Document ByKg4EvaXRBZm91GQVvO20LeJ

Vttto Polyman Inc. A Subsidiary of VhlO Chemical Company October 23. 1985 15990 N. Barker'! Landing Rd. Port Office Box 19029 Houston.Tojia* 77224 ReceMbgneJ7Q1531-3200 OCT 24 85 Route: _ A Peter L. de la Cruz. Esq Keller and Heclcnan 1150 17th St. N.V., Ste. 1000 Washington, DC 20036 X.P-------- Dear Peter: Enclosed you will find the proposed contents of our Drug Master File which you prepared and I have reviewed. My suggested changes are, for the most part, minor and highlighted In yellow. We prefer to open the DMF In the name of Vista Polymers Inc. Instead of Vista Chemical Company unless you feel particular need to do otherwise. Also, while Phil Carey Is certainly flattered by your referring to him as "Assistant General Counsel," around here he is more generally known as Attorney, with aspirations. As for the resin recipes, we would like to add to all five the use, in item #3, of Blsphenol A (2,2,-Bls(4-hydroxyphenol)propane. Please specify a use range of 0.01 - 0.03Z on each recipe page. At this time, I would also like to set up a Medical Device Master File (MDMF). I assume the contents of an MDMF for Vista Polymers would exactly resemble those of the DMF, with the exception of the department of the FDA to which the file Is addressed. If this is the case, please call me with the name and address of the person at FDA to whom this material should be sent and I will generate the appropriate request on Vista letterhead. I appreciate your assistance and look forward to receiving word from you that both an MDMF and a DMF have been established in our name by mid-November. Sincerely, Bruce H. Borsuk Market Development /eab Enclosures cc: R. Phil Carey bcc: RES, JAK, HRF, ELK, TGG (w/o enclosures) VEV-143968 VISTA CHEMICAL COMPANY DRUG MASTER FILE FOR POLYVINYL CHLORIDE PRODUCTS September ____, 1985 <JEU-143969 TABLE OF CONTENTS tab A. Request to Open DMF B. Address List C. Persons Authorized to Reference DMF D. Authorization of Counsel E. Product Formulations and Technical Information 1. Vista PVC 5265 Resin 2. Vista PVC 5305 Resin 3. Vista PVC 5385 Resin 4. Vista PVC 5425 Resin 5. Vista PVC 5465 Resin A page VEV-i43970 I RECEIVED AUG 21 '85 TO: R. E. Swantkowskl Rou'.J:, Communication From: Date: Subject: B. H. Borsuk August 19, 1985 Copy: FDA-RAP: Clarification of Resin pftgprov X-F: VIS1A Further to my IOC of 8-15 notifying you of our resins' approval by Keller & Heckman for food packaging, I must clarify. This approval is conditional upon our using certain antioxidants in the manufacturing process. Currently these are BHT or Irganox 245. Keller & Heckman saw in our recipes that these antioxidants can be used in our manufacturing process and, since they are both FDA approved, passed favorable judgement on our resins. We also use Naugard 492 & Isonox 132 as antioxidants. These are not FDA-approved and any resin produced with these would be FDA-approved only after proper migration studies are carried out, and the results are favorable according to Keller & Heckman. Although I still support sending a letter to AHC, I must state that sending this letter and supplying "FDA-approved" resin to AHC, or any other customer, is based upon an internal committment to use only BHT or Irganox 245 or other FDA approved antioxidant. Use of Naugard 492 or Isonox 132 for resin intended for a food packaging application would invalidate such a letter to a customer. DRW, RFC, NJF, TFO. 43986 * TO: R.E. Swantkowskl FROM: DATE: SUBJECT: B.H. Borsuk August 15, 1985 FDA - RAP: APPROVAL OF 5265, 5305, & 5385 RESINS I received this week the opinion letter from Keller & Heckman stating that our 5265, 5305, and 5385 resins "nay properly be said to be in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable Food Additive Regulations." Koute: This does not preclude 5425 and 5465 from such compliance, Keller & Beckman simply understood that present marketing opportunities for Vista Polymers in FDA application Involved our low and medium molecular weight resins. Copy: I suggest the next step in developing our market for FDA-approved resin is to provide AHC a letter communicating the opinion of our outside counsel, thus allowing AHC to purchase 5265 and/or 5305 for use in food packaging. AHC has X-F: indicated that such approval will be sufficient for all of their food and drug packaging applications, although we may also communicate verbally to AHC our intentions to set up a Drug Master file should they find it necessary to refer to same in connection, with a new drug packaging product. As for AHC's request of resin compliance specifically with 21 CFR 175.300, Keller & Heckman's opinion does Include approval under that regulation; I have confirmed this verbally with Peter de la Cruz. I have attached a draft of a letter which can be used for AHC and should properly come from you as Manager of Marketing. Please advise as to its acceptability. I have reviewed it with Phil Carey. 1 have also attached copies of most of Keller & Hackman's, response, if you wish to see any of the other references specifically mentioned by Peter de la Cruz, please advise. Tom O'Brien would like to deliver the letter to AHC at his meeting with them on August 29. Bruce H. Borsuk Market Development cc: JAH, HRF, ELK, CMS, SEM, HJH,(Tg5>, JF, DWH, HDG, RBQ, EJM NJF, TFO, RPC (w/AHC draft letter attachment only) BHB/rlc Dear __________ We are pleased to Inform you that after careful review of Vista Polymers PVC resins by our outside counsel Keller & Heckman of Washington, D.C., we have received a favorable opinion regarding their use in food and drug packaging applications. Specifically, we have a letter on file stating that: "when used as intended [Vista's PVC 5265 and 5305 resins] may properly be said to be in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable Food Additive Regulations." This compliance Includes 21 CFR 175.300 Resinous and polymeric coatings. We are also establishing a Drug Master File at the Food and Drug Administration. This can be useful for your future reference in connection with any new drug packaging application for which you may want to use Vista PVC resins. We appreciate your business and look forward to continuing to supply your needs. R.E. Swantkowskl Manager of Marketing cc: Mr. Tom F. O'Brien Saddlebrook, NJ VEV-143988 JOKM* t HCLklH jcmomk h, ntcnnnf* HAfltlM *. WKtCO**c* iomm *. dkwc> FCTCIt LHU CMUt CHUlftTlN* A. M*A*ME* ihiMlkv i. nwimore lAWWmCC A. MALPfHM mMaiaM*Ar-tlntHcHvOmHs * e*IWC. pTMonABm.tm-uWMjQBiHuRlUimfTti i m(WcOTiiCatAahm. *u0)1m 141 M. WO*|ft tLXWt MtNVCW MCLLX* law orricBS Keller and Heckman 1180 17" STREET, K.W. SUITE lOOO WASHINOTON, D.C. BOOQ8 (SOS) *87-1100 tMeCMMOMrnmt 4 pcnMhi.bJ" August 12/ 1985 TCLXX (IOH IH-TUI CASLX AOOftttS "ftCUMM'' (202) 457-1116 Mr. Bruce H. Borsuk Vista Polymers, Inc. Vista Chemical Company 15990 North Barker's Landing Road P. 0. Box 19029 Houston, Texas 77224 Re: FDA Status of PVC Resins 5265, 5305 and 5385 Dear Bruce: We have reviewed the information submitted in your July 9, 1985 letter and later supplemented by your July 18, 1985 telephone call and are satisfied that the products present no food additive problem. We are enclosing two letters expressing this opinion. The first letter briefly states our conclusion in a way that will not disclose the formulation of the products. Many of our clients have found such a letter useful as a marketing tool to indicate the propriety of using their materials for its intended use. The second letter details the FDA status of each component and describes the basis for our conclusion. We trust you will find the enclosed opinion letters fully responsive to your request for our opinion. If you should have any comments or questions, please let us know. Cordially yours, fa Enclosures Peter L. de la Cruz cc: William L. McClain, Esquire R. Phil Carey, Esquire VEV-143989 A JOPtPM t kcllc* JKROMt H. HBCKMAM CH>H,n M. MCCMAM MUMM H. HMHttANI, M. MALCOLM P. MACAATMUn V. PLACM CAROifCHMMlt CMAlPTlNC A. HlAPWiP PMimrr a. nwwtoro LAWMNCI W. IIALPHIM PAtPM A. PIMMOMP MAJMtC. NAtCP nnuA naoH PAPPUS AS OPMNIP LAW OFFICES Keller and Heckman 1150 17" street, N.w, SUITE lOOO WASHINGTON* D.C. 80005 (SOS) 457-1100 August 12, 1985 Tcutconcii rapi t annuffM -ni"*"wmtw'i owner ouu. mrnofn (202) 457-1116 Mr. Bruce H. Borsuk Vista Polymers, Inc. Vista Chemical Company 15990 North Barker's Landing Road P. 0. Box 19029 Houston, Texas 77224 Re: FDA Status of PVC Resins 5265, 5305 and 5385 Dear Bruce: In response to your July 9, 1985 letter and our subsequent telephone conversation on July 18, 1985, we have considered the Food and Drug Administration ("FDA") status of Vista's PVC Resins 5265, 5305 and 5385 intended for use for various food and drug packaging applications, based on our careful review of the formulations and other pertinent data, it is our opinion that when used as intended these resins may properly be said to' be in com'pTiance with the Federal Food, Drug, and Cosmetic Act and all applicable Food Additive Regulations. We trust this letter will be fully responsive to your request for our opinion. If you should have any questions or if we can be of any further assistance, please contact us. Cordially yours, tklm (X*. Peter L. de la Cruz h MUCPNLIMUn JUOM H. CNMvnMc a. iiMiim MMItftV ft. riAHMOTO LAWftCMGS F. hamnmn mark root even* c. aou*m jjjifftALFH ft. limwQMft UlM J. HVN LAW OFFICES Keller and Heckman I1BO I7" STREET. N.W. SUITE lOOO WASHINGTON. D.C. 80000 (808) 487-1100 August 12, 1985 A utoft) a-7ftfta (202) 457-1116 Bruce H. Borsuk Vista Polymers, Inc. Vista Chemical Coiqpany 15990 North Barker's Landing Road P. 0. Box 19029 Houston, Texas 77224 Re: FDA Status of PVC Resins Dear Bruce: In your July 9, 1985 letter and subsequent telephone call on July 18, 1985, you provided information concerning the formulations for Vista's PVC Resins 5265, 5305 and 5385, and requested an opinion concerning their Food and Drug Adminis tration ("FDA") status. These resins are intended for use in various food and drug packaging applications. He have analyzed the information provided and, as discussed more fully below, w have no hesitation in providing our opinion that these products may be used as intended and that such use may properly be said to be in compliance with the Federal Food, Drug, and Cosmetic Act ("Act") and all applicable Food Additive Regulations. A. Regulatory Background To put our opinion into perspective, it may help to review the legal/regulatory background applicable to food con tact substances. Section 201(s) of the Act defines a "food additive" in pertinent part as: [A]ny substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the charac teristics of any food ... if such substance VEV-143991 Bruce H. Borsuk August 12, 1985 Page 2 Relxer and Heckman is not generally recognized ... to be safe under the conditions of its intended use; except that such term does not include-- < *** (4) any subtance used in accordance with a sanction or approval granted prior to the enactment of this paragraph pursuant to this Act. This definition is repeated in section 170.3(d) of the Pood Additive Regulations which adds, again in relevant part, the following explanatory information: A material used in the production of containers and packages is subject to the definition [of "food additive"] if it may reasonably be expect ed to become a component ... directly or indirectly of food packed in the container. . . . .If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive. Thus, a substance that is reasonably expected to becom a component of food when employed in a food contact application must be (a) the subject of an applicable Food Additive Regula tion, (b) the subject of a prior sanction or approval, or (c) deemed generally recognized as safe (GRAS). If the sub stance is not reasonably expected to become a component of food under the intended conditions of use, it is not a food addi tive, and It may be so employed without any prior action by or consultation with the Food and Drug Administration (FDA). As further background information. Food Additive Regu lations are all Issued on the premise that substances must be evaluated (and cleared where appropriate) on a generic rather than a proprietary basis. In the case of plastics resins, as long as the basic resin is: (a) listed in a regulation or otherwise cleared, ,(b) manufactured in accordance with good manufacturing practices* and (c) complies with applicable extraction requirements, then the resin is covered by that UEV-143992 Bruce H. Borsuk August 12, 1985 Page 3 A Kbli.br and Heckman regulation--even though different manufacturers may make the resin by different processes. PDA stated many years ago that a "basic resin" is the material that comes out of the polymerization kettle, i.e., a* basic resin is the product that results when the polymerization process has been carried to commercial completion. Substances such as catalysts, chain regulators, chain transfer agents, and all other materials required to produce the basic resin are considered part of the basic resin and not subject to indepen dent regulatory consideration. Thus, the clearance afforded the basic resin automatically clears those substances which are necessarily used during the polymerization stage to produce it. We are enclosing relevant portions of a report to the Food Packaging Materials Committee ("PPM") of The Society of the Plastics Industry, Inc. (SPI), in December of 1966. The report covers a presentation by an PDA spokesperson to the PPM Committee in which the "basic resin" doctrine was set forth. The basic resin doctrine merely reflects the practical reality that FDA could never hope to write generic regulations for food packaging materials that describe and specifically clear every substance that might properly be a component or contaminant of the packaging material as a result of every con ceivable manufacturing process that yields a suitable resin. Since trace quantities of these "unregulated" substances are not perceived to present a public health hazard, FDA has wis ly chosen not to subject such substances to the burdensome pre clearance provisions of section 409 of the Act that apply to food additives. On the other hand, the basic resin doctrine does not apply to those substances added to the basic resin in order to prepare a technologically useful plastic packaging material. Thus, stabilizers, plasticizers, pigments, lubricants, and the like, which may be added to a basic resin in order to facili tate its processing or to affect the technological properties of the final plastic product, must be considered as matters separate from the clearance afforded the basic resin. 43993 Bruce H. Borsuk August 12, 1985 Page 4 t / tA \N Keller and Heckman B. FDA States of Vista PVC Resins Turning now to a consideration of the specific formula tions for Vista Resins 5265, 5305 and 5385, we note that the three products are each comprised of greater than 99 weight percent of PVC basic resin along with fractional percentages of calcium stearate and antioxidants. The formulations for the three PVC resins vary only in the ratio of reagents used and the specific initiator and suspending agents employed. The antioxidants used are butylated hydroxytoluene (BHT) and/or Irganox 245. Also, odorless mineral spirits may be added and subsequently removed during polymer finishing to provide cer tain property advantages. The major component of these formulations, polyvinyl chloride ("PVC") is prior-sanctioned for use as the basic resin in food packaging applications and presents no food additive concerns, assuming it is produced in accordance with good manu facturing practices. As you kpow, FDA proposed in 1975 to ban all rigid and semirigid PVC products while allowing continued use of thin film and coatings or closure liners. The Agency has never finalized its 1975 proposal. Continuous refinements TnPVC production techniques have reduced the level of residual vinyl chloride monomer in rigid products to levels which are hardly measureable and which are of little safety and regulatory con cern. This opinion was expressed by the Agency in a 1979 letter, a copy of which is enclosed for your information. For years the Agency has promised a new regulation for PVC. In fact, we're now told to expect something before "the end of the year." It is our understanding that a new proposal will be issued reaffirming the acceptability of rigid and semi rigid PVC products provided they meet certain residual monomer specifications. Informed rumor leads us to believe that a limit of 10 parts per billion (ppb) residual monomer will be placed on such products. Lower limits of residual monomer are anticipated for plasticized films and other plasticized pro ducts. In any event, we recommend that when Vista PVC resins are formed into various food contact surfaces, the residual monomer levels in those surfaces should be no higher than the aforementioned levels. If you are interested, we can provide VEy-l43994 Bruce H. Borsuk August 12, 1985 Page 5 Kbiler and Heckman analytical methodology which is suitable to determine the residual vinyl chloride levels in your materials. The materials used to prepare the basic PVC resin include suspending agents, initiators, chain transfer agents, and killing agents. These are all considered part of the basic resin and, as such, are of no regulatory concern. Calcium stearate, which is used as an antistatic agent, is considered -- gras in flonHon iai-1229- The antioxidant BHT is prior-sanctioned in section 181.24. while the other antioridant, Irganox 245 (ethylene bis(oxyethylene)-bis-(3-tertbutyl-4-hydroxy-5methylhydrocinnamate)), is cleared in section 178.2010 for use at levels not to exceed 0.2% bv weight of rigid vinyl chloride plastics prepared from vinyl chloride homopolymers and/or vinyl chloride copolymers used in accordance with a prior-sanctioned or applicable regulations. A copy of this regulation is enclosed for your files. We note that the formulations for Vista PVC Resins 5265, 5305 and 5385 all use less than 0.2% Irganox 245. Because these substances are GRAS, priorsanctioned, used in accordance applicable regulations or subsumed under the basic resin doctrine, they may be used as intended. We understand that odorless mineral spirits may be added during polymerization of the vinyl chloride and subsequently removed during the polymer drying process. This treatment increases the porosity of the PVC resin which, in turn, improves drying and subsequent blending with other materials. No residues of the odorless mineral spirits are expected to remain in the finished PVC resin after drying. As such, the mineral spirits are not anticipated to be a food additive. Nevertheless, and as an added measure of comfort, odorless mineral spirits are cleared for use as a directfood additive in section 173.34Q as a defoamlng agent for use in processing it is our opinion that when a material is cleared for direct fooa additive use, it may be considered GRAS in indirect additive-Applications provided thsTaiit Idlpati levels in food resulting from contact with the packaging mafff* rial is rar less thanthat permitted from the dlearefl direct^ food contacfJudes. "This is the"case with the use of mineral spirits~here. ~~' To summarize briefly, all components of Vista's PVC Resins 5265, 5305 and 5385 are either prior-sanctioned, GRAS, or cleared under an appropriate Food Additive Regulation. VEV-143995 Bruce H. Borsuk August 12, 1985 Page 6 Keller and Heckman We trust you will find we have been responsive to your request concerning the FDA status of Vista's PVC resins. If you should have any questions concerning this matter, or if there is any other way we may be of help, please do not hesi tate to contact us. Cordially yours, Enclosures Peter L. de la Cruz 43994 t \ TO: Distribution ^7 HDPc f FROM: DATE: B. H. Borsuk July 19, 1985 SUBJECT: FDA-RAF UPDATE VIS1A Peter de la Cruz is sending me an opinion letter stating that, provided BHT or Irganox 245 are used as the antioxidant, our 5385, 5265 and 5305 resins are suitable for use in food packaging. He will also state that we would comply with the regulations mentioned by AHC and RJR Fllmco. We also discussed the following: 1. RVCM LEVELS: Resin should start with RVCM levels of 0.5 - 1.0 ppm. The blending process should reduce this level to 15-20 ppb. Processors can then achieve their self-imposed level of 10 ppb on finished sheet and film. The FDA's RVCM regulation is not forthcoming. It seems the FDA's issues with carcinogenic food color additives may effect the draft pending for the PVC regulation. (See attached letter.) 2. VISTA RESIH RECIPES: Peter informs me there are no major problemsiwith our resins for food and drug applications. Use of all additives (with the exception of the Naugard antioxidant) are cleared as follows: ADDITIVE CURRENT STATUS Na tri-polyphosphate Methocel PVA All named initiators alpha-metbylstyrene CTA's Ca Stearate OMS BHT part of basic resin doctrine direct food additive prior-sanctioned as Indirect food additive part of basic resin doctrine part of basic resin doctrine part of basic resin doctrine generally recognized as safe (GRAS) regulated as Indirect food additive prior-sanctioned The amount of each additive used in any reactor should be "only that amount which is necessary to achieve the desired effect." Therefore, Peter made no specific conanents on the additive ranges. RECEIVED JUL 2 3 1935 MEDICAL VEV-143997 3. NAUGARD 492: Antioxidants are not part of the basic resin doctrine. In order to use one it must be subject to a specific regulation or prior-sanctioned for use as a food additive or GRAS or "not reasonably expected to become a component of food" In order to use the Naugard 492 or Isonox 132 in FDA applications* we must demonstrate to K&H zero extraction using methods sensitive to 50 ppb. K&H will provide us with proper protocol. The extractions can be done by the supplier, by Vista, or by an outside Independent testing lab, although K&H prefers the first two options for us. In the absence of extraction testing, such as for Isonox 132, K&H can manually calculate the maximum potential migration (which assumes 100Z antioxidant migration from each square inch of PVC packaging). 4. DRUG MASTER FILE: should list the amounts of VCM, water, Ca stearate, and (generlcally identified) antioxidants used to produce each resin. No other recipe details are necessary. Prior to the FDA's assigning a Master File number, we can inform Klockner and AHC that such a file has been established and they may refer to it when notifying the FDA of their intention to use Vista resin to manufacture their drug packaging, Peter does not anticipate the FDA's having any problem with the use of a Naugard 492 or Isonox 132 because drug consumption is Infrequent and periodic compared to food consumption, therefore potential risk is lower. Ve would also list, generlcally, BHT and Irganox 245. 5. Phil Carey and I will meet with Peter and Dan Dixler on August 22nd to get a short course In "PVC in FDA Applications" as well as continue to discuss RVCM, Master Files, calculated migrations, and Medical Device liability. Bruce H. Borsuk Technical Sales Representative /Jsh DIST: RDM RES HRF ELK RFC CMS SEM HJH DWH JF HDG EJM RBQ . VEV-143998