FDLI - 55th Annual Meeting April 24, 2012

Food Safety Modernization Act

The Role of 3rd Party Auditing

Bruce Silverglade, Esq.

Principal

Olsson Frank Weeda Terman Matz

FSMA and 3rd Party Auditing

• What the law says -

• What is the reality?

• What should industry do?

FSMA Provisions Regarding 3rd Party Auditing

• 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

• Foreign Supplier Verification Program (FSVP) Section 805 – relation to 3rd Party Auditing

• FDA must 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

• 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

• 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

• FSMA contains provisions for:– Regulatory audits v. consultative audits– Requirements for submitting audits to FDA– Provisions regarding conflict of interest– Provisions for withdrawing accreditation

• Statutory requirements need to be detailed further in regulations

Developments at FDA – Agency Says Priorities Are:

• 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

• Ensuring the independence and objectivity of private certification bodies and auditors

» Mike Taylor, GFSI conference, February 16, 2012

Developments at FDA – Agency Says Priorities Are:

• Determining what information from audits should be provided to FDA and what information should be made public

• 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?

» Mike Taylor, GFSI conference, February 16, 2012

Developments at FDA

• FDA has not ruled out starting a pilot program where the Agency would act as its 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

Accreditation Body

GFSI Guidance Document

SQFLicensed AccreditedCertification Body

BRCLicensed Accredited

Certification Body

Other GFSI Schemes

Licensed AccreditedCertification Body

ISO/IEC Guide 65

IAF Members

The Accreditation Process - NOW

Verifies Scheme Compliance to GFSI Guidance Document

Licenses Certification Body to perform audits

IAF Members peer review Member Accreditation Bodies

Certified Supplier

Certified Supplier

Certified Supplier

Verifies CB Compliance to ISO/IEC Guide 65 and Scheme requirements

Audits and certifies suppliers to scheme requirements; Performs 2nd party and 3rd party audits

SO Approves AB’s to accredit Certification Bodies

11

Accreditation Body

GFSI Guidance Document

SQF

Accredited

Third party auditor

BRCAccredited

Third Party Auditor

Other GFSI Schemes

Accredited

Third-Party auditor

ISO/IEC Guide 65

IAF Members

The Accreditation Process After FDA Issues FSMA Regulations . . . ?

GFSI Verifies Scheme Compliance to GFSI Guidance Document

Licenses Certification Body to perform audits

IAF Members peer review accreditation bodies

Certified Supplier

Certified Supplier

Certified Supplier

Verifies CB Compliance to ISO/IEC Guide 65 and Scheme requirements

Audits and certifies suppliers to scheme requirements; Performs regulatoryand consultative Audits.

SO Approves AB’s to accredit Certification Bodies

12

FDA

FDA

Foreign Government

FSMA – 3rd Party Auditing Delays

• 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

• The four delayed proposed regulations:– Preventive controls (human food)– Preventive controls (animal feed)– Fresh produce safety– Foreign Supplier Verification Program for

importers

• 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

• 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

• 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

Additional Developments - FSSP

• Formation of the Food Safety Service Providers

Additional Developments –Pew Charitable Trusts

• Collaborative Food Safety Forum on imports and third party certification

• FDA participated with industry and consumer groups

• Report issued March 2012

Congressional Developments

• January 10, 2012 letter from Democratic House minority coalition to FDA

Congressional Developments

• FSMA “requires that with respect to imported foods, FDA establish an accreditation system and model auditing standards for third party audits. 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 Developments

• “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.”

Congressional Developments

• DeLauro/Latham establish Congressional Food Safety Caucus

• Bipartisan effort – may be used to influence implementation of FSMA

What to Do

• Wait and see . . . [NO!]

Instead . . .

• Ascertain alignment of interests

• Develop a position

• Determine how to make best use of delay

• Be proactive

Olsson Frank Weeda Terman Matz

• Bruce Silverglade, Principal

• Bsilverglade@ofwlaw.com

• 202-518-6316