June, 1998

FDA processing comments on labeling rules


After a relatively short comment period, Food and Drug Administration officials are now reading comments submitted on its proposed fresh juice labeling regulation. The agency wants to require warning labels on all fresh juices that have not been treated to achieve a 5-log (100,000-fold) kill step of pathogens.
FDA officials will read all the comments and address them when they publish their final rules. The final rules must be published 60 days before implementation, and some observers believe the agency wants the labeling rule in place by October 1.
The comment period is still in effect for the proposed HACCP regulations. Send comments before July 8 to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. See the May issue of the Great Lakes Fruit Growers News for details of this proposed regulation.
Comments submitted by the U.S. Apple Association sharply questioned many of the assumptions FDA has made about cider and repeatedly protested against the short time (30 days) allowed for comments. USApple also stated that the proposed regulations do not take into consideration the steps already taken by cider producers to reduce risks of foodborne illness.
The Michigan Department of Agriculture submitted comments which stressed the need for improved risk communication methods and expressed concern about singling cider out as a product which requires a warning label.
USApple had filed a request to extend the comment period an additional 30 days beyond the May 26 deadline. This request was denied by FDA. On June 2, the agency offered to extend the comment period for an additional 30 days retroactive to May 26, but shortened the time of implementation from 60 to 45 days, which was unsatisfactory to USApple.
After analysis, the FDA proposal was declined, largely because the association believed additional comments from the industry would not budge an agency which has already decided on its position.
"We're not expecting them to make any changes in labeling at all," said Julia Stewart Daly, USApple director of communications. "We're extremely pessimistic as to whether they will seriously consider any comments they will receive. It's fairly evident they had their minds made up going into it."
In its comments, USApple expressed its support for consumer education on serious food safety issues and informed purchasing decisions, but believes FDA's proposals are motivated by a different goal.
"We can only conclude that the agency's goal is not to educate consumers, but to engineer a situation in which it can force the industry into implementing 5-log reduction measures by creating an adverse, unsustainable marketing environment. The association must outright reject the label proposal on the basis that such an extreme, alarmist statement that is punitive of all producers is not justified compared to the low levels of risk posed by fresh apple cider," said USApple.
The association believes the risks of fresh cider do not justify a warning label and that labels are an ineffective way to communicate to consumers about fresh juice risk. USApple cited a 1997 "FDA-generated media campaign against cider" that helped sour the public on the product and had a spillover negative effect on pasteurized products. This campaign contributed to a reduction in sales of pasteurized product by 10-40%. It also fueled a perception by some consumers that fresh-market apples and all fresh cider is contaminated by harmful pathogens.
FDA's proposed warning label language reads: "WARNING: This product has not been pasteurized and therefore may contain harmful bacteria that can cause serious illness in children, the elderly and persons with weakened immune systems."
USApple proposes its own information statement to be placed in the product's main display label. It would say "This is a natural product that has not been pasteurized or otherwise treated. There is a slight risk that it may inadvertently contain harmful bacteria that can cause serious illness in children, the elderly and persons with weakened immune systems."
The level of fresh juice risk must be placed in context for consumers, according to USApple. Otherwise, they will incorrectly assume all fresh juice is contaminated. Use of the word "natural" tells consumers of the potential for naturally-occurring pathogens in the product.
"It is our position that it is important to inform consumers that there are naturally-occurring risks in life, including fresh juices," said USApple. "In this respect, fresh apple cider is no different than other natural food products, and should not be singled out for excessive regulation."
The Michigan Department of Agriculture comments note the partnership between MDA, the industry, Michigan State University and the Detroit FDA office in helping increase the safety of the state's cider. The partnership has produced a set of good manufacturing practices, food safety workshops and schools and a pilot HACCP project.
MDA's comments support effective risk communication, which "is more than the one-way flow of information from regulators to consumers via warning labels. In our experience, risk communication is an interactive process between all food safety stakeholders. When effective, it empowers each to take those steps within their span of control which will decrease the potential for foodborne illness."
MDA agrees that the FDA proposal would allow consumers to have access to fresh products and provide them with product information for informed decision making.
"However, MDA feels that this potential risk must not be overstated but be both acknowledged and balanced against the proven health benefits of regular fresh fruit and vegetable consumption," according to the comments.
MDA's statement expressed concern about the implications of requiring a warning label for products not processed to achieve a 5-log reduction in pathogens. The only step or series of steps presently shown to achieve this reduction is heat pasteurization. Many other ready-to-eat food products (such as lettuce and alfalfa sprouts) cannot be pasteurized.
"Should outbreaks be linked with one or more of these products (as they have), the Agency would need to place warning labels on these products or juice processors could rightly claim discriminatory regulatory practices. We question if the Agency has sufficient information upon which to justify a decision to require labeling of one ready-to-eat product linked to an outbreak of E. coli 0157:H7 and not to require it of another," said MDA.
The Michigan agency also signaled how it would comment on the HACCP regulations, stating it "suspects that the 5-log reduction standard may be overly conservative."