Food Safety Modernization Act (FSMA) and
Global Food Safety Measures for Functional
Food and Dietary Ingredients
Frederick A. Stearns
Keller and Heckman LLP
1001 G Street, NW, Washington, DC 20001
Phone: 202-434-4288
Email: stearns@khlaw.com
Presented to: FDLI Safeguarding Ingredient Supply Chain Conference
September 10, 2013
Washington, DC
Washington, D.C. ● Brussels ● San Francisco ● Shanghai
Agenda
• Food Safety Modernization Act (FSMA)
• Enacted January 4, 2011
• Applicability to ingredient suppliers?
• Provisions
• Improving capacity to prevent food safety problems
• Improving capacity to detect and respond to food safety
problems
• Improving safety of imported food
 Global Food Safety Initiative (GFSI)
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A Note on Timing . . .
 August 2012: FDA sued by Center for Food Safety
(public interest group)
• FDA missed several statutory deadlines for regulations
• CFS sought court order compelling action
 April 2013: Court agreed FDA violated FSMA
• Parties to propose implementation schedule by May 20, 2013
(extended to June 10)
 June 21, 2013: Court-ordered rulemaking deadlines:
• November 30, 2013: all proposed rules to be published
• March 31, 2014: latest allowed comment deadline
• June 30, 2015: publication of final regulations
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Who Must Register?
“Any factory, warehouse, or establishment
(including a factory, warehouse, or establishment
of an importer) that manufactures, processes,
packs, or holds food [for consumption in the
United States].”
- FD&C Act § 415(c)(1)
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What is “food”?
“[F]ruits, vegetables, fish, dairy products, eggs,
raw agricultural commodities for use as food or as
components of food, animal feed (including pet
food), food and feed ingredients, food and feed
additives, dietary supplements and dietary
ingredients, infant formula, beverages (including
alcoholic beverages and bottled water), live food
animals, bakery goods, snack foods, candy, and
canned foods.”
- 21 C.F.R. § 1.227(b)(4)(ii)
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Improving Capacity to Prevent
Food Safety Problems
 Title I Major Provisions
• Record keeping and inspection of records
• Registration of food facilities
• Hazard analysis, risk-based preventative controls,
and food safety plans
• Contaminant-specific regulations
• FDA reporting requirements
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Hazard Analysis, Risk-Based Preventative Controls
(HARPC) and Food Safety Plans
 Hazard analysis
• Registered facility required to conduct a written
analysis of known or reasonably foreseeable hazards
affecting food (e.g., biological, chemical, physical,
radiological, natural toxins, pesticides, drug residues,
decomposition, parasites, allergens, unapproved food
and color additives)
• A hazard re-evaluation required at least every three
years or sooner if there is reasonable potential for a
new hazard or significant increase in a previously
identified hazard
• Delayed implementation of this section for small
businesses
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HARPC and Food Safety Plans (2)
 Risk-based preventative controls - facility must:
• Implement preventive controls to minimize or prevent
the hazard
• Monitor effectiveness of controls, establish corrective
actions, and verify effectiveness of their activities
• Maintain records relating to monitoring activities,
verification activities, and efficacy of preventive
controls for at least two years
• Develop a written plan documenting compliance
• Make food safety plan and all related records
available to FDA upon written or oral request
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HARPC Proposed Rules
 Published in 78 Fed. Reg. 3646 (Jan. 16, 2013)
• HARPC statutory provision in effect on July 5, 2012
• FDA: enforcement will not start until a date to be
specified in the final regulations
• Comments accepted until November 15, 2013
 Proposal:
• Clarifies definition of “farm” for registration
• Revises current Good Manufacturing Practice (GMP)
regulations now in 21 C.F.R. Part 110
• Implements HARPC requirements of FDC Act
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Proposed Rules - HARPC Exemptions
 “Qualified facilities”
• Based on low annual food sales (threshold to be set)
 Low-risk, on-farm activities performed by very small or
small businesses
 Foods subject to HACCP regulation
 Dietary supplements (in compliance with):
• 21 CFR Part 111 (cGMPs)
• Serious adverse event reporting
 Alcoholic beverages
 Activities within the definition of “farm”
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Improving Capacity to Detect and Respond to Food
Safety Problems
 Title II Major Provisions:
• Inspections
• Traceability and surveillance
• Laboratory accreditation and testing
• Recall authority
• Administrative detention
• Reportable Food Registry
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Improving Safety of Imported Food
 Title III Major Provisions
• Foreign supplier verification program
• Voluntary qualified importer program
• Import certification and accreditation
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FSVP – Proposed Regulations
 Published at 78 Fed. Reg. 45730 (July 29, 2013)
 Intended to be consistent with HARPC to avoid
duplicate requirements
 Applies to “importer”
• US purchaser of goods
• If none yet, US consignee
• If none yet, US agent for of foreign owner
 Importers required to develop, maintain, and follow
FSVP for each imported food (unless an exemption
applies)
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FSVP Proposal - Exemptions
 Juice and seafood in compliance with HAACP
 Food imported for research and evaluation
 Food imported for personal consumption
 Alcoholic beverages
 Food transshipped or imported for further export and
not consumed/distributed in US
 Products complying with low acid canned food
requirements (exempt for microbiological hazards only)
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FSVPs – Basic Elements
 Compliance status review of foods and suppliers
 Hazard analysis
 Foreign supplier verification activities
 Investigations and corrective action (if needed)
 Periodic reassessment of FSVP
 Importer identification at entry
 Recordkeeping
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FSVPs – Dietary Supplement Components
 Dietary supplement component importer must:
•
•
•
•
Maintain list of foreign suppliers
Identify importer at time of entry
Keep records
Annually obtain written certification from dietary
supplement customers that they are in compliance with
specification provisions of 21 CFR Part 111
 Otherwise, subject to full FSVP requirements
 No reduced burden for conventional food/food
ingredients
 [Curious: regulation defines “dietary supplement
component” but does not use the term]
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Global Food Safety Initiative (GFSI)
 Launched in 2000
 Managed by The Consumer Goods Forum
 Independent global network
• More than 650 members
• 70 countries represented
 Both “retail” and “manufacturing” members
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GFSI Effect
 “Once certified, accepted everywhere”
• Certification to GFSI-recognized scheme reduces
need for multiple quality audits
 GFSI “business case” for suppliers:
• “Certificated companies are more disciplined, more
efficient and more profitable”
• “Certificated companies show equivalence of process
across countries and continents”
• “GFSI recognised standards are accessible and are
shared by many”
• “Certificated companies will have a legal defence in
place”
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Companies Accepting GFSI-Recognized Schemes
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FDA Position on GFSI?
 FSMA “Frequently Asked Questions”:
• “I.4.9 Has FDA considered using the GFSI (Global
Food Safety Initiative) program as the (or one of a
few) third party accreditation?”
“ . . FDA is currently developing regulations and model accreditation
standards directed by FSMA section 307 on third-party accreditation.
FSMA directs the agency to look to existing standards to avoid
unnecessary duplication of costs and efforts. . . . To the extent that the
questioner is asking whether FDA will rely on GFSI benchmarked
standards, we cannot answer the question at this time. To the extent
that the question is asking whether GFSI will have a role in the thirdparty program, we can say that after the third-party rulemaking is final,
the program will go into effect and accreditation bodies can begin to
seek FDA recognition and likewise, third-party auditors (also known as
certification bodies) can begin to seek accreditation from an
accreditation body recognized by FDA.”
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Conclusion
 FSMA presents substantial challenges to food
and food ingredient manufacturers
• Significant aspects of law still to be implemented
• FDA is behind schedule with regulations/guidances
 GFSI may provide an opportunity to meet some
requirements, but too early to tell
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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.
Washington, D.C. ● Brussels ● San Francisco ● Shanghai