On July 5, 2019, the U.S. Department of Agriculture (USDA) Office of Procurement and Property Management published a final rule that will amend the Guidelines for Designating Biobased Products for Federal Procurement (Guidelines) to add 30 sections designating the product categories within which biobased products would be afforded procurement preference by federal agencies and their contractors. These 30 product categories contain finished products that are made, in large part, from intermediate ingredients that have been designated for federal procurement preference. Additionally, USDA is amending the existing designated product categories of general purpose de-icers, firearm lubricants, laundry products, and water clarifying agents. The rule will be effective on August 5, 2019.
According to the final rule, when USDA designates by rulemaking a product category for preferred procurement under the BioPreferred Program, manufacturers of all products under the umbrella of that product category that meet the requirements to qualify for preferred procurement can claim that status for their products. To qualify for preferred procurement, a product must be within a designated product category and contain at least the minimum biobased content established for the designated product category. With the designation of these specific product categories, USDA invites manufacturers and vendors of qualifying products to provide information on the product, contacts, and performance testing for posting on its BioPreferred website. USDA states that procuring agencies will be able to use this website “as one tool to determine the availability of qualifying biobased products under a designated product category.”
For further information, see Bergeson & Campbell, P.C.’s memorandum on the final rule. In the memorandum, we link to the Biobased and Renewable Products Advocacy Group (BRAG®) and its interest in biobased products.
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Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.
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On May 22, 2019, the U.S. Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.” It provides recommendations on the design and evaluation of comparative analytical studies that intend to demonstrate that a proposed therapeutic protein product is biosimilar to a reference product licensed under the Public Health Service Act (PHS Act). Additionally, the draft guidance makes recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application. Comments on the draft guidance are due on or prior to July 22, 2019. In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards. Plant biotechnology consists of methods used to introduce new traits or characteristics to a plant (e.g., plants resistant to insect pests, plants with reduced food waste, or plants with reduced levels of harmful elements, amongst others). To assist developers in this field, FDA has a voluntary premarket Plant Biotechnology Consultation Program, which provides developers with the opportunity to engage with FDA to help navigate the appropriate regulatory pathways. The program includes individualized advice from FDA’s biotechnology and food safety experts prior to a plant-based product being permitted to enter the market and allows for biotechnology developers to consult with these FDA experts throughout the entire development, data collection, and evaluation process. On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon. In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S. According to FDA’s recent framework for the efficient development of safe biotechnology products, Plant and Animal Biotechnology Innovation Action Plan, Dr. Gottlieb stated that FDA has taken important steps to help advance new products. Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA). On July 30, 2018, Senators Susan Collins (R-ME) and Chris Coons (D-DE) reintroduced their sustainable chemistry bill, the Sustainable Chemistry Research and Development Act of 2018 (S. 3296). This bill encourages the development of new and innovative chemicals, products and processes with an improved “environmental footprint” through efficient use of resources, reducing or eliminating exposure to hazardous substances, or otherwise minimizing harm to human health and the environment. The legislation is intended to support new innovations in chemistry that benefit the economy, the environment, and human health. The bill supports coordinated efforts in sustainable chemistry across federal agencies through research and development, technology transfer, commercialization, education, and training programs -- including partnerships with the private sector. The bill does not include any regulatory components, nor does it authorize new spending. Its goal, rather, is to coordinate better federal activities in sustainable chemistry and encourage industry, academia, nonprofits, and the general public to innovate, develop, and bring to market new sustainable chemicals, materials, products, and processes. On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.” Further, comments submitted to the docket “addressed a range of issues that could impact the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation.” FDA states that after considering the public comments that were received on the draft guidance, it determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved, and that it intends to “issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.” FDA will communicate publicly when new draft guidance is issued. On December 8, 2017, the U.S. Department of Commerce (DOC) issued in the Federal Register a notice on the postponement of final determinations of sales in less than fair value (LTFV) investigations into biodiesel from Argentina and Indonesia and the extension of provisional measures. As reported in the Biobased and Renewable Products Advocacy Group (BRAG®) blog post “DOC Initiates Biodiesel Antidumping, Countervailing Investigation,” DOC initiated LTFV investigations of imports of biodiesel from Argentina and Indonesia on April 12, 2017. DOC is postponing the deadline for issuing the final determinations until February 15, 2018, and extending the provisional measures from a four-month period to a period of no more than six months. According to the notice, a postponement is permitted given that each preliminary determination was affirmative; the requests in each investigation were made by the exporters and producers who account for a significant proportion of exports of the subject merchandise from the country at issue; and no compelling reasons for denials exist. On August 28, 2017, the U.S. Department of Commerce (DOC) announced in the Federal Register that a preliminary determination had been issued in the antidumping (AD) and countervailing duty (CVD) investigations on biodiesel from Argentina and Indonesia. DOC preliminarily determined that countervailable subsidies are being provided to producers and exporters of biodiesel from Argentina and Indonesia. The period of investigation for both countries is January 1, 2016, through December 31, 2016. On August 15, 2017, the U.S. Department of Commerce’s (DOC) International Trade Administration (ITA) announced in the Federal Register that the preliminary determination in the antidumping (AD) and countervailing duty (CVD) investigations on biodiesel from Argentina and Indonesia will be postponed. A request to postpone the determinations was submitted by a petitioner on July 6, 2017, and, pursuant to Section 733(c)(1)(A) of the Tariff Act of 1930, ITA determined that there was no compelling reason to deny the request. The preliminary determination will now be due by October 19, 2017, and the final determination will be due within 75 days of the issuance of the preliminary determination. |
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