14794 Federal Register 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; 
Availability of Environmental 
Assessment for Public Comment; 
Request for Comments on Need for a 
Programmatic Environmental Impact 
Statement 
aoency: National Institutes of Health, 
PHS, DHHS. 
action: Notice. 
summary: This notice announces the 
availability for public comment of the 
"Environmental Assessment and 
Finding of No Significant Impact," dated 
January 21, 1985, “concerning the 
application to the National Institutes of 
Health (NIH), under the NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules, of Drs. Steven Lindow 
and Nickolas Panopoulos of the 
University of California, Derkeley, to 
field test ice-nucleation-minus bacteria 
prepared by recombinant DNA 
techniques for purposes of biological 
control of frost damage to plants." In 
addition, this notice requests comments 
on the need for a programmatic 
| Environmental Impact Statement in 
connection with NIH approvals of 
proposals to release into the 
environment organisms containing 
recombinant DNA molecules. 
date: Comments must be received by 
May 15, 1985. 
address: The January 21. 1985, 
Environmental Assessment and Finding 
of No Significant Impact is available 
upon a request to the NIH Office of 
Recombinant DNA Activities (ORDA), 
Building 31, Room 3B10, National 
Institutes of Health, Bethesda, Maryland 
20205. Phone: (301) 496-6051. Comments 
should be submitted to the same address 
and will be available for inspection and 
copying on weekdays between the hours 
of 8:30 a.m. and 5:00 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Dr. William J. Gartland, ORDA, Building 
31, Room 3B10. National Institutes of 
Health. Bethesda, Maryland. 20205, (301) 
496-6051. 
SUPPLEMENTARY INFORMATION: 
I. Background 
The NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(49 FR 48266, November 23. 1984) require 
that recombinant DNA experiments 
"conducted at or sponsored by an 
institution that receives any support for 
recombinant DNA research from the 
National Institutes of Health" (section I- 
C of Guidelines) which involve 
/ Vol. 50. No. 72 / Monday, April 15. 1985 1 Notices 
"deliberate release into the environment 
of any organism containing recombinant 
DNA, except certain plants as described 
in Appendix L" (section II I- A of 
Guidelines) must have prior approval 
from NIH before the experiment is 
conducted. 
The NIH approved the application of 
Drs. Lindow and Panopoulous to field 
test ice-nucleation-minus bacteria 
prepared by recombinant DNA 
techniques on June 1. 1983 (48 FR 24549). 
Prior to the conduct of the field test, a 
lawsuit was filed challenging the 
approval on the grounds that NIH 
violated the National Environmental 
Policy Act (NEPA), (42 U.$.C. 4321 et 
seq.), and the Council on Environmental 
Quality (CEQ) regulations implementing 
NEPA (40 CFR Parts 1500-1508), by 
failing to prepare an Environmental 
Assessment (EA) or an Environmental 
Impact Statement (EIS) in connection 
with the approval of the Held test. 
On May 16, 1984, the United States 
District Court for the District of 
Columbia, in Civil Action No. 83-2714 
( Foundation on Economic Trends el a!., 
v. Margaret M. Heckler et at.), issued a 
preliminary injunction which enjoined 
NIH from "approving or continuing to 
approve experimentation involving the 
deliberate release of recombinant DNA 
under * * * the * * * NIH Guidelines 
* * * until such time as the Court enters 
final judgment." The University of 
California was enjoined from 
proceeding with the Lindow-Panopoulos 
experiment "until such time as the Court 
enters final judgment.” 
The order of the District Court was 
appealed by the NIH and the University 
of California and on February 27, 1985, 
the United States Court of Appeals for 
the District of Columbia vacated the 
District Court's injunction as it applied 
to future approvals of deliberate release 
experiments by NIH. but upheld the 
preliminary injunction as it applied to 
the University of California experiment, 
concluding that the injunction should 
remain in effect until completion of an 
appropriate Environmental Assessment. 
II. The Environmental Assessment 
The NIH had begun preparation of an 
Environmental Assessment of the 
University of California experiment 
after the entry of the District Court order 
and that assessment and a Finding of No 
Significant Impact (FONSI) were 
completed on January 21. 1985. 
This notice announces the availability 
for public comment of this 64-page EA- 
FONSI. 
For convenience, the Table of 
Contents of the EA-FONSI 
p«k» 
1.0 Introduction und Summary I 
2D Background: Previous Administrative Action ... 3 
3.0 l\irpoi*€ and Need 0 
3.1 l*urpos« of the fVoposed Action tt 
3.2 Need for the l*ropo»ed Action 9 
4.0 Description of IVuposed Action and Alterna- 
tive* — - - II 
4.1 Proposed Action 11 
4.2 Alternative* to the Proposed Action r . 10 
4.2.1 Approval of Ordinal Proposal (Sep- 
tember 17. 1902) Without Restriction J8 
4.2.2 Approval of Modified Proposal 
(March 0. 1903) Without Restriction 10 
4.2.3 Approval of Propositi as Approved 
by NIH on June 1. 1903. With Changes 
Proposed by the Investigators 10 
4.2.4 Withhold Approval 17 
5.0 Environment Effects 17 
5.1 The Physical Environmental - 17 
5.2 Proposed Test Organisms 22 
5.2.1 Characteristic* of P. ». »yrin#oe and 
£ herbteolo strains 22 
5.2.2 Construction of INA Deletion Mu- 
tants ... 26 
52.3 Previous Field Tests with INA Minus 
Bacteria .. .. 2!l 
5.3 Effects of the Proposed Field Test 30 
5-3.1 Risk Assessment ... 30 
5.3.2 The Test Plot 34 
5.3.3 Crops and Non-Commerica! Plant 
Species - 36 
5.3.4 Local Epiphytic Bacterial Pupulo- 
tions 37 
5.3.5 Insect Populations 39 
5.3.0 Animal Populations 41 
5.3.7 Atmosphere and Climate 41 
5.3 8 Scientific and Agricultural Benefits 45 
5.3.9 Worst Case Considerations 40 
5.4 Effects of Alternatives — 40 
5.4.1 Approval of Original Proposed With- 
out Restriction.. - 40 
5.4.2 Approval of Modified Proposal 
Without Restriction 49 
5.4 3 Approval of Proposal as Approved 
by NIH on )une 1. 1903. With Changes 
Iboposed by the Investigators 49 
5.4.4 Withhold Approval .. .. 50 
5.5. Summary and Conclusions 50 
8 0 Consultation - 52 
7 0 References .. 53 
Appendix A — Background Concerning the NIH 
Guidelines for Research Involving Recombinant 
DNA Molecules .... 57 
Appendix B — Description and Location of Tule- 
lake Field Station Bl 
Appendix C — Diagram of Test Plot and Descrip- . 
lion of Treatments - Cl 
Comments on the EA and FONSI will be 
considered by the Director, NIH, when, 
he decides whether to reapprove the 
field test proposed by the University of 
California. 
III. The Need for A Programmatic 
Environmental Impact Statement 
In its February 27, 1985, decision the 
Appeals Court stated that, "If NIH gives 
adequate environmental consideration 
to each deliberate release experiment 
. . . then we cannot, at this point, say 
that such consideration will obstruct 
environmental review. We thus reverse 
the District Court's finding that plaintiffs 
are likely to succeed in showing, at this 
point, that the governing law requires 
NIH to complete a programmatic EIS on 
deliberate release experiments." 
However, the Appeals Court went on to 
state that, "NIH should at least consider 
whether a programmatic EIS is required 
to fulfill the agency's legal obligations 
[ 117 ] 
