FDA June 6 FSMA Meeting to Focus on Detentions, Inspections, Etc.

FDA is also seeking written comments on these issues by July 6, 2011.

(See ITT’s Online Archives or 05/20/11 news, 11052027, for BP summary of an FDA press release announcing the meeting.)

Seeks Comment on Use of Greater Detention Authority in Preventive Environment

FDA explains that the FSMA provides it with a more flexible standard for administratively detaining human and animal food products under 21 USC 334(h)(1)(A) that are potentially in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under the new law, FDA may administratively detain food if FDA has “reason to believe” that the food is adulterated or misbranded. This is a lower standard than the previous threshold of “credible evidence.”

FDA has previously explained that this authority to detain food is separate and distinct from its authority to refuse admission of imported food under section 801(a) of the FD&C Act (aka import detention), and that it has never been able to administratively detain an article of food under 21 USC 334(h) due to the high standard. However, with this change, it expects it could use these administrative detentions up to 195 times during any given year, and according to 21 USC 334(h)(1)(A), these detentions can occur when found during any inspection, examination, or investigation under the FD&C Act.¹

Regarding this stronger authority, FDA seeks comments on:

• how to employ the revised administrative detention authority in a preventive controls environment; and
• examples from state regulators who recently used their embargo/detention authorities where the subject food was produced contrary to established food safety preventive control standards such as those defined under the juice or seafood Hazard Analysis and Critical Control Points (HACCP) rules;

Seeks Criteria for Inspection Frequency, Ways to Use Control Plans to Prioritize Inspections, Etc.

The FSMA also establishes a mandated inspection frequency, based on risk, for food facilities that are required to register under section 415 of the FD&C Act and requires the frequency of these inspections to increase immediately. For foreign facilities, the FSMA mandates that within one year of enactment, FDA inspect at least 600 foreign facilities and double those inspections every year for the next 5 years.

Regarding the mandated increase in inspections, FDA seeks comments on:

• the inspection approaches and tools FDA could use to satisfy the domestic and foreign inspection frequency mandates, including by working with State and local governments;
• how FDA might use firms’ written preventive control plans that will be required by the FSMA, or information from those plans, to prioritize FDA’s work and develop inspectional strategies;
• how FDA should work with foreign governments with respect to inspections of those food facilities in their countries that offer food products for import to the U.S.
• data sources that could assist with the designation of high risk/non-high risk facility inventories and for targeting foreign firms for inspection;
• criteria FDA should consider when defining its high risk and non-high risk facility inventories and how FDA should acquire that information;
• how FDA should evaluate or “weigh” the criteria to determine risk;
• factor(s) that should be considered the most important and whether the factors should vary depending on the circumstances;

Asks How and Under What Circumstances FDA Should Suspend a Registration

FDA can also suspend registration of a facility if it determines that food manufactured, processed, packed, received, or held by the facility poses a reasonable probability of serious adverse health consequences or death and the facility either created, caused, or was otherwise responsible for that reasonable probability or knew of, or had reason to know of, such reasonable probability and packed, received, or held the food. A facility that is under suspension is prohibited from introducing food into commerce in the U.S.

FDA is seeking comments on:

• how it should implement food facility registration suspension; and
• under what circumstances FDA should suspend a registration.

Seeks Comments on Circumstances Meriting a Mandatory Recall, Etc.

In addition, FDA was given mandatory recall authority for foods other than infant formula. This authority applies when FDA determines that there is a reasonable probability that an article of food is adulterated or misbranded and the use of or exposure to such article of food will cause serious adverse health consequences or death to humans or animals.

On mandatory recalls, FDA seeks comments on:

• circumstances under which FDA should use its mandatory food recall authority;
• when FDA should use food facility registration suspension in conjunction with ordering a mandatory food recall.

(Note that FDA is also seeking comments on the reportable food registry, which FDA must improve and make available for use by grocery stores to inform the public of food safety incidents.)

Comments to Inform FDA’s Implementation Strategies

The information and views received from the public will inform FDA's FSMA implementation strategies relative to enforcement authorities; frequency and targeting of facility inspections; manner of inspection in a preventive controls environment; and improving the reportable food registry (RFR).

Registration Necessary to Attend Event and Suggested to View Webcast

Registration is required to attend and/or present at the event. Registration is due by May 31, 2011 and is available here. The event will also be webcast. FDA recommends that persons interested in viewing the webcast also register here in order to provide webcast participants with information before and after the meeting.

¹See ITT’s Online Archives or 05/05/11 news, 11050511, for BP summary of FDA’s interim final rule on this type of administrative detention.

(See ITT’s Online Archives or 01/04/11 and 03/07/11 news, 11010426 and 11030720, for BP summary of the FSMA and an FDA overview of it, including the new enforcement and inspection provisions.

See ITT’s Online Archives or 05/18/11 news, 11051808, for BP summary of FDA stating that foreign food facility inspections would increase and inspectors would especially be looking at implementation of preventive controls.)

FDA contact - Patricia Kuntze 301-796-8641, Patricia.Kuntze@fda.hhs.gov

(FR Pub 05/26/11, D/N FDA-2011-N-0366)