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Important Clarification of FSMA Produce Rule Ag Water Compliance Dates

Opinion

Boy did I get this wrong…but so did many others…most seriously, some domestic and international trainers and Lead Trainers providing the Produce Safety Alliance (PSA) Grower Training programs.

At this time, two diametrically opposed understandings and information transfer communications of the compliance dates for growers to have completed initial water‐testing profiles are still propagated in some PSA Grower Training events.

The purpose of this communication is to assist in correcting this situation and supporting PSA efforts to have one standardized message on agricultural water testing as the specific provisions and requirements evolve and are resolved.

Recognizing that the PSA Director and staff made an effort in December 2017 to clarify the modified dates proposed in Extension of Compliance Dates for Subpart E Agricultural Water ∙ § 112.41 (title abbreviated for simplicity), released in September 2017,  the correct interpretation did not uniformly penetrate the full cadre of trainers and industry food safety professionals.  When first released, many others and I failed to consult our copy of Bureaucracy‐speak for Dummies and thought we understood the intent and implications, especially for those growers not currently conducting routine water testing.

Though some may be shocked to learn the proposed revisions to compliance dates for establishing a Microbial Water Quality Profile were unclear, the nuance of when initiation of baseline testing was required evaded even ardent PSA‐engaged individuals. To many of us, common‐sense views of compliance meant you were ready to go not ready to start.

A few of us, notably including Don Stoeckel of the PSA staff (dstoeckel@cornell.edu), have been working for some time to get definitive and simplified clarification, for trainers and growers, on the proposed compliance dates by which covered farm operations must have a fully developed and on‐going Microbial Water Quality Profile.

I have recently communicated with the Center for Food Safety and Applied Nutrition (CFSAN) staff at the Food and Drug Administration (FDA) as this variable interpretation of compliance dates has come up multiple times and been problematic in grower training conducted in California. The uncertainty led to subsequent vigorous debates between suppliers and buyers as they work to update audit specifications to meet Food Safety Modernization Act (FSMA) requirements.

Once more acutely aware of the on‐going split in interpretation, FDA CFSAN was very helpful and responsive to me in making their intent clear, unofficially, and indicating a timeframe for finalization of the dates.

I was informed that the proposed extension of compliance dates is moving close to review by FDA general counsel and finalization for publication is anticipated in the near future. Though not yet published, I felt this note was important to disseminate now and as broadly as possible to PSA trainers and the industry in the interim.

The clarification and confirmation received (see below for the formal request submitted to the FSMA Technical Assistance Network (TAN)  in November 2017 and the very recent official response*) is immensely crucial to PSA trainers and university extension responding to questions of industry and auditor interpretation.

Equally, as state agency staff have been attending PSA training and preparing for their role in the On‐Farm Readiness Review program and, ultimately, in compliance inspections, it is critical that uniform and clear information sharing regarding the tiered compliance dates are communicated (See this PSA web page).

In closing the circle, through sharing my FDA CFSAN communication discussions with PSA staff, here is our best “unofficial” understanding of when water testing must be initiated.

In accordance with the revised and extended compliance dates for establishing a microbial water quality profile  (MWQP) for covered activities under Subpart E– Agricultural Water (this, of course, assumes that some testing program and an MWQP is retained during the interval between 1/26/2018 and 1/26/22), the following applies:

  • The initiation of microbial indicator testing would not be a compliance requirement for larger businesses (> $500K) until the compliance date of 1/26/22
  •  The initiation of microbial indicator testing would not be a compliance requirement for small businesses (> $250K < $500K) until the compliance date of 1/26/23
  • The initiation of microbial indicator testing would not be a compliance requirement for very small businesses (> $25K < $250K) until the compliance date of 1/26/24
  • The earliest complaint MWQP expectation for surface water, for example, would not occur until 1/26/24‐26 for the larger businesses

Bottom line: Those of us who interpreted the language of the proposed extension and shared our understanding with many others that, if further revisions were not developed, the earliest testing programs would need to be in progress following the 1/26/18 compliance date for the Produce Rule and completed for a compliant MWQP by the 1/26/22 Subpart E compliance date for larger businesses (and so forth for other business tiers) got it wrong, according to FDA.

A copy of this note and a simplified table is being sent to all attendees of our PSA training and the clarification will be shared at the upcoming Water Summit, February 27‐28, 2018.

Question to TAN

This question is about FDA’s Proposed Rule “Standards for the Growing, Harvesting, Packing and Holding Produce for Human Consumption; Extension of Compliance Dates for Subpart E.
The proposed rule states: “As part of this proposed extension, we also propose to simplify the subpart E compliance period structure such that all compliance dates for subpart E provisions as applied to non-sprout produce would occur at the same time.”
This language of the proposed rule is not explicit about whether the proposed compliance dates of 2022, 2023 and 2024 (depending on business class size) apply to the provisions about calculating the microbial water quality profile (MWQP( and using the results to determine the appropriate ways in which water may be used (112.45 (b)).
This question has immediate relevance to farms, because if the intent of the proposed rule is to have an MWQP in place at the proposed compliance dates, then some farms would be required to being sampling as early as 2018.
Thank you for whatever information you can provide about the intent of the proposed rule related to timing of sample collection in support of MWQP calculations and operational decision making.

TAN Response

Response Thank you for writing. First, we note that since finalizing the Produce Safety Rule, FDA has received feedback that some of the standards outlined in Subpart E, “Agricultural water” (21 CFR Part 112, §§ 112.41-112.50), which include numerical criteria for pre-harvest microbial water quality, may be too complex to understand, translate, and implement. These factors can be important to achieving high rates of compliance.

In response to these concerns, the FDA is exploring ways to simplify the microbial quality and testing requirements for agricultural water while still protecting public health. For more information, see “FDA Considering Simplifying Agricultural Water Standards” at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm546089.htm

As discussed in your inquiry, FDA has proposed to extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the Produce Safety Rule (82 FR 42965 (Sept. 13, 2017)). The proposed compliance dates are in the table, below. See 82 FR 42965 (Sept. 13, 2017) for more information on this proposed rule.

Table:

Proposed Compliance Dates for Requirements in Subpart E for Covered Activities Involving Covered Produce
(Except Sprouts Subject to Subpart M)

Proposed time periods starting from the effective date of November 27, 2015,
produce safety final rule (January 26, 2016)

Size of covered farm    Compliance Period  Compliance Date

Very small business           8 years                              January 26, 2024

Small business                    7 years                              January 26, 2023

All other businesses           6 years                             January 26, 2022

If finalized, these compliance dates would mean, for example, that a farm that is not small or very small must begin sampling (emphasis and highlight added by Suslow) and testing untreated surface water in accordance with § 112.46(b)(1)(i)(A), as applicable, no later than January 26, 2022.

Additionally, the farm has discretion under § 112.46(b)(1)(i)(A) as to both (1) the number of samples they include in their initial survey, provided that the total must be 20 or more samples (unless the farm establishes an alternative testing frequency in accordance with § 112.49); 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.

FDA intends to use the extended time period to work with stakeholders as it considers the best approach to address their concerns while still protecting public health. The extended compliance dates will also give farms an opportunity to continue to review their practices, processes, and procedures related to agricultural water and how it is used on their farms.

It is important that as FDA implements FSMA, the agency strikes an appropriate regulatory balance and decreases regulatory burdens whenever appropriate. FDA remains committed to protecting public health while implementing rules that are workable across the diversity of the food industry.

Thank you for contacting FDA’s FCIC/TAN.

View popular Food Safety Modernization Act (FSMA) questions and answers identified by the Technical Assistance Network (TAN), on our website.

This communication is intended for the exclusive use of the inquirer and does not constitute an advisory opinion (21 CFR 10.85(k)). Also, note that this response is not intended to be a comprehensive list of all applicable requirements. Please check FDA’s web page (www.fda.gov) regularly for guidance reflecting our current thinking.

Additional information on FSMA can be found on FDA’s FSMA web page (www.fda.gov/fsma). This communication may contain information that is protected, privileged, or confidential. If you have received it in error, please immediately delete all copies.

 

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