WASHINGTON — The Food and Drug Administration detailed potential conflicts of interest and appearance issues on Nov. 15 when releasing its draft guidance on convening a GRAS panel. The guidance also gives recommendations on identifying panel members who have “appropriate and balanced expertise,” and it recommends limiting the data and information provided to a GRAS panel to publicly available information.
GRAS stands for generally recognized as safe. Companies in the food and beverage industry may convene a panel to determine whether a substance is GRAS under the conditions of its intended use. If the panel determines the substance is GRAS, companies then voluntarily may submit a notice to the F.D.A., hoping the agency will send out a letter saying it has “no questions” about the substance’s GRAS status.
Information on the GRAS panel draft guidance was published in the Nov. 16 issue of the Federal Register. More information may be found here.
The draft guidance recommends the GRAS panel should not include employees of the GRAS proponent (the entity seeking the GRAS status), the proponent’s attorney or agent, or employees of the proponent’s attorney or agent. Such individuals generally would have a conflict of interest due to a financial interest in the outcome of the panel’s deliberation. However, if such a person had specialized experience that could be helpful to a GRAS panel, the person possibly could provide information to the panel without participating in the panel’s deliberations. Such participation would be analogous to “non-voting members” who are granted a waiver when necessary to provide expertise to an F.D.A. advisory committee.
“Conflicts of interest include financial interests that can be directly and predictably affected by the work of the GRAS panel, whereas appearance issues include a broader and more complex set of interests and relationships that could cause a reasonable person to question impartiality,” the draft guidance said.
Appearance issues could include affecting the financial interest of a household member, having or seeking a financial relationship with an affected entity, or advocating specific views or positions on a scientific issue relevant to safety assessment.
The F.D.A. in the guidance said a GRAS panel at a minimum should include people with expertise in chemistry or biochemistry, toxicology, and exposure assessment. A company may try to have several experts for each scientific discipline. Having only one expert of a scientific discipline might leave the GRAS panel with no means to resolve questions raised by one panel member.
A substance must meet two conditions to be GRAS under its intended use, according to the F.D.A. First, there must be a reasonable certainty of no harm under the conditions of its intended use. Second, qualified experts, based on publicly available scientific information, must recognize the intended use of the substance in food as safe.
“Although general recognition of safety does not require unanimous agreement, general recognition of safety does not exist if there is a genuine dispute among qualified experts that the use of a substance is safe (81 FR 54960 at 54977), or a severe conflict among experts regarding the safety of the use of a substance (62 FR 18938 at 18939),” the draft guidance said. “Thus, when generally available data and information document a genuine dispute, or severe conflict, in the larger scientific community, a GRAS panel report could not provide evidence that the available data and information are ‘generally accepted’ even if multiple members of a GRAS panel have expertise in a particular scientific discipline. Instead, the GRAS panel report would more appropriately be a resource for the proponent to use in identifying data gaps and information about ongoing scientific debate and dispute.”
The draft guidance said companies should document the selection and vetting of each GRAS panel member as well as the deliberations and output of the panel. Companies should establish clear roles and responsibilities for each member of the panel and also establish clear decision-making procedures.
The F.D.A. will accept comments on the draft guidance until May 15, 2018. Electronic comments may be sent to www.regulations.gov. Written comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docker number FDA-2017-D-0085.