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Showing 12 posts by Alan J. Sachs.

California Appeals Court Upholds State’s Reliance On Conclusion By A Foreign Agency To Classify Glyphosate As “Cancer-Causing”

Two courts recently examined California’s regulation of glyphosate, a widely used pesticide ingredient, for its alleged health risks via the state’s Proposition 65 warning program. The decisions are noteworthy for the contrasting approaches that they take with respect to the amount of deference to give to international regulatory actions that are incorporated by reference into U.S. law. Read More ›

USDA Seeks Comments on Proposed Bioengineered Food Disclosure Standard

On May 3, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced its proposed bioengineered food disclosure standard.  Consistent with the federal mandate signed into law on July 29, 2016, the proposed National Bioengineered Food Disclosure Standard (NBFDS) establishes the first-ever nationwide labeling requirements for bioengineered food.  USDA is charged with finalizing its implementing rules by July 29, 2018, and is accepting public comments on its proposal for 60 days. Read More ›

USDA Accepting Public Comments on “Clean Meat” Labeling Petition

On February 8, 2018, the United States Cattlemen’s Association (USCA) filed a petition with the United States Department of Agriculture (USDA) requesting that the Agency establish a food labeling requirement that the term “beef” only be used to refer to products that “come from cattle that have been born, raised, and harvested in the traditional manner.”  If USDA takes the requested action, manufacturers of new “clean meat” products would be prevented from labeling their products as “beef” or “meat.”  Industry stakeholders and other interested members of the public may submit comments on USCA’s petition until April 23, 2018. Read More ›

EU’s Highest Court Issues Advisory Opinion Supporting Exemption of Directed Mutagenesis Products From GMO Regulation

In a case with wide-reaching implications for the European Union’s (EU) regulation of products developed using CRISPR/Cas9 and other targeted genome-editing techniques, the European Court of Justice (ECJ) released an advisory opinion by an Advocate General last month suggesting that products developed using new mutagenesis techniques should be exempt from risk assessment and other requirements applicable to genetically modified organisms (GMOs).  Subsequent adoption of the Advocate General’s conclusions by the ECJ would mean that products developed using directed nuclease mutagenesis methods such as CRISPR/Cas9, TALEN, and zinc-finger nucleases will not be subject to regulation as GMOs under the EU’s 2001 GMO Directive (2001/18/EC).    Read More ›

EPA Issues New Strategic Plan with Sharp Changes to Agency Goals and Policies

On February 12, 2018, the U.S. Environmental Protection Agency ("EPA" or “Agency”) released its FY 2018-2022 EPA Strategic Plan (“the Plan”), the primary agenda for EPA’s implementation of three over-arching goals set by Administrator Scott Pruitt, as follows:

  1. Core Mission: “[P]rovide Americans with clean air, land, and water, and ensure chemical safety.”
  2. Cooperative Federalism: “Rebalance the power between Washington and the states….”
  3. Rule of Law and Process: “Administer the law…to refocus the Agency on its statutory obligations under the law.”
Read More ›

Environmental Protection Agency Streamlines Pesticide Residue Chemistry Data Requirements for Seed Treatment Uses

On January 26, the U.S. Environmental Protection Agency (EPA) announcedreduced residue chemistry data requirements for many seed-treatment pesticide uses.  The new guidance introduces important changes to EPA policy and creates a new tiered approach for applicants to use in determining field trial requirements for new seed-treatment uses.  Read More ›

USDA Announces New Phytosanitary Requirements for Soybean Exports to China

On December 27, 2017, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced a new procedure for U.S. soybean exporters to comply with China’s phytosanitary import requirements and ensure the continued export of U.S. soybeans.  Soybean growers and exporters in the United States should understand the new procedure, which went into effect on January 1, 2018 and applies to both bulk and container shipments of raw, unprocessed soybeans to China. Read More ›

USDA Issues Annual Agricultural Biotechnology Report for China

On December 29, 2017, the United States Department of Agriculture’s Foreign Agricultural Service (USDA-FAS) issued its annual report on the status of agricultural biotechnology in China.  According to the new report, which outlines China’s recent trade, policy, and marketing activities in connection with both plant and animal biotechnology, China has still not approved any major genetically engineered (GE) food or feed crops for cultivation, notwithstanding pledges it made in 2016 to advance commercialization of new domestic types of Bt corn, Bt cotton, and herbicide-resistant soy by 2020.  Particularly given China’s status as the largest importer of GE crops and one of the largest producers of GE cotton in the world, the new report is important to agriculture and biotechnology stakeholders in the United States and around the world.  Read More ›

Competing Cosmetic Safety Bills Would Each Expand FDA Regulatory Authority

On October 25, 2017, Senator Orin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act.”[1] The proposed legislation would amend the Federal Food, Drug and Cosmetic Act of 1938 (“FFDCA”) and allow the Food and Drug Administration (“FDA”) to regulate finished cosmetic products based on their safety and the safety of their components. Senator Hatch’s legislation presents an alternative to the Personal Care Products Safety Act (S. 1113), a bill reintroduced in May 2017 by Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine).[2] The Senate referred the bill to the Health, Education, Labor, and Pensions Committee on
October  25, 2017. Read More ›

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology.  The first document, a proposed update to the 1986 framework, intends to clarify the current roles of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) – the three primary agencies involved in the regulation of biotechnology products.  Members of the regulated industry, other stakeholders, and members of the broader public may submit comments on the proposed update until November 1, 2016.  The second document presents a national strategy outlining future steps that the Agencies intend to take to ensure that the regulatory system addresses novel biotechnology product types going forward.  As directed by the Executive Office of the President last year, the Agencies have also commissioned development of a third document by the National Academies of Sciences, Engineering and Medicine (NAS) to address future biotechnology products and opportunities to enhance capabilities of the regulatory system.  The NAS expects to release its report at the end of 2016.  Read More ›