The food industry has long been familiar with the requirement that facilities involved in the handling, packing, holding, storing, manufacturing or other processing of food must register with the Food and Drug Administration. This requirement alerts the FDA to all facilities that come in contact with food and provides it the right to inspect for regulatory compliance, as well act more quickly in the event of a report of food contamination or adulteration. Additionally, the FDA’s recall system is tied to facility registrations, which help track down the source and cause of such food-related issues.
Facility registration is also a baseline requirement for facilities in preparing for inspection by a FDA representative. Registration provides the investigator with a basic profile of the facility so the inspector can have an inspection plan prior to visiting the facility. However, since the passage of the Food Safety Modernization Act (FSMA) and the subsequent passage of a number of final rules, the FDA’s approach to facility registrations has evolved.
New facility registration requirements
With the passing of FSMA in 2011, the FDA added new requirements to its facility registration process for food facilities. The new requirements were formalized in a final rule, which has now been published. The requirements under this rule are in some instances already effective, and the industry must respond to these new requirements. Some of the new requirements include:
- Mandatory electronic facility registration and Unique Facility Identifier: Though not to be implemented until 2020, all facility registrations will be done online, and every facility will receive a new UFI, or unique facility identifier.
- Assurances to provide FDA inspectors access to facilities: The new registrations now include sections in which the facility explicitly grants FDA inspectors access to the facility during reasonable hours under the FDCA standards.
- Email contact required: The new registrations include the requirement that a facility’s FDA contact provide his or her email address to the FDA for contact purposes. This implicitly includes a requirement that this email address be monitored and the employee in charge of the email address understands how to manage communications from the FDA.
In addition, the changes to facility registrations include a new and slightly more complicated requirement that a registration must include a list of the “general goods categories” of any food manufactured, processed, packed, or held at the facility. In September 2016, the FDA released new guidance, entitled “Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition),” in which the FDA has amended the food categories that must be identified on a registration if they are “manufactured/processed, packed or held at [a registered] facility.” Section 102 of FSMA (Pub. Law 111-353) allows the FDA to create these requirements “by guidance” and without the lengthy public comment and review processed normally reserved by agency rulemaking.
In total, nine categories of human foods must be identified on a facility registration, one of which was added to the list by this guidance. These include baby food products (including formula), cheese and cheese products, certain dietary supplements, fruit and fruit products, fruit or vegetable juices and pulps, nuts and edible seeds, shell egg and egg products, vegetables and vegetable products. Certain fish and seafood products were added by the new guidance. Additionally, two categories were removed, including acidified foods defined under 21 C.F.R. § 114.3(b) and low acid canned food products defined under 21 C.F.R. § 113.3(n).
For animal foods, the changes were a little more extensive. There are now 32 categories of animal foods on the list, of which seven are new. These new categories are animal protein products, botanicals and herbs, direct fed microbials, forage products, human food byproducts not otherwise listed on the FDA registration form, processed animal waste products, and technical additives. No categories were removed from the lists.
It is important to also note that these different categories are not exhaustive, and for both animal and human foods, the FDA registration form provides a place to fill in a description of any foods manufactured, processed, packed, or held at the facility that are not represented in the provided lists.
FDA leverages facility registrations to enforce compliance
Most recently, the FDA has leveraged the facility registration of SM Fish Corp. as leverage to force a company with contaminated products to respond to FDA concerns and consumer reports. In 2015, the FDA had inspected SM Fish Corp.’s facility and found Listeria contamination in 15 of 105 locations sampled throughout the facility. This resulted in a Form 483 inspection report detailing the findings and outlining expected actions SM Fish would take to address the issues and reduce the prevalence of Listeria in its facility. The FDA conducted a follow-up inspection in August 2016 and learned that the facility’s cleaning and sanitation procedures were insufficient and unsuccessful in solving the environmental Listeria contamination. Listeria was found in just as many locations as during the previous inspection and some was found on food-contact surfaces. At least some of the strains detected and analyzed at the DNA level had been present for both inspections and had likely been present for more than a year.
As a result, on Sept. 4, 2016, the FDA leveraged its FSMA authority to suspend the facility registration for SM Fish Corp., thereby prohibiting SM Fish from selling or distributing any food from its facility. The FDA also encouraged SM Fish to expand the scope of an earlier recall related to these inspections to include all SM Food products until SM Fish shows that food from its facility no longer has a reasonable probability of causing serious health consequences or death to humans.
All these new changes mean the industry must take a serious look at its facility registrations. No longer can facilities see registration as a minor requirement which does not require a great deal of time or effort but now may play a key role in inspections and enforcement actions. With the FDA leveraging a facility’s registration in order to gain compliance with the new food safety regulations promulgated by the FDA (Including the new HARPC and cGMP rules, FSVP, Produce Safety, Safe Food Transportation), facility registration must now be a priority. While registration is not a long process, ensuring that a facility’s registration accurately and truthfully reflects the activities being performed is vital to ensure foundational compliance with FDA regulatory requirements.
Thompson Coburn has a team of experienced food industry attorneys who have been involved in not only facility registrations but larger FSMA compliance for companies of all sizes. If you have any questions about facility registration, FSMA, FDA compliance or any other matters discussed in this blog post, please feel free to contact our Life Sciences Decoded team.
Diane Romza-Kutz is a partner and Fredric Roth is an associate in Thompson Coburn's health care practice group.