Changes For Registered Firms – Thou Shalt Follow This Guidance
by David Acheson on August 23, 2012 in Food Safety
FSMA gives FDA new authority around registration requirements, and just last week the Agency released some of these new requirements. Fair warning: If you are required to register, you need to pay attention to these changes. What is unusual is that in the draft guidance published last week by FDA, it set forth mandatory requirements. While most guidance recommends “Thou canst,” this new guidance commands, “Thou shalt.”
The proposed guidance, “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories,” sets forth FDA’s determination of the necessity for additional food categories and the additional food categories to be included as mandatory fields in food facility registrations.
As stated in the draft, FDA guidance is ordinarily non-binding and contains standard language stating that it “should be viewed only as recommendations” and that it represents FDA “current thinking on this topic.” However, this publication adds, “FDA is not including this standard language in this draft guidance because it is not an accurate description of the effect of this guidance. This guidance contains findings that serve as the predicates for binding requirements on industry.”
For this mandate, FDA is invoking its new FSMA authority (section 102, Registration of Food Facilities). As described in the Federal Register notice of the proposed guidance, section 102 provides that, “when determined necessary by FDA through guidance, a registrant is required to submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3) or any other food categories, as determined appropriate by FDA, (including by guidance) of any food manufactured, processed, packed, or held at such facility. ”
The list itself provides a second departure from the ordinary. Again invoking section 102, FDA is extending the list of food categories required for registration because it “believes that the following additional food categories are appropriate for food facility registration and will include such categories as mandatory fields in the food facility registration form when FDA finalizes this guidance.”
This mandatory inclusion of these additional categories (for which the entire list is available on the guidance posting) makes me wonder if this is something like what the high-risk food list might look like. It is, at least, an interesting speculation.
It is also interesting that included among the new categories are, what I see as some interesting inclusions and exclusions, such as cheese and cheese products—but not dairy as a whole (but maybe this is because of the PMO listings for fluid milk), and dietary supplement “categories” – listing specific categories of “Proteins, Amino Acids, Fats and Lipid Substances; Animal By-Products and Extracts; Herbals and Botanicals.” It doesn’t seem to me that there is a lot left on the dietary supplement shelf if you take into account that whole lot.
What this also means is that the dietary supplement industry needs to pay attention to these changes as well. Sometimes there is confusion in that industry as to what parts of FSMA apply – the short answer is: Most of it!
It also puts a similar call out to distribution centers and warehouses. While FSMA repeatedly refers to application to “food manufactured, processed, packed, or held at such facility,” there is some confusion as the precise definition of “hold” facilities.
This was, however, addressed back in 2004, when FDA issued a Question and Answer document on food facility registration, which was originally implemented as part of the Bioterrorism Act. One question asked whether food retail storerooms, distribution centers, or warehouses were considered “holding facilities” and are required to be registered. The answer from FDA:
“A: If a facility qualifies as a ‘retail food establishment’ under 21 CFR § § 1.226(c) and 1.227(b)(11), storerooms that are co-located do not need to be registered because they are considered to be part of the retail food establishment. In contrast, a separate distribution center or warehouse is required to be registered because these facilities are not part of a ‘retail food establishment,’ and further, these facilities themselves do not satisfy the definition of ‘retail food establishment’ because they do not provide the food directly to consumers from their facility.”
Thus, it is critical that distribution centers and warehouses that are not part of a retail food establishment understand that they do need to be registered with FDA and follow all related requirements.
As FDA continues to implement FSMA, it will be interesting to see what other departures from the “ordinary” are taken. And – whether increased authority continues to be invoked with commandments taking precedence over recommendations.
As a final reminder, the window for re-registration is due to open on October 1, 2012, and last for three months. Expect more details on this as we get closer to that time.
In other FSMA news, FDA has issued its Annual Report to Congress as required by the Act. The report focused on a few key areas including:
FDA’s continuing focus on “devoting significant time and resources” to building of a “fully integrated national food safety system” through coordination and cooperation with state, local and federal agencies as well as public health partners.
The appropriations used and number of inspected registered food facilities. As of December 10, 2011, there were 421,121 active registered food and feed facilities (167,033 domestic and 254,088 foreign). Noting that FSMA’s amendments to section 415 of the FD&C Act have not been fully implemented yet, the update stated that these numbers reflect food facilities registered under the Bioterrorism Act requirements, i.e., the section 415 requirements prior to FSMA. Additionally, it stated that 11,007 of the 22,325 CFSAN-identified high-risk domestic food firms were inspected in FY 2011.
The establishment of 13 foreign posts, 11 of which are staffed with a total of 31 U.S. direct hires (USDH) and 17 locally employed staff (LES) and are fully operational as of June 2012.
The number and cost of import lines examined/sampled, noting that FDA had physically examined (conducted field exams or analyzed samples) 243,400 food and feed import lines in FY 2011, at an average cost of approximately $170 per field exam and approximately $2,800 per sample analyzed.
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Changes For Registered Firms – Thou Shalt Follow This Guidance by David W. K. Acheson is licensed under a Creative Commons Attribution-ShareAlike 3.0 Unported License.