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, CAE
American Bakers Association
Senior Vice President, Government Relations & Public Affairs
December 8, 2014
Washington, DC

2. 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

3. 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

4. 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

5. 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

6. 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?

7. 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

8. 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

9. 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

10. 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

11. 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

12. Food Defense Many companies in good shape on this front
FDA’s Food Defense Plan Builder Tool is very useful

13. 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

14. Sanitary Transportation
Straightforward and well written – clear to industry what is needed

15. Thanks & Questions
Thanks for the opportunity to present the Bakers’ Perspective
Lee Sanders, CAE
American Bakers Association
Senior Vice President, Government Relations & Public Affairs

16. FSMA Challenge: INFORMATION
Charles M. Breen
Senior Consultant
EAS Consulting Group

17. 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 Oxford University Press. ~9400 words

18. INFORMATION Recognition and Acquisition Analysis
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?”

19. INFORMATION Decision Action To answer, “Which option works best?”
Implementation of decision
Documentation 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 information
Of hazards reasonably likely to occur
Of means to control such hazards
To 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 butter
2007 ConAgra Salmonella in peanut butter
Nor was PCA the last
2012 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 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

26. Where to get Information
FDA
Subscribe to recall notices
Review annual RFR reports
Trade associations
Google alerts
Clipping service

27. 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.”

28. FSMA: Enforcement Implications for FDA and the Food Industry
Frederick A. Stearns
Keller and Heckman LLP
1001 G Street, NW, Washington, DC
Phone:
Presented at FDLI: Enforcement, Litigation & Compliance
December 8, Washington, DC

29. 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

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 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)

31. 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

32. 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

33. 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)

34. 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

35. 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.

36. 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

37. 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

38. Thank you! Questions? Please contact:
Frederick A. Stearns
Keller and Heckman LLP
1001 G Street, NW, Washington, DC
Phone:
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.