Dec. 18, 2017 – -The Almond Alliance of California (Almond Alliance) submitted comments on behalf of the California Almond industry including the Almond Board of California (ABC) to help the Food and Drug Administration (FDA) identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced.
As FDA considers opportunities to streamline and simplify the regulations to reduce burdens on industry, the Alliance has identified two specific areas where regulatory reform could make a significant difference for the California almond industry while still protecting public health. These recommendations are specific to the almond industry and would not currently apply to any other tree nuts as the almond industry is currently the only tree nut industry with a validated pasteurization program:
- Add California almonds to the Produce Safety Rule’s “rarely consumed raw” list, so that they are exempt from the rule.
California almonds should be recognized as “rarely consumed raw.” To achieve this result, FDA should consider petitions from industry seeking amendments to the “rarely consumed raw” list. When the agency considers such petitions, it should consider food safety-related information, like the Federal Marketing Order (FMO) requirement for commercial processing, rather than NHANES data. Additionally, where appropriate and necessary, the “rarely consumed raw” list should identify particular subsets of produce commodities – such as “California almonds” rather than “almonds.” This would address any concerns the agency has that foreign almonds are not subject to the FMO.
Rule-making to add California almonds to the “rarely consumed raw” list would be deregulatory in nature, and therefore consistent with the recent Executive Orders.
Alternatively, should a deregulatory rule-making prove too difficult to execute, FDA could use a Compliance Policy Guide to exercise enforcement discretion with respect to California almonds—functionally treating them as if they are on the list in the regulation.
- Remove the written assurance provisions from the commercial processing exemption under the Produce Safety rule, so that only written disclosures are needed to qualify for the exemption when there is a FMO in place.
FDA should rescind the written assurance provisions in situations where a FMO is in place that requires commercial processing. This is appropriate for public health because the FMO already ensures that the food is subject to adequate treatment. Use of only the written disclosure provision is adequate to ensure that recipients of the food understand that it is for further processing.
Rule-making to remove the written assurance provisions from the regulation in these situations is deregulatory in nature, and therefore consistent with the recent Executive Order. Should rule making not prove feasible, FDA could use another tool like a Compliance Policy Guide to announce that it will exercise enforcement discretion for the written assurance provisions in perpetuity.