From: Peter S. Unger [punger@a2la.org] Sent: Thursday, May 13, 2004 11:10 AM To: fdadockets@oc.fda.gov Subject: [Docket No: 2002N-0085];[FR Doc: 04-09699];[Page 23460-23473]; Public Health Security and Bioterrorism: Food importation; sampling services and private laboratories requirements The American Association for Laboratory Accreditation (A2LA) offers the following comments on the subject proposed rule. Founded in 1978, A2LA is a non-profit (501c3), public service organization to promote laboratory quality and competence. A2LA is the largest, general purpose laboratory accreditation body in the United States and the third largest in the world. It maintains the full range of national and international recognitions available. A2LA supports the Food and Drug Administration’s efforts in its attempt to “establish a uniform, systematic and effective approach to assure that private laboratories conducting tests on FDA-regulated products submit scientifically sound data”. It is with this in mind that we submit the following comments on this proposed rule, especially as it pertains to the consideration of laboratory accreditation. The proposal not to use accreditation of participating private laboratories appears to be based on some outdated facts and incorrect assumptions regarding 1) the standard to use; 2) the manner for FDA accreditation body recognition; 3) the capacity of the accreditation bodies to accredit the participating laboratories; and 4) the costs incurred by the laboratory. We would like to clarify. First, in subpart 59-D, page 16, paragraph 2, as it pertains to the issue of an appropriate standard to use, and in the comments in section 3, page 33 paragraph 3; “Questions about the accreditation standard,” it appears that there is some confusion in the consideration of the appropriate standard to use. ISO/IEC 17025:1999, "General requirements for the competence of testing and calibration laboratories testing laboratories," has been available for five years and has been fully implemented by more than 40 internationally recognized laboratory accreditation bodies. 17025 requires in addition to its general requirements the application of specific criteria for each and every type of test performed, the standard of good laboratory accreditation practice. Second, while the mechanisms for FDA accreditation body recognition/ determination of competence were not discussed this “question” was used as one basis for justifying the rejection of the accreditation approach. There are four formal organizations already in place to serve the recognition needs of the United States laboratory accreditation community. Domestically, the mutual recognition arrangement (MRA) of the National Cooperation for Laboratory Accreditation (NACLA) currently identifies five US accreditation bodies complying with national and international standards for accreditation bodies . The basis for NACLA recognition involves a three-step process: Careful review of the accreditation body's documents and procedures; a thorough on-site evaluation by a team of NACLA experts (in which FDA can participate) to determine the accreditation body's compliance with NACLA procedures and the international standard for accreditation bodies (ISO/IEC Guide 58) including evaluation of assessors in the field; and review of the evaluation team's report and recommendation by the NACLA Acceptance Panel in which a FDA representative can participate. Internationally, these recognitions are accomplished though a similar MRA arrangement involving the International Laboratory Accreditation Cooperation (ILAC). Two other regional MRAs also cover the United States, the Asia-Pacific Laboratory Accreditation Cooperation (APLAC) and the Inter-American Accreditation Cooperation (IAAC) and support the ILAC Arrangement. The ILAC Arrangement, entered into effect on 31 January 2001, recognizes competent accreditation bodies and provides the technical underpinning to international trade by promoting cross-border stakeholder confidence and acceptance of accredited laboratory data between economies. The ILAC Arrangement recognizes more than 40 such accreditation bodies. Third, the statements in Section 3, page 33, paragraph 3, are either misleading or factually incorrect. “First, there are very few accrediting bodies qualified to accredit laboratories. Since a small percentage of laboratories that submit data to the FDA are currently accredited (10 to 15 percent of more than 100 private laboratories), the infrastructure to accredit unaccredited private laboratories does not currently exist”. While there may be only one accreditation body currently qualified to accredit food laboratories based in the United States (i.e., A2LA), A2LA currently has the capacity to accredit an additional 85 laboratories over the next 18 - 24 months for food testing and can easily expand that capacity if there were some advanced notification of more than 85 laboratories wanting to apply. Considering that we are dealing with imported food, it is reasonable to assume some increased interest by recognized foreign accreditation bodies and their accredited food testing laboratories. This is where the ILAC MRA could be a useful tool to FDA. The claim of insufficient accreditation infrastructure is simply unfounded. Fourth in Section 3, page 33, paragraph 3, as it pertains to the costs incurred by the laboratory to achieve accreditation, while the amount stated for a first year accreditation appears reasonably accurate, the rationale that this cost to the laboratory is a burden that is too great to be borne because it would necessarily cause the laboratory to undergo “hiring of additional personnel, training, proficiency testing and quality assurance procedures” belies the prime justification for establishing the proposed rule in the first place. That accreditation confers significant benefit to the laboratories is shown by: § An attestation to the world (not just FDA) that the laboratory is qualified to provide services for which it is accredited. § A regular, objective “check-up” that helps a laboratory’s management to make continual improvements in its operation. § Increased laboratory productivity, resulting from a decrease in the number of clients and regulators who insist on having their own staff audit the laboratory. More of these clients now base their confidence on a recognized third-party accreditation. § International recognition of the accredited laboratory’s competence if the accreditation body is a signatory to the mutual recognition arrangement of ILAC. § Accreditation assessments help the laboratory staff to stay on the “cutting edge” of technology developments in its field. § Significant discounts in liability insurance premiums are not uncommon, when the insurer appreciates the verification-of-competence that accreditation represents. § Improved performance by laboratory staff. Undergoing regular assessments enhances staff discipline and its sense of professionalism. Employees are more likely to be committed to observing the firm’s quality management system and standards of performance. With its restricted budget, FDA must rely on third-party laboratories to support its regulatory efforts. The proposed rule requires that the importer provide the FDA with qualifications of the laboratory (subpart 59.103, point 2) but then offers no criteria for what is required. If there is some added assurance through the reliance on accreditation, the resources devoted by FDA to reviewing laboratory qualifications should be greatly reduced. Laboratory accreditation could also be of benefit to the FDA by helping to improve the quality of data submissions as well as to reduce the number of occurrences of unacceptable data reporting packages. This would be manifest in a shorter amount of time necessary for the staff to complete their review (see page 34, subpart D, item 1). Additionally, it does not address the importance of measurement traceability, which is fundamental to accurate measurement and addressed in the ISO/IEC 17025 standard. Unless the FDA is considering creating new requirements for data quality, the logical means to demonstrate the qualification of private laboratories is conformance to the ISO/IEC 17025 standard and demonstration of the competence of the laboratory to perform specific analytical tests. Several important principles are imbedded in the requirements of the 17025 standard. These are summarized as follows: Capacity: A laboratory must have the resources (people with the required skills and knowledge, environment with the required facilities, equipment and instruments, procedures to ensure consistency of test processes, and quality control for the key steps in the testing processes) in order to carry out the tests and produce reliable results. Responsibility: A laboratory must have persons in its organization who have the authority to execute specific functions with its overall scope of test work -- and can demonstrate accountability for their results. Scientific Approach: A laboratory should carry out its work based on accepted scientific principles, preferably following consensus-based methods or standards, and that deviations from accepted methods must be substantiated in a manner considered generally acceptable by experts in the field. Objectivity: The results produced should be based upon measurable quantities. If results are subjective, they must be produced by people deemed qualified to make subjective judgments. Impartiality: The pursuit of reliable results through the use of accepted scientific principles is the primary and overriding influence on the persons carrying out the testing. All other influences are secondary and not permitted to take precedence. Transparency: The processes within a laboratory producing objective results must be open to external as well as internal scrutiny, so that factors which may adversely affect the laboratory’s pursuit of objective results based upon scientific principles can be easily identified and mitigated. Measurement Traceability: The results produced are based on a recognized system of measurement that derives from accepted known quantities (SI system if units of measurement) or other well-characterized references. The chain of comparison of measurement between these accepted, known quantities and the device providing the objective result is unbroken for the transfer of measurement characteristics, including uncertainty, for the whole of the measurement chain. Reproducibility and Uncertainty: The test method used to produce results will produce results within an acceptable spread or range. These last points, especially the concepts of traceability and estimation of measurement uncertainty, do not appear to be addressed by the proposed regulation, both of which are built into the ISO/IEC 17025 criteria. However, they figure greatly into the reliability of the analytical values obtained in the testing. Requiring private laboratories to be accredited to the ISO/IEC 17025 standard will instill better quality in the laboratory community which should improve the level of credibility that the FDA seeks in the data submissions that it reviews. We would be pleased to provide further information and cooperate with FDA in fulfilling the aims of the rule-making effort. Sincerely, Peter S. Unger, President, A2LA 5301 Buckeystown Pike, Frederick, MD 21704 Phone: 301 644 3212; Fax: 301 662 2974 http://www.a2la.org; mailto:punger@a2la.org