Response to Comments on the OMP XL Project NPRM June 27, 2005 2 Index of Commenters 1. OMPP 00001 Leslie Burris, Retired Division Director ( Argonne National Laboratory), Private Citizen, Naperville, Illinois 2. OMPP 00002 Richard Grondin, Vice President, Mixed Waste Operations, ATG, Inc., Richland, Washington 3. OMPP 00003 Paul C. Childress, Vice President, Eurotech, Fairfax, Virginia 4. OMPP 00004 Shimoga R. Prakash, Ph. D., Director, Isotope Chemistry, DuPont Pharmaceuticals Company, Newark, Delaware 5. OMPP 00005 Jerome A. Klun, Research Entomologist, United States Department of Agriculture, Beltsville, Maryland 6. OMPP 00006 James C. Wiley, Jr., Vice President and Department Manager, ChemSyn Laboratories, Lenexa, Kansas 7. OMPP 00007 Clint Gregg, Safety and Environmental Compliance Officer, ChemSyn Laboratories, Lenexa, Kansas 8. OMPP 00008 Eric Boeldt, CHP, Radiation Safety Officer, The Pennsylvania State University, University Park, Pennsylvania 9. OMPP 00009 William V. Lipton, ScD, CHP, Private Citizen, Ann Arbor, Michigan 10. OMPP 00010 Alan E. Waltar, Professor and Head, Department of Nuclear Engineering, Texas A& M University, College Station, Texas 11. OMPP 00011 Scottie Walker, Health Physicist, Sandia National Laboratories, no address given 12. OMPP 00012 W. J. Quapp, PE, Teton Technologies, Inc., Idaho Falls, Idaho 13. OMPP 00013 John M. Raymont, Jr., President and CEO, NUKEM Nuclear Technologies, Columbia, South Carolina 14. OMPP 00014 William R. Sugnet, Private Citizen, Granite Bay, California 15. OMPP 00015 Daniel F. Liberman, Ph. D., RSO, Associate Director, Environmental Affairs and Safety, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut 16. OMPP 00016 Robin L. Elliott, Chair, State of Delaware Authority on Radiation Protection, Dover, Delaware 17. OMPP 00017 Sheryl J. Loux, Research Biochemist, Private Citizen, Kalamazoo, Michigan 18. OMPP 00018 Jane Poths, Ph. D., Nuclear Chemist, Private Citizen, Los Alamos, New Mexico 19. OMPP 00019 Robert Fazio, Ph. D., President, ViTrax Company, Placentia, California 20. OMPP 00020 Richard S. Thomason, Ph. D., Senior Scientist, Private Citizen, Aiken, South Carolina 21. OMPP 00021 Bachir Latli, Ph. D., Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut 22. OMPP 00022 William J. Wheeler, Ph. D., Private Citizen, no address given 23. OMPP 00023 Mary North Abbott, Project Manager, Environmental Containment & Control Program, MSE Technology Applications, Inc., Butte, Montana 3 24. OMPP 00024 M. W. Overhoff, Ph. D., President, Overhoff Technology Corporation, Milford, Ohio 25. OMPP 00025 Michael P. Last, Clerk, The Campus Consortium for Environmental Excellence, Boston, Massachusetts 26. OMPP 00026 Roy G. Post, Professor Emeritus, University of Arizona, Private Citizen, Tucson, Arizona 27. OMPP 00027 Bill Weaver, Private Citizen, Hummelstown, Pennsylvania 28. OMPP 00028 James W. Davis, Director Operations Nuclear Generation Division, Nuclear Energy Institute, Washington, DC 29. OMPP 00029 Andy Lawrence, Director, Office of Environmental Policy and Guidance, United States Department of Energy, Washington, DC 30. OMPP 00030 Kenneth L. Miller, Chairman of the Board, Norman W. Henry, III, TRAC Chair, and John R. Vincenti, Executive Secretary, The American Council of Users of Radioactive Isotopes ( ACURI) Association, University Park, Pennsylvania 31. OMPP 00031 Michael Lemon, Radiation Safety Officer, Environmental Health and Safety, The University of Kansas, Lawrence, Kansas 32. OMPP 00032 Wesley R. Van Pelt, Ph. D., CIH, CHP, President, Wesley R. Van Pelt Associates, Incorporated, Paramus, New Jersey 33. OMPP 00033 Joseph M. Melnic, Private Citizen, Middletown, Pennsylvania 34. OMPP 00034 Larry W. McNamara, President, Nuclear Services, Permafix Environmental Services, Gainesville, Florida 35. OMPP 00035 Cynthia L. Salisbury, Vice President, Regulatory Affairs, Polytek Development Corp., Easton, Pennsylvania 36. OMPP 00036 James. M. Phillips, Office of General Counsel, The University of Texas System, Austin, Texas 37. OMPP 00037 J. Richard Heys, Ph. D., Chief Financial Officer, International Isotope Society, King of Prussia, Pennsylvania 38. OMPP 00038 Hiroi Morimoto, Private Citizen, El Cerrito, California 39. OMPP 00039 Joseph M. Melnic, Technical Manager, Lionville Laboratory, Inc., Lionville, Pennsylvania 40. OMPP 00040 Janet Griffin, Manager, Environmental Affairs, Schering Plough Corporation, Kenilworth, New Jersey 41. OMPP 00041 Cameron Huff, Private Citizen, no address given 42. OMPP 00042 Gail Martin, Private Citizen, no address given 43. OMPP 00043 Li Yang Chang, Ph. D., Chemical/ Environmental Engineer, Environment, Health and Safety Division, Lawrence Berkeley National Laboratory, no address given 44. OMPP 00044 Alice E. Till, Ph. D., Vice President Science Policy and Technical Affairs, Pharmaceutical Research and Manufacturers of America, Washington, DC 45. OMPP 00045 Craig Barney, Manager, Environmental Programs, Stanford University, Stanford, California 46. OMPP 00046 George Bramblett, Project Manager, Decontamination and 4 Decommissioning, Del Mar, California 47. OMPP 00047 Jeffry A. Siegel, Ph. D., Chairperson, American College of Nuclear Physicians/ Society of Nuclear Medicine Joint Government Relations Committee, Reston, Virginia 48. OMPP 00048 Carl E. Walter, Professional Nuclear Engineer, State of California, no address given 49. OMPP 00049 Vincent D. Chase, M. S., CHP, President, New Jersey Chapter of the Health Physics Society, no address given 50. OMPP 00050 David C. McGraw, Director, Environment, Health and Safety Division, Ernest Orlando Lawrence Berkeley National Laboratory, Berkeley California 51. OMPP 00051 Philip G. Williams, Ph. D., Senior Scientist at Lawrence Berkeley National Laboratory, Private Citizen, Oakland, California 52. OMPP 00052 Richard H. Nolan, Director, Berkeley Site Office, United States Department of Energy, Lawrence Berkeley National Laboratory, Berkeley, California 53. OMPP 00053 Steven R. Brehio, Associate Director, EH& S, Northeastern University, Boston, Massachusetts 54. OMPP 00054 Leonard R. Smith, Chairperson, Committee on Regulatory and Legislative Issues, Council on Radionuclides, and Radiopharmaceuticals ( CORAR), Inc., Moraga, California 55. OMPP 00055 Dr. R. Tom Walters, Ph. D., Walters, Aiken, South Carolina 56. OMPP 00056 Marty Scanlon, PE, CerOx Corporation, Sunnyvale, California 57. OMPP 00057 Robert E. Peterson, University Radiation Safety Officer, Office of Environmental Health and Safety, The Ohio State University, Columbus, Ohio 58. OMPP 00058 Penny S. Amy, Ph. D., Professor and Director Biotechnology Programs, Department of Biological Sciences, University of Nevada Las Vegas, Las Vegas, Nevada 59. OMPP 00059 W. W. Bailey, Duratek, Inc., Columbia, Maryland 60. OMPP 00060 David W. Reaney, Manager Treatment Systems, Retech Systems LLC, Ukiah, California 61. OMPP 00061 Robert D. Gallagher, President, NSSI/ Sources & Services, Inc., Houston, Texas 62. OMPP 00062 Joseph Castronuovo, MD, Private Citizen, no address given 63. OMPP 00063 Carrie Wager, Ph. D., Private Citizen, no address given 64. OMPP 00064 Vincent D. Chase, M. S., CHP, President, New Jersey Chapter of the Health Physics Society, no address given   identical to Comment # 49 65. OMPP 00065 Edward A. Tupin, M. S., CHP, Private Citizen, Atlanta, Georgia 5 Because many of the specifics comments are common to more than one commenter, the Agency is responding to the comments by repeating the comment, listing all the commenters that made the comment in bold text ( using the index number ascribed to the commenters), and then responding. Supportive comments may be paraphrased, but adverse comments will be repeated verbatim.

Comment: Many commenters submitted the following comment either verbatim or excerpted and condensed specific portions of it.

"[ We] are writing to offer [ our] strongest support for the innovative Project XL application described by the U. S. Environmental Protection Agency ( EPA) in the above referenced proposed rule.

Pharmaceutical mixed waste ( LLMW), containing small quantities of tritium or carbon 14, represents a management and disposal problem vastly out of proportion with the chemical or radioactive hazards inherent in the waste. Dual regulation under both the Nuclear Regulatory Commission ( NRC) and EPA has resulted in a high regulatory burden for generators, and difficulties in all stages of waste management and disposal. There are very few treatment and disposal options available for mixed waste, and is some cases no outlets are available at all. When available, mixed waste treatment and disposal is economically prohibitive for most academic and biomedical research institutions, with costs ranging from 100' s to 1000' s times as much as equivalent quantities of either radioactive or hazardous chemical waste. The high regulatory burden for managing and disposing of the waste, complex and overlapping regulations, limited and/ or nonexistent treatment and disposal options and the high costs associated with the mixed waste issues have served as a huge disincentive to conducting research and development studies which rely on tritium or carbon 14 labeled chemicals.

In this rulemaking, the EPA is proposing site specific regulatory relief from RCRA so that the organic component of LLMW may be destroyed by catalytic oxidation, and the radioactive residues ( tritiated water or carbon dioxide) will be collected and disposed as LLRW). This is a simple and straightforward solution.

" In this specific XL pilot project, EPA is testing its belief that, in certain scenarios ( e. g., small volumes of pharmaceutical R& D generated LLMW being treated by a bench scale high temperature catalytic oxidation unit in an NRC licensed laboratory), NRC regulatory oversight provides sufficient safeguards to ensure protection of human health an the environment without additional RCRA Subtitle C oversight." [ Federal Register, Vol. 66, No. 142, 24 July 2001, p. 38401].

As noted in the proposed rule, the project is made all the more sensible by considering the small volumes of waste involved, the small scale of the treatment process, treatment on site by the waste generators, the sophisticated level of expertise of the staff involved in the treatment, and the protective controls already in place under NRC regulation of the radioactive materials in question. 1 CORAR members include the major manufacturers and distributors of radio pharmaceuticals, radioactive sources and research radionuclides used in the U. S. for therapeutic and diagnostic medical applications and for industrial, environmental and biomedical research and quality control.

6 In addition to the advantages of small chemical scale and local application of the process by highly skilled staff, the method has been shown to achieve organic destruction efficiencies superior to those required of large scale commercial processes ( e. g., incineration), and prevents the release of the radioactive treatment residue to the environment. The environmental benefits of the process are therefore very clear.

[ We] urge the EPA to finalize this initiative as soon as possible. Early demonstration of the efficacy of the Ortho McNeil Pharmaceutical, Inc. approach will hasten the nationwide deployment of this technology and the EPA's innovative regulatory solution proposed here. Thank you for the opportunity to comment on this proposed rule.

Commenters: OMPP 00001, OMPP 00003, OMPP 00004, OMPP 00006, OMPP 00007, OMPP 00008, OMPP 00009, OMPP 00010, OMPP 00011, OMPP 00012, OMPP 00013, OMPP 00014, OMPP 00015, OMPP 00016, OMPP 000017, OMPP 00018, OMPP 00019, OMPP 00020, OMPP 00021, OMPP 00022, OMPP 00023, OMPP 00024, OMPP 00025, OMPP 00026, OMPP 00027, OMPP 00028, OMPP 00030, OMPP 00031, OMPP 00032, OMPP 00033, OMPP 00035, OMPP 00036, OMPP 00037, OMPP 00038, OMPP 00039, OMPP 00040, OMPP 00041, OMPP 00042, OMPP 00043, OMPP 00044, OMPP 00045, OMPP 00046, OMPP 00047, OMPP 00048, OMPP 00049, OMPP 00050, OMPP 00051, OMPP 00053, OMPP 00055, OMPP 00056, OMPP 00057, OMPP 00058, OMPP 00059, OMPP 00060, OMPP 00061, OMPP 00062, OMPP 00063, OMPP 00064, OMPP 00065.

EPA Response: EPA appreciates the commenters' strong support for today's site specific rule.

Comment: In addition to the above comment, one commenter ( Department of Energy's Lawrence Berkeley National Laboratory) cites another example of success with the catalytic oxidation process based on data collected at their laboratory and notes that petitions for delistings were submitted to the Agency by the laboratory that further support the performance of this process.

EPA Response: This rulemaking pertains to a site specific pilot to treat waste without a permit. Thank you for submitting the results of these studies. The data is supportive of the rulemaking and is consistent with the data submitted by OMP. Berkeley's delisting petitions, however, are not relevant to today's rulemaking. EPA appreciates this commenter's strong support for today's site specific rule.

Comment: These comments on the above referenced proposed rulemaking are submitted on behalf of the Council on Radionuclides and Radiopharmaceuticals ( CORAR) 1. 7 CORAR members and their customers in the medical and research community generate mixed waste and are therefore interested in this proposed rule.

CORAR has repeatedly expressed concern to the U. S. Environmental Protection Agency ( EPA) that the current regulatory framework for mixed waste is counterproductive and prevents generators from pro actively minimizing and safely disposing of mixed waste. CORAR recognizes that the EP A is attempting to remove the current regulatory impasse and supports these developments.

CORAR supports the proposed rule to exempt the Ortho McNeil Pharmaceuticalsite specific mixed waste treatment process from RCRA requirements. CORAR supports this rulemaking because the EP A intends to use this project to obtain information to justify a similar generally applicable national exemption for this treatment process.

However, although CORAR supports the proposed rule and EPA's stated intent, we are concerned that the entire effort has taken so long. More importantly we are concerned that this represents only a partial solution to the mixed waste regulatory problem. Ultimately the EPA should be moving to completely eliminate dual regulation of mixed waste. CORAR asserts that dual regulation can be mostly eliminated if EPA transferred regulatory authority for mixed waste containing byproduct material to the NRC and Agreement States.

Furthermore the EPA should also exempt mixed waste containing accelerator produced radioactive materials from RCRA when these wastes are managed by a generator who is also an NRC or Agreement State licensee in accordance with their byproduct license conditions. CORAR strongly urges that the EPA consults with the NRC to determine whether treatment of mixed waste can be safely carried out by NRC licensees without a RCRA permit.

It is CORAR's expectation that consultation with the NRC will enable the EPA to learn that NRC and Agreement State licensed research facilities and their manufacturer suppliers safely use virtually every chemical processing method known, including a variety of high temperature catalytic oxidation processes, to make and use radioactive materials and chemicals with hazardous characteristics. These practices have been safely conducted for many decades with negligible off site impact and far below regulatory limits. EPA regulation of any such practices because they involve the handling of " wastes" at best adds no value to the overall objectives of health, safety and environmental protection, and at worst is counterproductive.

CORAR therefore supports this proposed rule, urges EPA to expand its applicability nationally and recommends that EPA should simultaneously pursue the complete elimination of dual regulation by collaborating with the NRC to this effect. We have attached specific comments which we hope will be useful.

CORAR appreciates the opportunity to comment on this proposed rule and would be glad to provide any further information or clarification. 8 EPA Response: EPA appreciates the commenter's general support for the rule and responds to its specific comments below.

Comment 1. Page 38396, Col. 1, § 1 " Project XL Site Specific Rulemaking for the Ortho McNeil Pharmaceutical, Inc. Facility in Spring House, Pennsylvania."

a. This heading appeared in the contents section of the Federal Register. It does not indicate that the topic addresses radioactive material or mixed waste. Because of this omission numerous organizations who have an interest in these subjects were unaware of the rulemaking and or were unable to submit timely comments.

b. CORAR recommends that in future publications of this type the subject matter should be clearly defined in the title.

Response 1. EPA will consider the commenter's recommendation in future notices of this type.

Comment 2. Page 38396, Col. 3, § 3 " All other hazardous wastes generated and/ or managed at the OMP facility remain subject to current RCRA subtitle C regulations. Similarly, mixed wastes generated in other pharmaceutical research and development facilities remain subject to current RCRA regulations."

a. These statements appear to contradict EPA's conditional exemption for the treatment of mixed waste in tanks and containers and for allowing mixed waste containing short lived radioactive materials to be held for decay under U. S. Nuclear Regulatory Commissions ( NRC) and Agreement State regulations.

b. CORAR recommends that this section be revised in the final rule to prevent confusion.

Response 2. To be clear, nothing in today's final rule affects OMP's ability to claim any other available conditional exemptions from hazardous waste regulations applicable to any hazardous waste generated or managed at it's Spring House, Pennsylvania facility. EPA has added language to the preamble for the final rule to eliminate any confusion by noting that exemptions and exclusions from regulatory requirements ( which include the exemptions referred to by the commenter) are considered to be included within the term " RCRA Subtitle C regulations."

Comment 3. Page 38396, Col. 3, § 3 and Page 38397, Col. 1, § 1 " The pilot project will also provide the Agency additional data regarding the performance of the on site, bench scale hightemperature catalytic oxidation unit used to treat the mixed wastes, which will also be considered as a part of any future determination regarding the implementation of the regulatory flexibility on a national basis."

a. CORAR is concerned that the EPA has taken 5 years to propose this site specific rule and may 9 take another five years to promulgate a rule with national applicability .

b. The NRC usually takes a few weeks to a few months to routinely make similar decisions for individual sites when processing license and license amendment applications.

c. Since the NRC licensing process is proven to be effective and also provides for occupational protection it is clear that the EPA should transfer oversight on the use of this technology to the NRC.

d. The EPA should be aware that radiochemical manufacturers have several decades of experience in safely using catalytic high temperature oxidation methods to manufacture products and to process low level radioactive wastes in accordance with NRC and Agreement State regulations and license conditions. The radiochemicals and hazardous , hemicals used are identical to those found in mixed waste.

e. It is clear that the EP A should defer to NRC oversight and allow such licensees to use the same processes for the much smaller quantities of mixed waste.

Response 3. EPA notes the commenter's concerns, but believes that the five year review period for evaluating this XL project is reasonable and will provide adequate information on which to make future decisions regarding the regulation of bench scale high temperature catalytic oxidation treatment of small volumes of mixed waste. EPA appreciates the commenter's information on radiochemical manufacturers, but notes that such information is beyond the scope of the current rulemaking.

Comment 4. Page 38398, Col. 2, § 4 and Col. 3, § 1 " OMP does not believe the RCRA Subtitle C regulatory controls, as applied to the LLMW... provide any additional environmental protection than is otherwise provided by AEA oversight, RCRA serve as a major disincentive...

CORAR agrees with the concerns expressed in these paragraphs. The cost of obtaining a RCRA permit or using a RCRA permitted commercial treatment facility to process mixed waste is often prohibitive and prevents the provision of products, services and research that is vitally important to society. A similar conclusion was recently published by the National Academy of Sciences in " The Impact of Low Level Radioactive Waste Management Policy on Biomedical Research in the United States". Washington, DC, 2001.

Response 4. EPA notes the commenter's agreement with EPA on this point.

Comment 5. Page 38398, Col. 3, § 2 " NRC... with jurisdiction over the radioactive component of the waste."

a. The Atomic Energy Act assigns jurisdiction over radioactive materials, which are byproducts 10 from nuclear reactors, to the NRC.

b. NRC is responsible for oversight of public and occupational radiation exposure from byproduct material and must consider the total radiation exposure to individuals from controllable man made sources of radiation including accelerator produced radiation when individuals are exposed to radiation from both sources.

c. To ensure proper control of radiation exposure it is also necessary for the NRC to consider facility and operational characteristics that might contribute to radiation exposure. Consequently, the NRC has considerable expertise and experience in oversight of hazardous chemicals and fire and explosion control and regularly reviews these characteristics and practices when inspecting licensees and developing license conditions. The NRC's involvement includes radiochemicals, radiochemicals that have hazardous chemical characteristics, mixtures containing radiochemicals and hazardous chemicals and even facilities where radiochemicals and hazardous chemicals are separate, but in the same building complex.

d. This is why NRC and Agreement States regulations, licensing and enforcement practices are fully protective for licensees managing processes involving both radioactive materials and hazardous chemicals, regardless of whether the practice involves what EPA has defmed as " waste".

e. This is why CORAR recommends that EPA should transfer jurisdiction over mixed waste to the NRC.

Response 5. EPA notes the commenter's recommendation, but views the recommendation as going beyond the scope of today's site specific rule.

Comment 6. Page 38398, Col. 3, § 4 " Members of the regulated community have raised concerns that this dual regulatory oversight of low level mixed waste.. .. is excessively burdensome, duplicative and costly without providing any additional protection of human health and the environment than that achieved under one regulatory require."

a. CORAR has frequently commented to the EP A on this subject and agrees with the above statement.

b. CORAR asserts that currently the NRC provides the best regulatory framework for mixed waste because it effectively provides for both general and specific site control of both the radioactive and hazardous chemical component of the waste and a broad range of treatment and storage practices to comprehensively provide occupational, public and environmental protection.

Response 6. EPA notes the commenter's assertion and views it as supporting today's site specific rule.

Comment 7. 7. Page 38399, Col. 1, § 3 "... the conditional exemption [ for Mixed Waste] allows, , 11 a generator to treat LLMW ... under a NRC... license, in tanks or containers..."

a. CORAR supported EPA's conditional exemption rule, but pointed out that the rule was insufficient because it did not eliminate dual regulation and did not include accelerator produced radioactive materials nor thermal treatment practices that can be safely conducted by NRC licensees who have the necessary expertise and experience.

b. CORAR recommends that EPA should enter into a Memorandum of Understanding with the NRC to transfer authority over mixed waste.

c. CORAR recommends that the EPA's conditional exemption should be applied to mixed waste involving accelerator produced radioactive material when the generator is an NRC or Agreement State licensee and uses the same controls as those specified in their license for byproduct materials.

Response 7. EPA appreciates the commenter's recommendations, but note that these comments and recommendations do not address today's site specific rule.

Comment 8. Page 38399, Col. 1, § 4 " The treatment technology being employed by OMP is not exempted under the Mixed Waste Rule because it does not within a tank or container." a. This sentence does not make grammatical sense.

b. The EPA should be aware that high temperature catalytic oxidation conversion processes are safely used in containers.

c. CORAR recommends that the use of high temperature catalytic oxidation conversion processes for the treatment of mixed waste should also be exempt from RCRA requirements when the practice is conducted according to the conditions of an NRC or Agreement State license.

d. CORAR recommends that the final mixed waste rule ( 66 FR 27217) be revised to remove the tank and container limitation.

Response 8. a. The sentence quoted by commenter found at 66 FR 38399 is missing a word. The sentence was intended to read: " The treatment technology being employed by OMP is not exempted under the Mixed Waste Rule because it does not occur within a tank or container."

b. Based on information submitted by OMP, EPA determined that OMP's treatment process does not occur in a tank or container.

c. EPA notes the commenter's recommendation and views it as supporting today's site specific rule. 12 d. The commenter's recommendation regarding an amendment to the mixed waste rule ( 40 CFR Part 266 Subpart N is not relevant to today's site specific rule.

Comment 9. Page 38399, Col. 2, § 3 "...( yielding water and C 2)..."

a. Replace " C 2" with " Co 2".

Response 9. EPA will correct the typographical error in the final preamble.

Comment 10. Page 38400, Col. 1, § 3 and Col. 2, § 1 "... the treatment process exceeds LDR treatment standards for organics and only negligible amounts of radioactivity are released2"

a. EPA has considered the release to the environment of radioactive materials, but has not identified the hazardous chemical components or the quantities of these which are released to the environment.

b. In footnote 1 to this statement " This volume of air. emissions" should be replaced by " These annual average concentrations of radionuclides in effluent air". Also the limits in 10CFR20 quoted for tritium and carbon 14 are incorrect. The limits should be 10 7

Ci/ mL for tritium and 3 x 10 7

Ci/ mL for 14CO2 or 3 x 10 9

Ci/ mL for 14C compounds as specified in 10CFR20.

c. It is not clear in this section whether the 14C released as effluent air is in the fonn of 14CO 2 or other radiocompounds.

d. While the concentration of hazardous chemicals and radioactive materials is of technical interest there is no explanation to the public of the significance of these releases. CORAR recommends that the EP A should give a realistic indication of the actual impact that such releases could have on the maximally exposed member of the public living or working near the generator's facility.

e. While the EP A claims that the concentration air emissions from OMP are less than 0.05% of the NRC IOCFR20 concentration limit the actual impact on members of the public should be very much lower than 0.05% of NRC regulatory limit for exposure to individual members of the public. It is simple to show that the maximum dose to individuals who reside at about 100 meters from the point of discharge would be about 0.00001% of the NRC dose limit. This annual radiation dose is roughly equal to the average radiation received in 1 second from natural background radiation sources in an individual's own home. ..

f. Both the International Commission on Radiological Protection ( ICRP) and the National Council on Radiation Protection and Measurements ( NCRP) recommend that any sources that cause 13 public exposures of less than 1 mrem per year are negligible and should not be regulated. This recommended negligible amount appears to be 100,000 times higher than the impact from OMP's emissions. Hence OMP's emissions should not be regulated by any agency including either the NRC or EPA.

Response 10a. As discussed in the preamble, OMP uses organic compounds to develop the radiolabeled compounds used to study the bioabsorption and metabolism of the pharmaceuticals/ drugs being developed. The radiolabeled compound is composed of an isotopically labeled organic compound and a solvent, with the specific solvent used being dependent upon the specific research being conducted. Thus the Agency does not believe it necessary to identify the specific solvents being used ( which will be identified when OMP submits its annual reports), only that a significant portion of the solvents used would otherwise be subject to regulation as hazardous wastes when spent ( and thus be defined as mixed wastes) under RCRA.

Response 10b. We agree that the language in the footnote should be changed to " These annual average concentrations of radionuclides in effluent air." We also agree that the NRC emission limits that were reported in Footnote 1 in 1999 appear to no longer be valid. The tritium effluent concentration as stated in Footnote 1 (" 2.00E 8 mCi/ mL for tritium") should be changed to read " 1 x 10 7 mCi/ mL". The effluent concentration for carbon 14 should read 3 x 10 7 mCi/ mL (( present as carbon dioxide 14C) and not " 6.00E 8 mCi/ mL" as stated in the footnote.

c. As stated in the preamble, the treatment of carbon 14 labeled compounds generates radioactive CO 2, which is then passed through a potassium hydroxide solution and thus converted to potassium carbonate. No releases of 14C as effluent air are expected, but should such a release occur, the form of the 14C would be radioactive CO 2.

d., e., and f., The Agency notes that these three comments are very closely related and linked. In comment d., the commenter suggests EPA provide the public a realistic indication of the actual impact that a potential release would have on the maximally exposed member of the public living or working near the generator's facility. In comment e., the commenter provides that indication by stating that the annual dose would be roughly equal to the average background radiation received in one second from natural background radiation sources in an individual's home. In comment f, the commenter expresses the belief that the potential radiation exposure levels are negligible and should not be regulated by either the NRC or EPA. While the Agency acknowledges that the risks from potential releases are extremely small ( which is one reason the Agency believes this is an appropriate innovative pilot project to pursue), the comments speak to broader national policy considerations that are beyond the scope of today's site specific rulemaking.

Comment 11. P .38400, Col. 3, § 2 and P. 38401, Col. 1, § 3 "... for OMP to continue to be able to treat the small volumes of mixed wastes within the same laboratory that created the 14 wastes...". " While the Agency continues to maintain... mixed waste treatment professes that cannot be undertaken in a tank or container warrant RCRA oversight..."

a. CORAR not only supports this conclusion but also does not believe aMP should be limited to the current scope and location of pilot operations as long as any other practice is carried out in accordance with an NRC license.

b. As previously discussed, NRC licensed activities that involve the processing of hazardous and radioactive chemicals are carried out without EP A oversight and without health, safety or environmental impairment. CORAR does not agree with the EP A position that because waste treatment processes are somehow unique, regardless of whether they are conducted in a tank or container, they are subject to EP A regulation.

Response 11. a. EPA disagrees with the commenter's general assertion that OMP should not be limited by the terms of the rule as long as " any other practice is carried out in accordance with an NRC license." For the reasons expressed in the preamble, EPA believes the conditions established in the site specific exclusion are reasonable and ensure that this pilot project is protective of human health and the environment.

b. It is not clear what the commenter's remark means. However, to the extent that the commenter is suggesting that EPA does not have regulatory authority over the hazardous component of mixed waste, EPA strongly disagrees. EPA's regulatory authority over mixed waste is well established. See 66 FR 27217 ( May 16, 2001).

Comment 12. P. 38400, Col. 3, § 3 " OMP ... could increase from the current 10 curies/ year to approximately 50 curies/ year" .

a. It is not clear whether the curies stated are 3H or 14C or both radionuclides.

b. In either case 10 curies of either 3H or 14C released in air effluent during a year would have a negligible effect. For measurable scenarios, maximum doses to members of the public near the facility would be far below 1 mrem/ year for 3H or 14CO 2 and about 0.2 mrem for l0 Ci of 14Ccompounds using NRC's conservative default values. Hence this would be considered negligible and not worth regulating by the NCRP and ICRP.

c EPA should be aware that manufacturing facilities in urban locations that routinely process tens of thousands of curies of 3H and equivalent quantities of 14C compounds using a wide variety of processes, including high temperature catalytic oxidation, with mostly limited containment have annual off site impacts that are typically less than 1/ 1000 of the regulatory limit and well below the negligible level recommended by the NCRP and ICRP Response 12a. The curies stated are both 3H and 14C. As described in the discussion of the laboratory practices at the facility, both tritium and carbon 14 are used. When tritium is treated, 15 3H is generated, and when carbon 14 is treated, 14C ( in the form of radioactive carbon dioxide) is generated ( and subsequently converted to radioactive potassium carbonate). Thus the estimate of the potential increase in the volume of curies that would be generated in the laboratory was intended to reflect the total combination of radioactive materials.

Response 12b. The Agency agrees with the commenter that the volumes of curies at issue are very small and would have negligible effect. The Agency accepts this comment as supportive of this rulemaking.

Response 12c. The Agency acknowledges the commenter's statement and considers the comment to be supportive of this rulemaking.

Comment 13. P. 38400, Col. 3, § 4 and P. 38401, Col. 1, § 1 "[ EPA] is proposing in today's notice to provide a site specific exclusion in 40CFR261.4( b) ( i. e., " Solid wastes which are not hazardous wastes") for the mixed wastes generated and treated in OMP's... R& D laboratory Instead of being considered " mixed wastes," these wastes will simply be considered low level wastes... subject to NRC.. regulation. Further,..., no " delisting" is required for these residuals ( since the original wastestream was not a RCRA " listed" waste)...".

a. CORAR supports the intent of this EPA proposed rule change in 40CFR261.4( b).

b. CORAR also recognizes that the EPA has the authority to establish regulatory interpretations such as this and the one classifying liquid waste forms as " solid waste", even though these interpretations are illogical or counter intuitive.

c. It appears necessary to establish these confusing regulatory interpretations because the EPA regulatory framework is inadequately designed for achieving the regulatory outcome that is being sought. This is another example of why regulatory oversight should be transferred to the NRC and Agreement States whose regulatory frameworks are comprehensive and are well designed to address site specific conditions through the licensing process.

Response 13. EPA appreciates the commenter's support for this rule and notes the commenter's general observations about the RCRA program that are not relevant to today's site specific rule.

Comment 14. Page 38402, Col. 1, § s 2 and 3 " G. How Will This Project Result in Cost Savings and Paperwork Reduction?..."

a. The cost data presented in these paragraphs is insufficient to answer basic economic questions. For example, it is not stated whether the $ 20,000 $ 35,000 per curie rate is only for treatment or for subsequent disposal. Consequently, it is not clear whether the $ 300,000 is the actual cost savings. It appears that this number is an estimate of the difference between two processes. However, it seems that the use of an outside vendor operating with a RCRA permit is not a 16 viable alternative. Hence the cost saving should be estimated from considering past practice which is to store the material until the regulations change.

b. It would be useful if the EPA could compare the cost of using this treatment process under a RCRA permit compared with under NRC licensee's conditions.

Cost consideration should include the cost of permits, documentation, reporting and subsequent safe disposal of the end products to meet all current regulatory requirements.

Response 14a. The $ 300,000 figure was a rough estimate based primarily on the costs of off site treatment and disposal   i. e., the cost for off site waste management. This estimate did not accurate reflect the alternative costs of operating the high temperature catalytic oxidization unit or management of the low level radioactive waste. The key point of the economic discussion was to reflect the significant costs that would otherwise be incurred with what OMP believes is no environmental benefit ( i. e., that the on site treatment can be conducted as safely, if not more so, than RCRA permitted and NRC licensed off site treatment. EPA disagrees that the baseline cost consideration should be long term storage, but rather believes the appropriate consideration should be the off site treatment and disposal of the mixed wastes. Under the current program, treatment and disposal in a RCRA permitted NRC licensed facility is the allowable off site waste management alternative to long term storage. Had the Agency used long term storage as the economic baseline, the baseline would not have reflected the regulatory costs associated with maintaining RCRA jurisdiction over these materials when they are treated and disposed ( which is one of the aspects being evaluated by this pilot project).

b. EPA understands the commenter's suggestion that the Agency compare the costs of RCRA permitting to NRC licensing for the HTCO process. However, insofar as this is a site specific rulemaking, that Agency believes it is more appropriate to focus on the specific considerations relevant to the site. In this case, OMP was ( and remains) clear that seeking a RCRA permit was not a viable option. Off site waste management is the only realistic alternative that OMP would consider. The Agency agrees that if this regulatory flexibility is considered on a national scale, an economic comparison as suggested by the commenter could be a more useful component of a more generic economic analysis.

Comment: OMPP 00029 Although the Department [ of Energy] supports this action, two technical comments are offered for EPA's consideration. First, the Department suggests that EPA revise its proposed regulatory language under 40 CFR 261.4( b)( 17) by replacing " mixed waste" with the phrase " low level waste." As proposed, using the term " mixed waste" may be misleading. Specifically, RCRA as amended by the Federal Facility Compliance Act of 1992, defines the term " mixed waste" as " waste that contains both hazardous waste and source, special nuclear, or byproduct material subject to the AEA." However, since EPA proposes to explicitly exclude the OMP radioactive/ organic waste mixture from being hazardous ( i. e. the proposed regulatory 17 provision falls under § 261. 4( b ) which identifies " solid wastes which are not hazardous wastes"), it would not be appropriate to refer to the OMP waste mixture as a " mixed waste."

Second, a discussion in the preamble ( at 66 EB. 38401, col. 1) states that, because the residuals resulting from the OMP " treatment process will not be derived from hazardous wastes, no " delisting" is required for these residuals ( since the original wastestream was not a RCRA " listed" waste)." DOE notes that the above parenthetical statement could be misleading since readers might infer it to mean that delistings would be necessary for treatment residuals if the original OMP waste meets a listing description ( e. g., F001  F005). DOE points out that, as proposed, each contaminated aqueous mixture will be excluded from RCRA Subtitle C regulation at its point of generation ( assuming all the specified conditions are met). Thus, whether the original waste stream would otherwise meet a listing or exhibit a characteristic has no bearing on the RCRA status of its treatment residual, since the residual would be derived from an excluded waste. If this type of discussion is included in the pre~~ I. e.~ o the final rule, DOE suggests that EPA modify the parenthetical to read as follows [ font = addition; strikeout font = deletion]:

... no " delisting" is required for these residuals ( since the original wastestream was not a RCRA " listed" waste ).

DOE recognizes that pilot projects such as the OMP XL project are important in Agency efforts to consider new strategies that reduce regulatory burdens and promote economic growth while achieving better environmental and public health protection. Provided EPA finds this XL pilot project to be a success, the Department encourages the Agency to expedite the implementation of this regulatory flexibility on a nationwide basis. Such relief could alleviate RCRA permitting related time and resource constraints that currently act as a disincentive to the development of environmentally protective on site treatment for other small volumes of research and development laboratory generated mixed wastes.

EPA Response: In addition to supporting EPA's rule, this commenter offers two technical comments for EPA's consideration. The first suggestion is that EPA revise its proposed regulatory language by replacing the term " mixed waste" with the term " low level waste". The commenter states that using the term " mixed waste" in the rule may be misleading. The commenter points out that by statute the term " mixed waste" contains both a RCRA hazardous waste and source, special nuclear, or by product material subject to the AEA, but by operation of the rule waste generated and treated using an on site bench scale high temperature catalytic oxidation unit at OMP's facility are excluded from being hazardous waste. Therefore, according to the commenter the rule should not refer to these wastes as " mixed waste". EPA agrees that use of the term " mixed waste" could cause confusion in this context, but does not agree that the rule should use the term " low level waste". If " low level waste" contains only source, special nuclear, or by product material subject to the AEA, then the waste is excluded from RCRA jurisdiction because it is outside the scope of the statutory definition of " solid waste". Therefore, using the term " low level waste" would also be inappropriate. 18 To eliminate possible confusion EPA has revised the rule text to substitute the term " solid waste" for " mixed waste" and to replace a reference to § 261.3 with a reference to the mixed waste rule at § 266.10. Thus the rule now reads as follows:

"( 17) Solid waste that would also otherwise meet the definition of mixed waste pursuant to § 266.210 that is generated and treated using an on site bench scale high temperature catalytic oxidation unit at the Ortho McNeil Pharmaceutical, Inc. ( OMP) research and development facility in Spring House, Pennsylvania are excluded from the definition of hazardous waste . . ."

The Commenter's second technical comment . . . EPA agrees with the commenter and will revise its discussion in the final preamble as the commenter has suggested.

Comment: OMPP 00002 I am writing on behalf of ATG, Inc., a RCRA/ TSCA permitted ( EPA ID No. WAR00001035) and NRC Licensed facility ( WN I0508 1), in opposition to the abovereferenced rule.

ATG is a RCRA permitted commercial processor of low level mixed waste, such as that addressed by the proposed rule change. ATG has recently completed the construction of a thermal treatment facility for mixed waste at a cost of $ 35M. The annual capacity of our plant for mixed wastes, such as the subject of this rule, is over 1,000,000 pounds.

Based on our experience with operating a mixed waste treatment facility for nearly two years, we have the following concerns regarding the general approach to waste treatment advocated by the proponents of this rule.

1. The potential for release of large quantities of radioactive materials in heavily populated areas where many pharmaceutical laboratories are located due to equipment malfunction and consequent adverse public reaction.

2. The disincentive such a program provides to commercial treatment facilities to expand capacity and improve services.

Since the OMP XL ( Ortho McNeil Pharmaceutical Excellence and Leadership) project was proposed, considerable commercial capacity for treating liquid mixed wastes has come on line, most notably ATG's own Mixed Waste Facility in Richland, W A.

Treating pharmaceutical waste in a RCRA permitted commercial facility such as ours provides the following advantages:

1. General availability of treatment options sooner, 19 2. Lower total cost nationally by having consolidated treatment operations rather than scattered installations,

3. Greater potential for recycling tritium and C 14 from a few commercial generators, rather than dozens of small laboratory treatment/ generators, 4. Greater reliability from having dedicated, rather than intermittent hobby, operators for complex equipment,

5. Low potential for contaminant release to the environment during handling and treatment.

Rather than encourage the proliferation of small treatment facilities that only address part of the problem, we suggest that generators of RCRA mixed wastes use the existing permitted capacity. ATG can treat not only the liquid mixed wastes, but also the solid mixed wastes that are generated during the handling of the liquids.

ATG recognizes the depth of frustration generated in the past when trying to identify disposal options for mixed waste. However, ATG's Richland , WA facility along with two other permitted mixed waste facilities in the United States provide the capacity to safely process the wastes being proposed for exemption.

EPA Response: The Agency acknowledges the concerns expressed by this commenter. However, the Agency remains committed to pursuing this innovative pilot project. We note that both of the commenter's concerns are directed at the issue of whether the site specific exclusion finalized in this rulemaking should be adopted on a national basis and not at the site specific exclusion itself. Thus, the comments are not relevant to the current rulemaking. We also note that the commenter did not question the technical performance of the high temperature catalytic oxidizing unit.

We believe addressing commenter's specific concerns over national application of today's sitespecific rule would be premature because the precise parameters of such a rule are unknown. Should, however, the Agency decide to pursue developing a rule to expand the conditional exclusion approach in today's rule on a national basis, the commenter will have a further opportunity to raise its concerns in comments to the Agency. The Agency would then have to consider and respond to those comments before issuing that final rule.

Comment: OMPP 00034 This is in response to the above referenced Federal Register allowing treatment of mixed wastes without a permit. Perma Fix Environmental Services, Inc., ( PESI) operates three facilities in Tennessee and Florida possessing RCRA/ TSCA permits and radioactive materials licenses for the commercial treatment of mixed wastes. PESI is generally opposed to the treatment of mixed wastes by unlicensed, and/ or non permitted facilities. PESI believes that authorization to allow wastes to be treated on a one time, part time basis as outlined in this rule, is unnecessary, is inconsistent with EPA's charter to protect the general public, and sets a serious precedent. More specifically, 20 1. By definition, this rule making reduces treatment standards and ignores established criteria for facilities intending to perform treatment of mixed wastes. Current rules, to be waved by this action, require extensive submittal and assurances to the regulatory agencies that strict controls and qualified personnel will be in place to assure proper handling of potentially hazardous materials. In other words, ignoring the current rules reduces controls and represents a risk to the workers.

2. The proposed rule, to allow unlicensed/ non permitted facilities to treat potentially hazardous materials, may result in uncontrolled releases off site. Without assurance that sufficient controls ( engineering and procedures) are in place, mistakes can result. Historically, these types of incidences have eroded the public confidence in an industry which, unfortunately, has sustained compound restrictions to the already established and compliant facilities. These more severe controls thereby reduce the industry's ability to address new waste forms requiring treatment. In other words, if a release happens under this rule, the public could lose confidence in the EPA and state, erode confidence in our industry's ability to control these materials which would set the industry back years.

3. The proposed rule reduces the established requirement to obtain licenses and permits for treatment of mixed waste allowing the treatment of waste at facilities that are not licensed or permitted for such activities. PESI has invested considerable time and capital to established three properly licensed/ permitted facilities for treatment of mixed wastes. In other words, we are concerned that reducing established, proven standards for treatment of hazardous wastes greatly devalues the existing commercial investment thus reducing the viability of the commercial business sector and diminishes the development of additional treatment options for future mixed wastes.

4. And, it is hard to understand how the benefit of relaxing the established permitting and licensing process for treatment of mixed waste offsets the risks. The USEP A and the states have spent considerable time and money to establish methods for issuing permits and licenses to businesses and generators to assure the safe handling and processing of these wastes. Why is it necessary to override what has taken years to develop? If the pharmaceutical industry wishes to enter the waste treatment business, processes exist for them to obtain permits and licenses. This is especially true, when there are existing alternatives available to the generator in the form of treatability studies. This existing regulations allow the generator to develop the technology, demonstrate that it can be used effectively and safely, thus assuring all parties the efficacious use of the treatment.

5. And finally, the precedenting impact of this decision is unknown. While this decision on the surface may appear forward looking to some, once allowed for one, what criteria will be used to prevent the denial of future requests? The USEPA could sustain extreme criticism from the public and the generators for allowing such a precedenting decision. In other words, the USEPA is taking undo risks with the worker protection and the environment while trying to appear accommodating to the industry. This, unfortunately, creates unknown precedences that could 21 create major unforeseen problems.

In summary, there is no reason to change the current permit/ licensing processes for the treatment of mixed waste. Sufficient procedures exist to allow generators to obtain proper approvals. Furthermore, there exist fully authorized commercial facilities to treat these wastes.

EPA Response: This commenter expressed a general opposition to the " treatment of mixed wastes by unlicensed, and/ or non permitted facilities" and believes that " authorization to allow wastes to be treated on a one time, part time basis as outlined in this rule, is unnecessary, is inconsistent with EPA's charter to protect the general public, and sets a serious precedent." EPA disagrees with the commenter's views. We believe that it is appropriate in this rule, which implements a pilot project under the Project XL program, to explore an innovative treatment process for small volumes of mixed waste in light of the information presented by Ortho McNeil Pharmaceutical, Inc.( OMP). OMP asserts that RCRA Subtitle C controls serve as a major disincentive to the environmentally protective on site treatment of small volumes of mixed waste such as generated by the pharmaceutical industry in the research and development of new pharmaceuticals. We also believe that the on site treatment of OMP's small volumes of mixed waste will be done in a manner protective of human health and the environment. The on site treatment of OMP's mixed wastes has already been extensively tested under a " treatability study" exemption provided in 40 CFR 2614( f). In addition, the conditions that the rule imposes on the exclusion will assure that the treatment process will continue to be protective and will provide the Agency with the data necesssary to determine wether to adopt the exclusion on a national basis.

This commenter also expressed several more specific remarks in opposition to the rule. These are addressed below.

1. The rule " reduces treatment standards and ignores established criteria for facilities intending to perform treatment of mixed wastes" . . . ignoring the current rules reduces controls and represents a risk to the workers." ( Emphasis in original comment).

EPA disagrees that the rule reduces treatment standards. The exclusion is conditioned upon OMP treating the waste using the high temperature catalytic oxidation unit which has consistently destroyed the organic component of the waste ( routinely achieving destruction and removal efficiencies ( DRE) of 99.999% to 99.99999%) beyond the LDR treatment standard. EPA also disagrees that the rule represents an increased risk to workers. The management of the mixed waste remains subject to AEA requirements. As explained in the recently promulgated Mixed Waste rule ( 66 FR 27217 May 16, 2001), EPA generally believes that given NRC regulatory controls, protection of human health and the environment from chemical risks would not be compromised by deferral to NRC's management requirements. EPA specifically believes that given the circumstances such as a professionally trained lab staff [" sophisticated level of expertise of the technicians that work in the lab"] is included in a list of reasons why EPA thinks an NRC license is sufficient to protect HHE in section III C, and a small volume of mixed waste ( no more than 50 liters/ year) treated within an NRC licensed laboratory that the exclusion will not 22 result in any increased risk to the laboratory workers. For a more complete technical description of the unit, operations parameters an analytical methodology, see " A Prototype High Temperature Catalytic Oxidation Process For Mixed Waste In A Pharmaceutical Research Laboratory," available in the docket for today's rule.

2. According to the commenter, the rule to " allow unlicensed / non permitted facilities to treat potentially hazardous materials, may result in uncontrolled releases off site." The commenter then states a concern that if an uncontrolled release were to occur under the conditional exclusion, then public confidence in the industry would be in jeopardy which could lead to public pressure for even more stringent regulatory control over the waste treatment industry. EPA does not share the commenters concerns. First, today's rule excludes the mixed waste from RCRA hazardous waste regulation from only one facility   OMP's Spring House, Pennsylvania facility. Second, even though the facility does not have to obtain a RCRA permit, the facility is NRC licensed and subject to NRC regulation including requirements restricting off site releases of mixed waste. Third, by its terms the rule only excludes from regulation up to 50 liters/ year. Finally, throughout the development of this XL project OMP has cultivated local community and local environmental group involvement to ensure that the local community understands the nature and scope of today's rule. Based on these considerations, EPA believes that the rule is unlikely to result in an uncontrolled release of hazardous waste that would cause the kind of public backlash that the commenter envisions.

3. The proposed rule " reduces the established requirement to obtain licenses and permits for treatment of mixed waste . . .[ the commenter] has invested considerable time and capital to established [ sic] three properly licensed/ permitted facilities for treatment of mixed wastes. Hence, according to the commenter the proposed rule would " devalue the existing commercial investment thus reducing the viability of the commercial business sector and diminishes the development of additional treatment options for future mixed wastes." ( Emphasis in original comment).

The Agency acknowledges the concerns expressed by this commenter. However, the Agency remains committed to pursuing this innovative pilot project. We note that the commenter's concern is directed at the issue of whether the site specific exclusion finalized in this rulemaking should be adopted on a national basis and not at the site specific exclusion itself. Thus, the comment is not relevant to the current rulemaking.

We believe addressing commenter's specific concern over national application of today's site specific rule would be premature because the parameters of such a rule are unknown. Should, however, the Agency decide to pursue developing a rule to expand the conditional exclusion approach in today's rule on a national basis, the commenter will have a further opportunity to raise its concerns in comments to the Agency. The Agency would then have to consider and respond to those comments before issuing that final rule.

4. The commenter states that it is hard to understand how the benefit of relaxing the established 23 permitting and licensing process for treatment of mixed wastes offsets the risks. The commenter further states that if the pharmaceutical industry wishes to enter the waste treatment business, processes exist for them to obtain permits and licenses. The commenter questions why it is necessary to issue today's rule when " existing regulations allow the generator to develop the technology, demonstrate that it can be used effectively and safely, hus assuring all parties the efficacious use of the treatment."

EPA disagrees with the commenter's position that the risks posed by today's rule out weigh its benefits. As explained in the preamble to the final rule, the benefits of granting this sitespecific conditional exclusion is to test in a tightly controlled environment whether NRC regulation alone provides sufficient protection for human health and the environment for the thermal treatment of small volumes of low level mixed wastes. If, after a period of evaluation, the Agency determines that such treatment of small volumes of mixed wastes generated and treated in a pharmaceutical research laboratory do not require RCRA hazardous waste regulation to ensure protection of human health an the environment, then EPA may adopt the approach on a national basis. Deferring regulation of this waste stream to NRC would reduce waste management costs of pharmaceutical research and development activities, thereby leaving more money available for actual research and development off pharmaceuticals.

5. Finally, the commenter expresses concern that the precedential impact of today's rule is unknown which could create " major unforseen problems." The commenter does not offer any examples of the potential major problems. In any event, EPA does not share the commenter's concerns. Today's rule is being issued as part of Project XL which, as explained in the preamble to the proposal, is a program " intended to encourage EPA to experiment with potentially promising regulatory approaches, both to assess whether they provide benefits at the specific facility affected, and whether they should be considered for wider application." 66 FR 38397 ( July 24, 2001). The preamble to the proposal also addressed the issue of the precedential impact of an XL rule. The preamble states:

Adoption of such alternative approaches or interpretations in the context of a given XL project does not, however, signal EPA's willingness to adopt that interpretation as a general matter, or even in the context of other XL projects. It would be inconsistent with the forward looking nature of these pilot projects to adopt such innovative approaches prematurely on a widespread basis without first determining whether they are viable in practice and successful in the particular projects that embody them. Furthermore, as EPA indicated in announcing the XL program, EPA expects to adopt only a limited number of carefully selected projects. These pilot projects are not intended to be a means for piecemeal revision of entire programs. Depending on the results in these projects, EPA may or may not be willing to consider adopting the alternative interpretation again, either generally or for other specific facilities. Id.


[Federal Register: July 30, 2008 (Volume 73, Number 147)]
[Rules and Regulations]
[Page 44151-44153]
[DOCID:fr30jy08-9]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0725]
RIN 1625-AA00

Temporary Safety Zone: Red Bull Flugtag, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
the Red Bull Flugtag to be held on the waters of the Willamette River
in the vicinity of McCall's Waterfront Park in Portland, Oregon. The
safety zone will restrict vessels from entering the designated area
during the marine event. This temporary rule is needed to provide for
the safety of participants in the event.

DATES: This regulation is effective from 10:30 a.m. to 5 p.m. on August
2, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0725 and are available online
at www.regulations.gov. They are also available for inspection or
copying at two locations: The Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and Coast Guard
Sector Portland, 6767 N. Basin Ave., Portland, OR 97217 between 8 a.m.
and 4 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: BM2 Joshua Lehner, c/o Captain of the
Port Portland, 6767 N. Basin Ave., Portland, OR 97217-3992, and (503)
240-9311.

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for not publishing an NPRM and for
making this rule effective less than 30 days after publication in the
Federal Register. The emergent and dynamic nature of the event did not
allow previous notice. Publishing a NPRM would be contrary to public
interest since immediate action is necessary to ensure the safety of
participants and spectators. If normal notice and comment procedures
were followed, this rule would not become effective until after the
date of the event. For this reason, following the normal rule making
procedures in this case would be impracticable and contrary to the
public.

Background and Purpose

    The Coast Guard is establishing a temporary safety zone to allow
for a safe marine event. This event occurs on the Willamette River in
the vicinity of McCall's Waterfront Park in Portland, Oregon and is
scheduled to start at 10:30 a.m. and last until 5 p.m. on August 2,
2008. This event may result in a number of recreational vessels
congregating near the marine event. The marine event poses several
dangers to the participants including river currents, vessel traffic
and debris on the river. Accordingly, the Safety Zone is needed to
protect event participants and spectators from safety hazards
associated with the event. This safety zone will be enforced by
representatives of the Captain of the Port Portland. The Captain of the
Port may be assisted by other federal, state, and local agencies.

Discussion of Rule

    This temporary rule will create a safety zone to assist in
minimizing the inherent dangers associated with the marine event. These
dangers include, but are not limited to, river currents, vessel traffic
and river debris. The Coast Guard, through this action, intends to
promote the safety of personnel, vessels, and facilities in the area.
Due to these concerns, public safety requires these regulations to
provide for the safety of life on the navigable waters.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. The Coast Guard expects the economic
impact of this temporary rule to be so minimal that a full Regulatory
Evaluation under the regulatory policies and procedures of DHS is
unnecessary. This expectation is based on the fact that the safety zone
established by this rule encompasses an area on the Willamette River
near McCall's Waterfront Park in Portland, Oregon that is not a major
commercial navigation or public boating area. This regulation is
established for the benefit and safety of the recreational boating
public, and any negative recreational boating impact is offset by the
benefits of allowing the marine event. This rule will be effective from
10:30 a.m. to 5 p.m. on August 02, 2008. For the above reasons, the
Coast Guard does not anticipate any significant economic impact.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
transit or anchor in a portion of the Willamette River during the time
mentioned under Background and Purpose. This safety zone will not have
a significant economic impact on a substantial number of small entities
due to its short duration and small area. The only vessels likely to be
impacted will be recreational boaters, small passenger vessel
operators. Because the impacts of this proposal are expected to be so
minimal, the Coast Guard certifies under 605(b) of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) that this temporary rule will
not have a significant economic impact on a substantial number of small
entities.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    We have analyzed this rule under Executive Order 13132 and have
determined that this rule does not have implications for federalism
under that order.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
governs the issuance of Federal regulations that require unfunded
mandates. An unfunded mandate is a regulation that requires a State,
local, or tribal government or the private sector to incur direct costs
without the Federal Government's having first provided the funds to pay
those unfunded mandate costs. This rule will not impose an unfunded
mandate.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
and Department of Homeland Security Management Directive 5100.1, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded,
under the instruction, that there are no factors in this case that
would limit the use of a categorical exclusion under section 2.B.2 of
the Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation because it establishes a safety zone. A
final ``Environmental Analysis Check List'' and a final ``Categorical
Exclusion Determination'' will be available in the docket where
indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. A temporary section in 165.T13-052 is added to read as follows:

Sec.  165.T13-052  Safety Zone; Red Bull Flugtag, Portland, Oregon.

    (a) Location. The following area is a safety zone: The waters of
the Willamette River from surface to bottom 200' radius surrounding the
Red Bull Flugtag; in the vicinity of McCall's Waterfront Park in
Portland, Oregon.
    (b) Enforcement period. This rule will be in effect from 10:30 a.m.
to approximately 5 p.m. on August 02, 2008 in the described waters of
the Willamette River in Portland, Oregon.
    (c) Regulations. In accordance with the general regulations in
Sec.  165.23 of this part, no person or vessel not participating in the
actual marine event may enter or remain in this zone unless authorized
by the Captain of the Port or his designated representatives. Vessels
and persons granted authorization to enter the safety zone shall obey
all lawful orders or directions of the Captain of the Port or his
designated representatives.
    (d) Vessels wishing to request permission to enter the safety zone
may contact the official patrol on VHF Channel 16 or by calling 503-
240-9311.

    Dated: July 21, 2008.
F.G. Myer,
Captain, U.S. Coast Guard, Captain of the Port, Portland.
[FR Doc. E8-17385 Filed 7-29-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: August 18, 2008 (Volume 73, Number 160)]
[Notices]
[Page 48235]
[DOCID:fr18au08-76]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1771-DR]

Illinois; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Illinois (FEMA-1771-DR), dated June 24, 2008, and
related determinations.

DATES: Effective Date: August 8, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that pursuant to the
President's June 30, 2008, amended declaration authorizing Federal
funds for emergency protective measures, including direct Federal
assistance, at 90 percent Federal funding of total eligible costs under
the Public Assistance program, the National Oceanic and Atmospheric
Administration's National Weather Service River Forecast Center has
established that the rivers in the State of Illinois, which have
experienced historical flooding, fell below flood stage on August 6,
2008.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs, 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-19016 Filed 8-15-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register: June 16, 2010 (Volume 75, Number 115)]
[Notices]
[Page 34183]
[DOCID:fr16jn10-107]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Micro Laboratories, Inc.; Order of Suspension of Trading

June 11, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Micro Laboratories, Inc. (``Micro Laboratories'') because it has not
filed any periodic reports since the period ended June 30, 2005. Micro
Laboratories is quoted on the Pink Sheets operated by Pink OTC Markets,
Inc. under the ticker symbol MLAR.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company, and any equity securities of
any entity purporting to succeed to this issuer.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company, and any equity securities of any entity
purporting to succeed to this issuer, is suspended for the period from
9:30 a.m. EDT on June 11, 2010, through 11:59 p.m. EDT on June 24,
2010.

    By the Commission.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-14574 Filed 6-14-10; 11:15 am]
BILLING CODE 8010-01-P