On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy and the environment. In a related development, the U.S. Department of Agriculture (USDA) proposed on May 1, 2012, amendments to 7 C.F.R. Part 3201, Guidelines for Designating Biobased Products for Federal Procurement.[pullquote]
These notices express the federal government's sustained interest in spurring the development of biobased products, and its commitment to using its purchasing power to increase the biobased product market. A brief summary of each development follows.
National Bioeconomy Blueprint
Its goal is "to enable a vibrant U.S. bioeconomy in the years and decades ahead, with potential to deliver major economic and social benefits." The blueprint identifies five strategic objectives:
1. Support research and development investments that will provide the foundation for the future bioeconomy;
2. Facilitate the transition of bioinventions from research lab to market, including an increased focus on translational and regulatory sciences;
3. Develop and reform regulations to reduce barriers, increase the speed and predictability of regulatory processes, and decrease costs while protecting human and environmental health;
4. Update training programs and align academic institution incentives with student training for national workforce needs; and
5. Identify and support opportunities for the development of public-private partnerships and precompetitive collaborations — where competitors pool resources, knowledge and expertise to learn from successes and failures.
USDA's Proposed Rule
The major provisions of the proposed USDA rule include:
Designation of intermediate ingredient or feedstock categories. This would follow the same process that USDA uses in the ongoing designation of product categories. USDA would establish a minimum biobased content for each intermediate ingredient or feedstock category, based on an evaluation of available data. USDA would set the minimum biobased content requirement at the highest level practicable, considering technological limitations.
Designation of complex assembly categories. The proposed rule would establish procedures for designating complex assembly products (multicomponent assembled products with one or more component being made with biobased material) within the scope of the federal biobased-products procurement preference program. Although Food, Conservation, and Energy Act (FCEA) Section 9001 doesn't specifically mention these multicomponent assembled products, USDA believes that including this type of finished product in the BioPreferred Program "will encourage the increased use of biobased materials and, thus, further advance the objectives of the program."
Replacement of "designated item" with "designated category". Current guidelines use the term "designated item" to refer to a generic grouping of biobased products identified in Subpart B as eligible for the procurement preference. According to USDA, this has created confusion because the word "item" is also used to refer to individual products, rather than a generic grouping of products. USDA proposes to replace the term "designated item" with the term "designated product category."
In addition, USDA would add a definition for the term "qualifying biobased product" to refer to an individual product that meets the definition and minimum biobased content criteria for a designated product category and is, therefore, eligible for the procurement preference.
Procurement preference for new and emerging markets. USDA would amend paragraph (b) of Section 3201.5 to add a statement that "USDA will designate for preferred procurement those product categories and intermediate ingredient or feedstock categories that are determined to create new and emerging markets for biobased materials." According to USDA, this would emphasize the Section 9002 objectives "to improve demand for biobased products" and "to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities." The new paragraph is intended to replace the current mature market exclusion, which limits the types of product categories eligible for the federal procurement preference. USDA is proposing this change to be more consistent with the objectives and legislative intent of the Biobased Markets Program.
USDA requests comment on all aspects of the proposed amendments to the guidelines by July 2, 2012.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at [email protected].
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author.