A fully functioning Integrated Food Safety System (IFSS) allows for acceptance of state data in federal enforcement actions and means that the U.S. Food and Drug Administration (FDA) and states can act efficiently and proactively to prevent foodborne illnesses. Accreditation is an integral part of mutual reliance and a critical element of an IFSS. Over the past 5 years, FDA has invested over $50 million toward the accreditation of state food and feed testing laboratories to the ISO/IEC 17025:2005 standard (ISO 17025).
Earlier this year, 27 of the original 30, and 1 of the 6 additional (funded in 2015), FDA-funded state laboratories have either achieved ISO 17025 accreditation or expanded their scope of accreditation. The active monitoring of cooperative agreement deliverables shows that all of the original 30 FDA-funded food laboratories are on track to achieve or expand their accreditation by the end of the funding cycle in August 2017. This investment in accreditation has been critical to protecting the U.S. food supply, largely by strengthening state food testing laboratories’ capacity and capability. Grant-
required sampling plans have resulted in several successful food recalls that directly protected public health.
Sustaining ISO 17025 accreditation demonstrates a commitment to quality and supports the central goal of the Food Safety Modernization Act (FSMA)—the creation of a prevention-based IFSS. By facilitating long-term, permanent improvements to our nation’s laboratory system, FDA’s investment in ISO 17025 laboratory accreditation is an efficient and cost-effective path to advance public health initiatives and improve the safety of the U.S. food supply.
The Association of Public Health Laboratories (APHL), the Association of Food and Drug Officials (AFDO) and the Association of American Feed Control Officials (AAFCO) were awarded funding by FDA beginning in 2012 to assist laboratories with these improvements to the national food and animal feed safety system by strengthening multidisciplinary laboratory collaboration. This 5-year agreement helps prepare food and feed testing laboratories seeking to achieve or expand their scope of ISO/IEC 17025:2005 accreditation.
The cooperative agreement with APHL, AFDO and AAFCO focuses on several key needs related to accreditation, collaboration and mutual reliance: systematic laboratory training, direct technical assistance, communication among federal, state and local laboratories and with regulatory and public health programs, and expanded proficiency-testing options that meet the ISO 17043 standard for proficiency-testing providers. Additional products related to mutual reliance include guidelines in the key areas of electronic sharing of analytical data, obtaining defensible samples and acceptance of state data for regulatory action.
We invited three members of APHL to help describe why a laboratory might join this program. We also intersperse success stories from various laboratories to illustrate these benefits. The members are Kristina McCallum, microbiologist IV/deputy laboratory manager in the biochemistry laboratory at the Colorado Department of Agriculture, Tracy Stiles, director, microbiology division, at the Massachusetts State Laboratory Institute, and Yvonne Salfinger, retired from the Florida Department of Agriculture and Consumer Services, currently an APHL consultant and emeritus member.
FSM: What are your major food safety challenges?
McCallum: A challenge that we have as a regulatory laboratory is trying to stay at the forefront of technology while meeting the requirements of our customers and federal partners. As a regulatory laboratory, we do not always have the freedom to utilize the latest technology. We are often mandated by our customer to use methods designated as “official methods” (e.g., AOAC, FDA BAM [U.S. Food and Drug Administration Bacteriological Analytical Manual], USDA MLG [U.S. Department of Agriculture Microbiology Laboratory Guidebook]) for regulatory sample testing. There are instances where we can use rapid methods and/or new technology that have not been accepted as an official method by AOAC or other agency, but that require a full method validation by our laboratory. Method validations require a lot of time and effort by staff as well as resources. Although the CDA-BCL [Colorado Department of Agriculture Biochemistry Laboratory] participates in AOAC collaborative studies for new methodology and/or technology, we don’t often have the funding to adopt that technology.
Stiles: The major challenges faced by Massachusetts are related to getting samples for testing. Be it in a foodborne outbreak or for routine surveillance, the state is sometimes unable to collect samples in a timely manner and to appropriately submit them to the laboratory to be tested. The reasons for this vary from inexperience in proper collection and submission by local boards of health to manufacturing firms not wanting to contribute to a voluntary surveillance program.
Salfinger: I am no longer in the laboratory but worked at the Florida Department of Agriculture, Bureau of Food Laboratories.
I started working in laboratories in 1982, when we had our first CLIA [Clinical Laboratory Improvement Amendments] inspection at the Florida Department of Health Bureau of Public Health Laboratories. I learned early on the need for and benefits of having external audits and also, through the years, developed more and more a need for formal root-cause analysis, increased quality control and overall more consciousness for quality. Standard Operating Procedures (SOPs) used to be retyped (!) between the holidays at Christmas and New Year’s since that was a “quiet” time. With the advent of computers, we were able to get away from using rulers to make lines on pages, and standardization of our forms and copies was made easier with copy machines being available on the floors. As testing became more automated, and test portions were smaller and smaller, quality control became more fastidious. Testing became faster as well, and decreasing turnaround times became paramount. Prevention of errors became a focus.
FSM: Why would a laboratory choose to join this program? Was compliance with ISO 17025 a major issue?
McCallum: Our laboratory has been accredited to ISO 17025 for 6 years prior to joining the FDA AFRPS [Animal Feed Regulatory Program Standards] CAP. A driving force in our decision to become accredited has been our participation in federal grant programs. Our laboratory was a participant in USDA’s Microbiological Data Program under which routine surveillance of produce for pathogens was performed. In addition, our laboratory is federally funded by USDA-FSIS [Food Safety and Inspection Service] Food Emergency Response Network (FERN) to conduct research and perform surveillance of food for biological threat agents. To enhance the strength of these programs, both of these grant programs emphasized the need for participating laboratories to be accredited to ISO 17025. We applied for the FDA AFRPS grant to assist other state agriculture laboratories in becoming accredited because we have seen the benefits of accreditation firsthand and felt that we could help make the path to accreditation easier for laboratories just starting out. In addition, maintaining ISO 17025 accreditation can be very costly, depending on the size of your scope. The CDA-BCL scope of accreditation includes feed, fertilizer, microbiological and pesticide methods. On average, the annual cost of maintaining our ISO 17025 accreditation with our current scope of methods is approximately $45–$50K. This includes costs for equipment calibrations, quality assurance staff time, laboratory staff time, calibration/reference materials and proficiency testing programs. Many state agriculture laboratories have to rely on federal grants to help fund critical laboratory programs and functions, such as the purchase of new equipment and maintenance of existing equipment due to costly maintenance agreements. As many state agriculture laboratories struggle to constantly do more with less, federal grant programs provide necessary funding for the hiring of new personnel, training, proficiency programs, updating equipment and maintaining laboratory supplies and equipment.
I believe that the most important reason for any laboratory to become accredited is to ensure the laboratory is reporting quality, fit-for-purpose data. State agriculture/health food laboratories perform the majority of the regulatory food testing in the United States. The data generated from state agriculture laboratories is critical for state, local and federal regulatory agencies to further build on existing regulatory programs, to perform risk assessments and ultimately to prevent or remove potentially dangerous food from reaching the consumer’s dinner table.
Our journey to achieving ISO 17025 accreditation was long and seemed unachievable at times. It takes a lot of time and effort on the part of the entire laboratory staff as well as support from management. It is important for laboratories just beginning this journey to remember that many of the requirements in ISO 17025 are probably being met by their laboratory already and that those processes and procedures simply need to be documented. I encourage laboratories to reach out to their colleagues working in accredited laboratories for guidance and assistance throughout the process. Understanding the written requirements can be challenging as some of the requirements are vague and open to different interpretations. We have documents in our laboratory that have been revised 19 times! It is very easy, in the beginning, to write SOPs and policies too restrictive, which in turn leads to a lot of corrective actions for noncompliance. On the flip side, writing policies and SOPs too vague or unclear to staff members also leads to noncompliance. The goal of accreditation is to constantly improve, not to be perfect. Constant improvement takes a good quality system, management system and dedicated staff who see accreditation as a positive change and not a burden.
Stiles: The Massachusetts State Public Health Laboratory recognized the importance of becoming accredited to the ISO 17025 standard. Being able to defend results because the quality system has been audited against the standard is worth the cost of accreditation in itself. When testing food for a foodborne outbreak, for example, all final reports and raw data are submitted to the federal agencies for review. If those federal agencies know the laboratories are accredited, it makes the review easier and the data more likely to be accepted, as the quality system and method itself have already been reviewed.
Salfinger: When I went to the Florida Department of Agriculture, Division of Food Safety in 2002, I went as the new quality manager to help achieve laboratory accreditation to ISO 17025. The Florida Food Safety Laboratories had started on the path due to a contract with the USDA Pesticide Data Program and the Microbiological Data Program (MDP). These programs mandated achieving accreditation. Because of this, our laboratory actually accredited most testing in microbiology but also chemistry, which was not being funded. However, our quality manager was involved in all the testing in the laboratory, whether they were under our scope of accreditation or not. Our commissioner was informed of this work by the assistant commissioner and former laboratory director—the commissioner was fully on board and pushed for accreditation at the highest level. So, compliance with ISO/IEC 17025 accreditation was a priority for our laboratory leadership.
Staff acceptance was slow, however, so change-management training is a priority for laboratories working toward this major change. Changes include a lot of the paperwork, increased quality controls, more documentation of things we were already doing and ensuring SOPs were current and written to more accurately reflect what was happening in the laboratory. It took about 4 years for this large laboratory to become accredited—initially, 56 methods were in our scope. Once we became accredited to the scope with these methods, we were able to breathe, do preventive actions and work toward writing our methods smarter. Eventually, our laboratory was accredited to a more manageable 29 methods, mostly due to consolidation of methods with the same technology and writing them differently. Meanwhile, the MDP disappeared in 2012. However, we kept all our accreditation (except for those specific MDP methods)—dropping accreditation was not an option for us.
We became part of the FDA Accreditation CAP in 2012, which provided some funding to expand our scope. This included working toward accrediting some of our FERN methods, which have some unique challenges, such as confidentiality.
FSM: What practical benefits have you seen from this program?
McCallum: Through our participation in the FDA AFRPS CAP, the CDA-BCL has enhanced our feed program with the addition of amino acid analysis. Funds from this grant have been used for method validation, with the goal of adding analysis of amino acids in animal feeds to our scope of accreditation by the end of the 5-year grant period. With help from this program, our laboratory is also in the process of moving analysis of feeds and feed ingredients for mycotoxins from ELISA [enzyme-linked immunosorbent assay] technology to the much more robust LC/MS/MS [liquid chromatography/tandem mass spectrometry] method. In addition, this CAP is being used for the mentor/mentee program. Through this program, our laboratory has been able to provide direct assistance to three mentee laboratories. We were able to invite two of those laboratories to visit our laboratory for a week. During that week, we covered every major requirement of the ISO 17025 standard and were able to demonstrate how our laboratory meets the requirements. This was valuable as many of these objectives could not have been completed over the telephone.
Stiles: One of the biggest benefits I see is having a set of rules to stand up against in the laboratory. For example, the methods available and the matrices (food commodities) for which they can be used are described annually in a manual of test services. This manual is reviewed and signed by state regulatory program officials each year. When confronted with an outbreak or food for testing, the program side knows if it is a developed accredited method or not. Likewise, all of the rules for submission are outlined and explained to the program officials in ongoing, targeted training. They have been trained and understand that quality of results starts at sample collection and have all the tools they need to submit accordingly. In addition, when submitting data to federal agencies, those agencies already know our quality management system and methods have been independently audited and found to be acceptable.
Salfinger: I retired in 2012 from the State of Florida, and since then, I have been working with the CAP and the associations (including APHL, AFDO and AAFCO) and specifically with several laboratories that were not funded for achieving accreditation. Some are moving very swiftly, with a few achieving accreditation within a couple of years of starting. Having their food testing under a quality management system with external auditing makes sense in this day and time. Benefits of ISO include a more structured environment for root-cause analysis, ensuring internal and external audits are performed on a scheduled cycle, ensuring proficiency testing is performed on a scheduled cycle and basically ensuring the laboratory has good documentation for sharing data with other regulators and the industry that they regulate. As a manager, having all the paperwork available, legible and clear was one of the biggest values of the accreditation. Having a systematic approach to issues that might arise in the laboratory, from purchasing to working with the inspection program to sample intake to testing to reporting to quality assurance measures, is the benefit of accreditation.
FSM: What improvements to the program would you like to see in the future?
McCallum: I would like to see funding increased to allow more state agriculture laboratories into the FDA AFRPS CAP. Because of the cost involved in [attaining] and maintaining ISO 17025 accreditation, there are laboratories that may desire accreditation but cannot achieve it due to lack of funding. I would hate to see these great laboratories get shut out of future federal grant programs only because they could not afford the accreditation process.
Stiles: Necessary improvements include future funding for maintenance of accreditation. Accreditation is expensive. Many states, Massachusetts included, hired staff into the quality assurance departments in order to develop the quality system outlined in the 17025 standard. We hired testing staff to process the required surveillance samples that FDA mandated in the ISO CAP. The costs of accreditation alone are high and may be prohibitive to laboratories who don’t have federal funding available. In addition, ongoing routine surveillance activities could be impacted. FDA is continuing to fund the Manufactured Food Regulatory Program, which requires funded programs have a lab available for testing, but there is no requirement to submit routine samples or to fund that laboratory through this cooperative program. It is a risk in many states that regulatory program officials will opt out of routine surveillance once the ISO CAP ends.
Improvements to the CAP would be some assurance of some level of funding for the future, especially in terms of personnel. Having an uncertain budget increases the uncertainty in the hiring, which in itself can be long and arduous. Hiring might actually take place 6 months into the calendar year, with only 6 months left until the next budget cycle, which could be decreased in funding amount. The CAP has presented a wonderful opportunity for 30+ laboratories to have funding toward accreditation. Now it is up to the laboratories to maintain and enhance their accreditation!
FSM: Do you still have food safety challenges that are not being met? Does FSMA complicate the picture?
McCallum: In the regulatory laboratory environment, data acceptance between our laboratory and federal agencies is critical and will be an important part of the national integrated food and feed testing system. The push for state laboratories to become ISO 17025 accredited will allow for more data sharing between state laboratories and federal agencies for regulatory, surveillance and risk assessment purposes. Laboratories must maintain ISO 17025 accreditation, meaning the cost for a laboratory to become ISO 17025 accredited does not end once the laboratory becomes accredited. It is our agency goal to add all testing methods for our CDA programs to our scope of accreditation. As I mentioned earlier, the more methods a laboratory adds to their scope of accreditation, the higher the annual cost is for maintaining accreditation. The challenges we face in the future are securing funding for maintaining our accreditation status for the current scope and future addition of methods to our scope.
Stiles: As mentioned above, the biggest challenge we face in Massachusetts is getting samples to test. The manufacturing firms are not obligated to submit samples for testing, and the state program officials are not bound by their FDA CAP to submit either. The federal program officials would like routine surveillance of food to continue, but without a federal mandate, it may be difficult to attain. In addition, state officials in Massachusetts rely on the local boards of health for collection and submission of food samples. Oftentimes, the submission guidelines are not adhered to because [the boards] are too far removed from the state laboratory and haven’t been adequately trained. With 351 cities and towns in Massachusetts, having all local boards of health fully trained and competency assessed regularly is a huge task. Accreditation costs will continue to be a challenge also, but Massachusetts recognizes the importance of maintaining accreditation and is committed to doing just that.
Food Safety Magazine thanks these APHL members for sharing their expertise. A special thank-you goes to Michelle M. Forman, senior specialist, media, at the APHL for helping coordinate the participants and providing background material for this article.