U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement announcing the agency's Plant and Animal Biotechnology Innovation Action Plan. Gottlieb describes the plan as identifying priorities in three areas: (i) "advancing human and animal health by promoting product innovation and applying modern, efficient and risk-based regulatory pathways;" (ii) "strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology;" and (iii) "increasing engagement with domestic and international partners on biotechnology issues." The plan indicates that FDA will "adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them." The statement also announced that the agency's Center for Veterinary Medicine will host a webinar on genome editing in animals on December 3, 2018.
Tag Archives biotechnology
The Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) has released the proposed National Bioengineered Food Disclosure Standard, which would establish "a mandatory uniform national standard for disclosure of information to consumers." The proposal defines “bioengineered food” as food “that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques" "for which the modification could not otherwise be obtained through conventional breeding or found in nature.” AMS seeks comments on "how to interpret the statutory definition of 'bioengineering,' and thus the scope of the regulatory definition of 'bioengineered food,'" according to the announcement. "In particular, AMS is interested in any additional studies conducted on this issue, the cost of implementation under each policy, and whether certain policies describing the scope of foods subject to the disclosure standard would lower costs to affected entities." Comments on the proposed rule must be received by July…
As gene-edited foods advance and move “closer to supermarket shelves,” agricultural and biotechnology groups are looking to avoid a dispute over public perception of the technology, according to the Wall Street Journal. Gene-editing technologies such as CRISPR/Cas9, TALEN and zinc-finger nucleases are different from techniques that create genetically modified organisms (GMOs), which involve the insertion of genes from external species to create plants with new characteristics. In contrast, gene-editing technology allows researchers to alter the plant’s DNA; the industry reportedly describes the process as “an extension of plant breeding, the centuries-old practice of crossing plant strains to create improved offspring." Industry regulators, including the U.S. Department of Agriculture, have indicated that they will not regulate gene-edited plants as strictly as those engineered with external DNA. However, the Non-GMO Project has barred gene-edited plants and animals from bearing its verification label, and opponents reportedly refer to the new technique as “GMO 2.0.”…
The U.S. Food and Drug Administration (FDA) has announced it will hold a public advisory committee meeting of its Science Board on June 26, 2017, in Silver Spring, Maryland. The Science Board will hear an update on FDA’s biotechnology activities related to animals and plant-derived food as well as a report from the National Antibiotic Resistance Monitoring System Review Subcommittee. Written submissions of data, information or opinions may be made on or before June 19, 2017. Issue 638
A budget plan passed to fund the U.S. government until September 2017 reportedly includes $3 million to pay for an information campaign about genetically modified organisms (GMOs) in food. As a partnership between the U.S. Food and Drug Administration (FDA) and the Department of Agriculture, the campaign will apparently seek to counter "misinformation about agricultural biotechnology." “It is not the responsibility of the FDA to mount a government-controlled propaganda campaign to convince the American public that genetically modified foods are safe,” Rep. Nita Lowey (DN.Y.) said. See The Washington Post, May 3, 2017. Issue 633
The U.S Congress has passed legislation (S.764) requiring food and beverage manufacturers to disclose the use of ingredients made with genetically modified organisms (GMOs). Crafted by U.S. Sens. Pat Roberts (R-Kan.) and Debbie Stabenow (D-Mich.) and backed by the Organic Trade Association (OTA), the bill defines bioengineered foods as those intended for human consumption that contain genetic material “modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques” and “for which the modification could not otherwise be obtained through conventional breeding or found in nature.” If signed by President Barack Obama (D) as expected, the legislation would direct the Secretary of Agriculture to establish within two years a mandatory standard for the disclosure of GMO ingredients in applicable products by “text, symbol, or electronic or digital link” such as a QR code, excluding URLs not embedded in the link. The new rules would also allow certified organic products bear “non-GMO” labels…
The National Academies of Sciences, Engineering and Medicine (NAS) has released a study examining research into man-made gene drives, a type of gene editing that allows for the spread of gene modifications “throughout a population of organisms intentionally.” Titled Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values, the report focuses on techniques that use segments of bacterial DNA—such as clustered regularly-interspaced short palindromic repeats (CRISPR)—paired with a guide protein (CRISPR-associated protein 9, or Cas9) “to make targeted cuts in an organism’s genome.” Organisms modified using CRISPR-Cas9 then pass these changes to their offspring through sexual reproduction, a process that allows scientists to alter whole populations in an effort to eradicate insect-borne infectious diseases, for example. Calling these developments “both encouraging and concerning,” the report seeks to provide “an independent, objective assessment of the state of knowledge and responsible practices for research, risk assessment,…
Ganeden Biotech Inc. has filed a lawsuit against American Brewing Co., Inc. and its 2015 acquisition, B&R Liquid Adventure, alleging the companies infringe its patents on a particular strain of probiotic bacteria through the marketing and sale of their búcha® beverage. Ganeden Biotech, Inc. v. Am. Brewing Co., Inc., No. 16-0876 (N.D. Ohio, filed April 13, 2016). Ganeden asserts that it holds a patent on a specific GBI-30 strain of Bacillus coagulans as used in tea and another patent on the strain as used in all other products. B&R began selling búcha® in 2013 and lists the GBI-30 strain as an ingredient, according to the complaint. “Because Ganeden holds a patent on GBI-30 and is the legitimate source of GBI-30, Ganeden believes that Defendants’ products likely contained Bacillus coagulans (which Defendants could have obtained elsewhere) but not always the GBI-30 strain as labeled,” the biotech company argues. For allegations of patent infringement and unfair…
Environmental activist Erin Brockovich uses the U.S. Food and Drug Administration’s (FDA’s) recent determination that genetically engineered salmon is safe for human consumption and requires no labeling as such to rally consumers into action against genetically modified organisms (GMOs) in a December 1, 2015, opinion piece in Time. “The biotech industry and the FDA have hijacked not only our basic rights as consumers, but also our fundamental human rights in the face of corporate monopolization of our food supply,” Brockovich said. “They are jeopardizing our health and the environment more than ever before. When will the government agencies put in place to protect us stop servicing the bottom line of corporations?” Brockovich briefly reviews the findings of various agencies and organizations worldwide, ultimately imploring readers to “help spark a larger conversation about the food we are eating in this country” by voicing their GMO-related concerns to federal lawmakers. Issue 586
In conjunction with its decision to approve the first genetically engineered (GE) animal for human consumption, the U.S. Food and Drug Administration (FDA) has published final labeling guidance for foods derived from GE crops and draft labeling guidance for GE salmon. Titled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants,” the final guidance document seeks to assist “food and feed manufacturers that wish to voluntarily label their plant-derived food products or ingredients (for humans or for animals) as having been made with or without bioengineering.” In addition, the agency’s draft labeling guidance—“Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon”—describes the preferred labeling terms for products marketed as containing or avoiding transgenic salmon. Emphasizing that such labeling should be “truthful and not misleading,” the agency recommends that manufacturers wishing to identify their products as not derived from GE ingredients use…
