Annex 2 Special Considerations Reference

I. Foods that might be served raw or not cooked according to the Food Code
(Refer also to last page of Annex 1 for parasitic considerations for fish.)

Raw Animal Food	Menu Items	Hazards
Beef	Steak Tartare Carpaccio	Salmonellae Escherichia coli O157:H7
Poultry	Duck	Salmonellae Campylobacter jejuni
Finfish	Lightly cooked fish, sushi, raw-marinated, cold-smoked fish	Anisakis simplex Diphyllobothrium spp. Pseudoterranova decipiens
	Reef fish: (barracuda, amberjack, horse-eye jack, black/jack, other large species of jack, king mackerel, large groupers, large snappers)	Ciguatera toxin
Shellfish	Oysters Clams	Vibrio vulnificus Vibrio spp. hepatitis A Norwalk-like viruses
Eggs	Quiche, hollandaise sauce Eggs Benedict, mayonnaise, mousse, tiramisu, chicken croquettes, rice balls, stuffing, lasagna, french toast, chicken franchaise, crab cakes, egg nog, fish stuffing, Caesar salad, ice cream	Salmonella enteritidis Enteritidis

II. Foods that are a Concern Because of Emerging Issues

Produce	Tomatoes, sprouts, lettuce cantaloupe, raspberries, green salads, strawberries	Salmonellae, E. coli O157:H7, Shigellae, Cyclospora cayetanensis, hepatitis A, Norwalk-like viruses
Juice	Apple juice/cider, other fruit or vegetable juices	Salmonellae, E. coli O157:H7, Cryptosporidium parvum

III. Hazards associated with other foods.

(Hazards guide to follow later)

NOTICE: This is a Draft document to guide operators in voluntarily applying HACCP principles in food establishments in the retail segment. It will be trial tested in a structured FDA pilot. The pilot, Notice of which will appear in the Federal Register, is an open process and as experience is gained from the various phases of that pilot, this Guide will be modified. The Agency recognizes that this document has areas that need to be further clarified and developed with broader input and based on industry's experiences with the practicalities of integrating the HACCP approach in their operations. The Guide will continue to evolve and improve. It is anticipated that the field application of this guidance document will identify additional processes, special food considerations, or other facets of a HACCP program that need to be addressed. It is also expected, as reflected in the Annex, that the listing of commodity-specific haza developing their HACCP systems. The Agency fully recognizes the diversity of "retail food establishments" and their varying in-house resources to implement HACCP. That recognition is combined with an understanding that the success of such implementation is dependent upon identifying realistic and useful ways of making it happen that are customized to the operation. FDA is open to record keeping applications that minimize the burden of instituting a HACCP system while providing the added consumer protection. FDA is most interested in receiving comments from parties who may review or use this Guide either within the pilot program or outside of that process. Of particular interest to the Agency are alternative ways of controlling hazards, input regarding special food considerations as described in Annex 2, and specific comments with respect to providing additional practical HACCP guidance for the retail industry. To submit comments, please photocopy the pages of concern, mark them up with your suggested changes, and forward them to: Dr. John E. Kvenberg HACCP Policy Strategic Manager (HFS-10) Office of Policy, Planning and Strategic Initiatives Food and Drug Administration 200 C Street, S. W. Washington, DC 20204