II

103D CONGRESS

1ST SESSION S. 1517

To establish a marine biotechnology program within the National Sea Grant

College Program, and for other purposes.

IN THE SENATE OF THE UNITED STATES

OCTOBER 5 (legislative day, SEPTEMBER 27), 1993

Mr. HOLLINGS (for himself, Mr. PELL, Mr. KERRY, and Mr. STEVENS) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation

A BILL

To establish a marine biotechnology program within the

National Sea Grant College Program, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Marine Biotechnology

5 Investment Act of 1993’’.

6 SEC. 2. FINDINGS.

7 The Congress finds and declares the following:

8 (1) Throughout human history, the oceans and

9 Great Lakes have been an important source of food

10 and a wealth of other natural products.
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1 (2) Marine biotechnology holds tremendous

2 promise for expanding the range and increasing the

3 utility of products from the oceans, understanding

4 and treating human illness, and enhancing the qual5 ity and quantity of seafood.

6 (3) Marine biotechnology offers opportunities to

7 improve the stewardship of marine resources

8 through the development and application of effective

9 methods to restore and protect marine ecosystems,

10 to manage fisheries, and to monitor marine biologi11 cal and geochemical processes.

12 (4) The United States currently is a world lead13 er in marine biotechnology, a position with the po14 tential for contributing to business and manufactur15 ing innovations, creation of new jobs, and stimula16 tion of private sector investment.

17 (5) Maintaining national leadership in the face

18 of growing foreign competition will require Federal

19 investment in a well-defined and coordinated na20 tional program of research, development, and private

21 sector partnership, based on the existing responsibil22 ities and expertise of the National Oceanic and At23 mospheric Administration and other Federal agen24 cies.
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1 (6) In particular, the National Sea Grant Col2 lege Program should play a leading role in the devel3 opment of marine biotechnology in the United

4 States, building on proven capabilities in research,

5 technology transfer, and education.

6 SEC. 3. DEFINITIONS.

7 As used in this Act—

8 (1) The term ‘‘Council’’ means the Federal Co9 ordinating Council on Science, Engineering, and

10 Technology or any successor organization respon11 sible for the coordination of scientific research

12 among Federal agencies and departments.

13 (2) The term ‘‘Director’’ means the Director of

14 the Office of Science and Technology Policy.

15 (3) The term ‘‘marine biotechnology’’ means

16 the application of molecular and cellular techniques

17 to marine or other aquatic organisms for the pur18 poses of—

19 (A) identifying, isolating, developing, and

20 enhancing products that are derived from the

21 marine environment;

22 (B) developing and applying techniques to

23 conserve, manage, and protect marine and

24 coastal resources; and
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1 (C) monitoring human health and treating

2 disease.

3 (4) The term ‘‘release of organisms’’ means the

4 intentional or accidental release, from a contained

5 research facility into the surrounding environment,

6 of a living marine or other aquatic organism in

7 which the genetic material has been purposely al8 tered at the molecular or cellular level in a way that

9 could not result from the natural reproductive proc10 ess of that organism.

11 (5) The term ‘‘Sea Grant director’’ means the

12 director of a college, program, or regional consor13 tium designated under the National Sea Grant Col14 lege Program Act (33 U.S.C. 1121 et seq.).

15 (6) The term ‘‘Strategy’’ means the National

16 Marine Biotechnology Strategy developed under sec17 tion 4, or any revision thereof.

18 SEC. 4. NATIONAL MARINE BIOTECHNOLOGY STRATEGY.

19 (a) IN GENERAL.—The Director, through the Council

20 and its Committee on Life Sciences and Health, shall de21 velop a National Marine Biotechnology Strategy for the

22 establishment and implementation of a comprehensive re23 search and development effort to assist the Nation in un24 derstanding and using marine biotechnology. The Director

25 shall submit the Strategy to the President and Congress
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1 within one year after the date of enactment of this Act

2 and shall submit a revised Strategy at least once every

3 three years thereafter.

4 (b) ELEMENTS OF THE STRATEGY.—The Strategy

5 shall—

6 (1) establish, for the ten-year period beginning

7 in the year the Strategy is submitted, goals and pri8 orities for a coordinated Federal effort in marine

9 biotechnology;

10 (2) describe specific activities to achieve such

11 goals and priorities, including—

12 (A) basic and applied research initiatives;

13 (B) essential infrastructure development;

14 (C) education and training programs; and

15 (D) development of partnerships among

16 government agencies, industry, and academia to

17 translate research findings into practical use;

18 (3) set forth the role of each participating Fed19 eral agency and department, identifying and ad20 dressing (consistent with the responsibilities estab21 lished in this Act) relevant programs and activities

22 of such agencies and departments that would con23 tribute to the effort;
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1 (4) estimate, to the extent practicable, funding

2 requirements for the Federal marine biotechnology

3 effort described in the Strategy; and

4 (5) provide for, with respect to federally-funded

5 activities that may involve release of organisms, co6 ordinated oversight by Federal departments and

7 agencies, including establishment of—

8 (A) guidelines and performance standards

9 that are necessary for the safe conduct of such

10 activities and for preventing significant environ11 mental risk; and

12 (B) procedures to ensure compliance with

13 such guidelines and performance standards.

14 (c) CONSULTATION.—In developing and revising the

15 Strategy, the Director—

16 (1) shall consult with Federal, State, academic,

17 commercial, and environmental entities involved in

18 marine biotechnology;

19 (2) may convene meetings and workshops, in

20 consultation with the National Academy of Sciences

21 and the Sea Grant directors; and

22 (3) shall, within ninety days of the date of en23 actment of this Act, contract with the National

24 Academy of Sciences for a report on activities that

25 may involve release of organisms, which shall—
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1 (A) assess the nature, likelihood, and ex2 tent of any potentially deleterious effects on the

3 marine environment associated with release of

4 organisms;

5 (B) identify existing laws, regulations,

6 guidelines, and protocols that apply to release

7 of organisms;

8 (C) examine and evaluate the adequacy of

9 oversight by each Federal agency or department

10 supporting activities that may involve release of

11 organisms; and

12 (D) recommend (for the conduct and over13 sight of activities that may involve release of or14 ganisms) regulations, guidelines, performance

15 standards, and procedures to assess and mini16 mize the environmental risk associated with

17 such release.

18 SEC. 5. NATIONAL OCEANIC AND ATMOSPHERIC ADMINIS19 TRATION.

20 (a) IN GENERAL.—The Secretary of Commerce, in

21 consultation with the Council, shall, within the National

22 Oceanic and Atmospheric Administration, maintain a bal23 anced program of marine biotechnology activities, com24 prised of—
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1 (1) the program established by section 206 of

2 the National Sea Grant College Program Act (33

3 U.S.C. 1121 et seq.), as added by section 6 of this

4 Act;

5 (2) research conducted under agreements with

6 academic institutions for the purposes of developing

7 and applying marine biotechnology to the manage8 ment, conservation, and use of living marine re9 sources; and

10 (3) marine forensics, biotoxins, and

11 microbiological research on new methods for ensur12 ing the safety of seafood, implementing and enforc13 ing marine environmental statutes, and addressing

14 coastal pollution.

15 (b) RESTRICTION RELATING TO RELEASE OF ORGA16 NISMS.—The Secretary of Commerce shall not conduct ac17 tivities (including the award of a grant or contract) that

18 may involve release of organisms, unless such activities—

19 (1) have been reviewed and approved under

20 other applicable Federal law; or

21 (2) are found by the Secretary of Commerce,

22 based on a written assessment, to pose no significant

23 environmental risk.

24 (c) AUTHORIZATION OF APPROPRIATIONS.—In addi25 tion to the sums authorized to be appropriated under sec-
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1 tion 212 of the National Sea Grant College Program Act

2 (33 U.S.C. 1131), there are authorized to be appropriated

3 to the Secretary of Commerce, to enable the National Oce4 anic and Atmospheric Administration to carry out this

5 Act, not to exceed $12,000,000 for each of the fiscal years

6 1994, 1995, 1996, and 1997.

7 SEC. 6. SEA GRANT MARINE BIOTECHNOLOGY PROGRAM.

8 (a) ESTABLISHMENT.—The National Sea Grant Col9 lege Program Act (33 U.S.C. 1121 et seq.) is amended

10 by inserting immediately after section 205 the following

11 new section:

12 ‘‘SEC. 206. MARINE BIOTECHNOLOGY PROGRAM.

13 ‘‘(a) MARINE BIOTECHNOLOGY PROGRAM.—Subject

14 to the availability of appropriations under section 212(d),

15 the national sea grant college program provided for under

16 section 204 shall include a marine biotechnology program

17 under which the Secretary, acting through the Director,

18 shall—

19 ‘‘(1) make grants and enter into contracts in

20 accordance with this section; and

21 ‘‘(2) engage in other activities authorized under

22 this Act;

23 to further research, development, education, technology

24 transfer, and risk assessment in marine biotechnology.
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1 ‘‘(b) ADMINISTRATION.—In carrying out the marine

2 biotechnology program, the Secretary shall—

3 ‘‘(1) coordinate the relevant activities of the di4 rectors of the sea grant colleges and the Marine Bio5 technology Review Panel established under sub6 section (d); and

7 ‘‘(2) provide general oversight of the review

8 process under subsection (d)(1) to ensure that the

9 marine biotechnology program produces the highest

10 quality research, development, education, and tech11 nology transfer.

12 ‘‘(c) GRANTS AND CONTRACTS.—

13 ‘‘(1) APPLICATIONS.—Applications for grants

14 and contracts under this section shall be—

15 ‘‘(A) made in such form and manner, and

16 include such content and submissions, as the

17 Secretary shall by regulation prescribe;

18 ‘‘(B) forwarded through the appropriate

19 directors of sea grant colleges to the National

20 Sea Grant Office; and

21 ‘‘(C) reviewed by the Marine Biotechnology

22 Review Panel in accordance with subsection (d).

23 ‘‘(2) TERMS AND CONDITIONS.—Any reference

24 in subsection (d) of section 205 or in the last sen25 tence of subsection (a) of section 205 to grants and
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1 contracts provided for under that section shall be

2 treated, as the context requires, as including any

3 grant applied for or made, or contract applied for or

4 entered into, under this section.

5 ‘‘(3) AWARDING OF GRANTS AND CON6 TRACTS.—The Secretary shall award grants and

7 contracts under this section on the basis of the rec8 ommendations for award made by the Marine Bio9 technology Review Panel under subsection (d).

10 ‘‘(d) MARINE BIOTECHNOLOGY REVIEW PANEL.—

11 ‘‘(1) ESTABLISHMENT AND DUTIES.—Subject

12 to the availability of appropriations under section

13 212(c), the Director, in consultation with the direc14 tors of the sea grant colleges, shall convene a panel,

15 to be known as the Marine Biotechnology Review

16 Panel, that shall—

17 ‘‘(A) review, on a competitive basis, the ap18 plications made under this section for grants

19 and contracts to determine their respective sci20 entific, technical, educational, and commercial

21 merits and likely contributions toward achieving

22 the purposes of this section; and

23 ‘‘(B) on the basis of the review under sub24 paragraph (A), and with due regard for the

25 overall balance and coordination of the marine
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1 biotechnology program, make recommendations

2 to the Secretary regarding the awarding of

3 grants and contracts under this section.

4 ‘‘(2) MEMBERSHIP.—The Marine Biotechnology

5 Review Panel shall—

6 ‘‘(A) consist of not more than fifteen indi7 viduals with scientific or technical expertise in

8 marine biotechnology or relevant related fields,

9 including at least one qualified individual with

10 expertise in marine or freshwater ecological risk

11 assessment;

12 ‘‘(B) reflect a balance among areas of ex13 pertise consistent with the purposes of this sec14 tion;

15 ‘‘(C) not include Federal employees or di16 rectors of sea grant colleges; and

17 ‘‘(D) reflect geographic balance, consistent

18 with the primary objectives of a high level of ex19 pertise and balance among areas of expertise.

20 ‘‘(3) ALLOWANCES.—Each member of the Ma21 rine Biotechnology Review Panel shall receive travel

22 expenses, including per diem in lieu of subsistence,

23 in accordance with sections 5702 and 5703 of title

24 5, United States Code.’’.
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1 (b) DEFINITIONS.—(1) Section 203 of the National

2 Sea Grant College Program Act (33 U.S.C. 1122) is

3 amended by redesignating paragraphs (6) through (15) as

4 paragraphs (7) through (16), respectively, and by insert5 ing after paragraph (5) the following new paragraph:

6 ‘‘(6) The term ‘marine biotechnology’ means

7 the application of molecular and cellular techniques

8 to marine and other aquatic organisms for the pur9 poses of—

10 ‘‘(A) identifying, isolating, developing, and

11 enhancing products that are derived from the

12 marine environment;

13 ‘‘(B) developing and applying techniques to

14 conserve, manage, and protect marine and

15 coastal resources; and

16 ‘‘(C) monitoring human health and treat17 ing disease.’’.

18 (2) Section 203(4) of the National Sea Grant College

19 Program Act (33 U.S.C. 1122(4)) is amended by inserting

20 ‘‘marine biotechnology,’’ immediately after ‘‘marine tech21 nology,’’.

22 (c) AUTHORIZATION OF APPROPRIATIONS.—Section

23 212 of the National Sea Grant College Program Act (33

24 U.S.C. 1131) is amended—
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1 (1) in subsection (b), by inserting ‘‘but not in2 cluding section 206’’ immediately after ‘‘section

3 209’’;

4 (2) by redesignating subsections (c), (d), and

5 (e) as subsection (d), (e), and (f), respectively; and

6 (3) by inserting immediately after subsection

7 (b) the following new subsection:

8 ‘‘(c) MARINE BIOTECHNOLOGY PROGRAM.—

9 ‘‘(1) GRANTS AND CONTRACTS.—There is au10 thorized to be appropriated to carry out the provi11 sions of section 206 (other than for administration)

12 an amount—

13 ‘‘(A) for each of the fiscal years 1994 and

14 1995, not to exceed $20,000,000; and

15 ‘‘(B) for each of the fiscal years 1996 and

16 1997, not to exceed $25,000,000.

17 ‘‘(2) ADMINISTRATION.—There is authorized to

18 be appropriated for the administration of section

19 206, an amount—

20 ‘‘(A) for each of the fiscal years 1994 and

21 1995, not to exceed $200,000; and

22 ‘‘(B) for each of the fiscal years 1996 and

23 1997, not to exceed $250,000.’’.

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