Standard, 29 C.F.R. 193.3.1200. Putting aside for the moment the question of residual /inyl chloride monomer (RVCM) levels, we agree that PVC itself Ls not a hazardous chemical or a car- cinogen under the Hazard Communications Standard. In determining a substance's carcinogencity, please note that the Hazard Comirninication Standard directs employers to consult the National T'oxicology Program's (NTP) Annual Report on Carcinogens, In t ernational Agency for Research on Cancer (IARC) monographs, and Subpart C of Part 1910 of the Agency's regulations. Th e Registry of Toxic Effects of Chemical Substances (RTEC S ) published by the National Institute for Occupational Safety a rd Health (NIOSH) serves as a handy SPI-01429 DRAFT -2- reference to NTP and IARC studies. RTECS also includes the interpretation by the cot .tractor used by NIOSH of statements made in NTP and IARC stuc ies. While these characterizations are helpful, they are not necessarily binding and we agree that PVC is not a carcinogen d espite the confusion that the NIOSH Registry may create on th is point. Consistent with the Agency's earlier position, we can confirm that vinyl chlori 3e polymers and copolymers are not subject to the training o r labeling requirements of the OSHA vinyl chloride standard w len the handling, shipping, storage and further processing of the resin or compound are not expected to result in emp Loyee exposure to vinyl chloride monomer above the action . .evel of 0.5 ppm. This conclusion is based on the exclusion of fabricated products from the standard and the Agency's earlier : .nterpretat ion of the term "release of vinyl chloride monomer" a: i constituting a release at or above the action level. The interrelations hip of the Hazard Communication Standard and the vinyl chi oride standard was another issue we discussed. When compound or resin is expected to result in exposure to vinyl chloride monomer (VCM) above the action level SPI-01430 DRAFT -3- (0.5 ppm), the training s nd labeling requirements of the vinyl chloride standard apply a s well as the provisions of the Hazard Communications Standard, subject to the limits on scope and applicability found in tb e Hazard Communications Standard. If PVC resin or compound are likely to result in VCM exposure below the action level, tlhen the labeling and training pro visions of the vinyl chloride standard do not apply and the Hazard Communications Standard would not be triggered. Manu facturers must individually determine whether other components in the compound or resin, apart from PVC and VCM, might independently subject the product to the provisions of the Hazard Communications Stahdard. We appreciate the opportunity to address your concerns. Please do not hesitate to contact us again if you have further quest ions. Sincerely, John B. Miles, Jr. Direct or Directorate of Field Operations SPI-01431 U.S. Department of Labor Ar1! \ 3 0 itco Occupational Safety and Health Administration Washington. D C 20210 Reply to the Attention of: Mr. Peter A. Susser Keller and Heckman 1150 17th Street, N.W. Washington, D.C. 20036 Dear Mr. Susser: This is in response to yo ur letter of February 26 , regarding the hazard of polyvinyl chi.or ide . We appologize for the delay in responding to your inquitfy We have contacted member of the editorial review board of the Registry of Toxic Effect; of Chemical Substances (RTECS) published by the National Ir) stitute for Occupational Safety and Health (NIOSH) in regard to your suggestion that RTECS may contain an error where it includ s in the data record some carcinogenic determinations for polyv nyl chloride that are ascribed to the International Agency for Research on Cancer (IARC). We have been informed that entries, " Carcinogenic Determination: Animal Positive" and "Carcinogenic petermination: Human Indefinite", were not made in error. Rath? r,9 they are the interpretation by the contractor used by NIOSH of statements made in IARC 19, 1979. The vinyl chloride stand rd controls the labeling that polyvinyl chloride must bear with espect to information on carcinogenicity. Provision 29 CFR 1 910.1017 (1) (4 ) requires that containers of polyvinyl chloride she 11 be labeled as containing vinyl chloride. Moreover, the provision requires that the label state that polyvinyl chloride s a cancer-suspect agent. Such labeling, however, is not requ ired for "fabricated products." A "fabricated product" is c escribed at 29 CFR 1910.1017 (b)(6) as "...a product made wholly or partly from polyvinyl chloride, and which does not require fu rther processing at temperatures, and for times, sufficient to cause mass melting of the polyvinyl chloride resulting in the release of vinyl chloride." Consequently, polyvinyl chlor ide resin that has not yet been processed into film, or sheeting, o r has not yet undergone final molding or extrusion, must be labele d in accordance with 29 CFR 1910.1017 (1)(4); whereas the film, sheeting, final molded products, and final extruded products c o not. Whenever labeling accordi ng to 29 CFR 1910.1017 (1) (4 ) applies for a polyvinyl chloride product, then the provisions of the Hazard Communication Stan dard, 29 CFR 1910.1200, also apply, subject to the limits on scope and applicability found in the standard. SPI-01432 2- - We appreciate the opportunity to address your concerns, do not hesitate to contact us again if you have further questions. Please Sincerely, WvN in in B. Miles, Jr., Di re ctor lirectorate of Field Op Orations SPl-01433 DRAFT 1- - Gail M. Brinkerhoff Office of Health Standards Occupational Safety and Health Administ rat ion Room N-3104 200 Const itutuion Ave., NW Washington, D.C.20210 Re: Status of ]pVC Under Hazard Communication Standard Dear Mr. Brinkerhoff: Peter Susser and I appreciated the opportunity to meet with you on May 20, 198(, to discuss the status of polyvinyl chloride (PVC) resin under the Hazard Communication Standard (HCS). 29 C.F.R. 191C.1200. By way of background, in a February 26, 1986 letter, we sought OSHA's confirmation that PVC resin is not a carcinogen under the Hazard Communication Standard. In part, we sought clarification on the relationship between the HCS and the "Registry of Toxic Effects of Chemical Substances" (RTECS) published by the National Institute for Occupational Safety and Health (NIOSH). In response, we received a letter from John B. Miles, dated April 30, 1986, st iting that the characterization of PVC studies by the Internati snal Agency for Research on Cancer (IARC) found in RTECS is "the interpretation by the contractor used by NIOSH." Mr. Mi 1 s' letter went on to say that whenever labeling is required undt r OSHA's vinyl chloride standard, 29 SPI-01434 C.F.R. 1910.1017, then the provisions of the Hazard Communi cations Standard also apply subject to the limits on scope and applicability found in HCS. We requested a meeting to discuss OSHA's response and appreciate your clarifi cation that interpretations of IARC studies contained in th e NIOSH Registry (RTECS) are not necessarily binding. R ather, parties assessing the carcino genic status of substan ses should consult the studies themselves to reach a defin Ltive conclusion. In discussing w` lether PVC resin must be designated as carcinogenic under HSC, you indicated that the Agency was concerned with exposure to vinyl chloride monomer (VCM) in the resin. In this regard, you referred to the hazard determination provisions of HCS. Section 1910.1200(d)(5)(iv) provides that when a component ir i a mixture must be evaluated (here the residual vinyl chloride monomer), the employer should determine whether: (1) it is press mt at less than 0.1%, (2) workers handling the resin woulc be exposed above the OSHA permissible exposure limit (PEL) or threshold limit value (TLV) established by the American Council of Governmental Industrial Hygienists (ACGIH), or (3) "could resent a health hazard to employees in SPI-01435 DRAFT those concentrations irj which it is present in the mixture." For example, you stated that when the further processing of PVC resins may result in exposure to vinyl chloride in excess of the action level contai ned in the vinyl chloride standard (0.5 parts per million), the PVC resin must be labeled in accordance with the requirements o f the vinyl chloride standard. As promised dur ing our meeting, I am enclosing copies of letters written in 1 )75 by Barry J. White, then OSHA's Associate Assistance S eCretary for Regional Programs, clarifying the meaning of "rel uase of vinyl chloride." The letters essentially state that PVC which does not release an amount of vinyl chloride which wo uld likely result in employee exposure at or above the action evel are exempt from the provisions of the vinyl chloride stan dard. Also as promisee, a copy of the Occupational Safety and Health Review Commissior decision in Secretary of Labor v. Hooker Chemical Company, (OSHRC Docket No. 78-4862) is enclosed. In that case, an OSHA inspector issued a citation to Hooker Chemical Company alleging a failure to provide training on vinyl chloride for employees who worked in the calendering, compounding and warehouse areas of a Hooker facility. Hooker SPI-01436 DRAFT -4- contested the citation on the basis that employees working in these areas were not suit ject to OSHA's vinyl chloride standard because they were not ej: posed to vinyl chloride monomer above the action level. Both Hooker and OSHA's monitoring for vinyl chloride in the calende and compound facilities indicated concentrations significant iy below the 0.5 parts per million (ppm) action level. In May 1979, Judg e Charles K. Chaplin issued a decision that adopted Hooker's po|s it ion and vacated the OSHA citation. He held that the training provisions of the standard do not apply to areas where the vinyl chloride level in the ambient air is below the action Level. Although not req ijested to do so by any party, a Commissioner on the Occupational Safety and Health Review Commission directed that the case be reviewed. In responding to the review proceeding^, OSHA changed its position and filed the letter stating that the Judge's decision should be affirmed. Significantly, the Secretary of Labor's letter stated that: "Training i equirements are not applicable in this case because respondent's cited compounding and calendering operations simply are not processes which could result in SPI-01437 DRAFT -5- hazardous exposure to v Lnyl chloride by the nature of the operations themselves." Because OSHA indicated that it did not wish to pursue the case the Review Commission left the Judge's decision intact. Again, we appreciate your assistance in clarifying Mr. Miles' letter and trust that the enclosed materials will be helpful. Sincerely, Enclosures Peter L. de la Cruz SPI-01438