Over the last several months, we (like the entire industry) have done a great deal of speculating on FSMA-related proposed rules. So in this newsletter, we wanted to focus on what has happened rather than what might happen. Following is a recap of recent FSMA activity, focused on what has been published to date.
With eight new guidance documents and three new rules published in the Federal Register over the last year or so (and two more in clearance, reportedly related to fees), FDA has continued to advance its food safety charge, despite budget, resource, and FSMA-lag issues. As stated by Deputy Commissioner for Foods Michael Taylor, in a talk at last week’s Science Writer’s Symposium, “FDA eagerly embraces change in its food safety program and is hard at work laying the foundation for a modern, prevention-oriented food safety system.”
When compared against the 90-some deliverables required by FSMA, including regulations, guidance documents, notices, studies, reports to Congress, and pilot projects, the number may seem small. However, as Taylor said, “While FDA lacks the resources to do everything at once, we have worked hard to prioritize our efforts and to deliver on both immediate and longer term FSMA mandates.”
The eight documents and three rules include:
Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories, (Draft Guidance), Docket #FDA-2012-D-0585 – August 2012
Remember, facilities must re-register between October 1 and December 31. As discussed in our newsletter of August 23, Changes For Registered Firms – Thou Shalt Follow This Guidance, this draft guidance sets forth FDA’s determination of the necessity for additional food categories and the additional food categories to be included as mandatory fields in food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. In addition to setting the “guidance” as “mandatory,” the list itself provides a second departure from the ordinary. Among the new categories are some interesting inclusions and exclusions, such as cheese and cheese products—but not dairy as a whole, and dietary supplement “categories” encompassing pretty much the whole lot. And although this guidance document was recently released, FDA says that there are three more to be released “later this year.”
FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (Draft Guidance), Docket #FDA-2011-D-0674 – February 2012
A revision of a 2005 guidance makes records access a whole lot easier and significantly lowers the bar for the regulators. This draft guidance provides updated information pertaining to FDA’s authority to access and copy records relating to food. Prior to the passage of FSMA, FDA had access to records relating to food that was reasonably believed to be adulterated and present a threat of serious adverse health consequences or death to humans or animals. FSMA expands FDA’s access to records beyond records relating to the specific suspect article of food to those relating to any other article of food that the FDA reasonably believes is likely to be affected in a similar manner. In addition, FDA can now access records if FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. Our March 2012 newsletter, New FSMA Rule To Lower the Bar for FDA Access to Your Records, provides more information on this topic.
The Interim Final Rule, Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements, was published in February 2012, Docket #FDA-2002-N-0153
Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (Guidance) Docket #FDA-2011-D-0598 – February 2012
Written in a Question/Answer format, this guidance provides updated information on the establishment and maintenance of records, and FDA’s authority to access records relating to foods that may cause serious adverse health consequences or death to humans or animals, as amended by FSMA. Additional guidance on FDA’s records access authority is provided in “FDA Records Access Authority Under Sections 414 and 704 Federal Food, Drug, & Cosmetic Act: Questions and Answers” and our newsletter, New FSMA Rule To Lower the Bar for FDA Access to Your Records.
What You Need to Know About Administrative Detention of Foods (Guidance) Docket #FDA-2011-D-0643 – October 2011
This is one of the few new FSMA authorities that FDA has actually used since the signing of the Act last year. This guidance provides information pertaining to FDA’s authority to order the administrative detention of food for human or animal consumption as amended by FSMA. The authority given by the FD&C Act was originally amended by the Bioterrorism Act of 2002. Among other things, the Bioterrorism Act provided FDA the authority to order the detention of any article of food if, during an inspection, examination, or investigation, an FDA officer or qualified employee were to find credible evidence or information indicating that it presents a threat of serious adverse health consequences or death to humans or animals. It also made it a prohibited act to move an article of food in violation of a detention order or to remove or alter any mark or label required by a detention order that identifies an article of food as detained. In the Final Rule, criteria was set for ordering administrative detention, however Section 207 of FSMA now amends that criteria, allowing FDA to order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. More information is available in our November 2011 newsletter, Details on New Administrative Detention Regulations.
The Interim Final Rule, Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption, Docket #FDA-2011-N-0197 was published in May 2011.
Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act (Guidance) Docket #FDA-2011-D-0721 – September 2011
This guidance provides answers to common questions about the new fee provisions and FDA’s plans for their implementation, and we’ve heard that additional guidance on fees is forthcoming. FSMA provides FDA with the authority to assess and collect fees related to food from, among others the responsible party for each domestic facility and the US agent for each foreign facility subject to a reinspection to cover reinspection-related costs; the responsible party for a domestic facility and an importer who does not comply with a recall order issued under section 423 or 412(f) of the FD&C Act, to cover food recall activities associated with such order performed by FDA; and each importer subject to a reinspection, to cover reinspection-related costs. Beginning October 1, 2012, the FDA hourly rate if domestic travel is required will be $221 (previously $224/hour); if foreign travel is required, the rate will be $289/hour (previously $335/hour). More information on the user fees is available at FSMA – Don’t Shoot the Messengers – But Listen To Them.
Enforcement Policy Concerning Certain Prior Notice Requirements (Guidance) – June 2011
This document provides guidance to submitters of prior notice of imported food on enforcement of interim final rule “Information Required in Prior Notice of Imported Food.” The interim final rule amended its regulations on prior notice of imported food. As required by FSMA, a person submitting prior notice of imported food, including food for animals, must report the name of any country to which the article has been refused entry. Because prior notice must be submitted electronically, the agency had to make changes to several of its information technology systems including the Prior Notice System Interface (PNSI) and the Operational and Administrative System for Import Support (OASIS).
The Interim Final Rule, Information Required in Prior Notice of Imported Food, Docket #FDA-2011-N-0179 was published in May 2011.
New Dietary Ingredient Notifications and Related Issues (Draft Guidance), Docket #FDA-2011-D-0376 – September 2011
In response to a request, FDA extended the comment period on the guidance intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications (also referred to as “NDI notifications”). The guidance incorporates a Question/Answer format to addresses the NDI topics as well as parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement. The agency encourages manufacturers and distributors to consult this guidance during their safety review of a dietary supplement that contains a NDI and in preparing NDI notifications.
Fish and Fishery Products Hazards and Controls Guidance (Guidance), Docket #FDA- 2011-D-0287 – April 2011
The guidance provides an updated fourth edition of Fish and Fishery Products Hazards and Controls Guidance which supports and complements FDA’s regulations for the safe and sanitary processing and importing of fish and fishery products using hazard analysis and critical control point (HACCP) methods. According to a Letter to Industry (Nov. 9, 2011), the guidance was “being implemented without prior public comment because the Agency determined that prior public comment was not feasible or appropriate.” The Agency made this determination because the updated information in the guidance significantly enhances the seafood industry’s ability to protect the public health and provides important recommendations for conducting a hazard analysis and implementing a HACCP plan. However, the letter said, FDA would consider the extent to which a firm may have used previous recommendations from the Third Edition of the guidance when determining what actions will be taken when violations of FDA’s HACCP regulations are observed.
Leverage Resources Wherever They May Be
As reported by Food Safety News, the pending sequestration of Congress could result in an automatic 8 percent budget cut for FDA at the beginning of 2013. Already stressed with low funding and limited resources, such cuts could only further hurt the enactment and implementation of FSMA rules.
Even if this were to be resolved and the 8% cut not be made, however, it behooves FDA to keep alert for and leverage the research and resources of other governments where and when it can.
For example, the Food Standards Agency (FSA) of the U.K.recently published a call for researchers interested in carrying out an evaluation of accredited assurance schemes and the extent to which they demonstrate compliance with EU food safety requirements, specifically those relating to imported food. The research will also explore the results of an FSA-led pilot scheme, which assessed compliance performance between consignments of fresh, perishable fruits and vegetables that were accompanied by certification issued by independently accredited assurance scheme bodies, and those that were not accompanied by such certification.
With FSMA driving the certification of third-party auditors for foreign facility inspections, the results of such research could be very informative for FDA as well as third-party auditors and those being audited, providing real data on some of the pitfalls associated with these types of schemes.
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FSMA Update – Where Are We? by David W.K. Acheson is licensed under a Creative Commons Attribution-ShareAlike 3.0 Unported License.