FDA Regulatory CounselingLake Bluff, Illinois, USA 60044(847) 234-7500

Regulatory Update

Richard O. Wood

rowood@woodburditt.com

2010 Mid-Winter MeetingNew Orleans

Regulatory Presentation

• FDA Tree Nut Presentation• FDA Salmonella Inspection Program• FDA Inspection Refresher• Food Safety Legislation• COOL Reinterpretation

FDA Pecan Salmonella Inspection Program

• By FDA, not states• Including accumulators• Comprehensive environmental sampling• Different inspectional requests in different districts

Refresher –Handling FDA Inspection

• Limited right to documents• Section 704 FDC Act

– to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein.

– the inspection shall extend to all records and other information described in section 414 when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death.

• Environmental Sampling• Photographs

Congress is Responding – New Food Safety Laws

• Food Safety Enhancements Act of 2009 (HR 2749)• Food Safety Modernization Act (S 510)

Food Safety Enhancement Act (FSEA) Provisions

• Requires each food facility to: – conduct a hazard analysis; – implement preventive controls; and – implement a food safety plan.

FSEA Provisions

• Preventive Controls:– Sanitation procedures and practices– Training (supervisor, manager and employee hygiene)– Process controls– Allergen control program– GMPs– Supplier verification activities

FSEA Provisions

• Food Safety Plan must include scientific/technical validation that the system of controls will prevent, eliminate or reduce hazards to an acceptable level.

• FDA would have access to all records relating to determining whether a food may be adulterated or misbranded.

COOL 2 Federal Agencies 2 Sets of Rules

U.S. Customs and Border Protection (“CBP”)

U.S. Department of Agriculture (“USDA “)

Tariff Act of 1930

(19 U.S.C. 1202 et seq)

Agricultural Marketing Act of 1946

(including the 2008 Farm Bill) (7 U.S.C. 1638 et seq.)

19 CFR Part 134 Country of Origin Marking

7 CFR Part 65Country of Origin Labeling

USDA’s COOL Rule

Processed Pecan Exclusion

• Preamble to USDA COOL Rule– Specific processing that turns a raw, green pecan into a

“Processed Food Item” includes cooking (e.g., frying, broiling, grilling, boiling, steaming, baking, roasting), and curing (e.g., salt curing, sugar curing, drying).

– the vast majority of pecans sold at retail will not be affected since most pecans are dried/heat-processed/shelled before being sold at retail.

USDA’s COOL Rule

Processed/Not Processed

Processed Food Items Not Processed Food Items-Roasted pecans-Roasted or raw pecans mixed with other nuts (i.e., a jar of mixed nuts)-Shelled pecans that underwent a drying step during the shelling process-Shelled pecans that were steamed during the shelling process-Shelled pecans that were given an application of heat as part of a sterilization / kill step

-Raw, green pecans-Shelled pecans that were neither dried, nor cooked, nor given any application of heat

COOL – Current Status