New FSMA Compliance Dates Provide Extensions for Industry and FDA Efforts
Updated: Nov 22, 2018
Industry now has an additional two years to come in compliance with some provisions of four of FSMA's final rules. FDA announced the extensions last week 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.
The extensions of the "Final Rule; Extension and Clarification Of Compliance Dates For Certain Provisions," published on August 24, are related to provisions regarding written customer assurances, facilities that only pack and/or hold raw agricultural commodities that are produce and/or nut hulls and shells, certain facilities that would qualify as secondary activities farms except for the ownership of the facility, facilities coloring raw agricultural commodities, cotton ginning facilities under the animal food rule, food contact substances under FSVP rule, and Grade “A” milk products. In the announcement, FDA also clarified the agricultural water testing compliance timeframe of the produce rule. So it is important to say upfront that most of the rules did not change with regard to deadlines.
While the revised compliance dates vary by rule and facility size, the general extension is two years, and impact provisions of the final rules for Preventive Controls for Human Food, Preventive Controls for Food for Animals, Produce Safety, Foreign Supplier Verification Programs (FSVP). Following are summaries of the extensions, with full details available on the final rule page of the Federal Register.
Written customer assurances. Customer provisions of each of the rules provide for modified requirements or exemptions if a hazard is validated as being controlled downstream. In such cases the manufacturer/processor must include disclosure documents with the food that it is not processed to control the hazard and obtain a written assurance from the customer of their (or their customer's) further controls. Along with providing industry with additional compliance time, the extension enables FDA to consider the best approach to address feasibility concerns. The earliest date of compliance for this extension is September 19, 2018, for large human food facilities.
An extension has been made for facilities that only pack and/or hold raw agricultural commodities that are produce and/or nut hulls and shells that are covered by the two Preventive Controls rules for human and animal food, including CGMPs, in order to align the dates with the compliance dates for farms conducting similar activities under the Produce Safety rule. The earliest compliance date is January 26, 2018.
Compliance dates are extended for operations that would be secondary activities farms except that they do not meet the ownership criterion if the operation: is not located on a primary production farm; is devoted to harvesting, packing, and/or holding of raw agricultural commodities; and is under common ownership with the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested packed, and/or held by the operation. Additionally, FDA is considering modifying the definition of a farm to address ownership issues. The earliest compliance date is January 26, 2018.
Compliance is extended for
Noting that significant safety concerns in food contact substances are relatively rare and there exists an extensive premarket approval and review processes to help assure safety, FDA will use the extended time to consider how to best address feasibility concerns for the application of FSVP to these substances. The earliest compliance date is May 28, 2019.
Compliance dates for facilities that color raw agricultural commodities are extended to align with the Produce Safety rule. Currently coloring is considered a manufacturing/processing activity that requires food facility registration and is subject to the Preventive Controls rule, however FDA is considering modifying the definition of a farm to address “coloring” activities. The earliest compliance date is January 26, 2018.
Off-farm facilities solely engaged in cotton ginning that provide products without further processing for use as animal food now have an additional 16 months to comply with applicable requirements in the CGMP and Preventive Controls for Animal Food rule. The earliest compliance date is January 28, 2019.
Unified Under a Single Date:
This final rule extends the compliance date for National Conference on Interstate Milk Shipments (NCIMS) facilities producing Grade “A” milk and milk products to comply with CGMPs under the CGMP and Preventive Controls for Human Food rule. Originally, these facilities had different compliance dates for the CGMPs and the preventive control requirements. This change will create a single compliance date, September 17, 2018, for facilities producing Grade “A” milk products to comply with all requirements.
In determining how they sample agricultural water to develop a microbial quality profile farms subject to the Produce Safety rule have discretion in the number of samples they take in their initial survey, provided that the total is 20 or more samples, and in the time period over which such samples are taken, provided that it is at least two years and no more than four years. For example, FDA clarifies that this does not mean that covered farms have only two years in which to conduct their initial surveys for untreated surface water under if they begin testing on the compliance date for that provision, rather they have 2 to 4 years to fulfill the requirement. For example, a farm that is not small or very small must begin sampling and testing untreated surface water no later than January 26, 2018. The rule provides additional examples of approaches that farms may consider when collecting water samples and how they relate to compliance dates for the water-related requirements of the Produce Safety rule.
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