A Comparison of Contrasts

FDA seems to be taking its task for proactive outreach very seriously lately. I’ve noticed a general increase in the frequency and type of communications in my email box — from Constituent Updates on new guidance and policy to “Remarks from the Commissioner” and “Conversations with” various officials. I see this as a positive step in helping both the industry and consumers increase their understanding of FDA regulations and activities. So I could have written this column on any number of those communications: No matter how much FDA communicates, it’s impossible to address every issue, concern, or question of the vast array of products, processes, and practices of our markedly diverse industry.

But there were two recent publications that I found to be of particular interest due to the contrast in their focus on facility inspections — but parallel significance to the industry. One provides a summary of compliance issues FDA has found in its facility inspections; the other provides certain facilities with a temporary pass on compliance for some FSMA provisions.

FIRST THE PASS ... In early January, FDA announced that it has implemented an enforcement discretion period for four FSMA rules. During the period, FDA does not intend to enforce specific provisions as they currently apply to certain entities or activities of four rules: the Preventive Controls (PC) rules for human and animal foods, Foreign Supplier Verification Programs (FSVP), and Produce Safety. The purpose of the discretion period is to allow FDA time to consider changes or other approaches to address concerns. FDA had previously extended the compliance dates for many of these provisions.

What This means to you. Following are general overviews of the facilities or activities impacted by these and why FDA chose to exercise enforcement discretion. (For more information on each, see FDA’s Fact Sheet and Guidance.)

1. Facilities that would be farms except for certain factors and activities. Some establishments not currently defined as farms conduct typical farm activities. But, because they are not considered farms, they are subject to the PC and CGMP requirements (unless another exemption applies). The agency intends to initiate a rule that could change the PC requirements for facilities that conduct activities similar to those of farms.
2. Written assurances provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health. Each of the four rules includes “customer provisions” intended to provide written assurance to a manufacturer, processor, importer, or farmer that the food will be processed to control for hazards before it reaches consumers. FDA has received feedback that certain product distribution chains would require vastly more written assurances and resources to comply than FDA anticipated.
3. The animal food PC requirements for certain manufacturing/processing activities performed on human food by-products used as animal food. These include drying/dehydrating, evaporating, pressing, chopping and similar activities to reduce weight, bulk, or volume; and/or mixing, centrifuging, and similar activities to combine ingredients or separate components (e.g., water and solids). Enforcement discretion does not apply when these activities are performed to prevent or significantly minimize animal food hazards, or when they introduce animal food hazards. Since issuing the 2016 Draft Guidance (#239) “Human Food By-Products For Use As Animal Food,” FDA has become aware of concerns about how the PC requirements apply to the listed activities on by-products before they are stored or transported which do not affect their safety profile.
4. FSVP requirements for importers of food-contact substances. The FSVP regulation applies to the importation of “food” as defined in the FD&C Act, which includes food-contact substances. After considering the issue and stakeholder comments and other input, FDA is exercising enforcement discretion because of certain characteristics related to the nature, premarket review/oversight, and regulatory framework of food-contact substances.

THE INSPECTION ISSUES ... In December, FDA published a summary of the inspectional observations documented on 483s issued through its electronic system from October 1, 2015, to September 30, 2016.  

An FDA Form 483 is issued to a facility’s management at the conclusion of an inspection if the investigator observes any conditions that could violate the FD&C or related acts. The company is then encouraged to respond to the 483 in writing with its corrective action plan, then implement it expeditiously. To determine if further action is needed, FDA considers the 483, the Establishment Inspection Report, evidence/documentation collected on-site, and the company’s response.

With 4,528 483s issued through FDA’s electronic system, the most common problems that were observed and documented by inspectors were those related to cleaning and/or sanitation, pests/pest control, HACCP or FSMA compliance, and recordkeeping. In fact, more than 1,300 related directly to cleaning and/or sanitation practices, and nearly 1,000 related to pests and their control.

It is more difficult to assess the number of issues related to compliance and recordkeeping as there is a lot of overlap with these and other citations. Suffice it to say that the word “record” or “document” appears nearly 500 times in the list of issues. This does not even account for the number of 483s issued for each, e.g., the 148 issued under “You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan”; the 95 for “You are not maintaining sanitation control records that document ...”; etc.

WHAT IT ALL MEANS. It’s interesting; but what does it mean to you? If you think about it, the two FDA publications show that, whether the agency is looking at what is or what isn’t being enforced during inspections, it is looking at inspections. And with FSMA’s mandate to increase its inspections year to year; FDA’s “new authorities and tools to respond effectively when problems emerge”; and OIG’s latest blasting of FDA’s “inefficient” recall process, your chances of being overlooked have decreased dramatically.

So if I were a facility manager, I would take another look what’s in (with particular focus on sanitation, pests, and documentation) and what’s out (likely relieving a lot of unwarranted concern for some), so that I would be as prepared as possible when that FDA knock comes at my door.