For an excellent and current update on Agricultural Biotechnology, see Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues, Cong. Res. Serv., CRS Rep. No. 43767 (Mar. 29, 2021).

 

This page is under construction. Refer to the report cited above, check back next semester for updated information.

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Documents & Links

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The resources for this chapter are divided into five categories. Each begins with the most recent resources, followed by resources referenced in Food, Farming, & Sustainability.  

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General Approach to Regulation

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New 2020 Development: The USDA published a final rule revising its regulatory approval process for genetically engineered plants and organisms and " reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks." 85 Fed. Reg. 29,790 (final rule to be codified at 7 C.F.R. § 340) (May 18, 2020). The new rule is titled the Sustainable, Ecological, Consistent, Uniform, Responsible Efficient rule. In a clear marketing initiative to those skeptical of the lack of regulatory structure, it is referred to the "SECURE" rule. Phased implementation runs from June 2020 to October 2021. The Congressional Research Service has completed a helpful In Focus Report that summarizes the rule and the new regulatory process. See, USDA’s SECURE Rule to Regulate Agricultural Biotechnology, CRS In Focus Rep, IF-11573 (June 12, 2020)

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FDA Press Release,  FDA Announces Plant and Animal Biotechnology Innovation Plan (Oct. 31, 2018).  This announcement outlines the key priorities that the FDA plans to pursue "to support innovation in plant and animal biotechnology while advancing the agency’s public health mission." The announcement states that the "overall goal of the action plan is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation."

 

Direct link:  FDA’s Plant and Animal Biotechnology Innovation Action Plan (Oct. 30. 2018).

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Article Summarizing Review & Update to Coordinated Framework:  

 

• Bergeson & Campbell, P.C., White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology (Jan. 10, 2017)

 

 

2017 Update to the Coordinated Framework:

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• Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (Jan. 7, 2017).

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• National Strategy for Modernizing the Regulatory System for Biotechnology Products, Emerging Technologies Interagency Policy Coordination Committee’s Biotechnology Working Group (Sept. 2016) (downloaded from the archived Obama Whitehouse site).

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2017 Proposed Changes to USDA APHIS Regulations for Genetically Engineered Organisms:

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Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms, 82 Fed. Reg. 7008 (proposed rule to revise 7 C.F.R. pt. 340 )(Jan. 19, 2017).  On February 10, 2017, USDA APHIS announced an extension to the comment period through June 19, 2017.  81 Fed. Reg.  74,722 (Feb. 10. 2017).

 

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Prior Attempt to Propose Revised Rule: 

APHIS Announces Withdrawal of 2008 Proposed Rule for Biotechnology Regulations, USDA, APHIS (Feb. 27, 2015).

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Background Related to the Update to the Coordinated Framework:

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Docket No. FDA-2015-N-3403, Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Regulations.gov docket folder).

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Transcripts and Documents from Public Meetings to discuss "Modernizing the Regulatory System for Biotechnology Products,"  USDA APHIS website

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John P. Holdren, Howard Shelanski, Darci Vetter, and Christy Goldfuss, Improving Transparency and Ensuring Continued Safety in Biotechnology, (introducing the EOP memo below) (July 2, 2015).

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Modernizing the Regulatory System for Biotechnology Products, issued by the Executive Office of the President (EOP) (direction to agencies to develop updated coordinated framework for regulation of biotechnology) (July 2, 2015). 

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Other General Resources:

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GAO Report: Genetically Engineered Crops: USDA Needs to Enhance

Oversight and Better Understand Impacts of Unintended Mixing with

Other Crops, GAO-16-241 (Published: Mar 15, 2016; Publicly Released:

Apr 14, 2016).

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Tadlock Cowan, Agricultural Biotechnology: Background, Regulation,

and Policy Issues, Cong. Res. Serv. Rep. No. RL-32809 (July 20, 2015).

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Guidance for Industry: Regulation of Intentionally Altered Genomic

DNA in Animals, Draft Guidance, FDA, Center for Veterinary Medicine

(Jan. 2017).

 

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Genetically Modified Salmon (AquAdvantage)

 

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Guidance for Industry: Regulation of Intentionally Altered Genomic DNA in Animals, Draft Guidance, FDA, Center for Veterinary Medicine (Jan. 2017).

 

 

FDA, Animal & Veterinary, Development & Approval Process, Genetic Engineering, Genetically Engineered Animals webpage, AquAdvantage Salmon (last updated April 2016) (includes posting of documents regarding approval).

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The FDA issued Import Alert 99-40 on January 29, 2016 prohibiting the entry into commerce of genetically engineered salmon. The reason for the alert was listed as follows:

 

The Fiscal Year (FY) 2016 Omnibus Appropriations Act covering the funding of the federal government during fiscal year 2016 (FY16) was signed into law by the President on December 18, 2015 becoming Public Law No: 114-113. In part, this law directs that during FY16 the FDA shall not allow the introduction or delivery for introduction into interstate commerce of any food that contains genetically engineered salmon, until FDA publishes final labeling guidelines for informing consumers of such content.

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In September 2016, the Import Alert was modified as follows:

 

NOTE: The revision to this Import Alert dated ***09/30/2016*** provides clarification that the directive under Public Law No. 114-113 remains in effect under any Continuing Resolutions passed prior to the passage of the Fiscal Year 2017 Omnibus Appropriations Act. When the FDA receives and reviews the 2017 Omnibus Appropriations Act or FDA finalizes the guidelines as directed, the Import Alert will be modified accordingly or deactivated.

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FDA'S Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon;

 

• Notice of the Draft Guidance was published in the Federal Register, 80 Fed. Reg. 73,193 (Nov. 24, 2015).  

 

• The draft guidance requires no special labeling for genetically engineered salmon or its products and provides guidance as to how non-genetically engineered products can be labeled to indicate its status as non-GMO.

 

•  Senator Murkowski (R. Alaska) is credited with the insertion of a labeling requirement in the Agriculture Appropriations bill, resulting in the Import Alert above. 

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Harold F. Upton and Tadlock Cowan, Genetically Engineered Salmon, Cong. Res. Serv. Rep. R43518 (Dec. 8, 2015).

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Eugene H. Buck, Genetically Engineered Fish and Seafood: Environmental Concerns, Cong. Res. Serv. Rep. No. R41486  (Jan. 23, 2015).

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Genetically Modified Crops

 

2017 Proposed Changes to USDA APHIS Regulations for Genetically Engineered Organisms:

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Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms, 82 Fed. Reg. 7008 (proposed rule to revise 7 C.F.R. pt. 340 )(Jan. 19, 2017).  On February 10, 2017, USDA APHIS announced an extension to the comment period through June 19, 2017.  81 Fed. Reg.  74,722 (Feb. 10. 2017).

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GAO Report: Genetically Engineered Crops: USDA Needs to Enhance Oversight and Better Understand Impacts of Unintended Mixing with Other Crops, GAO-16-241 (Published: Mar 15, 2016; Publicly Released: Apr 14, 2016).

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Tadlock Cowan, Unapproved Genetically Modified Wheat Discovered in Oregon and Montana: Status and Implications, Cong. Res. Serv. Rep. No. 43100 (Dec. 4, 2014).

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Tadlock Cowan & Kristina Alexander, Deregulating Genetically Engineered Alfalfa and Sugar Beets: Legal and Administrative Responses, Cong. Res. Rep. No. R41395 (May 22, 2013).

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Farmers Legal Action Group, Inc., (FLAG), Farmers Guide to GMOs (Feb. 1, 2009).

 

 

Monsanto website, Why Does Monsanto Sue Farmers Who Save Seeds? 

 

 

Organic Seed Growers and Trade Association, et al., v. Monsanto Company, et al. 718 F.3d 1350 (Fed. Cir. 2013).   The Supreme Court denied the plaintiff’s request for review.  Supreme Court Case No. 13-303 (Jan 13 2014). 

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Labeling of Genetically-Engineered Foods

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The National Bioengineered Food Disclosure Law became law in July 2016, pre-empting all state GMO labeling laws and charging the USDA Agricultural Marketing Service (AMS) with developing a national mandatory system for disclosing the presence of genetically engineered ingredients in food products. The USDA was given two years to develop the regulatory framework for labeling.  

 

The USDA reports that it has "established a working group to develop a timeline for rulemaking and to ensure an open and transparent process for effectively establishing this new program, which will increase consumer confidence and understanding of the foods they buy, and avoid uncertainty for food companies and farmers."  

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Emily Lanza, Legal Issues with Federal Labeling of Genetically Engineered Food: In Brief  Cong. Res. Serv. Rep. No. R43705 (Sept. 22, 2015).

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2011 Text from Food, Farming, & Sustainability regarding labeling of genetically modified foods, as well as the relevant text from the 2015 Supplement​.

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FDA Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants

 

 

FDA Approach to GE Labeling:  Labeling of Foods Derived From Genetically Engineered Plants

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Historical Resources on State Efforts to Require GMO Labeling:  

 

California Proposition 37, Mandatory Labeling of Genetically Engineered Food (2012), Ballotpedia.org.

 

 

Washington Mandatory Labeling of Genetically Engineered Food Measure, Initiative 522 (2013), Ballotpedia.org.

 

 

Reid Wilson, Maine becomes second state to require GMO labels, Washington Post, (January 10, 2014). 

 

 

Text of Vermont GM Labeling Law,  9 VSA §§ 3041 - 3048 (2015).

 

 

District Court decision in Challenge to Vermont Labeling Law, Grocery Mfrs. Ass’n et al v. Sorrell, No. 5:14–cv–117  D. Vt. ( Apr. 27, 2015), --- F. Supp. ---, 2015 WL 1931142.

 

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International Trade and Genetically Engineered Products

 

 

Tadlock Cowan, Agricultural Biotechnology: Background and Recent Issues, Cong. Res. Rep. No. RL-32809 (July 20, 2015).

 

 

Tadlock Cowan, Unapproved Genetically Modified Wheat Discovered in Oregon and Montana: Status and Implications, Cong. Res. Serv. Rep. No. R43100 (Dec. 4, 2014). 

 

 

USDA Announcement, USDA Announces Close and Findings of Investigation into the Detection of Genetically Engineered Wheat in Oregon in 2013; Opens New Investigation Into Separate Detection of GE Wheat in Montana in 2014 (Oct. 29, 2014).

 

 

2011 Text from Food, Farming, & Sustainability regarding international trade and genetically modified foods, as well as the relevant text from the 2015 Supplement​.