July 10, 2001

(202) 434-4120

simmons@khlaw.com

The Society of the Plastics Industry, Inc.

Food, Drug, and Cosmetic Packaging Materials Committee

Dear Ladies and Gentlemen:

In this letter we report on the Food and Drug Administration's (FDA) development of a database of cumulative estimated dietary intake (CEDI) and acceptable daily intake (ADI) information, which will be maintained on its website. We also discuss the Bureau of Alcohol, Tobacco, and Firearms and FDA's jurisdiction over the alcoholic beverage industry, including alcoholic beverage containers. Finally, we bring you up-to-date on the Environmental Protection Agency's peer review of the draft dioxin reassessment, the European Commission's decision to extend for the sixth time the ban on the marketing of toys and childcare articles made of soft polyvinyl chloride containing certain phthalate plasticizers and intended to be placed in the mouth by children under three years of age, and other matters of interest to the Committee.

1. FDA Developing CEDI/ADI Database
   
   
2. ATF and FDA Authority to Regulate Alcoholic Beverage Safety
   
   
3. FDA Subcontractor Completes Review of Comments on Labeling of Irradiated Foods
   
   
4. FDA Directs Inspectors to Check Packaging Materials for Allergans
   
   
5. Jeffords Defection from GOP Could Affect Food Safety Agenda and Search for New FDA Commissioner
   
   
6. EPA Peer Review of Draft Dioxin Reassessment Completed
   
   
7. EC Decides to Extend Ban on Soft PVC Toys
   
   
8. EU Drafting Guidelines on Petitions for Biocidal Substances
   
   

1. FDA Developing CEDI/ADI Database

One notable difference between Food Additive Petitions and Food-Contact Notifications for food-contact substances is the new responsibility placed on submitters to calculate the cumulative estimated dietary intake (CEDI) to potential migrants. Submitters of FCNs are required to estimate the CEDI from all sources of exposure, rather than just the estimated dietary intake (EDI) from the use that is the subject of the notification. Up until now, this information could only be obtained from the Agency on a case-by-case basis. Now, CEDI information can be found on FDA's website at http://www.cfsan.fda.gov/~dms/opa-edi.html.

Information on the "acceptable daily intake" (ADI) of certain substances also can be found on the FDA database. The ADI, another critical aspect of notifications, is the highest intake level of the substance that may be cleared based on the available data. ADIs are determined from the lowest "no-observed effect level" (NOEL) established in feeding studies performed on the substance.

The CEDI/ADI database certainly is not exhaustive, and the Agency continues to compile information on substances and add them to the list. Submitters can continue to contact FDA to obtain CEDI/ADI information for those substances not found on the database.

2. ATF and FDA Authority to Regulate Alcoholic Beverage Safety

The Bureau of Alcohol, Tobacco, and Firearms (ATF) enforces a broad range of laws governing the production, distribution, and labeling of alcoholic beverages (beer, wine, and distilled spirits). The Federal Alcohol Administration Act, passed after prohibition, coupled with certain Internal Revenue Code provisions, authorizes ATF to regulate the alcohol industry and to provide protection for consumers of alcoholic beverages. In addition to law enforcement and tax collection activities, ATF is responsible for testing alcoholic beverages to determine potential adulteration problems. To accomplish this goal, the Bureau relies on the ATF National Laboratory Center (NLC) to test new alcohol products that enter the marketplace. Each year, ATF laboratories also sample alcoholic beverages in the stream of commerce in an effort to identify contaminates or adulterates.

While ATF has primary jurisdiction over the alcoholic beverage industry, ATF has consistently utilized the scientific and public health expertise of FDA to ensure protection to consumers of alcoholic beverages. In fact, ATF is authorized by law to utilize the services of any government department or agency to carry out its powers and duties under the Federal Alcohol Administration Act. ATF regularly consults with FDA regarding the approval of ingredients in alcoholic beverages and the requirement of label disclosure for certain substances. ATF has also developed a consultative approach to adulteration problems. For example, a Memorandum of Understanding (MOU) issued in 1987, authorizes FDA to assist ATF in ensuring the public safety of alcoholic beverages. More specifically, the MOU directs FDA to contact ATF when FDA learns or is advised that an alcoholic beverage is or may be adulterated. FDA must also provide laboratory services and health hazards evaluations at ATF's request.

ATF essentially defers to FDA when new substances are used in alcoholic beverage containers. Alcoholic beverages are considered food under the Federal Food, Drug, and Cosmetic Act (the FFDC Act), and ATF has long taken the position that all alcohol storage containers (including metal/plastic containers, cups, pouches, tubes, and closures) are food-contact substances. For this reason, ATF requires importers and producers to notify the Bureau whenever new materials are used in contact with alcoholic beverages and to show compliance with FDA's food additive regulations.

Certainly, ATF will accept without difficulty the use in alcoholic beverage containers of substances explicitly cleared by FDA in food additive regulations covering the intended conditions of use. ATF will also allow the use of substances cleared under FDA's new Food-Contact Notification system, which has superseded the process of issuing food additive regulations. FDA excludes substances that are "generally recognized as safe" (GRAS) from the definition of "food additive" and exempts these substances from premarket clearance requirements. For new container materials that are claimed to be GRAS, the Bureau requires producers to declare that the substance is listed as GRAS in Parts 182, 184, or 186 of the food additive regulations. In instances where the proposed substance is not listed in the regulations, general recognition of safety must be based on scientific procedures, or in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. However, ATF will not accept company self-determinations of GRAS status for substances not specifically listed in the GRAS regulations. ATF instead requires producers to obtain a written confirmation from FDA stating that the substance qualifies as GRAS.

The approval process becomes much more laborious when alcohol producers intend to use materials that are not cleared for use under indirect food additive or GRAS regulations, or by Food-Contact Notifications. In such instances, ATF requires producers to obtain an "opinion" from FDA stating that the uncleared substances will not be expected to become a component of the alcoholic beverage. According to FDA, this means that manufacturers must file a food-contact notification (FCN). Once an FCN becomes effective, ATF will concur with FDA by issuing a letter to the producer stating that the uncleared substance can be used. This procedure is the same for any uncleared (by FDA) substance that will contact alcoholic beverages.

It is evident that the Bureau's deference to FDA poses a number of obstacles for producers who wish to use new substances in alcohol containers. First, ATF broadly concludes that all alcohol containers are considered to be composed of indirect food additives. This generalization does not account for cases in which a substance is not reasonably expected to become a component of the alcoholic beverage and, therefore, is not considered to be a "food additive" under the FFDC Act. Under the FFDC Act, a company may independently determine whether a substance is a food additive. For example, FDA exempts from food additive regulations substances that are separated from food by a functional barrier. Also, substances that migrate to food at insignificant levels (generally less than 50 ppb) are not food additives by definition, and may be used without any prior consultation with FDA. ATF's current procedure for approval of alcoholic beverage containers does not recognize these exemptions, and as a result, compels the filing of an FCN for any proposed component of packaging for alcoholic beverages that does not already have explicit FDA clearance. Filing an FCN can sometimes be an expensive process, and the process can seem frustrating when such a submission is not necessary under the FFDC Act; however, filing an FCN is still better than having to file a Food Additive Petition, the action that would be required to satisfy ATF if the FCN program had not been put in place.

3. FDA Subcontractor Completes Review of Comments on Labeling of Irradiated Foods

FDA's subcontractor, ICF, has completed its review of the 5, 902 letters the Agency received in response to its request for comments on whether and in what form labels should be placed on irradiated foods. The comments were solicited in FDA's February 17, 1999 advanced notice of proposed rulemaking (See 64 Fed. Reg. 7834). Congress has directed FDA to issue a final rule by March 1, 2002.

ICF is reporting that 73% of all respondents support mandatory labeling of irradiated foods. Some consumer interest groups call for clear labeling of irradiated foods, while others, such as Public Citizen, completely oppose the irradiation of food. Food companies and industry associations generally oppose labels or support voluntary labeling.

Currently, foods that have undergone irradiation must be labeled as such. Foods that merely contain irradiated ingredients are not required to be labeled. The "radura" logo must be placed prominently, along with a disclosure statement that the food has been irradiated.

4. FDA Directs Inspectors to Check Packaging Materials for Allergans

A recently-issued FDA Inspection Guide includes directions to check packaging materials for allergens. The April 2001 Guide, entitled "Guide to Inspections of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients," has a specific reference to the possible presence of wheat residue on foil due to the use of a wheat ingredient in a releasing agent used in the production of the foil.

Typically, the focus on allergenic substances has been in relation to the food ingredients themselves. The reference in the Inspection Guide is at least an indicator that FDA is beginning to look at packaging ingredients as possible routes of exposure to allergenic substances.

5. Jeffords Defection from GOP Could Affect Food Safety Agenda and Search for New FDA Commissioner

Sen. Tom Harkin (D-Iowa) is now Chairmen of the Senate Agriculture Committee, which will give him a stronger platform from which to push his food safety agenda. Harkin previously has called for the creation of a single food safety agency, and supports giving USDA undisputed authority to set and enforce microbial performance standards.

The shift in power in the Senate also may have an effect on the search for a new FDA Commissioner. Controversial issues such as the RU-486 "abortion pill," cloning and stem cell research are already rumored to be hindering the Bush Administration's search for a new FDA Commissioner. Now that new Senate health committee chair Edward Kennedy (D-MA) will be overseeing the FDA commissioner Senate confirmation process, these controversial topics may become even more of an issue.

6. EPA Peer Review of Draft Dioxin Reassessment Completed

As we have been reporting to you, in 1994 the Environmental Protection Agency (EPA) released a draft reassessment report that classifies dioxin as a human carcinogen, and estimates that, in worst-case scenarios, dioxin may pose a risk as high as 1 in 100 to 1 in 1,000 for the general population. The report also confirms that food is the primary source of exposure to dioxin.

EPA science advisors have since conducted a peer review of the assessment, and forwarded their last review to the Agency on June 1, 2001, clearing the way for EPA to update and finalize the report. EPA officials have suggested that they will not finalize the report until FDA and the U.S. Department of Agriculture (USDA) review the study. At the same time, sources at FDA and USDA say that the agencies do not plan to conduct their own review of the assessment. Rather, they are going to defer to a study being conducted by the National Academy of Sciences (NAS).

The NAS study was initiated by EPA, FDA and USDA last August in an effort to resolve the interagency debate over dioxin. The NAS study is focusing on whether widespread dioxin contamination in air and water affects the domestic food supply and whether regulatory action is warranted to protect the public health.

7. EC Decides to Extend Ban on Soft PVC Toys

The European Commission (EC) has extended for the sixth time its ban on the marketing of toys and childcare articles made of soft polyvinyl chloride (PVC) containing certain phthalate plasticizers and intended to be placed in the mouth by children under three years of age. The PVC materials covered by the EC decision contain one or more of the following phthalates: di-iso-nonyl phthalate (DINP), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), di-iso-decyl phthalate (DIDP), di-n-octyl phthalate (DNOP), and butylbenzyl phthalate (BBP).

As we reported to you previously, the original decision, which was instituted on December 7, 1999, alleged that phthalates pose a serious and immediate risk to children, and required Member States to take all necessary measures to implement the decision in less than 10 days. The EC action was taken despite strong opposition from the Commission's own scientific advisors (the Scientific Committee for Toxicology, Ecotoxicity, and the Environment (CSTEE)), which took the view that the data do not indicate a significant risk. The ban is now in effect until September 6, 2001.

In June, 2001, the Chronic Hazard Advisory Panel of the Consumer Products Safety Commission (CPSC) released a report concluding that the risk to children of DINP plasticizer in PVC is "minimal to non-existent." The panel did acknowledge that studies show that DINP can cause developmental and reproductive effects in rats, but the usage in toys is at such low levels that the risk in humans is at most "extremely low." The panel cautioned, however, that "there may be a DINP risk for any young children who routinely mouth DINP-plasticized toys for 75 minutes per day or more." The report is available on CPSC's website at http://www.cpsc.gov/LIBRARY/FOIA/Foia01/os/dinp.pdf.

Some toy manufacturers had voluntarily stopped using DINP in the manufacture of toys when CPSC launched its investigations. Now, in light of CPSC's findings, David Miller, President of the Toy Manufacturers Association, is quoted in the July 2, 2001 issue of Plastics Business News as saying that his association will encourage its members to go back to using DINP.

8. EU Drafting Guidelines on Petitions for Biocidal Substances

Concerns have been raised over several petitions that have been submitted to the European Union's (EU) Scientific Committee on Food (SCF) for biocidal products. The SCF is having difficulty in determining what criteria to use in evaluating the safety of these products for use in food-contact applications. In fact, some of these products appeared in earlier drafts of the sixth amendment, but were removed in subsequent drafts due to concerns as to whether they were being reviewed adequately given their "special" nature.

In response to these concerns, the SCF's Food Contact Materials Working Group is preparing guidelines to establish the data requirements for the safety evaluation of these substances. The guidelines will be prepared in close cooperation with the Food Microbiology and Hygiene Working Group.

* * *

As always, if you have any questions on the above, or if we can be of assistance in any other way, please do not hesitate to contact me, Jerry Heckman or Deborah Ziffer.

Cordially yours,

Ralph A. Simmons

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