Ag water standards dominate Produce Rule queries on FDA network

By Joseph James Whitworth contact

- Last updated on GMT

GAO evaluates FDA response to Produce Rule questions
A GAO report on a FDA system has found most FSMA produce-rule related questions concerned agricultural water standards.

The Government Accountability Office (GAO​) report covers the Technical Assistance Network (TAN) used to evaluate and respond to questions and concerns about the rule.

Since a GAO report last year​ 2,665 more questions were submitted to the TAN, 230 of which were related to the produce rule and of those, 154 were by businesses.

Testing for agricultural water standards

Most produce rule-related TAN questions concerned agricultural water standards, such as methods for testing water.

Some businesses submitted questions to clarify whether a specific water testing method they intended to use was acceptable.

One question was: “Should be take samples only during the time we planted vegetables? Where do we have to sample – from the canal? From the water outlet on the reservoir?”

GAO FDA TAN
Source: GAO

Some businesses expressed concerns about costs associated with new water testing requirements as well as the testing method in the standards had not traditionally been used so finding laboratories that use it would be difficult.

Officials said they plan on hosting a water summit in 2018 with stakeholders and technical experts.

FDA is reviewing agricultural water standards and in September published a proposed rule to extend compliance dates for two years depending on company size. A move condemned​ by two food safety watchdog groups.

The produce rule, one of the regulations required by the Food Safety Modernization Act, establishes the first enforceable national food safety standards for the commodity.

Implementation will occur from 2017 to 2022 based on business size and other factors.

GAO examined TAN questions from businesses; interviewed FDA officials and groups such as the Produce Safety Alliance working with FDA on the rule and produce industry associations and a farming organization.

Time to response

Produce industry representatives told GAO that FDA is open to hearing questions and concerns, but businesses need more information to comply with the rule and are awaiting FDA’s guidance on parts of it.

FDA officials said they faced two challenges in evaluating and responding to business concerns: identifying firms subject to the rule and providing consistent, region-specific information.

The GAO report last year said the network was ‘struggling to cope’ with one industry associating saying it took four months to get an answer.

As of June this year, the agency had responded to about 84% (312) of the 372 questions about the produce rule submitted by businesses to the TAN since it began, according to FDA data. The agency’s median response time was 48 business days.

FDA had responded to 81% (4,307) of all 5,291 questions submitted to the TAN with a median response time of 16 business days.

“Officials we interviewed said that FDA’s longer median response time for produce rule questions submitted by businesses was because the agency needed additional time to address several unique produce rule questions that were not considered during the rulemaking process,”​ said GAO.

Representatives from three groups said responses were often slow to arrive and one of these groups said times remained largely unchanged since the last GAO report.

“Representatives from four groups we interviewed also said that some responses lacked sufficient clarity or specificity to adequately address questions and that industry needed more specific, tailored responses from FDA.

“For example, some FDA responses restated information from the published produce rule without providing additional detail, and other responses contained “canned” language that did not directly address the question.”

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