The Food Safety Modernization Act: FDA's Six Month "Progress Report"
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The Food Safety Modernization Act (“FSMA”) has now been law for more than six months. In turn, FDA issued a progress report on its implementation efforts since the FSMA was signed into law last January:
Preventive Controls:
In April, almost 500 persons participated in the agency’s public meeting seeking information on preventive controls used by industry to identify and address hazards associated with specific types of food and specific processes. FDA is actively seeking further industry comment (through August 22) on its rulemaking for preventive controls. Please click on the following links to review the docket on preventive controls and submit your comments electronically or via mail.
Imported Foods:
More than 500 persons were given the opportunity in a March public meeting to weigh in on each of the four FSMA import safety provisions: Accredited Third-Party Certification; Import Certifications of Food; Voluntary Qualified Importer Program; and Foreign Supplier Verification Program.
On May 5, 2011 FDA issued an interim final rule requiring that a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.
Food Smuggling:
On July 3, 2011 FDA issued a joint anti-smuggling strategy developed with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) to prevent smuggled foods from entering the United States and potentially threatening consumer safety and national security.
Registration Suspension:
Effective July 3, 2011 FDA has the power to suspend the registration of a food facility, thus ceasing operations, if it believes there is a “reasonable probability” that food from the facility could cause harm to humans or animals.
Administrative Detention of Food:
Also on July 3, 2011 the rule on criteria under which FDA may order administrative detention of food product went into effect. FSMA lowered the standard, granting FDA the power to detain food product for up to 30 days if it has “reason to believe” that a product is adulterated or misbranded and may cause harm to humans or animals. Click on the following link to review the Rule on Administrative Detention.
Seafood:
FDA issued an updated guide to the seafood industry on appropriate controls for hazards associated with fish and fishery products. Industry may employ different controls if the alternative controls satisfy the applicable statute and regulations. Click on the following link to view Seafood Hazard and Control Guidance.
Inspections and Compliance:
In June, almost 700 people participated in the agency’s public meeting regarding FDA’s development of guidance and regulations and/or the implementation of: Enforcement Authorities; Frequency and Targeting of Facility Inspections; Manner of Inspection in a Preventive Controls Environment; and Enhancement of the Reportable Food Registry (RFR).
Funding:
FDA’s progress report did not touch on what might be FSMA’s biggest obstacle: funding. The agriculture appropriations bill recently passed by the House of Representatives would decrease funding to the FDA next year by $87 million.
Hopefully, the agency is receiving abundant, constructive advice from industry that will lead to practical regulations which facilities can utilize to improve their food safety, regardless of whether FDA is able to frequently stand over their shoulders and inspect.
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