Introduction.

On January 18, 2001, the United States Food and Drug Administration (FDA) released its long awaited revisions to its policy on genetically engineered foods. These revisions consist of two documents: (1) A proposed regulation entitled "Premarket Notice Concerning Bioengineered Foods," and (2) a voluntary guidance entitled "Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering." See, 66 Federal Register 4706, 66 Federal Register 4839 (January 18, 2001). What follows is a brief synopsis and analysis of the proposals. The Center for Food Safety will provide a more in-depth analysis in the coming days.

I. Proposed Pre-market Notification

The new FDA proposal reaffirms its 1992 Policy on genetically engineered foods and does not require any mandatory pre-market safety testing of genetically engineered foods. The FDA restates its position that genetically engineered foods are assumed generally recognized as safe so they are not subject to mandatory pre-market safety review under the Federal Food Drug and Cosmetic Act's Food additive petition process. Despite the filing of the CFS, et al. legal petition (March 19, 2000) and the public testimony of numerous people, the Agency maintains this position by asserting that the Agency is aware of no new science calling into question the safety of GE foods.

In addition to not requiring specific pre-market safety testing, the FDA maintains that companies may voluntarily consult with FDA concerning the safety of their foods. This appears to be a regression from its past suggestions that these consultations would be mandatory. In the proposal, FDA readily admits the voluntary nature of such consultation will continue:

The only really new requirement put forth in the proposed regulation is that a genetically engineered (GE) food producer must send a letter to FDA notifying FDA of its intent to market such a food. The letter must be sent 120 days in advance of marketing.

The letter (known as a pre-market biotechnology notice) must include information of several topics including descriptions of the foods, methods of the food's development, use of antibiotic resistant markers, information about substances introduced into the foods (including allergencity issues), and information comparing it to a conventional, comparable food.

As exposed in the StarLink incident, the FDA currently has no immediate ability to trace a GE food through the food supply should a harm to public health become apparent. As a result, the FDA specifically seeks comment as to whether a producer's pre-market notification letter should be required to include methods by which its food could be detected once in the marketplace.

There are several exemptions to the notification requirement. GE foods already on the market are exempt from the new requirements. CFS will have to analyze the other exemptions more closely.

II. Public Disclosure

The FDA trumpets that this new process will make safety and review information about GE foods more transparent and accessible to the public. However, this is not likely to be a reality for a number of reasons. First, the FDA asserts that pre-market notification letters and voluntary consultation documentation filed with the Agency will be subject to the provisions of the Freedom of Information Act (FOIA). While that may appear transparent, the FDA notes that producers of GE foods may claim that any such information (including the premarket notification letter itself) is a trade secret or confidential business information subject to an exemption to public disclosure requirements. It is also important to note that the continued voluntary nature of the consultation submissions may effectively prevent public scrutiny from the real safety and testing data of GE foods. Recent court cases have made it extremely difficult for the public to get FOIA release of documents voluntarily submitted to an agency and later claimed as trade secrets or confidential business information(CBI).

FDA has stated it will make available its response letters sent back to GE food producers using the notification procedures and any information not claimed by a producers as trade secrets or CBI.

III. Environmental Review

Despite formally adopting a regulation allowing genetically engineered foods to enter the commercial market unobstructed, the FDA has exempted its proposal from environmental review procedures under the National Environmental Policy Act.

IV. Voluntary Labeling Guidance

While admitting that the public comments it has received overwhelmingly support labeling, FDA reasserts that it will not require the mandatory labeling of GE foods. In concert with that decision, FDA has release non-binding guidance on how labeling should take place for producers who want to voluntarily label their products. The guidance document suggests that FDA will attempt to severely limit the type of voluntary labels claiming that products avoid using GE foods. (See attached memo "Why Voluntary Labeling of Genetically Engineered Food Won't Help Consumers"). In particular, the FDA makes the following assertions:

Use of the terms "GMO free" and "GM free" will be misleading in most foods;

Use of the term "free" in claim of absence of genetically engineered material will be misleading because consumers will assume an absolute zero level of GE contamination, and food producers cannot test to meet such assurances level and a threshold level defining "free" has not been established; and

Any statement about not being genetically engineered implying that the labeled food is superior to foods not so labeled would be misleading.

It should be noted that in the case of genetically engineered bovine growth hormone (rBGH) small dairies were sued by Monsanto for rBGH-free labels because such products asserted superiority over dairy products derived for rBGH treated cows and impugned the safety of Monsanto's product. While the guidance is non-binding legally, the last bullet point appears to set up a scenario similar to rBGH for non-GE food voluntary labeling.

The FDA does say that cumbersome statements such as, "we do not use ingredients that were produced using biotechnology" would not be misleading.

The guidance also reaffirms that the voluntary labeling scheme shifts the financial burden onto those food companies not using GE foods by reasserting that companies using non-GE food labeling claims need verification systems in place including chain of custody documentation, testing results or be certified organic.

V. Public Comment Period

The good news is that these rules are not final. The FDA, as required by law, has opened a comment period to hear from the public. This comment period lasts until April 3, 2001.

Comments can be submitted by writing to: Docket No. 00N-1396 & Docket No. 00D-1598, FDA Commissioner, Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Comments can be submitted electronically through the Center for Food Safety's action website found at: http://www.foodsafetynow.org

Conclusion.

The Center for Food Safety believes that the new FDA proposal is contrary to law and wholly inadequate. It does little, if anything, to provide the public with assurances that GE foods are safe for human health and the environment. It also fails to provide consumers their right-to-know by limiting the labeling of GE foods to a voluntary labeling scheme. The new proposal can be summed up as follows:

• Does not require mandatory pre-market safety testing;
  
  
• Does not require pre-market environmental review;
  
  
• Does not require mandatory labeling of GE foods;
  
  
• Limits voluntary non-GE labeling;
  
  
• Only requires a letter of notification prior to the marketing of a GE food; and
  
  
• Is unlikely to provide the public with adequate information on GE foods for independent review.

source: http://www.centerforfoodsafety.org/facts&issues/CFSNewFDAAnalysis.html?cam_id=70 12mar01