Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration in the agencies' interagency agreement for the joint oversight of cell-cultured meat. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: FDA and USDA partially concurred with this recommendation. FDA stated that it concurred with the intent of incorporating the seven leading practices into the interagency agreement, and both agencies said that they are open to incorporating the practices into their development of the structure for joint oversight of cell-cultured meat. However, the agencies stated that they did not agree to revise the agreement at this time. FDA and USDA stated that the agreement is a general framework and that incorporating the leading practices would constitute an inappropriate level of detail. Instead, the agencies stated that they believe it would be most valuable to incorporate the leading practices into a more detailed joint framework or standard operating procedure they plan to issue. We appreciate the agencies' willingness to incorporate the leading practices for effective collaboration into their efforts. The March 2019 interagency agreement states that the agencies have the ability to modify it as needed and will review the agreement every 3 years to determine whether they should modify or terminate it. Therefore, the agencies are due to revisit the agreement in March 2022, if not sooner. Regarding the agencies' concern that incorporating the leading practices in the interagency agreement would add an inappropriate level of detail, we note that, as we state in our report, the existing agreement already partially incorporates each of the seven leading practices. We continue to believe that FDA and USDA should more fully incorporate the seven leading practices for effective collaboration into their interagency agreement for the joint oversight of cell-cultured meat. Developing a more detailed joint framework or standard operating procedure in accordance with the existing interagency agreement that incorporates those leading practices would meet the intent of our recommendation to improve the effectiveness of the agencies' collaboration.

Recommendation: The Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should more fully incorporate the seven leading practices for effective collaboration in the agencies' interagency agreement for the joint oversight of cell-cultured meat. (Recommendation 2)

Agency: Department of Agriculture
Status: Open

Comments: FDA and USDA partially concurred with this recommendation. FDA stated that it concurred with the intent of incorporating the seven leading practices into the interagency agreement, and both agencies said that they are open to incorporating the practices into their development of the structure for joint oversight of cell-cultured meat. However, the agencies stated that they did not agree to revise the agreement at this time. FDA and USDA stated that the agreement is a general framework and that incorporating the leading practices would constitute an inappropriate level of detail. Instead, the agencies stated that they believe it would be most valuable to incorporate the leading practices into a more detailed joint framework or standard operating procedure they plan to issue. We appreciate the agencies' willingness to incorporate the leading practices for effective collaboration into their efforts. The March 2019 interagency agreement states that the agencies have the ability to modify it as needed and will review the agreement every 3 years to determine whether they should modify or terminate it. Therefore, the agencies are due to revisit the agreement in March 2022, if not sooner. Regarding the agencies' concern that incorporating the leading practices in the interagency agreement would add an inappropriate level of detail, we note that, as we state in our report, the existing agreement already partially incorporates each of the seven leading practices. We continue to believe that FDA and USDA should more fully incorporate the seven leading practices for effective collaboration into their interagency agreement for the joint oversight of cell-cultured meat. Developing a more detailed joint framework or standard operating procedure in accordance with the existing interagency agreement that incorporates those leading practices would meet the intent of our recommendation to improve the effectiveness of the agencies' collaboration.

Recommendation: As the three cell-cultured meat working groups move forward, the Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration, such as identifying specific outcomes and a way to monitor and evaluate progress toward outcomes. (Recommendation 3)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: As the three cell-cultured meat working groups move forward, the Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should more fully incorporate the seven leading practices for effective collaboration, such as identifying specific outcomes and a way to monitor and evaluate progress toward outcomes. (Recommendation 4)

Agency: Department of Agriculture
Status: Open

Comments: In March 2020, USDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should clearly document in their interagency agreement, or other publicly available document, which agency will oversee cell-cultured seafood other than catfish. (Recommendation 5)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Secretary of Agriculture, in coordination with the Commissioner of the Food and Drug Administration, should clearly document in their interagency agreement, or other publicly available document, which agency will oversee cell-cultured seafood other than catfish. (Recommendation 6)

Agency: Department of Agriculture
Status: Open

Comments: In March 2020, USDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Secretary of Agriculture should work with the Commissioner of FDA to develop a mechanism to facilitate coordination with relevant nonfederal stakeholders, including state, local, and tribal governments, on actions related to date labels as part of their efforts to reduce food loss and waste. (Recommendation 1)

Agency: Department of Agriculture
Status: Open

Comments: USDA agreed with our recommendation and is planning actions to implement the recommendation.

Recommendation: The Commissioner of FDA should work with the Secretary of Agriculture to develop a mechanism to facilitate coordination with relevant nonfederal stakeholders, including state, local, and tribal governments, on actions related to date labels as part of their efforts to reduce food loss and waste. (Recommendation 2)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: FDA agreed with our recommendation and is taking actions to implement the recommendation. For example, as of August 2020, FDA said it is meeting regularly with USDA and EPA to coordinate activities including to clarify and communicate information on food date labels. FDA also named a representative to the Association of Food and Drug Officials (AFDO) Food Recovery Committee. FDA is encouraging the Committee to explore how date labels on packaged foods can create a barrier to food donation and to track state legislative activities related to date labeling of food. We will update the status of this recommendation as FDA makes more progress.

Recommendation: The Administrator of APHIS should develop a timeline for (1) defining birds that are not bred for research and that are covered by the Animal Welfare Act, and (2) requiring that research facilities report to APHIS their use of birds covered by the act. (Recommendation 1)

Agency: Department of Agriculture: Animal and Plant Health Inspection Service
Status: Open

Comments: According to APHIS officials, the agency developed a timeline and a work plan for an Advance Notice of Proposed Rule Making (ANPRM) to define "bred for use in research" as it applies to birds (as well as to rats and mice) under the Animal Welfare Act and submitted it to USDA officials on July 18, 2019. However, as of October 2019, USDA had not established a date to publish the ANPRM and had instead placed it on the department's long-term regulatory agenda. We will continue to monitor USDA's efforts and provide updated information when it becomes available.

Recommendation: The Administrator of APHIS should instruct federal agencies to report their use of animals covered by the Animal Welfare Act in federal facilities located outside of the United States. (Recommendation 2)

Agency: Department of Agriculture: Animal and Plant Health Inspection Service
Status: Open

Comments: USDA disagreed with this recommendation for several reasons. For example, USDA stated that the absence of an exclusion to the requirements of the Animal Welfare Act or its regulations for federal research located outside of the United States does not create a requirement to collect information about such facilities' use of animals. In October 2019, APHIS officials said the agency continues to disagree with the recommendation. However, we have no reason to believe that such facilities should be excluded under the Act, and we continue to believe that the Administrator of APHIS should instruct federal agencies to report their use of animals in activities covered by the Animal Welfare Act in federal facilities located outside of the United States. We will continue to monitor any actions taken by APHIS to address this recommendation and provide updated information when it becomes available.

Recommendation: In developing the definition of field studies, the Administrator of APHIS should provide research facilities with clear criteria for identifying field studies that are covered by the Animal Welfare Act's regulations and that facilities should report to APHIS as well as field studies that facilities should not report. (Recommendation 3)

Agency: Department of Agriculture: Animal and Plant Health Inspection Service
Status: Open

Comments: In its comments on our draft report, USDA stated that APHIS agreed to issue a guidance document by December 31, 2018. According to APHIS officials, the agency prepared a draft guidance document entitled "Research Involving Free-Living Wild Species" for departmental review in April 2019. As of October 2019, APHIS was in the process of reviewing comments from the department. We will continue to monitor APHIS and USDA's actions to implement the recommendation.

Recommendation: The Administrator of the Food Safety and Inspection Service (FSIS) should document the agency's process for deciding which products to consider for new pathogen standards, including the basis on which such decisions should be made. (Recommendation 1).

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open

Comments: As of September 2019, FSIS is drafting a document that will outline the agency's process for deciding which products to consider for new pathogen standards, including the basis on which such decisions should be made. FSIS estimates the document will be finalized in the fourth quarter of fiscal year 2020. As of October 2020, FSIS has not completed this action.

Recommendation: The Administrator of FSIS should set time frames for determining what pathogen standards or additional policies are needed to address pathogens in beef carcasses, ground beef, pork cuts, and ground pork. (Recommendation 2).

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open

Comments: In October 2019, FSIS proposed new pathogen reduction performance standards for Salmonella in raw ground beef and beef trimmings. FSIS told us the agency is developing performance standards for some pork products and plans to issue draft standards sometime in fiscal year 2020 but as of October 2020 has not completed this action.

Recommendation: The Administrator of FSIS should include available information on the effectiveness of on-farm practices to reduce the level of pathogens as it finalizes its guidelines for controlling Salmonella in hogs. (Recommendation 3).

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open

Comments: As of September 2019, FSIS is revising its draft guidelines for controlling Salmonella in hogs. The agency plans to include in the guidelines available scientific information on the effectiveness of on-farm practices to reduce Salmonella. FSIS estimates it will complete its revision of the guidelines in the fourth quarter of fiscal year 2020 but as of October 2020 has not completed this action.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop a process, which may include time frames, to establish appropriate durations of use on labels of all medically important antibiotics used in food animals.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA published a notice in the Federal Register In September 2016 requesting information from the public about how to establish appropriately targeted durations of use for therapeutic products affected by Guidance for Industry #213 with no defined duration of use. According to HHS, FDA evaluated the comments received and plans to develop a strategy to address this issue. In July 2019, HHS stated that FDA published a Request for Applications on April 1, 2019 for study proposals to help establish more targeted or defined durations of use for approved medically important antimicrobial drugs used in the feed of food-producing animals. There are currently no such products approved for use in water with an undefined duration of use. According to HHS, due to significant scientific and technical challenges, FDA anticipates that this initiative will require substantial time to fully implement so the primary objective is to update product dosage regimens to better target when and for how long the drug may be used.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to establish steps to increase veterinary oversight of medically important antibiotics administered in routes other than feed and water, such as injections and tablets.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA recognizes that a limited number of medically important antimicrobial products, available in dosage forms other than feed or water (e.g., injectable), continue to be marketed as OTC products and the agency intends to work with the sponsors to put these products under veterinary oversight. In July 2019, HHS stated that FDA released a broad 5-year plan in September 2018 outlining steps to support stewardship of medically important antimicrobials in veterinary settings. As part of that plan, FDA intends to publish a draft strategy, likely in the form of draft guidance for industry, to bring all dosage forms (such as injectables and tablets) of medically important antimicrobial drugs under veterinary oversight. The draft strategy will also provide a framework, including proposed timelines, for transitioning from over-the-counter to prescription marketing status for all approved medically important antimicrobial drugs that are not yet subject to veterinary oversight. FDA plans to issue this draft strategy no later than the end of fiscal year 2019. In conjunction with issuing the draft strategy, FDA intends to publish a list of affected new animal drug applications.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop performance measures and targets for actions to manage the use of antibiotics such as revising the veterinary feed directive and developing guidance documents on judicious use.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS noted that FDA has taken steps to develop performance measures and targets. According to HHS, FDA issued a final rule in May 2016 revising annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, and turkeys). Additionally, in August 2017, FDA published a paper proposing the use of a biomass denominator to adjust annual data on the volume of antimicrobials sold or distributed for use in food-producing animals in the United States. According to HHS, this adjusted estimate will provide insight into broad shifts in the volume of antimicrobials sold for use in food-producing animals. FDA is also funding two grants for antimicrobial use data collection. These collection efforts are intended to provide part of the baseline information on antimicrobial use practices in the four major food-producing animal groups (i.e., cattle, swine, chickens, and turkeys), which is a critical element in measuring overall impact of the agency's judicious use strategy. FDA expects these data collection efforts to provide important information on methodologies to help optimize long-term strategies to collect and report such antimicrobial use data. In addition, FDA has been working in close collaboration with USDA, including providing input on recent surveys administered by USDA to collect information on antimicrobial use on farms. In July 2019, according to HHS, FDA agrees that performance measures and targets are needed to help gauge the success of antimicrobial stewardship efforts. While the agency continues to work on developing such measures and targets, FDA reported a decrease in domestic sales and distribution of all medically important antimicrobials intended for use in food-producing animals (e.g. decreased by 33 percent from 2016 through 2017). HHS noted that the reduction in sales volume is an important indicator that ongoing efforts to support antimicrobial stewardship are having a significant impact even though sales data do not necessarily reflect antimicrobial use.

Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS and the Administrator of the Food Safety and Inspection Service to work with the Director of CDC to develop a framework for deciding when on-farm investigations are warranted during outbreaks.

Agency: Department of Agriculture
Status: Open

Comments: USDA agreed with this recommendation. In August 2018, USDA's Animal and Plant Health Inspection Service (APHIS) stated that it is working closely with USDA's Food Safety and Inspection Service (FSIS) and HHS' Centers for Disease Control and Prevention (CDC) to develop a framework for deciding when on-farm antimicrobial resistance investigative activities are warranted. In September 2019, according to APHIS officials, the lead agencies, including APHIS, FSIS, and CDC, have agreed that it is imperative that cross sector partners from a range of animal agriculture industries be included in developing the framework that was requested in GAO's final report. A framework for making decisions regarding on-farm antimicrobial resistance investigative activities simply will not work without including industry sector partners in the development of the framework, according to APHIS officials. Due to the logistics of getting all of the cross sector partners together, APHIS is unable to schedule the next meeting in the series to develop the Pre-Harvest Framework until December 2019. APHIS anticipates that it will take the remainder of fiscal year 2020 to work through additional meetings with partners and finalize this framework.

Recommendation: To better inform users of the annual monitoring report about the frequency and scope of pesticide tolerance violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to disclose in the agency's annual pesticide monitoring program report which pesticides with EPA-established tolerances the agency did not test for in its pesticide monitoring program and the potential effect of not testing for those pesticides.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In February 2020, FDA said that the recommendation should be closed as not implemented. FDA has previously said that it remained concerned that the disclosure of pesticides for which FDA does not test would enable users to more easily circumvent the pesticide monitoring program, which could jeopardize public health and, at a minimum, would undermine FDA's law enforcement efforts. In addition, FDA said that it discloses in its annual reports all pesticides tested for within the reports' annual scope as required by the Pesticide Monitoring Improvements Act of 1988. FDA's annual reports also clarify that not all pesticides for which EPA has established tolerances were analyzed. FDA said that the Pesticide Monitoring Improvements Act of 1988 does not specifically direct the agency to report information on untested pesticides with EPA-established tolerances. We continue to believe that disclosing the pesticides that are not included in FDA's testing program would be consistent with OMB best practices for reporting limitations relevant to analyzing and interpreting results from a data collection effort. In particular, we continue to believe that FDA should be more transparent about the potential effect of not testing for all pesticides for which EPA has established tolerances. We also note that the Department of Agriculture's Food Safety and Inspection Service implemented a similar recommendation to disclose information about its pesticide monitoring program. As a result, we are keeping this recommendation open.