Effective as of May 23, 2022, A2LA is recognized to accredit laboratories under the FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF) program. Under the LAAF program, LAAF-recognized Accrediting Bodies (AB) may accredit testing laboratories to the LAAF program specifications associated with each standard and test method included in the LAAF Program. Please read below for updated frequently asked questions regarding this rule.
When does this rule go into effect?
February 1, 2022
Is A2LA a recognized accrediting body?
Effective May 23, 2022, A2LA has been accepted into FDA’s FSMA LAAF Program and we are now a recognized AB with the FDA.
When can I apply for LAAF accreditation?
While A2LA has been recognized, the rule requires sufficient ABs capacity prior to ABs accrediting laboratories under this program. When the Agency has determined sufficient accreditation capacity, they will publish a Notice in the Federal Register. There is currently no anticipated timeframe for this and we will share the news as soon as we receive it.
Am I required to participate in the LAAF program?
No, this is a voluntary program.
Can I apply for LAAF-accreditation through any accreditation body?
No. Only those accrediting bodies that are recognized by the FDA can accredit to the LAAF guidelines.
Does this rule apply to all food testing?
No. Only certain food and environmental testing is subject to this rule.
When would I be required to use a LAAF-accredited lab?
- To support removal of a food from an import alert through successful consecutive testing.
- To support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act.
- As required by existing FDA food safety regulations, when applied, to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water).
- When required by a directed food laboratory order, a new procedure being implemented in this final rule will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances.
- In certain administrative processes, such as in connection with an appeal of an administrative detention order.
Are there any extra requirements for LAAF-accredited laboratories?
Yes. In addition to being accredited to ISO/IEC 17025:2017, LAAF-accredited laboratories must also:
- demonstrate successful proficiency testing for every test on their LAAF-accredited scope in a 12 month period;*
- send all proficiency testing results, regardless of the outcome, to the accrediting body within 30 days of receipt;
- have procedures for monitoring the validity of results using reference materials or quality control materials, 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; and
- submit all LAAF-accredited test results directly to the FDA, in English.
*These requirements are also in the 2018 AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals
Do I have to have an on-site assessment to add-on the LAAF accreditation requirements?
Not necessarily. If, within the previous 2 years, the accrediting body conducted an on-site assessment to ISO/IEC 17025:2017, then the initial LAAF assessment may be conducted remotely (similar to a scope expansion). Any laboratory seeking LAAF-accreditation that has not undergone an on-site assessment to ISO/IEC 17025:2017 must have the initial assessment on-site. (Certain assessment activities may be conducted remotely, where applicable.)
Please refer to A2LA’s Food and Pharmaceutical Testing Laboratory Accreditation Program for further information.