January, 2017

    February 6, 2017


    Obama White House Releases 2017 Update to Coordinated Framework for the Regulation of Biotechnology

    On January 4, the White House announced the release of a 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The update comes as a part of an Obama Administration effort to modernize the regulatory system for biotechnology products that charged the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA) to accomplish three tasks:

    • clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
    • develop a long-term strategy to ensure that the federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
    • commission an expert analysis of the future landscape of biotechnology products.

    The update is intended to be a comprehensive summary of the roles and responsibilities of the three principal regulatory agencies with respect to regulating biotechnology products. In addition, the government also released a National Strategy for Modernizing the Regulatory System for Biotechnology Products, which details the regulatory structure and oversight for all products of modern biotechnology. The strategy is intended to provide a framework for federal agencies to maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable, and efficient regulatory practices.

    Trump Selects Perdue for Agriculture Secretary

    On January 19, just one day before his inauguration, President-Elect Trump announced his nomination of Sonny Perdue for Secretary of Agriculture. Perdue is a part of Trump’s agriculture advisory group and was thought to be a strong candidate shortly after the election. The announcement of Purdue completes the nominations for cabinet positions.

    Perdue is a former two-term governor of Georgia and has a history of working on agriculture issues. He grew up on a farm, holds a Doctorate of Veterinary Medicine from the University of Georgia, and has run several agribusinesses. His veterinary experience is a hopeful sign that the nominee for understands the importance of animal science and will support animal agriculture during his tenure at USDA. Confirmation hearings for Perdue are expected to be scheduled in mid- to late-February.

    USDA Transition Efforts Expanding

    Along with the announcement of Sonny Perdue as Trump’s nominee for Agriculture Secretary, the Trump transition team has recently announced that Sam Clovis will be leading the “beachhead” team at USDA. Clovis, a national co-chair of Trump’s campaign, is an Iowa native and former economics professor. After the inauguration, beachhead teams were deployed to the various departments to help ensure a smooth transition, start establishing new administration policies, and continue the process of filling other political positions (USDA has approximately 250).

    First 2018 Farm Bill Hearing Scheduled

    On January 25, Senate Agriculture Committee Chairman Pat Roberts (R-KS) announced plans to hold the committee’s first hearing for the next Farm Bill. The hearing will take place on February 23 at Kansas State University in Manhattan, Kansas, and is titled “Hearing from the Heartland: Perspectives on the 2018 Farm Bill from Kansas.” The hearing will officially mark the beginning of the 2018 Farm Bill process, with more hearings expected by the Senate and House Agriculture Committees this year.

    Obama Administration Finalizes Organic Animal Welfare Rules

    As one of the last regulatory actions of the Obama’s Department of Agriculture, the Agricultural Marketing Service published its Final Rule on organic animal welfare standards on January 18. The Final Rule goes into effect 60 days from publication and establishes production standards for organic livestock and poultry, including transport and slaughter.

    Key components of the rule include

    • Requiring that producers provide animals with daily access to the outdoors and that outdoor areas include vegetation and/or soil. Additionally, exit doors must be distributed to ensure animals have ready access to the outdoors. It does not allow enclosed porches to be considered outdoors or to meet the requirement for outdoor access.
    • Specifying the amount of space required indoors for chicken broilers and layers, prohibits forced molting, restricts the use of artificial light, limits the amount of ammonia in the air indoors, and requires perching space for laying chickens indoors.
    • Describing when producers can confine animals indoors temporarily and codifies flexibility for producers to confine animals when their health, safety, or well-being could be jeopardized.
    • Adding humane handling requirements for transporting livestock and poultry to sale or slaughter, and clarifies humane slaughter requirements.
    • Prohibiting several kinds of physical alteration, like de-beaking chickens or docking cows’ tails.

    The Final Rule was met with strong criticism by livestock, dairy, and poultry groups, as well as bipartisan concerns from several key Members of Congress. Senate Agriculture Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI) both issued statements critical of the USDA action. House Agriculture Committee Chairman Mike Conaway (R-TX) also expressed his disappointment in the Final Rule. For text of the Final Rule and additional information, click here.

    Trump Administration Places Temporary Freeze on Late-Term Obama Regulations

    On January 20, 2017, the new White House Chief of Staff Reince Priebus issued a Memorandum for the Heads of Executive Departments and Agencies on “Regulatory Freeze Pending Review.” The memorandum, which is subject to exemptions for emergency situations or other urgent circumstances relating to health, safety, financial, or national security matters, is designed to ensure that the President's appointees or designees have the opportunity to review any new or pending regulations. The move is similar to a freeze that President Obama placed on regulations at the beginning of his first term.

    Specifically, the memorandum asks departments and agencies to

    • Send no regulations to the Federal Register until a department or agency head appointed or designated by the President after noon on January 20, 2017, reviews and approves the regulation.
    • For regulations that have been sent to the Federal Register but not yet published, immediately withdraw them (subject to the exceptions described above and consistent with Federal Register procedures).
    • For regulations that have been published in the Federal Register but have not taken effect, temporarily postpone their effective date for 60 days for the purpose of reviewing questions of fact, law, and policy (and possible further review). This provision will temporarily delay the effective date of the Organic Animal Welfare Rule and the recently finalized GIPSA rule.

    Trump Signs Executive Order on Reducing Regulation and Controlling Regulatory Costs

    On January 30, President Trump signed an Executive Order entitled “Reducing Regulation and Controlling Regulatory Costs.” The action addresses a promise he made on the campaign trail to curtail the impact of federal regulations. The Executive Order institutes a policy that for every one new regulation issued, at least two prior regulations must be identified for elimination. The order also calls for a reduction in costs of regulations and places a cap of zero dollars on new regulations for the remainder of fiscal year 2017. Any new incremental costs associated with new regulations in 2017 must be offset by the elimination of existing regulatory costs. Beginning in fiscal year 2018, each agency will be given a set budget for regulatory expenses. Agencies will be required to identify budget offsets for any regulation that is estimated to have increased costs in that fiscal year. The White House Office of Management and Budget will provide additional guidance to agencies on how to comply with the new policies.

    Trump’s actions signal a significant shift in the regulatory climate. The new policies may make it more difficult for USDA to advance rules such as those required by the GMO labeling legislation signed into law last year.

    Interim Communications Policies Cause Controversy

    In addition to a temporary freeze on regulations, several agencies have placed temporary restrictions on external communications. A memo from the Agricultural Research Service (ARS) Chief of Staff caused concern as it was reported by media that the agency would be restricting any outward-facing communications until further notice. USDA’s Acting Deputy Secretary clarified the Department’s official policy with guidance that superseded the ARS memo. The USDA’s interim measures sets protocols that press releases and policy statements must be routed through the Secretary’s office.

    The Acting Deputy Secretary, a long-time career employee, stated in the memo that “In order for the Department to deliver unified, consistent messages, it's important for the Office of the Secretary to be consulted on media inquiries and proposed response to questions related to legislation, budgets, policy issues, and regulations.” “Policy-related statements should not be made to the press without notifying and consulting the Office of the Secretary. That includes press releases and on and off the record conversations.” The interim policy is very similar to the policy instituted during the early stages of the Obama Administration.

    Senate Agriculture Appropriations Subcommittee Roster Announced

    On January 24, Senate Appropriations Committee chair Thad Cochran announced the roster for the Senate Agriculture Appropriations Subcommittee. Senator John Hoeven (R-ND) was selected to replace outgoing chair Jerry Moran (R-KS) to head the Subcommittee. Other members of the subcommittee include:

    John Hoeven (ND) – Chair
    Jeff Merkley (OR) – Ranking Member
    Thad Cochran (MS)
    Dianne Feinstein (CA)
    Mitch McConnell (KY)
    Jon Tester (MT)
    Susan Collins (ME)
    Tom Udall (NM)
    Roy Blunt (MO)
    Patrick Leahy (VT)
    Jerry Moran (KS)
    Tammy Baldwin (WI)
    Marco Rubio (FL)