By Lynn L. Bergeson
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(FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.”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 Additionally, the draft guidance makes recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing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 Comments on the draft guidance are due on or prior to July 22, 2019.
By Lynn L. Bergeson
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.
By Lynn L. Bergeson
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.
Part of these efforts includes FDA’s 2015 decision to approve an application related to GE salmon containing the first approved IGA in an animal meant for food consumption. In 2016, however, the U.S. Congress directed FDA not to allow into commerce any food containing GE salmon until it issues final labeling guidelines for informing consumers of the GE salmon content in the food. Consequently, in compliance with Congressional views, FDA implemented an import alert in that same year that prevented GE salmon from entering the U.S. With the enactment of the National Bioengineered Food Disclosure Standard (NBFDS) by Congress, the U.S. Department of Agriculture (USDA) was made responsible for the implementation of a mandatory standard for disclosing foods that are bioengineered. FDA was, therefore, divested of its authority over labeling GE content in human foods. Given the Congressional enactment of NBFDS, Dr. Gottlieb stated that FDA believes this Congressional mandate on GE salmon has been satisfied by USDA’s issuance of final regulations implementing NBFDS. NBFDS requires that human food containing GE salmon be labelled to indicate that it is bioengineered. Therefore, FDA has deactivated the import alert that prevented GE salmon from entering the U.S.
By Kathleen M. Roberts
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).
ISSUE: While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” requiring EPA to conduct new chemical assessments. If these new chemicals are converted to other substances by downstream customers, those substances are likely also new, requiring additional new chemical submissions and assessments. Each new chemical submission and assessment represents a cost and a commercial delay and each is a barrier to adoption of what may be a promising sustainable technology. These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of the novel, renewable chemicals -- restrictions that may not apply to older chemistries even though they may be functionally identical in performance, hazard, and risk. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter controls.
POTENTIAL SOLUTION: To address these issues, the Biobased and Renewable Products Advocacy Group (BRAG®) has submitted to EPA, in partnership with the Biotechnology Innovation Organization (BIO), a BRAG member, a White Paper proposing a TSCA Inventory representation and equivalency determinations for renewable and sustainable biobased chemicals. EPA’s initial response to the White Paper has been positive and staff has indicated a willingness to conduct equivalency determinations if submitted.
REQUEST: BRAG is now seeking companies interested in participating in a pilot project to prepare and submit such requests. Specifically, we are looking for companies that manufacture or plan to manufacture a Class 2 chemical substance that is functionally equivalent to another Class 2 chemical, but due to existing naming conventions, the two chemicals are not listed as equivalent. If your company fits this description and you wish to support an effort to alleviate commercial burden for yourself and others in the future, please consider working with BRAG on this important project so we present impactful equivalency cases to EPA.
BRAG and Bergeson & Campbell, P.C. (B&C®) are committed to this project. As such, we will evaluate all candidate chemicals submitted, select what we believe is a good test case for the project, and prepare as a courtesy the necessary submission paperwork and equivalency arguments, in conjunction with the nominating company.
By Lynn L. Bergeson
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.
By Lynn L. Bergeson
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.
By Lauren M. Graham, Ph.D.
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.
By Lauren M. Graham, Ph.D.
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.
Pursuant to Section 703(e)(1) of the Tariff Act of 1930, DOC preliminarily determined that critical circumstances exist with respect to imports of biodiesel from Indonesia for Musim Mas and Wilmar Trading. Similarly, DOC preliminary determined that critical circumstances exist with respect to imports of biodiesel from Argentina for LDC Argentina and Vicentin, but do not exist with respect to all other exporters or producers not individually examined. DOC will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of biodiesel from Argentina and Indonesia entered, or withdrawn from warehouse, for consumption, and to require a cash deposit equal to the subsidy rates indicated in the respective Federal Register notice. For Indonesian companies not individually examined, DOC applied an “all-others” subsidy rate, which was calculated by weight averaging the calculated subsidy rates of the two individually examined company respondents.
More information on the methodology and results of DOC’s analysis is available in the Preliminary Decision Memorandum, which is a public document on file in the Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). DOC invites comments on the preliminary determinations from interested stakeholders. Following DOC’s final determination, the International Trade Commission (ITC) will make its final determination within 45 days.
By Lauren M. Graham, Ph.D.
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.
ITCA previously postponed the determinations following a May 22, 2017, request from a petitioner, as reported in the Biobased and Renewable Products Advocacy Group (BRAG®) blog post DOC Postpones Preliminary Determinations for Biodiesel AD/CVD Investigation.
On March 13, 2017, the South Dakota Farmers Union announced that the National Farmers Union had passed a resolution calling for the U.S. Environmental Protection Agency (EPA) to open the market to higher blends of ethanol during its annual meeting in San Diego. The resolution, which was brought forward by the South Dakota Farmers Union delegation, promotes the use of higher blended fuels, such as E30, as a way to expand the retail fuels infrastructure and support the Renewable Fuel Standard (RFS).
In addition to passing the resolution, the National Farmers Union filed legal comments regarding EPA’s overreach in its interpretation of the Clean Air Act (CAA), which limits ethanol content to 15 percent. Doug Sombke, President of South Dakota Farmers Union, called on EPA and all government regulators to reverse statements and policies that unfairly limit the amount of ethanol in fuel and stated that both the state and national organization continue to seek greater market access for higher blended fuels.