FDA platform to respond to FSMA produce rule questions reviewed

A report found the FDA has responded to almost three quarters of the questions received so far with an average time of 22 days.

However, one industry association told GAO it took four months to get an answer.

Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, referred to as the produce safety rule, is one of seven Food Safety Modernization Act (FSMA) rules.

The rule established the first enforceable national standards for on-farm growing, harvesting, packing and holding of domestic and imported produce.

It established standards related to agricultural water quality; the use of soil amendments, such as raw manure; the presence of domesticated and wild animals; worker training, health, and hygiene; and sanitation of equipment, tools, and buildings.

TAN question response rate and time​

FDA has developed an information clearinghouse called the Technical Assistance Network (TAN) to support understanding and implementation of the FSMA rules.

Phase 1 evaluates and responds to questions related to publication of FSMA rules. Phase 2 which FDA expects to begin in 2017 will evaluate and respond to questions from FDA and state inspectors who ensure industry compliance with FSMA rules.

FDA received 2,626 TAN questions from September 2015, when the TAN became operational, to September 2016. As of early October, the agency had responded to about 72% of all questions received.

About 14% of questions (363) were about the produce rule and of these 60% (218) came from “industry/business.”

According to FDA, median response time for questions forwarded to subject matter experts is 22 business days.

FDA said if a question is unaddressed after 30 days it will send an automated message saying the agency is working on a response and a second after 60 days if the question is still unresolved.

FDA officials told GAO that response times may be longer because agency guidance on the produce rule and other FSMA rules is under development and the agency does not want to provide information that might conflict with the subsequent guidance.

They added that while simpler questions can be addressed immediately by FDA staff about 95% are more complex.

Representatives from industry associations and other organizations said wait times for answers can be long and some had not yet received answers to questions.

Produce rule concerns​

Some in industry expressed concerns about the produce rule standards, including the scientific basis for standards in such areas as water quality.

Others warned about the costs associated with meeting the new standards, particularly for smaller businesses.

FDA officials said the agency tracks TAN questions to help inform FSMA policy, guidance, and training and the agency intends to maintain the TAN to respond to stakeholder questions and concerns after the produce rule and other rules are fully implemented.

The Agricultural Act of 2014, also referred to as the 2014 Farm Bill, included a provision for GAO to report on the ongoing evaluation and response process of the rule.

GAO interviewed FDA officials and two organizations assisting with implementation of the rule and representatives from six produce industry associations and one large retailer.

The rule includes staggered compliance dates depending on average annual produce sales of a business and other factors from 2017 and 2018 to 2020 for smaller businesses.