Food Safety: FDA Continues to Evaluate and Respond to Business Concerns about the Produce Rule

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.

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.

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, beginning in the summer of  2017, a Salmonella outbreak linked to imported papayas sickened more  than 200 people in 23 states and killed 1, according to the Centers for  Disease Control and Prevention; in 2011, 147 people fell ill and 33 died  as a result of eating cantaloupes contaminated with Listeria. Other  produce-related outbreaks in recent years have involved cucumbers, hot  peppers, alfalfa sprouts, bean sprouts, and packaged salads. The Food  and Drug Administration (FDA), an agency within the Department of  Health and Human Services, is responsible for ensuring the safety of  produce, along with many other foods. Overall, FDA is responsible for  ensuring the safety of more than 80 percent of the U.S. food supply.

Because produce is often consumed raw, without processing to reduce or  eliminate contaminants, preventing contamination is key to ensuring safe  consumption. In January 2011, the FDA Food Safety Modernization Act  (FSMA) was signed into law, representing the largest expansion and  overhaul of U.S. food safety law since the 1930s. FSMA, according to  FDA, marked a historic turning point by focusing on preventing rather  than reacting to foodborne illnesses. FSMA does so, in part, by requiring  FDA to promulgate new rules that, combined, provide a framework for  industry to implement preventive measures and for FDA to oversee  implementation. In response to FSMA, FDA developed seven  foundational rules; among them is the rule entitled Standards for the  Growing, Harvesting, Packing, and Holding of Produce for Human  Consumption—also known as the produce rule. This rule, which FDA  promulgated in November 2015, established the first enforceable national  standards for on-farm growing, harvesting, packing, and holding of  domestic and imported produce. Among other things, the rule  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.

Some in the produce industry have raised questions and expressed  concerns about the produce rule standards, including questions about the  types of produce covered by the rule. Others have expressed concerns  about the costs necessary to comply with the rule, particularly for smaller  businesses. The Agricultural Act of 2014, also referred to as the 2014  Farm Bill, required that FDA ensure the final produce rule include “a plan  to systematically … develop an ongoing process to evaluate and respond  to business concerns.”

The act included a provision for GAO to report, 1 year after the  promulgation of the final produce rule and again the following year, on the  ongoing evaluation and response process. In November 2016, we issued  our first report. We found that FDA developed an information  clearinghouse, called the Technical Assistance Network (TAN), to  evaluate and respond to questions and concerns from businesses  regarding implementation of the produce rule and other FSMA rules. In  addition to using the TAN to respond to questions, FDA uses TAN  questions to help inform the development of FSMA policy, guidance, and  training to help businesses understand and comply with the produce rule  and other FSMA rules. FDA officials told us the agency was developing a  survey, along with other metrics, to assess the effectiveness of the TAN.

This follow-up report examines (1) the steps FDA has taken since GAO’s  2016 review to evaluate and respond to business concerns regarding the  produce rule; (2) the steps FDA has taken to assess the effectiveness of  its efforts to evaluate and respond to business concerns regarding the  rule; and (3) the challenges FDA officials reported facing in evaluating  and responding to business concerns regarding the rule.

To examine the steps FDA has taken since GAO’s 2016 review to  evaluate and respond to business concerns regarding the produce rule,  we reviewed information on FSMA and the produce rule on FDA’s  website; attended relevant food safety conferences, including the  Association of Food and Drug Officials conference in Houston, Texas;  interviewed FDA officials involved in implementation of the rule; and  obtained data from FDA on the number of questions submitted to the  TAN. To better understand the types of issues businesses were  communicating to FDA, we also examined the full text of questions and  concerns about the rule that businesses submitted to the TAN. We  classified the questions and concerns into categories based on the type  of question, such as requests for additional information or clarification  regarding the produce rule. We assessed the reliability of the TAN data  by interviewing agency officials knowledgeable about the data and  determined that the data were sufficiently reliable for our report. In  addition, we interviewed representatives from four organizations assisting  FDA with implementation of the rule and an official from one state  department of agriculture. We also interviewed representatives from two  produce industry associations and a farming organization from the  northeastern United States. We selected groups with large  memberships; those representing both large and small business; those  representing specific produce commodities, such as sprouts; those  involved with educating businesses on produce rule implementation; and  those representing different geographic locations across the United  States. The information we obtained from these interviews is not generalizable to all produce industry associations, businesses, or others  affected by the produce rule, but it provides illustrative examples. To  examine the steps FDA has taken to assess the effectiveness of its  efforts to evaluate and respond to business concerns, we interviewed  FDA officials to learn about any ongoing or planned efforts. To examine  the challenges FDA faces in evaluating and responding to business  concerns, we interviewed FDA officials.

We conducted this performance audit from December 2016 to November  2017 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.

This section provides an overview of the produce rule and describes how  FDA is partnering with states to implement the rule.

Overview of the Produce Rule and Compliance Dates

Produce is an important part of a healthy diet but is susceptible to  contamination from numerous sources, including agricultural water,  animal manure, equipment, and farm workers. The produce rule  established standards to help ensure the safe growing and handling of  produce. For example, the rule requires that businesses take steps to  ensure that agricultural water that comes into contact with produce is safe  and of adequate sanitary quality for its intended use. As part of this, the  rule established microbial water criteria to determine the presence of  generic E. coli, which is the most commonly used indicator of fecal  contamination, and referenced a testing method published by the  Environmental Protection Agency to test for the presence of generic E.  coli. The rule also established standards specific to sprouts, which are  especially vulnerable to contamination because of the warm, moist, and  nutrient-rich conditions needed to grow them. In addition to the general  requirements of the produce rule, the rule also includes requirements for  businesses specifically related to preventing contamination of sprouts,  which have been associated with foodborne illness outbreaks.

The rule applies to businesses that grow, harvest, pack, or hold produce,  including produce that will be imported or offered for import, with some  exemptions based on the produce commodity and the size of a business.  For example, the rule does not apply to produce that is rarely consumed  raw, such as asparagus or black beans, and produce that is to be  consumed on the farm. In addition, the rule does not apply to  businesses that have an average annual monetary value of $25,000 or  less of produce sold during the previous 3-year period.

FDA’s implementation of the produce rule will occur over several years.  According to the rule, compliance dates are phased in from 2017 through  2022 based on business size and other factors. Compliance dates for  certain agricultural water standards and for sprouts differ from the  compliance dates for other provisions in the rule. For example,  compliance for large businesses under certain agricultural water  standards with covered activities not involving sprouts is due in January  2020; compliance for small businesses under certain agricultural water  standards with covered activities not involving sprouts is due in January  2021; and compliance for very small businesses under certain agricultural  water standards with covered activities not involving sprouts is due in  January 2022. In 2019, FDA intends to start inspecting produce  businesses, other than those growing sprouts. At that time, FDA is to  assess compliance with the produce rule, with the exception of the  agricultural water standards, for all produce other than sprouts. See fig.  1 for more information on implementation timelines.

FDA-State Partnership in Helping to Ensure Compliance with the Rule

FSMA authorized and encouraged FDA to coordinate with states in  helping to ensure compliance with the produce rule. According to FDA  officials, developing a working relationship with states to implement the  rule is of critical importance because states may have an understanding  of farming practices as a result of their historically close relationship with  farms. To facilitate coordination with states, FDA established the State  Produce Implementation Cooperative Agreement Program. The program  is to provide funds to support a variety of state activities, including  educating and providing technical assistance to produce businesses, to  the 43 participating states. Through the program, FDA obligated  approximately $22 million in 2016 to 42 states and approximately $31  million in 2017 to 43 states to help these states implement the rule.

In addition, in September 2014, FDA entered into a 5-year cooperative  agreement with the National Association of State Departments of  Agriculture—an organization representing state agriculture departments  in all 50 states and 4 U.S. territories. Under this cooperative agreement,  the association is working with FDA to support implementation of the  produce rule by, among other things, providing technical assistance to  states to help them implement their produce safety programs. FDA  renewed the cooperative agreement in 2016 with an expanded scope to  include states’ assistance with helping businesses understand what is  expected of them ahead of compliance dates.

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. FDA has also taken other steps,  including funding training for industry, conducting visits to farms, and  publishing guidance, to evaluate and respond to concerns. In addition,  FDA is reviewing the produce rule agricultural water standards and in  September 2017 published a proposed rule to extend compliance dates  associated with those standards.

FDA Continues to Evaluate and Respond to Business Concerns through Its Information Clearinghouse

FDA has continued to use the TAN to evaluate and respond to questions  and concerns from businesses and other stakeholders regarding all of the  FSMA rules, including the produce rule. Since our last report, we found  that FDA received 2,665 additional questions submitted to the TAN from  September 4, 2016, through June 30, 2017. Of those 2,665 additional  questions, 230 questions (about 9 percent) pertained to the produce  rule. Of those 230 questions, 154 questions (about 67 percent) came  from individuals who self-identified as belonging to “business/industry.”  (See fig. 2.)

We reviewed the full text of questions about the produce rule that were  submitted to the TAN by those who identified themselves as belonging to  business/industry. We reviewed all such questions submitted since  September 10, 2015, when the TAN first began operating, through March  31, 2017, the date of the most recently available information when we  conducted our audit work (321 total questions). Questions spanned a  variety of topics related to the rule, with the most commonly asked  questions pertaining to the rule’s agricultural water standards. For  example, some businesses submitted questions to clarify whether a  specific water testing method they intended to use was acceptable. Other  commonly asked questions related to the types of produce covered by the  rule and whether a particular business was subject to the produce rule or  a related FSMA rule known as the preventive controls for human food  rule, which mandates new food safety requirements for food facilities,  such as food processing businesses. For example, one business owner  who grows almonds and also processes them submitted a question about  whether the business is subject to the produce rule or the preventive  controls rule. In addition, we found that most submissions (281 questions,  or 88 percent) contained requests for additional information or clarification  from FDA about implementing the produce rule. Examples of questions  about the produce rule that were submitted by businesses are shown in  figure 3.

According to FDA data, as of June 2017, the agency had responded to  about 84 percent (312) of the 372 questions specifically about the  produce rule submitted by businesses to the TAN since it began  operating. The agency’s median response time to these questions was 48  business days. As of June 2017, FDA had responded to 81 percent  (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.

To understand produce businesses’ concerns in detail, FDA officials said  they track questions submitted to the TAN. For example, these officials  said they track the number of questions requesting more information  about implementing the standards in the produce rule. These officials said  that FDA is using these data to inform the development of resources to  help businesses comply with the rule. For example, the officials told us  that they are developing a set of commonly asked TAN questions about  the produce rule that businesses can examine on FDA’s website prior to  submitting their questions to the TAN. FDA has already published similar  commonly asked TAN questions for some of the other FSMA rules.  Representatives we interviewed from two industry associations said that  such a list of questions would be helpful as businesses work to comply  with the produce rule.

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.

Training: FDA has funded partnerships to deliver training to help produce  businesses meet the new requirements under the produce rule.

The Produce Safety Alliance (PSA)—a collaboration involving Cornell  University, FDA, and the U.S. Department of Agriculture—has  developed a standardized national training curriculum about the  produce rule and has conducted training sessions for more than 6,100  industry participants in the United States and foreign countries. In  addition to serving an educational role, PSA training sessions help  FDA evaluate and respond to business concerns. For example, FDA  officials told us the agency uses questions submitted to the TAN to  inform PSA course content, thereby helping to ensure that the training  sessions address the most commonly asked questions. In addition,  FDA officials and PSA representatives we interviewed said that PSA  trainers are able to respond to questions from industry participants  during the training sessions. These representatives said that they  forward questions that PSA trainers are not able to answer during  training sessions to FDA using the TAN and through regular meetings  with FDA officials. One PSA trainer we interviewed said that face-to- face interactions with businesses at training sessions are the major  way her organization hears about business questions and concerns.

The Sprout Safety Alliance (SSA) is a collaboration between the  Illinois Institute of Technology and FDA to enhance the sprout  industry’s understanding of the produce rule. SSA has developed a  training curriculum to help businesses comply with produce rule  standards related to sprout production. SSA has conducted training  courses for over 100 industry participants in the United States and  Canada. According to an SSA representative, SSA has addressed  questions and concerns from sprout industry participants during  trainings. This representative also said SSA communicates with FDA  about questions SSA trainers are unable to answer.

Table 1 provides information about trainings provided by PSA and SSA.

Educational Farm Visits: FDA officials participated in educational farm  visits in 2016 and 2017 across the United States. According to FDA  officials we interviewed, these visits were intended to broaden FDA’s  knowledge of industry practices on these farms and were not for  compliance or inspection purposes. FDA officials said they learned about  a variety of industry concerns during these visits, including industry’s  concerns with the water standards under the produce rule. FDA  conducted these visits in a number of states, including Alaska, Arizona,  California, Colorado, Georgia, Maine, Maryland, Nevada, New Mexico,  Oregon, Texas, Vermont, Washington, Wisconsin, and the U.S. Virgin  Islands, according to agency officials.

Outreach to Produce Industry Associations: According to FDA  officials, the agency performs outreach to various produce industry  associations to educate businesses about the produce rule, answer  questions, and learn about produce business concerns. For example,  FDA officials said that, since we last reported on the produce rule, they  have attended industry conferences and held outreach meetings with  produce industry associations and they learned about specific concerns,  such as businesses’ need for additional training on the produce rule and  for information on how to identify materials that are suitable to properly  sanitize surfaces with which produce comes into contact.

On-farm Readiness Reviews: According to agency officials, these are  voluntary reviews during which state inspectors and educators,  accompanied by FDA officials, review businesses’ progress toward  meeting the produce rule standards to promote compliance with the rule.  States and FDA piloted the program in 2016 and, according to agency  officials, they plan to roll out the full program in late 2017 or early 2018.  In addition to helping businesses comply with the rule, FDA officials said  these reviews have helped the agency learn about businesses’ questions  and concerns. For example, officials said they learned during these  reviews that some businesses needed additional information regarding  water testing methods under the rule, including information on the number  of water samples to be collected and the locations of testing laboratories.

Produce Safety Network: Recognizing regional differences in growing  practices, FDA established the Produce Safety Network in 2017 to  address the unique needs of produce businesses in various parts of the  country, according to agency officials. This network was established, in  part, to respond to business questions and concerns, according to FDA  officials. The network is made up of FDA produce safety experts and  specialized investigators based in different parts of the country who help  evaluate and respond to questions from businesses, state regulators, and  other stakeholders in their regions, according to agency officials. For  example, according to FDA officials, these produce safety experts learned  about business questions regarding FDA’s list of produce the agency  considers rarely consumed raw and not subject to the produce rule. In  response to these concerns, the network developed a fact sheet outlining  FDA’s rationale for developing the list.

Guidance: According to FDA officials, the agency has been working on  guidance to assist businesses in complying with the produce rule. FDA  officials said guidance allows FDA to respond to questions and concerns  related to the rule. For example, in January 2017, FDA published draft  guidance on sprout-specific requirements under the rule. FDA officials  told us they conducted outreach to sprout businesses before releasing  this guidance to let businesses know why the guidance was issued and  that it was available for public comment. In developing the guidance, FDA  also took into account public comments made during the rulemaking  process, according to FDA officials. An SSA representative we  interviewed confirmed this, saying that the draft guidance was responsive  to comments made by sprout businesses during rulemaking that asked  FDA to include specific examples of how businesses were to comply with  requirements. This representative said the draft guidance contained  relevant examples. In addition, in early September 2017, FDA published  guidance to help small businesses comply with the produce rule. The  guidance provides small businesses with information about who must  comply with the rule, training required, and which businesses are eligible  for qualified exemptions from the rule, among other things. See appendix  I for a list of published and forthcoming FDA produce rule guidance.

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. 4).

According to FDA, its review of the water standards is an effort to simplify  the standards and make them easier for businesses to comply with. FDA  also said that it would use the extended compliance period to work with  produce businesses as it considers the best approach to respond to their  concerns about the standards. The extended compliance period will also  allow FDA to provide additional outreach and training.

FDA officials we interviewed said that their decision to review the water  standards and extend compliance dates was in response to industry  concerns. They also said that they learned about these concerns through  some of the steps they have taken, which we identify in this report. For  example, FDA officials said they heard numerous questions and concerns  from businesses about the water standards during educational farm visits.  Also, as we note above, questions about the water standards were the  most common produce rule-related questions submitted to the TAN.  According to representatives we interviewed from two industry  associations, some businesses did not fully understand the water  standards because, among other things, they said the standards do not  provide a clear definition of “agricultural water,” leaving some businesses  uncertain about what water sources and water uses are subject to the  rule. In addition, according to documentation from an industry meeting  with FDA, some businesses have expressed concerns about costs  associated with the new water testing requirements. Some businesses  have also expressed concerns that the water testing method described in  the standards has not traditionally been used by industry and that finding  laboratories that use this method will be difficult. The standards allow for  the use of alternative testing methods, but some businesses have  expressed concerns that FDA has not specified these alternative testing  methods, thereby leaving businesses uncertain about what methods will  be acceptable to FDA. Along with its announcement of a review of the  water standards, in September 2017, FDA announced a list of eight water  testing methods it determined to be equivalent to the method described in  the standards. According to FDA officials, the list was established in  response to business concerns, and the agency will add to this list as  additional equivalent methods are identified.

FDA officials we interviewed did not provide specific details or a timeline  for the agency’s review of the water standards. These officials said the  agency is considering adding clarifying information on the standards in  forthcoming guidance and, if necessary, making changes to the standards  themselves by revising the produce rule. In addition, officials said they  plan on hosting a water summit in early 2018 with stakeholders and  technical experts.

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. In October 2016, FDA  implemented the first part of its survey assessing the TAN. This first part  of the survey, which FDA sent to businesses and other stakeholders that  submitted questions to the TAN, solicited feedback about the TAN web  page provided for submitting questions. This survey included questions  about how stakeholders learned about the TAN web page, the clarity of  the page, and how FDA could improve the page. Officials told us they  have begun making changes to the TAN web page based on the survey  results. For example, FDA increased the character limit for questions  submitted and provided additional information about FSMA on the web  page. 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. FDA officials told us that the  agency will begin sending out this survey with its responses to TAN  questions in spring 2018.

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. These outcomes are specified in a draft  strategic framework the agency has developed to monitor implementation  of the produce rule. The framework includes outcomes such as  businesses’ compliance with the produce rule, expanded use of  incentives for compliance, and increased dissemination of good practices  and other on-farm findings. According to FDA officials, outcomes in the  framework that relate to FDA’s efforts to evaluate and respond to  business concerns include:  increased effectiveness of technical assistance provided to  businesses by FDA and its partners,  improved working relationships with businesses, and  increased capacity of FDA partners to educate businesses.

Performance metrics are to be targeted to measure these outcomes,  officials said. These officials also stressed that the draft strategic  framework is subject to change.

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. Regarding the TAN, representatives we interviewed from  two of these groups said that they had received timely responses from  FDA to some questions they had submitted to the TAN, and most groups  we interviewed said that at least some of the TAN responses they  received provided useful information. However, representatives we  interviewed also had two major concerns:

Representatives from three groups said that responses were often  slow to arrive; representatives from one of these three groups  commented that response times remained largely unchanged since  we last reported on the produce rule in November 2016.  Representatives from another group commented that FDA’s response  times to TAN questions seemed to be related to the complexity of a  question. For example, questions that required straightforward  answers often received faster responses, while questions requiring  more complex answers often got slower responses and, in some  cases, FDA responded that the question would be answered in  forthcoming guidance.

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.

FDA officials acknowledged that it has been challenging for the agency to  provide timely and complete responses to TAN questions, especially early  on in the TAN’s operation, but that the agency has to work through  complex policy questions related to the rule in order to respond. These  officials said they are working to respond more quickly to TAN questions  and are revising the FDA review process for TAN responses. Officials  also stated that they anticipate posting commonly asked produce rule  questions and responses on the TAN web page to provide immediate  assistance to businesses for some questions. This is similar to what the  agency has done for other FSMA rules, officials said.

Regarding FDA’s other efforts to evaluate and respond to business  concerns, representatives from one group we interviewed told us that  FDA continues to be open to hearing questions and concerns from the  produce industry. 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. Representatives from one of these groups also commented that  guidance is needed to explain the produce rule in plain language so that  businesses can more easily understand the rule. In addition,  representatives from two of these groups said that the produce rule  training available to businesses is helpful but limited in the absence of  guidance. For example, some questions cannot be answered completely  during trainings without additional information from guidance.

FDA officials told us they are aware of businesses’ concerns about the  need for additional guidance. These officials said they are working to  publish guidance on various topics related to the produce rule, as we  have described elsewhere in this report. For example, officials said they  planned to issue draft compliance and implementation guidance near the  first compliance date of January 2018 for businesses producing  commodities other than sprouts (see app. I).

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.

Identifying businesses subject to the produce rule: While the produce  rule specifies the types of commodities subject to the rule, FDA does not  have an inventory of farms producing those commodities and therefore  does not know which businesses are subject to the rule. As we have  previously reported, FDA’s existing business inventory data are drawn  from information provided by businesses required to register with FDA.  Farms, however, are not required to register. According to FDA officials,  the lack of a registration requirement for farms limits the data the agency  has to inform its implementation of the produce rule. For example, FDA  officials we interviewed said that not having data regarding farms can  make it difficult for FDA to connect businesses with the educational and  technical assistance resources to help them comply with the rule. FDA  officials told us the agency’s State Produce Implementation Cooperative  Agreement Program should help address this challenge. The program,  which provides resources to each participating state to support a variety  of state activities related to implementing and enforcing the produce rule,  includes funding for states to develop and maintain an inventory of  businesses subject to the rule. According to the program’s funding  announcement, inventory data will be used to determine education and  outreach needs related to the produce rule as well as to plan compliance  and enforcement activities. FDA officials told us that states participating in  the program have started to build their inventories of farms. According to  these officials, participating states plan to have their inventories  completed before they begin inspections of produce businesses. For  states not participating in the cooperative agreement program, FDA  officials said the agency is developing farm inventories.

Providing consistent and region-specific responses to business  questions and concerns: FDA officials told us that it can be a challenge  to ensure that FDA and its state partners provide consistent responses to  businesses’ questions that are also tailored to account for regional  differences in growing conditions. For example, officials said that if a  business in one part of the country receives information from one of  FDA’s state partners, it can be a challenge to ensure that businesses in  other parts of the country also receive the same information, whether  from states or from FDA. At the same time, however, information provided  to businesses may need to be tailored to account for regional differences  in growing conditions. FDA officials told us that, to address this challenge,  FDA’s Produce Safety Network staff are stationed around the United  States and work closely with states participating in FDA’s Cooperative  Agreement Program. According to these officials, this relationship  provides a mechanism for states and FDA to share information about the  produce rule and helps ensure that information provided by states is  consistent with FDA’s interpretation of the rule. In addition, these officials  stated that having network staff in different growing regions allows those  staff members to develop expertise in the growing conditions and  practices in their regions, which in turn enhances their ability to provide  outreach and technical assistance that is specifically tailored to the  unique needs of those regions. For example, according to FDA officials, if  a state in the Cooperative Agreement Program receives a question about  the rule from a business, Produce Safety Network staff work with the  state and FDA subject matter experts to craft a response that the state  can provide to the business and that is tailored to the growing practices  and conditions in the region. This approach helps ensure that FDA and its  state partners speak with one voice about the produce rule and that the  information provided is sensitive to regional differences in the produce  industry, officials said.

We provided a draft of this product to HHS. HHS provided us with  technical comments, which we incorporated as appropriate.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of Health and Human Services, and other  interested parties. In addition, the report is available at no charge on the  GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-3841 or morriss@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. Key contributors to this report are listed in appendix II.

Appendix I: FDA Outreach and Guidance Related to the Produce Rule

Appendix II: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Anne K. Johnson (Assistant  Director), Ramsey Asaly, Tim Bober, Kevin Bray, Alexandra Edwards,  Ellen Fried, Cindy Gilbert, Hayden Huang, Dan Royer, Kiki  Theodoropoulos, and Rajneesh Verma made key contributions to this  report.

High-Risk Series: Progress on Many High-Risk Areas, While Substantial  Efforts Needed on Others. GAO-17-317. Washington, D.C.: February 15,  2017.

Food Safety: A National Strategy Is Needed to Address Fragmentation in  Federal Oversight. GAO-17-74. Washington, D.C.: January 13, 2017.

Food Safety: FDA’s Efforts to Evaluate and Respond to Business  Concerns Regarding the Produce Rule. GAO-17-98R. Washington, D.C.:  November 28, 2016.

Food Safety: FDA Coordinating with Stakeholders on New Rules but  Challenges Remain and Greater Tribal Consultation Needed. GAO-16- 425. Washington, D.C.: May 19, 2016.

Department of Health and Human Services, Food and Drug  Administration: Standards for the Growing, Harvesting, Packing, and  Holding of Produce for Human Consumption. GAO-16-299R. Washington,  D.C.: December 16, 2015.

Federal Food Safety Oversight: Additional Actions Needed to Improve  Planning and Collaboration. GAO-15-180. Washington, D.C.: December  18, 2014.

People often eat fruits and vegetables raw, so it's important to prevent contamination that may lead to foodborne illness.

In 2011, a new law brought major changes to food safety efforts. One of these changes was the Food and Drug Administration's produce rule. It established the first enforceable national food safety standards for produce.

We reported in 2016 on FDA's use of an information clearinghouse to respond to business concerns about the standards. In this report, we examined FDA's responses since then, which have included funding training for industry and announcing a review of water quality standards under the rule.


Faith-Based Grantees: Few Have Sought Exemptions from Nondiscrimination Laws Related to Religious-Based Hiring

The federal government provides billions of dollars in grant funding to organizations offering social services, including FBOs. In carrying out their mission, some FBOs prefer to hire individuals who share their religious beliefs. Although the 1964 Civil Rights Act prohibits employment discrimination based on religion, section 702(a) of the Act exempts FBOs from this prohibition, thereby allowing them to hire based on religion. However, some federal grant programs contain statutory restrictions prohibiting this practice. Since a 2007 DOJ legal opinion, federal agencies allow faith-based grantees to use RFRA as a basis for seeking an exemption to allow religious-based hiring.

GAO was asked to review the extent to which faith-based grantees have sought RFRA exemptions from statutory restrictions on religious-based hiring. This report describes (1) what is known about faith-based grantees that have certified exemption from statutory restrictions on religious-based hiring, per RFRA, since 2007; and (2) how agencies inform grantees of statutory restrictions on religious-based hiring and requirements for demonstrating their eligibility for an exemption.

GAO reviewed information from DOJ, HHS, and DOL grantees from fiscal years 2007 to 2015 that were subject to statutory restrictions on religious-based hiring. GAO interviewed faith-based grantees that certified as exempt and a selection of those that did not. GAO also reviewed agency grant documentation and guidance provided to grantees and interviewed cognizant officials to understand the processes FBOs must follow to certify as exempt.

From fiscal years 2007 through 2015, few faith-based grantees sought an exemption based on the Religious Freedom Restoration Act of 1993 (RFRA) from nondiscrimination laws related to religious-based hiring. Specifically, GAO found that the Department of Justice (DOJ), Department of Health and Human Services (HHS), and Department of Labor (DOL) awarded funding to at least 2,586 grantees through at least 53 grant programs containing nondiscrimination hiring restrictions during this time. The number of relevant grant programs could be higher, because GAO could not identify all such programs due to data limitations. Across the 3 agencies, GAO identified 117 grantees that were potential Faith-Based Organizations (FBOs). Of the 117 potential FBOs, 9 DOJ grantees were FBOs that certified as being exempt from statutory restrictions on religious-based hiring. GAO interviewed 6 of these FBOs, all of which stated that hiring individuals who share their religious beliefs was critical to their mission, and that had the RFRA exemption not been available to them, they likely would not have sought the grant.

DOJ, DOL, and HHS inform grant applicants and recipients of statutory restrictions on religious-based hiring and processes for obtaining an exemption from such restrictions generally through grant materials. DOJ and DOL also provide relevant information on their web sites. All three agencies require grantees that seek to make employment decisions based on religion to self-certify that they meet requirements to be eligible for an exemption, but vary in how they review and approve requests for exemptions. For example, DOJ, DOL, and HHS have policies requiring grantees to submit their exemption self-certification, but only DOL reviews exemption requests and either approves them or provides a reason for denial.

Each year the federal government provides billions of dollars to  organizations that provide social services to needy families and  individuals. Some of these funds are provided through competitive grants  to faith-based organizations (FBOs), which may include religious groups,  like churches, mosques, synagogues, and temples, or charitable  organizations affiliated with religious groups.

In some instances, FBOs believe it is necessary to only hire individuals  who share their religious beliefs in order to carry out their mission. Title  VII of the Civil Rights Act of 1964 prohibits employment discrimination  based on religion, as well as other factors such as race, color, sex, and  national origin. However, section 702(a) of the Act exempts FBOs with  respect to basing employment decisions on religion, thereby permitting  FBOs to intentionally, and exclusively, hire individuals who share their  religious beliefs. In light of section 702(a), FBOs that receive federal  grant funding have generally been permitted to make employment  decisions based on religion. There are, however, certain federal grant  programs that are subject to statutory restrictions that prohibit grant  recipients from using grant funding, in whole or in part, to discriminate or  deny employment on the basis of religion, among other factors.

In 2005, the Office of Justice Programs (OJP) within the Department of  Justice (DOJ) awarded grant funding to World Vision, a FBO, under a  program that was subject to a statutory provision that prohibited recipients  from considering religion when making employment decisions in  connection with the grant. World Vision had a policy to hire only Christian  staff in order to maintain its identity as a Christian organization. OJP  informed World Vision about the grant program’s statutory restriction,  which prohibited religious-based hiring. World Vision petitioned OJP  arguing that it should be exempted from the statutory restriction based on  the Religious Freedom Restoration Act of 1993 (RFRA). Although RFRA  does not explicitly address religious-based hiring, under RFRA, the  government may not substantially burden a person’s exercise of religion,  unless it can prove a compelling interest in doing so. World Vision  argued that being required to comply with the restriction substantially  burdened its exercise of religion and that the government did not have a  compelling interest in prohibiting World Vision from making religious- based hiring decisions. In response, DOJ’s Office of Legal Counsel (OLC)  issued an opinion in June 2007 stating that RFRA could be reasonably  construed to require OJP to exempt World Vision from the statutory  requirement restricting federal grantees from hiring on the basis of  religion. Pursuant to this OLC opinion, and RFRA, certain federal  agencies have permitted FBOs that receive funding under a program that  is subject to a statutory restriction on religious-based hiring to certify that  they are exempt from such restrictions.

Since OLC issued this opinion, however, the extent to which faith-based  grantees have certified that they are exempt from statutory restrictions on  religious-based hiring is not readily available. You asked us to examine  the extent of use and the various procedures regarding these exemptions.  This report addresses the following questions:  1.  What is known about faith-based grantees that have certified that they  are exempt from statutory restrictions on religious-based hiring, per  RFRA, since 2007?  2.  What processes do selected federal agencies use to notify grantees  about statutory restrictions on religious-based hiring and the related  exemption, per RFRA, and what processes do agencies require FBOs  to follow to demonstrate they are eligible for an exemption?

In conducting our work, we reviewed the RFRA, the OLC opinion, laws  and regulations related to religious-based hiring, and our prior work on  the federal government’s efforts to monitor FBOs and their performance.  We sought to include federal agencies that, because of their mission, may  be likely to provide funding to FBOs. Therefore, we selected the five  agencies required by Executive Order 13198 to establish a Center for  Faith-Based and Community Initiatives: DOJ, Department of Education  (Education), Department of Health and Human Services (HHS),  Department of Housing and Urban Development (HUD), and Department  of Labor (DOL). These centers were established in each department to  help the federal government coordinate a national effort to expand  opportunities for faith-based and other community organizations and  strengthen their capacity to meet social needs in American communities.

To address our first objective, we asked each agency to identify any  grantees that certified they were exempt from statutory restrictions on  religious-based hiring. We also asked each agency to identify all grant  programs that met the following criteria—the grant program was subject  to a statutory restriction on religious-based hiring; nonprofits, including  FBOs, were eligible to be primary recipients of the grant funding; and  funding was awarded during fiscal years 2007 through 2015. We selected  this timeframe because it covered the period immediately after the OLC  opinion was issued through the most recent fiscal year for which grant  awards had been announced at the start of our review. We subsequently  removed Education and HUD from our scope after the agencies reported  that they did not have any grant programs that met our criteria.

We could not determine the complete universe of FBOs that are eligible  to be primary recipients of grant funding or the amount of federal funds  they receive because DOJ, DOL, and HHS do not maintain, and are not  required to maintain, information on whether or not an organization is an  FBO. Also, there is no formal, federal-level definition of FBOs, which  makes it difficult to identify and count them. In addition, DOJ was unable  to identify the total number of grant programs from fiscal years 2007  through 2015 that were subject to nondiscrimination provisions and for  which nonprofits, including FBOs, were eligible to be primary recipients of  grant funding, in time for our review. As a result, the information we  received may not represent the complete number of DOJ grant programs  and grantees subject to the provisions; therefore, we use the term “at  least” in our report because the number of relevant grant programs could  be higher.

Because DOJ’s OJP and Community Oriented Policing Services (COPS)  components, DOL, and HHS do not collect information on which grantees  are FBOs and potentially eligible for an exemption, we sought other ways  to identify potential FBOs. After reviewing Internal Revenue Service (IRS)  documents, in particular IRS Publication 4838, Instructions for Requesting  Information on Exempt Organizations (Effective January 2010), we  determined that the IRS collects and maintains data on tax-exempt  organizations that could indicate whether the organizations are faith- based. In addition, DOJ’s Office on Violence Against Women (OVW)  component utilized progress reports that allow grantees to self-identify as  FBOs. We asked DOJ, DOL, and HHS to provide information, including  name, contact information, and Employer Identification Number (EIN), for  all of the grantees that received funding for each of the grant programs  that met our criteria. Additionally, we contracted with LexisNexis to  provide us with the relevant IRS data for each of the grantees. We  analyzed the IRS data to determine which grantees had at least one faith- based indicator; and for the purpose of our review, we refer to such  grantees as potential FBOs. If DOJ, DOL, or HHS had potential FBOs,  we provided the agency with a list of these grantees and asked them to  confirm whether any of these grantees certified that they were exempt  from statutory restrictions on religious-based hiring.

We contacted all nine of the grantees that the agencies identified as  having certified that they were exempt, and six responded to our interview  requests. These interviews yielded information on how the grantees  certified that they were exempt from restrictions on religious-based hiring;  why they determined it was important to hire someone who shared their  religious beliefs; and what they would have done had the exemption  option not been available to them. Additionally, we contacted all 35  potential faith-based grantees we identified that agencies reported had  not filed a self-certification to be exempted from religious-based hiring  restrictions that were awarded funding in fiscal years 2014 and 2015  through any of the grant programs that met our criteria. We selected this  timeframe to increase the likelihood that grantees would be able to recall  the details of the grant application process. Five of the 35 potential faith- based grantees responded to our interview request. We interviewed these  faith-based grantees to discuss, among other things, whether the  grantees were familiar with the exemption option and why they decided  not to seek the exemption.

To address our second objective, we obtained and reviewed grant  solicitations, language of the relevant statutory restrictions, grant  applications, agency policies, and exemption documentation submitted by  faith-based grantees. To better understand the agencies’ familiarity with  the OLC opinion and the processes the agencies have in place to accept  and review exemption documentation, we interviewed agency officials  and attorneys from DOJ, DOL, and HHS.

We conducted this performance audit from April 2016 to October 2017 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

Few Grantees Certified They Were Exempt from Statutory Restrictions on Religious-Based Hiring

Nine DOJ Grantees Certified They Were Exempt from Statutory Restrictions on Religious- Based Hiring

From 2007 to 2015, HHS, DOL, and DOJ awarded funding to at least  2,586 grantees through at least 53 grant programs that were subject to  statutory restrictions on religious-based hiring. Specifically:

HHS identified one grant program subject to statutory restrictions on  religious-based hiring for which nonprofits were eligible to be primary  recipients—the Projects for Assistance in Transition from  Homelessness (PATH) program, which is administered by the  Substance Abuse and Mental Health Services Administration  (SAMHSA). Generally, only states are eligible to be primary  recipients for PATH grant awards. However, HHS may award PATH  grants directly to public or nonprofit entities if a state does not submit  an application or does not meet program requirements. From this  program, no grants were awarded to nonprofit organizations and  therefore no FBOs were awarded grants.

DOL identified 18 grant programs subject to statutory restrictions on  religious-based hiring for which nonprofits were eligible to be primary  recipients. All 18 of these grant programs were in DOL’s Employment  and Training Administration (ETA). From these 18 programs, 931  grantees were awarded grants, including 19 we identified as potential  FBOs.

DOJ identified at least 34 relevant grant programs administered by  OVW, COPS, and six different program offices within OJP that were  subject to statutory restrictions on religious-based hiring. The 34  relevant grant programs represent the minimum number of grant  programs that were subject to nondiscrimination provisions and for  which nonprofit organizations were eligible from fiscal years 2007  through 2015. The number of relevant grant programs could be  higher. As discussed below, OJP was unable to identify the total  number of relevant grant programs and total number grantees  awarded grants under these programs, including potential FBOs.  More specifically within DOJ:

OVW identified 20 grant programs subject to statutory restrictions  on religious-based hiring. From these 20 programs, 604 grantees  were awarded grants, including 25 that OVW identified as  potential FBOs.

OJP identified at least 10 grant programs subject to statutory  restrictions on religious-based hiring. According to officials, OJP  was not able to readily identify grant solicitations that were  available to nonprofit organizations from fiscal years 2007 to 2015  and subject to statutory restrictions on religious-based hiring. This  effort, according to OJP, would have required a manual search of  each grant solicitation. However, OJP was able to identify at least  10 grant programs subject to statutory restrictions on religious- based hiring. From these 10 programs, at least 1,113 grantees  were awarded grants, including 74 we identified as potential  FBOs.

COPS identified four grant programs subject to statutory  restrictions on religious-based hiring. From these four programs,  57 grantees were awarded grants, none of which were potential  FBOs.

Of the 117 potential FBOs we identified across the three agencies, nine  faith-based grantees, all of which were awarded DOJ grants, certified that  they were exempt from statutory restrictions on religious-based hiring  (see figure 1). These 9 grantees were, therefore, allowed to consider a  prospective employee’s religious faith when making employment decisions in connection with the grant. DOL and HHS reported that none  of their grantees have sought exemptions from religious-based hiring  provisions.

As shown in Table 1, 8 of the 9 faith-based grantees that certified that  they were exempt were awarded funding through DOJ grant programs  from fiscal years 2008 to 2010. The remaining exempted grantee  received a funding award in 2015. The total funding awarded to the 9  grantees was approximately $3.2 million, which is less than 1 percent of  the $804 million in grants that DOJ awarded that are subject to statutory  restrictions from fiscal years 2007 to 2015. DOJ reported that 8 of these  grantees received the awards on a noncompetitive basis because they  were identified for funding in a DOJ appropriation or accompanying  committee report.

Exempted Faith-Based Grantees Stated that Hiring Staff to Assist with Grant Activities on the Basis of Religion Was Critical to Their Mission

We interviewed 6 of the 9 grantees that certified that they were exempt  from religious-based hiring restrictions. Each of the 6 grantees that we  interviewed stated that: hiring individuals who share their religious beliefs to assist with grant  activities was critical to their mission and organizational success;  they include a “statement of faith” on their organization’s job  application form and ask the applicant to attest to the statement of  faith, or hired individuals of the same faith already employed within  their organization; and had the RFRA exemption not been available to them, they likely would  not have sought the grant or they would have had to seek executive- level approval within their organization to apply for the grant.

At least 3 of the 6 grantees stated that they were a recipient of other  federal grant funding, but those grants were not subject to statutory  restrictions on religious-based hiring, and therefore did not require an  exemption to make hiring decisions based on religion. Based on grant  award documentation, 6 of the 9 grantees used the funding to provide  assistance to at-risk youth. However, other services that the remaining  grantees provided included first responder training and programs to  reduce homelessness, among others, and support and response efforts  for victims of sexual assault.

As discussed earlier, we also selected 35 potential faith-based grantees  that received funding in fiscal years 2014 and 2015 and that agencies  reported had not filed a self-certification to be exempted from religious- based hiring restrictions. We interviewed 5 of these 35 grantees to  discuss, among other things, whether the grantees were familiar with the  exemption options. The five faith-based grantees said they did not recall  seeing information about the exemption option in the grant application or  grant award documentation, or were not looking for information about the  exemption because they were not considering religion in their hiring  decisions. Two of the faith-based grantees that did not certify as exempt  told us that, while they ask that the applicant have an understanding of  the traditions, culture, or languages of their religion, they do not require  applicants to share the same faith.

Federal Agencies Primarily Use Grant Documentation to Notify Grantees of Restrictions on Religious-Based Hiring and Requirements for Demonstrating Eligibility for Exemptions

Agencies Notify Grantees of Statutory Restrictions on Religious-Based Hiring through Grant Materials that Identify Relevant Regulations

DOJ, DOL, and HHS inform grant applicants and recipients of statutory  restrictions on religious-based hiring and processes for obtaining an  exemption from such restrictions through grant announcements. The  agencies also use additional methods that varied across all three  agencies for providing this information to grantees.

DOJ specifically made this information available on agency web pages as  well as in the documentation that is provided to grant recipients. DOJ’s  Center for Faith-Based and Neighborhood Partnerships has a web page  specifically for FBOs that have applied for or received grant funding.  This web page includes a list of Frequently Asked Questions, including  one that addresses hiring employees with federal grant funds. The Office  for Civil Rights within OJP also provides information on its web page  regarding how FBOs may certify that they are exempt from statutory  restrictions on religious-based hiring. Additionally, it includes a link to a  copy of DOJ’s exemption certification form. We interviewed  representatives from four potential faith-based grantees that received a  DOJ grant in fiscal years 2014 or 2015 and did not certify for an  exemption. All four grantees said they could not recall seeing information  in the grant application or award documentation about the exemption  option or were not looking for it because they were not considering  religion in their hiring decisions.

Similarly, DOL has a web page devoted specifically to explaining statutory  restrictions on religious-based hiring to faith-based grant applicants and  recipients, which also covers the process for seeking exemptions from the  restrictions. The web page makes reference to DOL’s regulations  related to religious-based hiring by FBOs and also has a link to the June  2007 OLC opinion. Additionally, DOL has prepared a guidance  document—available from its grants program overview web page—that  explains in detail the process for seeking exemptions and how they are  reviewed and approved. A representative from the one potential FBO we  interviewed that received a DOL grant in fiscal years 2014 or 2015 but did  not certify that they were exempt could not recall seeing information about  the exemption option.

Lastly, in addition to providing information in grant announcements, HHS  provides all SAMHSA grant applicants seeking funds for substance abuse  prevention and treatment services with a form that cites laws and  regulations governing religious organizations that receive SAMHSA  funding, including the regulation that outlines the exemption process.   HHS requires the applicants to sign the form, and in doing so, the  applicants are certifying that they are aware of and will comply with  applicable laws that allow FBOs to provide SAMHSA-funded services  without impairing their religious character and without diminishing the  religious freedom of those who receive their services.

Agencies Rely on Grantees to Self-Certify that They Meet Eligibility Requirements for Exemptions from Statutory Restrictions on Religious- Based Hiring

DOJ, DOL, and HHS all require grantees that seek to make employment  decisions based on religion to self-certify that they meet requirements to  be eligible for an exemption from statutory restrictions on religious-based  hiring, but vary in how they review and approve requests for exemptions.

DOJ faith-based grantees that wish to demonstrate they are eligible for an  exemption from statutory restrictions on religious-based hiring must  complete and sign a “Certificate of Exemption for Hiring Practices on the  Basis of Religion.” If an applicant is awarded a grant, it must submit a  copy of the signed version of this form through DOJ’s Grants  Management System. By signing the form, the grantee is certifying that:  federally-funded services will be offered to all qualified beneficiaries  without regard for the religious or nonreligious beliefs of those  individuals; activities that contain inherently religious content will be kept separate  from grant-related activities or offered to clients voluntarily; and  the organization believes that the services provided are an expression  of its religious beliefs, employing persons of a particular religion is  important to its mission, and not being able to hire such persons  would be a substantial burden to the organization.

DOJ does not review these self-certification submissions to approve or  deny the requests. It only reviews them for any indication that the  applicant may not be an FBO, in which case DOJ officials said they would  follow up with the grantee to get clarification. Agency officials also said  DOJ would review any self-certifications as part of grantee compliance  reviews and in response to complaints from other parties. The self- certification form covers the entire grant award period, and can cover  multiple DOJ grants as long as all of the grant programs are subject to the  same statutory restrictions on religious-based hiring. There is no deadline  for submitting the self-certification and DOJ officials told us that while it is  understood that self-certifications should be submitted before grant funds  are dispersed, grantees do not need to do so.

DOL faith-based grantees that wish to demonstrate they are eligible for  an exemption also self-certify, but are required to submit their request to  DOL for review and approval by the Assistant Secretary responsible for  issuing or administering the grant. In its request, the grantee must  certify that: providing the services to be funded by the grant is an exercise of its without the grant, its ability to provide the services funded by the grant  would be substantially diminished, and providing those services is  demonstrably tied to the recipient’s religious beliefs; employing individuals of a particular religious belief is important to its  religious identity, autonomy, or communal religious exercise;  conditioning the grant award on compliance with the nondiscrimination  provision creates substantial pressure on it, in providing the services  being funded, to abandon its belief that hiring based on religion is  important to its religious exercise; and  it will comply with the requirements of 29 C.F.R. part 2, subpart D,  Equal Treatment in Department of Labor Programs for Religious  Organizations; Protection of Religious Liberty of Department of Labor  Social Service Providers and Beneficiaries.

The Assistant Secretary’s office then reviews exemption requests and  approves them or provides a reason for denial. DOL has instituted a 30- day deadline to reply back to the grant applicant with its decision. DOL  implemented this process in response to the 2007 OLC opinion. However,  agency officials said they have never used this process because, as  explained earlier in this report, DOL has not received any exemption  requests. They also told us exemptions are only valid for the grant award  period and new requests must be re-submitted if the grant is renewed.  However, an exemption can cover multiple grants to the same grantee as  long as those grants are received from the same DOL component. Lastly,  the officials said that grant funds can be disbursed before the grantee has  submitted an exemption request.

HHS faith-based grantees seeking to demonstrate that they are eligible  for an exemption from statutory restrictions on religious-based hiring must  self-certify that they meet several requirements outlined in HHS  regulations. To demonstrate its eligibility for an exemption, a grantee  must certify that:  it sincerely believes employing individuals of a particular religion is  important to the definition and maintenance of its religious identity,  autonomy, and/or communal religious exercise;  it makes employment decisions on a religious basis in analogous  programs;  it believes the grant would materially affect its ability to provide the  type of services in question; and providing the services in question is expressive of its values or  mission.

Grantees must then submit their self-certification to HHS requesting an  exemption, and maintain supporting justification documentation on file if  needed for future review. However, as explained earlier in this report,  there is currently only one HHS grant program that is subject to a  statutory restriction on religious-based hiring and for which FBOs are  eligible to be primary recipients—the PATH program. We did not identify  any faith-based recipients of grants from this program from fiscal years  2007 through 2015, and HHS officials confirmed that no nonprofit entities  received any grants from the program during this time.

We provided a draft of this report to the Departments of Labor, Justice,  and Health and Human Services. Although the agencies did not provide  formal comments, the Departments of Justice and Health and Human  Services did provide technical comments that we incorporated, as  appropriate.

As agreed with your office, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time we will send copies of this report to the  Secretaries of Health and Human Services and Labor; the Attorney  General; and appropriate congressional committees. In addition, the  report will be available at no charge on the GAO website at  http://www.gao.gov.

If you or your staff have any questions about this report, please contact  either Diana Maurer at (202) 512-8777 or maurerd@gao.gov; or Cindy  Brown Barnes at (202) 512-7215 or brownbarnesc@gao.gov. Contact  points for our Offices of Congressional Relations and Public Affairs may  be found on the last page of this report. Key contributors to this report are  listed in Appendix I.

Appendix I: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Mary Crenshaw, Adam Hoffman,  and Kristy Love (Assistant Directors); David Ballard; Dominick Dale;  Michele Fejfar; Melissa Hargy; Joel Marus; Heidi Nielson; Kelly Rolfes- Haase; and Katrina Taylor made key contributions to this report.