Presentation on theme: "-The Baking Industry’s Perspective-"— Presentation transcript:
1 -The Baking Industry’s Perspective- What are the Greatest Challenges for Industry Compliance with FSMA, and What are Enforcement Concerns to Keep in Mind?-The Baking Industry’s Perspective-Lee Sanders, CAEAmerican Bakers AssociationSenior Vice President, Government Relations & Public AffairsDecember 8, 2014Washington, DC
2 Food Safety Paradigm Shifted from a reactive snapshot in time Risk-Based Approach should dedicate resources to the highest prioritiesNew Paradigm has preventive systems and plans in place to strengthen overall food safety
3 FSMA Definitions Ambiguity in Terminology Overlapping Requirements in Various ProposalsOverwhelmed by enormity/complexityShift to one size fits allComplexity of Bakery PlantsInterpreting and Complying
4 Who Determines Risk Plant or Auditor? HARPC analysis determines if risks are low and tests are minimalCombination of raw materials and process stepsCurrent HACCP program not clearly in line with new HARPC/FSMA requirementsFDA Inspector may determine greater riskEnforcement Plan or Enforcement Discretion?FDA auditors with specific knowledge of bakeries would be helpful.Bakery facilities are different from other facilities
5 Documentation Making documentation available Food Safety Plans Conducting Environmental Pathogen testingVerification and Validation of Cleaning and other activities to reduce/eliminate identified food safety risksResponsibility to implement and assure compliance falls with industryIn-Plant Photography
6 Records Access Onsite Records Have a consistent plan and way of communicating in your recordsConsistent documentation and standard operating procedures can streamlineMultiple HACCP plans, et alWhat constitutes a “record”Smaller suppliers impactedResources to develop required food safety, preventive control and record maintenance?
7 Ingredient and Finished Product Testing Huge cost burden on industryCould create the risk of unnecessary recalls with no increase in food safetyTesting can be used for validationTesting not effective for verification as industry cannot perform enough testing to be statistically significantRisk of false positives and negatives too high to be meaningful
8 Foreign Supplier Verification Currently beyond the capabilities of industryNecessary audit capabilities don’t exist in many countriesRequirements open to interpretation2 years will be inadequate for compliance – most likely will take 5 yearsRe-evaluation of sourcing imported ingredients
9 TimelinesAdditional time will be required to ensure food safety is built into the product development, ingredients and ultimately finished productsAdditional ResourcesNew Departments and StaffLonger lead times
10 InspectionsTrend of increased FDA inspections that are more enforcement orientedMore 483s for Food IndustryFDA proceeding as if final rules are in place
11 TrainingCritical for Industry to be engaged now to prepare and develop staff teamsFDA training critical to have standard inspection and operating procedures so less subjective and varied from inspector to inspector
12 Food Defense Many companies in good shape on this front FDA’s Food Defense Plan Builder Tool is very useful
13 Food FraudFDA re-opened for additional comments regarding significant hazards/hazard analysisIndustry guidance necessary on what needs to be looked at if this is required
14 Sanitary Transportation Straightforward and well written – clear to industry what is needed
15 Thanks & QuestionsThanks for the opportunity to present the Bakers’ PerspectiveLee Sanders, CAEAmerican Bakers AssociationSenior Vice President, Government Relations & Public Affairs
16 FSMA Challenge: INFORMATION Charles M. BreenSenior ConsultantEAS Consulting Group
17 INFORMATIONInformation, 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 Oxford University Press. ~9400 words
18 INFORMATION Recognition and Acquisition Analysis Known unknowns and unknown unknownsLearning of information’s existenceGetting what’s neededAnalysisTo answer, “So what?”And, “What can (or should) be done?”
19 INFORMATION Decision Action To answer, “Which option works best?” Implementation of decisionDocumentation of decision and its validation, implementation, monitoring, records review, periodic reanalysis, corrective actions, etc.
20 FSMA’s Draft Rules Relies on prevention Prevention not possible without informationOf hazards reasonably likely to occurOf means to control such hazardsTo say nothing of extensive documentation requirements
21 Information Mandate § 117.130 Hazard analysis. 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 §
22 Information Mandate“[K]nown or reasonably foreseeable hazards ” occurs 26 times in draft Safe Produce Rule, proposed part 112
23 When Did Hazard Become Reasonably Likely? 2008 PCA was not the first finding of Salmonella in peanut butter2007 ConAgra Salmonella in peanut butterNor was PCA the last2012 Sunland Peanut Corp Salmonella in peanut butter
24 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
25 RPC associated illnesses “Umpqua Dairy resumed milkproduction in Roseburg on Wednesdayafter a statewide salmonella outbreak[T]he milk and juice thatwas recalled was not tainted. Rather,the containers were contaminatedwith salmonella. Turns out thata machine that washes cases carrying products on a conveyor belt around the plant was infested with salmonella ”The Oregonian, August 25, 2010
26 Where to get Information FDASubscribe to recall noticesReview annual RFR reportsTrade associationsGoogle alertsClipping service
27 Signals RecognitionFDA 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.”
28 FSMA: Enforcement Implications for FDA and the Food Industry Frederick A. StearnsKeller and Heckman LLP1001 G Street, NW, Washington, DCPhone:Presented at FDLI: Enforcement, Litigation & ComplianceDecember 8, Washington, DC
29 New FDA Enforcement “Opportunities” Expanded enforcement authoritiesImpending new regulatory obligations for industryProhibited acts linked to FSMA provisionsIncreased potential for FDA inspectionsExpanded record inspection authorityNew FDA fee collection opportunities
30 Expanded Enforcement Authorities Suspension of Facility Registration“Reasonable probability” that exposure to food will cause serious adverse health consequences or death to humans or animalsFacilities have to know or have reason to know of such reasonable probabilitySunland (November 26, 2012) (peanut butter/Salmonella)Roos Foods (March 11, 2014) (cheeses/Listeria monocytogenes)Mandatory Recall AuthorityFDA 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)
31 Expanded Enforcement Authorities (2) Administrative DetentionFDA 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
32 Impending New Regulatory Obligations Hazard Analysis and Risk-Based Preventive Controls (HARPC)May include product testing, environmental monitoring, and supplier program requirementsFinal rules (human and animal) due August 30, 2015Foreign Supplier Verification Program (FSVP)Final rule due October 31, 2015Defense against Intentional AdulterationFinal rule due May 31, 2016
33 FSMA-Specific Prohibited Acts Failure to comply with HARPC requirementsFailure to comply with produce safety standardsFailure to comply with intentional adulteration provisionsFailure to comply with product tracing-related recordkeeping requirementsFailure to comply with mandatory recall orderKnowing 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)
34 Inspections Facility inspections determined on a “risk” basis Factors of a “high-risk” facility:Risk profile of the foodCompliance history of the facilityRigor and effectiveness of the facility’s hazard analysis and preventive controlsWhether the facility is certified for compliance with requirements to import foodFDA guidance issued March 2012
35 Inspections (2) FDA must inspect: All domestic high-risk facilities within five years of enactment, and at least once every three years thereafterOther domestic facilities within seven years of enactment, and at least once every five years thereafterAt 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.
36 Inspection of RecordsBroader FDA records access during inspections when “reasonable probability” of serious adverse health consequences or death from foodPrior authority: Access records of food at issueNew authority: Access records of food at issue and related products if reasonable belief that they are likely to be affected in similar mannerFDA must provide written notice
37 Fees FDA can collect fees for: Facility reinspections Capped at $25 millionMandatory food recallsCapped at $20 millionImporter reinspectionsFY 2015: $217/hr/FDA employee ($305/hr if foreign travel)Voluntary Qualified Importer ProgramFood and animal feed export certificates
38 Thank you! Questions? Please contact: Frederick A. StearnsKeller and Heckman LLP1001 G Street, NW, Washington, DCPhone: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.
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