After a number of false alarms and delays, FDA released on January 4, 2013, the most significant proposed regulations implementing the Food Safety Modernization Act (FSMA) to date. The release comes on the two-year anniversary of President Obama's signing of FSMA.
Specifically, FDA released two separate sets of proposed regulations:
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
- Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption
CGMPs and Preventive Controls for Human Food
The preventive controls regulations form much of the backbone of FSMA. These rules implement the requirement under FSMA that food facilities (a) analyze potential hazards associated with their facilities; (b) develop and implement controls to significantly minimize or prevent those hazards; (c) verify the controls are working (and take corrective action if they are not); and (d) periodically reassess those hazards and controls. Regulated facilities will need to create written plans — similar to but broader than HACCP plans — that show their analysis and implementation of controls, and document verification and monitoring of the controls.
Along with preventive controls, FDA has released overhauled Current Good Manufacturing Practices (CGMPs, previously 21 CFR Part 110). Preventive controls and revised CGMP will together constitute a new 21 CFR Part 117, and the previous CGMPs will be revoked. FDA indicates it will work with industry and academia to develop a training curriculum with respect to the requirements once the final rule has been released. In addition, FDA will be releasing a guidance document to help businesses comply with these new requirements.
A few controversial requirements were at least tentatively rejected by FDA in this proposed rule, including a requirement that companies submit their food safety plans to FDA, and a requirement that companies engage in either environmental monitoring or finished product testing as part of their risk-based preventive controls. FDA is taking comments on these provisions.
Produce Safety Standards
The second set of proposed regulations released implement the requirement that FDA publish minimum standards for the safe production and harvesting of fruits and vegetables. They apply only to farms that grow, harvest, pack or hold produce in a raw or unprocessed state. Some farms would not be covered by the rule, or would be eligible for a partial exemption based on the amount of food sales and to whom they sell.
The proposed standards are not "one-size-fits all." They are designed to provide flexibility so that food safety practices can be appropriate for the scale of production and type of agricultural practices being used. In so doing, the rules take into account the risks associated with the commodity, including past illness outbreaks and recalls; the practices associated with growing, harvesting, packing and holding the produce; and how the produce will be used and consumed after it leaves the farm. As a result, the rules do not apply to raw agricultural commodities that are rarely consumed raw (such as artichokes, asparagus, beets, cranberries, potatoes and sweet corn), those produced for personal or on-farm consumption, and (with certain documentation) those destined for commercial processing (such as canning, commercial processing or refining) that will adequately reduce microorganisms of concern.
FDA's proposed rules focus on identified routes of microbial contamination of produce, including: (1) agricultural water; (2) biological soil amendments of animal origin; (3) health and hygiene; (4) animals in the growing area; and (5) equipment, tools and buildings. These standards build upon FDA's prior commodity-specific guidance, as well as science-based industry practices and standards, such as the Leafy Greens Marketing Agreements in California and Arizona. States or foreign countries may request a variance from some or all of the rules if required by local growing conditions, provided the same level of public health is assured.
Implementation Timeline, Comment Period and Public Hearings
As expected, the regulations include both significant comment and implementation periods. For preventive controls regulations, FDA proposes a 120-day comment period. FDA then anticipates publishing a final rule, effective 60 days after publication, with a compliance date beginning one year after publication for all but small and very small businesses. For the produce safety regulations, FDA proposes a 120-day comment period. The final rule would become effective 60 days after publication, with a compliance date for all but small and very small businesses beginning two years after publication.
FDA will also hold a number of public hearings, including those in different regions of the country, in order to explain these rules and provide another opportunity for input from industry and stakeholders.
There are three additional regulations that FDA has already drafted and are expected to be released in the near future. They include preventive control regulations for feed and pet food facilities; Foreign Supplier Verification Program (FSVP) regulations; and accredited third-party certification regulations for imported foods and ingredients.
Faegre Baker Daniels will continue to monitor FDA's implementation of FSMA, including the further development of these regulations, and provide updates. Questions on FSMA and its implementation can be directed to Sarah Brew
or Steve Toeniskoetter