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

Pending Regulations FDAAA of 2007 FSMA of 2011 Unapproved animal drugs

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

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

FDAAA of 2007 Ingredient standards & definitions

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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, 9600 underfunded and undermanned FDA to establish offices in some countries

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

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…

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

FSMA FDA FSMA website located in Food (CFSAN) section http://www.fda.gov/Food/FoodSafety/FSMA Can sign up for updates

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

Questions?