FDA Publishes FSMA's Final Rule On Record Access Requirements
By Laurel Maloy, contributing writer, Food Online
The FDA received only two comments during the open comment period on the interim final rule for Establishment and Maintenance of Records
On April 4, the FDA finalized the interim final rule (IFR) regarding establishment and maintenance of records for small entities. First published on Feb 23 two years ago, the interim rule was written to bring record keeping into compliance with the Food Safety Modernization Act (FSMA). The FDA did not adopt any changes to the requirements in the IFR, originally published in the Federal Register (77 FR 10658), as a result of the public comment period
The IFR has been in effect since March 2012. This means all small entities have had time to digest and incorporate these record keeping practices into their operations. The entire discussion on guidance for the industry can be viewed here. Any food producer, processor, manufacturer, grower, or transporter is able to contact the FDA to discuss alternative approaches to their record keeping practices. The guidance is nonbinding on the FDA or the public, as long as the approach “satisfies the requirements of the applicable statutes and regulations.” The applicable statues and regulations are:
- Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
- Regulatory Procedures Manual (RPM) for FDA staff
- Investigations Operations Manual (IOM) for FDA staff
The Final Rule will be published in the Federal Register, with a printable PDF available prior to the expected publication and effective date of April 4. It reiterates 2011 Centers for Disease Control (CDC) data, citing the fact that about 48 million Americans annually are the victims of foodborne illnesses, with a death toll of approximately 3,000. The final rule also stresses the effectiveness of a strategy of prevention, the purpose behind FSMA, which was signed into law by President Obama on Jan 4, 2011.
Under Executive Orders 12866 and 13563, a Cost Benefit Analysis was conducted with the result being the economic impact on small businesses would be negligible. The final rule does not drastically change what is already required for record keeping. It simply grants the FDA access more quickly and to a broader scope of records. The goal is to prevent illnesses by being able to initiate and complete an investigation more quickly. The fact the FDA will have access to those records, beyond those relating to the specifically suspect food products, will enhance the FDA’s proactive efforts towards ensuring food safety.
Are your prepared for a visit from the FDA?
The final rule, though only a formality, as no changes were made to the IFR, concretes the FDA’s rights. The FDA has the right to inspect or receive copies of all documentation they deem necessary in order to investigate suspected adulterated food products as soon as possible. The rule specifies this time period is not to exceed 24 hours. FDA access authority for these records extends to any and all entities who play a role in the bringing an adulterated food product to market.