Food Safety Regulatory
Compliance
Food Safety Modernization Act
The Role of 3rd Party Auditing
June 25, 2012
FSMA –
The Role of 3rd Party Auditing
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Bruce Silverglade, Esq.
Principal
Olsson Frank Weeda Terman Matz
bsilverglade@ofwlaw.com
FSMA and 3rd Party Auditing
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What the law says . . .
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What is the reality?
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What should industry do?
FSMA Provisions Regarding
3rd Party Auditing
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FDA may require certification of
imports under section 801(q)
Certification must be provided by the
government in the originating
country, or
An accredited 3rd party auditor
FSMA Provisions Regarding
3rd Party Auditing
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FDA must also establish a voluntary
qualified importer program (VQIP)
under section 806
Requires a facility certification by
FDA or an accredited third party
auditor
FSMA - Accrediting Auditors
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FDA must establish a system for
recognition of accreditation bodies
that accredit third-party auditors by
January, 2013
But can directly accredit auditors
starting at that time
FSMA - Accrediting Auditors
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FDA must publish model
accreditation standards by July 2012
(Delayed)
FDA must publish regulations
preventing conflicts of interest
between 3rd party auditors and food
companies by July 2012 (Delayed)
FSMA
Other 3rd Party Auditing Provisions
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FSMA contains provisions for:
• Regulatory audits v. consultative audits
• Requirements for submitting audits to
FDA
• Provisions regarding conflict of interest
• Provisions for withdrawing accreditation
The Accreditation Process NOW
Verifies CB Compliance to ISO/IEC Guide 65 and Scheme requirements
ISO/IEC Guide 65
Accreditation
Body
GFSI Guidance
Document
Licensed
Accredited
SQF
Certification Body
Licensed
Accredited
BRC
Other
GFSI
Schemes
Certification Body
Licensed
Accredited
Certification Body
Licenses Certification
Body to perform audits
Verifies Scheme Compliance to
GFSI Guidance Document
IAF Members
SO Approves AB’s to
accredit Certification Bodies
Certified
Supplier
Certified
Supplier
Certified
Supplier
Audits and certifies
suppliers to scheme
requirements;
Performs 2nd party
and 3rd party audits
IAF Members peer review Member Accreditation Bodies
9
The Accreditation Process After FDA
Issues FSMA Regulations . . . ?
Verifies CB Compliance to ISO/IEC Guide 65 and Scheme requirements
Foreign
Government
Accredited
ISO/IEC Guide 65
FDA
Accreditation
Body
GFSI Guidance
Document
SQF
Third party auditor
BRC
Accredited
Other
GFSI
FDA
Schemes
GFSI Verifies Scheme Compliance
to GFSI Guidance Document
IAF Members
Third Party Auditor
Accredited
Third-Party auditor
Licenses Certification
Body to perform audits
SO Approves AB’s to accredit Certification Bodies
Certified
Supplier
Certified
Supplier
Certified
Supplier
Audits and certifies
suppliers to scheme
requirements;
Performs regulatory
and consultative
Audits.
IAF Members peer review accreditation bodies
10
Developments at FDA –
Agency Says Priorities Are:
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Determining the right level of
training and experience for an
accredited auditor, how much
specialized knowledge auditors
need to demonstrate
competence, and the most
predictive measures of an
auditor’s competence
Developments at FDA –
Agency Says Priorities Are:
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Ensuring the independence and
objectivity of private certification
bodies and auditors
Developments at FDA –
Agency Says Priorities Are:
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Establishing how FDA should
structure the relationship with
accrediting bodies -- What are the
thresholds of expertise, experience
and capacity that must be reached to
be recognized by FDA as an
accrediting body?
Developments at FDA –
Agency Says Priorities Are:
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Determining what information from
audits should be provided to FDA and
what information should be made
public
Mike Taylor, GFSI conference, February 16, 2012
Developments at FDA
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FDA has not ruled out starting a pilot
program where the Agency would act as
their own accreditor
FDA has funded the NEHA to develop a
personnel certification credential for food
auditors. Intent initially is for use for
federal and state government auditors,
but could form basis for standards applied
to 3rd party auditing industry
FSMA – 3rd Party Auditing Delays
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New York Times reports on April 2 that
White House is delaying FDA proposed
rules in numerous areas involving food,
drug, cosmetics
Delay includes a package of four proposed
regulations implementing FSMA including
the FSVP
Administration is concerned about impact
on November election – requests
economic impact data from FDA
FDA’s Plan for FSMA
Implementation
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The four delayed proposed
regulations:
• Preventive controls (human food)
• Preventive controls (animal feed)
• Fresh produce safety
• Foreign Supplier Verification
Program for importers
FDA’s Plan for FSMA
Implementation
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Delaying the issuance of these four
FDA proposed rules also delays FDA
issuance of proposed rules for 3rd
party auditors which the agency
said would be next in line for release
FSMA Delays
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First four proposed rules sent to OMB
November 2011, but review
extended
Mike Taylor first said rules will be out
in “next few weeks,” Mike Landa said
“in next few months,” other FDA
officials said “this summer”
Reality may be not until after the
election
Diverse Interests
Press to End Delay
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Global Food Safety Initiative urges
HHS to Act
Consumer groups urge
Administration to release rules
Unusual alignment of interests
Diverse Interests Urge
Administration to Act
FOR IMMEDIATE RELEASE Contact: Chris Waldrop
March 19, 2012 202-797-8551
Consumer Federation of America Member Groups
Urge Release of Delayed Food Safety Proposals
Consumer Federation of America today announced that as part of
CFA’s annual meeting held last week, its members voted to support
a resolution urging the Obama Administration to issue four proposed
food safety rules that have now been delayed for over two months.
“On behalf of CFA’s nearly 300 members, we urge the
Administration to immediately issue these important food safety
proposals,” said Chris Waldrop, Director of CFA’s Food Policy
Institute. “The longer these proposals are delayed, the longer it will
take to fulfill the promise of the Food Safety Modernization Act,
which is intended to better protect consumers from food borne
illness.”
The Administration is now two and a half months overdue on
meeting deadlines mandated by Congress. In late February, the
White House Office of Management and Budget (OMB) announced t
Congressional Developments
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House Appropriations Committee
passes FDA FY ’13
Appropriations Bill
Report language states:
Congressional Developments
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The Committee is aware the
Administration missed the January 4,
2012, statutory deadline for
publishing a notice of proposed
rulemaking for fresh produce safety
standards and final regulations on
the content of the Foreign Supplier
Verification Program for imported
food.
Congressional Developments
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The Committee encourages the
Administration to meet the statutory
timelines for implementing P.L. 111–
353 and expects FDA to follow a
timeline for issuing rulemakings
consistent with the sequence and
logistics of establishing requirements
for a preventive controls framework
for domestic and imported foods.
Congressional Developments
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The Committee directs FDA to submit
a report within 180 days of
enactment of this Act that describes
the justification for any proposed
rule or final regulation being 60 days
or more beyond the timeline.
Congressional Developments
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The Committee further directs FDA to
continue to provide such report at the
same time that the agency submits its
annual budget justification to the
Committee.
This language will pressure the White
House and the FDA to speed up issuance
of regulations for the FSVP and 3rd party
auditing, and other elements of FSMA.
Congressional Developments
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DeLauro/Latham establish
Congressional Food Safety Caucus
Bipartisan effort – may be used to
influence implementation of FSMA
Congressional Developments
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January 10, 2012 letter from
Democratic House minority coalition
to FDA
Congressional
Minority Letter to FDA
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FSMA “requires that with respect to
imported foods, FDA establish an
accreditation system and model
auditing standards for third party
audits.
Congressional Developments
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“While the law requires these steps
only for imported foods, industry
officials told the Committee that the
FDA standards will influence the
actions of auditors inspecting
domestically grown products
(produce) as well. . .
Congressional
Minority Letter to FDA
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“We hope that FDA will consider our
findings when drafting these rules,
and we suggest that FDA consider
developing a voluntary model
program for domestic auditors that
could become the standard of care
for third-party auditing programs in
the United States.”
What to Do
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Wait and see . . . [NO!]
Ascertain alignment of interests
Develop a position
Determine how best to make use
delay
Be proactive
What to Do
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And that is what we are doing to do
now with a case study.
What are the agency’s priorities and
how should a company react now,
and during the official comment
period?
Olsson Frank Weeda Terman Matz
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Bruce Silverglade, Principal
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Bsilverglade@ofwlaw.com
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202-518-6316