Meyer Glitzenstein & Eubanks LLP 4115 Wisconsin Avenue, N.wW., Suite 210 245 Cajetan Street Washington, D.C. 20016 Fort Collins, CO 80524 ‘Telephone (202) 588-5206 Telephone (970) 703-6060 Fax (202) 588-5049 Fax (202) 588-5049 Imink@meyerglitz.com beubanks@meyerglitz.com September 22, 2015 Se nd EI Dean Bolstad, Senior Advisor BLM Division of Wild Horses and Burros 20 M Street, S.E. Washington, DC 20003 Email: dbolstad@bim.gov Facsimile: 775-861-6618, 202-208-5010 John F, Ruhs, Acting State Director BLM Nevada State Office 1340 Financial Blvd. Reno, NV 89502 Email: jruhs@blm.gov Facsimile: 775-861-6601 Michael Herder, District Manager Ely District Office 702 North Industrial Way, HC 33 Box 33500 Ely, NV 89301 Ema Facs @bln : 775-289-1910 Alan Shepherd, Wild Horse & Burro Program State Lead BLM Nevada State Office 1340 Financial Blvd. Reno, NV 89502 Email: ashepherd@blm.gov Facsimile: 775-861-6601 Re: istrict W. n An Man: rea Program T ecyeled paperDear BLM Officials: | am writing on behalf of the American Wild Horse Preservation Campaign (“AWHPC”) concerning the recent decision by the Bureau of Land Management ("BLM") 10 use the controversial and, as yet, not fully tested GonaCon™ - Equine immune- contraceptive vaccine ("GonaCon”) as outlined in the August 18, 2015 Decision Record (DR) for Ely District Water Canyon Wild Horse Growth Suppression Pilot Program Environmental Assessment (EA) DOI-BLM-NV-120-2015-0014-EA. Although, as explained in detailed comments submitted by AWHPC on June 15, 2015, and hereby attached and incorporated by reference, there are myriad reasons why this “pilot program” violates the Wild Free Roaming Horses and Burros Act ("Wild Horse Act"), 16 U.S.C. § 1331 et seq.and the National Environmental Policy Act ("NEPA"), 42 U.S.C. § 4321 et seq. I write to focus principally on the Proposed Action, which fails even to establish a formal scientific study for this precedent-setting application of GonaCon™ jn federally-protected wild horses as a part of this action. The Proposed Action as outlined in the Decision Record (DR) for Ely District Water Canyon Wild Horse Growth Suppression Pilot Program Environmental Assessment (EA) DOI-BLM-NV-L20-2015-0014-EA would establish a 10-year “Pilot Program” utilizing GonaCon™, which has never been used before by the BLM on wild horses. This precedent- setting use of GonaCon™ by the BLM must be conducted in a scientifically responsible ‘manner as outlined by the National Academy of Sciences (NAS), whieh noted in its June 2013 Report, that “[fJew data on horses” are available for use of GonaCon and that “GonaCon has not been tested extensively in equids.” Using Science to Improve the BLM Wild Horse and Burro Program: A Way Forward (June 2013) at 7. The Report also concluded that “further studies on behavioral effects of this product are needed We therefore request that the Proposed Action be delayed until the DR and Final EA adequately address the potential impacts on wild horses, and the proposal is revised to establish a formal research study and protocol executed in conjunction with a reputable scientific institution. The current Proposed Action involves experimenting on America’s wild horses without any scientific oversight or review, or, for that matter, any scientific ‘method for determining the impacts of the experiments on the horses themselves. Further, the use of GonaCon in this unscientific, unregimented proposal will place in jeopardy the individual horses’ long-term well-being and their natural, social behaviors, which are attributes that make wild horses celebrated American icons, treasured by Americans and others around the world. National Academy of Sciences, “Using Science to Improve the BLM Wild Horse and Burro Program: A Way Forward,” 2003, p. 7.L ks Sufficient 1n GonaCon"™'s Effects to Proceed Without a Formal Scientifi ‘Study, When it comes to use in free-roaming wild horses, GonaCon™ remains at the experimental stage. Hence, not much is known about its long-term safety and efficacy and the impacts to natural wild horse behaviors and natural social behaviors, which are the differentiating factors for these federally-protected animals. In fact, in response to a request from the BLM to review the best science and fertility control alternatives available for use in the BLM Wild Horse and Burro Program, the NAS specifically responded that: Preserving natural behaviors is important, so GonaCon seems [emphasis] more appropriate for use in females in that some research has suggested [emphasis] that female sexual behavior continues. However, further studies on behavioral effeets of this product are needed.” A review of research on the use of GonaCon™ reveals the lack of data to support implementation of a “Pilot Program” that does not involve a reputable scientific institution to engage in scientifically rigorous and systematic data collection and analysis. A copy of that review is attached. ‘The attached analysis reveals that because published research on GonaCon™ in horses is limited, there are remaining questions regarding negative impacts to pregnant mares (association with abortion when given in early stages of pregnancy), long-term physiological effects, and whether the vaccine is a permanent sterilant or reversible. Even the short-term social/behavior effects are not yet established Tl The Environmental Assessment is Ina In addition, the Final Environmental Assessment ("EA") for the Ely District Water Canyon Wild Horse Growth Suppression Pilot Program fails to adequately describe the proposed action, including specifying the formulation, dosage and application timeline and fails to incorporate the available science and data on GonaCon™ as outlined by the NAS. Thus, the EA fails entirely to adequately the potential impacts of the proposed action on wild horses analyze ‘The 2013 NAS review specifically outlined the following Advantages and Disadvantages for using GonaCon™ 2 “Using Science to Improve the BLM Wild Horse and Burro Program: A Way Forwar 2013, p.7 ‘NAS,Advantages * Effective for multiple years © Sexual behavior exhibited * Social behaviors not affected in the single field study Disadvantages © Capture may be needed for hand injection of the initial vaccine and any boosters. © Lower efficacy than PZP-vaccine products, especially after first year. * Sexual behavior may not be cyclic, inasmuch as ovulation appears to be blocked. + Should not be administered during early pregnancy because abortion could occur. © Few data on horses, NAS Report at 150 (emphasis added). Yet the EA states that “[tJhis immunocontraceptive vaccine [GONACON] has a longer lasting effect and has been shown to provide multiple years of infertility in several wild ungulate species including horses (Killian et al., 2008; Gray et al., 2010).” Final EA at 16. However, the data available on efficacy are based on only one pen trial involving eight vaccinated mares and 29 free-ranging horses (of which 14 became pregnant). The EA glosses over the lack of science to establish the reversibility rate of the vaccine — meaning whether the vaccine is a permanent sterilant or reversible, The EA then summarily states that “treated animals usually regain fertility,” citing “Powers et al., 2011” ~a publication that is not included in the accompanying bibliography. ‘The BLM’s additional assertion that “GnRH appears to lead to fewer behavioral modifications than PZP in this species in the short term,” is contradicted by available data on the two vaccines. In fact, only one study addresses the behavioral effects of GonaCon™ ~ “Behavior of feral horses in response to culling and GnRH immunocontraception” (Ransom, et. al, 2014), and states that it is unknown whether the social behaviors documented in that study were attributed to the vaccine or to the effects of “culling” or removal of horses from the herd. ‘The EA's response to AWHPC’s comment regarding GonaCon is also inadequate. AWHPC explained that “GonaCon is an experimental fertility control vaccine that interferes with the production of reproductive hormones, which drive natural behaviors in wild horses. Therefore, GonaCon will alter natural behaviors, and that “The National Academy of Sciences also concluded that “[fJurther studies of its behavioral effects are needed” before GonaCon is used by the BLM.” See AWHPC Comments at 5. In response, the EA cites only the NAS general conclusion that “Three methods (PZP-22 and SpayVac, GonaCon, and chemical vasectomy) are considered the most promising for 4managing fertility in free-ranging horses and burros because they have the fewest and least serious effects on those parameters...” However, the EA omits entirely the NAS' conclusion that “further studies on behavioral effects of this product are needed . ...” Also absent from analysis, or even mention in the EA. is the NAS Report’s discussion of the potential impacts of GonaCon, which, as outlined above, include “lower efficacy” than PZP, alteration of sexual/reproductive behaviors, cause of abortions in pregnant mares if given during early stages of pregnancy, as well as the NAS’sconclusion that there are “few data” about the effects of GonCon in horses. Instead of citing the NAS Report in detail, the EA relies heavily on a paper by Ransom et. al. (2014) on GonaCon use in wild horses in the Teddy Roosevelt National Park. However, that paper is not sufficient evidence of GonaCon’s impacts in wild horses, because its study group included just 15 mares (14 mares were eliminated from the study when they became pregnant after receiving the GonaCon vaccine) and because the authors admit that they could not determine whether some impacts observed resulted from the vaccine or the effects of a recent culling (removal) of horses from the herd. Moreover, even the authors of this paper concluded that “long-term influences of GnRH [GonaCon] remain uncertain.” See Ranson et al., Applied Animal Behavior Science 157 (2014) at 91. In addition, the EA fails to adequately analyze alternative to the Proposed Action, including accurate evaluation of the use of the PZP vaccine (ZonaStat-H) to achieve its population suppression goals. As you know, PZP has been in use in equid species for decades and is well-established as both safe and effective. In conclusion, the EA fails woefully to analyze the available science and potential impacts of the vaccine on the wild horses in this area, and the data contained in the EA simply do not support the use of this vaccine in a “pilot project” on wild horses outside the bounds of a formal scientific study. ML sta ement In addition to lacking data to support the adverse impacts of the application of this experimental vaccine in federally-protected wild horses, BLM is required under NEPA and its implementing regulations to prepare an Environmental Impact Statement ("EIS") concerning this action before using this vaccine. NEPA provides that agencies must prepare an EIS for all "major Federal actions significantly affecting the quality of the human environment,” 42 U.S.C. § 4332(C), that must consider (1) the “environmental impact of the proposed action”; (2) any “adverse environmental effects which cannot be avoided”; (3) “alternatives to the proposed action”; (4) the relationship between "local short-term use of man's environment and the maintenance of long-term productivity"; and (5) “any irreversible and irretrievable commitment of resources” involved in the proposal. Id. at § 4332(c)(1)-(v) (emphasis added) Implementing regulations promulgated by the Council on Environmental Quality ("CEQ") provide that, in determining whether a proposed action may have a "significant" 5impact on the environment, and hence require the preparation of an EIS, the agency is to consider a list of enumerated factors, including the degree to which the effects on the environment “are likely to be highly controversial; the degree to which “the possible effects” are “highly uncertain or involve unique or unknown risks," the degree to which the action "may establish a precedent for future actions with significant effects:" and whether the action "threatens a violation” of federal law. 40 C.F.R. § 1508,27(b). Further, “[bJoth short- and long-term effects are relevant” to the significance analy sis, id. § 1508.27(a), as are "[iJmpacts that may be both beneficial and adverse." Jd. at § 1508.27(b)(1) ("A significant effect may exist even if the Federal agency believes that on balance the effect will be beneficial"), Itis well established that the presence of any one of these facts "should result in an agency decision to prepare an EIS." Humane Soc'y of the US. v. Johanns, $20 F, Supp.24 8, 20 (D.D.C. 2007) (quoting Fund for Animals v. Norton, 281 F. Supp. 2d 209, 218 (D.D.C. 2003) ("courts have found that the presence of one or more of [the CEQ significance factors should result in an agency decision to prepare an EIS") (other citations omitted). Here, there can be no legitimate doubt that BLM's decision to use GonaCon in a “pilot program” implicates several of these significant factors. First, the decision is “highly controversial,” particularly in light of the lack of science available to support this precedent application of this experimental vaccine. It is also highly controversial in the public realm as evidenced by the more than 11,000 email comments the BLM has received in opposition to this, Proposed Action. Second, BLM’s Proposed Action clearly involves “possible effects” that are “highly uncertain or involve unique or unknown risks,” 40 C.F.R. § 1508.27(b), as evidenced by the NAS-specific comments on the risks associated with GonaCon™ as well as the conclusions of the recent paper on GonaCon use in wild horses in the Teddy Roosevelt National Park, which concluded that "long-term influences of GnRH [GonaCon] remain uncertain.” ‘Third, there can be no doubt that the agency's decision here “may establish a precedent for future actions with significant effects.” Jd. The agency itself describes the Final Environmental Assessment for the use of GonaCon as a “Pilot Program.” Fourth, because BLM's experimental approach is completely at odds with BLM's obligations under the Wild Horse Act to “protect” these wild horses, to preserve them “as an integral part of the natural system of the public lands,” to manage them in a manner that is “designed to achieve and maintain a thriving natural ecological balance on the public lands," and to employ management activities “at the minimal feasible level,” 16 U.S.C. § 1833, its decision to use this experimental, highly controversial vaccine on these wild horses also necessarily “threatens a violation” of federal law ~yet another of the significance criteria. 40 CER. § 1508.27(b). ‘Therefore, because at least four of the significance factors are present here, and particularly because BLM's chosen management approach represents a radical departure fur the ‘way it has dealt with these issues in the past, clearly BLM is required to prepare an EIS beforeproceeding with this action. IV. Conclusion In summary, the proposed precedent-setting “pilot” application of GonaCon™ in federally-protected wild horses has not been adequately analyzed under NEPA and cannot be justified in the absence of a properly-designed, rigorous scientific study conducted in conjunction with a reputable academic institution. In fact, its use in a “pilot program” is specifically contraindicated by the 2013 NAS Report, which stated definitively that “further studies on behavioral effects of this product are needed...” Therefore, we request that the BLM revise the EA to reflect the lack of scientific data on the use of GonaCon and its impacts on wild horses, as well as questions raised about those impacts in both the NAS Report and the 2014 Ransom study. Further, any use of GonaCon that takes place on wild horse herds under the BLM’s jurisdiction must be implemented only as part of a well-designed, rigorously-controlled and documented scientific study conducted in conjunction with a reputable scientific organization, Utilizing this preferred scientific approach will be beneficial to both the BLM and the wild horses — as the agency will gain important data/research on this experimental vaccine, and the horses will be monitored in a scientific manner to ensure any deleterious behavioral or harmful physiological effects will be scientifically documented and analyzed. In light of the above, we believe that the agency cannot proceed with the Proposed Action as currently designed. If it chooses to do so, it will be in violation of NEPA and the Wild Free-Roaming Horses and Burros Act, as well as the BLM's own procedures and policies regarding the first-time use of fertility control vaccines in BLM herds. Ce: Horst G. Greezmiel, Associate Director for NEPA Oversight, CEQ