1. Regulatory Update for US
Pet Food Association Canada
November 4, 2011
Angele Thompson, Ph.D.
Thompson PetTech

2. Pending Regulations
FDAAA of 2007
FSMA of 2011
Unapproved animal drugs

3. FDAAA of 2007 Food & Drug Admin Amendments Act
Overtaken by FSMA, but not gone
Established the Reportable Food Registry for all foods, in place for 2 years
Report SAHCODHA – class 1 recalls
First yr – pet food was 5% of all reports
86 of 229 primary RFR entries for Salmonella - 18 in category of animal feed/pet food

4. FDAAA of 2007
Sec 1002 – specific for pet food and other animal feed - due Sept. 2009
Three parts –
Labeling standards including nutritional info
Ingredient standards & definitions
Processing standards
First two have been written and were in clearance, but overtaken by FSMA

5. FDAAA of 2007
Ingredient standards & definitions

6. FDAAA of 2007 Ingredient standards & definitions
In doing this section, FDA looked at its MOU with AAFCO
Decided AAFCO definitions not supportable by FDA in a legal sense
Thrown entire ingredients definition system on its ear into chaos
FDA has been trying to insert ‘standards’ into definitions during the last 18 months
AAFCO has been working on revising its IDC process

7. FDAAA of 2007 Ingredient standards & definitions
AAFCO wants to include ‘standards’ but no one has a definition for ‘standards’
AAFCO wants to charge for reviews which duplicates what FDA will be doing
Wants to set up a system with expert panel reviews
But AAFCO does NOT have expert panels or any experience with them
Doesn’t make sense
Meanwhile, the list in the FDA GRAS notification for animal ingredients process keeps growing without any ingredient clearing the list. First submissions back in May 2011.

8. Food Safety Modernization Act
Know as FSMA or FizzMA
US Congressional mandate
Classically underfunded

9. Food Safety Modernization Act
FSMA – Took over FDA resources
Significantly expands FDA authority over food facilities
Covers both domestic and foreign facilities that manufacture, process, pack or hold any kind of food
Regardless of interstate or intrastate

10. FSMA Leverages Bioterrorism Act registration
Starting Oct-Dec 2012, must reregister every 2 years
FDA can suspend registration
basically shut down a facility
Changed administrative detention from “credible evidence or information” to “reason to believe” a product is adulterated now in effect
First detention happened Oct. 11

11. FSMA Big areas Mandatory recall & fees Written Food Safety Plans
Preventive controls/Hazard analysis
Written food defense plans
Mandated inspection frequency
Foreign supplier verification

12. FSMA Mandatory recall Effective now
If FDA sees a “reasonable probability” that a product is adulterated or misbrand and facility doesn’t issue a voluntary recall, then FDA can make recall mandatory
Requires action to be authorized by the Commissioner, not lower

13. FSMA
Fees
In case of: reinspection, mandatory recall, or Voluntary Qualified Importer Program
Plus for export certificates
Charge per hour required to address issue
FDA’s guesstimate for hourly rate: domestic $224/hr; foreign $325/hr
“cap” of $25 million, no one is sure what that means

14. FSMA Written Food Safety Plans (FSP) Develop, implement and verify
Inspectors authorized to review
FDA was leaning towards having all plans submitted to one central location
CSPI (consumer group) was demanding this in open FDA hearing

15. FSMA Written Food Safety Plans (FSP)
The Act says“sufficient flexibility to be practical for all types and sizes of facilities” Plans must be flexible to each location, not one size fits all
Facilities have different products and different ingredients
Living and changing documents, required to keep them current with facility
Must be taken within the context of the facility
Highly confidential

16. FSMA Written Food Safety Plans (FSP)
Industry does support review of plans by inspectors during inspection of facility
Industry strongly objects to central submission
out of context
confidentiality issues
potential threat to food defense

17. FSMA Preventive Controls (PC) & Hazard Analysis
The Act says PC must be “science and risk- based and reasonably appropriate measures” Also that must evaluate “known or foreseeable” hazards associated with facilities
Controls must prevent or minimize identified hazards
Also must say why something isn’t a hazard
Not prescriptive, but for example follow cGMP

18. FSMA Preventive Controls (PC) & Hazard Analysis
Must monitor effectiveness of PC
Must verify actions
Must record non-compliances
Must have corrective actions and verify those
Maintain the records for at least 2 years
Reanalyze hazards at least every 3 years, not one and done, + at every significant change in facility

19. FSMA Written Food Defense Plan
for ‘high risk’ products based on vulnerability no definition of ‘high risk’ yet
maybe short shelf life products
just had workshop in OK two days ago

20. FSMA Mandated inspection frequency
For “high risk” facilities – within 5 yr and every 3 yr thereafter; all others within 7 yr and every 5 yr thereafter
Foreign inspections mandated to double each year
Requires unprecedented # of inspectors
FDA will have to partner – AAFCO, states, USDA
Proper training is CRITICAL

21. FSMA Mandated inspection frequency
Big question – What is “high risk” facility?
Criteria in Act
Identified food safety risks for products
Facilities history of compliance, past recalls
“Rigor and effectiveness” of FSP

22. FSMA Mandated inspection frequency
Big question – What is “high risk” facility?
Possible continuum for microbial contamination
Fresh, raw products for human consumption, like leafy produce
Minimally processed food for human consumption
Raw products brought into home for pets
Animal parts for consumption by pets
Minimally processed food for pets
Shelf stable products for humans or pets (no refrigeration)
Food for consumption by food producing animals

23. FSMA Foreign supplier verification
Act requires that imported products:
offer “same level of public health protection”
are not adulterated or misbranded
do not contain undeclared allergens (this last is not for pet foods/animal feeds)
Must engage in verification activities, which are undefined right now

24. FSMA Foreign supplier verification
Voluntary Qualified Inspection Program
To expedite imports from ‘trusted’ sources
Third party inspection
Third party would have to be certified but certification rules come after implementation of VQIP
FDA Inspections 600, 1200, 2400, 4800, underfunded and undermanned
FDA to establish offices in some countries

25. FSMA Foreign supplier verification Must not compromise trade
Must be consistent with WHO and all other treaties
Will probably be challenged

26. FSMA
FDA in September expressed concerns about recent recall of ‘pet foods’ for Salmonella contamination
FDA has zero tolerance for Salmonella in ‘pet foods’
Some pet foods have been raw or minimally processed, but still recalls for dry have happened”
FDA is looking for industry to do more…

27. FSMA Industry needs to stay tuned
Keep participating in ‘listening sessions’
Keep submitting comments
Continue to do continuous improvement
In fact, at least one comment has been submitted by a Canadian province

28. FSMA FDA FSMA website located in Food (CFSAN) section
Can sign up for updates

29. Unapproved Animal Drugs
Might not think about pet foods, but FDA has explicitly included not only ‘therapeutic veterinary products’ (their words in Sept.), but maybe also hairball and urinary tract products
Were told that this is finished with internal clearance and ready for publication in Federal Register
Keeping a close eye on this

30. Questions?