Sept. 12, 2017 – – As part of the implementation of President Trump’s Executive Order 13771 entitled, ‘‘Reducing Regulation and Controlling Regulatory Costs,’’ and Executive Order 13777 entitled, ‘‘Enforcing the Regulatory Reform Agenda,’’ the Food and Drug Administration (FDA) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing FDA to achieve their public health mission and fulfill statutory obligations.
Questions that FDA are seeking comment on include:
- Is the regulation still current, or is it outdated or unnecessary in some way?
- Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority?
- Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations?
- Have regulated entities had difficulties complying with the regulation?
- Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations?
- Do the entities covered by these standards or guidance take steps to meet the standards and to document that they meet the standards?
- Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records, e.g., reporting, record-keeping, or labeling requirements?
- Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection?
- What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
This is an opportunity for the almond and food industry to address areas of concern as it relates to implementation of the Food Safety Modernization Act Rules. Areas where there are opportunities to provide input on issues of major concern as it relates to FSMA include:
- The definition of Farm, particularly as it relates to almond huller/shellers.
- A mechanism for getting produce on and off the rarely consumed raw list. Produce on the rarely consumed raw list are exempt from the Produce Safety Rule, however, the list does not allow for items to be added or removed; it is a onetime list. Almonds are currently not on the list based on a limited data set that does not account for treatment under the industry pasteurization program.
- Challenges with written assurances to comply with the commercial processing exemption, in particular as it relates to almonds that are exported.
- Given that the almond industry has a pasteurization program in place that is administered by the Federal Marketing Order under the auspices of USDA, a federal agency, there are some opportunities to address redundancies for entities meeting voluntary standards that provide equivalent public health protection.
The Almond Alliance will be working closely with the Almond Board to develop comments to address areas that FDA should consider for reform. The comments are due December 7, 2017. If you have any suggestions to include in our comments please contact Kelly Covello at email@example.com