washington, d.c. ● brussels ● san francisco ● shanghai presented to: fdli safeguarding...

Washington, D.C. ● Brussels ● San Francisco ● Shanghai

Presented to: FDLI Safeguarding Ingredient Supply Chain ConferenceSeptember 10, 2013 Washington, DC

Frederick A. StearnsKeller and Heckman LLP

1001 G Street, NW, Washington, DC 20001Phone: 202-434-4288 Email: [email protected]

Food Safety Modernization Act (FSMA) and Global Food Safety Measures for Functional

Food and Dietary Ingredients

│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 20132

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)


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


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)


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)


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


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


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


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


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”


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


Improving Safety of Imported Food

Title III Major Provisions

• Foreign supplier verification program

• Voluntary qualified importer program

• Import certification and accreditation


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)


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)


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


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]


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


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”


Companies Accepting GFSI-Recognized Schemes

http://fr.wikipedia.org/wiki/Image:Coca-ColaLogo.png


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 third-party 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.”


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

Washington, D.C. ● Brussels ● San Francisco ● Shanghai

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.

Frederick A. StearnsKeller and Heckman LLP

1001 G Street, NW, Washington, DC 20001Phone: 202-434-4288 Email: [email protected]

Thank you!Questions? Please contact:

washington, d.c. ● brussels ● san francisco ● shanghai presented to: fdli safeguarding...

Documents

unapproved food

functional food

pet food

components of food

food safety public

food safety problems

global food safety measures

live food animals