Food Protection Trends - January/February 2014 - (Page 46)

been used since 1999 as a basis for the accreditation of testing and calibration laboratories, including food-testing laboratories. ISO 17025 provides a framework upon which laboratories can build quality management systems to ensure data reliability. An ISO 17025 standard interpretation aid, issued by the Association of Analytical Communities International Analytical Laboratory Accreditation Criteria Committee (1), has served as an important tool for laboratories seeking accreditation, as well as for accrediting bodies to assure compliance and competency. While several local, state, and federal government laboratories have sought and achieved ISO 17025 accreditation, the population of commercial laboratories with ISO 17025 accreditation is relatively small. Increasing awareness of the importance of reliable data in supporting food safety programs has placed a spotlight on both laboratory competence and the use of validated, "fit for purpose" testing methods. Accordingly, food manufacturers and regulatory agencies are expressing competency and method expectations beyond those included in the ISO 17025 standard. However, such expectations are expressed with variable levels, based on whether the analysis is conducted on a commercial, third-party basis, or for regulatory purposes. Moreover, expectations that laboratory analysis is conducted according to ISO 17025 or analogous standards (such as those stated in the current Global Food Safety Initiative guidance) may lead to variations in the interpretation of equivalency. As expectations continue to evolve, guidance for establishing standards beyond ISO 17025 is warranted. This approach is needed to ensure laboratory competency and method performance, which in turn, will drive the generation of reliable data used to manage food safety programs worldwide. The laboratory accreditation program, included as part of FSMA, is intended for laboratories that conduct regulatory testing on behalf of FDA, but may also include private laboratories. It is possible that the FSMA-directed accreditation program will encompass much of the ISO 17025 standard, although it is unclear at this time as to whether such an accreditation will sufficiently address FDA expectations. The relevance of laboratory accreditation per FSMA for private laboratories and non-regulatory food testing is currently unknown, as is whether expectations could potentially evolve into something similar to those for the pharmaceutical industry in that laboratory analysis is considered part of current Good Manufacturing Practices and thereby under the legal authority of FDA. By comparison, non-regulatory testing for food items regulated by the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS), including meat, poultry, and processed egg products, also is conducted by commercial in-company or third-party laboratories without regulatory oversight. However, FSIS has recently issued guidance documents for regulated establishments to assist in the selection criteria for private laboratories, based on accreditation, technical competence, and validity of test methods. A recently updated guidance entitled "Establishment Guidance for the Selection of a Commercial or Private Microbiological Testing Laboratory," is intended to provide free, easy-to-interpret information, including a laboratory assessment checklist for food processors to determine if the 46 Food Protection Trends January/February laboratory, and associated data, are reliable (3). This guidance document highlights that FSIS laboratories are ISO 17025 accredited and that ISO 17025-accredited laboratories would meet their recommended guidance. The document also states that while laboratory accreditation is not a specific requirement, accreditation provides an increased level of confidence in the accuracy and quality of test results. Laboratory accreditation per FSMA: Expanding FDA's ability to test food, with quality and reliability Section 202(a) of FSMA requires FDA to establish a testing program that uses accredited laboratories to augment the thirteen field laboratories currently operated by the agency and to utilize them to analyze samples in an effort to protect public health. The stated goal of Section 202(a) is to increase the number of laboratories that are qualified to perform testing of food. By expanding both the domestic and foreign capacity of food testing via accredited laboratories, an increased level of testing for routine surveillance, importing compliance, and foodborne illness investigations can exist. Additionally, the accreditation requirements are aimed to advance quality assurance and scientifically sound sampling programs, thereby driving the collection of reliable data more effectively. Quality is further enhanced by a grant program, under Section 210, which is designed to improve the capacity of laboratories to detect disease agents. Meanwhile, reliability is assured through direct reporting of test results to FDA, along with FDA review and periodic re-evaluation of accrediting bodies, and oversight of the laboratories they accredit, as described below. Process of laboratory accreditation per FSMA Under the program, FDA recognizes third-party, accrediting bodies that will accredit government and private laboratories to test food for regulatory purposes. These accredited labs will report results of public health concern directly to FDA. The agency is required to establish a registry of accrediting bodies and accredited laboratories that includes laboratory contact information. The accrediting body or the accredited laboratory is responsible for reporting any changes that would affect the recognition of the accrediting body or the accreditation of the laboratory. What laboratories qualify for accreditation per FSMA? Accredited laboratories may be government-operated or privately run. The only eligibility requirement is a demonstrated capability to conduct one or more sampling and analytical testing methodologies for food. Overseas laboratories also can be accredited, provided they meet the same standards applicable to laboratories located in the U.S. Laboratories must be accredited for the particular sampling or analytical testing methodologies they use for analysis conducted for regulatory purposes. The scope of accreditation could be noted on the registry, enabling businesses to identify whether the laboratory is appropriate for the testing they are seeking. An exception to this limitation is provided in cases where a new methodology has been developed and verified, but the laboratory has not yet been accredited to perform it, but only if the use of the new methodology is necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak. This

Table of Contents for the Digital Edition of Food Protection Trends - January/February 2014

Food Protection Trends - January/February 2014
Contents
Economically Motivated Adulteration of Honey: Quality Control Vulnerabilities in the International Honey Market
Efficacy of Quaternary Ammonium Compounds on Different Conveyor Chips Contaminated with Poultry Rinsate
What Implications Does a Baseline of Self-efficacy of Food Safety in Adolescent Populations Have for Future Food Safety Education Interventions?
Food Safety Risks in Restaurants and School Foodservice Establishments: Health Inspection Reports
INOFOOD 2013 Conference & Expo
The 3rd Asia Pacific International Conference on Food Safety
China International Food Safety & Quality Conference (CIFSQ) + Expo
Dubai International Food Safety Conference (DIFSC)
Beyond the Bio
FSMA: Article 7
PDG
Industry Products
Coming Events

Food Protection Trends - January/February 2014