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
• 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
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
• 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
• 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
• 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
• Trend of increased FDA inspections that
are more enforcement oriented
– More 483s for Food Industry
• FDA proceeding as if final rules are in
• 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
• FDA’s Food Defense Plan Builder Tool is
very useful
Food Fraud
• FDA re-opened for additional comments
regarding significant hazards/hazard
• 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
FSMA Challenge:
Charles M. Breen
Senior Consultant
EAS Consulting Group
• 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
• 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?”
• 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
– Of hazards reasonably likely to occur
– Of means to control such hazards
– To say nothing of extensive documentation
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
• 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
– 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: stearns@khlaw.com
Presented at FDLI: Enforcement, Litigation & Compliance
December 8, 2014
Washington, DC
New FDA Enforcement “Opportunities”
• Expanded enforcement authorities
• Impending new regulatory obligations for
• 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
• 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
– Final rule: February 5, 2013
Impending New Regulatory
• 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,
• 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
• 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
• Importation of food from importer without compliant
foreign supplier verification program (FSVP)
• Facility inspections determined on a “risk”
• 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
– Other domestic facilities within seven years of
enactment, and at least once every five years
– 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
• 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: stearns@khlaw.com
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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