Oregon Draft Policy Recommendations for Plant-Made Pharmaceuticals

To: Oregon Department of Agriculture, Oregon Department of Human Services
and Members of the Biopharming Ad Hoc Committee

The Biotechnology Industry Organization (BIO) and Oregonians for Food & Shelter (OFS)
appreciate the opportunity to comment on the draft policy document prepared by the Oregon
Biopharming Ad Hoc Committee.

BIO is the national trade association for the biotechnology industry, representing more than
1,100 biotechnology companies, academic institutions, state biotechnology centers and related
organizations across the United States and 31 other nations. BIO members are involved in the
research and development of healthcare, agricultural, industrial and environmental biotechnology
products, with over 300 biotechnology-derived drugs in clinical development addressing cancer,
heart disease, Parkinson’s, Alzheimer’s and other intractable diseases.

OFS is a member-funded, state grass roots coalition representing more than 11,000 natural
resource based individuals, businesses and trade organizations in Oregon, including BIO. OFS’s
mission is “to promote the efficient production of quality food and fiber, while protecting human
health, personal property and the environment, through the integrated, responsible use of pest
management products, soil nutrients and biotechnology.” This is OFS’s 26th year of service to
Oregon’s natural resource base and the businesses and communities it supports.

New advances in biotechnology make it possible to turn plants into "factories" that produce
therapeutic proteins for use in the manufacture of drugs, medicines and therapies. Plant-made
pharmaceuticals (PMPs) are the result of an innovative application of biotechnology to plants to
enable them to produce therapeutic proteins that could ultimately be used by the medical
community to combat life-threatening illnesses. BIO and OFS and its members are committed to
protecting human health and the environment by ensuring the safety of PMPs during all stages of
OFS development and production through a close working relationship with state and federal
regulatory authorities to assure that applicable requirements are both rigorous and enforceable.
BIO and OFS applaud the commitment the State of Oregon has shown to new technologies and
research through initiatives such as the Oregon Nanoscience and Microtechnologies Institute.
That commitment is also evident in the thoughtful approach the Committee has taken to the
issues involved with the cultivation of PMPs. It is BIO’s and OFS’s position, however, that the
Committee’s recommendations as a whole are premature at this point.

The U.S. Department of Agriculture (USDA) established its Biotechnology Regulatory Services
(BRS) division in 2002 to place increased emphasis on USDA’s regulatory responsibilities for
biotechnology. Prior to that time, plant products of biotechnology were regulated under the
general authority of USDA’s Animal and Plant Health Inspection Service (APHIS). APHIS has
a long history of regulating agricultural biotechnology products, overseeing the safe conduct of
more than 10,000 field tests of plants produced through biotechnology.

Since 2002, BRS has been consistently reviewing and strengthening the requirements for PMP
field trial permits, as well as the rigor of the division’s oversight of permit compliance. These
modifications to the PMP permitting requirements are based on the experience that BRS
personnel have developed over years of dealing with these types of field trials. It is anticipated
that PMP permit requirements will continue to be strengthened over the next several planting
seasons. Doing so at the federal level promotes needed uniformity and a level regulatory playing
field across the entire U.S. This puts no state in a position of advantage or disadvantage.

Additionally, BRS announced in 2004 that it was undertaking substantial revisions to its
regulations for all plants developed through biotechnology, including PMPs. These regulations
will reflect new authority that USDA was granted under the Plant Protection Act of 2000 and,
according to public statements made by BRS, will fundamentally alter certain aspects of the
current permitting system, including that used for PMP permits. The promulgation of these new
regulations is being accompanied by the preparation of a Programmatic Environmental Impact
Statement (PEIS), which will examine the potential environmental impacts of this rule-making.
The PEIS process includes the opportunity for public comment. Additionally, the rulemaking
itself will be subject to public notice and comment. We understand that BRS currently
anticipates publication of the draft PEIS by winter of 2006 – prior to the 2007 growing season.
In the interests of regulatory economy, the State of Oregon would be best served by directing its
resources towards participating in the ongoing federal policy revisions and rulemaking processes,
rather than moving ahead prematurely with a policy that would unnecessarily stifle new and
valuable technology. Until the State has a better understanding of the types of permit
requirements that will be implemented at the federal level, as well as any unique issues that
might require review at the state level, adopting policies at the state level may well prove an
unnecessary expenditure of time, effort and limited financial resources.

Moreover, a number of the specific recommendations do not appear to be designed to address
Oregon-specific issues, but are much more broadly based. It would be more appropriate to
submit these approaches to BRS for nationwide consideration rather than to seek to impose them
at the state level. If, based on its years of experience with these field trials, BRS does not
determine that certain specific measures need be taken to protect agriculture and the environment
nationwide, there may be little basis to require such measures in a particular state.

Additionally, several of the proposed recommendations are likely to disproportionately stifle
research and development efforts by small companies and academics. Requiring a researcher to
post a bond or demonstrate financial responsibility for potential inadvertent release would create
an insurmountable burden, essentially preventing those researchers from operating in the State.
It would be particularly onerous and detrimental to future research programs at State universities,
as their research budgets have been slashed and are already overtaxed. This requirement is
neither science- nor risk-based, and is not based on any evidence of harm to human health or the
environment caused by any PMP planting.

As the Committee recognized, any adventitious presence from PMP field trials is likely to pose
no significant impacts on human or environmental health. The State of Oregon does not require
the posting of bonds or other demonstration of financial responsibility for other agricultural
activities. Even a suggestion that a financial requirement would be necessary would erroneously
portray PMPs as needlessly dangerous to agriculture and human health.

Another proposed recommendation would work a similar hardship on small companies and
academic researchers. As the Committee has recognized, the creation of an extensive permit
review system for PMP field trials would require significant State expenditures, and would likely
become a resource burden for the State. However, due to the small size of this industry, and the
high percentage of small companies and academic researchers in the field, application fees high
enough to pay for services would inevitably be more expensive than most researchers could bear.
Given the extensive regulatory oversight administered by BRS, the cost involved with extensive
State oversight would be an unnecessary expense, whether paid for by researchers or the State.
Another proposed recommendation suggests that the State enter into an agreement or
Memorandum of Understanding (MOU) with BRS regarding certain information and authority
sharing. While all interested stakeholders agree that increased collaboration among the state and
federal governments should be encouraged, several provisions of the proposed MOU will require
careful legal scrutiny. With regard to the sharing of confidential business information (CBI),
such cooperation will depend on the State Department of Agriculture’s ability to adequately
protect the information. This will, in turn, depend on State law, which would be beyond the
scope of any MOU. Similarly, the proposed MOU provision that would authorize the State to
modify, restrict or veto a permit would appear to conflict with the scope of BRS’s authority as
set forth in the federal Plant Protection Act of 2000.

Changes made by ODA to their CBI statues in 1999 when promulgating the Pesticide Use
Reporting System insured confidentiality of that information. Perhaps this is a template ODA
can use to expand CBI protection to include confidential PMP information.
BIO and OFS support the careful and balanced approach the Committee has taken with regard to
this issue. We highly support the State’s efforts to encourage new technologies, to strengthen its
communications with the public regarding the role new technologies play in Oregon, and to
increase the State’s interaction with federal authorities regarding PMPs.

However, in order to make the most effective use of both State and federal resources, BIO and
OFS suggest that the State take no further action on regulatory components of this policy until
the completion of the current federal rulemaking. During the course of that rulemaking, the State
will have the opportunity to more fully explore all its recommendations, and to receive feedback
from not only BRS, but from a multitude of other interested states and other stakeholders. Once
that process is complete, the State will be in a position to better understand whether any
additional action may be necessary.

With no existing PMP problems in Oregon and no PMP planting permits even requested for the
near future, the State can afford to take some extra time to deal with this issue using a
scientifically based, uniform and federally coordinated approach that protects the public, the
environment, Oregon’s research community, the economy and the societal benefits this
technology will likely bring.

Again, BIO and OFS appreciate the opportunity to present their views on this important issue,
and offers any help and technical expertise our organizations can provide in the future.

Respectfully,

Terry Witt
Executive Director
Oregonians for Food & Shelter (OFS)
3415 Commercial Street SE, Suite 100
Salem, OR 97302

Sean Darragh
Executive Vice President, Food and Agriculture
Biotechnology Industry Organization (BIO)
1225 Eye Street NW, Suite 400
Washington DC 20005