December 20, 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 a new bioterrorism prevention bill passed by the House of Representatives (but not yet by the Senate) that would significantly expand the Food and Drug Administration's (FDA) authority to respond to threats of bioterrorism. We also report on the passage of the FY 2002 agriculture spending bill, which had been delayed due to the September 11th terrorist attacks and anthrax scares in Washington, D.C. Finally, we discuss FDA's lowering of the consumption factor for polyethylene terephthalate (PET) from 0.21 to 0.16; the status of the search for a new FDA Commissioner; recent developments in the area of food irradiation; and a new procedure at FDA requiring that all warning letters issued by the Agency must receive clearance from the Agency's Office of Chief Counsel before they are issued. We also want to take this opportunity to wish everyone a happy holiday season and a safe, healthy, and prosperous New Year.

1. Bioterrorism Prevention Bill Overwhelmingly Passes House on Fast-Track Approval
   
   
2. Congress Approves FDA FY 2002 Funding
   
   
3. FDA Lowers Consumption Factor for PET
   
   
4. FDA Commissioner Candidate List Expanded
   
   
5. FDA Rejects Food Contact Notification on EVOH to Hold Food for Irradiation; FDA Asked to Report on Outcome of Irradiation Focus Groups; Public Citizen Continues Its Assault on Irradiation of Food Products
   
   
6. FDA Office of Chief Counsel Must Clear All Agency Warning Letters
   
   

1. Bioterrorism Prevention Bill Overwhelmingly Passes House on Fast-Track Approval

As we have been reporting to you, there are several pieces of legislation that have been introduced in Congress that would expand the authority of the Food and Drug Administration (FDA) in response to threats of bioterrorism. Over the past couple of weeks, a new bill, H.R. 3448 ("Public Health Security and Bioterrorism Response Act of 2001"), was introduced and initially moved swiftly through Congress. On December 12th, only a few days after being introduced, the legislation was overwhelmingly approved by the House. The Senate was rumored to be poised to approve the bill by the end of the year, but passage of the bill likely will be delayed until after the new year, as Congress will be adjourning for winter recess at the end of this week. The prospects for passage at all in the Senate are unclear; the Senate currently appears more inclined to increase funding for FDA and other agencies to address bioterrorism and less interested than the House in expanding government authority.

H.R. 3448, in Section 302, would provide FDA with the authority to detain an article of food for up to 30 days if there is credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death. H.R. 3448 also has provisions that would impose new facility registration requirements and require at least 24 hours advance notice of importation. We believe the drafters of H.R. 3448, and the members of the House in passing it, intended most of the provisions to apply to food products, not packaging. The terminology used in some parts of the bill, however, might be interpreted in some cases as extending to food packaging.

One portion of the bill, Section 304, specifically references food packaging. This section would authorize FDA to impose new record keeping requirements "as may be necessary to trace the source and chain of distribution of food and its packaging" to address credible threats of serious adverse health consequences or death. This "traceability" concept, currently very much in vogue in Europe, could impose a significant burden on industry, depending on the regulations issued by FDA.

We, along with SPI, are closely monitoring the specific language and the progress of the various bioterrorism bills and will continue to keep the Committee informed. SPI is specifically working to protect the interests of Committee members and is prepared to take appropriate action if it appears that there are any provisions that would have a significant adverse effect on members.

2. Congress Approves FDA FY 2002 Funding

Congress recently passed the FY 2002 agriculture spending bill, which was signed by the President on November 29th. Included in the legislation is the full $1.414 billion President Bush sought for FDA, a 9.5% increase from the FY 2001 level. Of this total, $312 million will go to the Center for Food Safety and Applied Nutrition. Separate legislation is pending in Congress that would provide FDA with additional funding to expand its food safety inspection capacity to thwart threats of bioterrorism

3. FDA Lowers Consumption Factor for PET

Market data recently submitted to FDA on polyethylene terephthalate (PET) has provided the basis for the Agency's re-revision of their consumption factor (CF) for the polymer. As you may know, prior to FDA's May 2000 guidance document "Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations," the long-standing CF for PET was 0.05. When the Agency issued this guidance, it raised the CF to 0.21, a significant increase.

In a September 27, 2001 memorandum, the Agency responded to additional data submitted by the American Plastics Council (APC) and the National Association for PET Container Resources, Inc. (NAPCOR) and lowered the CF from 0.21 to 0.16. The new CF is a result of the smaller contributions of carbonated soft drink bottles and custom containers to the overall CF for PET due to slightly lower poundage values for these two market segments than FDA previously used. Keller and Heckman and SPI staff also reviewed the data developed by APC and NAPCOR before it was submitted.

4. FDA Commissioner Candidate List Expanded

The search for a new FDA Commissioner does not seem to be coming to a close, as new names continue to surface on the candidate list. Two of the most recently added names are David Sundwall, president of the American Clinical Laboratory Association, and Mark McClellan, a member of the White House's Council of Economic Advisors. Both of these candidates are medical doctors, a credential that likely would appeal to members of the Congressional subcommittee that will oversee the nomination of the next FDA Commissioner.

Dr. Sundwall was vice president and medical director of American Healthcare System, the largest coalition of not-for-profit multi-hospital systems in the United States, before joining the American Clinical Laboratory Association. Prior to his position on the White House Council of Economic Advisors, Dr. McClellan was an associate professor in the Department of Economics and the Department of Medicine at Standford University.

5. FDA Rejects Food Contact Notification on EVOH to Hold Food for Irradiation; FDA Asked to Report on Outcome of Irradiation Focus Groups; Public Citizen Continues Its Assault on Irradiation of Food Products

We understand that FDA has rejected the food-contact notification (FCN) for ethylene vinyl alcohol (EVOH) to hold food for irradiation. As we have reported previously, this FCN was filed by the National Center for Food Safety and Technology (NCFST), located near Chicago. It appears that the "rejection" was due to a change in FDA's position on the type of samples tested, not on a finding that EVOH actually is "unsafe" as part of packaging for food that is irradiated. We understand that this is FDA's first formal objection to an FCN; other filings deemed unacceptable by the Agency have been withdrawn by the filers.

This development is disappointing, and we are concerned about FDA's apparent difficulty in settling on a consistent position with respect to the proper approach for obtaining clearance of polymers and additives used to hold food for irradiation. Nevertheless, this development leads us to reiterate our position that materials with FDA compliance for food contact (absent irradiation) also may be used to package food that is then irradiated (without further clearance by FDA) as long as appropriate data establish that there is no significant change in the nature or amount of potential migrants. We note the following statement on this subject in the December 17, 2001, edition of Food Chemical News (page 7).

"Sources inside and outside FDA told Food Chemical News that they do not believe the agency will use its resources to challenge these self-determination claims."

6. FDA Office of Chief Counsel Must Clear All Agency Warning Letters

Effective December 14th, all warning letters issued by FDA must receive clearance from the Agency's Office of Chief Counsel before they are issued. Under the system in effect before that date, FDA districts had the autonomy to issue warning letters, which are considered a key enforcement tool of the Agency. FDA was informed of the new mandate in a memorandum issued by Health and Human Services Deputy Secretary Claude Allen.

It is being speculated that the new process will result in the issuance of fewer warning letters. The new process could result in FDA's establishing stricter criteria for drafting a warning letter, under which inspectors would draft letters only in instances where the Agency has sufficient evidence to seize the product if the company does not immediately correct the problems identified in the letter. Recent reports indicate that over 90 percent of current warning letters do not meet that standard of evidence.

Even if stricter criteria are not implemented and inspectors continue to draft warning letters at their current rate, it is likely that the Office of Chief Counsel would deny some of the drafts or simply not get around to reviewing all of them.

* * *

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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