Our Food Safety Modernization Act (FSMA) overview continues today with a look at the inspection and compliance section. Not only does FSMA outline rules for farms and facilities but it also lays out the role of the Food and Drug Administration (FDA) in carrying out FSMA rules and ensuring compliance. This section is referred to as inspection and compliance and can be broken down into four main areas: 1) records and records access, 2) recalls, 3) registration, and 4) administrative detention.
Records and Records Access
For the first time, FDA has been given an inspection mandate. FSMA requires inspections to be based on risk. It calls for all high-risk domestic food facilities to be inspected within five years of FSMA’s signing and then at least once every three years after that. Additionally, all other domestic food facilities are to be inspected within seven years of signing and then at least once every five years thereafter. To look further into FSMA’s framework which assists FDA in identifying high-risk facilities, see: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm295345.htm
FSMA expanded FDA’s records access to include: 1) access beyond records related to the specific suspect article of food for which FDA reasonably believes is adulterated and presents a threat of serious adverse health consequences to now include records relating to any article of food reasonably likely to be affected in a similar manner and 2) when FDA believes there is a reasonable probability that the use of or exposure to the article of food will cause serious adverse health consequences or death to humans or animal (FDA Guidance Document).
Companies will be provided with an opportunity for an informal hearing before an order to require recall is made. Under the Food, Drug and Cosmetic Act (FDCA) §423(a), FDA is required to first give a responsible party the opportunity to stop distribution and conduct a voluntary recall of the food. If the responsible party refuses to or does not voluntarily stop distribution or recall the food within the time and in the manner prescribed by FDA, FDA may proceed under the mandatory recall authority articulated in FDCA §423. Section 206 of FSMA sets out the procedure and requirements FDA will follow for mandatory recalls.
Section 102 of FSMA requires food facilities to submit registrations to FDA containing additional information. Specifically, a registration for a domestic facility is required to contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the U.S. agent for the facility. All food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FDCA. Also, if determined necessary by FDA, registrations must contain information regarding other applicable food categories for foods manufactured/processed, packed, or held at registering facilities (FDA Guidance Document).
All food facilities required to register with FDA under section 415 of the FDCA must renew their registrations with FDA every other year during the period of time beginning on October 1 and ending on December 31 of each even-numbered year. If you have not registered your facility you do not, however, have to wait until October 1 of the present year to register. Registrants must use Form 3537 to register, update, or renew a registration. Facilities may register online at www.fda.gov/furls. There is no fee associated with initial registration, or with updating or renewing a registration.
FSMA enhances FDA's administrative detention authority by authorizing FDA to administratively detain articles of food the FDA has a reason to believe may be adulterated or misbranded. FDA intends to revise its administrative detention regulations and other relevant documents to reflect this new standard.
Next week we will take a look into the FSMA’s enhanced relationships goal. Until then, happy reading and feel free to send me any questions you might have about FSMA: firstname.lastname@example.org.