Document G5k41wKEMQEYNEJD3M2G45J2n

) AMERICAN INDUSTRIAL HEALTH COUNCIL 1073 CENTRAL PARK AYENUE SCARSDALE. NEW YORK 10533 (914) 725-1492 January 18, 1980 MEMORANDUM FOR AIHC I ; Comparison of OSEA Proposal (10/4/77) With Final Regulation The attached memorandum provides a side-by-side comparison of fundamental aspects of the final OSHA cancer policy and the 1977 proposal. More detailed analyses will be prepared as required. ALCOA0005069 I Comparison of OSHA ^Proposal (10/4/77) With Final' Regulation DEFINITIONS Potential Occupational Carcinogens 1977 Proposal Any substance which causes, as .the result of oral, respiratory, dermal or other exposure result ing in systemic distribution, an increased incidence of benign and/or malignant neoplasms or a significant decrease in the latency period between exposure and onset of neoplasm in humans or in one or more experimental mammalian species. Final Rule i Similar to Proposal. Includes mixtures and substances which are metabolized into potential carcinogens by mammals. Routes of exposure included are oral, dermal, respiratory and any other which results in induction of tumors away from administration site. Short-Term Tests Includes, but is not limited to, positive results in more than one of five specified tests. Positive results in two or more of ^ame five specified tests, * ) ) Scientific Review Panel No specific provision. Upon the request of the Secretary, the Director(s) of NIERS, NCI and/ or NlOSH will convene a panel of. appropriately qualified govern- j , _ment_-emoloyees "to provide recoin-/ mendations to the Secretary in the identification, classification, and regulation" of potential car cinogens. The report of the panel (due in 90 days) is not binding on the Secretary but will be placed in the record and an appropriate _time for comment thereon will be allowed. No provision is made for public input to the panel. The role of the panel would appear to be circumscribed by the classi fication criteria contained, in the regulation. ALCOAO 00507 0 1 AMENDMENTS TO THE REGULATION By petition after notice and hearing. Three mechanisms are provided: (a) no later than every three years, NCI, NIEHS and/or NIOSH shall, upon the Secretary's re quest, report whether scientific or technical advances warrant any changes; (b) at any time, NIEHS, NCI or NIOSH may recom mend changes based on scientific or technical advances; (c) any interested person may petition for change based on substantive new issues or evidence which differ significantly from those presented or reviewed in this generic rulemaking. Such peti tions may be presented in con nection with an individual sub stance proceeding. CLASSIFICATION CRITERIA Category I Potential Carcinogens A presumption exists that a toxic substance shall be classi fied by the Secretary as a "Category I Toxic Substance" if; (a) it meets the definition of a potential occupational carcinogen in (1) humans, (2) two mammalian test species; (3) a single mammalian species, if replicated, or (4) a single mammalian species if supported by short-term tests or (b) if the Secretary finds other sufficient evidence to classi fy the substance in Category I. A substance shall be classified as Category I if it meets the definition of a potential occu pational carcinogen in (1) humans, (2) a single mammalian assay, if in concordance with other evi dence, or (3) in a single mamma lian assay where the Secretary finds concordance unnecessary. Evidence of concordance may in clude any of the following: positive results from testing in the same or other species, posi tive results in short-term tests, and induction of tumors at injec tion or implantation sites. Category II Toxic Substances Category II includes any sub stance which meets the defini tion of a "potential occupa tional carcinogen" in animal or human studies where the A substance shall be classified in Category II if it meets the criteria of Category I but the evidence is merely suggestive or it meets the Category I criteria -2- ALCOA0005071 Secretary finds the evidence only suggestive. This classification is mandatory rather than presumptive. In addition, a presumption exists that a substance shall be classified in Category II if it yields positive results in a single unreplicated animal test or the Secretary finds other suf ficient evidence to so classi fy the substance. in a single mammalian species without concordance, Category III Potential Carcinogens Includes substances for which there are insufficient data to classify them in Category I or II. Not regulated, Category IV Potential Carcinogens Substances which meet the definition of potential occupational carcinogen but are not found in any.American workplace. Not regulated, No provision-comments solicited. PRIORITIES (1) The Secretary will prepare a "candidates list" based on "brief scientific review of available data". Items on this list may be considered for further scientific study and/or regulation. The Secretary may, but need not, ten tatively identify substances on the list as Category I or II candidates. This list will be published in the Federal Register at least annually. Sources of "available" data are listed as: (1) data submitted by any person; (2) data referred to by NIOSH or the U.S. Department of Health and Human Services (HHS) in any communication (including the "Suspected Carcinogens" list); (3) literature referred' to in -3- ALCOA0005072 U.S. Public Health Service's, Publication Ho. 149; (4) IARC monographs; (5) the TSCA Inven tory of Chemical Subs-tances; (6) the HHS Annual Report to the President; (7) any other relevant data of which the Secretary has actual knowledge. (2) The Secretary will also establish two priority lists which will designate approxi mately 10 Category I and 10 Category II potential carcino gens. These lists are to be published in the Federal Register at least every six months. Place ment on a priorities list is merely "a policy determination that the Secretary plans to address some or all of these sub stances prior to other substances on the candidates list. Factors to be considered in setting prior ities include: (1) estimate of workers exposed; (2) estimated exposure levels; (3) reported potency; (4) extent to which regu latory action could reduce other environmental and occupational hazards; (5) similarity of mole cular structure to known potential carcinogens; (6) availability of suitable substitutes, or likely low magnitude of social and economic costs of regulation; and (7) actions being taken or planned by other agencies dealing with similar hazards. DATA Relies on positive human and animal data for the identifica tion and classification of po tential carcinogens. Accepts data based on high doses. Deter mined that there are no threshold or safe levels of exposure; announced that substances are non organ or species specific; considered benign and malignant Generally similar to proposal. Increases in spontaneous tumors will be considered evidence of qualitative carcinogenicity. Tumors, at site other than induc tion (for routes of exposure other than oral, dermal or respiratory) will be' considered only "concor dant" or "suggestive". Thresholds disclaimed at oresent. Substances 4 ALCOA000507 3 tumors equivalent; allowed only limited consideration of meta bolic or pharmacokinetic data; held positive results generally to outweigh negative outcome; and statistical significance to be considered. are to be considered potential occupational carcinogens if, when metabolized by mammals, they yield one or more potential carcinogens. However, 1990.144 does allow for the consideration of certain scien tific questions in individual pro ceedings if specified criteria are met. The following exceptions to the general rule are created: (1) Negative epidemiological studies. Will be considered only if it meets the following criteria: (a) study involved at least 20 years exposure and 30 years observa tion after initial exposure; (b) documented reasons are provided for predicting the expected tumor site(s) if the substance were' a human carcinogen; and (c) the study group was sufficiently large to allow detection of a 50% increase at any of the predicted sites. Arguments that such studies may be used to establish numerical upper limits on human risk will be con sidered only if criteria (a) and (b) are met and (d) specific data on the level of exposure are pro vided, based either on direct measurements taken periodically through the exposure period or other unequivocal evidence. (2) Tumors at site of administra tion . Arguments against consider ing tumors at site of administration will only be considered if: (a) the route of administration is not oral, respiratory or dermal; and (b) evidence establishes that induc tion of local tumors is related to the physical configuration or form ulation of the administered material and that tumors are not induced when the same material is adminis tered in a different configuration or formula. (3) Metabolic differences. Argu ments based on differences between human metabolism and that of test animals will be considered only if: (a)' a"complete metabolic profile. D ALCOA0005074 including identities of trace metabolites, is available for a human group representative of exposed workers; (b) a similar metabolic profile is presented for the experimental animal species; (c) documented evidence is provided for ascribing the car cinogenic activity in the test species to metabolites produced only in that species and not in humans; and (d) documentation is provided that other metabolites produced also in humans are not also carcinogenic. (4) Use of high doses in animal testing. Arguments against con sidering studies involving high doses will be entertained only if the following criteria are net: (a) documentation that at the dose levels used the substance is meta bolized by the experimental animal into metabolic products which in clude one or more not produced at lower doses; (b) demonstration that the metabolite(s) produced only at high doses are the ultimate carcinogen(s) and that the low dose metabolites are not carcinogenic; and (c) documented evidence is presented to show that the meta bolite (s) produced only at high doses in the animal are not pro duced in humans exposed to low doses. (5) 3enign tumors. Will consider evidence that substance is capable of producing only benign tumors only if: (a) data are available from at least two well-conducted bioassays in each of two mammal species; (b) each of the bioassays was a full lifetime test; (c) tissu slides are made available to OSHA and the tumors are diagnosed as benign by at least one qualified pathologist not involved in the original study; and (d) all of the tumors are of types known not to progress to malignancy or az a beni stage when observed. In the latter case, data must be presented to M.COK0005015 show that multiple sections of the affected organ(s) were ade quately examined for invasion and mestastases. (6) Indirect mechanisms. The Secretary will consider disregard ing positive animal results, if evidence demonstrates that the mechanism by which the observed tumor incidence is effected is indirect and would not occur if humans were exposed (e.g., car cinogenic animal virus or aug mented caloric intake). None. RISK ASSESSMENT Limited. Will be used to set priorities and estimate residual risk after regulatory action. Risk quantification will not be considered in determining the appropriate level of control. "[C]autious and prudent" assump tions will be used in performing risk assessments. CATEGORY I CONTROL Lowest feasible level. Engineer ing and work practice controls given priority over personal pro tective devices. No considera tion of potency. Model standards to be used as guidelines. Deviation from the model to be on a case-by-case basis. Variation from major con trol headings only if Secretary explains why heading is inappro priate. Exposure limit to be set as low as feasible. Primary reliance is on "engineering and/ or work practice controls". Other controls will require a variance by the Secretary. Personal pro tective controls may only be used: (1) during period while engineering and work practice controls are being implemented; (2) where employer establishes non-feasibil ity of engineering and work prac tice controls; (3) where engineer ing and work practice controls are insufficient to reduce exoosure -7- ALCOA0005076 below PEL (still must use engineer ing and work practice controls to reach their lowest achievable level); and (4) emergencies. No occupation al exposure will be permitted if a su able substitute is available. No exposure is generally to be the "lowest level detectable in an in dustrial environment with existing analytical technology". Lower levels may be set in cases where analytical methodology is poorly developed. CATEGORY II CONTROL Control for chronic health effects other than cancer. Model standard adopted as guideline. PEL to be set on case-by case basis "as appropriate and consistent with the statutory requirements". Primary reliance, is placed, as in Category I, on engineering and work practice controls. SUBSTITUTES No exposure to Category I potential carcinogen if less hazardous suitable substitute is determined by the Secretary to be available. Same. The Secretary will consider economic and technological feasi bility of the substitute, includ ing relative effectiveness, avail ability, relative degree of hazard and practicability. MIXTURE/ACTION LEVEL EXCLUSIONS None. Will be considered in individual proceedings and set as appro priate . MODEL STANDARDS Generic standards rigidly applied. Model standards are to be used as guidelines for regulation. Compliance plans must be sub mitted. Occupational health -8- ALCOA0005077 programs will be included unless determined and explained to be inappropriate by the Secretary. EMERGENCY TEMPORARY STANDARDS Automatic for Category I. Issuance of an ETS will be con sidered for all Category I po tential carcinogens. Employee exposure to Category I substances is to be generically considered a "grave danger". Necessity of ETS to protect workers will be considered according to statutory criteria or a case-by-case basis. SIGNS AND LABELING Secretary may require labels on goods shipped out of the plant. Generally the same. PUBLIC NOTICE Notice of classification to be published in Federal Register. Candidate and priority lists may be published in the Federal Register without prior notice. Within 30 days after beginning a study concerning the "economic and/or technological feasibility of specific standards" the Secretary will publish an ANPR which will specify, among other things, the scope of the study, the estimated issuance date of the proposal, the date for sub mitting relevant studies or in formation and procedural require ments for asserting new issues or evidence. LIMITATION OF ISSUES TO EE CONSIDERED IN RULEMAKING Issues limited to the follow ing: (a) whether Secretary correctly classified the toxic substance according to Category Issues limited to the following: (a) appropriateness of substance grouping; (b) whether substance or group meets definition of -9- ALCOA0005078 I criteria; (b) whether Secre tary was correct that Category I classification should not be rebutted; (c) determination of lowest feasible occupational exposure or whether less hazard ous suitable substitutes exist; (d) whether substance has unique properties or uses that make protective measures inappropriate or infeasible; (e) environmental impact. potential occupational carcino gen , !including reliability of scientific studies; (c) applica bility of data to entirety of substance group; (d) whether evidence submitted on scientific issues (see DATA, supra) is sufficient to warrant exception; (e) whether data submitted re garding new issues or evidence is sufficient to warrant amend ment of rule; (f) whether the substance meets the Category I or Category II criteria; (g) the environmental impact from regu lation of the substance; (h) any issues required by statute or executive order; (i) the lowest feasible level (for Category I carcinogens) including technolog ical and economic considerations; (j) the appropriate employee expo sure level (for Category II car cinogens) consistent with the Act's requirements; (k) the ; availability of suitable sub- j stitutes; (1) whether the pro- ^ visions of the proposal and model standards are appropriate (except' that use of lowest feasible level, reliance on engineering and work , practice controls and no occupa-' tional exposure where substitutes exist cannot be challenged). All workplaces. COVERAGE i All workplaces are covered but ; the manner of regulating will be; determined, as appropriate, in individual proceedings. Considera tion will be given to setting seDarate .standards for laboratories No provision. MEDICAL REMOVAL No provision. May be considered ' in individual proceedings. OSHA is currently investigating the possibility of proposing a general removal protection, regulation which. - 10 - ALCOA0005079 would apply to toxic and carcinogenic chemicals. Access. l i ACCESS TO MEDICAL RECORDS No provision on access. Will be covered by 03EA's soon to be published final standard on Access to Employee Exposure Medical Records. ENVIRONMENTAL IMPACT To be addressed in individual rulemakings. To be addressed in individual rulemakings. ALCOAO 005080 I III Co j X V ALCOA0005068 <7g/j//j 0H3W 71- a y CD rH * E 2 3 C 0 oH 0 H Q +J (0 <0 H cd N 0 0 HH0O U C <D r~ (0 m \ < O' C rMSN 1 O 0\ u CM n X 0 CQ m