A2LA received recognition by the United States Food and Drug Administration (FDA) as an FDA LAAF Accrediting Body. The Laboratory Accreditation for Analyses of Foods (LAAF) became official on February 1, 2022, and A2LA is very proud to be the first to be approved and ready to offer A2LA accreditation under the FDA LAAF program. Here is what you need to know about the application process and what labs are now required to do:
- New rules mean new requirements; what’s in the FDA’s final rule?
- A new lab seeking accreditation must be ISO/IEC 17025:2017 accredited
- Existing ISO/IEC 17025 labs will need to expand your scope
FDA LAAF Final Rule Requirements
- Demonstrate successful proficiency testing for every test on their LAAF-accredited scope in 12 months;*
- Send all proficiency testing results, regardless of the outcome, to A2LA within 30 days of receipt;
- Have procedures for monitoring the validity of results using reference materials or quality control material to be run with each batch of samples being tested;*
- Follow specific impartiality and conflict-of-interest requirements, such as not accepting any money, gift, gratuity, or item of value from the owner/consignee of the food being tested;
- Submit all LAAF-accredited tests directly to the FDA in English; and,
- Develop/obtain required information related to sampling and test analysis.
*These requirements are also in the 2018 AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals.
Conforming to these new guidelines from the final rule on LAAF will ensure your organization is on the right track to LAAF accreditation. So, what do you need to do to begin the process?
New Labs Seeking LAAF Accreditation Need to have an ISO/IEC 17025 Accreditation on the Books
For a new lab to gain consideration for LAAF accreditation, it must be ISO/IEC 17025:2017 accredited. This does not mean a new lab cannot apply for LAAF. It simply means the A2LA assessment will cover both the LAAF standards and ISO/IEC 17025 standard to achieve accreditation.
If a new lab has accreditation to ISO/IEC 17025, they can expand their scope to include a LAAF assessment, as long as the ISO/IEC 17025 assessment was done on-site in the last two years. The assessment can be virtual in this case, but if the assessment has not been completed on-site in that time frame, the initial LAAF assessment MUST be on-site.
First, apply with A2LA and note that you want to gain LAAF accreditation. Many LAAF guidelines came from the AOAC Food Program, and A2LA can add those to your lab’s assessment, essentially making your lab one of the best around because you are ISO/IEC 17025, LAFF, and AOAC accredited. The AOAC requirements are not necessary to receive the LAAF accreditation, but going the extra mile in the name of quality serves the consumer and you better. It is a bit of a process for new labs to gain accreditation. However, labs that carry ISO/IEC 17025 accreditations have an easier time.
The Process is Simpler for Existing ISO/IEC 17025 Accredited Labs
Laboratories that already have ISO/IEC 17025:2017 accreditation only need to expand their scopes. To do that, contact your Accreditation Officer (AcO) at A2LA to request a scope expansion, or you can log in through the customer portal and submit the information.
Simple enough, but what does your working lab need to do? Well, if already accredited to the additional AOAC Food Program requirements, you’re 90% of the way to becoming LAAF accredited. If not, ask your AcO about how the AOAC requirements can help your LAAF assessment and accreditation.
Finally, your lab will need to provide all necessary information through Touchstone. Remember, the additional AOAC requirements are not needed to be LAAF accredited, but with the same guidelines pretty much in place for both, it makes sense to pursue them to ensure the highest level of food testing.
And that is everything you need to know about the FDA LAAF rule that is now in effect. We’re happy to help you and your lab meet your food testing compliance goals. Contact us today to learn more about this new accreditation offering.