On September 10, 2015, the FDA published all 450 pages of the FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules in the Federal Register. It seemed like an overwhelming and daunting task to read, understand and immediately communicate the meaning and implications of these rules to PMA members, the media and food safety colleagues. This article is all about how you may wish to consider approaching these new rules.
Background: The Hierarchy of Regulations
FSMA Statute: The FSMA statute passed by Congress and signed into law by President Obama in 2011 authorizes and directs FDA to create a new and modern food safety regulatory framework. The law is written at the 50,000 foot level of detail and provides a framework and road map for FDA to create a series of new food safety regulations. As an aside the FSMA statute did not provide FDA with Congressional appropriations (I.e. funding) to actually implement this new law and that’s a whole other story. See “Not Funding FSMA Doesn’t Make It Go Away”.
FSMA Regulations: Secondly the newly issued final regulations are written at the 10,000 foot level of detail to provide flexibility in the way firms implement and achieve compliance with the new regulations and for FDA to verify compliance. However, with great flexibility comes great ambiguity.
FSMA Guidance: As required by the FSMA statute, the last piece of the regulatory hierarchy is FDA companion guidance and these documents will provide greater details and interpretation regarding rule coverage and compliance to both FDA inspectors and industry at the boots on the ground level. It is anticipated that these guidance documents will provide examples of safe harbors for compliance but other means of compliance are often also possible. These forthcoming compliance documents from FDA will be open to public comments and stakeholder input is critical to assure that the FDA companion guidance make sense, are practicable to implement and are easily understood by all stakeholders.
Reviewing The New Final Regulations
The new final FSMA PCHF and PCAF rules are comprised of two important parts; the preamble and the codified sections. Although at the back of the document, I would suggest reading the codified portion of the rules first as they provide a bare bones detailed description of what actual rule coverage and requirements are. Pay special attention to the definitions which are found at beginning of the codified section. The codified sections of the PCHF can be found starting on page 56140 of the official Federal Register version published on 17 September 2015, which can be found here. The preamble, which means to walk before, provides the rationale as to why FDA made specific policy choices and it provides FDA responses to public comments submitted to the proposed rules. If you start with the codified section as suggested and have questions as to what exactly FDA was thinking about a particular provision, you can search the preamble using key words or codified section number to find discussion in the preamble pertaining to specific provisions.
After reading the new PCHF and PCAF rules you are likely to have situation specific questions regarding how these rules may apply to your operations because as noted above the new regulations are written at the 10,000 foot level of specificity and FDA guidance is pending. To answer such questions FDA has set up a new online web portal where questions can be submitted to the Agency. It is important for stakeholders to submit situation specific inquiries and clarifying questions to the FDA about the new FSMA PC rules at this point in time, so as to inform the FDA as to what type of questions need to be addressed in the forthcoming guidance documents.
Don’t be discouraged and remember these final rules are complex and convoluted legal documents, written by and for food and drug law attorneys and they really are not intended for easy use by the average food safety practitioner. This is an important point and one should always consider consulting with legal counsel before implementing procedures, policies or practices to determine your legal rights and responsibilities and to determine compliance to the Federal Food Drug and Cosmetic Act as well as applicable local, county and state laws.
FDA Fact Sheets, FAQs as well as the PCHF
final rules in their entirely may be found at the links provided or by going to the FDA FSMA website.