The Food Safety Modernization Act: Foreign Supplier ... Food Safety Modernization Act: Foreign...

The Food Safety Modernization Act: Foreign

Supplier Verification & Third-Party Auditor Rules

August 1, 2013

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The Food Safety

Modernization Act:

Foreign Supplier Verification and

Third-Party Auditor Rules

• Housekeeping Items

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answer as many as we can within our time limit.

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– The webinar recording and presentation slides will

be made available to those attendees who have

registered online, as well as on the SQF website.



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Today’s Agenda

• Upcoming SQFI Events

• Brief FSMA Background

• Foreign Supplier Verification Program

• Third-Party Auditing Rules

• Q & A

2013 SQF Information Days

www.sqfi.com/infodays

• AugustAugustAugustAugust

– Mexico City, Mexico Mexico City, Mexico Mexico City, Mexico Mexico City, Mexico ---- August 13August 13August 13August 13

– Guadalajara, Mexico Guadalajara, Mexico Guadalajara, Mexico Guadalajara, Mexico ---- August 15 August 15 August 15 August 15

• September

– Melbourne, Australia – Sept. 10

– Sydney, Australia – Sept. 12

– Tokyo, Japan – Sept. 18



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• Official 2013 conference

website: www.sqfi.com/2013conferencewww.sqfi.com/2013conferencewww.sqfi.com/2013conferencewww.sqfi.com/2013conference

– Registration open and online

– Training courses & training course

registration

– Sponsorship opportunities available

– Housing available

– Program layout available

– Brochure available

2013 SQF International Conference

Today’s Speaker

Erik Lieberman Erik Lieberman Erik Lieberman Erik Lieberman Regulatory Counsel,

Food Marketing Institute



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Overview

• Background

• Foreign Supplier Verification Program

– What are the new obligations for food importers?

• Third-Party Auditing Rules

– What does it mean for programs like SQF?

• Conclusion

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How Did We Get Here?

• Major food safety incidents in years leading up to enactment of FSMA:

– Spinach (E. coli) and peppers (Salmonella)

– Pet food and baby formula (Melamine)

– Peanut butter (Salmonella)

– Eggs (Salmonella)

• Support of food industry and consumer groups



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Food Safety Modernization Act

• Passed both chambers of Congress with bipartisan support

• Signed by President Obama in January 2011 (P.L. 111-353)

• FDA currently in the process of implementing the law– The core four rules have now been released:

• Preventive Controls, Produce Safety, Foreign Supplier Verification and Third-Party Auditor Accreditation

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Proposed Rule on Foreign Supplier Verification

Program



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Foreign Supplier Verification Program

• Requires all importers to establish a program to verify that imported food:– Is produced in compliance with Preventive

Controls Rule*

– Is produced in compliance with Produce Safety Rule*

– Is not adulterated

– Is in compliance with allergen labeling requirements

*or a standard that provides the same level of public health protection

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Current Food Import Requirements

• Pre-FSMA, all U.S. standards apply to imported food entering U.S.– All importing of food is considered to be

introduction into interstate commerce

– All applicable requirements of Federal Food, Drug and Cosmetic Act (FD&C Act) apply

• Cannot be adulterated or misbranded

• Prior notice

• Food facilities must be registered

• Many more….



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What are the new importer obligations under FSMA?

• Affirmative obligation to verify that products are being produced overseas in compliance with preventive controls and produce safety rules and are not adulterated or misbranded

• Import certifications

• Prior notice change

– Previous refusal of article by another nation

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Who is the Importer?

• The person in the U.S. who has purchased an article of food that is being offered for entry into the United States:– If no U.S. owner (food has not been sold at time

of entry) then the importer is the person in the U.S. to whom the food has been consigned

– If no U.S. owner or consignee, then importer is:• U.S. agent or representative of foreign owner or

consignee at the time of entry

– FDA definition not tied to U.S. Customs definition of importer of record



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• Where food has not been sold or consigned to a U.S. person at the time of entry, the foreign owner or consignee would need to have a U.S. agent or representative who would be responsible for meeting FSVP requirements

• Foreign owners/consignees must designate a U.S. agent or representative as the importer who would be responsible for complying with FSVP

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• Note that importer can rely on qualified individual (i.e. accredited third-party auditor) to perform FSVP activities on its behalf—but importer still bears ultimate legal responsibility



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What Foods Are Covered?

• All human and animal food except:– Juice and seafood produced in compliance with

HACCP regulations

– Food imported for research or evaluation (no retail sale)

– Food imported for personal consumption

– Alcoholic beverages

– Transshipped or imported for further processing and export

– Products exclusively regulated by USDA

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Required FSVP Program

• All covered foods: Must develop, maintain and follow an FSVP that provides adequate assurances that your foreign supplier is:

– Producing food in compliance with processes that provide same level of public health protection as Preventive Controls Rule, Produce Safety Rule; and

– Producing food in a manner which will not render it adulterated or misbranded (with respect to allergen labeling)



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Required FSVP Program

• Low-acid canned foods

– With respect to microbiological hazards that are controlled by LACF rules (Part 113), importer must verify and document that food was produced in accordance with part 113

– Full FSVP for all other matters not related to part 113

– Or can do full FSVP for all matters including micro hazards controlled by LACF rules

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Who Must Develop/Perform FSVP?

• “Qualified Individual” generally– A person who has the necessary education,

training, and experience to perform the activities needed to meet the requirements of FSVP

– Does not have to be an employee of importer (can outsource to third-party auditors)

– Regarding the performance of verification activities related to preventive controls implemented by a foreign supplier, qualified individual must have successfully completed training at least equivalent to that received under a standardized curriculum recognized by FDA or otherwise be qualified through job experience



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Who Must Develop/Perform FSVP?

• An accredited third-party auditor is a qualified individual

• A foreign government employee can be considered a qualified individual

• Do not need qualified individual to perform certain tasks:

– Make list of suppliers, filling out CBP form, maintaining records

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Review of Compliance Status

• Before importing a food must review the compliance status of (1) the food and (2) the foreign supplier

• Must review:– Whether they are the subject of:

• An FDA warning letter

• Import alert

• Requirement for FSMA 801(q) import certification related to food safety

– Review must be documented

– Must continue to monitor and document compliance status as long as you import from supplier



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Who is the Foreign Supplier?

• The establishment that manufactures/processes the food, raises the animal, or harvests the food that is exported to the U.S. without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labels or other de minimis activities

• Definition not the same as a registered food facility:– Includes animal (game meat) and produce farms

– Does not include facilities that only pack/hold

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Hazard Analysis

• Importers must conduct for each food imported:

– Hazards reasonably likely to occur and the severity of the illness or injury if such hazard were to occur

– Hazard analysis must be documented

– Hazard analysis must be used to determine required verification activities



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Hazard Analysis:Potential Hazards

• Must consider hazards that may occur naturally, or may be unintentionally introduced, including:

– Biological hazards

– Chemical hazards

– Physical hazards

– Radiological hazards

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Hazard Analysis: Hazard Evaluation

• Must consider the effect of the following on the safety of the finished food:– Ingredients– Condition, function and design of foreign supplier’s

establishment and equipment– Transportation practices– Harvesting, raising, manufacturing, processing, and

packing procedures– Packaging and labeling activities– Storage and distribution– Intended or reasonably foreseeable use– Sanitation, including employee hygiene– Any other relevant factors



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Hazard Analysis

• May identify hazards by reviewing hazard analysis conducted by foreign supplier

– Must document the determination made based on such review

• Fruits and Vegetables: Not required to conduct hazard analysis for microbiological hazards (but must verify compliance with Produce Safety Rule/equivalent standard)

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Foreign Supplier Verification Activities

• Must maintain a written list of foreign suppliers

• Must establish and follow adequate written procedures for conducting verification activities

• Must provide adequate assurances that hazards are adequately controlled



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Foreign Supplier Verification Activities

• If determine no hazards are reasonably likely to occur then no verification activities required (still must maintain foreign supplier name on written list)

– Must reassess determination at least every 3 years

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Hazards Controlled By Importer

• Certain hazards associated with an imported food might be controlled through actions that the importer takes after the food is brought into the U.S.

• For hazards importers control, must document annually that you have established and are following procedures to adequately control the hazard– Example: Domestic food facility imports raw peanuts for

use as ingredient in its products. If the importer identifies Salmonella as a hazard reasonably likely to occur, the importer would not need to conduct a verification activity for the hazard since the importer itself treats the peanuts with a process to reduce Salmonella.

– FDA says such process controls are generally applicable to micro hazards only, not chemical and radiological



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Hazards Controlled by Customer

• Importer must document that U.S. customer controls hazards by obtaining written assurance annually that it has established and is following procedures to control the hazard

• Example: customer is a business that purchases the imported food for further processing or distribution—imported macadamia nuts as ingredient in cookie

• Importer must verify customer controls the hazard by obtaining written assurance. Procedures put in place to control hazard must be briefly stated on assurance.

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Hazards Controlled by Foreign Supplier

• FDA set forth two options in proposed rule and will pick one in the final rule



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Hazards Controlled by Foreign Supplier—Option 1

• For hazards which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA) must:

– Conduct or obtain documentation of onsite audit before importing food

– Conduct or obtain documentation of onsite audit at least annually after initial audit

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• For non-SAHCODA hazards must conduct one or more of the following activities before using or distributing food and periodically thereafter:– Periodic onsite auditing-must conduct or

obtain documentation of audits

– Periodic lot-by-lot sampling—importer conducts or obtains documentation from supplier of lot-by-lot or periodic sampling and testing of food



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– Periodic review of supplier’s food safety records (i.e. records of foreign supplier’s audit of its supplier’s hazard control activities (ingredients in product foreign supplier produces))

– Other appropriate procedure based on the risk associated with the hazard

• Must determine and document which verification activities are appropriate to verify adequate control of hazard and how frequently such activities must be conducted

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• Onsite audit must consider any FDA food safety regulations that apply to food and supplier and must include review of supplier’s written food safety plan, if any, and suppliers implementation of plan

• Instead of onsite audit, importer may rely on results of an inspection of the foreign supplier by FDA or food safety authority of a country whose system has been recognized by FDA as equivalent to U.S. (only New Zealand currently)



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• Must promptly review the results of verification activities. If results show that hazards are not adequately controlled must take corrective actions.

• Qualified individuals who conduct verification activities must not have financial interest in foreign supplier and payment must not be related to results– Does not prohibit importer from conducting

verification activities

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Hazards Controlled By Foreign Supplier—Option 2

• No requirement for initial onsite audit or subsequent periodic audits (although FDA states they believe onsite auditing generally adequate for SAHCODHA controls and solicits comments on whether alternatives could be effective)

• Importer has discretion to choose appropriate activities to verify that hazards are controlled

• Importer has discretion to determine and document how frequently verification activities should be conducted



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Hazards Controlled By Foreign Supplier—Option 2

• In determining frequency of verification activities must consider:

– Risk presented by hazard

– Probability that hazard is SAHCODHA

– Food and supplier’s compliance status

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Option1 for Produce Importers

• Before importing produce subject to Produce Safety Rule must conduct or obtain documentation of onsite audit that examines control of microbiological hazards associated with the fruit or vegetable. Audit must provide assurances that supplier is producing fruit of vegetable in compliance with Produce Safety Rule.



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Option 2 for Produce Importers

• No onsite audit mandated

• Importer has option of conducting verification activities consistent with Option 2 for processed foods

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Investigations and Corrective Actions

• Must promptly conduct a review of any customer, consumer or other compliant received to determine whether it relates to the adequacy of FSVP

• If importer becomes aware that food is adulterated or misbranded (as to allergens) must promptly investigate and document investigation



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• Importer must promptly take appropriate corrective actions if determines food is not produced in compliance with FSMA standards

– Appropriate corrective action includes discontinuing use of foreign supplier until problem addressed. Must be documented.

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• If importer determines that a foreign supplier is noncompliant outside of verification activities or FSVP reassessment, must promptly investigate and determine whether the FSVP is adequate and change it if necessary

• Must document



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Reassessing Effectiveness of FSVP

• For each food imported, importer must reassess FSVP at least every 3 years

• Must promptly reassess effectiveness if importer becomes aware of new information about potential hazards associated with food

• Must update hazard analysis in conjunction with FSVP reassessment– If hazards change must promptly determine

whether verification activities must change and must promptly implement such changes. Must document.

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Identifying Importer at Entry

• Importer must obtain a Dun & Bradstreet Data Universal Numbering System (DUNS) number

• For each line entry of food, importer name and DUNS number must be provided to CBP

• Foreign owner or consignee must designate a U.S. agent or representative as importer for purposes of FSVP rule



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Recordkeeping

• Importer must sign and date records concerning FSVP upon initial completion and upon any modification

• Must maintain records in English• Must make them available promptly to FDA on

request• Must be maintained at place of business or at a

reasonably accessible location (off-site server)• Must send records electronically to FDA if agency

requests them• Must generally maintain records for two years

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Dietary Supplements-Modified Requirements

• Dietary supplements imported for further processing– Importers of dietary supplements and supplement

components complying with part 111 (CGMP) would not be required to comply with most FSVP requirements

• Finished dietary supplements (packaged and labeled)– Must verify compliance with CGMP– Separate hazard evaluation not required– Onsite auditing not mandated



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Very Small Importers or Imports from Very Small Foreign Suppliers

• Importer/foreign supplier must have less than $500,000 average annual food sales in previous 3-year period and document it annually

• Modified requirements:– Do not have to do hazard analysis or specific

foreign supplier verification activities

– Just need written assurance of supplier that supplier is compliant

– Must take corrective action and maintain records

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Imports form Country with FDA Recognized/Equivalent System

• Generally exempt from FSVP requirements

• Before importing, must document that foreign supplier is in and under regulatory oversight of the country and that food is within scope of FDA recognition

• Before importing must determine and document whether foreign supplier is in good compliance standing with foreign regulator and must continue to monitor status

• Only New Zealand at this time!



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Noncompliance Consequences

• Refusal of admission of food

• Criminal penalties:

– Prohibited act under 21 U.S.C. 331§333. Penalties

(a) Violation of section 331 of this title; second violation; intent to defraud or mislead

(1) Any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both.

(2) Notwithstanding the provisions of paragraph (1) of this section,1 if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.

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Noncompliance Consequences

• CEO can be held responsible for violations of regulation

• U.S. v. Park—Corporate officials strictly liable for company violations of FD&C Act

• Will FDA use this power to go after importers in the event of a large outbreak?



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Proposed Rule on Accreditation of

Third-Party Auditors

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Overview

• FSMA Sec. 307 directs FDA to set up a system for recognizing accreditation bodies to accredit third-party auditors to conduct audits for purposes of FSVP among other things VQIP

• Not a blanket regulation of all third-party auditors, only those that choose to opt-in



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From 78 Fed. Reg. 45783

(July 29, 2013)

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What is Accreditation Under this Rule?

• Means a determination by a recognized accreditation body (AB) (or, in the case of direct accreditation, by FDA) that a third-party auditor/certification body (auditor) meets the applicable requirements of the regulation



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Who is an Accreditation Body?

• An authority that performs accreditation of auditors

• ANSI?

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Who is an Accredited Auditor/Certification Body

• Definition for auditor and certification body (CB) is the same

• A foreign government, agency of a foreign government, foreign cooperative or any other third party that is eligible to be considered for accreditation to conduct food safety audits and to certify that eligible entities meet requirements of FD&C Act (i.e. FSMA)



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Who is an Accredited Auditor/Certification Body

• A auditor may be a single individual or an organization

• May use audit agents to conduct food safety audits

– Agent may be employee or other agent or contractor of auditor

– Agent is not individually accredited but must

be qualified

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Who is Subject to the Regulation?

• Accreditation bodies

• Auditors

• Eligible entities seeking food safety audits or food or facility certifications from an accredited auditor

• Opt-in for firms that seek to assist in FSMA compliance



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Eligibility of Accreditation Body

• AB must demonstrate that it has authority (as a governmental entity or through contractual rights) to perform assessments of auditor to determine its capability including:– Reviewing records

– Conducting onsite assessments of audits

– Performing reassessments or surveillance to monitor compliance of auditor

– Suspending, withdrawing reducing scope of accreditation of auditor among other things

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Eligibility of Accreditation Body

• Must demonstrate:

– Adequate resources (skilled personnel/financial) and capabilities

– Protections against conflicts of interest

– Adequate quality assurance procedures

– Adequate recordkeeping procedures



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AB Assessment of Third-Party Auditors Seeking Certification

• In the case of accrediting a foreign governments or government agency, reviews and audit to determine if it has programs, systems and standards in place to meet eligibility requirements of rule and FDA model accreditation standards including legal authority, competency, conflicts of interest, quality assurance and records

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• Other third-party or foreign co-op/processor, review and audit of training and qualifications of audit agents and review of internal systems to determine if criteria in previous slide are met



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• AB must review and observe a statistically significant number of onsite audits to assess compliance

• AB must require auditor to comply with reporting and notification requirements of rules and agree to submit electronic food and facility certifications

• Must maintain records on denial of accreditations

• Must have written appeals process for denials

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AB Reporting Requirements

• AB must conduct self-assessment annually and report to FDA

• Must immediately notify FDA of:– Granting accreditation to auditor

– Withdrawing/suspending/reducing scope of accreditation

– Determining that auditor failed to issue a food/facility certification in contravention of rule.

• Must notify FDA within 30 days of denying accreditation



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Various AB Requirements

• Specific requirements to protect against conflict of interest

• Must maintain records electronically for 5 years

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Applying for AB Recognition

• Application submitted to FDA• Reviewed on first in, first out basis.• Recognition lasts for no more than 5 years. Then

must reapply for renewal.• Recognition may be revoked for:

– Refusal to allow FDA to access records– Failure to take timely and corrective action when

auditor loses accreditation or other significant problem identified or at direction of FDA

– Fraud or submitting false statements– Other good cause

• Process for reinstatement



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Accreditation of Auditors By ABs

• ABs accredit auditors although FDA can directly accredit them in certain circumstances (if it has not identified and recognized an AB to meet needs of law within 2 years of establishing audit program)

• Auditor may be foreign government, or agency, foreign coop or another third-party

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Auditor Accreditation Requirements

• Auditor must demonstrate it has adequate legal authority to perform assessments and issue certifications, including authority to

– Review relevant records

– Conduct onsite audits

– Suspend or withdraw certification for violations

• Must demonstrate adequate staff and financial resources to perform duties



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• Must demonstrate that written conflict of interest prevention measures implemented and capability to meet conflict of interest requirements in rule

• Must demonstrate implementation of adequate written quality assurance procedures:

– Must identify areas that need improvement and quickly take corrective action

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• Must demonstrate that adequate written recordkeeping procedures implemented



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Rules for Accredited Auditors: Competency of Agents

• Auditor must ensure that each auditing agent has:– Relevant knowledge and experience– Determined to be competent through observation

of audits– Participates in annual food safety training under

auditor training plan– Has no conflicts of interest– Agrees to notify its accrediting body immediately

upon discovery during an audit of any condition that could cause or contribute to a serious risk to public health

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Rules for Accredited Auditors: Competency of Agents

• Auditor cannot use audit agent to conduct a regulatory audit if same agent conducted a consultative or regulatory audit at same entity in preceding 13 months

– Requirement is waived if auditor demonstrates to FDA there are insufficient auditors in region



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Audit Requirements

• Auditor must require entity seeking audit to:– Identify scope and purpose of audit

– Provide a 30-day operating schedule for facility including information relevant to audit

– Determine whether the requested audit is within its scope of accreditation

• Auditor must ensure it has authority to:– Conduct an unannounced audit

– Access any relevant records and areas of the facility/food/processes

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Audit Requirements

– Conduct sampling and analysis where FDA requires it

– Notify FDA immediately if at any time during the audit, auditor/agent discovers a condition that could cause or contribute to a serious risk to the public health

– Prepare consultative and regulatory audits pursuant to the rule, and submit regulatory audits to FDA and AB

– Allow FDA and AB to observe any audit for evaluation purposes



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Audit Protocols

• Audit must be conducted unannounced during 30-day operating schedule provided by entity and must be focused on the highest food safety risks associated the facility, its processes and the food within the scope of the audit

• Audit must include:– Records review– Onsite assessment– Environmental or product sampling and analysis

where appropriate

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Audit Protocols

• Audit must be sufficiently rigorous to allow auditor to determine whether entity is in compliance with FD&C Act at time of audit and for a regulatory audit, whether entity would likely remain in compliance with FD&C Act for at least 12 months following audit

• Audit observations and assessments, including corrective actions, must be documented and must be used to support the findings contained in the audit report



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Two Categories of Audits

• Consultative– To determine compliance with FD&C Act and industry

standards and practices– Used for internal purposes only– Cannot be used for determining eligibility for food or facility

certification under FSMA or for onsite audit under FSVP

• Regulatory– To determine whether entity is in compliance with FD&C

Act– Results used to determine eligibility for food or facility

certification– May be used by importer in meeting onsite audit

requirements for FSVP

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Audit Report RequirementsConsultative Audit

• Report must be prepared in English no later than 45 days after audit completed

• Must include:– Name and address of the facility and entity (corporate

etc.), if different– Unique facility identifier (DUNS # and GPS

coordinates)– Names and phone numbers of persons responsible

for food safety compliance at the facility– Dates and scope of audit– Any deficiencies observed that require corrective

action, corrective action plan and the date on which such corrective actions were completed



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Audit Report RequirementsRegulatory Audit

• Report must be prepared in English and submitted to FDA and accreditation body no later than 45 days after audit completed

• Must contain:– Name and address of facility, unique facility identifier

and where applicable, FDA facility registration number

– Identity information of entity if different

– Dates and scope of regulatory audit

– Processes and foods observed

– Identity of person responsible for FD&C Act compliance at facility

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Audit Report Requirements Regulatory Audit

– Any deficiencies observed during the audit that present a reasonable probability that the use of or exposure to a violative product:

• Will cause SAHCODHA; or

• May cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

– Corrective action plan for addressing each deficiency identified unless corrective action implemented immediately and verified onsite

– Whether sampling and lab analysis is used in facility



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– Whether entity has issued a food-safety related recall of food from facility during preceding 2 years and details on food and reason for recall

– Whether entity has made significant changes to the facility, its processes or products during preceding 2 years

– Any food or facility certifications issued to entity during preceding 2 years, including scope and duration

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• Audit report must be submitted to FDA regardless of whether certification was issued

• Auditor must implement written procedures for appeals challenging adverse audit results



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Certifications

• Auditors issue food and facility certifications

• Facility certification: issued for purposes of Voluntary Qualified Importer Program (expedited review and importation of food) that facility is in compliance with FD&C Act

• Food certification: issued for purposes of compliance with import certification provision of FSMA (FDA may require a certification for certain foods as a condition of granting admission into U.S.)

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Certifications

• Auditor must complete a regulatory audit before issuing a food or facility certification

• If as a result of observation during regulatory audit, entity must implement a corrective action plan, auditor may not issue a certification until onsite verification that CAP implemented (except for correcting recordkeeping)



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Certifications

• Auditor must consider each observation and assessment to determine whether entity is in compliance with FD&C Act at time of audit and would likely remain in compliance for duration of certification

• Auditor—not audit agent, makes determination whether to issue certifications

• Certifications valid for no more than 12 months

• Single audit may result in one or more food or facility certifications

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Auditor Monitoring Requirements

• If auditor has reason to believe that an entity to which it issued a certification may no longer be in compliance with requirements of FD&C Act, auditor must conduct monitoring to determine whether the entity is in compliance and immediately notify FDA if it determines that entity is not compliant.



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Auditor Self-Monitoring

• Auditor must conduct an annual self-assessment that includes:– Performance of officers, personnel and agents

(OPA)

– Degree of consistency among OPA in performing audits

– Compliance with conflict of interest requirements

– Actions taken to respond to FDA or AB

– Other aspects as requested by FDA

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Auditor: Required Submission of Reports

• Regulatory audit must be submitted to FDA electronically in English to AB and FDA no later than 45 days after completion

• Auditor self-assessment must be submitted to AB within 45 days of anniversary date of accreditation



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Auditor: Immediate Notification to FDA

• Auditor must immediately notify FDA when it discovers any condition found during a regulatory or consultative audit that could cause or contribute to a serious risk to public health– Must provide name and address of entity, facility

(if different), FDA registration # (if applicable)

– Condition for which the notification is submitted.

– Must immediately notify entity and then AB after notifying FDA

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Auditor: Immediate Notificationto FDA

• Auditor must immediately notify FDA of withdrawing or suspending certification and basis for the action



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Auditor: Odds and Ends

• Auditor must implement written program to protect against conflict of interest

• Auditor must retain records for 4 years

• Consultative audit records may be accessed by FDA under limited circumstances

• Accreditation term for auditor may not exceed 4 years

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Withdrawal of Accreditation

• FDA will withdraw accreditation from an auditor if food or facility certified is linked to an outbreak of foodborne illness that has reasonable probability of SAHCODHA, or

• If FDA determines auditor no longer meets accreditation requirements, or

• Refusal to allow FDA to access records or to conduct an audit, assessment or investigation



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Questions?

Thank you!

Erik Lieberman

[email protected]

(202) 810-4044

www.sqfi.com/2013conferencewww.sqfi.com/2013conferencewww.sqfi.com/2013conferencewww.sqfi.com/2013conference

WE HOPE TO SEE YOU WE HOPE TO SEE YOU WE HOPE TO SEE YOU WE HOPE TO SEE YOU

SOON!SOON!SOON!SOON!2013 SQF International Conference



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Thank You for Attending!

• Be on the lookout for:

– Today’s presentation in PDF format

– A quick survey

– Webinar recording on the SQF website

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