PARTNERING WITH THE REGULATORS: The Role for 3rd Party Accreditation in Food Safety

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2 PARTNERING WITH THE REGULATORS: The Role for 3rd Party Accreditation in Food Safety Roger Brauninger American Association for Laboratory Accreditation (A2LA), Frederick, Maryland

3 Topics Role of Accreditation & third party relationships Preparing for Assessment Examples of public-private partnerships

4 Transatlantic Trade & Investment Partnership joint letter (ISO/IEC/ILAC/IAF) Operating in the public interest across all market sectors, accreditation determines the technical competence, impartiality, reliability and integrity of conformity assessment bodies. Accreditation works through a process of transparent and impartial evaluation of these organizations against internationally recognized standards and other requirements. 06/01/2013

5 Principles for Federal Engagement in Stds Activities to Address National Priorities Should explicitly include consideration of conformity assessment approaches that take account of elements from international systems, to encourage private sector support and minimize duplicative testing. Should evaluate whether their objectives necessitate creating government-unique conformity assessment schemes, which may be expensive to develop and maintain, may impose additional costs on the private sector, and may not be recognized beyond national boundaries. In doing so, agencies should use existing best practices and leverage available resources in the private sector as well as within the Federal Government. (White House OMB Memo 1/17/12)

6 Agency Use of Third-Party Programs to Assess Regulatory Compliance Agencies that establish third-party programs generally cannot or do not delegate their regulatory authority to conformity assessment bodies: Authorize conformity assessment bodies to perform certain technical tasks to assess conformity. Regulatory agencies rely on these assessments in their own enforcement of regulatory requirements. The goal is to leverage expertise and resources in the private sector to serve regulatory objectives. Because the regulatory agency must remain ultimately responsible for achieving regulatory objectives, it is vital to provide public oversight of third-party assessment activities. Administrative Conference of the United States-Recommendations (12/6/12)

7 Agency Use of Third-Party Programs to Assess Regulatory Compliance (cont) Key Considerations: Potential for the agency to achieve efficiencies through reducing its direct compliance assessment costs and resource needs. The capacity of the agency to perform effective oversight and its related costs. The costs to regulated entities of paying third parties to perform conformity assessment activities. Administrative Conference of the United States-Recommendations (12/6/12)

8 Accreditation Bodies Certification Body Accreditation in the Market CONFIDENCE + TRUST + ASSURANCE Accreditation service Testing Cal Inspect Cert Conformity assessment bodies Inspection Body Test Lab Cal Lab Conformity Assessment Service Product/ service Market Conforming product/service Requirements Purchasers Regulators Demands for competent conformity assessment Suppliers Trade Organizations & Authorities Demands for facilitating trade

9 Lab Accreditation Models Model 1 - One national accreditation body that takes care of all the accreditation needs in that economy Usually government-run or government-sponsored/ recognized Model 2 - Two national accreditation bodies - one for testing and one for calibration Usually government-run or government-sponsored Model 3 - Multiple accreditation bodies offering accreditation in various fields of testing and calibration within one economy mix of government-run programs, and private sector programs mix of single field programs and multi-discipline programs

10 Laboratory Accreditation in the U.S. U.S. follows Model 3 Multiple accreditation programs In all levels of the U.S. government In many private sector organizations Scope of programs many serve only a narrow sector of the economy several are broad-based multi-discipline programs many programs overlap

11 The Regional Co-operations ILAC ARAC EA APLAC IAAC AFRAC SADCA ILAC APLAC IAAC EA SADCA AFRAC ARAC International Laboratory Accreditation Cooperation Asia Pacific Laboratory Accreditation Cooperation Inter-American Accreditation Cooperation European Cooperation for Accreditation Southern African Development Community Accreditation African Regional Accreditation Cooperation Arab Accreditation Cooperation 11

12 Coverage of the ILAC MRA ILAC MRA Signatories ILAC Associate Members ILAC Affiliate Members

13 Interlocking recognitions One accreditation Cooperation ILAC Mutual Recognition APLAC, IAAC, SADCA, EA ANSI/ISO/IEC Peer Evaluation Requirements USA Accreditation Bodies A2LA, ACLASS, ASCLD-LAB, IAS, L-A-B, NVLAP, PJLA ANSI/ISO/IEC Laboratories

14 Primary Objective of MRAs Eliminate conformity assessment as a T.B.T. through Recognition of Competence between Accreditation Bodies

15 Accreditation Requirements AB s Policies and Procedures Supplementary Field Specific Criteria and any specific PT requirements Technical Requirements of Specific Test Methods and Procedures ISO/IEC Accreditation Criteria

16 Accreditation Process CAB submits the application, supporting documentation including the quality manual and standard operating procedures, etc. Staff reviews materials and proposes assessment team Assessment team is assigned and contacts applicant to arrange date and logistics Assessment occurs Final written report is issued

17 Accreditation Process (cont) Applicant responds to findings with root cause investigations, corrective actions and objective evidence Accreditation Body reviews the responses for completeness and correctness Report and responses are reviewed by the accreditation council to make a decision on accreditation Accreditation is valid for a 2 year cycle at which time a renewal on-site assessment will occur. Annual review / surveillance assessment

18 Examples of Relevant public/private partnerships:

19 DEPARTMENT OF DEFENSE DoD Environmental Laboratory Accreditation Program (DoD ELAP) laboratory accreditation of environmental testing laboratories performing testing in support of restoration programs at DoD operations: 4 U.S. Accreditation Bodies (AB) were recognized based on their agreement to abide by the conditions and criteria set for by DoD ELAP: The U. S. AB must: Maintain ILAC MRA signatory status and operate in accordance with ISO/IEC AB must assess to the requirements for ISO/IEC 17025, 2003 NELAC Chapter 5, and the DoD Quality Systems Manual (QSM).

20 DEPARTMENT OF DEFENSE Environmental Laboratory Accreditation Program (cont) The U. S. AB must: Provide the EDQW with assessment reports and accreditation information. Inform EDQW of upcoming assessments and submit to observation by EDQW personnel. Participate in meetings with the EDQW as part of continual improvement efforts. Allow (EDQW )to attend its ILAC MRA peer evaluation. Maintain DYNEX spreadsheet of accredited laboratories on EDQW website.

21 CONSUMER PRODUCT SAFETY COMMISSION In conformance with the Consumer Product Safety Improvement Act of 2008 (CPSIA), all products falling under these regulations must be tested against the Commission's children's product safety rules by a laboratory accredited to ISO by an accreditation body who is a signatory to the ILAC Mutual Recognition Arrangement (ILAC MRA) and the accreditation must be registered with, and accepted by the Commission. This global recognition is important in that a majority of children s products are manufactured outside of and imported into the United States.

22 Continent Country Number of CPSC Labs Asia China (including Taiwan and Hong Kong) India (including Bangladesh and Sri Lanka) Others (11 nations) North America Total United States Mexico (including Central America) Canada Europe Total United Kingdom Germany Others (13 nations) Total 65

23 ENVIRONMENTAL PROTECTION AGENCY Recognition of testing laboratories for Energy Star EPA recognizes laboratories performing product testing in support of the ENERGY STAR and its specific product family test methods and requirements. Laboratory recognition criteria require that the laboratory in question gain and maintain accreditation to ISO/IEC through a Recognized Accreditation Body. To be recognized, accreditation bodies are required to operate in accordance with ISO and be an ILAC signatory. Accreditation body must first undergo a separate recognition process with the EPA in order to be approved to accredit testing laboratories. Must include Asr. training on the current requirements described in the ENERGY STAR Laboratory Recognition Requirements. The laboratories are also required to abide by additional requirements documented by the EPA prior to gaining recognition to test products for this voluntary program.

24 ENVIRONMENTAL PROTECTION AGENCY Recognition of testing laboratories for Energy Star (cont): Certification bodies that review this test data must be accredited by signatories to the IAF MLA. AB must participate in meetings with EPA as necessary as part of continual improvement efforts in the enhanced testing program: brief EPA staff on the status of the program, common deficiencies, and issues related to accreditation of laboratories. AB must report to EPA of any major changes that may affect it's capability, scope of recognized activities, or compliance with the ENERGY STAR requirements.

25 1 Assessor Comparison between programs DOD CPSC EPA Specifier Approval? Yes No No Train / Refresher Required? Yes No Yes 2 Observations Specifier Accompany Asesssment Team? Yes No Yes, permitted 3 Asr Report Submitted to Specifier? Yes No Yes (upon request by specifier) Specified Input on CAR? No No Yes, (Only where procedures related to the program are in question) Available Upon Request? Yes Yes Yes 4 Accreditation Notification Sent to Specifier? Yes No Yes Scope Sent to Specifier? Yes No Yes, Responsibility is by Lab Notification of Scope Changes? Yes No Yes, when they relate to the program

26 Equal Treatment: In these examples all of the organizations are treated equally by the regulatory agency; same recognition criteria for ABs same accreditation requirements in the assessments of the conformity assessment bodies This is especially important internationally. Otherwise, if different standards were used it could be considered a trade barrier.

27 Why Public/Private Partnerships can be Successful Programs can be tailored to specific regulator needs but are based on common international consensus standards ISO/IEC and ISO/IEC Partnerships enable varying degrees of oversight by federal agencies based on their comfort level. These partnerships place the costs of accreditation on the laboratories being assessed/audited. They fit seamlessly into the accreditation bodies programs and systems while easily being catered to the specifier.

28 Benefits of Public/Private Partnerships Greater consistency between assessments. High level of technical competence of assessors. High level of confidence in ABs based on the requirement for peer evaluations. Agencies maintain oversight of their individual programs. Increase in resources that were dedicated to performing assessments and managing accreditations.

29 Public/Private Partnership Paradigm: A Regulatory Agency approves Accreditation Bodies that accredit Conformity Assessment Bodies that assess whether Regulated Entities or Regulated Products are in conformity with A Regulatory Standard Administrative Conference of the United States-Recommendations (12/6/12)

30 Questions / Comments

31 For Further Information Contact: Roger M. Brauninger Phone: American Association for Laboratory Accreditation 5301 Buckeystown Pike, Suite 350 Frederick, MD