The Food and Drug Administration is hosting a series of public hearings on the Food Safety Modernization Act, which was signed into law in January. The first hearing reviewed how the new law will affect food imports, and the second covered FDA's exploration of issues involving appropriate preventive controls. Another hearing, which likely will discuss compliance and enforcement options, is expected soon.
The Food Safety Modernization Act focuses on three main areas: new responsibilities for food manufacturers and food producers, tighter controls over imports and stronger FDA enforcement powers. FDA decided to hold the meetings prior to rulemaking to gather input and encourage industry participation in the rulemaking process. IDFA expects FDA to issue several proposed rules by the end of the year.
Implementing Import Provisions
At the first hearing, several FDA officials, including Deputy Commissioner for Foods Michael Taylor, reviewed the bill's provisions relating to imported foods. Approximately 250 participants, representing the food industry, consumer organizations, foreign governments and certification agencies, attended the hearing.
Much of the conversation centered on third-party certification, with some tension noted between consumers, who want FDA to handle all verification, and industry participants, who encourage FDA to rely upon existing systems and standards. FDA officials emphasized that this hearing was just the beginning and that they plan to work closely with industry partners throughout the rulemaking and implementation process.
They also said they're cognizant of the costs new regulations could bring, especially for small businesses, and are looking for industry collaboration to help move the implementation process forward as efficiently as possible.
The transcript and webcasts of several breakout sessions are available here.
Implementing Preventive Control Provisions
The second hearing focused on implementing the preventive control provisions of the new bill. FDA officials emphasized that changes won't appear any time soon since a great deal of groundwork remains to be laid first. This includes finalizing the modernization of the current Good Manufacturing Practices (cGMPs), which were last revised for food in 1986.
Although they expect the preventive control measures to be broader than existing Hazard Analysis and Critical Control Points (HACCP) plans, FDA officials said these plans and the cGMPs would provide a good foundation. They also agreed with industry participants that any preventive control measures must be flexible. In addition, FDA will not mandate a specific format for recordkeeping, so companies will not have to change their procedures.
During this hearing, FDA officials reinforced their interest in seeking input and engaging all interested participants to help develop practical implementation methods. IDFA will work closely with FDA during the rulemaking process and plans to work with its committees while preparing comments.
The transcript and webcasts of the breakout sessions have not yet been posted but will be available soon on the FDA website.
Members with questions may contact Clay Detlefsen, IDFA vice president of regulatory affairs, at firstname.lastname@example.org.