FDA to send notice before accessing records under bioterrorism law
FDA to send notice before accessing records under bioterrorism law
WASHINGTON -- Food inspectors knocking at a company's door in the event of a food-safety emergency will have to send a written notice first notifying the company of the records that need to be searched under the new bioterrorism law.
The Food & Drug Administration has just released new guidelines that spell out the hoops government officials will need to jump through before FDA inspectors demand access to company records.
The new bioterrorism law allows FDA inspectors expanded access to company records if there is a reasonable belief an adulterated food could cause adverse health effects or death to humans or animals.
According to the new guidelines, once FDA has determined that a particular food product poses a serious health risk to the public, the agency would submit a written notice to the owner, operator or agent in charge of the company to review records FDA needs as part of its investigation.
The International Fresh-cut Produce Association reminded its members in late November that these records may include certain confidential commercial or trade secret information. FDA said it would shield against disclosing this information to the public, but might share it with other government officials or FDA contractors.
However, the law blocks FDA inspectors from accessing recipes for food or formulations - always securely guarded by food companies - and from reviewing information related to pricing, personnel or sales, as well as records from farms and restaurants.
The Food & Drug Administration has just released new guidelines that spell out the hoops government officials will need to jump through before FDA inspectors demand access to company records.
The new bioterrorism law allows FDA inspectors expanded access to company records if there is a reasonable belief an adulterated food could cause adverse health effects or death to humans or animals.
According to the new guidelines, once FDA has determined that a particular food product poses a serious health risk to the public, the agency would submit a written notice to the owner, operator or agent in charge of the company to review records FDA needs as part of its investigation.
The International Fresh-cut Produce Association reminded its members in late November that these records may include certain confidential commercial or trade secret information. FDA said it would shield against disclosing this information to the public, but might share it with other government officials or FDA contractors.
However, the law blocks FDA inspectors from accessing recipes for food or formulations - always securely guarded by food companies - and from reviewing information related to pricing, personnel or sales, as well as records from farms and restaurants.
