Attachment II - Page 42 
Federal Register / VoL 49, No. 252 J Monday. December 
50896 
harmonization. With respect to 
international harmonization the U.S. will 
seek to promote scientific cooperation, 
mutual understanding of regulatory 
approaches and international agreement 
on a range of common technical issues 
such as the development of consistent 
test guidelines, laboratory practices, and 
principles for assessing potential risks. 
The Organization for Economic 
Cooperation and Development (OECD) 
has formed a working group on 
biotechnology safety and regulation. 
EPA, through OTS and ORD 
representatives, is participating with the 
Departments of State, Agriculture, and 
HHS on the U.S. delegation. The goal of 
the OECD biotechnology working group 
is to review and monitor member 
nation's biotechnology regulations and 
risk assessment approaches as a step 
toward international harmonization. 
V. References 
The following books, articles, reports, 
and memoranda were used in preparing 
this notice: 
(1) Abramson, SJL. Associate General 
Counsel, Pesticides and Toxic 
Substances Division. Memo regarding 
the applicability of FIFRA or TSCA to 
microbiological agents used to control 
ice nucleation. To Don R. Clay, Acting 
Assistant Administrator for Pesticides 
and Toxic Substances. October 20, 1983. 
(2) Alexander, M. 1983. Testimony 
before U.S. House of Representatives 
Subcommittees on Science, Research, 
and Technology and Investigations and 
Oversight. Committee on Science and 
Technology. Hearings on Environmental 
Implications of Genetic Engineering. 
June 22, 1983. Washington. D.C. 
(3) Baker, J.J.W. and G.E. Allen. 1982. 
The study of biology. Fourth edition. 
Addison-Wesley Publishing Co., 971 pp. 
(4) Brock, R.D. 1972. The role of 
induced mutations in plant 
improvement, in Induced Mutations and 
Plant Improvement, pp. 513-520. 
International Atomic Energy Agency. 
Vienna. 
(5) Campbell, A. 1978. Tests for gene 
flow between eucaryotes and 
procaryotes. Journal of Infectious 
Diseases 137: 681-685 Jc47 
(6) Chiu, N. 1984. Development of 
classification scheme(s) for listing 
genetically engineered substances on 
TSCA Chemical Substance Inventory. 
Data Management Branch, Information 
Management Division, Office of Toxic 
Substances, Environmental Protection 
Agency, Washington, D.C., 43 pp. 
(7) Chiu, N. 1984. Genetically 
engineered organisms and nucleic acids. 
Data Management Branch, Information 
Management Division, Office of Toxic 
Substances, Environmental Protection 
Agency, Washington, D.CL, 120 pp. 
(8) Colwell, R.R. 1983. Biotechnology 
in the marine sciences. Science 222:19- 
24. 
(9) Curtin, M.E. 1983. Microbial mining 
and metal recovery: corporations take 
the long and cautious path. 
Biotechnology 1:229-235. 
(10) Demain, A.L 1981. Industrial 
microbiology. Science 214: 987-095. 
(11) Graham, J.B. and CLA. Istock. 
1979. Gene exchange and natural 
selection cause Bacillus subtilis to 
evolve in soil culture. Science 204:637— 
639. 
(12) Itakura, K. and AT). Riggs. 1980. 
Chemical DNA synthesis and 
recombinant DNA studies. Science 
209:1401-1405. 
(13) Keeton, W.T. 1980. Biological 
science. W.W. Norton and Ca„ N.Y. 
(14) Kellogg, S.T„ D.K. Chatterjee. and 
A.M. Chakrabarty. 1981. Plasmid- 
assisted molecular breeding: new 
technique for enhanced biodegradaton 
of persistent toxic chemicals. Science 
214:1133-1135. 
(15) Krimsky, S. 1982. Local 
monitoring of biotechnology: the second 
wave of recombinant DNA laws. 
Recombinant DNA Technical Bulletin 5: 
79-84. 
(16) Lewin. B. 1983. Genea. John Wiley 
and Sons; N.Y., 715 pp. 
(17) Lewin, R. 1983. The birth of 
recombinant RNA technology. Science 
222:1313-1315. 
(18) McChesney, FT. and R. Adler 
Biotechnology Released From the Lab: 
The Environmental Regulatory 
Framework, 13 Environmental Law 
Reporter 10368 (1983). 
(19) Moat, AG. 1979. Microbial 
physiology. John Wiley and Sons, N.Y„ 
600 pp. 
(20) National Institutes of Health. 
1983. Guidelines for research involving 
recombinant DNA molecules. Federal 
Register 48: 24556-24581. 
(21) Office of Technology Assessment 
1981. Impacts of applied genetics: 
microorganisms, plants, and animals. 
Congress of the United States, 
Washington, D.C. 
(22) Office of Technology Assessment. 
1984. Commercial biotechnology: an 
international analysis. Congress of the 
United States, Washington, D.C. 
(23) Powledge, T.M. 1983. Prospects 
for pollution control with microbes. 
Biotechnology 1: 743-755. 
(24) Ruvkun, G.B. and F.M. AusubeL 
1981. A general method for site directed 
mutagenesis in prokaryotes. Nature 
289:85-88. 
(25) Saunders, J.R. 1979. Specificity of 
DNA uptake in bacterial transformation. 
Nature 278:601-602 
31. 1984 / Notices 
(26) Sharpies, F.E. 1983. Spread of 
organisms with novel genotypes: 
thoughts from an ecological perspective. 
Recombinant DNA Technical Bulletin 
8:43-50. 
(27) Springbom Laboratories, Inc. 
1983. Report on biotechnology. Prepared 
for EPA, OPTS. Economics and 
Technology Division. Regulatory 
Impacts Branch. Work Assignment 1-3. 
Subtask 5, Contract No. 68-01-6601. 
(28) Starr, M.P. 1975. A generalized 
scheme for classifying organismic 
associations. Symposium Society 
Experimental Biology 29: 1-20. 
(29) Stent. G.S. and R. Calendar. 1978. 
Molecular genetics: an introductory 
narrative. Wit Freeman and Co„ San 
Francisco, 773 pp. 
(30) Stem. KJL 1982. Introductory 
plant biology. Second edition. W.C. 
Brown. Co. PubL, Dubuque. Iowa. 
(31) Subcommittee on Investigations 
and Oversight. 1984. The environmental 
implications of genetic engineering. U.S. 
Congress House of Representatives. 
(32) Talbot. B„ Deputy Director, 
National Institute of Allergy and 
Infectious Diseases. December 21, 1983. 
Memorandum on questions for public 
comment and agenda for Recombinant 
DNA Advisory Committee. To W. 
Gartland, Director. Office of 
Recombinant DNA Activities, National 
Institutes of Health. 
(33) U.S, EPA. Reporting for the 
Chemical Substance Inventory. 
Information Management Division, 
Regulatory Impacts Branch. Work 
Assignment 1-3, Subtask 5, Contract No. 
68-01-6801. 
(34) U.S. EPA Candidate list of 
Chemical Substances. Addendum III: 
Chemical Substances of Unknown or 
Variable Composition, Complex 
Reaction. Products and Biological 
Materials. Office of Toxic Substances, 
March 1978. 
(35) U.S. EPA TSCA Chemical 
Substance Inventory. Office of Toxic 
Substances. May 1979. 
(36) Whittaker, R.H. 1969. New 
concepts of kingdoms of organisms. 
Science 163:150-160. 
VI. Public Record 
EPA has established a public record 
for this statement of policy. 
Records related Vo this document 
(docket number OPTS-00049) are 
available for inspection in Rm. E-107, 
401 M St. SW- Washington, D.C. 20460 
from 8:00 am. 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 for inspection in Rm. E-107, 
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