The U.S. Food Safety Modernization Act
(FSMA) affects the entire produce supply chain around the world and represents a radical change in food safety regulations for our industry. While seven major implementing regulations of FSMA have now been finalized, PMA’s Issues Leadership work continues to assure these new regulations achieve their stated food safety objectives and are practical and workable for our industry members to implement. Here’s an update regarding FSMA implementation important for members to be aware of and understand.
FSMA Guidance to Industry
The U.S. Food and Drug Administration (FDA) has begun to publish “Draft Guidance to Industry.” Such guidance provides clarification and situation-specific compliance information to assist industry in understanding how to comply with lengthy and complex FSMA implementing regulations. In August, FDA published two Draft Guidance for Industry noteworthy for members that the PMA Science & Technology Committee will be reviewing and commenting on to FDA.
This draft guidance clarifies which business activities meet the definition of a “farm,” as defined by FDA. This is important because if a business meets the FDA definition of “farm,” it is exempt from FDA Food Facility Registration requirements and from certain requirements of FDA FSMA Preventive Controls for Human Foods Rule.
FDA’s current thinking on the classification of activities as “harvesting,” “packing,” “holding,” or “manufacturing/processing” is provided in this draft. FDA also offers situation-specific examples of these classification activities as well as activities classified in more than one way.
This draft guidance does not, however, solve the problem of on-farm and off-farm packinghouses engaged in similar activities being subject to two different FSMA implementing regulations (on-farm subject to the Produce Safety Rule and off-farm the Preventive Controls Rule).
FDA guidance is currently pending regarding how §117.8 of the Preventive Control Rule for Human Foods can be met. This provision applies to off-farm packing and holding of raw agricultural commodities and allows companies to be deemed compliant with the current Good Manufacturing Practices provisions of the Preventive Controls for Human Food Rule if a firm is following applicable requirements for packing and holding of fresh produce as set forth in the FSMA Produce Safety Rule (21CFR 112).
Additionally, the recently issued draft guidance does not offer any insights regarding other aspects of the “farm” definition such as an interpretation of “under one management” or “in one general but not necessarily contiguous physical location.”
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
This draft guidance pertains to produce businesses subject to the Preventive Controls for Human Foods Rule such as fresh-cut produce processors, off-farm packinghouses, off-farm re-packing operations and others. It is intended to assist industry in complying with the Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls provisions of the Preventive Controls for Human Food Rule.
FDA has issued the first five draft chapters of what will be multi-chapter guidance for review and comments by stakeholders. The current draft guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about establishing a food safety plan. The FDA will release additional chapters of the draft guidance for public comment as they are completed. It is anticipated that FDA will have released all chapters of this draft guidance by early 2018.
Compliance Date Extensions and Clarifications
In late August, FDA announced compliance date extensions and clarifications for FSMA final rules
. FSMA compliance dates vary based on enterprise size.
FDA has extended the FSMA Preventive Controls for Human Foods Rule compliance dates
for FDA registered facilities that are solely engaged in packing and/or holding activities on produce raw agricultural commodities (RACs). The new compliance
date is extended by 16 months and is now synchronized with the compliance dates for businesses in the same size categories in the Produce Safety Rule.
Additionally, the FDA has clarified its interpretation of compliance dates for water testing in the Produce Safety Rule
. The agency has explained various ways by which a farm should begin testing untreated surface water so they can develop microbiological profiles of their water sources before the compliance deadlines. These changes are being made by FDA "to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules."
Funding for FSMA Implementation
On Sept. 9, the FDA awarded $21.8 million
in cooperative agreement funds to 42 states to help implement the FDA FSMA Produce Safety Rule. These funds will be used by states to develop and provide education, outreach and technical assistance. The funds will also be used in development of programs to address the specific and unique needs of the growers in their farming communities.
PMA has strongly advocated on behalf of state agencies to assume this FSMA education, compliance and enforcement role. State agencies have a better understanding and knowledge of the specific growing and harvesting practices in their areas and many have long standing relationships with produce growers and state/local produce associations.
PMA has worked closely with the National Association for State Departments of Agriculture (NASDA) and the Association for Food and Drug Officials (AFDO) towards this goal. I recently had the opportunity to participate in NASDA’s annual meeting in Lincoln, Neb. There, I was able to meet with both FDA senior officials and state regulators to discuss FSMA implementation challenges and hurdles that many in the produce business community are facing and looking for practical solutions to.
PMA staff also participated in and helped plan with state departments of agriculture farm tours with FDA senior leadership in the Delaware
and California. These tours and stakeholder meetings allowed FDA and state officials to understand and hear directly from produce business owner and operators about FSMA implementation challenges and current produce safety programs.