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Federal Regular / Vol. 61. No. 101 / Thursday, May 23, 1996 / Notices 25873 resolution, u id upon proper showing that there are genuine issues of material fact that cannot be resolved on the basis of swom statements, affidavits, depositions, or other documents or that the nature of the matter in issue is such that an oral hearing and crossexamination are necessary for the development of an adequate record. It is further ordered. That Haewoo Air k Shipping Co., Ltd. d/b/a Haewoo Shipping Co., Ltd. is designated Respondent in this proceeding; It is further ordered. That the Commission 's Bureau of Enforcement is designated a party to this proceeding; It is further ordered. That notice of this Order be published in the Federal Register, and a copy be served on parties of record: It is further ordered. That other persons having an interest in participating in this proceeding may file petitions for leave to intervene in accordance with Rule 72 of the Commission's Rules of Practice and Procedure. 46 CFR 502.72; It is further ordered, That all further notices, orders, and/or decisions issued by or on behalf of the Commission in this proceeding, including notice of the time and place of hearing or prehearing conference, shall be served on parties of record; It is further ordered. That all documents submitted by any party of record in this proceeding shall be directed to the Secretary, Federal Maritime Commission. Washington, D.C. 20573, and comply with Subpart H of the Commission's Rules of Practice and Procedure. 46 CFR 502.111-119, and shall be served on parties of record; and It is further ordered. That in accordance with Rule 61 of the Commission's Rule* of Practice end Procedure, 46 CFR 502.61, the initial decision of the Administrative Law Judge shall be issued by January 20, 1997, and the final dedsion of the Commission shall be issued by May 20, 1997. By the Commission. Joseph C Polking, Secretary. (FR Doc. 96-13056 Filed 5-22-66; 8:45 am) iLLsm cooa 7is-sf-M GENERAL ACCOUNTING OFFICE Federal Accounting Stenderde Advisory Board; Meeting AOKNCV; General Accounting Office. Action; Notice of Meeting. SutNAfiT: Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L No. 92-463), as amended, notice is hereby given that the Federal Accounting Standards Advisory Board will meet on Thursday, May 30.1996. from 9 a.m. to 4 p.m. in room 7C13 of the General Accounting Office. 441 G St.. NW,, Washington, DC. The purpose of the meeting is to discuss and review the (1) Accounting for Natural Resources document, (2) JFMIP Cost Accounting Systems and Reporting project. (3) Invitation for Views; Accounting for the cost of Capital document, and (4) Rule 203 of the AlCPA's Code of Ethics. Any interested person may attend the meeting as an observer. Board discussions and reviews are open to the public. FOR FURTHKR MFOMUTION CONTACT: Ronald S. Young. Executive Staff Director. 750 First St, NE.. Room 1001, Washington, DC 20002, or call (202) 512-7350. Authwlty Federal Advisory Committee Act Pub. L No. 92-463, section 10(a)(3), 86 Sut 770.774 (1672) (current version at 5 U.S.C app. Motion l(XaX2) (1668); 41CTR 101-6.1015 (I960). Dated: Mey 20.1666. IFR Doc. 96-13040 Filed 5-22-66:6:45 ami M iera coee tete-et-e DEPARTMENT OF HEALTH AND HUMAN SERVICES Hearth Cere Financing Atknlniatrstfon [HCFA3171 Agency Information CoBectlon Aotivrtlaa: Submission lor QMB Review; Comment Request In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1998, the Health and Cara Flnandng Administration (HCFA), Department of Health and Human Services, haa submitted to the Office of Management and Budget (OMB) the following proposals for the collection of information. Interested p--are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the propoeed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Request: Reinstatement, without change, of a previously approved collection for which approval has expired; Title of Information Collection: State Medicaid Eligibility Quality Control Sampling Plan; Form No.: HCFA-317; Use: The State MEQC sampling plan is necessary for HCFa to monitor the States' operation of the MEQC system. The sampling plan includes all data involved in the States' sample selection process--population sizes and sample frame lists, sample sizes, sample selection procedures, and claims collection procedures; Frequency: Annually: Affected Public: State, local, or tribal government; Number of Respondents: 55; Total Annual Responses: 110; Total Annual Hours: 2,640. To request copies of the proposed paperwork collection referenced above. E-mail your request, including your address, to PaperworkOhcfa.gov, or call the Reports Clearance Office on (410) 786--1326. Written comments and recommendations for the propoeed information collections should be sent within 60 days of this notice directly t the HCFA Paperwork Clearance Officer designated at the following address: OMB Human Resources and Housing Branch, Attention: Allison Eydt, New Executive Office Building, Room 10235, Washington. D.C 20503. Dated: May 16.1968. Trtlse B. Larson. Director, Management Planning and Analysts Staff, Office ofFinancial and Human ftosourcM. Health Can Financing Administration. (FR Doc. 66-12662 Filed 5-22-66; 8:45 am) Agency tor Toxic Subemncee and Dtoenae Ragtay [ATSM-llfll Mtolntel Rtofc Lavato tor Priority Subatonee* and Outdance for Pertw--on AtiNNCT: Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health end Human Services (HHS). ACTON; Notice. SUMMARY: The Comprehensive Environmental Response. Compensation, and Liability Act (CERCLA) (42 U.S.C. 9604 at seq.), as amended by the Superfund Amendments and Raauthorization Act (SARA) (Pub. L 99-199), requires that CMA113588 25874 Federal Register / Vol. 61. No. 101 / Thursday. May 23. 1996 / Notices ATSDR develop jointly with the U.S. Environmental Protection Agency (EPA), in order of priority, a list of hazardous substances most commonly found at facilities on the CERCLA National Priorities List (NPL) (42 U.S.C. 9604(i)(2)l; prepare toxicological profiles for each substance included on the pnonty list of hazardous substances, and to ascertain in the toxicological profiles, significant human exposure levels (SHELs) for hazardous substances in the environment, and the associated acute, subacute, and chronic health effects (42 U.S.C. 9604(11(3)); and assure the initiation of a research program to fill identified data needs associated with the substances (42 U.5.C. 9604(i)(5l). The ATSDR Minimal Risk Levels (MRLs) were developed in response to the mandate for SHELs and to provide screening levels for health assessors and other responders to identify contaminants and potential health effects that may be of concern at hazardous waste sites and releases. This notice announces the internal guidance for derivation of MRLs for priority hazardous substances by ATSDR. The guidance represents the agency 's current approach to deriving MRLs and reflects the most current scientific assessment. Comments from the public on the process of deriving MRLs are welcome. The MRLs for a particular substance are published in the toxicological profile for that substance. A listing of the current published MRLs is provided at the end of the notice. ADDRESSES: Comments on this notice should bear the docket control number ATSDR-llO and should be submitted to: Division of Toxicology, Agency for Toxic Substances and Disease Registry. Majistbp E-29,1600 Clifton Road, NE., * Atlanta, Georgia 30333. FOR FURTHER INFORMATION CONTACT: Dr. Selene Chou. Division of Toxicology, Agency for Toxic SubstancM end Disease Registry, 1600 Clifton Road. NE.. Mailstop E-29, Atlanta. Georgia 30333. telephone (404)639-6308 or FAX (404)639-6315. SUPPLEMENTARY INFORMATION: CERCLA requires that ATSDR prepare toxicological profiles for priority hazardous substances, and to ascertain significant human exposure levels for these substances in the environment, and the associated acute, subecute, and chronic health effects (42 U.S.C. 9604(0(31). Minimal Risk Levels (MRLs) were developed as an initial response to the mandate. Following discussions with scientists within the HHS and the EPA, ATSDR chose to adopt a practice similar to that of the EPA's Reference Dose (RfD) and Reference Concentration (RfC) for deriving substance-specific levels. An MRL is an estimate of the daily human exposure to a hazardous substance that is likely to be without appreciable risk of adverse noncancer health effects over a specified duration of exposure. These substance* specific estimates, which are intended to serve as screening levels, are used by ATSDR health assessors and other responders to identify contaminants and potential health effects that may be of concern at hazardous waste sites and releases. It is important to note that MRLs are not intended to define clean-up or action levels for ATSDR or other Agencies. The toxicological profiles include an examination, summary, and interpretation of available toxicological information and epidemiologic evaluations of a hazardous substance. During the development of toxicological profiles. MRLs are derived when ATSDR determines that reliable and sufficient data exist to identify the target organ(s) of effect, or the most sensitive heelth effect(s) for a specific exposure duration for a given route of axpoaure to the substance. MRLs are based on noncancer heelth effects only and are not based on s consideration of cancer effects. Inhalation MRLs are exposure concentrations expressed in units of parts par million (ppm) for gases and volatiles. or milligrams per cubic meter (mg/m3) for particles. Orel MRLs are expressed as daily human doses in units of milligrams per kilogram per day (mg/ ^AtIdR uses the no-observed-adverae- effact-leveL/uncertainty factor approech to derive MRLs for hazardous substances. The MRLs are set below levels that, based on currant information, might causa advene health effects in the people moat sensitive to such substance-induced effects (Baross and Doureon 1986; EPA I960). MRLs are derived for acute (1-14 days), . intermediate (15-364 days), and chronic (366 days and longer) axpoaure durations and for the oral and inhalation routes of exposure. Currently, MRLs for the dermal route of axpoaure are not derived because ATSDR net not yet identified a method suitable for this route of exposure. MRLs tre generally based on the most sensitive substanceinduced end point considered to be of relevance to humans. ATSDR does not use serious health affects (such as irreparable damage to the liver or kidneys, or birth defects) as a basis for establishing MRLs. Exposure to a level above the MRL does not mean that adverse heelth effects will occur. MRLs are intended to serve as a screening tool to help public heelth professionals decide where to look more closely. They may also be viewed as a mechanism to identify those hazardous waste sites or other hazardous substance exposures that are not expected to cause adverse health effects. Most MRLs contain some degree of uncertainty because of the lack of precise toxicological information on the people who might be most sensitive (e.g., infants, elderly, and nutritionally or immunologically compromised) to the effects of hazardous substances. ATSDR uses a conservative (i.e., protective) approach to address these uncertainties, consistent with the public health principle of prevention. Although human data are preferred. MRLs often must be based on results of animal studies because relevant human studies are lacking. In the absence of evidence to the contrary, ATSDR assumes that humans are more sensitive than animals to the effects of hazardous substances, and that certain persons may be particularly sensitive. Thus, the resulting MRL may be as much as a hundredfold below levels shown to be nontoxic in laboratory animals. Proposed MRLs undergo a rigorous review process. They are reviewed by the Heelth Effects/MRL Workgroup within the Division of Toxicology; an expert panel ofpeer reviewers; the agency wide MRL Workgroup, with participation from other federal agendas, including EPA; and are submitted for public comment through the toxicological profile public comment period. Each MRL is subject to change as new information becomes available concomitant with updating the toxicological profile of the substance. ` MRLs in the most recent toxicological profiles supersede previously published levels. A listing of the current published MRLs is provided at the end of this notice. Categories Used to Derive MRLs The following health effect end points can be used to derive MRLs: Systemic Respiratory Cardiovascular Gastrointestinal Hematological Musculoskeletal Hepatic Renal Endocrine Dermal Ocular Metabolic Body weight change Other systemic effects Immunological and Lymphoreticular Neurological Reproductive CMA 113589 Federal Register / Vol. 61. No. 101 / Thursday, May 23, 1996 / Notices 23875 Developmental effects begin to appear, rad whether the unique situation. The following key To provide a better analysis of the toxic potential of the profiled substance, the same effect can be considered under more than one system category: for example, behavioral effects in the offspring can be either neurological or developmental. However, only one system category per exposure route and duration should be chosen as the basis for deriving the MRL. If two different effpcts within two different systems would result in the same MRL value, the MRL should be derived from the one that is best supported by data from all exposure routes and durations. Classification of End Points as NOAELs, Less Serious LOAELs or Serious LOAELa MRLs are derived from no-observedadverse-effect levels (NOAELs). In the absence of NOAELs. MRLs can be less serious effects occur at approximately the same levels as serious effects or st substantially lower levels of exposure. In general, a dose that evokes failure in a biological system and can lead to morbidity or mortality (e.g.. acute respiratory distress or death) is referred to as a serious LOAEL. A more specific classification scheme is as follows. No Adverse Effects Weight loss or decrease in body weight gain of less than 10%. Changes in organ weight of nontarget organ tissues not associated with abnormal morphologic or biochemical changes. Increased mortality over controls that is not statistically significant (p > 0.05). Some adaptive responses. points should be considered: Good quality human data are generally preferred over animal data. Only one MRL is derived per exposure period (acute, intermediate, or chronic) for each route of exposure. The MRL is generally based on the highest NOAEL (that does not exceed a LOAEL) or the lowest LOAEL for the most sensitive end point for that route and exposure period. Although not a preferred end point for MRL derivation, decreased body weight gain can be used when the decrease is greater than 10% and when the study provides some indication that weight loss is due to a systemic effect of toxicant and not reduced food and/ or water intake. It is preferable to derive MRLs using data for each exposure duration. However, when this is not possible derived from less serious lowestobserved-advers effect levels Less Serious Adverse Effects because of limitations of the database for a given duration, an MRL derived for (LOAELs). MRLs are not derived from serious LOAELs. In its 1986-1988 Reversible cellular alterations at the one duration may sometimes be ultrastructural level (e.g., dilated applicable to MRL(s) for other Biennial Report Volume U. ATSDR endoplasmic reticulum) and at the light* duntion(s) of the same route based on defines an adverse health effect as a microscopy level (e.g.. cloudy swelling, consideration of the overall database. harmful or potentially harmful change in the physiologic function, psychologic state, or organ structure that may result in an observed deleterious health outcome. Adverse health effects may be manifested in pathophysiologic changes in target organs, psychologic effects, or overt disease. This definition is interpreted to indicate that any effect that enhances the susceptibility of an organism to the deleterious effects of other chemical, physical, microbiological, or environmental influences should be considered adverse. fatty change). Necrosis (dependent upon location, distribution, reversibility or the degree of associated dysfunction), metaplasia, or atrophy with no apparent decrement of organ function. Serum chemistry changes. s.g., moderate elevations of serum aspartate aminotransferase (SGOT), serum alanine aminotransferase (SGPT). Weight loss or decraese in body weight gain of 10%--19%. Soma adaptive responses. Serious Effects Selection of Most Sensitive Effect The MRLs are based on the concept that a threshold level of exposure exists below which no noncancer health effect is likely to occur, and. therefore, an exposure level protective against the most sensitive effect would also be protective against all other effects. The most sensitive effect is the first advene effect that occurs or is expected to occur in humans as doss increases. However, information on the mechanisms of action should be considered when assessing the significance of the effects. ATSDR acknowledges that a considerable amount of judgement it Deeth Clinical Where the target organ of affect is not nt .igniflrant wyn clearly identified, an MRL is usually not required in this process and that, in impairment (e.g., convulsions, icterus, derived. However, the lack of some cases, there will be insufficient cyanosis). quantitative data for a particular system data to decide whether or not an effect Morphologic changes in organ category does not preclude derivation of will lead to significant dysfunction. tissues that potentially could mult in an MRL if other evidence, such as ATSDR generally will not derive an severe dysfunction (s.g., marked information horn human cast studies, MRL if no adverse health affect has bam necrosis of bepstocytes or renal toxicokinetics, and other exposure reported in the published pear reviewed tubules). routes, indicates that this system would literature in any target organ (e.g.. all Weight loss or decrease in body not be expected to be moat sensitive to free standing NOAELs) for a given might grin of 20% or greater. the substance for the exposure route and duration. However, data from other Serum chemistry changes (e.g., duration of concern. durations and routes of exposure may lend support for selecting an major elevations of SGOT, SGPT) Major metabolic effects (a.g., Toxicokinetics data enter into consideration whan comparing appropriate end point to derive an MRL ketosis, acidosis, alkalosis). information across species, routes, and Deciding whether an end point is a NOAEL or a LOAEL depends in part Cancer effects. Additional guidance on the durations for determination of the most sensitive effect. Comparison of the upon the toxicity that occurs at other assessment of and-point-spacific health metabolism of the compound exhibiting doses in the studies evaluated, and in effects is available upon request. the toxic effect in animals with its part upon knowledge regarding the mechanism of toxicity of the substance. The distinction between less ssrious Tho Adequacy of Database for Derivation of an MRL matsholism in humans may affect the choice of the moat sensitive end point. Toxicokinetic differences among species and serious LOAEL is intended to help It is difficult to provide strict rules and for various chemical forms of tha the users of the toxicological profiles see governing this determination. Each compound may help to explain an at what levels of exposure "major" profiled substance presents its own apparent inconsistency among studies. CMA 113590 25876 Federal Bngfoter / Vol. 61, No. 101 / Thursday. May 23, 1996 / Notices Difference* *ctom route* of exposure --n *l*o be explained by different rites of absorption, metabolism (both detoxication and activation), and excretion. Selection of a Representative, Quality Study for MRL Derivation ATSDR emphasizes its preference for using data from humans whenever such data are reliable and appropriate for MRL derivation. However, human studies must be of sufficient duration and contain an adequate number of documented exposed individuals to be useful in risk assessment. In the absence of adequate human studies, animal studies ore used. The authorfs) of the study must provide enough information on the oral dose or inhalation exposure concentration administered to the treated animals to allow for estimation of on equivalent human oral dose or inhalation exposure. For both oral and inhalation studies, the data presented in the study should st least include the air. water, or food concentration, the duration of exposure, the frequency of exposure (i.e., per day and per week), the age of the animals, and evidence that the food and water consumption rates were not abnormal (e.g,, from weight gain data) for an animal of similar age. Background documents on general factors that ATSDR considers in evaluating the quality of a study are available upon request Other general principles that have been accepted in practice when evaluating studies include; Considerations to the exposure scenario more likely to occur in environmental exposures. For example, drinking water or feeding studies ere preferred over gavage oil studies far oral exposures. Determination whether the study data show a dose-response consistent with other studies. The following effects are not used foe MRL derivation: Increased incidence of mortality. Serious LOAELe. Health effects that occur in teat species as a result of mechanisms, or metabolic processes that ore not found in humans (e.g.. a2u-globulin nephropathy in male rats). Spontaneously occurring disorders that are species and gender related (e.g., chronic progressive nephropathy in mala rats). Effects of unknown biological significance, baaed on mechanism of action, tbit do not affect known target organs. Cancer effects. Computation of Inhalation MIL* 1. Extrapolating From Animals to Humans When animal data is used in the absence of adequate quantitative human data, exposure concentrations should be converted to human equivalent concentrations by using dosimetry adjustment in accordance with EPA (1990), "Intenm Methods for Development of Inhalation Reference Doses" (EPA/600/9-90/066A, August 1990). Standard reference values should be obtained from EPA (1968): "Recommendations for and Documentation of Biological Values for Use in Risk Assessment" (EPA 600-687/008. February, 1968). For inhalation exposures to gases or vapors, it may be necessary to convert to human equivalent exposure* for respiratory effects (e.g., using the regional gas dose ratio for the targeted region of the respiratory tract) or extrarespiratory effects (e.g., using the blood to air partition coefficient ratio). For inhalation exposure to particles, it may also be necessary to convert to human equivalent exposures for respiratory effects (e.g.. using the regional deposited does ratio for the targeted region of the respiratory tract), or extnnepiratary effects (e.g., using the regional deposited dose ratio and uptake foam the entire respiratory system). 2. Adjusting From Intermittent to Continuous Dosing ATSDR defines an MRL as "on estimate of the doily human exposure to a hazardous substance that la likely to be without appreciable risk of advene naneencer health effects over a specified duration of sxpaeure". Hie ideal study would involve continuous dosing over the course of the study. If a study did not involve continuous dosing over the entire exposureperiod. on adjustment is usually made. The "intermittent exposure dose" (either the NOAEL or LQAKL of the critical effect selected to be used for MRL derivation) is multiplied by correction feetore to adjust for foil day and week exposures. For example, in intermediate (longer than 14 days) or chronic (longer than 364 days) studies in which the experimental ware doeed for 8 hours i day for S days s week, the estimated "adjusted does" becomes: Adjusted does * Intermittent dose x (6 hours/24 hours) x (5 days/7 days) Intermediate and chronic duration inhalation studies ora usually doeedjusted for day and week exposures: acuta duration inhalation studies con be duration adjusted from intermittent exposures to 24 houru continuous exposure, but are not adjusted to 1 week. For example, acute studies in which animal* were exposed for 6 hours/day for 3 days can be adjusted as follows: Adjusted dose * Intermittent dose x (6 hours/24 hours) However, making duration adjustments may not be appropriate in every instance. Hie toxicokinetics and mechanism of action should be examined to the fullest extent possible before a determination is made to adjust for intermittent exposures. The following ore some factors to consider in adjusting for dose and duration. When the critical effects ora mainly dependent on the exposure concentrations and the substance being tested is rapidly metabolized and/or excreted, does adjustment is inappropriate. If the effects being examined ore mainly duration dependent (e.g., longer periods of exposure increase the severity of the effects being studied) and metabolism/exoetion is moderate to slow, or the study identifies a cumulative effect, duration adjustment may be appropriate. 3. Converting From Salt to Parent Substance Salt concentrations or doses ore converted to equivalent concentrations or doeee of the parent substance by multiplying by the molecular weight ratio of parent to salt. Computation of Oral MRLs l. Converting From Concentration to Does For feeding studies. the equation for the conversion foam food concentrations is: (ppm in food) x (C/kg body weight) mg/kg/day The food consumption factor (0 is kg of food consumed per day. Unless the food consumption rate and body weights ere available, standard reference values should be obtained from EPA (IMS). Far drinking water studies, the equation for conversion from water concentrations is: (ppm in water) x (C/kg body weight) * mg/kg/day The water consumption rata (C) is liters of water consumed per day. Unless C end body weights are provided in the study, standard reference values should be obtained from EPA (1988) or EPA (1986), os appropriate. CMA 113591 Federal Register / Vol. 61. No. 101 / Thursday. May 23, 1996 / Notices 25877 2. Converting From Intermittent to Daily study of the sensitive population was Dosing used. By definition an MRL is "an estimate Interspecies Extrapolation of the daily human exposure to a hazardous substance that is likely to be without an appreciable risk of adverse noncancer health effects over a specified duration of exposure". If the principal study did not involve daily dosing over the entire exposure period, an adjustment is usually made. The "intermittent dose" is multiplied by the fraction of the study days over which the test animals were actively dosed. Acute oral studies are not adjusted to 1 week; intermediate and chronic oral studies are usually dose-adjusted to full week exposures. For example, for animals orally dosed weekly 5 days a week, the estimated "continuous dose" In the absence of adequate human data, animal data are used; a UF of 10 is generally used to account for extrapolation from animals to humans. However, a UF of 3 or 1 may also be used when comparative toxicological data indicate that similar effects are expected in humans at comparable exposure levels. For inhalation MRLs. when dosimetry adjustment is made for converting animal exposure levels to human equivalent concentrations, a UF of 3 is generally applied to account for any remaining uncertainty (Jarabek and Segal 1994). LOAEL to NOAEL Extrapolation becomes; MRLs are derived from NOAELa. In adjusted dose = intermittent dose x (5 the absence of a NOAEL, the lowest days/7 days) LOAEL that causes less serious adverse Uncertainty factors and modifying health effects is used, and a UF of 10 is factor generally applied. When the less serious When sufficient human data are not available to allow an accurate assessment of noncancer health risks. ATSDR may extrapolate from available LOAEL approaches the threshold level, that is, only minimal effects are observed representing an early indication of toxicity, the effect level is information using uncertainty factors (UFs) to account for different areas of considered to be a minimal LOAEL. and a UF of 3 may be used. uncertainty in the database to derive MRLs. In addition, a modifying factor (MF) may be applied to reflect additional scientific judgement on the database. MRLs are derived from human equivalent no-observed-adverse-effect levels and are calculated as follows: MRL = (NOAEL) ec / (UF x MF) When an appropriate NOAEL does not exist, the lowest LOAEL should be used and a UF is applied for the use of a LOAEL. Additional uncertainty factors for human variability to protect sensitive subpopulations, for interspecies extrapolation when animal studies are used for derivation of MRLs. ar.d for extrapolation across exposure Extrapolation Across Durations It is preferable to derive MRLs using data for each exposure duration. However, when the database supports extrapolation across acute, intermediate, or chronic exposure durations, a UF may be applied based on scientific judgement. For example, the chronic inhalation MRL for cnlotdane was derived from the intermediate inhalation MRL with an additional UF of 10 to account far aooas duration extrapolation; the chronic inhalation MRL was supported by the limited data on chronic exposure as well as the date on oral exposure. Modifying Factor (MF) durations are also used. An MF greater than zero and up to 10 The default value for each individual UF is 10; if complete certainty in data exists, a value of one can be used; and may be applied to reflect additional concerns about the database not covered by the UFs. The default value for MF la an intermediate value is three. By 1. An example is the use of an MF of multiplying these individual 3 to account for the incomplete database uncertainty factors, a combined UF is obtained. in deriving the chronic oral MRL for 4,4'-methylenebis(2-chloroanillne). The use of UFs and MFs should be Another possible consideration is that if based on scientific judgement on a case a test substance is known to by-case basis. General guidelines are as bioaocumulate, some studies may follows: overestimate the does needed to cause Intrahuman variation An UF of 10 is generally used to account for intrahuman variation. effects. In such cases, a modifying factor may be applied. EPA Rflfe end ATSDR MRLs However, a UF of 3 or l may be applied The current approach for MRL when a large epidemiologic study or a derivation by ATSDR is similar to the methods used by EPA to denve Reference Doses (RfDs) and Reference Concentrations (RfCs) for chronic exposures. The following table shows the difference in methodology used by ATSDR and EPA in deriving MRLs and RfDs/RfCs respectively. As with RfD methodology, in deriving MRLs. ATSDR uses UFs and MFs to account for extrapolation from animals to humans, from LOAEL to NOAEL. for intraspecies variation, for across duration extrapolation, and for professional judgement on the database. In addition, EPA uses a UF for an incomplete database (EPA 1990) whereas ATSDR incorporates scientific judgement, including an incomplete database in the MF. However. ATSDR does not extrapolate across route of exposure at this time. It is recognized that the EPA derives RIDs as part of its regulatory decision-making process. Extrapolation across route of exposure (most commonly using data horn inhalation studies to estimate levels by the oral route) is sometimes used to develop an RfD where there is inadequate route-specific information. Because MRLs may be based on more recent data and are derived using a slightly different methodology, or because MRLs are derived as a result of different scientific judgement. MRLs and RiDs (or RfCs) for the same substance are not necessarily of the same value. MRL RtO/RtC Eipoiuf du ration. Route at exposies. UFs used Human verMtty. dee ax- Acuta Mermedfete Chranc Oral............ MwMion Yee........ . Yee---------- Clwonc. Oral. intatation. Yea. Yes. LOAB.to NOAEL. Extrapo lation Yee Yea. Yes----------- Yee. OteaOon. tnoomptoH No ------ Yes. Across NO HMlMnlMMI* Yee. raises* Mn. MF - -- Yee Yee. MRLs for faasntial Trace Elements Since many nutritionally essential elements have been found to be CMA 113592 I 25878 Federal Register / Vol. 61. No. 101 f Thursday, May 23, 1996 / Notices common contaminants at soma toxic waste sites, consideration was given to both essentiality and toxicity when deriving MRLs for these substances. Special reference was given to background levels and levels that have been published as Recommended Oietary Allowances (RDA) or Estimated Safe and Adequate Daily Dietary Intakes (ESADDIs) by the Food and Nutrition Board of the National Research Council. MRLs shoutd not be in conflict with the corresponding RDAs and should be protective for all age groups. MRLs vs. Ambient Leveb Since MRLs serve as screening tools for health assessors, it is important to compare MRLs with ambient levels reported in environmental monitoring studies. When MRLs are lower than ambient levels, the relevance of the MRLs is in question, and special consideration is warranted. Future Approaches ATSDR is considering the application of physiologically based pharmacokinetic (PBPK) modeling lo enhance understanding of dose and across*route extrapolations. In addition. ATSDR is evaluating the utility of Benchmark Dose modelling, to obtain low-incidence response exposure levels calculated from mathematically fitted dose-response curves, as an adjunct to the current NOAEL/LOAEL approach in deriving MKLa. Reference* Barnes DC and Dounon M (1986). Reference Dote (RfD): Description and Use in Health Risk Assessments. Regulatory Toxicology and Pharmacology 8:471-486. EPA 1)986). Research and Development: Reference Values for Risk Assessment(ECAO-CJN-477 September 1986). EPA (1988). Recommendations for and Documentation of Biological Values for Use in Risk Assessment. (EPA 600-6-87/ 008 February 1988). EPA (1990). Interim Methods for Development of Inhalation Reference Concentrations. (EPA/600/8-90/066A August 1990). farabek AM and Segal 5A. (1994). Noncancer Toxicity of inhaled Air Pollutants: Available Approaches for Risk Assessment and Risk Management, in. Patrick DR. ed Toxic Air Pollution Handbook. New York: Van Nostrand Reinhold. pp. 529-541 Dated: May 17.1996. Claire V. Brooms. DeputyAdministrator, Agencyfor Toxic Substances and Disease Registry. ATSDR minimal Risk Levels (MRLs) for hazardous Substances (March 1996} SuOstanca name arcKiAPHTHpue , ACETONE ...................... ACROLEIN..................... ACRYI ONITRII.E ai nniw AMMONIA...................... ANTHRACENE .............. ARSENIC ....................... RFN7PNF ............. BIS (2-CHLORO-ETHYL) ETHER. BIS (CHLORO-ETHYL) ETHER. BORON BROMOOICHLOROME- THANE. BROMOFORM ............... 8ROMOMETHANE....... CADMIUM ...................... CARBON DISULFIDE .... CARBON TETRACHLORIDE. CHLORDANE ................. CAS No. Routa Duration vakrn Factors End point 000083-32-0 000007-64-1 000107-02-8 000107-13-1 000300-00-2 007884-41-7 000120-12-7 007440-38-2 000071-43-2 000111-44-4 ORAL ___________ INHALATION_______ INHALATION_______ INHALATION_______ ORAI . INHALATION_______ INHALATION---------ORAL INHALATION ORAL--------------------ORAL_____________ ORAL______________ ORAL ORAL INHALATION INHALATION ORALORAL--------------------ORAL--------------------INHALATION INHALATION INTERMEDIATE___ ACUTE---------------- INTERMEDIATE----- CHRONIC------------- INTERMEDIATE----- ACUTE --________ INTERMEDIATE___ CHRONIC------- ----- ACUTE---------------- ACUTE_____ --. INTERMEDIATE___ CHRONIC------------- ACUTE CHROMC ------ ACUTE . _____ CHROMC________ INTERMEDIATE___ tfTERMEDIATE___ CHRONIC________ ACUTE__________ INTERMEDIATE___ 0.6 mflfeqMay ... 28 ppm..... 13 ppm --------- -- 13 ppm__________ ZmgfegMay -- -- 0.00006 ppm _ 0.000008 ppm_____ 0.0005 myfcyday -- 0.1 ppm__________ 0.1 mgfejKhty.... 0.01 mgAcg/day------0.04 mgftgfday 0.002 mgfeg/day....._ 0.00003 m^HgAtay.... 0.5 ppm_____ _____ 0.3 ppm . 0.3 mqfeaiMay___ _-- 10 m^tagMy____ ... 0.003 mgfepAMy___ 0.06 ppm___ --.-- 0X2 ppm---------- 300 Hepatic9 flennikupral 100 Haurtilnipcal. 100 NfluroiOQinL 100 HamatntogKal. 100 Ocular. 1000 Raaptratcry. 100 HamatotogmaL 10 Naurotogeal. 100 Developmental. 1000 Raproducnva. 100 HemaJotagwaL 1000 1000 Hepatic. 100 Raapvmry. 10 RaapMfery. 100 Othar. 100 Hapailc. 3 Dermal. 300 Immunological. 1000 OOOf ffVpiL 000642-68-1 INHALATION INTERMEDIATE___ 0.0003 ppm----------- 100 Bipnfevyi 007440-42-8 ORAI 000075-27-4 ORAL MTERMEDIATE___ 0.01 mgfegMay------- ACUTE 0X4 mpifepttay____ 1000 DvMlopniiMii 1000 h^muCs 000075-2S-2 000074-83-0 007440-0-8 000075-15-0 000068-23-5 ORAL ORAI................... ORALINHALATION_______ INHALATION INHALATION ORAL INHALATION ORAL--------------------INHALATION_______ ORAL--------------------INHALATION_______ CHRONIC________ ACUTE__________ CHRONIC ACUTE __________ INTERMEDIATE___ CHRONIC INTERMEDIATE___ CHRONIC- -- CHRONIC CHROMC________ ACUTE---------------erunt .................. 0X2 mgfegfday-- 0J mpitpday 0.2 mgAtgMay-------- 0.06 ppm---------- 0.06 ppm_________ 0.006 ppm ------------ 0.003 mgftQAMy----- 0.0002 moAn*_____ 0.007 rngfeghfey___ 0.3 ppm ----- 0.01 mgAtpttty------- A9 p|M ...... . 1000 RanalAJrfeafy 100 NuraiogicaL 100 c. 100 NturaiogU. 100 MMQiOQBlL 100 Namtogxal. 100 QHboMM. 10 RanalfUrinary. 3 RanaVUrfeary. 30 HaamgicN. 300 Hvptttc. 300 iimMllR 000067-74-8 INHALATION ORAL--------------------ftAAl INHALATION --___ INHALATION_______ ORAL INTERMEDIATE___ ACUTE__________ INTERMEDIATE___ INTERMEDIATE----CHRONIC___ ACUTE ---------------- 0X6 ppm -- 0.02 mgfegAfey -- 0.007 mgfegMay___ 0.0002 mgyin* 0.00002 mgfm*------- 0.001 rngfegMiy ---- 100 HipaHCe 300 100 Hapahc. UrMMpkanifce. 100 1000 Hepabc. 1000 UVWufjnMrea- CMA 113593 Federal Register / Vol, 61, No. 101 / Thursday. May 23, 1996 / Notices 2S879 ATSDR Minimal .^isk levels (MRLs) For Hazardous Substances--Continued [March 199| Substance name CAS No. Route Duration value Factors End pom CHLORFENVINPHOS ... 000470-90-6 1 CHLOROBENZENE ...... rwi nfinniRRDMnMP* THANE. 000108-90-7 000124--48--1 CHLOROETHANE ........ 000075-00--3 r.m nRnFHRU 000067-66-3 CHLOROMETHANE ..... 000074-87-3 DRPYRIPOS 002921-88-2 CHROMIUM, HEXAVALENT. 018540-29-9 rnflAt t r.BFSfM , MFTA. OBFROt ORTHO. OBFROI , BABA. CYANIDE ....................... CYCLOTETRAMETHYL- UlsC TETRANITRAMINE. (M0108-39-4 000106-44-6 000067-12-6 002691-41-0 CYCLOTRIMETHY LENETRINITRAMINE (RDX). DOT P,P'. 000121-82-4 % 000060-29-3 DI(2-ETHYLHEXYL) PHTHALATE. 000117-81-7 0J-N-6UTYL PHTMAL- 000084-74-2 ORAL......................... ORAL......................... ORAL ..................... ORAL......................... ORAL......................... ORAL......................... ORAL......................... ORAL ......... INHALATION ............. INHALATION ............ INHALATION ............. INHALATION ............ INWA| ATION ORAL ................ ORAL......................- ORAI INHALATION............ INHALATION............ INHALATION............ ORAI. ...... INHALATION..... ....... INHALATION---------- INHALATION INHALATION............. ORAI .................. OPA| ORAL__ ......._______ ORAL_________ ....... ORAL--------------------- ORAL..................... . ORAL--------------------- ORAL ........ ................ ORAL__ . ORAL ORAL______________ ORAL...... ........... __ . oral *11111111111 n> <---- INTERMEDIATE....... CHRONIC.................. ACUTE ...................... INTERMEDIATE....... CHRONIC.................. INTERMEDIATE....... ACUTE ...................... CHRONIC.................. ACUTE ...................... INTERMEDIATE....... ACUTE ...................... INTERMEDIATE....... CHRONIC.................. ACUTE ...................... INTERMEDIATE ....... CHRONIC.............. ACUTE ....... .............. INTERMEDIATE....... CHRONIC_________ ACUTE .................. CHRONIC_________ INTERMEDIATE____ CHRONIC................. INTERMEDIATE____ ACUTE___ "____ ACUTE ....___ _ ACUTE ______ ____ _ INTERMEDIATE-----ACUTE____________ INTERMEDIATE------ ACUTE __ INTERMEDIATE____ ACUTE ...................... INTERMEDIATE____ ACUTE _____ ______ INTERMEDIATE INTERMEDIATE------ 0.0006 mgikg/aay..... 0.000 mykg/day....... 0.002 mg/kg/day....... 0.002 m^k^day....... 0.002 rng/kg/dey....... 0.4 m^k^day........... 0.04 mg/kgtday......... 0.03 mg/k^day......... 1300 ppm .................. 76 ppm ...................... 1 ppm .......... ............ 0 06 ppm 0.02 ppm ................... 0.3 mglkg/day........... 0.1 nngkydey ........... 0.01 mglk^day_____ 0.5 ppm ---------- 0.4 ppm ...... 0.4 ppm----------------n 000 mglkgMfy .... 0.00002 mgW' 0.00002 m^m> 0*00002 mQfrrP_____ nnnnn* mo/m*......... 0.06 mpWVday ,, ... O.flft 0.06 mqlkpflday . a06 gnvkgMay-------0.1 mgftgAMy ,,--.-- 0.06 mgftgrdey_____ 0.06 mgfcgtaay --__ 0.03 mgifcQMwr-------0.0006 m^Vday__ _ 0.0006 mgfegttey...... 1 inQrRDrOn .............. 0.4 mgfcgMey -- (L6mgftgAy---------- DI-N-OCTYL PHTOAL- 000117-84-0 ORAL.............. .......... ACUTE 2 ............-- 100 100 1000 1000 1000 100 1000 Heoetic. Hepatic. Lympnoreticular Neurological. Hepatic. Renat/Unnary , 1000 Hepatic. 10 Neurological. 100 Body Weight. 30 Hepatic. 100 Hepatic. 100 Hepatic 100 Hepatic. 100 Hepatic. 1000 Hopatic. 100 NeurologcaJ. 100 Body Weight. 100 Body Weight. to 10 Respiratory. 10 Respiratory. to 1000 160 too 100 100 1000 flaapifrjrj 11--iwMQQEijj rieiantngrN Reproductive. NaUfQlOQKtf* 1000 Hepatic. 100 Nauratogeal. 300 1000 100 100 Reproduce*. Developmental. Hepatic. RaprodtxSNe. 100 100 Developmental. 1000 *n*a-p--s-p-ac_* DIAZINON ____________ OICHLORVOS ........ ...... DIFLORIN ...................... DIETHYL PHTHALATE DISULFOTON.......... ENDOSULFAN ENDRIN _____________ EHTYL BENZENE ____ ETHYLENE GLYCOL .... ETHYLENE OXIDE____ FLUORANTHENE FLUORENE ___________ 000333-41-6 000082-73-7 000080-67-1 000084-66-2 000298 04 4 000115-29-7 000072-20-8 000100-41-4 000107-21-1 000076-21-8 0Q0M6H1-B 000086-73-7 ORAL........ --_______ INHALATION_______ IM1ALATION_______ INHALATION_______ ORAL______________ ORAL ORAL. ORAL ORAL ***!ii**i n****+** ORAL--------------------IkMAI ATV3M INHALATION_______ ORAL. - ______ ORAL _ ORAL______________ ORAL___________ __ ORAL. ORAL _____________ ORAL.. --. INHALATION __ ____ ORAL______________ INHALATION ORAL ......................... ORAL __ _______ .... MTERMEDIATE____ ACOlfe ................... INTERMEDIATE____ CHRONIC__________ ACUTE ------- INTERMEDIATE____ ACUTE . ._ CHROMC__________ ACUTE____________ MTEMEDIATE-----ACUTE INTERMEDIATE------ ACUTE____________ INTERMEDIATE____ CHRONIC__________ INTERMEDIATE____ CHROMC__________ INTEM4EDIATE____ CHRONIC__________ INTERMEDIATE____ CHROMC__________ INTERMEDIATE INTERMEDIATE INTERMEDIATE____ 0.0002 mgfogMey -- 0002 ppm 0.0003 ppm 0.00006 ppm---------(L004 mpkgrday____ 0.0C3 mgfcgWay-----0.00007 m0WMy <LOOOO6mgA0dar -- O .... .. 0.006 2E-4mgm*_______ 0.001 mgtcgMey-----96-6 mgftgMRr-----oc 0 iiyiymf --** a002 mgfcgttay____ 0.002 mgfc^dey-----0.002 mgttgkMy .TM.. 0.0003 mgtegMey -- 0*3 ppflt ****i*iii*iiiiuiiii n np ppm ___ .. 0,4 mgfligHay . __ . 0.4 mgAgAMy______ 1000 100 100 100 1000 10 1000 100 300 300 30 30 100 100 1000 100 100 100 100 100 100 100 300 300 DeveiopmentaL HmM&QpG*. HtunloQfcM* NMQlOQlttii 11--Itc. Rapnaduettve. rnPHCi Nauratopal. riiifnino il Developmental. NtmtopRsal. lnwmnoioyi)t Hapabc Nawdogcal. Naurotofpcal. Developmental. Renai/Urmary. RanaVUnnaty. Hapaoc. IlNiabc. CMA 113594 25880 Federal Register / Vol. 61. No. 101 / Thursday. May 23, 1996 / Notices ATSDR Minimal Risk Levels (MRLs) For Hazardous Substances--Continued (Man* 19961 SuOstanca nam CAS No. Route Duration value Factors End point HEXACHLOROBENZE- 068476-30-2 INHALATION............ 000118-74-1 ORAL......................... NE. j ORAL......................... ORAL......................... HEXACHLOROBUTAOI- 000087-68-3 ORAL......................... ENE. MEXACHLOROCYCLO- 000319-85-7 ORAL......................... HEXANE, BETA-. HEXACHLOROCYCLO- 000058-89-9 ORAL......................... HEXANE. GAMMA-. HEXACHLOROETHANE 000067-72-1 ORAL......................... INHALATION............ INHALATION ................. ORAL r>BA| ........... . WvnOA7lKIF 000302-01-2 INHALATION............ ISOPHORONE............... .JP-d JET FUEL tP.7 IPTP1JP1 000078-59-1 060815-00-4 w706OO-??-T ORAL ...-.................... ORAL......................... INHALATION............ INHALATION _______ KEPONE ........................ 000143-50-0 ORAL --.............. ORAL_____________ KEROSENE ................... M KYI FNF MANfiANFSE MERCURY, INORGANIC MERCURY, METALLIC 006006-20-6 000106-38-3 007439-96-6 HZQOOO-io-T 007439-97-6 ORAL--------------------INHALATION_______ OflAI ................ ...... INHALATION ORAL .......... ORAL_____________ INHALATION_______ INHALATION____ METHOXYCHLOR......... METHYL PARATHION METHYL-T-BUTYL 000072-43-6 000298-00-0 001634-04-4 ORAL ORAL............ ORAL---------------- _ INHALATION-------------------- ETHER. INHALATION_______ INHA1ATY1N ........... METHYLENE CHLO- 000075-09-2 ORAL. ORAL__________________ ______ INHALATION-------------------- RIDE. INHALATION .. METHYLMERCURIC CHLORIDE. ORAL__________________________ 000115-06-3 ORAL. MIREX ..................................................... N-NITROSODI-N-PRO- PYLAMINE. NAPHTHALENE ........................ NICKEL ................................................. P-XYLENE ....................................... PENTACHLOROPHEN- OL. ORAL 002386-66-6 ORAI __________ _ . 000621-64-7 ORAL 000061-20-3 007440-02-0 000106-64-3 000067-66-6 INHALATION_____________ ORAL__________________________ ORAL---------------------------------------INHALATION_____________ naai ORAL_______ _____ PHENOL ........................ POLYBROMINATED BIPHENYLS. ORAL______________ 000106-66-2 ORAL_______ ______ 067774-32-7 ORAL. POLYCHLORINATED BIPHENYLS. 001336-36-3 ORAL... ... PROPYLENE GLYCOL DINITRATE. 006423-13-1 INHALATION --. . SELENIUM....................................... 007782-49-2 INHALATION_________ INHALATION_____________ DRAI SODIUM FLUORIDE ........ STYRENE ......................................... 007681-49-4 000100-42-6 ORAL.............................. - . IMHAI.ATIOM ........ ORAL__________________________ ACUTE ...................... ACUTE ...................... INTERMEDIATE....... CHRONIC.................. INTERMEDIATE....... INTERMEDIATE....... ACUTE ...................... INTERMEDIATE-----ACUTE ...................... INTERMEDIATE....... AniTF INTERMEDIATE....... INTERMEDIATE____ INTERMEDIATE-----CHRONIC..... ........... INTERMEDIATE____ CHRONIC ACUTE ...................... INTERMEDIATE____ CHRONIC__________ INTERMEDIATE____ INTERMEDIATE________ CHRONIC... ______ ACUTE INTERMEDIATE-----------ACUTE----------------------------------CHRONIC----------------------------ACUTE----------------------------------INTERMEDIATE____ CHRONIC__________ ACUTE INTERMEDIATE-----------CHROMC_____ __ _ ACUTE____ __________ INTERMEDIATE________ ACUTE INTERMEDIATE________ CHROMC. ACUTE _______________________ INTERMEDIATE________ CHROMC ACUTE------------------------- -- CHROMC__________________ ACUTE ~ .. INTERMEDIATE________ INTERMEDIATE________ ACUTE ...................... ACUTE----------------------------------- INTERMEDIATE____ Arum: ACUTE __ .__________ CHROMC__________________ ACUTE wrtwii miiMiimu INTERMEDIATE------------CHROMC__________________ CHunaar CHROMC__________________ CHROMC_______ ________ INTERMEDIATE________ 0.02 mg/mi............... 0.006 m^k^day....... 0.0003 mglkglday..... 0.00002 m^kg/day .... 0.0002 mg/k^day..... 0.0003 mg/kg/day..... 0.01 m^qyday......... 0.00004 mgfeg/day.... 0.5 ppm ..................... 0.09 ppm ....... ........... 0.1 mgAgAMy........... 0.01 mglitg/Oaif......... 0.0002 ppm ............... 3 mg/kQ/day............... 0.2 mgftgftMy............ 9 ..................... 0.3 mg/m*...... ,,......... 0.01 mgfttg/day 0.0006 nxyktybey..... 0.0006 mgik^day..... 0.01 mg/itH________ 0.6 mgAffiMy______ 0.0003 mg/rn*---------- 0.007 mgAcg/day 0.002 mgfcQ/day-----0.00002 mgmP-------0.000014 mg/m-----0.02 mgfcg/day.......... 0.02 mflfcgway-------- 0.0003 mg/kg/day___ 2 ppm +<**--*****,**-. 0.7 ppm . ----------0.7 ppm__________ * 0.4 mgWdey---------- 0l3 mgftg/day 0.4 ppm----------------- 0.03 ppm ----- 0.00012 momomt.... 0.00012 mg/kg/ctoy -- 0.0006 mgikg/dey___ 0.096 mg/kg/day------ 0.002 ppm-------------- 0.06 mgdtg/day_____ 0.02 mgikgAMy-------0.00004 mgrtn* ,,TM,, 1 mglhgMRr -- 0.006 mgAtg/tMy------ 0.001 mgftp/day____ OJmgAg/dqr---------0.01 mg/kg/day-------- 0.00002 m^kg/day.... 0*003 ppm ................. 0.00004 ppm 0.00004 ppm----------0.002 mg/k0dty TM.. 0.06 mgftg/ctay-------0.06 ppm---------------02 mgAtg/day---------- 1000 Neurologai. 300 Developmental. 300 Reproductive. 1000 Developmental. 1000 Renal/Unnary. 300 Hepatic. 300 Neurological. 300 100 100 100 100 1000 100 1000 300 300 100 100 100 1000 1000 100 100 100 100 100 1000 1000 100 100 Immundo^eal. Neurological. Respiratory. Hepatic. Hepatic. Hepatic. Other. Hepatic. Hepatic. Hepatic. Neurotognai. RenatfUnnary Renal/Unnary. Hepatic. HepNic. NauralogBaL Renal/Unnary. Renel/Uhnary. Developments. NOUfQiQQiCfll. Reproductive. Reproductive. Naurotogwal. Ntuortopetf. 100 Nttf0i0Qici)i 100 Renal/Urinary. 100 N**otogc4. 300 HepaPc. too Heuroiogcal. 1000 Hepatic. 100 Hepatic. 10 DevNopmentN 10 Dvwiopmintal. 100 1 laptic. 100 rmpnc* 1000 1000 300 100 100 1000 NnjnlOQttlr Nauroiopctf* Hepatic. Rupiniofy DavetapmantaL 1000 Hepatic. 100 OlvUOpflMMlL 100 Endaenra. 300 10 NnraloQictf* 1000 1000 10 10 100 1000 Hymokyii HmMntofldL DeimaL MututoiKaimii. Hmrtiogal. HtpSbC CMA113595 Federal Register / Vol. 61, No. 101 / Thursday. May 23, 1996 / Notices 258*1 ATSDR Minimal Risk Levels (MRLs) For Hazardous Substancfs--Continued [Mart* 1996] Sufistanca name CAS No. Route Duration Value | Factors End point TETRACHLOROETHYLE IE000127-18--4 INHALATION ............. ACUTE ...................... 0.2 ppm .................... TETRACHLOROETH- YLENE. INHALATION............. CHRONIC................. 0.04 PPM ORAL......................... ACUTE ...................... 0.5 m^k^day........... TITANIUM TETRA- 007550-45-0 INHALATION ............ CHRONIC.................. 0.001 mg/m3 ............ CHLORIDE. TOLUENE ....... TDTAI XYI FNFS ......... 0001108-88-3 001330-20-7 INHALATION............ INHALATION ............ ORAL......................... ORAL......................... INHALATION............. ACUTE ...................... CHRONIC................. ACUTE ...................... INTERMEDIATE....... ACUTE ................... 3 ppm 1 ppm ................ ....... 0 fl mg/lrg/rtay .......... 0.02 mg/kg/day......... 1 ppm INHALATION INHALATION INTERMEDIATE CHRONIC 0.7 ppm ..................... 0 i ppm .................... TDXAPHENE ................. TRICHLOROETHYLENE OOBOOI-35-2 000079-01-6 ORAL......................... ORAL ........... ............ DBA!, INHALATION INHALATION............. ORAI, ................... INTERMEDIATE....... ACUTE ...!.................. INTERMEDIATE ACUTE ...................... INTERMEDIATE ACUTE ...... 0.2 mg/kg/day........... ft (106 ....... ft AA1 mgArgMay ....... O ppm ......... 0.1 ppm 0.5 mgjkgJriBy ........ ORAL INTERMEDIATE____ ft ftA9 mgArg/riay VANADIUM .................... 007440-62-2 INHALATION..... ....... ACUTE ......... ............ 0.00(B mg/m* VINYL ACETATE ........... VINYL, CHLORIDE....... 000106-06-4 000076-01-4 ORAL........... ............. INHALATION_______ INHALATION_______ INHALATION ORAI, INTERMEDIATE____ INTERMEDIATE____ ACUTE ................ INTERMEDIATE____ CHRONIC ........... 0.003 mgflqyray....... Q Qi ppm 0 fgem ............. ft.Oft ppm Aftnrra wuntoMai 7INC 007440-66-6 ORAL ......................... INTERMEDIATE .. ORAI....... .................... CHRONIC. n i mgkgM+ey , 1,1,1- 000071-66-6 INHALATION_______ ACUTE____________ 2 ppm --........ TRICHLOROETHANE. 1.1Z2-TETRA- INHALATION ,, ,, . INTERMEDIATE .. 0.7 ppm 000079-34-6 INHALATION_______ ACUTE ................... 1 pirn-------------------- CHLORO-ETHANE. INHALATION_______ INTERMEDIATE____ 0.4 ppm------,,---~... ORAL ACUTE ...................... 0.3 mQAgfcMy ORAL......................... INTERMEDIATE ..... OJi mg<liyWEy __ __ 1,1 ,2-TRI-CHLORO- ORAL_________ . CHRONIC_________ 0.3 mQikQ/day---------000079-00-6 ORAL......................... ACUTE ___________ ETHANE. 1,1-DI-CHLORO- ORAL--------------------- INTERMEDIATE____ 0.04 mgNg/day ...--__ 000076-36-4 INHALATION_______ INTERMEDIATE____ 0.02 ppm________ ... ETHENE. 1,1 -DI-METHYL-HYDRAZINE. ORAL______________ CHRONIC 0.009 mgStg/day------ 000067-14-7 INHALATION .... INTERMEDIATE____ 0.000009 ppm--------- 1,2.3-TRLCHLOflO- INHALATION CHRONIC-;________ 0.000009 ppm--------- 000006-18-4 INHALATION_______ ACUTE ____________ 0.0003 ppm PROPANE. 1Z-DI-BROMO-3- ORAL 000006-12-6 MHALATION INTERMEDIATE____ 0.06 nnAoWay-------INTERMEDIATE____ 0.0002 ppm________ CHLORO-PRO-PANE. 1Z-OI-CHLORO-ETHANE. ORAL. 000107-06-2 INHALATION INTERMEDIATE------ 0.002 mgftgMey-----ACUTE _______---- (L2ppm___________ INHALATION CMROMC................ 02 osm ............... ORAL . __ INTERMEDIATE 0l2 mtAW'day 12-DI-CHLOROETHENE. CIS-. 000166-60-2 ORAL ACUTE____________ 1 ............... ORAL-------------------- INTERMEDIATE____ OJmqAgWy______ 1J2-DI-CHLOROETHENE, TRANS-. 1Z-OI-CHLORO-PRO- 000156-60-6 INHALATION ACUTE____________ 02 ppm----------------- INHALATION INTERMEDIATE n.9 ppm __ __ _ ORAL--------------------- INTERMEDIATE_____ 0-2nigg*My 000078-67-6 INHALATION Amrp ___ __ 0,06 ppm - - - ---- PANE. INHALATION_______ INTERMEDIATE____ 0007 ppm_________ ORAI inns 0.1 1,2-04-METHYL-HYDRAZINE. ORAI______ __ ______ rr-,-T-T--T........... ORAL______ . 000640-73-6 ORAL __ INTERMEDIATE____ CHRONIC__________ INTERMEDIATE------ O07mofegMer_____ 009 mgikpttay-------00006 m^day___ 10 Naurotagwai. 100 1000 Development. 90 Respiratory. 30 30 300 300 Neurological. 100 300 100 1000 Ramai/I Innary 1000 Hpattc. 100 30 300 100 too too 100 RanaVUrmary. 100 too vir> 3 3 1 iRumipigai--1 100 NatxotopeaL 100 10 Neurotogm. 300 Hepatic. 100 300 Unity 300 Body Wwgrt 100 NaurotogsaL 100 100 Htptfie. 1000 Hipsttc 1000 1 Upmr 1000 HtpfltiC* 100 Raapamory. 100 nB>DC. 100 n^BQUQivV. 1000 100 300 300 100 n^roductNe. tffwwnfliojltii `` Ranal/Unnary- 100 HOTMDtoffCaL 1000 H^WttCe 1000 100 ll^ettc. 1000 1000 1000 1000 1000 1000 RMpMvy. Niuraio^ciL Hapatic. Hapettc. CMA113596 1 2S882 Federal Register / Vol. 61. No. 101 / Thursday. May 23, 1996 / Notices ATSDR Minimal Risk Levels (MRLS) for Hazardous Substances--Continued [Maren 1996] SuDstance name CAS No. Route Duration value . -j.ni.rMi nun. PROPENE. 1.3-Di-NiTRO-BENZENE t d-Hl-HHl DRO-RFN- 000542*75-6 000099-65-0 000106--46-7 INHALATION ............ INHALATION ............. ORAL......................... ORAL......................... INHALATION ............. INTERMEDIATE....... CHRONIC.................. ACUTE ...................... INTERMEDIATE....... INTERMEDIATE....... 0.003 ppm ................. 0.002 ppm .... .... 0.008 mgikg/oay .... 0.0006 mgfegmay..... 0.2 ppm .................... ZENE. 1 -METHYLNAPHTHA- ORAL......................... INTERMEDIATE....... 0.1 mgftfFday........... 000090-12-0 ORAL......................... CHRONIC.................. 0.07 mgriqyday......... LENE. 057117-31-4 ORAL ....................... ACUTE ...................... 0.000001 m^tyday CHLORO-DI-BENZO- FURAN. ORAL INTERMEDIATE....... ft 00WW03 rntyHy 001746-01-6 ORAt ~ ACHLORO-DIBENZO- ....... . ACUTE' day. 0.0000001 mgtydey P-DIOXIN. ORAL......................... INTERMEDIATE____ 0.000000001 mg/kgf (My. ORAL......................... CHRONIC_________ 0.000000001 mgfkQl 2.4,6-TRI-CHLOROPHENOL. 2,4,6-TRI-NITROTOL- <*y. 000088-06-2 ORAL......................... INTERMEDIATE____ 0.04 mgtagMBy-------000118-98-7 ORAL......................... INTERMEDIATE____ 0.0006 mflbflMay ... UENE. 2 4-OI-NITRO-PHENOL 2;4-oi-nitro-toluene 2,6-DI-NITRO-TOUJENE 4.4*-METHYL-ENE-BIS (2-CHLOROANILINE). 4.6-OI-NITRO-CLCRE- SOL. 000061-28-6 666121-14-2 000606-20-2 000101-14-4 ORAI ................... ORAL______________ ORAL______________ ORAL ORAL ORAL______________ AraiTF ........ ............ ACUTE ............ INTERMEDIATE____ CHRONIC_________ INTERMEDIATE____ CHRONIC ----------- 0.01 m^gWiy 0.06 mgifcQMay_____ 0.06 mQlkpWay_____ 0.002 ____ a04 mgfrgMiy_____ 0.003 mgfegfoey____ 000634-62-1 ORAL--------------------- ACUTE____________ a004 mgfctfday____ ORAL__________ _. INTERMEDIATE____ 0.004 mgftgMey____ F*aon . End point 100 Respiratory. 100 100 1000 100 Respiratory Reoroductive Hematoto^cai. Hepatic. 100 Hepatic. 1000 Respiratory. 3000 Immunological. 3000 Hepatic. 1000 Hapatic. 1000 Reproductive. 1000 R*producve. 100 Reproductive. 1000 100 1000 100 100 100 3000 twnmmmJ&Gm* f^pioductwi. HCMlOtQQicA Niuwio^cil. 100 Heuretogcal. 100 Namiopml. IFR Doc. 96-12991 Filed S-22-96; 6:45 ami SIUJM COM =ood and Drug Adminlatretion Advisory Committee; Science Board to he Food and Drug Administration; -"ormation of a Subcommittee agency: Food and Drug Administration. HHS. action: Notice. summary: The Food and Drug Administration (FDA) is announcing the formation of a subcommittee of the Science Board to the Food and Drug Administration (Science Board). This subcommittee has been established to address issues related to science and research in FDA. The subcommittee's preliminary recommendations will be presented to the FDA Science Board for full public discussion at a future Science Board meeting. FOR FURTHER INFORMATION CONTACT: Susan A. Homire, Office of Science (HF-33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20657, 301-827-3340. atMFI SllfTARY --tOWMAHON: The Food and Drug Administration (FDA) is announcing the formation of a subcommittee to the Sdence Board to the Food and Drug Administration. This subcommittee has been established to ddw Issues related to tcienoa and reaaairh in FDA. The subcommittee will meet several times over the next 6 to 9 months to develop prellminaiy recommendadone for the Science Board on a procMS for review of msaaich programs within FDA. During this period there will be opportunities for public comment; these opportunities will be announced in the Federal Kagfctar at least 15 daya prior to each schmiuled public meeting. The subcommittee's preliminary recommendation* will be presented to the Science Board for lull public discussion at a future Sdence Board meeting. This nodes is issued under the Federal Advisory Committee Act of October 6,1972 (Pub. L 92-463 (5 U.S.C. app. 2)). Dated: May 16.1996. Mkfcasi A. Friedraan, DeputyCommigMioiwfor Opmtioiu. (PR Doc. 96-12877 Filed 5-22-96:5:45 ami Inee--gHonaf Biological Product Trials; Proeadur* to Monitor CtMeal nOVB rniQIWi MQT19 w nWWV Commlttoa and Regueet for AtMNCV: Food and Drug Administration, HHS. action: Nodes. SUMSARY: The Food and Drag Admlnistradoo (FDA) is announcing a meeting of the clinical hold review committee, which review* the clinical hold order* that the Center for Biologies Evaluation and Research (CBER) has placed on certain investigational biological product trials. FDA is inviting any interested biological product company to use this confidential mechanism to submit to the committee for its review the name and number of CMA113597