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 April 21, 2000 (202) 434-4110 The Society of the Plastics Industry, Inc. Food, Drug, and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen: In this letter we provide you with information on recent developments with regard to the Food and Drug Administration's risk assessment of styrene. We also report on expected changes in personnel in the Center for Food Safety and Applied Nutrition, current priorities in the Office of Premarket Approval, and developments with EPA's Voluntary Children's Chemical Safety Testing Program, NSF/ANSI Standard 61 and Type I DMFs. Table of Contents
1. Developments in FDA's Risk Assessment for Styrene As you may recall, in the Fall of 1998, FDA decided to suspend action on all food additive petitions involving styrene monomers and polymers, including petitions involving both butadiene and styrene. This suspension was triggered, in part, by an extensive FDA review of all of the available toxicology data on styrene and a follow-up draft memorandum recommending that FDA decide whether styrene is a carcinogen. In response, FDA commissioned an outside contractor to review 20 selected epidemiology studies on styrene. The contractor's work will be considered by FDA's Cancer Assessment Committee (CAC), in determining if styrene should be deemed a carcinogen. If so, the Quantitative Risk Assessment Committee (QRAC) will develop a "virtually safe dose" (VSD) for styrene. In an effort aimed at allowing action on pending petitions to resume, while the CAC deliberated, FDA embarked on development of a unit risk for styrene based on the "worst case" animal study results available, assuming that styrene is a carcinogen. This unit risk determination was facilitated by submission by this Committee's Polystyrene Work Group of a toxicology study on styrene conducted for The Styrene Information and Research Center, Inc., (SIRC), in August 1998. This study showed carcinogenic effects in mice, which FDA used as the basis for a "worst case" estimated VSD of 1.2 ppb in the diet. On the basis of this interim estimated VSD, FDA has been able to act favorably on some pending petitions and notifications. As no decision is expected from the CAC in the immediate future, this worst case value for the time being will be the standard against which petitions and Food-Contact Notifications on products containing residual styrene will be evaluated. We have scheduled an April 25 meeting with FDA, however, for SIRC to present additional data suggesting that the effects found in mice may not require treatment of styrene as a human carcinogen.
1. Expected Retirements from CFSAN Office of Premarket Approval Apparently, due in part to the anticipated move of most or all of the Center for Food Safety and Applied Nutrition (CFSAN) to the new College Park, Maryland facility in the next year, a number of CFSAN personnel are expected to retire in the next several months. Eugene Coleman, Director of the Division of Petition Contro will be retiring this June. Also Julius Smith, a Consumer Safety Office (CSO) in the Office of Premarket Approval, one of the two CSO's handling Threshold of Regulation Requests, is expected to retire this coming Fall, as is Greg Cramer, a former review Chemist, now with the Office of Seafood. At least 3 additional key people involved in petition review have indicated that they will likely retire before the move to College Park, but as yet have not set dates.
1. OPA Gives Expedited Petitions and Food-Contact Notifications Top Priority The Office of Premarket Approval (OPA) has indicated that it is giving top priority to review of food additive petitions that qualify for expedited action due to pathogen reduction impact and food-contact substance notifications. Consequently, these priorities have eclipsed Agency action on Threshold of Regulation applications and other activities including rulemakings. George Pauli, director of OPA's Division of Product Policy, indicates that OPA has had to redirect its focus due to the major effort currently being expended on the new Food-Contact Notification program and its attendant demands for review of safety data. In its priorities for fiscal year 2000, CFSAN established a goal for OPA to complete 80%-90% of food and color additive petitions that qualify for expedited review within 360 days of their filing. At the end of February 2000, OPA had nine petitions under expedited review, five of which were submitted within one year. Six of the petitions are for ionizing radiation and one is for ultraviolet radiation.
1. New Framework Document Available for The Voluntary Children's Chemical Safety Testing Program As we reported to you in our most recent newsletter, the Environmental Protection Agency (EPA) made draft documents available concerning the Voluntary Children's Chemical Safety Testing Program(VCCSTP) in early March, 2000. On April 10, 2000, EPA posted a revised draft document on its website (http://www.epa.gov/chemrtk/kdsfr410.htm) in advance of the final stakeholder meeting on VCCSTP being held on April 26-27, 2000. You will note in the documents that EPA indicates it is explicitly examining all exposure pathways, including consumer products, food, and the environment. In addition, the draft list of chemicals considered for the voluntary program has been further refined, and EPA is apparently in the process of developing analyses to clarify the current availability of hazard data on the listed chemicals. As you know, this EPA program is being followed closely by SPI's Occupational Health and Environmental Issues Committee (OHEIC). For continuing information on this issue, please contact Lynne Harris of SPI, (202) 974-5217, who is directing OHEIC'>s activities concerning this EPA program.
1. Ballot for Proposed Updates to NSF/ANSI Standard 61 Proposed amendments to the American National Standards Institute/NSF International (ANSI/NSF) Standard 61, "Drinking Water System Components - Health Effects" are the subject of a ballot due to be returned on May 1, 2000. As you may know, the purpose of ANSI/NSF Standard 61 is to establish minimum health effects requirements for the chemical contaminants and impurities that are indirectly imparted to drinking water from products, components, and materials used in drinking water systems. The products and materials include process media, protective materials, joining and sealing materials, pipes and related products, mechanical devices used in treatment/transmission/distribution systems, and mechanical plumbing devices. Products or materials are evaluated by performing the extraction tests set forth in Annex B of Standard 61; the extraction testing procedure varies depending on the end-use of the product or material, i.e., distinct time and temperature procedures are established for pipes and related products, barrier materials, joining and sealing materials, process media, and mechanical devices. Furthermore, the compositional nature of the product or material dictates that the extract obtained using these procedures be analyzed for specific substances or groups of substances related to the chemical nature of the product or material, as set forth in Section 3 of Standard 61; in addition, NSF has recently incorporated a new analytical test, which is not specifically included in the Standard, with the intention of determining if there are any unexpected materials extracted that were not anticipated from a review of the formulated product. You may recall that a self-funded task group, formed under the auspices of this Committee, has been addressing certain issues under this Standard. In implementing its new analytical technique, NSF was finding additional migrants, including unidentifiable substances (and substances with questionable spectroscopic identification), and requiring toxicity data on these substances as a condition of certifying new products under the Standard, and even recertifying existing products. The most favorable of the proposed changes to ANSI/NSF Standard 61 is the addition to the standard of section B.9.4.2.4. entitled "General Requirements for unknowns via GC/MS analysis." This paragraph states that analytes detected during Gas Chromatography/ Mass Spectrometry (GC/MS) analysis for which identification cannot be ascertained will not be considered in determining a particular product's compliance with the standard. Rather, the testing organization will report the results to the product manufacturer with the expectation that the manufacturer will assist the testing organization in determining the identity of the compounds. This proposed amendment responds to the current issue of certified products failing re-certification due to the detection of unknown analytes during the GC/MS analysis. NSF has in such cases asked manufacturers to supply toxicology information to prove the product is safe despite its previous certification. Another proposed amendment is the inclusion of method validation procedures and general requirements for GC/MS analysis. These additions respond to complaints that non-NSF laboratories have not been provided the guidelines to certify manufacturer compliance with the standard., even though they possess the capabilities to do so. The amended ANSI/NSF Standard 61 now would have quality assurance guidelines to facilitate testing by other organizations.
1. FDA No Longer Accepting or Maintaining Type I Drug Master Files In the January 12, 2000 Federal Register, FDA published a final rule which becomes effective July 10, 2000 and eliminates Type I Drug Master Files (DMF). Stated another way, FDA will no longer accept submission of this type of DMF, nor will the Agency permit Investigational New Drug Applications (INDs), New Drug Applications (NDAs), or Abbreviated New Drug Applications (ANDAs) to reference information contained in a Type I DMF. Type I DMFs include manufacturing site, facilities, operating procedures, and personnel information. The Agency has determined that these submissions are not necessary to conduct inspections of manufacturing facilities or to facilitate the review of the chemistry, manufacturing, or controls sections of INDs, NDAs or ANDAs. Type I DMFs have only been recommended by FDA for foreign manufacturing establishments where drug ingredients are produced, but we know that some Committee members are involved with such products, as well as packaging materials. More About SPI: Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . Calendar of Events . Terms and Conditions of Use |
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 © Copyright 2005 The Society of the Plastics Industry.
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