As the compliance dates for the final rules issued by the Food and Drug Administration (FDA or Agency) implementing the requirements set forth by the Food Safety Modernization Act (FSMA) get closer, FDA is starting to address concerns about the “practicality of compliance” with certain specific regulatory provisions set forth by the final rules implementing the FSMA. On August 24, 2016, the FDA issued a final rule extending and clarifying the compliance dates for specific provisions in four of the final rules implementing FSMA:
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (80 Fed. Reg. 55,908)
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (80 Fed. Reg. 51,670)
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (80 Fed. Reg. 74,226)
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (80 Fed. Reg. 74,354)
Below are some highlights from the final rule.
Customer Provisions in Part 117 and Related Rules
FDA is extending the compliance dates with regard to the “Customer Provisions” that apply when a manufacturer/processor that identifies a hazard requiring a preventive control, does not control the hazard, and relies on an entity in its distribution chain to address the hazard. The current regulations require that the manufacturer/processor provide its direct customer with documentation that the food “is not processed to control [the identified hazard],” 21 CFR 117.135(a)(2)(i), (3)(i), and (4)(i), and in return, the customer must also provide “written assurances” to the manufacturer that the customer is “manufacturing, processing, or preparing the food in accordance with applicable food safety requirements” as set forth in 21 CFR 117.136(a)(2)(ii), (3)(ii), and (4)(ii).
After a meeting with industry, where industry representatives expressed concerns about the written assurances requirements (i.e., that some product distribution chains would require vastly more assurances and therefore more resources to comply with the requirement than was anticipated by FDA), FDA decided that to extend the compliance dates for 2 years for the written assurances provisions “while [the Agency] considers the best approach to address the feasibility concerns” raised by this requirement. The compliance date exemption applies to all the written assurances provisions required by the four rules mentioned above, with the earliest compliance date being September 19, 2018 for business that are “neither small or very small.” A table with all the new compliance dates can be found here.
Food Contact Substances and FSVP
The FDA is providing additional time for importers of food contact substances to comply with the FSVP rule. In the preamble to the final rule establishing the FSVP regulation, FDA noted that the definition of “food” for purposes of the FSVP includes “food contact substances that are considered “food” in section 201(f) of the [Federal Food, Drug, and Cosmetic Act] (FD&C Act).”
Since FDA published the FSVP final rule, industry has expressed concerns regarding the applicability of the FSVP regulation to food contact substances. According to FDA, industry representatives have, among other things, “asserted that the hazards associated with food contact substances are already adequately addressed through the food additive petition and food contact substance notification process . . . .”
After considering all this information, FDA is extending the compliance date for the importation of food contact substances by 2 years “so that [the Agency] can consider how to best address any feasibility concerns.” As a result of this extension, the earliest than an importer would need to comply with FSVP for the importation of food contact substances would be May 28, 2019.
Compliance dates for Certain Agricultural Water Testing Provisions in the Produce Safety Rule
In the final rule, FDA is also clarifying the compliance dates with respect to certain testing requirements related to agricultural water set forth in the Produce Safety Rule. Specifically, FDA focused on the requirements for covered farms to test untreated surface water. The Agency noted, that for each business size category, the compliance date for §112.46(b)(1) with respect to “untreated surface water testing is 2 years before the compliance date for the §112.44(b) microbial quality criteria for such water.” Emphasis added.
The Agency further clarified that
[t]his does not mean that farms have only 2 years in which to conduct their initial surveys for untreated surface water under §112.46(b)(1) if they begin testing on the compliance date for that provisions. Covered farms have 2-4 years in which to fulfil that requirement, per §112.46(b)(1)(i)(A). This means that, 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 relevant compliance date for the related microbial quality testing is 2 years later on January 27, 2020.
In setting a testing program, farms have discretion with regard to the “(1) number of samples they include in their initial survey, provided that the total number must be 20 or more samples; and (2) the time period over which such samples are taken, provided that the period must be at least 2 years and no more than 4 years.”
To that end FDA provided the following examples as approaches that are acceptable for covered farms:
- Beginning in 2018, conducting an initial survey consisting of taking 10 samples per year over 2 years (10 in 2018 and 10 in 2019) for a total of 20 samples; calculating the [Microbial Water Quality Profile] MWQP for the first time upon completing the 20-sample data set (e.g., at the end of 2019, early 2020); and applying any necessary corrective actions under § 112.45(b) as soon as practicable and no later than the following year (e.g., in 2020-2021).
- Beginning in 2018, conducting an initial survey consisting of taking 5 samples per year over 4 years (5 in 2018, 5 in 2019, 5 in 2020, and 5 in 2021) for a total of 20 samples; calculating the MWQP for the first time upon completing the 20-sample data set (e.g., at the end of 2021, early 2022); and applying any necessary corrective actions under § 112.45(b) as soon as practicable and no later than the following year (e.g., in 2022-2023).
- Beginning in 2018, conducting an initial survey consisting of taking 10 samples per year over 4 years (10 in 2018, 10 in 2019, 10 in 2020, and 10 in 2021) for a total of 40 samples; calculating the MWQP for the first time upon completing the 40-sample data set (e.g., at the end of 2021, early 2022); and applying any necessary corrective actions under § 112.45(b) as soon as practicable and no later than the following year (e.g., in 2022-2023).
FDA also published a new draft guidance to help industry comply with certain requirements in the Preventive Controls for Human Food final rule. The draft guidance is available for public comment and it contains five chapters of what is set to be a multi-chapter guidance document. The chapters currently available explain the Agency’s thinking on how to comply with the hazard analysis and risk-based preventive controls requirements, and establishing a food safety plan.
The Agency plans to release additional chapters of the draft guidance for public comments as soon as they are available, and to have released all chapters by early 2018. In order to make sure that any comments are considered by the Agency before a final guidance is published, any comments on the draft guidance should be submitted by February 21, 2017.