FSMA Update
Jennifer Erickson, Regulatory Counsel, Center for Veterinary
Medicine, FDA
Litigation and
Miriam Guggenheim, Partner, Covington & Burling LLP
Sandra Eskin, Director, Food Safety, The Pew Charitable Trust
Washington, DC
December 9-10, 2015
Moderated by Ben Firschein, Director, US Government Affairs,
Global External Affairs, USP
FSMA Updates
Jennifer Erickson, JD
FDA Center for Veterinary
Rule Status
Preventive Controls Rule for Human Food
Final Rule Published
Preventive Controls Rule for Animal Food
Final Rule Published
Standards for Produce Safety
Final Rule Published
Foreign Supplier Verification
Final Rule Published
Third-Party Accreditation
Final Rule Published
Sanitary Transportation
Final Rule in Progress
April 2016
Intentional Adulteration
Final Rule in Progress
June 2016
Guidance in Progress
• Current list of FSMA related guidance:
• Additional anticipated guidance:
– Human Food Hazards and PC
– Animal Food Hazards and PC
– Animal Food CGMP
– Human Food By-products for use as Animal
FSMA Technical Assistance Network
• Web portal for all stakeholders to submit FSMArelated questions
• Once question is submitted you get a notification
of receipt and case number
• Question is routed through information
specialists or subject matter experts for
• Questions will be tracked and trended to:
– assist in prioritization of policy, guidance, and
– Develop a list of FAQs.
FSMA Technical Assistance Network
FDA Staff Preparedness
• Program Alignment Group (PAG)
– Identifying our food safety staff
• Ongoing FSMA discussions
– FDA and regulatory partners
• Staff Training
– FSPCA course
– DHRD course
Implementation Resources
FDA FSMA (general website)
FDA Training Information
Food Safety Preventive Controls Alliance
FSMA Frequently Asked Questions
FSMA Technical Assistance Network
FSMA Update:
Preparing for Compliance
FDLI Enforcement, Litigation, & Compliance
December 9, 2015
Miriam Guggenheim
Covington & Burling LLP
Preparing for Compliance
• Read key rules for industry and know their compliance
dates (for large businesses)
– HARPC – September 19, 2016
– FSVP – May 27, 2017
– Produce safety – see rule; it’s complicated!
• Understand scope and exemptions
• Understand key definitions and concepts
• Understand what FDA expects – records, records,
FSMA Core Concept – Ensuring a
Culture of Compliance
• Taking full responsibility for assuring the safety of the food you
• Building food safety into the sourcing and production process
• Knowing your suppliers and the nature of the food you produce
• Keeping abreast of latest food safety developments and risks
– Scientific developments (salmonella in peanut butter)
– Economic adulteration (melamine)
• Taking corrective action where needed, in accordance with predetermined approach
Hazard Analysis and Risk-Based Preventive
Controls (HARPC) in a Nutshell
For each type of food manufactured, processed, packaged, or held at a
covered facility, must develop a written food safety plan that includes:
– A hazard analysis
– Preventive controls
– Oversight and management of preventive controls
• Verification activities
• Monitoring of PCs
• Corrective actions
These activities must be conducted or overseen by a preventive controls
qualified individual (“PCQI”)
Must document everything, and make available to FDA upon request
Preventive Controls Qualified Individual
• Has completed training in the development and
application of risk-based PCs at least equivalent to a
curriculum recognized by FDA; or
• Is otherwise qualified through job experience to develop
and apply a food safety system
• HACCP training/job experience may be sufficient
Focus on Key Definitions
• “Known or reasonably foreseeable hazard”
– A biological, chemical, radiological, or physical agent that could
cause illness or injury and is known to be (or has the potential to
be) associated with the facility or the food
• “Hazard requiring a preventive control”
– A “known or reasonably foreseeable hazard” for which a
knowledgeable person would establish 1+ PCs to significantly
minimize or prevent the hazard
• Must assess (1) the probability that the hazard will occur in the absence
of PCs; and (2) the severity of the resulting illness/injury
Compliance and Enforcement
• Will FDA question the qualifications or judgment of your
• Will FDA question your PCQI’s determination of hazards
requiring a preventive control?
• Will FDA question the adequacy of your preventive
• Will FDA promulgate guidance through warning letters?
FSVP Core Requirements Overview
• An importer must, for each food that it imports, implement an
FSVP for each foreign supplier before importing a food into
the United States as necessary to provide assurance that
hazards in food requiring a control are significantly minimized
or prevented
• The FSVP must include:
– a written hazard analysis
– an evaluation of the risks posed by a food and the foreign
supplier’s performance
– supplier verification activities to allow the importer to approve the
foreign supplier, and
– corrective action procedures
Key Definitions
• “Importer” is the U.S. owner or consignee of an article of food that is
being offered for import into the United States.
– If there is no U.S. owner or consignee, then the importer will be the U.S.
agent or representative of the foreign owner or consignee, as confirmed
in a signed statement of consent.
– “Owner or consignee” replaces the provision in the proposed rule that
made the importer the purchaser of the food, or if there is no purchaser,
the U.S. consignee.
• “U.S. owner or consignee” is defined as the “person in the U.S. who,
at the time of entry, owns the food, has purchased the food, or has
agreed in writing to purchase the food.”
• So first step is to determine whether you or someone else is the
Relevant Exemptions/Modified Requirements
An importer that is also a registered food facility and is controlling hazards
under the HARPC rule need not comply with the majority of the FSVP rule.
An importer who has established and implemented a risk-based supplychain program is deemed to be in compliance with FSVP requirements.
Juice, fish, and fishery products from foreign suppliers who are required to
comply with, and are in compliance with, the relevant HACCP regulations
are exempt from FSVP requirements.
For the importation of “covered produce” subject to the produce safety rule,
the importer’s hazard analysis of that food need not include an analysis of
biological hazards, because those hazards are covered by the produce rule.
Miriam Guggenheim
Covington & Burling LLP
The Role of Audits in Determining
FSMA Compliance
Sandra B. Eskin
Director, Safe Food Project
The Pew Charitable Trusts
901 E Street NW, 10th Floor | Washington, DC 20004
Work phone: 202-540-6407| Cell phone: 301-602-1918|
“FDA-certified” Auditor
The FDA Food Safety Modernization Act (FSMA), creates an “FDA-certified”
auditing program to be used in two specific instances -1) if FDA determines that a “hi-risk” imported product/foreign facility
requires “extra assurance” that it is safe; or
2) to qualify an importer to participate in the voluntary “fast-track”
import program known as “VQIP” (Voluntary Qualified Importer
Preamble to the Final FSVP Rule
• “Any qualified auditor conducting an audit relied upon by an importer
would need to meet the requirements for independence set forth in
[our regulations, which require no financial conflicts of interest and
that payment must not be related to results of audit].”
• “We believe that a person need not be an auditor formally accredited
under the third-party certification regulations or any other
accreditation system to have the technical expertise needed to
appropriately perform an onsite audit.”
FSVP Definitions
Audit means the systematic, independent, and documented examination . .
. to assess an audited entity’s food safety processes and procedures.
Qualified auditor means a person who is a qualified individual . . . and has
technical expertise, training, or experience (or a combination thereof)
necessary to perform the auditing function.
Qualified individual means a person who has the education, training, or
experience (or a combination thereof) necessary to perform an activity
required under this subpart, and can read and understand the language of
any records that the person must review in performing this activity.
More From the Preamble to the Final FSVP Rule
“The FSVP regulations do not require that a qualified auditor or
qualified individual be accredited under any accreditation scheme or
system, including FDA’s, as long as otherwise satisfies the
requirements to be a qualified auditor or individual [as those terms are
defined in the regulations].”
Preamble to the Final Produce Rule
• “[T]hird party audits are an important part of our overall compliance
• “ [A]s a complement to State and FDA inspections of farms, we
intend to leverage the conduct of reliable third-party farm audits by
USDA and others, as well as compliance with marketing
agreements, with a goal of annual verification of farms that must
comply with the rule.”
More from the Preamble to the Final Produce Rule
• “Adequately rigorous and reliable private audits can be an important
additional tool for fostering food safety and ultimately compliance
with this rule.”
• “FDA is not recognizing any auditing body in this produce safety