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    Results:

    Subject Term: "Food and drug legislation"

    5 publications with a total of 8 open recommendations
    Director: John Dicken
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To help FDA meet its goal of facilitating expanded access to investigational drugs by patients with serious or life-threatening diseases or conditions, when appropriate, the Commissioner of FDA should clearly communicate how the agency will use adverse event data from expanded access use when reviewing drugs and biologics for approval for marketing and sale in the United States.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Steve D. Morris
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To improve USDA's ability to oversee GE crops, the Secretary of Agriculture should direct the Administrator of the Animal and Plant Health Inspection Service (APHIS) to develop a timeline, with milestones and interim steps, for updating its existing regulations to cover GE crops developed with alternative technologies that either do not use plant pests or use plant pests but do not result in plant pest deoxyribonucleic acid in the crop developed.

    Agency: Department of Agriculture
    Status: Open

    Comments: In its August 2016 Statement of Action on our report, USDA notes that it has a timeline, but the department did not provide documentation of this timeline. The Statement of Action also indicates that USDA planned to update its biotechnology regulations and publish a proposed rule in the summer of 2016. As of December 2016, the proposed rule had not yet been published.
    Recommendation: To improve USDA's ability to better understand the economic impacts of unintended mixing of GE and other crops, the Secretary of Agriculture should direct the Administrator of the National Agricultural Statistics Service (NASS) to work with all relevant USDA stakeholders, including APHIS and the Organic Working Group, to determine what additional information should be sought in future organic surveys, such as the costs of reshipping and re-storing shipments rejected because of unintended GE presence, as well as the costs associated with finding new buyers for such shipments.

    Agency: Department of Agriculture
    Status: Open

    Comments: In its August 2016 Statement of Action on our report, USDA did not provide any new information on actions it has taken, if any, to implement this recommendation. For example, there is no indication whether stakeholders internal to the department have continued to meet to discuss the 2014 Organic Survey results and how to move forward with future survey questions to obtain additional data, such as data needed to better understand the economic impacts of unintended mixing with GE crops.
    Recommendation: To improve USDA's ability to better understand the economic impacts of unintended mixing of GE and other crops, the Secretary of Agriculture should direct the Administrator of NASS to include producers, growing identity-preserved crops, in addition to organic producers in USDA's survey efforts.

    Agency: Department of Agriculture
    Status: Open

    Comments: In its August 2016 Statement of Action on our report, USDA did not provide any new information on actions it has taken, if any, to implement this recommendation. We continue to believe that USDA should survey producers growing identity-preserved crops regarding their potential economic losses from unintended GE presence, as is being done for organic producers. As we previously reported, U.S. acreage planted to identity-preserved crops is significantly greater than that planted to organic crops; yet, little is known about the economic costs to identity-preserved farmers of unintended mixing.
    Director: Thomas Melito
    Phone: (202) 512-9601

    2 open recommendations
    Recommendation: While recognizing that cargo preference serves policy goals established by Congress with respect to the U.S. merchant marine, including maintenance of a fleet capable of serving as a naval and military auxiliary in time of war or national emergency, Congress should consider clarifying cargo preference legislation regarding the definition of "geographic area" to ensure that agencies can fully utilize the flexibility Congress granted to them when it lowered the CPFA requirement.

    Agency: Congress
    Status: Open

    Comments: We did not receive comments on the Matter for Congressional Consideration. As of March 2017, no legislation had been introduced to clarify the definition of 'geographic area' with regard to cargo preference laws.
    Recommendation: The Secretary of Transportation should direct the Administrator of MARAD to study the potential availability of all qualified mariners needed to meet a full and prolonged activation of the reserve sealift fleet. In the study, MARAD should identify potential solutions to address the mariner shortfall if one is still identified.

    Agency: Department of Transportation
    Status: Open

    Comments: In its written comments, DOT concurred with our recommendation to study the potential availability of all qualified mariners needed to meet a full and prolonged activation of the reserve sealift fleet. DOT stated that MARAD has been reviewing the adequacy of existing plans to recruit mariner volunteers to crew the full reserve fleet. Furthermore, DOT noted that 13,000 mariners are required to crew all the vessels in the fleet for sustained operations. On June 15, 2016, GAO contacted MARAD officials to clarify the current status of the National Maritime Strategy, which DOT officials had stated would contain the results of their review. The officials said that the Strategy is still in the interagency process for approval and is not likely to be published until the end of 2016. DOT told GAO in December 2016 that it had conducted an exercise in September 2016 to test mariner availability for an initial activation of the full fleet. However, this exercise did not fully address GAO's recommendation, as it did not test for a full and prolonged activation of the fleet. Furthermore, DOT officials told GAO in April 2017 that the National Maritime Strategy has not been released and is awaiting review from the current Administration.
    Director: Gomez, Jose A
    Phone: (202)512-2649

    1 open recommendations
    Recommendation: To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to better enable FDA to meet its responsibility to regulate dietary supplements that contain new dietary ingredients, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2011, FDA published draft guidance for industry on new dietary ingredient notifications and related issues. This draft guidance includes information on when a dietary ingredient is considered new, evidence of safety, and methods for ingredient identity. We are waiting for the draft guidance to become final to close the recommendation.
    Director: Dyckman, Lawrence J
    Phone: (202)512-9692

    1 open recommendations
    Recommendation: To provide more efficient, consistent, and effective federal oversight of the nation's food supply, Congress should consider commissioning the National Academy of Sciences or a blue ribbon panel to conduct a detailed analysis of alternative organizational food safety structures and report the results of such an analysis to Congress.

    Agency: Congress
    Status: Open

    Comments: The 2002 Farm Security and Rural Investment Act established a national Food Safety Commission charged with making specific recommendations for drafting legislative language. Among other things, the Commission is to make recommendations on how to improve the food safety system, create a harmonized, central framework for managing federal food safety programs, and enhance the effectiveness of federal food safety resources. However, as of January 2017, as far as current staff can ascertain, the Commission was never formed, and no recommendations were ever produced. Thus, although Congress acted to create a food safety commission through legislation, the substance of our matter--recommendations for analyzing alternative food safety structures--was not implemented. GAO subsequently made the same matter for congressional consideration in several later products, and the matter also appeared in the annual DOF report. As of January 2017, no action had been taken. Therefore, in January 2017, we reopened this matter.