Document gEgGry4YDgj4jV74rgkKxeKqL

4 JOSEPH E KELLER JEROME H HECKMAN WILLIAM H BORGHCBANI. JR MALCOLM D MACARTHUR WAYNE v, SLACK TERRENCE D. JONES MARTIN W, BERCOVlCl JOHN ELDRED CAROLE C HARRIS MARY MARTHA MeNAMARA MICHAEL F mORRONE MARK FOX EVENS JOHN B, RICHARDS JOHN B. DUBCCK PETER L dc CRUZ CHRISTINE A MEAGHER Shirley s, fujimoto LAWRENCE P HALRRIN RALPH A. SIMMONS PETER A SUSSER C DOUGLAS JARRETT SHEILA A. MILLAR MELVIN S DROZEH GEORGE 0 MlSKO FREDERICK J DAY. JR MARCI C, OREEHSTEIH* SUSAN J PlSNER MARCIA K. COWAN Patrick j. nurd s. craio tautfest MARK A. SIEVERS MICHAEL R. BENNET G. FRANKLIN KOONTZ CATHERINE N. ROEMCR Richard a. jaffE* JEFFREY s KERR** KRIS ANNE NONTElTH -- Elliot belilos**** SHANNON L DENMAHM* SUSAN E. FOX***** ADMITTED IN RENNSYLVANIA ONLY 'ADMITTED IN MISSOURI ONLY --ADMITTED IN VIRGINIA ONLY *ADMITTED IN MARYLAND ONLY `ADMITTED IN CONNECTICUT AND NEW YORK ONLY L.A.W OFFICES Keller and Heckman 1150 17*" STREET, N.W. SUITE lOOO WASHINGTON* D.C, 0030 (SOS) 956-5000 June 9, 1989 RECEIVED!1C STAFF IXLER, pm p CHARLES V. BREDtft, Pm D ROBERT A MATHEWS, Rh. D jun i rmMODDERMAN. Pm. D, HUTMIRC FOLEY JUSTIN C. PQWELL. Pm, O. Route:. TELECOMMUNICATIONS CHARLES F TURNER TELEX Copy: TELECOPIER File: X-F: +ODMLPZ "kelman- 'YUfrER'S DIRECT DIAL NUMBER (202) 956-5641 VIA TELECOPIER Mr. Thomas G. Grumbles vista Chemical Company 15990 North Barker's Landing Road Houston, Texas 77224 Re: Dear Tom: Options for Obtaining Appropriate FDA Status for Byproduct HC1 Following up on the telephone conversation that Holly Foley and I had with you today, the purpose of this letter is to provide you with a brief summary of the alternatives avail able for establishing appropriate Food and Drug Administration (FDA) status for Vista's hydrochloric acid (HC1) produced as a byproduct of linear alkyl benzene production. As we understand it, chlorine is used as a catalyst in this process with HC1 being produced as a byproduct. You have already generated a large amount of information on residual benzene levels in the HC1 but do not yet have a complete impurity profile on the acid. As we discussed, it is difficult to predict at this stage what the best alternative will ultimately be for estab lishing to FDA's satisfaction the safety of Vista's byproduct HC1 for use in direct food additive applications. The existing alternatives, however, may be broken down into the following: (1) a data submission to FDA demonstrating, if possible, that the byproduct HC1 is essentially equivalent, in terms of the nature and levels of impurities, to the acids which the Agency is currently willing to consider generally recognized as safe (GRAS); (2) submission of a GRAS Affirmation Petition specifi cally for HC1 produced as a byproduct of the Vista process; and (3) submission of a Food Additive Petition (FAP) for the acid. UEV-143752 Mr. Thomas G. Grumbles June 9, 1989 Page 2 4 Keller and Heckman The first two options would both have the objective of ensuring explicit inclusion of byproduct HC1 from the Vista process in the final GRAS Affirmation Regulation for hydrochloric acid which the Agency has been working on for the past five years. The third option would request promulgation of a separate Food Additive Regulation specifically clearing the use of the Vista acid in food additive applications. The best approach to take in submitting data to FDA I on Vista's byproduct HC1 will depend largely on the outcome of your additional analytical work on possible impurities present I in the acid. If the analytical data demonstrate that the HC1 is at least as pure as the acid that is currently considered by FDA to be GRAS--an unlikely outcome at this point--it may not be necessary to prepare more than an informal, informational submission of the data to the Agency. If the impurities tound in Vista's acid_differ from those found in-fhLrect proce&s__HC1 but are clearly Jjinocuous at the levels found, a GRASAffirmation Pet^tijsn Jnay-be indicated. Finaiiy, if relatively high levels of impurities are detectedTjpr if anvJ^;arcihogeris| are present in meagurahia gnantitipr; probably will be necessary tp,submit the data-JjL-bhe form of a Food Additive Petition. To provide you with some indication of the types of information needed and the necessary format to follow depending upon the type of submission chosen, we are enclosing herewith copies of SS 170.35 and 171.1 of the Food Additive Regulations, which set forth, section-by-section, the information require ments established by FDA for GRAS Affirmation Petitions and Food Additive Petitions, respectively. With specific regard to the byproduct HC1, whether a GRAS Affirmation_or_Food-Additive Petition is ultimately determined^to be the most appropriate optTgrn--tHe~~Following -types. _e.f ..information will be -needed: A description of the manufacturing process leading to the formation of byproduct HOI, including any steps taken to purify the acid; Specifications applied by Vista to HC1 that will be sold into the food processing industry, copies of analytical methods used to ensure compliance with the specifications, and data from several (3 to 5) production lots demonstrating compliance of the acid with your internal specifications. Specifications for the raw materials used in the process and methods for ensuring compliance with the same; VBM 43753 Mr. Thomas G. Grumbles June 9, 1989 Page 3 \ A Keixer and Heckman jt- The identities of possible impurities in the HC1 based upon the manufacturing process and purity of the starting materials; Results of analyses on a number of production lots encompassing at least a several week manufacturing period showing the measured levels of detectable impurities in the acid and the lower detection limit for any anticipated impurities that are not detected; % Data validating the reliability of the analytical procedure for impurities and demonstrating the claimed lower detection limits; A11 available toxicological data on the impurities 0 (with the exception of compounds, such as benzene, the safety of which FDA has already evaluated); v A description of the food processing applications T in which Vista's byproduct HC1 is used, and a rough breakdown of the percentages of the total quantity of HC1 produced by Vista that are used in the various applications; If possible, data demonstrating the fraction of T HC1 used in ion exchange resin regeneration that may remain in the resin and, in turn, may be added to corn syrup that is processed through the ion exchange column. (The latter information will be used to determine how much of the measured quanti ties of impurities in the HC1 may ultimately become a component of food when the HC1 is used in this "secondary" direct additive application.) In addition to this information specific to the produc tion and use of the byproduct HC1, a GRAS Affirmation Petition or Food Additive Petition will need to include an~Environmenta1 Assessment (EA) discussing the possible environmental"'impact of the use of byproduct HCi produced specifically by the Vista process. A description of the general types of information needed to complete an EA for either a Food Additive or GRAS Affirmation Petition is set forth in 21 C.F.R. 25.3la, "Environmental assessment for proposed approvals of FDA-regulated products-Format 1" (copy enclosed). We can provide you with more specific details of the EA requirements when and if you decide to file a petition for the acid. VEV-143754 Mr. Thomas G. Grumbles June 9, 1989 Page 4 A Keller and Heckman While it is premature to predict the type of submission to FDA that will best fit the circumstances once additional analytical data are developed, it appears likely that either al Food Additive Petition or GRAS Affirmation Petition will provel to be the best route for establishing appropriate status for \ Vista's byproduct HC1. However, in the event that the addi tional analytical data demonstrate that the acid is essentially identical to HC1 produced by the fused silica or burner acid procedures, both of which are considered by FDA to be GRAS, or if the analytical data are equivocal and do not clearly indicate that a petition is called for, it may prove wise to prepare an informal submission of data to the Agency and meet with the appropriate FDA officials to discuss the significance of the data and the appropriate course to take from that point. Such a submission should contain most of the information outlined above for inclusion in a petition but may be compiled in a more informal way and contain less detail on subjects other than the identities and levels of impurities in the acid. Regardless of the form taken by the submission, it will be essential to document with as much specificity as possible the composition of the acid and the procedures utilized to identify and quantify the impurities. As we discussed, while the information requirements for a GRAS Affirmation or Food Additive Petition and the FDA review process are well defined, it is difficult to predict with any confidence the duration of the review process and timing of publication of a responsive regulation. The uncertainty of the timing that is typical when dealing with FDA is exacerbated here by the fact that the Agency is in the process of preparing a rulemaking affirming as GRAS direct-process HC1. For this reason, if the data permit, it will probably be preferable to submit a GRAS Affirmation Petition for Vista's HCl rather than filing a Food Additive Petition since the acceptance for filing a GRAS Affirmation Petition will permit the immediate marketing of the byproduct HCl during the pendency of the GRAS petition review. In other words, the short-term goal of submitting a GRAS Affirmation Petition is simply to obtain acceptance of the Petition for filing; if FDA's initial review of the data lead to this acceptance, your marketing efforts need not be dis rupted while awaiting completion of the petition review pro cess. On the other hand, if a Food Additive Petition proves to be the only realistic alternative for submitting data on byproduct HCl to FDA, it will be necessary to await completion of the review and promulgation of a responsive Food Additive Regulation before marketing the acid for direct food additive U^43755 Mr. Thomas G. Grumbles June 9, 1989 Page 5 Keller and Heckman use. In this case, considering the rate at which the FDA staff typically operates, a responsive regulation for the acid is unlikely to issue before 12 months from the date of submission, and may well take 18 to 24 months. Once you have had a chance to review the information provided above, we will be happy to discuss with you in more detail the available options for moving forward to establish appropriate FDA status for the acid and, in particular, the analytical data that will be needed regardless of the specific alternative chosen. At that time, we will be pleased to discuss with you and your technical associates details of the analytical procedures that are most likely to yield the types of data needed as well as suitable analytical sensitivities for the various prospective impurities based on their relative toxicities. We look forward to hearing from you and stand ready to assist in any way possible. Enclosures Peter L. de la Cruz cc: William L. McClain, Esq. YEV-M375<s 4 To: Distribution nHreWk> Communication From: Date: H. A. Fishbein February 21, 1991 Subject: FOOD GRADE MURIATIC ACID UPDATE This letter will bring you up to date on recent activities by the International Food Additives Council (IFAC) and the Food Chemicals Codex (FCC) Revisions Committee with regards to food grade muriatic acid. Joe Gregg and I attended an IFAC Ad Hoc Hydrochloric Acid Committee meeting in January. Please see the minutes from this meeting (Attachment 3). Highlights of the current situation are as follows: FCC HC1 Monograph Revising the specifications for food grade muriatic acid is still on the agenda of the FCC Revisions Committee. However, a revised HC1 monograph is not expected for another year. me. Action FUn The Ad Hoc HC1 Committee will agree on a revised HC1 monograph and submit the proposal to the FCC Revisions Committee in 1991. The proposal will be submitted along with the data on "by-product" and "on-purpose" food grade muriatic acid which was specifically requested by the Revisions Committee. VISTA Action Flan Last year we agreed to delay completing a risk assessment evaluation of Vista's muriatic acid until a decision is reached on a Pacol at Baltimore. If this decision is that Baltimore will continue to produce by-product muriatic acid, I recommend that we begin to take independent steps to get our muriatic acid approved by the FDA. This recommendation is based on indications that Vista's HCl is one of the least contaminated by product muriatic acids available on the market, and that "on-purpose" muriatic acid is not as pure as once thought. The above items as well as the background on the food grade muriatic acid issue are discussed in greater detail in Attachment l. V YEV-143757 February 21, 1991 page 2 The next meeting of the Ad Hoc HC1 Committee Is planned for May 2, 1991 at IFAC headquarters in Atlanta. Mitchell A. Fishbein Senior Process Engineer Baltimore Chemical Plant /mw attachments Distributioni LRB, JQQi, JPW, DIM, JOGr, BJM (Baltimore) THH, (TGG^ RB, MFC, GEH, RES (Houston) A VEV-143758 A ATTACHMENT X page 1 Of 3 Background Vista along with seven other suppliers of food grade by-product muriatic acid are participating on an Ad Hoc Committee of IFAC, in an effort to maintain the Generally Recognized As Safe (GRAS) status of by-product muriatic acid sold to the food industry. The Food and Drug Administration (FDA) has not accepted the current FCC HC1 monograph. They are considering eliminating the GRAS status of by-product muriatic acid, unless the monograph J s revised and is acceptable to them. If the GRAS status of by-product acid is eliminated, each supplier would need to independently get the FDA to approve their muriatic acid. This can be both a costly and a multiple year process. See Attachment 4 for an overview of the various relationships with regulating food grade muriatic acid. FCC HC1 Monograph Revising the specifications for food grade muriatic acid is still on the agenda of the FCC Revisions Committee, although a revised HC1 monograph is not expected for another year. A revised HC1 monograph was not included in the third supplement to the third edition of the Food Chemicals Codex, which was issued for public comment last month. Instead, the Revisions Committee is planning^ to revise the HC1 monograph in the fourth edition, which is due out in 1992. In their effort to revise the HC1 monograph, the Revisions C mmittee has requested that the Ad Hoc HC1 Committee of IFAC submit to them any available data on "by-product" as well as "on-purpose" food grade muriatic acid. Specifically, they are interested in contaminants and their levels, toxicity data, and the production and use of HC1 for food processing. The Ad Hoc Committee is still in the process of gathering this data for submission to the FCC. IFAC Action Flan The action plan for the Ad Hoc HC1 Committee is to agree on a revised HC1 monograph and to submit the proposal along with the data specifically requested by the FCC Revisions Committee in 1991. The IFAC representative on the Ad Hoc HC1 Committee is Dr. Ebert, a toxicologist, who also happens to be a member of the FCC Revisions Committee. Dr. Ebert has recommended that th best approach for industry to maintain the GRAS status of by-product HC1 is for the Ad Hoc Committee to submit a proposed HC1 monograph with tighter limits on contaminants to the FCC Revisions Committe . The Ad Hoc committ e has agreed with this approach, alth ugh the Committee is having trouble r aching consensus on a n w monograph. KJBJ-143759 ATTACHMENT 1 page 2 of 3 T date, there is tentative agreement to reduce limits for total organic compounds from 5 ppm to 2 ppm and for heavy metals as lead from 5 ppm to 1 ppm. However, for other individual compounds there is not agreement. In fact, some represented companies will not even agree with the current limit for benzene, 50 ppb. In an effort to reach consensus on a new monograph, a confidential survey was completed. Individual companies reporting high levels fc*- contaminants of interest, ppm range, were asked if they could support a much lower level, such as 50 ppb, and if not, what level they could meet. For the results from this survey see Attachment 2. Vista was asked if we would be agreeable to limits of 50 ppb benzene and 1 ppm heavy metals, as lead. Since these are our current specifications, we did not object. In fact, Vista would be able to meet all of the limits proposed to the individual suppliers of by-product muriatic acid. VISTA Action Flan In June of 1989, the Business Area, Environmental, and the Baltimore Plant jointly developed a plan to complete a risk assessment evaluation,of Vista's muriatic acid. The evaluation would determine which further course of action to pursue, such as, applying for a food additives petition or possibly exiting the food grade market. It was subsequently decided at a Business Area/Manufacturing meeting in January of 1990, to delay the risk assessment evaluation until a decision is reached on a Pacol at Baltimore. If the outcome of the Pacol at Baltimore decision is that the Baltimore Plant will continue to produce by-product muriatic acid, we should begin to take independent steps to get our muriatic acid approved by the FDA. Through our participation on IFAC's Ad Hoc HC1 Committee, we have learned that Vista's muriatic acid is one of the least contaminated by-product muriatic acids on the market. The AD Hoc Committee is now in the process of gathering data on the impurities in "on-purpose" muriatic acid made by burning -hydrogen with chlorine. The FDA had originally concluded that the "on-purpose" burner acid was the least contaminated food grade muriatic acid available, and thus considered eliminating all by-product acid from food applications. We hear on the Ad Hoc Committee that the FDA now realizes that "on-purpose" burner acid is not as pure as once thought. A V VEV-l43760 ATTACHMENT 1 pag* 3 of 3 I xpect to hear before the next Ad Hoc HC1 Committee meeting in May 1991 what the contaminant levels are in "on-purpose" burner acid. If the contaminant levels in burner acid are found to differ not significantly from vista's by-product muriatic acid, this will support Vista taking independent action to get our muriatic acid approved by the FDA. Mitchell A. Fishbein Senior Process Engineer Baltimore Chemical Plant .V A \ VEVM 43761 ATTACHMENT 2 A COMPOUND Carbon Tetrachloride Chloroform Chlorofluorocarbons Heavy Metals Methyl ne Chloride Benz ne Chi rob nzene ( r Dichlorobenzene) T luen cific Fluorocarbons Chi r difluoro Dichlor fluoro Dichlorodifluoro Trichl rofluoro Results Of IFAC/HCL Committee Survey July 6, 1990 QUESTION 0.05 PPM Limit 0.05 PPM Limit Reduce 25 PPM 1 PPM Limit 0.05 PPM Limit 0.05 PPM Limit 0.05 PPM limit 0.05 PPM Limit CONSENSUS Kimed-Several Agreec Mix 1.0 PPM No One Agreed Max 2.0 10 PPM Total a possibility. Unanimous Agreement "NO" Max 2.0 Mixed-Some Agreed "NO" 0.7 PPM Limit "No" (IR1S/RFD is 10FPM) 10 10 4 10 (Total) MEM-143762 [NTEKXATIf >\.\L 4 Food Additives^ Council ATTACHMENT 3 February 6, 1991 A TO: Ad Hoc Hydrochloric Acid Committee RE: Minutes - Ad Hoc HCL Committee Meeting January 15, 1991 Attached are the Minutes of the Ad Hoc HCL Committee Meeting held on January 15, 1991 at The Madison Hotel, Washington, D.C. Please note those action items, indicated by an *, where you have agreed to an action item and plan. If you have questions and comments, please do not hesitate to call. Sincerely, AGE/nwn Attachment Q. h- (LhtAj- jUmj A. Q. Ebert, Ph.D. Executive Director A INTERNATIONAL FOOD ADDITIVES COUNCIL Ad Hoc Hydrochloric Acid Committee Meeting January 15, 1991 The Madison Hotel Washington, DC - 10:00 a.m. Minutes CALL TO ORDER The meeting was called to order and self-introductions were com pleted. The. Kellen Company Antitrust Guidelines were available and their contents briefly reviewed. H. LIST OF ATTENDEES A list of attendees Is attached to and made a part of these minutes. III. REVIEW OF PREVIOUS MINUTES The minutes of the June 7, 1991 meeting were approved as drafted. It was noted that additional follow-up action is required specifically the potential need for filing an FOI request on the matter of con stituent assays of high fructose corn sweeteners. IFAC Council agreed to follow-up on this matter*. iV. CPi CONSULTING ASSOCIATES REPORT A copy of a CPI letter to Mr. Talbot was circulated to members. A copy Is attached to the master book copy of these minutes. Several committee members reported that they are subscribing to a soon-to-be-publlshed SRI study on the Hydrochloric Acid busi ness. The subscribers agreed to review the SRI study on receipt, supplement the CPI data, and send additional Information to IFAC headquarters for potential submission to FDA and the FCC. ,\ \ KJBJ-143764 N A V. REVIEW OF CONSTITUENT DATA Results of the IFAC/HCL Survey of July 6, 1990 were discussed in the aggregate and a copy of the consensus data circulated. A copy of the report is sent to non-attending committee members and is attached to the master book copy of these minutes. Following discussion, participants agreed in a straw vote that a limit of 2mg/kg for total organic compounds could be proposed to FCC. This is a marked reduction from the 5mg/kg limit established in FCC III, 2nd supplement. Participants- also agreed to retention of the 25mg/kg total fluorlnated organic compounds limit based on the adequate safety data base that has been established for the fluorocarbons. Participants also informally agreed to a 1 mg/kg heavy metals limit. Therefore, staff agreed to draft a suggested revised monograph for review by the HCL Committee.* Noting the FCC's on-going interest in on-purpose acid, several participants whose companies produce on-purpose acid agreed to complete constituent assays for their product. Several committee members remarked on-purpose acid is not necessarily marketed for food use. Nevertheless, participants agreed to increase the Committee's database and have the constituent data made avail able to IFAC. Approximately six weeks will be required for comple tion of those assays.* These minutes further request that constituent data be identified as coming from on-purpose acid marketed for food use - or not. As a result of the re-emerging interest in on-purpose acid, it was suggested that several producers of this product be contacted and their membership on the IFAC Ad Hoc HCL Committee be solic ited. Committee members agreed to provide names and addresses for IFAC staff for follow-up.* VI. DISCUSSION OF AVAILABLE TOXICOLOGY DATA Noting that there were several review articles on various toxico logic constituents, either available or in preparation. It was the sense of the Committee to anticipate the collection of no additional toxicology data at this time. 2 ^'143765 A VII. DRAFT SUBMISSION TO FOOD CHEMICALS CODEX Staff agreed to prepare for Ad Hoc Committee review the following:* A suggested draft FCC Monograph for Hydrochloric Acid. A revision of the draft reply dated May 18, 1990 to Dr. Bigelow sent to Committee members - but not submitted to FCC. The revised reply will include: Information on HCL production and use from the CPI Report - to be supplemented by the SRI Report. Information on constituents and levels, thereof, as called for in the Bigelow letter of March 2, 1990 Paragraph 2. Information on constituents in on-purpose acid to be provided. Additional information felt to be appropriate. Decision will be based on informal discussion of HCL at the FCC Winter meeting. VIII. PLAN OF ACTION The Committee agreed: Informal discussion on HCL will continue at the Winter FCC meeting and, if heeded, elsewhere. Data on constituents in on-purpose acid will be acquired and circulated in the aggregate to each Ad Hoc HCL Committee members. The CPI Report will be supplemented by the SRI data. The draft response to Dr. Bigelow's March 2, 1990 letter will be sent to the Committee for review. The Committee will meet again in Atlanta at IFAC headquar ters on Thursday, May 2, 1991 (tentative, subject to confirmation). \3 VEV-143766 A IX. FINANCIAL STATUS A summary of expenditures incurred in 1990 was circulated. Staff pointed out that the treasury was now depleted. The proposed 1991 budget as indicated on a handout, attached to the master copy of these minutes was discussed and approved. With antici pated participation of eight companies, pro-rata invoices to fund the 1991 budget will be mailed. It was further agreed So increase the treasury by adding funds from new members as they join the organization. X. ADJOURNMENT There being no further business, the meeting adjourned at 12:16 p.m. 4 v#S>'V 437 INTERNATIONAL FOOD ADDITIVES COUNCIL HYDROCHLORIC ACID COMMITTEE MEETING THE MADISON HOTEL - WASHINGTON, D.C. TUESDAY, JANUARY 15, 1991 . LIST OF ATTENDEES Robert Buccafusco John Reid Judy Brunton Phillip Armstrong Donald Naragon Jim Joyce Randy Childers David Guenther Evert Talbot Mitch Flshbein Joe Gregg George Butler Allied-Signal, Inc. Atochem North America BASF Corporation Mobay Corporation Reagent Chemical & Research Vista Chemical Company Vulcan Chemicals Clausen Ely Andrew Ebert Covington & Burling International Food Addltivles Council ATTACHMENT 4 0 OVERVIEW OF RE^TIONSHIPS WITH REGULATING FOOD GRADE MURIATIC ACID II (1) ONE OF THESE ACTIONS BY THE FDA WILL BE NEEDED TO CONTINUE MARKETING VISTA BY-PRODUCT MURIATIC ACID FOR FOOD APPLICATIONS ,IF THE CURRENT GRAS STATUS OF BY-PRODUCT ACID IS ELIMINATED. (2) THE I FAC REPRESENTATIVE AND LEADER OF THE AD HOC HYDROCHLORIC ACID COMMITTEE IS ALSO ONE OF THE FOURTEEN MEMBERS OF THE FOOD CHEMICALS CODEX REVISIONS COMMITTEE. r 6?<Lb l-A 3 fl