Last week I attended the 2018 FSPCA Lead Instructor Conference for instructors of FSMA Food Safety Courses. As in last years conference I always learn something new. Here are some highlights for Animal Food. Just a reminder that there are two more dates to remember in terms of compliance:
9/17/18 – there is a countdown clock on the About page!
- Small business compliance with Hazard Analysis and Preventive Controls
- Very Small Business Compliance with Training & CGMP’s
9/17/19
- Very Small business compliance with Hazard Analysis and Preventive Controls
- All facilities (including Qualified or “exempt”) must be in compliance with training & CGMP’s
I have attempted to separated the information into several categories of Interest – General Information on Training, General Information on Inspections, Manufacturing/Processing Facilities, Hold Only Facilities, FSVP and Sanitary Transportation:
General Information on Training:
- To date 5,895 certificates have been issued domestically and 397 internationally. 370 classes have been held with an average of 17 participants per class. This includes industry, regulators (State and Federal), insurance companies, lawyers, students and many more). CFD has taught 15 classes to 142 students.
- There are 7,400 Animal Food Facilities in the US and about 4,300 are subject to the Preventive Controls portion of the rule. The remaining are subject to training and CGMP requirements of the rule.
General information on Inspections:
- FDA representatives elaborated on inspector training. In addition to the training provided alongside industry, inspectors take 8 days of additional training and are required to participate in OJE – On the Job Experience by observing inspections with experienced inspectors. They also have a Regulator TAN (Technical Assistance Network) where they are encouraged to phone a subject matter expert during inspections to get questions answered.
- As you may recall from earlier posts; FSMA inspections are a change in paradigm from observational to systemic inspections and these activities illustrate the additional training that must happen to shift this focus.
- CFD has trained 16 FDA Inspectors and 5 state inspectors from CT and 1 from NY.
- In the Government Fiscal Year 2018 there were 304 Animal Food CGMP inspections planned. As of early July 242 were complete. The average duration was 3 days. The number for FY2019 will be much larger and determined by FDA regional offices.
Manufacturing/Processing Facilities:
- Soon there will be a blended Animal Food course. It will include 1 1/2 day self paced on-line course followed by 1 day instructor led training. This will be available in late 2018. If you have interest in this format let us know.
- Additional Animal Food Safety Plan examples are under development. I will send those to past students when they are available. These are only examples.
- Preventive Controls Inspections will start in FY 2019 (around January 2019) for small businesses. The number of PCAF inspections will likely be about 150.
Hold Only Facilities:
- You are subject to the training and CGMP part of the rule. Depending on your size, the compliance dates are between September 2018 and September 2019.
- FDA Divisions have been instructed not to inspect this type of facility initially unless the facility is a PET FOOD only facility. However, inspections will happen in time. More information is coming soon from CFD!
FSVP (Foreign Supplier Verification Program):
- Since the compliance date in May 2017 there have been 13M lines of food imported to the US. 9M have used a DUNS number to identify the FSVP Importer. 1.4M have not and 2.5M have been exempt foods.
- These inspections are pre-announced because there are often errors in identifying the FSVP importer and the FDA found themselves visiting broker offices.
- FY17 – 285 Imspections, FY18 – 2,275 planned with 256 completed as of mid June. The issue above has made inspections challenging.
- Not all facilities that are subject to FSVP are registered facilities so that is challenging as well.
Sanitary Transportation of Human and Animal Food:
- 20 Inspections have been conducted by FDA in conjunction with CGMP inspections. These are not done under any state agreements.