8LM LIBRARY 88070405 United States Final Environmental Department of Agriculture Impact Statement Forest Service Record of Decision September, 1993 United States Department of the Interior Bureau of Land Management United States Department of Health and Human Services Food and Drug Administration SD 397 Y46 . P324 1993b v 4 . c 1 . iimoiwos 1 39?- ^ 7 , 3^ f b ‘ <7-5 l 5 £ Record of Decision USDA and Forest Service Management Bureau Land of Yew Pacific Final Environmental ImpactStatement August 1993 USDA ForestService USDI Bureau ofLand Management NationalForests andBLMDistricts in Washington, Oregon, California, Idaho, and Montana USDFIHS Food and Drug Administration Record of Decision Record of Decision Table of Contents Introduction I. A. Background B. Scope of the Decision LO C. Public Involvement <3 The Decision O II. Alternatives III. A. Alternatives Considered in Detail 11 B. The Environmentally Preferable Alternative 14 IV. Reasons for Selecting Alternative B A. Response to Major Issues 16 B. Other Decision Factors 18 V. Mitigation Measures 20 VI. Monitoring 23 VII. Findings Required by Other Laws 23 Implementation Date 24 VIII. 2 PacificYewRecordofDecision and ForestService Bureau ofLand Management Acronyms Know to BLM Bureau LandManagement of BMS Bristol-Myers Squibb Company CEQ Council on Environmental Quality CRADA CooperativeResearch andDevelopmentAgreement DEIS Draft Environmental Impact Statement FDA Food and DrugAdministration FEIS Final Environmental Impact Statement INDA Investigational New DrugApplication MOU Memorandum ofUnderstanding NCI National Cancer Institute NDA New DrugApplication ROD Record ofDecision USDA United States Department ofAgriculture USDHHS United States Department ofHealth and Human Services USDI United States Department ofthe Interior Introduction I. The Final Environmental Impact Statement (FEIS) documents the results ofthe environmental analysis ofharvest alternatives for Pacificyew ('Taxus brevifolia on National Forest System lands ) and lands administered by the Bureau of Land Management (BLM) in Oregon, Washington, Idaho, Montana, and California. We have read the FEIS and reviewed related materials, including responses to the Draft Environmental Impact Statement (DEIS) We published in January 1993. have also considered the current situation concerning demand for Pacific yew from federal lands. Our decision is based upon all of these items and this Record of Decision (ROD) documents ourreasons for adoptingAlternative B ofthe FEIS. Our decision applies to both National Forest System lands and lands administered by the Bureau of Land Manage- ment. 3 PacificYewRecordofDecision Record of Decision Background A. Pacific yew is a small, evergreen tree found in forests throughout the northwest, from southeast Alaska to northern California, as well as in parts of Idaho and Montana. Although rarely found in pure stands, the Pacific yew is not an endangered or threatened species. Inventories for Pacific yew in eight national forests and BLM six districts in Oregon, Washington, and Idaho found over 50 million yew trees over one inch in diameter at breast height. In the 1960’s and 1970’s, the National Cancer Institute (NCI) extracted taxol1 from Pacific yew samples and found that it had anti-cancer activity. During this time, researchers succeeded in defining the structure of the taxol molecule, its mechanism of action, and its activity against cancer cells in various animal systems. In 1982, the NCI filed an Investigational New Drug Application (INDA) with the Food and DrugAdministration (FDA) and began clinical trials using taxol extracted from Pacific yew bark. The clinical trials showed that taxol was very effective against a number of cancers, and in the late 1980’s, NCI con- tracted to have yew bark collected from National Forest System lands; approximately 132,000 pounds were collected. NCI then began a search for a pharmaceutical partner who could develop the drug, find a reliable taxol source, and bring it to market; after a competitive process, the Bristol-Myers Squibb Company (BMS) was selected and a CooperativeResearch and DevelopmentAgree- ment (CRADA) between BMS and NCI was completed. In 1991, the Departments ofAgriculture, Interior, and Health and HumanServices signed aMemorandum ofUnderstanding(MOU) BMS to coordinate activities and assist in obtaining raw material (yewbark) neededtoproducetaxol in accordancewith the CRADA. Based ontheMOU, the Forest Service and BLM each entered into a cooperative agreement with BMS to supply it with Pacific yew for taxol production. In 1991 and 1992, about 1.7 million dry pounds ofyew bark were harvested from federal lands for BMS. In August of 1992, the PacificYewAct (PL 102-335 106 Stat. 859) was passed by Congress and signed into law. TheAct ensures that 1 Taxol is nowa registeredtrademarkedname(Taxol®); however,inthis document weusethewordtaxol inagenericsense,referringtothedrugpaclitaxel (taxol)and relatedtaxanes thatarepresentin Pacificyew. PacificYewRecordofDecision and ForestService Bureau ofLand Management BLM the Forest Service and carry out efficient collection and utilization ofPacificyewfortaxol; specifies the conditions ofsale of Pacific yew from federal lands; ensures long-term conservation of Pacific yew; and prevents waste ofPacific yew resources. As part ofthe CRADA with NCI, BMS is obligated to investigate and establish alternative sources oftaxol and file for approval of New Drug Applications (NDA) for taxol. In December, 1992, the FDA NDA BMS BMS approved the filed by which allows to commercially market taxol, derived from Pacific yew bark, for treatment ofovarian cancer. Onemonth later, inJanuary of1993, BMS announced that, as aresult oftheirprogress with alternative approaches, they did not need Pacificyewbark from federal lands BMS in 1993. Although purchased bark from federal lands in 1993 to fulfill past obligations and assist the Forest Service and BLM in complying with the Pacific Yew Act (which requires pre- harvest ofyew in timber sales), it will most likely not be purchas- ing yew material from federal lands after the 1993 yew harvest season. Over the last two years, several other parties have requested federal yew for the purposes of taxol research or development. However, less than 10,000 pounds have been transferred since 1991 for these purposes. B. Scope of the Decision The scope ofthis decision applies to harvest ofPacificyew for taxol while there is a valid demand for Pacific yew biomass for use in research and treatment of cancer. This decision will be imple- mented only when there is a demand for Pacific yew from federal landsfor taxol. It provides a strategy forharvestingPacificyewfor the next five years (1993-1997) on National Forest System lands and lands administered by the BLM. This decision provides the framework, as well as some specific guidelines and mitigation measures, for Pacific yew harvest on federal lands. It does not specify exact locations ofyew harvest, exact numbers of yew for harvest in any one location, or the particular environmental risksfor each acrewhereyewispresent. Site-specific environmental analyses are required before any yew 5 PacificYewRecordofDecision Record of Decision harvest takes place; these analyses will be tiered to the FEIS. Conservation measures for listed threatened, and endangered , species that are developed during site-specific (project level) consultationrequiredby the Endangered SpeciesActmaybemore restrictive than, and will take precedence over, the measures described in the FEIS and ROD. To the extent that the standards and guidelines of future agency resource plans conflict with this Record of Decision, the direction contained in the agency plans will be pre-eminent. This decision also does not analyze or propose alternatives for the short- or long-term management of Pacific yew. Management of Pacific yew is an issue that will be addressed in agency resource plans and policies. This decision also does not analyze or propose solutions for other issues, such as theft ofPacificyew, the relation- ship prescribed by the CRADA between NCI and Bristol-Myers Squibb, or the development ofother sources oftaxol. If, within the five years covered by this ROD, the demand foryew BLM from National Forest System and lands exceeds the amount that can be supplied by this decision, the need for a new decision will be examined. If, afterthefiveyears coveredbythis ROD, there is still a demand for Pacific yew from federal lands for taxol, this analysis will be reviewed, and a new or supplementary EIS will be prepared if necessary. In order to continue yew harvest beyond five years, a new decision would be necessary. C. Public Involvement In the early phase ofthe environmental impact analysis, citizens, interest groups, businesses, and state, county, and other federal agencies helped us identify the important issues. The EIS inter- disciplinary team contacted the public by newsletter and in meet- ings to gather the issues and concerns that shouldbe addressed in the analysis. The team met with various groups and kept in touch with key contacts. The issues suggested by the public were used to guide the development ofthe EIS. Detailed information describingthe public involvement process is presented in Appendix A ofthe DEIS and FEIS. 6 PacificYewRecordofDecision and Forest Service Bureau ofLand Management InitialIssues and Concerns: Mostpeoplewhorespondedwanted the Forest Service and BLM to harvest yew for the production of taxol but, at the same time, protect the Pacificyew species and its environment. Three main issues were identified: Protect and maintain the Pacific yew species (establish re- serve areas or numbers ofreserve trees). Protect the ecosystem (riparian areas, wildlife, other plants, soil, fire cycles, old growth forests). Provide material from the Pacific yew for taxol. A number of suggestions were made that related to the above issues. These included: Establish a sustainable level of collection and analyze the impacts ofharvesting minimum to maximum amounts. Consider social, cultural, and tribal impacts ofcollectingyew. Regenerate yew by planting yew and managing for natural regeneration. Consider the economic impacts of yew collection on timber production, local employment, and a long-term local yew collection industry; look at future supplies oftaxol and other possible drugs and agreements for taxol production. Establish areas of collection and decide whether or not to enter set-aside areas such as wilderness, spotted owl habitat, Research Natural Areas, and roadless areas; decide whether or not tobuild newroads for access; and concentratecollection in certain areas or spread collection over wide areas. Establish collection methods; consider partial bark stripping, tree felling, and collection ofneedles and twigs. Utilize the yew completely, including all the bark, twigs, needles, and wood. Develop other sources oftaxol as soon as possible. Stop theft and illegal harvest. PacificYewRecordofDecision Record of Decision DEIS Comment PeriodAnd CommentAnalysis: TheFederal Register published the notice of availability for the DEIS on January 22, 1993. The public review period of 45 days ended March 15, 1993. Eighty-eight comments were received on the DEIS. This small number ofresponses may reflect the announce- ment by BMS on January 25, 1993, that it would no longer need bark from Pacific yew on federal lands. What follows are the major concerns expressed by the public following the release ofthe DEIS. • Restate the DEIS purpose and need; consider new alter- natives; prepare a supplement to the DEIS. • Create a needle harvest alternative. • Provide for sustained yield ofyew. • Protect the Pacific yew tree; continue inventory and re- search efforts; and re-establish yew in previously har- vested areas. • Protect the whole ecosystem. 8 PacificYewRecordofDecision