CSPI submitted its recent comments during an extended comment period on a proposed rule issued by the US Food and Drug Administration as part of the ongoing process to build out the Food Safety and Modernization Act (FSMA). This has been termed the most comprehensive overhaul of the food regulation system in the United States since the inception of the Food Drug and Cosmetic Act itself in 1938.
The new rule is titled Laboratory Accreditation for Analyses of Foods. The comment period for the rule was extended earlier this year.
CSPI: Do all testing in accredited labs
CSPI said it its comments that while it broadly supports the goals of proposed rule, it was disappointed by the Agency appearing to back down when it comes to lab accreditation. While the new rule would mandate testing of imported food in accredited laboratories, many domestic products seem to have slipped through that net, in CSPI’s view.
“We are concerned that the agency has construed its authority too narrowly, requiring accredited testing only in a few circumstances outside the context of food imports. For foods produced domestically, the Proposed Rule requires accredited testing only in rare formal proceedings or in relation to specific rules for shell eggs, sprouts, or bottled water. By failing to cover other domestic testing, the agency has fallen short of addressing important food safety problems as Congress intended under FSMA,” the group’s comments stated. CSPI was joined in its comments by the groups Consumer Reports, Center for Food Safety, Food & Water Action and Consumer Federation of America.
The comments urge that all food testing be done in labs with accredited to the ISO/IEC 17025:2005 standard.
Pavlick: Testing is not a control step
Larisa Pavlick, vice president of science and regulatory for the United Natural Products Alliance, said CSPI’s position makes a lot of sense on the surface.
“They think that it shouldn’t be just any lab; the testing should be done in an accredited lab. You would think that should be standard business practice,” Pavlick told NutraIngredients-USA.
Pavlick, who is a former FDA facilities inspector, said it’s important to keep in mind the distinctions inherent in FSMA. There are process control steps to mitigate risks that have been identified within the supply chain and verification of those steps. Testing, she emphasized, is a verification step, not a control step. If you have identified a risk in your supply chain, such as the possible introduction of a pathogen because of how a botanical is dried in the field, for example, it doesn’t satisfy the FSMA requirements to test to make sure that that pathogen is not present. The FSMA compliant thing to do is to develop and implement a plan to lessen the risk that the pathogen might get introduced in the first place.
“It’s a common error in our industry. I struggle to explain, or to translate, the verification requirements to most companies. Many will say, ‘I test it before I release it into manufacturing or for sale. This is our control step.’ My former FDA response: Nope! Not OK,” Pavlick said.
What about in house labs?
Pavlick said while CSPI’s call for lab accreditation is a common sense one on the surface, it could have some unintended consequences. Many companies have high quality in house labs that have served their purpose for years without a string of accreditations to their name.
“While I think it’s perfectly logical to call for this, what do you do with people who have in house labs? To get this accreditations is another audit and an additional cost,” she said.