Since genetically engineered (GE, sometimes called genetically modified organism or GMO) crop varieties first became commercially available in the mid-1990s, U.S. soybean, cotton, and corn farmers have rapidly adopted them in order to lower production costs and increase crop yields. Incidents of regulatory noncompliance have continued to spike concern about the adequacy of regulatory structures. Current Applications

			Crops

In 2013, GE crops were planted on an estimated 433 million acres worldwide ( Table 1 ), an increase of nearly 144 million acres over 2008. (See further discussion on FDA's review of GE salmon below.) Future GE Applications15

			"Input" Traits

For farmers, new insect-resistant and herbicide-tolerant GE varieties are under development or have been developed for other crops besides corn, cotton, and soybeans. The three lead agencies are USDA's Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA) at the Department of Health and Human Services, and the Environmental Protection Agency (EPA). All GE-derived products now on the U.S. market have undergone this process. Moreover, with the Coordinated Framework now nearly 30 years old, the fragmentation of the existing regulatory structure governing federal biotechnology policy today, the perceived lack of public transparency, and the overall confusion that biotechnology regulation seems to engender, the Obama Administration issued a memorandum on July 2, 2015, to update the Coordinated Framework to ensure that the regulatory structure is capable of meeting any biotechnology risks in the future. (21 U.S.C. Questions have been raised about the adequacy of using this regulatory protocol to address the myriad issues that approving the salmon might create. A significant step in the deregulation process involves an assessment of the plant's environmental impact. Several cases over the past several years have raised issues about the adequacy of APHIS's regulatory structure in moving to deregulate a GE plant. The GE salmon would be the first genetically engineered animal approved for human consumption and commercial-level farming. FDA is evaluating the GE salmon under its New Animal Drug Application Process (NADA), because the recombinant DNA construct that is intended to change the fish meets the definition of a drug as defined under the Federal Food, Drug, and Cosmetic Act. Difference between the United States and the EU regarding genetically engineered products and labeling of foods containing GE material are areas of significant conflict in the Transatlantic Trade and Investment Partnership (T-TIP) discussions. 1599)

On July 23, 2015, the full House passed a voluntary labeling bill, H.R. 1599 , to preempt current and future state laws that have been recently passed in Maine, Vermont, and Connecticut to require mandatory labeling of GE foods. H.R. 1599 would preempt any state authority over GE labeling in favor of a voluntary National Genetically Engineered Food Certification Program under amendments to the federal Agricultural Marketing Act of 1946. While preserving current jurisdiction, policies, definitions, and regulatory authority of FDA and APHIS, the Safe and Accurate Food Labeling Act of 2015 would also amend the Plant Protection Act by adding a new subtitle, the Coordination of Food Safety and Agriculture Programs. The voluntary consultative process under FDA's 1992 policy guidelines for the introduction of GE foods would continue. Under the bill, the voluntary National Genetically Engineered Food Certification Program within USDA would establish national standards for labeling both GE and non-GE foods. H.R. For poor countries without a well-articulated regulatory regime or scientific infrastructure for the introduction of GE products into their countries, the "science-based regulation" framing of the issue in the United States that underlies their promotion of GE crops conflicts with the EU precautionary principle. U.S. agricultural interests consider the EU regulation in particular to be unworkable and discriminatory. While not exhaustive, some of these issues may include:
evolving technologies, including the introduction of new "stacked trait" varieties—plant varieties with multiple genetically engineered traits—which is likely to increase; continuing development and the eventual commercialization of GE plant-based industrial and pharmaceutical output traits; oversight of second-generation biotechnology traits such as improved nutritional qualities and resistance to environmental stress (e.g., drought); transgenic animals and the food and industrial/pharmaceutical products derived from them; animal welfare concerns; importation of GE products; developing a low-level presence standard for unapproved GE materials in food and feed products; legal challenges to environmental assessments of transgenic plants and animals; issues related to transparency and the participation in policy and regulatory issues by various stakeholders (e.g., consumers, religious groups, animal welfare activists); compliance with existing and emerging regulatory structures in the United States and our trading partners, particularly the European Union; testing and measurement issues; traceability and labeling of GE products.
Biotechnology refers primarily to the use of recombinant DNA techniques to genetically modify or bioengineer plants and animals. Most crops developed through recombinant DNA technology have been engineered to be tolerant of various herbicides or to be pest resistant through having a pesticide genetically engineered into the plant organism. U.S. soybean, cotton, and corn farmers have rapidly adopted genetically engineered (GE) varieties of these crops since their commercialization in the mid-1990s. Over the past 15 years, GE varieties in the United States have increased from 3.6 million planted acres to 173 million acres in 2013. Worldwide, 27 countries planted GE crops on approximately 433 million acres in 2013. GE varieties now dominate soybean, cotton, and corn production in the United States, and they continue to expand rapidly in other countries, particularly in Latin America.
Ongoing policy issues include the impacts of GE crops on the environment (e.g., pest and weed resistance), whether GE foods should be labeled, their potential contamination of conventionally raised and organic plants, and issues of liability. Underlying these issues are concerns about the adequacy of federal regulation and oversight of GE organisms, particularly as newer applications (e.g., biopharmaceuticals, multiple GE traits in single organisms, GE trees, GE insects) emerge that did not exist when the current regulatory regime was established in 1986. The FDA is currently considering approval of the first GE animal for human consumption, a salmon engineered to grow to market size in half the normal time. Global trade issues involving GE organisms are a long-standing issue and are particularly salient in current U.S.-EU trade discussions on the Transatlantic Trade and Investment Partnership (T-TIP).
In the United States, agricultural biotechnology is regulated under the 1986 Coordinated Framework for the Regulation of Biotechnology. Three federal agencies—the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA)—share regulatory responsibilities. Regulatory non-compliance incidents and issues associated with environmental effects of GE plants have repeatedly raised concerns about the adequacy of existing U.S. regulatory structures. Questions have also arisen about the adequacy of USDA's Animal and Plant Health Inspection Service's (APHIS's) environmental assessments for deregulating GE plants.
In July 2015, the Administration announced in a memorandum to agency heads a review and update of the Coordinated Framework to ensure the capacity of the regulatory structure to address any future biotechnology risks. This is the first comprehensive review of the Coordinated Framework in nearly 30 years.
The 114th Congress passed a bill, H.R. 1599, to preempt various state laws that have been recently passed in Maine, Vermont, and Connecticut to require mandatory labeling of GE foods. While preserving current jurisdiction and regulatory authority of FDA and APHIS, the Safe and Accurate Food Labeling Act of 2015, as passed by the full House on July 23, 2015, would preempt any state authority over GE labeling in favor of a voluntary National Genetically Engineered Food Certification Program under the federal Agricultural Marketing Act of 1946. The certification program would establish national standards for labeling both GE and non-GE foods. A consultative process under FDA for the introduction of GE foods would continue, and a new notification system for GE plants used in food would be established.
Three bills have been introduced that would require labeling of GE products. One would amend the Federal Food, Drug, and Cosmetic Act to require labeling of GE fish (H.R. 393), and a separate bill would require labeling of all GE foods (H.R. 913/S. 511). A third bill, the Genetically Engineered Salmon Risk Reduction Act (S. 738), would require labeling of GE salmon and further require an environmental impact statement and risk analysis by the Under Secretary for Oceans and Atmosphere of the Department of Commerce.