FDA Has Continued to Take Steps to Evaluate and Respond to Business Concerns and Is Reviewing the Produce Rule Water Standards

Since we last reported on the produce rule, FDA has continued to use its  information clearinghouse, the TAN, to take steps to evaluate and  respond to questions and concerns from businesses and other  stakeholders regarding the produce rule. Of those 2,665 additional  questions, 230 questions (about 9 percent) pertained to the produce  rule. Questions spanned a  variety of topics related to the rule, with the most commonly asked  questions pertaining to the rule’s agricultural water standards. Examples of questions  about the produce rule that were submitted by businesses are shown in  figure 3. FDA Has Taken Other Steps to Evaluate and Respond to Business Concerns, Including Funding Training for Industry and Conducting Visits to Farms

Since we last reported on the produce rule, FDA has taken steps in  addition to the TAN to evaluate and respond to business concerns  regarding the produce rule. FDA Is Reviewing the Produce Rule Water Standards in Response to Business Concerns and Is Proposing to Extend Compliance Dates

FDA announced in March 2017 that it would conduct a review of the  agricultural water standards under the produce rule and, in September  2017, the agency published a proposed rule in the Federal Register that  would extend the compliance dates for the water standards by an  additional 2 years from the original compliance dates, depending on  business size, for produce other than sprouts (see fig. FDA Has Collected Some Survey Results to Assess the Effectiveness of the TAN and Has Continued to Develop Metrics to Assess Outcomes of Its Other Mechanisms

FDA has begun collecting survey results to assess the effectiveness of its  information clearinghouse, the TAN, and has continued to develop  metrics that will assess outcomes related to the agency’s overall efforts to  evaluate and respond to business concerns. FDA is also developing the second part of its TAN survey, which  will solicit feedback from stakeholders on the timeliness and quality of  answers provided by FDA through the TAN. In addition to its assessment of the effectiveness of the TAN, FDA  officials told us that the agency is continuing to develop metrics intended  to assess a number of desired outcomes resulting from implementation of  the rule, including outcomes related to FDA’s efforts to evaluate and  respond to business concerns. Because FDA officials we interviewed said they are in the early stages of  assessing the TAN and the agency’s other efforts to evaluate and  respond to business concerns, we asked produce industry  representatives for their perspectives on FDA’s efforts, including  representatives from two produce industry associations, a farming  organization, and four organizations working with FDA to implement the  produce rule. Nevertheless, representatives from four groups told us  that businesses need more information from FDA to comply with the  produce rule and are awaiting FDA’s forthcoming guidance pertaining to  the rule. FDA Officials Reported Facing Challenges Identifying Businesses Subject to the Produce Rule and Providing Consistent and Region-Specific Information in Their Responses

Through interviews with FDA officials, we identified two key challenges  that the agency faces in evaluating and responding to business concerns  about the produce rule: (1) identifying businesses subject to the produce  rule; and (2) providing consistent, region-specific information to  businesses in response to their questions and concerns. FDA officials told  us the agency’s State Produce Implementation Cooperative Agreement  Program plays a key role in addressing these challenges, as does the  Produce Safety Network. Department of Health and Human Services, Food and Drug  Administration: Standards for the Growing, Harvesting, Packing, and  Holding of Produce for Human Consumption.
Why GAO Did This Study

Although the United States has one of the safest food supplies in the world, foodborne illness is a common public health problem; some of this illness can be linked to produce. For example, in 2017, a Salmonella outbreak linked to imported papayas sickened more than 200 people in 23 states and killed 1. FDA's produce rule, one of a number of rules required by the FDA Food Safety Modernization Act, established the first enforceable national food safety standards for produce. The Agricultural Act of 2014 required that the produce rule include “a plan to systematically…develop an ongoing process to evaluate and respond to business concerns” about the rule and a provision for GAO to report on FDA's efforts 1 year after the promulgation of the final rule and again the following year. In November 2016, GAO issued the first report.
In this follow-up report, GAO examined (1) steps FDA has taken since GAO's 2016 review to evaluate and respond to business concerns regarding the produce rule, (2) steps FDA has taken to assess the effectiveness of its efforts to evaluate and respond to business concerns regarding the rule, and (3) challenges FDA officials reported facing in evaluating and responding to business concerns regarding the rule. GAO examined TAN questions submitted by businesses; interviewed FDA officials and representatives from groups, such as the Produce Safety Alliance, working with FDA to implement the rule; and interviewed representatives from produce industry associations and a farming organization.
GAO is not making any recommendations.

What GAO Found

Since GAO's November 2016 report on the Food and Drug Administration's (FDA) 2015 produce rule, the agency has continued to use its Technical Assistance Network (TAN) to evaluate and respond to questions and concerns about the rule. GAO found that since the issuance of its 2016 report, which contained data as of September 3, 2016, 2,665 more questions were submitted to the TAN, 230 of which pertained to the produce rule, and of those 230 questions, 154 were submitted by businesses (see fig.).
a The TAN also receives questions about other rules pertaining to the FDA Food Safety Modernization Act, such as rules on imported food and the sanitary transportation of food.
b Others include members of academia, consumers, and federal or state regulators.
Most produce rule-related TAN questions concerned agricultural water standards, such as methods for testing water. In addition to the TAN, FDA has taken other steps to evaluate and respond to business concerns, including funding training for industry and visiting farms. FDA is also reviewing the rule's water standards and published a proposed rule in September 2017 to extend the compliance dates associated with those standards in response to concerns.
FDA has begun collecting survey results on the web page used for submitting TAN questions and continues to develop a survey to assess the timeliness and quality of TAN responses. FDA also continued to develop metrics intended to assess its overall efforts to evaluate and respond to business concerns, officials reported. 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 forthcoming guidance on parts of the rule.
FDA officials reported facing two challenges in evaluating and responding to business concerns: identifying businesses subject to the rule and providing consistent, region-specific information in response to concerns. Officials said that the agency's cooperative agreement with 43 states plays a key role in addressing these challenges, as does the Produce Safety Network, a network of region-based FDA food safety experts.