Report Title:

Bioprospecting

 

Description:

Vests rights to biodiversity in the State.  Creates commission on bioprospecting and authorizes DLNR and commission to regulate bioprospecting and subsequent commercial use of the State's biodiversity through procedures governing access and the benefit sharing agreement process.  Appropriation for FY 2009-2010.

 


HOUSE OF REPRESENTATIVES

H.B. NO.

1195

TWENTY-FIFTH LEGISLATURE, 2009

 

STATE OF HAWAII

 

 

 

 

 

 

A BILL FOR AN ACT


 

 

relating to bioprospecting.

 

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 


     SECTION 1.  The legislature finds that House Concurrent Resolution No. 193, H.D. 1 (2006), declared that Hawaii's biological resources are assets of the public land trust that are culturally, spiritually, medicinally, and otherwise significant to Hawaiians and the general public.  The resolution also declared that Hawaii runs the risk of losing its biological resources as the State's natural habitats are developed, the natural environment is degraded, and non-sustainable consumptive practices are perpetuated.

     The resolution further stated that Hawaii's unique biological resources are assets of a public trust established in Article XI, section 1, of the Hawaii State Constitution, which states:

     "For the benefit of present and future generations, the State and its political subdivisions shall conserve and protect Hawaii's natural beauty and all natural resources, including land, water, air, minerals and energy sources, and shall promote the development and utilization of these resources in a manner consistent with their conservation and in furtherance of the self-sufficiency of the State.

          All public natural resources are held in trust by the State for the benefit of the people."

     The resolution also stated that Hawaii's biological resources are of great potential economic benefit in the areas of medicine, scientific research, biotechnology, and commercial development.  The resolution identified a need to develop public policy to balance development and commercialization with scientific research and conservation of Hawaii's fragile bio-resources, and fair and equitable benefit-sharing with the general public and Hawaiians, who are the beneficiaries of the public land trust.

     The legislature also finds that the adoption of regulations governing bioprospecting would assist researchers in understanding the rules and the procedures for bioprospecting in Hawaii, thereby making it easier for researchers to understand all the aspects of pursuing such a venture.  Furthermore, the absence of such regulations may be depriving the State of what could potentially be large monetary returns or other benefits from the use of its resources.  The resolution asked the governor to establish a temporary advisory commission on bioprospecting, placed it within the office of Hawaiian affairs for administrative purposes, and tasked it with making recommendations for policy development in the areas of:

     (1)  Prior informed consent;

     (2)  Equitable benefit sharing;

     (3)  Bio-safety protocols;

     (4)  A permitting and licensing process; and

     (5)  Cultural rights for the use of Hawaii's biodiversity.

     The governor completed making appointments to the temporary advisory commission in January 2007, and the commission held its first meeting on March 16, 2007.

     On February 5, 2008, the commission issued a report containing recommendations for legislation concerning bioprospecting.  The purpose of this Act is to implement those recommendations by:

     (1)  Establishing ownership of biological resources;

     (2)  Defining bioprospecting;

     (3)  Establishing a permanently funded commission on prospecting; and

     (4)  Requiring the department of land and natural resources to adopt rules pursuant to chapter 91 establishing requirements for obtaining a permit to conduct bioprospecting activities in the State.

     SECTION 2.  Chapter 171, Hawaii Revised Statutes, is amended by adding a new part to be appropriately designated and to read as follows:

"Part   .  BIODIVERSITY AND BIOPROSPECTING

     §   ‑1  Definitions.  As used in this part, unless the context otherwise requires:

     "Access to genetic resources" or "access" means to the obtaining of samples of biological or genetic materials within the State's jurisdiction for purposes of research on conservation, management, commercial application, or industrial use.

     "Benefit sharing" means equitable sharing of benefits with the providers of the material, on agreed terms, arising from the use of biological or genetic materials.

     "Biodiversity" means the total variety of life on earth, including genes, species, and ecosystems and the complex interactions among them.

     "Bioprospecting" means any activity undertaken to harvest or exploit for any purpose any sample or derivative in situ (in its original location or natural environment) or ex situ (removed from its original location or natural environment) of genetic or biochemical resources from plants, animals, or microorganisms; provided that "bioprospecting" does not include the taking of any biological:

     (1)  Resources from an area of land or water by Hawaiians and other peoples who have traditionally used the area of land or water in accordance with traditional customary practices;

     (2)  Material of living human origin;

     (3)  Samples that are part of usual practices in crop cultivation, animal husbandry, or aquaculture; and

     (4)  Resources for any commercial or related noncommercial activity, such as fishing for commerce or recreation, collecting of broodstock, and harvesting of trees, plants, and flowers.

     "Commercial use" means any use of biodiversity or genetic resources, their products, or their derivatives for monetary gain that includes selling in the market.

     "Commission" means the commission on bioprospecting established by this part.

     "Department" means the department of land and natural resources.

     "Hawaiians" means persons defined as "Hawaiian" in section 10-2.

     "Material transfer agreement" means an agreement executed between the individual who has recovered the biological resource and another individual who wants access to the material for the latter individual's own purposes, regardless of whether the purpose may be pure research or commercial.

     "Prior informed consent" means assent that is reached by means of a set of administrative procedures for deciding on whether to grant access to genetic resources on defined terms.

    "State lands" includes all public and other lands, including but not limited to submerged lands, owned or in possession, use, and control of the then Territory of Hawaii or the State of Hawaii, or any of its agencies.

     §   ‑2  Biodiversity ownership and rights.  (a)  Except as provided in this part, the ownership of, and right to, any biodiversity in, on, or under any lands located in the State of Hawaii, regardless of whether the lands are state lands or private lands, shall:

     (1)  Rest with the State; and

     (2)  Not be transferred by any lease, sale, right of entry, or other agreement, the ownership of and right to biodiversity being held by, and reserved to, the State.

     (b)  Disposition of biodiversity rights shall be in accordance with the laws relating to the disposition of biodiversity rights enacted by the legislature.

     (c)  Subject to subsection (a), all land patents, leases, grants, or other conveyances of any lands located in the State of Hawaii, regardless of whether the lands are state lands or private lands, shall be subject to, and contain a reservation to the State of, all the biodiversity.

    §   ‑3  Authority and responsibility of the State.  The State shall have the authority and responsibility to regulate bioprospecting and the subsequent commercial use of the State's biodiversity and to protect the knowledge, innovations, and traditional and customary practices of Hawaiians and other peoples.

    §   ‑4  Establishment of the commission on bioprospecting.  (a)  There is created the commission on bioprospecting to be placed within the department for administrative purposes.  The commission shall consist of eleven members consisting of:

    (1)  The chairperson of the board of trustees of the office of Hawaiian affairs or a designee;

    (2)  The president of the University of Hawaii or a designee;

    (3)  The director of business, economic development, and tourism or a designee;

    (4)  The chairperson of the board of land and natural resources or a designee;

    (5)  Five members who are to be appointed by the governor from candidates nominated by the president of the senate, the speaker of the house of representatives, and Hawaiian organizations and who are from the native Hawaiian community, reside in the State, and have a demonstrated background in:

        (A)  Traditional and customary use of biological and genetic resources;

        (B)  Indigenous and traditional technologies;

        (C)  Scientific and technical use of native Hawaiian practices;

        (D)  Legal procedures nationally and internationally, in connection with the protection or commercialization of biological and genetic resources; and

        (E)  Native Hawaiian cultural rights as contained in the Hawaii state constitution and the Hawaii Revised Statutes;

    (6)  Two members who are to be appointed by the governor from candidates nominated by the president of the senate, the speaker of the house of representatives, and members of the biotechnology industry based in Hawaii and who are representatives of the biotechnology industry and whose principal place of business is in the State.

    (b)  The commission shall elect its chairperson from among its own membership.  Members shall not be compensated for their services on the commission, but shall be reimbursed for actual and necessary expenses incurred in the performance of their duties.

    (c)  The commission may hire staff necessary for the performance of its duties, including an executive officer and administrative personnel.  The executive officer shall be appointed by the commission and shall be exempt from chapters 76 and 89.  Other departments of the state government shall make available to the commission data, facilities, and personnel as are necessary for the commission to perform its duties.  The commission may receive and utilize donations and any funds from federal or other governmental agencies.  It shall adopt rules in accordance with chapter 91 to guide its conduct, maintain a record of its activities and accomplishments, and make recommendations to the governor and to the legislature through the governor.

     §   ‑5  Duties of commission.  The commission's duties shall include but not be limited to the following:

     (1)  To enter into and enforce access and benefit sharing agreements related to proposed bioprospecting ventures; and

     (2)  As the initial task after its formation, to establish procedures governing an access and benefit sharing agreement process to include identification of stakeholders, prior informed consent, equitable benefit sharing, and biosafety encompassing the following considerations:

         (A)  Priority for participation in the process shall be given to the following stakeholders to be engaged in the discussion of every aspect of every component of the agreement:

              (i)  Landowners;

             (ii)  Hawaiians;

            (iii)  The community from which the resources are sampled;

             (iv)  Researchers;

              (v)  The University of Hawaii; and

             (vi)  The biotechnology industry;

              provided that discussion shall not necessarily be limited to these priority stakeholders;

         (B)  Prior informed consent shall be given by the requisite stakeholders, as determined by the regulatory process, prior to the commencement of a prospective bioprospecting venture;

         (C)  Benefit sharing shall provide for the distribution of any monetary and nonmonetary benefits that may result from the exploration activities to the stakeholders under subparagraph (A);

         (D)  Applicable biosafety protocols shall be addressed in all access and benefit sharing agreements; and

         (E)  The knowledge, innovations, and traditional and customary practices of Hawaiians and other peoples shall be protected.

     §   ‑6  Administrative rules.  The department, in consultation with the commission, shall adopt rules pursuant to chapter 91 establishing requirements for obtaining a permit to conduct bioprospecting activities.  The regulations shall include, but not be limited to, provisions:

    (1)  Establishing a two-track system for determining whether or not to approve a permit and allow a venture to proceed.  Under the two-track system, all permit applications shall be reviewed at the outset to determine whether the proposed activity:

         (A)  Involves any intent to use any sample to produce a commercial product or process; or

         (B)  Is for the purpose of conducting academic or scientific research that does not infringe on the knowledge, innovations, and traditional or customary practices of Hawaiians.

          Applications under subparagraph (A) shall be referred to the commission for review and recommendation prior to the department's decision on issuing a permit.  Applications under subparagraph (B) shall be placed on a fast track to the department for a decision.

    (2)  Requiring the permit holder to submit all proposed material transfer agreements to the commission to ensure that all legal requirements are being observed;

     (3)  Requiring the owners of ex situ collections to refer any requests for transfer of the specimens in their possession or control to the commission;

     (4)  Requiring all bioprospecting permits to require the permit holder to periodically report the use and location of any samples collected under the authority of the permit;

     (5)  Requiring all permit holders to obtain the commission's permission before transferring any samples to another party, for any reason;

     (6)  Establishing an efficient tracking system relating to the samples;

     (7)  Requiring all permit holders to inform the department and the commission when a discovery is made so that the commission may negotiate terms of any licensing agreements that might follow;

     (8)  Requiring a permit applicant to meet with all parties in the community who are interested in the project to attempt to arrive at an agreement that will allow the project to proceed;

     (9)  Protecting proprietary information that an applicant might be requested to reveal during the access and benefit sharing agreement proceedings;

    (10)  Requiring the commission to establish advisory groups to engage in the access and benefit sharing process;

    (11)  Upon the commission's determination that all stakeholders have agreed to an access and benefit sharing agreement, requiring the permit application to be referred back to the department for appropriate processing; and

    (12)  If a subsequent discovery leads to development of a commercially valuable product, requiring a permit holder initially granted a permit under paragraph (1)(B) to immediately resubmit an application for a permit under paragraph (1)(A), which shall be referred to the commission for further processing in accordance with this section."

     SECTION 3.  There is appropriated out of the general revenues of the State of Hawaii the sum of $          or so much thereof as may be necessary for fiscal year 2009-2010 and the same sum or so much thereof as may be necessary for fiscal year 2010-2011 for the establishment of the commission on bioprospecting as set forth in section 2 of this Act.

     The sums appropriated shall be expended by the department of land and natural resources for the purposes of this Act.

     SECTION 4.  This Act shall take effect upon its approval, except that section 3 shall take effect on July 1, 2009.

 

INTRODUCED BY:

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