Preventive Controls Presentation by Hogan Lovells

FDA’s Proposed Rule under FSMA for
Preventive Controls
Key Takeaways and Highlights
Joseph A. Levitt, Partner
Elizabeth Barr Fawell, Associate
January 11, 2013
Introduction and Overview
10 Key Takeaways
Highlights from Major Provisions
Key Points from the Produce Safety Proposed Rule
Question and Answer Session
• FDA has proposed two new regulations under
– 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
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
• Would place everything in a new
Part 117
10 Key Takeaways
1. Proposed rule generally tracks the statute
• Hazard analysis; preventive controls; monitoring;
corrective actions; verification; reanalysis; and
2. FDA generally provides industry flexibility
• Each facility to tailor food safety plan to its own
3. FDA has tried to align proposal with HACCP
• Preamble traces origins of HACCP
• Repeated references to other government HACCP
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
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
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
Food Safety Plan
• Prepared (or preparation overseen) by “qualified
• 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
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
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
Preventive Controls continued . . .
• Process controls: procedures,
practices, and processes performed on
– 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
• Allergen controls: procedures,
practices, and processes to
– Protect food from cross contact during
storage and use
– Ensure proper labeling
Preventive Controls continued . . .
• Preventive controls may be
implemented at critical control points
(CCPs), and also may be
implemented at points other than
• 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
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
• 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
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
– 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
• Corrective actions would need to be documented and
subject to verification and records review
• 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
– Food allergen controls, sanitation controls,
and the recall plan would not need to be
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
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
Verification continued . . .
• Reanalysis of the plan would be
– 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
– 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
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
• 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
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:
Name and location of the facility
Date and time of activity documented
Signature/initials of person performing the
Where appropriate the identity of the product
and production code
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
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
– 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)
• Exempt: Facilities solely engaged in the storage of
– Non-refrigerated packaged food not exposed to the
– 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
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
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
• 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)
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)
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
Microbiological hazards addressed by the LACF
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
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)
Produce Safety Proposed Rule (continued…)
• Would set standards to control for 6 specific
Worker Training and Health and Hygiene
Agricultural Water
Biological Soil Amendments
Domesticated and Wild Animals
Equipment, Tools, and Buildings
• Generally, more like cGMPs than HACCP
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)
• FDA responded in part to several of industry’s
• 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!
Contact Information
Joseph A. Levitt, Partner
Hogan Lovells US LLP
(202) 637-5759
[email protected]
Elizabeth Barr Fawell, Associate
Hogan Lovells US LLP
(202) 637-6810
[email protected]
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