Placeholder Banner

BIO Comments to USDA on its 340 Biotech Rules

June 19, 2017

Regulatory Analysis and Development
PPD, APHIS, Station 3A–03.8
4700 River Road Unit 118,
Riverdale, MD 20737–1238

Re: Docket No. APHIS-2015-0057. Evaluation of Existing Regulations; Importation, Interstate
Movement, and Environmental Release of Certain Genetically Engineered Organisms

Dear Sir or Madam:

The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response
to the USDA Animal and Plant Health Inspection Service’s (APHIS’) request for public input on the
proposed revisions to its biotechnology regulations in 7 CFR Part 340.1 Thank you for the
opportunity to provide input as APHIS considers revision of its regulations. We provided similar
comments in April 2016 in response to a request for public input on the agency’s Notice of Intent
(NOI) to prepare an Environmental Impact Statement (EIS) in connection with possible regulatory

BIO is the world's largest trade association representing nearly 1,000 biotechnology companies,
academic institutions, state biotechnology centers and related organizations across the United
States and in more than 30 other nations. BIO members are involved in the research and
development of innovative healthcare, agricultural, industrial and environmental biotechnology
products. BIO represents the majority of agricultural biotechnology product developers in North
America, including companies developing products subject to APHIS oversight.

For the past two decades, the products of agricultural biotechnology have been commercially
available and widely used by a growing number of farmers around the world. In the United States,
more than 90 percent of corn, cotton, canola, soybean, and sugar beet seeds planted contain at
least one biotechnology-derived trait. Farmers use these products because they enable the
production of more food, feed, and fiber on fewer acres using less energy and reduced pesticide

Download Full Comments Below
BIO Comments On 340 Proposed Rule 06192017
Read full comments below
Discover More
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a…
On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period…
October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology…