Withdraw from Consideration: At any point in the process, the committee may determine not to proceed with the development of a TLV® or BEI® and withdraw it from further consideration. Substances or physical agents that have been withdrawn from consideration may be reconsidered by placement on the Under Study list (step 1 above).
Summary: There are several important points to consider throughout the above process:
- The appropriate method for an interested party to contribute to the TLV® and BEI® process is through the submission of literature that is peer-reviewed and public. ACGIH® strongly encourages interested parties to publish their studies, and not to rely on unpublished studies as their input to the TLV® and BEI® process. Also, the best time to submit comments to ACGIH® is in the early stages of the TLV® and BEI® Development Process, preferably while the substance or agent is on the Under Study list.
- An additional venue for presentation of new data is an ACGIH®-sponsored symposium or workshop that provides a platform for public discussion and scientific interpretation. ACGIH® encourages input from external parties for suggestions on symposium topics, including suggestions about sponsors, speakers and format. ACGIH® employs several criteria to determine the appropriateness of a symposium. A key criterion is that the symposium must be the most efficient format to present the committee with information that will assist in the scientific judgment used for writing the Documentation and in setting the respective TLVs® or BEIs®. A symposium topic should be suggested while the substance/agent is under study, as symposia require considerable time, commitment, and resources to develop. Symposium topic suggestions submitted while a substance is on the NIC will be considered, but this is usually too late in the decision-making process. A symposium topic will not be favorably considered if its purpose is to provide a forum merely for voicing opinions about existing data. Rather, there must be on-going research, scientific uncertainty about currently available data, or another scientific reason for the symposium. Symposium topic suggestions should be sent to the ACGIH® Science Group (firstname.lastname@example.org).
- ACGIH® periodically receives requests from external parties to make a presentation to a committee about specific substances or issues. It is strictly by exception that such requests are granted. While there are various reasons for this position, the underlying fact is that the committee focuses on data that have been peer-reviewed and published and not on data presented in a private forum. A committee may grant a request when the data is significantly new, has received peer review, is the best vehicle for receipt of the information, and is essential to the committee's deliberations. The presentation is not a forum to merely voice opinions about existing data. In order for a committee to evaluate such a request, the external party must submit a request in writing that, at a minimum, addresses the following elements: (a) a detailed description of the presentation; (b) a clear demonstration of why the information is important to the committee's deliberations; and (c) a clear demonstration of why a meeting is the necessary method of delivery. This request must be sent to the ACGIH® Science Group (email@example.com).
Also, the committee may initiate contact with outside experts (a) to meet with the committee to discuss specific issues or to obtain additional knowledge on the subject, and (b) to provide written input or review of a Documentation. This is only done on an as needed basis, and not as a routine practice.
- ACGIH® does not commit to deferring consideration of a new or revised TLV® or BEI® pending the outcome of proposed or ongoing research.
Important dates to consider throughout each calendar year of the TLV®/BEI® Development Process:
- Public comments are accepted. See Note below.
- Committees meet.
Note: It is recommended that comments be submitted as early as practical, and preferably no later than May 31st to allow sufficient time for their proper consideration/review. This is particularly important for an NIC TLV®/BEI®.
Important Notice: The comment period for an NIC or NIE draft Documentation and its respective TLV(s)®, notation(s), or BEI(s)®, will be limited to a firm 4-month period, running from February 1 to May 31 of each year. (See Important Notice, step 3 above.)
Fourth Quarter: *
- TLV®/BEI® Committees vote on proposed TLVs®/BEIs® for NIC or final adoption.
- ACGIH® Board of Directors votes on ratification of TLV®/BEI® Committee recommendations.
* These actions typically occur early in the fourth quarter, but may occur during other periods of the quarter or year.
Endnote: Sample permission statement granting ACGIH® authorization to use, cite, and release unpublished studies:
[Name], [author or sponsor of the study**] grants permission to ACGIH® to use and cite the documents listed below, and to fully disclose them to parties outside of ACGIH® upon request. Permission to disclose the documents includes permission to make copies as needed.
Example: Joseph D. Doe, PhD, co-author of the study, grants permission to ACGIH® to use and cite the document listed below, and to fully disclose this document to parties outside of ACGIH®. Permission to disclose the document includes permission to make copies as needed.
"Effects of Quartz Status on Pharmacokinetics of Intratracheally Instilled Cristobalite in Rats. March 21, 2003." **This statement must be signed by an individual authorized to give this permission, and should include contact information such as title and address.
Last Revised April 2012
Introduction to the Chemical Substances TLVs®
General Information. The TLVs® are guidelines to be used by professional industrial hygienists. The values presented in this book are intended for use only as guidelines or recommendations to assist in the evaluation and control of potential workplace health hazards and for no other use (e.g., neither for evaluating or controlling community air pollution; nor for estimating the toxic potential of continuous, uninterrupted exposures or other extended work periods; nor for proving or disproving an existing disease or physical condition in an individual). Further, these values are not fine lines between safe and dangerous conditions and should not be used by anyone who is not trained in the discipline of industrial hygiene. TLVs® are not regulatory or consensus standards.
Definition of the TLVs®. Threshold Limit Values (TLVs®) refer to airborne concentrations of chemical substances and represent conditions under which it is believed that nearly all workers may be repeatedly exposed, day after day, over a working lifetime, without adverse health effects.
Those who use the TLVs® MUST consult the latest Documentation to ensure that they understand the basis for the TLV® and the information used in its development. The amount and quality of the information that is available for each chemical substance varies over time.
Chemical substances with equivalent TLVs® (i.e., same numerical values) cannot be assumed to have similar toxicologic effects or similar biologic potency. In this book, there are columns listing the TLVs® for each chemical substance (that is, airborne concentrations in parts per million [ppm] or milligrams per cubic meter [mg/m3]) and critical effects produced by the chemical substance. These critical effects form the basis of the TLV®.
ACGIH® recognizes that there will be considerable variation in the level of biological response to a particular chemical substance, regardless of the airborne concentration. Indeed, TLVs® do not represent a fine line between a healthy versus an unhealthy work environment or the point at which material impairment of health will occur. TLVs® will not adequately protect all workers. Some individuals may experience discomfort or even more serious adverse health effects when exposed to a chemical substance at the TLV® or even at concentrations below the TLV®. There are numerous possible reasons for increased susceptibility to a chemical substance, including age, gender, ethnicity, genetic factors (predisposition), lifestyle choices (e.g., diet, smoking, abuse of alcohol and other drugs), medications, and pre-existing medical conditions (e.g., aggravation of asthma or cardiovascular disease). Some individuals may become more responsive to one or more chemical substances following previous exposures (e.g., sensitized workers). Susceptibility to the effects of chemical substances may be altered during different periods of fetal development and throughout an individual's reproductive lifetime. Some changes in susceptibility may also occur at different work levels (e.g., light versus heavy work) or at exercise — situations in which there is increased cardiopulmonary demand. Additionally, variations in temperature (e.g., extreme heat or cold) and relative humidity may alter an individual's response to a toxicant. The Documentation for any given TLV® must be reviewed, keeping in mind that other factors may modify biological responses.
Although TLVs® refer to airborne levels of chemical exposure, dermal exposures may possibly occur in the workplace (see "Skin" in Definitions and Notations, page 71).
Three categories of TLVs® are specified: time-weighted average (TWA); short-term exposure limit (STEL); and a Ceiling (C). For most substances, a TWA alone or with a STEL is relevant. For some substances (e.g., irritant gases), only the TLV–Ceiling is applicable. If any of these TLV® types are exceeded, a potential hazard from that substance is presumed to exist.
Threshold Limit Value—Time–Weighted Average (TLV–TWA). The TWA concentration for a conventional 8-hour workday and a 40-hour workweek, to which it is believed that nearly all workers may be repeatedly exposed, day after day, for a working lifetime without adverse effect. Although calculating the average concentration for a workweek, rather than a workday, may be appropriate in some instances, ACGIH® does not offer guidance regarding such exposures.
Threshold Limit Value—Short-Term Exposure Limit (TLV–STEL). A 15-minute TWA exposure that should not be exceeded at any time during a workday, even if the 8-hour TWA is within the TLV–TWA. The TLV–STEL is the concentration to which it is believed that workers can be exposed continuously for a short period of time without suffering from 1) irritation, 2) chronic or irreversible tissue damage, 3) dose-rate-dependent toxic effects, or 4) narcosis of sufficient degree to increase the likelihood of accidental injury, impaired self-rescue, or materially reduced work efficiency. The TLV–STEL will not necessarily protect against these effects if the daily TLV–TWA is exceeded. The TLV–STEL usually supplements the TLV–TWA where there are recognized acute effects from a substance whose toxic effects are primarily of a chronic nature; however, the TLV–STEL may be a separate, independent exposure guideline. Exposures above the TLV–TWA up to the TLV–STEL should be less than 15 minutes, should occur less than four times per day, and there should be at least 60 minutes between successive exposures in this range. An averaging period other than 15 minutes may be recommended when this is warranted by observed biological effects.
Threshold Limit Value—Ceiling (TLV–C). The concentration that should not be exceeded during any part of the working exposure. If instantaneous measurements are not available, sampling should be conducted for the minimum period of time sufficient to detect exposures at or above the ceiling value. ACGIH® believes that TLVs® based on physical irritation should be considered no less binding than those based on physical impairment. There is increasing evidence that physical irritation may initiate, promote, or accelerate adverse health effects through interaction with other chemical or biological agents or through other mechanisms.
Excursion Limits. For many substances with a TLV–TWA, there is no TLV–STEL. Nevertheless, excursions above the TLV–TWA should be controlled, even where the 8-hour TLV–TWA is within recommended limits. Excursion limits apply to those TLV–TWAs that do not have TLV–STELs.
Excursions in worker exposure levels may exceed 3 times the TLV–TWA for no more than a total of 30 minutes during a workday, and under no circumstances should they exceed 5 times the TLV–TWA, provided that the TLV–TWA is not exceeded. The approach here is that the maximum recommended excursion should be related to the variability generally observed in actual industrial processes. In reviewing large numbers of industrial hygiene surveys conducted by the U.S. National Institute for Occupational Safety and Health, Leidel et al. (1975) found that short-term exposure measurements were generally lognormally distributed.
While a complete discussion of the theory and properties of the lognormal distribution is beyond the scope of this section, a brief description of some important terms is presented. The measure of central tendency in a lognormal distribution is the antilog of the mean logarithm of the sample values. The distribution is skewed, and the geometric mean (mg) is always smaller than the arithmetic mean by an amount that depends on the geometric standard deviation. In the lognormal distribution, the geometric standard deviation (sdg) is the antilog of the standard deviation of the sample value logarithms, and 68.26% of all values lie between mg/sdg and mg × sdg.
If the short-term exposure values in a given situation have a geometric standard deviation of 2.0, 5% of all values will exceed 3.13 times the geometric mean. If a process displays variability greater than this, it is not under good control, and efforts should be made to restore control.
The approach is a considerable simplification of the lognormal concentration distribution concept but is considered more convenient. If exposure excursions are maintained within the recommended limits, the geometric standard deviation of the concentration measurements will be near 2.0, and the goal of the recommendations will be accomplished. It is recognized that the geometric standard deviations of some common workplace exposures may exceed 2.0 (Buringh and Lanting, 1991). If such distributions are known and workers are not at increased risk of adverse health effects, recommended excursion limits should be modified based upon workplace-specific data. When the toxicologic data for a specific substance are available to establish a TLV–STEL or a TLV–C, these values take precedence over the excursion limit.
TWA and STEL versus Ceiling (C). A substance may have certain toxicological properties that require the use of a TLV–C rather than a TLV–TWA excursion limit or a TLV–STEL. The amount by which the TLVs® may be exceeded for short periods without injury to health depends upon a number of factors such as the nature of the contaminant, whether very high concentrations — even for short periods — produce acute poisoning, whether the effects are cumulative, the frequency with which high concentrations occur, and the duration of such periods. All factors must be taken into consideration in arriving at a decision as to whether a hazardous condition exists.
Although the TWA concentration provides the most satisfactory, practical way of monitoring airborne agents for compliance with the TLVs®, there are certain substances for which it is inappropriate. In the latter group are substances that are predominantly fast-acting and whose TLV® is more appropriately based on this particular response. Substances with this type of response are best controlled by a TLV–C that should not be exceeded. It is implicit in these definitions that the manner of sampling to determine noncompliance with the TLVs® for each group must differ. Consequently, a single, brief sample that is applicable to a TLV–C is not appropriate to the TLV–TWA; here, a sufficient number of samples are needed to permit determination of a TWA concentration throughout a complete cycle of operation or throughout the workshift.
Whereas the TLV–C places a definite boundary that exposure concentrations should not be permitted to exceed, the TLV–TWA requires an explicit limit to the excursions which are acceptable above the recommended TLV–TWAs.
Mixtures. Special consideration should also be given to the application of the TLVs® in assessing the health hazards that may be associated with exposure to a mixture of two or more substances. A brief discussion of basic considerations involved in developing TLVs® for mixtures and methods for their development, amplified by specific examples, is given in Appendix E.
Deviations in Work Conditions and Work Schedules.
Application of TLVs® to Unusual Ambient Conditions. When workers are exposed to air contaminants at temperatures and pressures substantially different than those at normal temperature and pressure (NTP) conditions (25°C and 760 torr), care should be taken in comparing sampling results to the applicable TLVs®. For aerosols, the TWA exposure concentration (calculated using sample volumes not adjusted to NTP conditions) should be compared directly to the applicable TLVs® published in the TLVs® and BEIs® book. For gases and vapors, there are a number of options for comparing air-sampling results to the TLV®, and these are discussed in detail by Stephenson and Lillquist (2001). One method that is simple in its conceptual approach is 1) to determine the exposure concentration, expressed in terms of mass per volume, at the sampling site using the sample volume not adjusted to NTP conditions, 2) if required, to convert the TLV® to mg/m3 (or other mass per volume measure) using a molar volume of 24.4® L/mole, and 3) to compare the exposure concentration to the TLV®, both in units of mass per volume.
A number of assumptions are made when comparing sampling results obtained under unusual atmospheric conditions to the TLVs®. One such assumption is that the volume of air inspired by the worker per workday is not appreciably different under moderate conditions of temperature and pressure as compared to NTP (Stephenson and Lillquist, 2001). An additional assumption for gases and vapors is that absorbed dose is correlated to the partial pressure of the inhaled compound. Sampling results obtained under unusual conditions cannot easily be compared to the published TLVs®, and extreme care should be exercised if workers are exposed to very high or low ambient pressures.
Unusual Work Schedules. Application of TLVs® to work schedules markedly different from the conventional 8-hour day, 40-hour workweek requires particular judgment to provide protection for these workers equal to that provided to workers on conventional work shifts. Short workweeks can allow workers to have more than one job, perhaps with similar exposures, and may result in overexposure, even if neither job by itself entails overexposure.
Numerous mathematical models to adjust for unusual work schedules have been described. In terms of toxicologic principles, their general objective is to identify a dose that ensures that the daily peak body burden or weekly peak body burden does not exceed that which occurs during a normal 8-hour/day, 5-day/week shift. A comprehensive review of the approaches to adjusting occupational exposure limits for unusual work schedules is provided in Patty's Industrial Hygiene (Paustenbach, 2000). Other selected readings on this topic include Lapare et al. (2003), Brodeur et al. (2001), Caldwell et al. (2001), Eide (2000), Verma (2000), Rouch (1978), and Hickey and Reist (1977).
Another model that addresses unusual work schedules is the Brief and Scala model (1986), which is explained in detail in Patty's Industrial Hygiene (Paustenbach, 2000). This model reduces the TLV® proportionately for both increased exposure time and reduced recovery (i.e., non-exposure) time, and is generally intended to apply to work schedules longer than 8 hours/day or 40 hours/week. The model should not be used to justify very high exposures as "allowable" where the exposure periods are short (e.g., exposure to 8 times the TLV–TWA for 1 hour and zero exposure during the remainder of the shift). In this respect, the general limitations on TLV–TWA excursions and TLV–STELs should be applied to avoid inappropriate use of the model with very short exposure periods or shifts.
The Brief and Scala model is easier to use than some of the more complex models based on pharmacokinetic actions. The application of such models usually requires knowledge of the biological half-life of each substance, and some models require additional data. Another model developed by the University of Montreal and the Institute de Recherche en Sante et en Securite du Travail (IRSST) uses the Haber method to calculate adjusted exposure limits (Brodeur et al., 2001). This method generates values close to those obtained from physiologically based pharmacokinetic (PBPK) models.
Because adjusted TLVs® do not have the benefit of historical use and long-time observation, medical supervision during initial use of adjusted TLVs® is advised. Unnecessary exposure of workers should be avoided, even if a model shows such exposures to be "allowable." Mathematical models should not be used to justify higher-than-necessary exposures.
TLV® Units. TLVs® are expressed in ppm or mg/m3. An inhaled chemical substance may exist as a gas, vapor, or aerosol.
TLVs® for aerosols are usually established in terms of mass of the chemical substance in air by volume. These TLVs® are expressed in mg/m3.
- A gas is a chemical substance whose molecules are moving freely within a space in which they are confined (e.g., cylinder/tank) at normal temperature and pressure. Gases assume no shape or volume.
- A vapor is the gaseous phase of a chemical substance that exists as a liquid or a solid at normal temperature and pressure. The amount of vapor given off by a chemical substance is expressed as the vapor pressure and is a function of temperature and pressure.
- An aerosol is a suspension of solid particles or liquid droplets in a gaseous medium. Other terms used to describe an aerosol include dust, mist, fume, fog, fiber, smoke, and smog. Aerosols may be characterized by their aerodynamic behavior and the site(s) of deposition in the human respiratory tract.
TLVs® for gases and vapors are established in terms of parts of vapor or gas per million parts of contaminated air by volume (ppm), but may also be expressed in mg/m3. For convenience to the user, these TLVs® also reference molecular weights. Where 24.45 = molar volume of air in liters at NTP conditions (25 C and 760 torr), the conversion equations for gases and vapors [ppm ↔ mg/m3] are as follows:
|TLV in ppm = || ||(TLV in mg/m3) (24.45) |
|(gram molecular weight of substance) |
|TLV in mg/m3 = || ||(TLV in ppm) (gram molecular weight of substance) |
When converting values expressed as an element (e.g., as Fe, as Ni), the molecular weight of the element should be used, not that of the entire compound. In making conversions for substances with variable molecular weights, appropriate molecular weights should be estimated or assumed (see the TLV® Documentation).
User Information. Each TLV® is supported by a comprehensive Documentation. It is imperative to consult the latest Documentation when applying the TLV®.
Additional copies of the TLVs® and BEIs® book and the multi-volume Documentation of the Threshold Limit Values and Biological Exposure Indices, upon which this book is based, are available from ACGIH®. Documentation of individual TLVs® is also available. Consult the ACGIH® website (www.acgih.org/store) for additional information and availability concerning these publications.
ACGIH® disclaims liability with respect to the use of TLVs®.
References and Selected Readings
- Brief RS; Scala RA: Occupational health aspects of unusual work schedules: a review of Exxon's experiences. Am Ind Hyg Assoc J 47(4):199-202 (1986).
- Brodeur J; Vyskocil A; Tardif R; et al.: Adjustment of permissible exposure values to unusual work schedules. Am Ind Hyg Assoc J 62:584-594 (2001).
- Buringh E; Lanting R: Exposure variability in the workplace: its implications for the assessment of compliance. Am Ind Hyg Assoc J 52:6-13 (1991).
- Caldwell DJ; Armstrong TW; Barone NJ; et al.: Lessons learned while compiling a quantitative exposure database from the published literature. Appl Occup Environ Hyg 16(2):174-177 (2001).
- Eide I: The application of 8-hour occupational exposure limits to non-standard work schedules offshore. Ann Occup Hyg 34(1):13-17 (1990).
- Hickey JL; Reist PC: Application of occupational exposure limits to unusual work schedules. Am Ind Hyg Assoc J 38(11):613-621 (1977).
- Lapare S; Brodeur J; Tardif R: Contribution of toxicokinetic modeling to the adjustment of exposure limits to unusual work schedules. Am Ind Hyg Assoc J 64(1):17-23 (2003).
- Leidel NA; Busch KA; Crouse WE: Exposure measurement action level and occupational environmental variability. DHEW (NIOSH) Pub. No. 76-131; NTIS Pub. No. PB- 267-509. U.S. National Technical Information Service, Springfield, VA (December 1975).
- Paustenbach DJ: Pharmacokinetics and Unusual Work Schedules. In: Patty's Industrial Hygiene, 5th ed., Vol. 3, Part VI, Law, Regulation, and Management, Chap. 40, pp. 1787-1901. RL Harris, Ed. John Wiley & Sons, Inc., New York (2000).
- Roach SA: Threshold limit values for extraordinary work schedules. Am Ind Hyg Assoc J 39(4):345-348 (1978).
- Stephenson DJ; Lillquist DR: The effects of temperature and pressure on airborne exposure concentrations when performing compliance evaluations using ACGIH TLVs and OSHA PELs. Appl Occup Environ Hyg 16(4):482-486 (2001).
- Verma DK: Adjustment of occupational exposure limits for unusual work schedules. Am Ind Hyg Assoc J 61(3):367-374 (2000).