FDA’s Proposed Rule under FSMA for
Preventive Controls
Key Takeaways and Highlights
Joseph A. Levitt, Partner
Elizabeth Barr Fawell, Associate
January 11, 2013
Agenda
•
•
•
•
•
Introduction and Overview
10 Key Takeaways
Highlights from Major Provisions
Key Points from the Produce Safety Proposed Rule
Question and Answer Session
www.hoganlovells.com
2
Introduction
• FDA has proposed two new regulations under
FSMA
– Preventive Controls for human food
•
Food Defense to come later
– Produce Safety
• Comments due May 16, 2013 (120 days)
• FDA says that more proposed rules are forthcoming
www.hoganlovells.com
3
Overview of Preventive Controls Proposal
• Adds a new set of regulations
implementing the Hazard Analysis
and Risk-Based Preventive
Controls provision of FSMA
• Updates and revises the cGMPs in
Part 110
• Includes several exemptions and
modified requirements
• Includes a subpart on
recordkeeping
• Would place everything in a new
Part 117
www.hoganlovells.com
4
10 Key Takeaways
1. Proposed rule generally tracks the statute
• Hazard analysis; preventive controls; monitoring;
corrective actions; verification; reanalysis; and
recordkeeping
2. FDA generally provides industry flexibility
• Each facility to tailor food safety plan to its own
circumstances
3. FDA has tried to align proposal with HACCP
• Preamble traces origins of HACCP
• Repeated references to other government HACCP
programs
www.hoganlovells.com
5
10 Key Takeaways (continued…)
4. Testing/supplier verification not required (yet)
• FDA notes cost implications
•
Economic analysis assumptions
• Nevertheless, FDA describes expectations in detail
• Requests comment on inclusion in final rule
• Need to read preamble and Appendix
5. Validation of preventive controls key issue
• FDA expects high level of scientific justification
6. Warehouse exemption
• Non-refrigerated warehouses – exempt
• Refrigerated warehouses – modified controls
• Frozen warehouses – based on reason for freezing
www.hoganlovells.com
6
10 Key Takeaways (continued . . .)
7. High emphasis on recordkeeping/FDA access
•
•
•
•
•
Keep records on-site at least 6 months
Always keep food safety plan on-site
Facility profiles (requested comment)
Remote access (requested comment)
Electronic records (Part 11)
8. Updates to cGMPs
• Outgrowth of cGMP Modernization Initiative
• Would replace Part 110 in its entirety
www.hoganlovells.com
7
10 Key Takeaways (continued . . . )
9. Defines small and very small businesses
• Small – less than 500 employees across the entire
company (SBA definition)
• Very small – either $250,000, $500,000, or $1,000,000 in
annual sales of food
10. Compliance dates
• 1 year for large businesses
• 2 years for small businesses
• 3 years for very small businesses
** All from date of publication of Final regulation
www.hoganlovells.com
8
Food Safety Plan
• Prepared (or preparation overseen) by “qualified
individual”
• Signed and dated by owner,
operator, or agent in charge
initially and each time modified
• Would need to include:
– Hazard analysis
– Preventive controls
– Procedures for monitoring (including frequency), corrective
actions, and verification
– Recall plan
• Would need to be written
www.hoganlovells.com
9
Hazard Analysis
• Identify and evaluate “known or reasonably
foreseeable hazards” for each type of food
– Proposal specifies categories of hazards to consider
during identification
– Proposal specifies factors to consider
during evaluation, including:
•
•
•
Severity of illness
Environmental pathogens in RTE foods
exposed to the environment
Foreseeable consumer use
• Determine which hazards are
“reasonably likely to occur”
• Include a justification for conclusions reached
www.hoganlovells.com
10
Preventive Controls
• Identify and implement preventive controls for those
hazards reasonably likely to occur
• Preventive controls must include,
as appropriate:
–
–
–
–
–
Process controls
Allergen controls
Sanitation controls
Other controls
Recall plan
• Although FSMA identified cGMPs, supplier
verification, and employee hygiene as preventive
controls, the proposed rule does not
www.hoganlovells.com
11
Preventive Controls continued . . .
• Process controls: procedures,
practices, and processes performed on
food
– Cooking, cooling, drying, acidifying, etc.
• Sanitation controls
– Would be required in certain situations
– Would need to include procedures for the
cleanliness of food contact surfaces and
the prevention of cross contact and cross
contamination
• Allergen controls: procedures,
practices, and processes to
– Protect food from cross contact during
storage and use
– Ensure proper labeling
www.hoganlovells.com
12
Preventive Controls continued . . .
• Preventive controls may be
implemented at critical control points
(CCPs), and also may be
implemented at points other than
CCPs
• Parameters associated with the
control (the factors that must be
controlled) would be required
– The maximum or minimum value or
combination of values to which the
parameter must be controlled
– This is similar to requiring critical
limits at critical control points, but
would apply to all preventive controls,
whether at a CCP or another point
www.hoganlovells.com
13
Recall Plan
• A written recall plan would be required
• Would be required to contain procedures for:
–
–
–
–
Notifying consignees
Notifying the public
Conducting effectiveness checks
Disposing of recalled product
• FDA is requesting comment on
whether it should require:
– A recall plan to include procedures for notifying FDA
– Mock recalls as a verification activity
www.hoganlovells.com
14
Monitoring
• Establish and implement written procedures for
monitoring preventive controls
– Would include frequency of monitoring activities
•
FDA does not specify monitoring frequency, but states that
monitoring must be performed at sufficient frequency to ensure
that the preventive controls are being performed consistently
• Monitoring activities would be:
– Documented
– Subject to verification activities, including records review
by a qualified individual within a week after the records
are created
www.hoganlovells.com
15
Corrective Actions
• Establish and implement written corrective action
procedures to be used if the preventive controls are not
properly implemented, including procedures to:
– Identify and correct a problem to reduce the likelihood it will
recur
– Evaluate all affected food for safety
– Prevent affected food from entering commerce if its safety
cannot be assured
• Take the same steps AND reanalyze the food safety
plan if either specific corrective action procedures have
not been established or a preventive control is
ineffective
• Corrective actions would need to be documented and
subject to verification and records review
www.hoganlovells.com
16
Verification
• Validation
– Express requirement in the proposed rule
– Conducted by a qualified individual
– Before the plan is implemented (or within
the first 6 weeks of production if
necessary); following reanalysis as needed
– Would include collecting and
evaluating scientific and technical
information
– Food allergen controls, sanitation controls,
and the recall plan would not need to be
validated
www.hoganlovells.com
17
Verification continued…
• Monitoring
– Verify that monitoring is being
conducted, such as through
observation or independent tests
• Corrective Actions
– Verify that appropriate decisions are being made
• Verification
– Verify that the preventive controls are consistently
implemented and are effective
• Calibration
– Establish and implement written procedures for the frequency
of calibrating process monitoring and verification instruments
www.hoganlovells.com
18
Verification continued…
• Internal Records Review
– Conducted or overseen by qualified individual
– Review monitoring and corrective action records within a
week after they were made
– Review calibration records within a reasonable time
• Consumer Complaints
– Proposal would not require review of consumer
complaints as a verification activity, but FDA seeks
comment on this issue
• Documentation
– All verification activities would need to be documented
www.hoganlovells.com
19
Verification continued . . .
• Reanalysis of the plan would be
required
– At least every three years
– Whenever a significant change is made in
the activities at the facility affecting the
hazard analysis
– Whenever a preventive control is found
ineffective
– Whenever a preventive control is not
properly implemented and there was no
established corrective action procedure
– Whenever the facility becomes aware of new
information about potential hazards
– As mandated by FDA in response to new
hazards and developments in scientific
understanding
www.hoganlovells.com
20
Qualified Individual
• Qualified individual(s) would need to do or oversee:
– Preparation of the food safety plan
– Validation of preventive controls
– Review of records for implementation of preventive
controls and appropriateness of corrective actions
– Reanalysis of the food safety plan
• Qualification would be either through
education/training or experience
• Applicable training would be documented, including
type, date, and person trained
www.hoganlovells.com
21
Recordkeeping
• New requirements would apply to all records
required by new Part 117
• FDA is proposing to require facilities to establish
and maintain records documenting
–
–
–
–
–
Written food safety plan
Monitoring of preventive controls
Corrective actions
Verification activities
Training for qualified individuals
www.hoganlovells.com
22
Recordkeeping continued…
• Records would need to be:
–
–
–
–
Originals, true copies, or electronic records
Contain actual values and observations
Be accurate, indelible, and legible
Be created concurrently with performance
of the activity documented
– Be as detailed as necessary to provide
history of the work performed
– Include:
•
•
•
•
www.hoganlovells.com
Name and location of the facility
Date and time of activity documented
Signature/initials of person performing the
activity
Where appropriate the identity of the product
and production code
23
Recordkeeping continued…
• Location:
– Retained for 2 years, but off-site storage permitted after
6 months if records can be provided within 24 hours
– Food safety plan must always remain on-site
– Electronic records considered on-site if accessible
• Electronic records:
– FDA proposes requiring compliance with Part 11, but
seeks comment on whether an exemption is appropriate
(as with BT Act)
• Disclosure:
– Records would be subject to disclosure under the FOIA
www.hoganlovells.com
24
Records Access
• Records would be required to be made “promptly
available to a duly authorized representative” “upon
oral or written request”
– FDA states this is consistent with its
HACCP regulations, which require
records be available for review and
copying
– FDA seeks comment on whether to
explicitly require facilities to send records
to the agency and whether they should be
required to be submitted electronically
• FDA seeks comment on whether to require the
submission of “facility profiles” (products, hazards, and
preventive controls)
www.hoganlovells.com
25
Warehouses
• Exempt: Facilities solely engaged in the storage of
– Non-refrigerated packaged food not exposed to the
environment
– Raw agricultural commodities (other than fruits or
vegetables) intended for further distribution or processing
• Modified Requirements:
– Facilities that store refrigerated
packaged food that requires
time/temperature control for safety
(TCS)
www.hoganlovells.com
26
Refrigerated Warehouses
• FDA expects the warehouse to learn whether a
particular food requires time/temperature control for
safety from the manufacturer, the label, or the
scientific/technical literature
– Rare for a frozen food to be a TCS food
• Modified requirements:
–
–
–
–
Establish and implement temperature controls
Monitor temperature controls
Take corrective actions
Verify that temperature controls are implemented consistently
(through calibrating devices and reviewing records)
– Document monitoring, corrective actions, verification activities
www.hoganlovells.com
27
Testing and Supplier Verification
• Although expressly mentioned in the
statute, testing and supplier verification
are not being required as preventive
controls/verification activities, likely due to
cost
• But the proposed rule contains extensive
discussion of the value of such programs,
key attributes, and FDA’s expectations for
such programs
• FDA seeks comment on whether to
impose requirements in these areas and
extent of any final requirements
(Read preamble and Appendix Carefully)
www.hoganlovells.com
28
Revisions to cGMPs
• In general, FDA proposes:
– Clarifying that certain provisions require protection against
cross contact of food in order to address allergens
– That provisions directed to preventing contamination of
food and food contact surfaces include preventing
contamination of food packaging materials as well
– Deleting certain provisions containing recommendations
– Modernizing and updating the language
• FDA is requesting comment on whether:
– It should mandate employee training
– It should require, rather than recommend, certain
provisions (e.g., cleaning non-food-contact surfaces)
www.hoganlovells.com
29
Other Exemptions/Modified Requirements
•
•
•
•
•
•
•
•
“Qualified facilities”
Very small businesses
Certain low-risk on-farm activities
Dietary supplements
Alcoholic beverages
Foods subject to seafood or juice HACCP
Farms
Microbiological hazards addressed by the LACF
regulation
www.hoganlovells.com
30
Legal Authority
• FDA cites the FFDCA, FSMA, and the PHS
• FSMA states that failure to comply with Preventive
Controls is a prohibited act
• Proposed rule states that failure to
comply with cGMPs and/or FSMA will
be considered in determining whether
food is adulterated or in violation of the PHS
• Preventive Controls requirements would apply to
intrastate activities
• Whether each provision of FDA’s proposal in within the
bounds of its statutory authority warrants close review
www.hoganlovells.com
31
Produce Safety Proposed Rule
• Rather than issue standards for
categories of produce considered highrisk, the proposed rule would apply to
almost all produce
• The requirements focus on agricultural
practices (not commodities), except:
– Specific commodities rarely consumed raw
(e.g., potatoes)
– Produce subject to a kill step through
commercial processing, so long as
documentation kept (e.g., oranges for juice)
– Produce that is not a raw agricultural
commodity (and therefore is subject to
Preventive Controls)
www.hoganlovells.com
32
Produce Safety Proposed Rule (continued…)
• Would set standards to control for 6 specific
hazards
–
–
–
–
–
–
Worker Training and Health and Hygiene
Agricultural Water
Biological Soil Amendments
Domesticated and Wild Animals
Equipment, Tools, and Buildings
Sprouts
• Generally, more like cGMPs than HACCP
www.hoganlovells.com
33
And a little reminder…
• Be sure your company has renewed the registration
of its facilities by January 31st
• Check on your co-manufacturers and suppliers, too!
– If they have not renewed their registrations, they likely will
be cancelled by FDA (which prohibits them from importing
product) and then will require re-registration (new number)
www.hoganlovells.com
34
Conclusion
• FDA responded in part to several of industry’s
concerns
• The proposed preventive controls requirements
warrant close review
• The absence of proposed requirements for testing
and supplier verification pose special challenges
• Economic assessment will be very important
 Lots of work ahead!
www.hoganlovells.com
35
Questions?
www.hoganlovells.com
36
Contact Information
Joseph A. Levitt, Partner
Hogan Lovells US LLP
(202) 637-5759
Joseph.Levitt@hoganlovells.com
www.hoganlovells.com
Elizabeth Barr Fawell, Associate
Hogan Lovells US LLP
(202) 637-6810
Elizabeth.Fawell@hoganlovells.com
www.hoganlovells.com
Hogan Lovells has offices in:
Alicante
Amsterdam
Baltimore
Beijing
Berlin
Brussels
Budapest*
Caracas
Colorado Springs
Denver
Dubai
Dusseldorf
Frankfurt
Hamburg
Hanoi
Ho Chi Minh City
Hong Kong
Houston
Jakarta*
Jeddah*
London
Los Angeles
Madrid
Miami
Milan
Moscow
Munich
New York
Northern Virginia
Paris
Philadelphia
Prague
Riyadh*
Rome
San Francisco
Shanghai
Silicon Valley
Singapore
Tokyo
Ulaanbaatar
Warsaw
Washington DC
Zagreb*
"Hogan Lovells" or the "firm" is an international legal practice that includes Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses.
The word "partner" is used to describe a partner or member of Hogan Lovells International LLP, Hogan Lovells US LLP or any of their affiliated entities or any employee or consultant with equivalent standing. Certain individuals, who are
designated as partners, but who are not members of Hogan Lovells International LLP, do not hold qualifications equivalent to members.
For more information about Hogan Lovells, the partners and their qualifications, see www.hoganlovells.com.
Where case studies are included, results achieved do not guarantee similar outcomes for other clients. Attorney Advertising.
© Hogan Lovells 2013. All rights reserved.
*Associated offices