FSMA Update: Final Rule for Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules

Written by Errin McCaulley – Research Assistant

On August 24, 2016 the Food and Drug Administration (FDA) announced a final rule in the Federal Register titled The Food and Drug Administration Food Safety Modernization Act: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules (81 Fed. Reg. 57,784). Generally, this final rule first extends compliance dates for certain provisions throughout four preceding final rules while, second, providing clarification for stakeholders with regard to specific provisions that FDA has received extensive correspondence on from stakeholders through FDA’s Technical Assistance Network (TAN).

Written Assurances Compliance Date Extensions

FDA has extended compliance dates for the written assurances provisions of the following rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls For Human Food (PCHF), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food For Animals (PCAF), Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule). Written assurances, for example, are required under PCHF when a producing facility identifies a hazard yet relies on a PCHF-covered customer receiving the food product with the identified hazard to take steps to ensure the hazard “will be significantly minimized or prevented.” 21 C.F.R. § 117.136(a)(2). In doing so, the facility must annually obtain assurances from this customer which stipulate “the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the identified hazard.” 21 C.F.R. § 117.136(a)(2)(ii).

PCHF’s original compliance date for “small businesses” (those with fewer than 500 full-time equivalent employees) was September 18, 2017 and is now September 18, 2019. All other businesses subject to PCHF (neither small nor very small as defined in the rule) had an original compliance date of September 19, 2016 and must now comply by September 19, 2018.

PCAF’s original compliance date for small businesses (those with fewer than 500 full-time equivalent employees) was September 17, 2018 and is now September 17, 2020. All other businesses subject to PCAF (neither small nor very small as defined in the rule) had an original compliance date of September 18, 2017 and must now comply by September 18, 2019.

FSVP’s compliance dates have been extended by 30 months. FSVP’s original compliance dates were the later of either May 30, 2017 or 6 months after the importer’s supplier was required to comply with PCHF, the Preventive Controls (PCs) or Current Good Manufacturing Practices (CGMPs) of PCAF, or the Produce Safety rule. With the extension in this final rule, the earliest a business subject to FSVP would have to comply with the written assurances provision of FSVP is May 28, 2019. Note that the extension of compliance dates for written assurances for FSVP are not impacted by the earlier mentioned extensions for written assurances under PCHF, PCAF, or the Produce Safety rule extension described below. This means an importer subject to FSVP must comply with the written assurances provisions of FSVP 30 months after the original compliance dates for the rules the supplier must comply with (e.g., PCHF).

The written assurances for the Produce Safety rule are being extended with regard to the exemption available in 21 C.F.R. § 112.2(b). This exemption allows operations to be exempted from compliance when “produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance.” 21 C.F.R. § 112.2(b)(1). In order to qualify, operations must make disclosures and obtain written assurances from customers. The extension is split into two categories: sprout operations and all other operations covered by the Produce Safety rule. First, for sprout operations the compliance dates for written assurances are as follows: sprout operations that are “very small business” (average sales of over $25,000 but no more than $250,000 during previous three years adjusted for inflation using 2011 as the base year) were originally required to comply by January 28, 2019 and now must comply by January 26, 2021; sprout operations that are “small business” (average sales between $250,000 and $500,000 during previous three years adjusted for inflation using 2011 as the base year) were originally required to comply by January 26, 2018 and now must comply by January 27, 2020; all other sprout operations (those exceeding $500,000 in average annual sales during previous three years adjusted for inflation using 2011 as the base year) were required to comply by January 26, 2017 and now must comply by January 28, 2019. Second, for all other covered produce operations excluding sprouts, the compliance dates are as follows: very small businesses (as defined in this paragraph) originally were required to comply by January 27, 2020 and now must comply by January 26, 2022; small businesses (as defined in this paragraph) originally were required to comply by January 28, 2019 and now must comply by January 26, 2021; all other businesses (as defined in this paragraph) were originally required to comply by January 26, 2018 and now must comply by January 27, 2020.

Extension of Compliance Dates for PCHF and PCAF

FDA has extended the compliance dates for facilities that are solely engaged in packing and/or holding activities on produce raw agricultural commodities (RACs) to the extent that these facilities are subject to PCHF. Under the Produce Safety rule, activities such as these occurring on a farm (as defined in 21 C.F.R. § 1.227) were covered by the Produce Safety rule. After receiving extensive stakeholder input, FDA has announced that these off-farm facilities, such as packinghouses, although subject to PCHF, may “still be able” to rely upon the Produce Safety rule when drafting their food safety plans and preventive control management components. These facilities, however, must still comply with PCHF. For eligible very small businesses as defined in PCHF, the original compliance date was September 17, 2017 and is now January 27, 2020. Eligible small businesses (less than 500 full-time equivalent employees) had an original compliance date of September 18, 2017 and must now comply by January 28, 2019. All other eligible businesses (neither small nor very small) had an original compliance date of September 19, 2016 and must now comply by January 26, 2018.

FDA has made a similar extension of compliance dates for facilities that are solely engaged in packing and/or holding activities on produce RACs and are subject to PCAF. Specifically, FDA noted that this extension is directed at facilities covered by PCHF or the Produce Safety rule but also produce human food by-products (such as culls) that are used in animal food. These facilities, under PCAF, must comply with either the CGMPs of PCHF or the applicable packing and holding requirements of the Produce Safety rule. For these types of facilities, FDA has extended the compliance dates for PCAF. PCAF’s original compliance dates were staggered with compliance with PCAF CGMPs occurring first, then compliance with PCAF PCs. Eligible very small businesses as defined in PCAF (note there is a difference in definition of very small business under PCAF as compared to PCHF) had an original compliance date for CGMPs of September 17, 2018 and PCs of September 17, 2019; respectively the new compliance dates are January 27, 2020 and January 26, 2021. Eligible small businesses (fewer than 500 full-time equivalent employees) had an original compliance date for CGMPs of September 18, 2017 and PCs of September 17, 2018; respectively the new compliance dates are January 28, 2019 and January 27, 2020. All other eligible facilities had an original compliance date for CGMPs of September 19, 2016 and PCs of September 18, 2017; respectively the new compliances dates are January 26, 2018 and January 28, 2019. These extensions only apply to facilities described above and do not apply to facilities that manufacture/process produce RACs or nut hulls in addition to their packing and/or holding activities.

Extension of Compliance Dates for Facilities that Would Qualify as Secondary Activities Farms Except for Ownership

FDA has extended compliance dates for both PCHF and PCAF for facilities that, despite their ownership, would qualify as secondary activities farms. These facilities, in order to qualify for the extension, must meet all the qualifications of a secondary activities farm (defined under “farm” in 21 C.F.R. § 1.227) except for the ownerships requirements. Furthermore, FDA is requiring that facilities, to qualify for the extension, must (1) not be located on a primary production farm; (2) be devoted to harvesting, packing, and/or holding of RACs; and (3) be 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.” 81 Fed. Reg. 57,784, 57,791 (Aug. 24, 2016). Under this extension of PCHF and PCAF, the new compliance dates will coincide with the compliance dates established for similarly sized operations under the Produce Safety rule. Under PCHF, the new compliance dates are as follows: eligible very small businesses (as defined in PCHF) had an original compliance date of September 17, 2018 and must now comply by January 27, 2020; eligible small businesses had an original compliance date of September 18, 2017 and must now comply by January 28, 2019; all other eligible operations (neither small nor very small) had an original compliance date of September 19, 2016 and must now comply by January 26, 2018. Under PCAF, the compliance dates are staggered with CGMPs first and PCs after. Eligible very small businesses (as defined in PCAF) had an original compliance date for CGMPs of September 17, 2018 and PCs of September 17, 2019; respectively the new compliance dates are January 27, 2020 and January 26, 2021. Eligible small businesses had an original compliance date for CGMPs of September 18, 2017 and PCs of September 17, 2018; respectively the new compliances dates are January 28, 2019 and January 27, 2020. All other eligible operations (neither small nor very small) had an original compliance date for CGMPs of September 19, 2016 and PCs of September 18, 2016; respectively the new compliance dates are January 26, 2018 and January 28, 2019.

Extension of Compliance Dates for Coloring of RACs

FDA has extended compliance dates for PCHF for facilities that color RACs. Coloring of RACs falls outside the “farm” definition of 21 C.F.R. § 1.227, therefore coloring triggers the applicability of PCHF as FDA considers coloring to be manufacturing or processing. The compliance date extension is only applicable to operations that, despite coloring RACs, would fall within the “farm” definition of 21 C.F.R. § 1.227. Eligible very small businesses (as defined in PCHF) had an original compliance date of September 17, 2018 and now must comply by January 27, 2020. Eligible small businesses had an original compliance date of September 18, 2017 and must now comply by January 28, 2019. All other eligible operations (neither small nor very small) had an original compliance date of September 19, 2016 and must now comply by January 26, 2018.

Extension of Compliance Dates for Facilities Solely Engaged in Ginning Cotton

FDA has extended compliance dates for PCAF for facilities that solely engage in ginning cotton in the production of animal food. Ginning cotton falls under the “farm” definition when conducted on a farm, but when conducted off of a farm it is either a packing activity or a manufacturing or processing activity. These facilities, under PCAF, are exempt from CGMP requirements of PCAF, yet must still comply with the preventive controls provisions of PCAF. Under the extension, eligible very small businesses (as defined in PCAF) had an original compliance date of September 17, 2019 and must now comply by January 26, 2021. Eligible small businesses had an original compliance date of September 17, 2018 and must now comply by January 27, 2020. All other eligible operations (neither small nor very small) had an original compliance date of September 18, 2017 and must now comply by January 28, 2019.

Extension of Compliance Dates for FSVP When Importing Food Contact Substances

FDA has extended the compliance date for FSVP for operations that import “food contact substances” which fall within the definition of “food” under § 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) codified at 21 U.S.C. § 321(f). A food contact substance is “any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.” 81 Fed. Reg. 57,784, 57,793 (Aug. 24, 2016). Importers had an original compliance date of May 30, 2017 and must now comply by May 28, 2019.

Extension of Compliance Dates for PCHF CGMPs for Facilities that Produce Grade “A” Milk

FDA has extended compliance dates for the CGMPs provisions of PCHF for facilities which produce grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO). In the PCHF final rule, PMO-regulated facilities were given an extended compliance date of September 17, 2018 for the preventive control provisions of PCHF. In this most recent final rule, FDA has extended the compliance date for CGMPs to September 17, 2018 as well.

Clarification of Compliance Dates for Water Testing under Produce Safety Rule

FDA has provided several clarifications regarding the water testing requirements of the Produce Safety rule. Specifically, untreated surface water under the Produce Safety rule was not granted a 2-year extended compliance period at the time of the rule’s issuance on November 27, 2015. FDA has clarified that this was necessary to ensure that farms were able to develop their “microbial water quality profile” (MWQP) within the allotted timeframe of the Produce Safety rule. The water testing requirements of the Produce Safety rule currently require very small farms (as defined in the Produce Safety rule) to begin testing to develop an MWQP no later than 4 years after the issuance of the final rule; small farms (as defined in the Produce Safety rule) must begin no later than 3 years after issuance; and all other farms (neither very small or small) must begin testing no later than 2 years after issuance. These compliance dates are still in effect. FDA has clarified that the timing requirements for beginning testing for each respective class-size of farm does not mean the farms have only that amount of time to complete an MWQP. The farms have discretion over the number of samples included in their initial survey and the time period over which these sample are taken, provided that (1) the time period of collection must be at least 2 years and no more than 4 years and the MWQP must be made up of at least 20 samples.