What are the Greatest Challenges for Industry Compliance with FSMA, and What are Enforcement Concerns to Keep in Mind? -The Baking Industry’s PerspectiveLee Sanders, CAE American Bakers Association Senior Vice President, Government Relations & Public Affairs December 8, 2014 Washington, DC Food Safety Paradigm • Shifted from a reactive snapshot in time • Risk-Based Approach should dedicate resources to the highest priorities • New Paradigm has preventive systems and plans in place to strengthen overall food safety FSMA Definitions • Ambiguity in Terminology • Overlapping Requirements in Various Proposals • Overwhelmed by enormity/complexity • Shift to one size fits all – Complexity of Bakery Plants – Interpreting and Complying Who Determines Risk • Plant or Auditor? • HARPC analysis determines if risks are low and tests are minimal – Combination of raw materials and process steps – Current HACCP program not clearly in line with new HARPC/FSMA requirements • FDA Inspector may determine greater risk – Enforcement Plan or Enforcement Discretion? • FDA auditors with specific knowledge of bakeries would be helpful. • Bakery facilities are different from other facilities Documentation • • • • Making documentation available Food Safety Plans Conducting Environmental Pathogen testing Verification and Validation of Cleaning and other activities to reduce/eliminate identified food safety risks – Responsibility to implement and assure compliance falls with industry • In-Plant Photography Records Access • Onsite Records • Have a consistent plan and way of communicating in your records – Consistent documentation and standard operating procedures can streamline – Multiple HACCP plans, et al – What constitutes a “record” • Smaller suppliers impacted – Resources to develop required food safety, preventive control and record maintenance? Ingredient and Finished Product Testing • Huge cost burden on industry • Could create the risk of unnecessary recalls with no increase in food safety • Testing can be used for validation • Testing not effective for verification as industry cannot perform enough testing to be statistically significant • Risk of false positives and negatives too high to be meaningful Foreign Supplier Verification • Currently beyond the capabilities of industry • Necessary audit capabilities don’t exist in many countries • Requirements open to interpretation • 2 years will be inadequate for compliance – most likely will take 5 years • Re-evaluation of sourcing imported ingredients Timelines • Additional time will be required to ensure food safety is built into the product development, ingredients and ultimately finished products – Additional Resources – New Departments and Staff – Longer lead times Inspections • Trend of increased FDA inspections that are more enforcement oriented – More 483s for Food Industry • FDA proceeding as if final rules are in place Training • Critical for Industry to be engaged now to prepare and develop staff teams • FDA training critical to have standard inspection and operating procedures so less subjective and varied from inspector to inspector Food Defense • Many companies in good shape on this front • FDA’s Food Defense Plan Builder Tool is very useful Food Fraud • FDA re-opened for additional comments regarding significant hazards/hazard analysis • Industry guidance necessary on what needs to be looked at if this is required Sanitary Transportation • Straightforward and well written – clear to industry what is needed Thanks & Questions • Thanks for the opportunity to present the Bakers’ Perspective Lee Sanders, CAE American Bakers Association Senior Vice President, Government Relations & Public Affairs email@example.com 202-789-0300 FSMA Challenge: INFORMATION Charles M. Breen Senior Consultant EAS Consulting Group firstname.lastname@example.org INFORMATION • Information, n., 2. a. Knowledge communicated concerning some particular fact, subject, or event; that of which one is apprised or told; intelligence, news. OED Online. September 2014. Oxford University Press. ~9400 words INFORMATION • Recognition and Acquisition – Known unknowns and unknown unknowns – Learning of information’s existence – Getting what’s needed • Analysis – To answer, “So what?” – And, “What can (or should) be done?” INFORMATION • Decision – To answer, “Which option works best?” • Action – Implementation of decision – Documentation of decision and its validation, implementation, monitoring, records review, periodic reanalysis, corrective actions, etc. FSMA’s Draft Rules • Relies on prevention • Prevention not possible without information – Of hazards reasonably likely to occur – Of means to control such hazards – To say nothing of extensive documentation requirements Information Mandate • § 117.130 Hazard analysis. (a) Requirement for a hazard analysis. (1) You must identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards . . .. [emphasis added] • Same language in animal PC draft rule at § 507.33 Information Mandate • “[K]nown or reasonably foreseeable hazards . . ..” occurs 26 times in draft Safe Produce Rule, proposed part 112 When Did Hazard Become Reasonably Likely? • 2008 PCA was not the first finding of Salmonella in peanut butter – 2007 ConAgra Salmonella in peanut butter • Nor was PCA the last – 2012 Sunland Peanut Corp Salmonella in peanut butter Reusable Packaging Association “Here are the facts: R[eusable] P[lastic] C[ontainer]s have been used to ship food products such as milk, eggs, and produce in the U.S. and Europe for more than 20 years without a single documented incidence of food contamination attributable to their use.” – Food Safety News, Nov. 4, 2014 RPC associated illnesses “Umpqua Dairy resumed milk production in Roseburg on Wednesday after a statewide salmonella outbreak .... [T]he milk and juice that was recalled was not tainted. Rather, the containers were contaminated with salmonella. Turns out that a machine that washes cases carrying products on a conveyor belt around the plant was infested with salmonella . . ..” The Oregonian, August 25, 2010 Where to get Information • FDA – Subscribe to recall notices – Review annual RFR reports • Trade associations • Google alerts • Clipping service Signals Recognition • FDA FY15 Budget Request for $263 M increase for food safety – “FDA will increase data gathering and analytical capacity to support risk-based priority setting and resource allocation, including automating and expediting risk analysis and integration of risk information into decision-making tools.” FSMA: Enforcement Implications for FDA and the Food Industry Frederick A. Stearns Keller and Heckman LLP 1001 G Street, NW, Washington, DC 20001 Phone: 202-434-4288 Email: email@example.com Presented at FDLI: Enforcement, Litigation & Compliance December 8, 2014 Washington, DC New FDA Enforcement “Opportunities” • Expanded enforcement authorities • Impending new regulatory obligations for industry • Prohibited acts linked to FSMA provisions • Increased potential for FDA inspections • Expanded record inspection authority • New FDA fee collection opportunities Expanded Enforcement Authorities • Suspension of Facility Registration – “Reasonable probability” that exposure to food will cause serious adverse health consequences or death to humans or animals – Facilities have to know or have reason to know of such reasonable probability • Sunland (November 26, 2012) (peanut butter/Salmonella) • Roos Foods (March 11, 2014) (cheeses/Listeria monocytogenes) • Mandatory Recall Authority – FDA may order recall if there is a reasonable probability that the food is adulterated or misbranded and will cause serious adverse health consequences or death (i.e., a “Class I” recall situation) • Kasel Associates (February 13, 2013) (pet treats/Salmonella) • USPLabs (November 6, 2013) (DMAA) Expanded Enforcement Authorities (2) • Administrative Detention – FDA may detain any food if there is “reason to believe” that the article of food is “adulterated or misbranded” – Old standard: “credible evidence or information indicating” that the food “presents a threat of serious adverse health consequences or death to humans or animals.” • Bonaterra Products (August 2011) (spices, tamarinds, and chili products/insect infestation) • Mill Stream: (December 2011) (ready-to-eat cold smoked salmon/Listeria monocytogenes) • Hi-Tech Pharmaceuticals (November 2013) (dietary supplements/DMAA) – Final rule: February 5, 2013 Impending New Regulatory Obligations • Hazard Analysis and Risk-Based Preventive Controls (HARPC) – May include product testing, environmental monitoring, and supplier program requirements – Final rules (human and animal) due August 30, 2015 • Foreign Supplier Verification Program (FSVP) – Final rule due October 31, 2015 • Defense against Intentional Adulteration – Final rule due May 31, 2016 FSMA-Specific Prohibited Acts • Failure to comply with HARPC requirements • Failure to comply with produce safety standards • Failure to comply with intentional adulteration provisions • Failure to comply with product tracing-related recordkeeping requirements • Failure to comply with mandatory recall order • Knowing and willful failure to provide requisite consumer notification under Reportable Food Registry (RFR) • Importation of food from importer without compliant foreign supplier verification program (FSVP) Inspections • Facility inspections determined on a “risk” basis • Factors of a “high-risk” facility: – Risk profile of the food – Compliance history of the facility – Rigor and effectiveness of the facility’s hazard analysis and preventive controls – Whether the facility is certified for compliance with requirements to import food • FDA guidance issued March 2012 Inspections (2) • FDA must inspect: – All domestic high-risk facilities within five years of enactment, and at least once every three years thereafter – Other domestic facilities within seven years of enactment, and at least once every five years thereafter – At least 600 foreign facilities within one year of enactment, and in each of the five years thereafter, shall inspect at least twice as many foreign facilities as inspected the previous year. Inspection of Records • Broader FDA records access during inspections when “reasonable probability” of serious adverse health consequences or death from food • Prior authority: Access records of food at issue • New authority: Access records of food at issue and related products if reasonable belief that they are likely to be affected in similar manner • FDA must provide written notice Fees • FDA can collect fees for: – Facility reinspections • Capped at $25 million – Mandatory food recalls • Capped at $20 million – Importer reinspections – FY 2015: $217/hr/FDA employee ($305/hr if foreign travel) – Voluntary Qualified Importer Program – Food and animal feed export certificates Thank you! Questions? Please contact: Frederick A. Stearns Keller and Heckman LLP 1001 G Street, NW, Washington, DC 20001 Phone: 202-434-4288 Email: firstname.lastname@example.org DISCLAIMER: This presentation and the accompanying discussion provide general information on recent legal and regulatory developments. They are not intended to be, and should not be relied upon as, legal advice.