The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

On August 2, 2019, the U.S. Department of Health and Human Services (HHS)’s Food and Drug Administration (FDA) announced via the Federal Register the rates for biosimilar user fees for FY 2020. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in an application. The established fees will apply to the period from October 1, 2019, through September 30, 2020.


 

By Lynn L. Bergeson

On August 6, 2019, the Minnesota Department of Agriculture (MDA) announced four grants aiming to expand biofuel access and production to advance the state’s renewable energy efforts. Awarded to four recipients by MDA’s Agricultural Growth, Research and Innovation (AGRI) Program, the grants total more than $500,000. One Bioenergy/Biochemical Pilot Project Grant was awarded, providing funding to advance bioenergy and biochemical production technology to a commercial scale. Three Biofuel Blending Infrastructure Grants were awarded to expand the use of blending infrastructure equipment in Minnesota.


 

By Lynn L. Bergeson

On August 6, 2019, the Utility Workers Union of America (UWUA) announced its partnership with The Power for America Training Trust Fund (P4A) for the launch of a renewable energy specialist apprenticeship program. Certified by the U.S. Department of Labor (DOL), the program aims at assisting individuals with a path to employment for highly demanded jobs in the renewable energy sector. Under this program, individuals will be taught specialized skills in the fields of solar generation, battery storage, and offshore and onshore wind. An earn-while-you-learn program, this two-and-a-half-year apprenticeship guarantees participants a job with a Michigan-based company. P4A is currently looking for more companies with which to form partnerships.

Tags: DOL

 

By Lynn L. Bergeson

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.


 

By Lynn L. Bergeson

On June 27, 2019, the California Air Resources Board (CARB) approved a rule requiring the gradual transition of fixed-route airport shuttles into 100 percent zero-emission vehicles (ZEV) by 2035. Applied to public and private shuttles that serve the state’s 13 largest airports, including rental car agencies, hotels, and parking facilities, the regulation was approved with an expectation to reduce greenhouse gas (GHG) emissions by at least 500,000 metric tons. According to CARB, the regulation will also benefit shuttle fleet owners through an estimated $30 million in reduced fuel and maintenance costs. Currently, six airports and private businesses serving nine airports already have zero-emission shuttles operating in the state. This new rule presents “a great opportunity for showcasing this process,” stated CARB Executive Officer, Richard Corey. CARB states that airport shuttles are well-suited to zero-emission technology because they operate on short, fixed routes up to 200 miles per day with low average speeds in a stop/go pattern. When operating in this manner, ZEVs are advantageous from an energy and fuel efficiency perspective. The rule will require annual reporting of vehicles to CARB in 2022, and end in 2035 with full compliance of ZEV airport shuttles.


 

By Lynn L. Bergeson

On June 28, 2019, the California Department of Toxic Substances Control (DTSC) will host the first public workshop on 1,4-Dioxane in Personal Care and Cleaning Products. 1,4-Dioxane, a solvent and stabilizer for chlorinated solvents, which is produced from both petroleum sources and from biobased ethylene oxide, has been identified by DTSC as a likely human carcinogen and an emerging contaminant found in beauty, personal care, hygiene, and cleaning products. DTSC is requesting additional information from stakeholders about potential adverse impacts from 1,4-dioxane in consumer products; its presence in personal care and cleaning products; and the feasibility of removing it from these products. To view the background document and submit comments, please visit DTSC’s CalSAFER portal. The comment period closes on August 21, 2019.


 

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

On May 15, 2019, the California Energy Commission (CEC) approved approximately $11 million for clean energy demonstration projects that include biofuels, renewable gas, and microgrids. Funded by CEC’s Alternative and Renewable Fuels and Vehicle Technology Program, in support of clean transportation innovation, $2 million from the total funds have been approved for technology and investment solutions in hopes of demonstrating cost-effective and more sustainable processes for creating biomethane for waste hauling trucks. Funding was also awarded in support of renewable gas production using wood waste from trees killed by beetle infestation and drought, as well as in support of the natural gas sector. Microgrids at schools and residential areas in the City of Lancaster are also being supported by a $5 million grant.  The project’s distributed energy resources will be integrated and managed by a virtual power plant that optimizes cost savings, grid resilience, and revenue generation. Further details can be found in CEC’s business meeting agenda.


 

By Lynn L. Bergeson

The Minnesota Department of Agriculture is offering an opportunity for funding to advance a bioenergy or biochemical production technology toward commercial scale through the construction and operation of a pilot plant. To be eligible for the AGRI Bioenergy/Biochemical Pilot Project Grant, applicants must be a Minnesota-based company, learning institution, local government unit, Native American Tribal community, or individual (including for-profit businesses and colleges/universities). Eligible grant projects will be for the development of innovative bioenergy or biochemical production technology ideas that have advanced beyond the proof of concept and are at the scaling up to pilot-plant stage. Up to $150,000 will be awarded and must be used for:  (1) wages, software, or anything else necessary to perform the tasks of the grant project’s work plan; and (2) equipment needed for the project implementation. Applications are due by 4:00 p.m. (CDT) on April 26, 2019.  For further details, see the Request for Proposals.


 

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.


 
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