Document omm0bK3ejn2rODvYpE0Lnrj68

BOX 53B ALLENTOWN, PA 18105 PHONE: 215-398-8343 from th dik of AP00051870 (i) DRAFT POST HEARING BRIEF TABLE OF CONTENTS CONFIDENTIAL tj r, I. THERE IS NO CANCER EPIDEMIC II. OSHA'S AUTHORITY DOES NOT EXTEND TO PROMULGATION OF AN INFLEXIBLE "GENERIC" RULE FOR SUBSTANCES THAT ARE NOT UNIFORM III.- SINCE OSHA INTENDS TO ENLARGE THE PROPOSED RULE IN UNDISCLOSED BUT SIGNIFICANT WAYS, A HEARING ON THE INCOMPLETE RULE IS WITHOUT MEANING AND DENIES DUE PROCESS 1. Epidemiology 2. Risk Assessment 3. Testing Standards and Guidelines IV. THE PROPOSED REGULATIONIS INFLEXIBLE, VAGUE AND INCOMPLETE V. THE PROPOSED REGULATION MANDATING A STANDARD OF NO EXPOSURE IF THERE ARE "SUITABLE SUBSTITUTES" IS INVALID, AND SHOULD BE ABANDONED BY OSHA (A) The Terms Used in the Proposed Regulation are Impermissably Vague * (B) The Proposed Requirement of "No Exposure" if a "Suitable Substitute" Exists or in Other Circumstances is Tantamount to Banning a Substance and is Beyond OSHA's Authority VI. THE METHOD OF CLASSIFICATION AND THE CRITERIA FOR OSHA'S CATEGORY I ARE IMPERMISSIBLY VAGUE AND ARBITRARY Introduction (A) There Should Be an Independent Scientific Evaluation of the Data (i) The AIHC proposal for an independent Scientific Data Evaluation and Classi fication Panel <ii) OSHA has Intermixed the Scientific and Regulatory Functions 1 6 13 15 16 18 20 23 23 26 32 33 33 35 37 AP00051871 (it) (B) The Criteria for OSHA Category X are Impermissibly Vague and Inflexible 1 Human Epidemiology 2. Animal Data 3. The proposed regulation places undue weight on animal studies at maximum tolerated doses 4. The need to clarify the meaning of statistical significance 5. The use of tumor prone species 6. Factors which influence the outcome of animal studies 7. Single species or two species 8. Replication 9. Short term tests (a) Short term tests should not be used as confirmatory evidence (b) If short term tests are to have a regulatory role, OSHA must define which tests can be reliably used, the battery of tests to be required and the criteria for evaluation 10. Route of exposure (C) OSHA is Correct in Rejecting Structure Similarity and Physical Induction Such as Injection Site Sarcomas as a Basis for Regulatory Action (i) Molecular structure or similarity (ii) Injection site sarcomas and other instances where induction due to physical causes e.g. implants or stones or calculi VII. THE PROPOSED REGULATION WOULD IMPERMISSIBLY "FREEZE" THE PRESENT STATE OF RELEVANT SCIENCE BY FORECLOSING RECONSIDERATION OF THE VALIDITY OF THE CLASSIFICATION SYSTEM AND OTHER. POLICY ISSUES IN RULEMAKINGS ON INDIVIDUAL SUBSTANCES, AND BY ERECTING FORMIDABLE BARRIERS TO OSHA'S OWN CONSIDERATION OF RELEVANT NEW SCIENTIFIC DEVELOPMENTS 40 41 44 46 51 S3 56 58 63 64 65 69 70 72 72 73 74 AP00051872 (iii) VIII. QUANTITATIVE RISK ASSESSMENT (A) Risk Assessment and Quantification is a Necessary Component of Regulatory Decisions (B) The Pact that there are Uncertainties Underline the Need for Risk Quantifica tion so far as Possible (C) Animal Data May be used for Quantitative Risk Assessment (D) Interchangeability or Fungibility of Carcinogens has not been Demonstrated (E) Epidemiology and Risk Assessment (F) Statistical Methods of Extrapolating to Low Dose Conclusion IX, ACCEPTABLE RISK OR LOW AS FEASIBLE Introduction A, The Record Demonstrates that OSHA Should Quantify Risk and it is Inconsistent to Set a Single Immutable Level of Control Without Consideration of the Risk Analysis B, The Proposed Regulation Improperly Fails to Provide for Consideration of Economic Feasibility C, The Record Supports the Conclusion that Exposure Levels Should be Established on the Basis of Acceptable Risk Rather Than Lowest Feasible D, Risks and Benefits E, The AIHC Alternative Provides a Reasonable Procedure for Identifying an Acceptable Level of Risk P, The OSHA Proposal Does Not Satisfy the Statutory Requirements of ''Feasibility" and "Reasonably Necessary" CONFiDtr-i 1 ;.-,L 78 * 79 83 83 85 87 88 89 91 91 91 93 96 99 104 105 AP00051873 (iv) X, EXCLUSION OF MISTURES AND AN ACTION LEVEL A, A Mixture Exclusion and an Action Level Should be Incorporated into theStandard B, Mixture Exclusion and an Action Level Could Materially Reduce Cost and the Number of Establishments' Regulated C, Recommendation XI, THE PROPOSED REGULATION UNLAWFULLY REQUIRES ISSUANCE OF EMERGENCY TEMPORARY STANDARDS WITHOUT APPRAISAL OF RISK XII. OSHA HAS A LEGAL AND MORAL OBLIGATION TO SET REGULATORY PRIORITIES XIII. OSHA'S MODEL STANDARDS ARE UNLAWFUL AND INAPPROPRIATE 1. Introduction A. Flexibility B. Compliance II. Scope and Application (Section (a)} A. Action Level B. Mixtures III. ^Definitions (Section (b)) IV. Permissible Exposure Limit (Section (c)) A. General B. Skin and Eye Contact C. Category II Substances V. Exposure Monitoring (Section (e)) VI. Methods of Compliance (Section (g)) VII. Respiratory Protection (Section (h)) VIII. Proetective Clothing and Equipment (Section (j)) IX. Housekeeping (Section (k)) X. Signs and Labels (Section (p)) 108 108 1 109 110 111 114 119 119 119 121 121 121 122 123 123 123 124 125 125 126 127 128 129 130 AP00051874 (v) XIV. OSHA HAS FAILED TO COMPLY WITH NATIONAL ENVIRONMENTAL POLICY ACT I. Introduction IX. A Detailed and Comprehensive Statement 1. Scope 2. Baseline 3. Environmental Impacts and Benefits 4. Adverse Impacts and Irretrievable Commitments 5. Secondary Impact 6. Alternatives 7. Interrelationships with Other Federal Agency Actions III. Early Consideration of Environmental Issues IV. Assessment of Generic Issues V. Irretrievable Commitments VI. Summary XV. OSHA HAS FAILED TO MEET ITS LEGAL OBLIGATIONS TO ASSESS THE POTENTIAL ECONOMIC IMPACT OF THIS REGULATION AND ALTERNATIVES THERETO I. ^Introduction XI. Legal Bases A. The OSHA Act B. NEPA C. Executive Order No. 11821 D. Executive Order No. 12044 III. OSHA's Position IV. OSHA's position is incorrect A. Burdens are Imposed by the Generic Regulation B. An Economic Analysis will be Meaningful and is Feasible 131, 131 133 135 135 135 136 138 138 139 140 141 142 142 144 144 144 145 145 146 147 148 150 150 151 AP00051875 UWI II IM wl 1 t |,ij_ (Vi) C. Analysis in Subsequent Rulemakings Will not be Meaningful and will Thwart the Purposes of Such an Analysis V. Snell Study VI. Summary XVI. OSHA SHOULD EXEMPT LABORATORIES FROM ITS GENERAL CARCINOGEN REGULATIONS XVIX, . CATEGORY IV SHOULD BE ELIMINATED BECAUSE OSHA LACKS STATUTORY AUTHORITY TO CREATE IT AND BECAUSE IT IS OTHERWISE UNWISE AND INAPPROPRIATE A. Statutory Authority B. Purpose of the List C. Procedural Problems D. Consequences of Listing E. Summary XVIII. RATE RETENTION SHOULD NOT BE A PART OF THE OSHA GENERIC PROPOSAL XIX. THE LABELING PROVISIONS OF THE MODEL STANDARDS ARE NOT AUTHORIZED BY LAW XX. KEY WORDS IN THE PROPOSED REGULATIONS ARE , IMPERMISSIBLY VAGUE < 1. Critical Terms in the Proposed Regulations are Vague and Inadequately Defined 2. Critical Terms In the Proposed Regulations are so Vague as to Preclude Effective Public Comment on the Proposed Rule 3. If Adopted in the Form Proposed, These Vague Provisions of the Proposed Regulations Would Deprive Affected Parties of Due Process of Law 153 153 154 154(a) 155 156 156 157 158 159 160 163 168 168 170 174 AP00051876