Attachment II - Page 43 
Federal Register / 
401 M St SW„ Washington, D.C. 20460 
from 8:00 a.m. to 4:00 p.m., Monday 
through Friday, except legal holidays. 
The record includes all information 
considered by EPA in formulating this 
policy. References cited in Unit VI are 
available in the OTS Library, Rm. E— 447. 
The list below describes the information 
in the record. 
1. OTS support and background 
documents on PMN review information 
needs and Inventory listing prepared as 
background for this notice. 
2. Consultant reports prepared under 
contract to EPA used in developing this 
notice. 
3. Statement of Don R. Clay, Acting 
Administrator, EPA Office of Pesticides 
and Toxic Substances, before the 
Subcommittee on Science, Research, 
and Technology, and Subcommittee on 
Investigations and Oversight, Committee 
on Science and Technology, U.S. House 
of Representatives, June 22, 1983, and 
related documents. 
4. EPA correspondence to persons 
outside EPA concerning applicability of 
TSCA to biotechnology. 
5. General statement of policy on the 
regulation of Biorational Pesticides (40 
FR 94:23994), May 14, 1979. 
6. A list of key events in the 
development of OPP’s regulation of 
microbial pesticides. 
7. A background paper by Betz, et. al., 
discussing the current regulatory status 
and the potential hazards posed by 
genetically engineered microbial 
pesticides, 1983. 
8. Subdivision M of EPA's Pesticide 
Assessment Guidelines. 
9. Final Report: Biorational Workshop, 
Gulf Breeze, Florida, August 1983. 
10. Final Report: Human Hazard 
Evaluation Testing for Biorational 
Pesticides, AIBS, July 1980. 
11. Memo regarding Applicability of 
FLFRA or TSCA to Microbial Agents 
Used to Control Ice Nucleation, from 
OGC to OPTS, October 26, 1983. 
12. Documents related to EPA’s 
biotechnology research strategy and 
biotechnology workshops developed by 
the Office of Research and 
Development. 
The docket of the record detailing its 
specific contents is available in the OTS 
Reading Room. 
DEPARTMENT OF AGRICULTURE 
Statement of Policy for Regulations 
Biotechnology Processes and Products 
Summary: This statement describes 
USDA’s regulatory policy regarding use 
of biotechnology processes and products 
in agriculture and forestry. It is not an 
exhaustive set of application 
requirements. It is intended to assist 
Vol. 49, No. 252 / Monday, December 31, 1984 / Notices 50897 
those entities engaged in biotechnology 
research, development, testing, 
evaluation, production, and application 
in understanding clearly how USDA will 
approach the regulation of industry’s 
processes and products. 
Address: Send written comments by 
mail or bring comments to: Ms. Karen 
Darling, Deputy Assistant Secretary. 
Marketing and Inspection Services, 
USDA, Room 242-E, Administration 
Building, 12th and Independence 
Avenue, SW„ Washington, DC 20250. 
Telephone: Area Code (202) 447-4256. 
For Further Information Contact: Dr. 
James W. Glosser, Assistant to the 
Administrator, Animal and Plant Health 
Inspection Service, USDA, Room 300-E, 
Administration Building, 12th and 
Independence Avenue, SW., 
Washington, DC 20250. Telephone: Area 
Code (202) 447-3580, or Dr. Edgar L. 
Kendrick, Administrator, Office of 
Grants and Program Systems, XlSDA, 
Room 326-A. Administration Building, 
12th and Independence Avenue, SW., 
Washington, DC 20250. Telephone: Area 
Code (202) 475-5720. 
Introduction: This document is 
intended to inform the public, scientists, 
and industry of USDA’s current 
perspective on the regulation of 
biotechnology processes and products. It 
describes the regulatory policies, the 
regulatory framework, and procedures 
for oversight in agriculture and forestry 
biotechnology. 
Biotechnology is the application of 
biological systems and organisms to 
technical and industrial processes. 
Applied to agriculture and forestry, it is 
any technique that uses living biological 
systems to make or modify products, to 
improve plants or animals, or to develop 
microorganisms for specific uses. 
Although the use of living biological 
systems in the genetic manipulation of 
organisms dates from man’s recognition 
that animals and crop plants could be 
selected and crossbred to produce a 
desired phenotype, during the past half- 
century, increased knowledge of 
molecular genetics has added to the 
sophistication of the genetic engineering 
of microorganisms. The manipulation or 
movement of genetic material by 
recombinant DNA technology arose 
about a decade ago and is often referred 
to as “modern biotechnology." The 
development of monoclonal antibodies 
from hybridoma techniques is also 
referred to as “modern biotechnology." 
The application of modem 
biotechnologies has made it possible to 
perform genetic engineering procedures 
and to develop monoclonal antibody 
products with an increasing number of 
applications in agriculture and forestry 
programs. 
Under the jurisdiction provided by 
numerous statutes (see attached matrix). 
USDA regulates and conducts research, 
among other areas, in animal biologies, 
organisms and vectors, importation and 
interstate movement of animals, plants, 
plant products, noxious weeds, seeds, 
inoculants, and other articles. 
The USDA has regulated, overseen, or 
collaborated in developing a vast 
number of biotechnological products 
and processes, new and old. As one 
example, in the exercise of this 
regulatory authority, the Animal and 
Plant Health Inspection Service (APHIS) 
has issued within the last two years 
seven licenses under the Virus-Serum- 
Toxin Act (21 U.S.C. 151-158) for five 
products produced by modem 
biotechnology procedures. These 
licenses were for bacterins, 
bacterintoxoids, and monoclonal 
antibodies for immunological or 
diagnostic uses. Additionally, there are 
at least 12 new license applications 
presently under review on a case-by- 
case basis. 
There exists in the agricultural and 
forestry community a system for the 
assessment of new cultivar, gqrmplasm, 
or microorganisms before their 
commercial release. For decades, the 
agricultural community, including State, 
Federal, and industrial researchers, 
have continuously assessed the impact 
of plant, animal (including invertebrate), 
and microbial species in a wide range of 
cropping and animal production 
systems, in order to assure stable 
agricultural production, as well as 
protection and preservation of the 
environment. The evaluation and 
approval procedures currently practiced 
are outlined in detail in a recent 
publication from the National 
Association of State Universities and 
Land Grant Colleges (NASULGC). 
Division of Agricultural Committee on 
Biotechnology. 1 
Although USDA'8 initial concerns 
about safety of the modern 
developments in biotechnology were at 
the laboratory level technological 
progress has extended these safety 
concerns to field research and industrial 
applications and production. As a 
consequence. USD^\ emphasizes the 
need for agency oversight at all stages, 
including research, development, testing, 
evaluation, production, application, and 
disposal. To date, no unique or safety 
problems have been associated with 
products of genetic engineering, 
conventional or modem. 
1 Emergency Blotechnologlea in Agriculture: 
laiuei and Policiei. ProgreM Report 111. November 
1984. 
[ 397 ] 
