Chemical Assessments: Agencies Coordinate Activities, but Additional Action Could Enhance Efforts
Published: 2014-09-29T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: With thousands of chemicals in commercial use in the United States, decision makers rely on toxicity assessment information to examine the risks these substances may pose. Several key federal agencies—including ATSDR, EPA, NIOSH, NTP, and OSHA—as well as state agencies, assess the toxicity of chemicals.
GAO was asked to review chemical toxicity assessment activities. This report (1) describes the chemical toxicity assessment activities selected federal and state agencies undertake; (2) assesses the extent to which these federal agencies' chemical toxicity assessment activities are fragmented, overlapping, or duplicative; and (3) assesses the extent to which these federal and state agencies coordinate their chemical toxicity assessment activities and challenges in doing so. GAO selected five key federal agencies that assess chemicals, and a nonprobability sample of agencies in 10 states that provide a range of assessment activities. GAO reviewed federal agency documentation and compiled summaries of chemical toxicity assessment activities and compared them with one another. GAO interviewed officials from these agencies, representatives from industry, and other stakeholders.
section_title: What GAO Found
paragraphs: The federal agencies GAO reviewed—the Agency for Toxic Substances and Disease Registry (ATSDR), the Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), the National Toxicology Program (NTP), and the Occupational Safety and Health Administration (OSHA)—undertake distinct chemical toxicity assessment activities that differ in type and purpose and are driven in part by statutory requirements; the 10 states GAO reviewed largely rely on federal agencies' assessment activities. For example, ATSDR's toxicity assessment activities include evaluating hazards at contaminated sites and NIOSH's activities include identifying potential health risks to workers. Agency officials from all 10 of the selected states told GAO that they have used assessment information produced by these federal agencies in the last 5 years. Officials from 6 of the 10 states told GAO they rely on federal assessments, and the remaining 4 said that they may produce their own assessments in some cases—for example, when a chemical is of interest to the state but is not a national priority.
The chemical toxicity assessment activities at these five federal agencies are fragmented and overlapping, but GAO did not find evidence that these activities are duplicative. Their activities are fragmented because they address the same broad area of national need—providing information on the toxicity of chemicals. The five agencies' activities overlap because some of them have similar goals—such as identifying the extent to which a chemical may cause cancer—or some target similar beneficiaries—such as the general public. GAO did not find evidence of duplication, however, because the agencies did not engage in the same activities or provide the same services to the same beneficiaries. For example, although both NIOSH and EPA develop chemical toxicity assessment information, NIOSH assesses the potential risks that chemicals pose to working-aged adults in occupational settings, such as over the course of a 40-hour workweek, and EPA assesses risks that chemicals pose to a broader population, including children, typically over the course of an entire lifetime.
Officials from all five federal agencies and 3 of the 10 states told GAO that they have coordinated their chemical toxicity assessment activities and also identified challenges. For example, some agency officials identified constraints on sharing confidential business information because of legal restrictions on dissemination of such information across agencies. The Office of Science and Technology Policy's (OSTP) National Science and Technology Council (NSTC) coordinates science and technology policies across the federal government. All executive department and agencies, whether or not they are represented on the NTSC, are to coordinate science and technology policy through it. Given that NSTC has previously facilitated federal coordination on cross-cutting topics, such as nanotechnology and pharmaceuticals in the environment, and given its purpose, an official from OSTP stated that NSTC could serve an interagency coordinating function to address certain cross-cutting challenges. By having an interagency body to address these, and any future cross-cutting challenges, the five selected federal agencies would be positioned to better coordinate their assessment activities in the most effective and efficient manner.
section_title: What GAO Recommends
paragraphs: GAO recommends that the Director of OSTP encourage the NSTC to support relevant federal agency officials' efforts to address, as appropriate, the agencies' cross-cutting coordination challenges. OSTP did not provide official written comments, but instead provided technical comments, which GAO incorporated as appropriate.

section_title: Letter
paragraphs: Thousands of chemicals are in commercial use in the United States, and  about 1,000 new chemicals are introduced into commerce each year.  These chemicals may provide a wide range of benefits to American  consumers, but exposure to certain substances, such as lead or  asbestos, may have adverse effects on human health or the environment.  Since the 1970s, Congress has enacted various laws to assess and  manage risks associated with chemical exposure, and several  government agencies have been established to assess and control  potential hazards.
Risk assessments—the characterization of the potential adverse health  effects of human exposures to environmental hazards—are a key public  policy tool for evaluating options for protecting public health and the  environment. Chemical risk assessments are a type of risk assessment  that examine risks such as the potential for a chemical to cause cancer or  the level at which a chemical may cause neurological or developmental  effects. Chemical risk assessments typically include four components:  (1) hazard identification, (2) dose-response assessment, (3) exposure  assessment, and (4) risk characterization. The first two steps—a  qualitative hazard identification, and a quantitative dose-response  assessment—are commonly referred to together as toxicity  assessments. Toxicity values are derived from dose-response  assessments. Toxicity assessments weigh available evidence regarding  the potential for a chemical to cause adverse effects in exposed  individuals and to provide, where possible, an estimate of the relationship  between the extent of exposure to a chemical and the increased  likelihood and severity of adverse effects. Toxicity assessments combined  with information from exposure assessments provide the foundation for  characterizing risk (see fig. 1).
Chemical toxicity assessments are the focus of this report and, while  many federal agencies perform chemical toxicity assessments, this report  focuses on five agencies that follow this four-step risk assessment  process: (1) the Agency for Toxic Substances and Disease Registry  (ATSDR); (2) the Environmental Protection Agency (EPA); (3) the  Centers for Disease Control and Prevention’s National Institute for  Occupational Safety and Health (NIOSH); (4) the National Institutes of  Health’s National Toxicology Program (NTP), within the Department of  Health and Human Services; and (5) the Occupational Safety and Health  Administration (OSHA), within the Department of Labor. In addition,  some state agencies develop their own toxicity assessment information.  Information derived from these assessments are used to make decisions  on a wide range of criteria, such as emissions standards for sources of  hazardous air pollutants, workplace safety and health standards, and  cleanup levels for contaminated sites.
To assess whether there may be opportunities to save federal resources  and help agencies provide more efficient and effective services, GAO  often evaluates the potential for fragmentation, overlap, or duplication  among federal programs. GAO has defined fragmentation, overlap and  duplication as shown in figure 2.
In 2009, GAO designated the need to transform EPA’s process for  assessing and controlling toxic chemicals as an area at high risk of waste,  fraud, abuse, and mismanagement or in need of broad-based  transformation. For example, in March 2008, we reported that data in  EPA’s Integrated Risk Information System (IRIS)—a human health  assessment program that evaluates scientific information on human  health effects that may result from exposure to chemicals in the  environment—was at serious risk of becoming obsolete because EPA  had not been able to keep its existing assessments current or complete  assessments of the most important chemicals of concern. In response to  our 2008 report and 2009 high-risk designation, EPA revised its IRIS  assessment process in May 2009. In December 2011, we reported that  these revisions restored EPA’s control of the process, increased  transparency, and established a 23-month time frame for its less  challenging assessments. Progress in other areas, however, has been  limited. For example, in our February 2013 update to our high risk list, we  found that EPA’s initial gains in productivity under the revised process  had not been sustained, and that EPA faced both long-standing and new  challenges in implementing the IRIS program.
You asked us to provide information on the range of federal chemical  toxicity assessment activities. Our objectives for this review are to: (1)  describe the chemical toxicity assessment activities selected federal and  state agencies undertake; (2) assess the extent to which, if at all, selected  federal agencies’ chemical toxicity assessment activities are fragmented,  overlapping, or duplicative; and (3) assess the extent to which, if at all,  selected federal and state agencies coordinate their chemical toxicity  assessment activities and the challenges, if any, associated with doing  so.
To examine these five federal agencies’ chemical toxicity assessment  activities, we reviewed publicly available information on these agencies’  activities and information from our past reports and compiled summaries  of these activities for each agency. We then submitted these summaries  to each agency to review for accuracy and incorporated their comments.  We also interviewed agency officials as necessary to clarify their  comments. We selected a nonprobability sample of 12 state agencies in  10 states that provide a range of chemical assessment activities. We  analyzed and reported interview responses using the state as the unit of  measure, as opposed to the particular agency. To examine these state  agencies’ chemical toxicity assessment activities, we conducted  structured interviews with officials in these agencies on the scope of their  chemical toxicity assessment activities in the last 5 years.
To examine these federal agencies’ chemical toxicity assessment  activities for fragmentation, overlap, and duplication, we reviewed the  summaries of agency toxicity assessment activities and agency  documentation that sets forth the scope and purpose of their chemical  toxicity assessment activities and compared them with one another and  with our definitions of fragmentation, overlap, and duplication. We also  further reviewed a nonprobability sample of inhalation toxicity values for  10 selected chemicals as developed by four of the five federal agencies  (ATSDR, EPA, NIOSH, and OSHA) and 1 of the 12 selected state  agencies, the California Environmental Protection Agency (CalEPA), that  conduct toxicity assessment activities for these inhaled chemicals. We  selected these 10 chemicals to provide a diverse representation of  organic and inorganic chemicals—the two major categories that comprise  the universe of all chemicals—with varying structures and chemical  properties, which we identified with the assistance of a GAO chemist and  a review of chemical toxicity values from federal agencies. We limited our  sample to chemicals for which the four of the five selected federal  agencies and 1 of the 12 selected state agencies had developed toxicity  values. Because this was a nonprobability sample, the information that  we obtained on these 10 chemicals is not generalizable to all chemicals.
To examine federal and state agencies’ coordination on chemical toxicity  assessment activities and any challenges they face, we administered  structured interviews to the five selected federal agencies and 12 state  agencies. For EPA, which unlike most of the other federal and state  agencies has multiple components that conduct chemical toxicity  assessments, we also interviewed officials from six program or regional  offices to determine the extent to which they coordinate their toxicity  assessment activities and identify any challenges to their efforts. In our  interviews, we asked officials from each of the five federal agencies  whether, and if so, how, their agency had coordinated with each of the  other four federal agencies within the past 5 years. The different  mechanisms through which agencies coordinate do not necessarily  indicate better quality or more effective coordination. Whether the type of  coordination mechanism affected quality or effectiveness of interagency  coordination is beyond the scope of this review. Agency responses to our  structured interviews were further evaluated by considering key practices  for collaboration and key considerations for implementing interagency  collaborative mechanisms. Appendix I provides additional information on  our scope and methodology.
We conducted this performance audit from May 2013 to September 2014  in accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Selected Federal Agencies Undertake Distinct Chemical Toxicity Assessment Activities, and Selected States Largely Rely on Federal Assessments
paragraphs: The federal agencies we reviewed undertake distinct chemical toxicity  assessment activities that differ in type and purpose and are driven  largely by agency needs derived from statutory requirements, while  officials in the 10 states we reviewed told us that they largely rely on  federal agencies’ chemical toxicity assessment activities. Officials in the  federal agencies we reviewed told us their toxicity assessments activities  include evaluating hazards at contaminated sites, identifying potential  health risks to workers, and providing information about potential toxic  chemicals to regulators. Officials in 6 of the 10 states we reviewed told us  they do not conduct their own toxicity assessments and rely instead on  existing sources of information primarily supplied by federal agencies,  while officials from the remaining 4 states told us they sometimes produce  their own assessments but more often rely on federal sources.
subsections: section_title: Federal Agencies’ Chemical Toxicity Assessment Activities Are Driven by Agency Needs Derived from Statutory Requirements and Differ by Type and Purpose
paragraphs: The toxicity assessment activities that these five federal agencies  conducted are driven primarily by agency needs derived from the  statutory authorities that created the programs. For example, several  programs are designed to provide quantitative values that can be used to  regulate chemicals, while others provide a qualitative conclusion about  the nature of a chemical that can be shared with regulatory agencies and  the public. The scope of some assessments is limited to whether the  chemical causes cancer, while other assessments look beyond cancer at  neurological, respiratory, and reproductive effects (see fig. 3).
ATSDR, a federal public health agency of the U.S. Department of Health  and Human Services, prepares toxicity assessments—called toxicological  profiles—in response to statutory requirements under the Comprehensive  Environmental Response, Compensation, and Liability Act (CERCLA).  These profiles provide interpretations of data that can be useful for  officials evaluating the chemical hazards at hazardous waste sites.  During the development of toxicological profiles, if the agency determines  that reliable and sufficient data exist to identify the specific health effects  that result from exposure to a hazardous substance, the agency will  derive Minimal Risk Levels (MRL). MRLs estimate safe levels of human  exposure, are quantitative in nature, and are not based on a  consideration of cancer effects. To address cancer, the agency issues  separate assessments that include qualitative conclusions regarding  cancer effects from human exposure to chemicals.
Although ATSDR is not a regulatory agency, CERCLA requires it to  prepare a list, in priority order, of chemicals that are most commonly  found at hazardous waste sites on the National Priorities List and which  are determined to pose the most significant potential threat to human  health. ATSDR then must prepare toxicological profiles on substances  on that list. ATSDR’s toxicological profiles typically evaluate the effects of  exposures to hazardous chemicals for three possible durations: acute (14  days or less), intermediate (15-364 days), and chronic (365 days or  more). According to ATSDR, these profiles generally take 18 to 24  months to complete. In recent years, ATSDR has typically completed six  or seven toxicological profiles each year; a total of 319 new and updated  toxicological profiles have been published or are under development.
ATSDR’s MRLs are an estimate of daily human exposure to a hazardous  substance at or below which that substance will likely not pose a  measurable risk of adverse noncancerous effects—such as neurological,  respiratory, and reproductive effects—over a specified time period. MRLs  are quantitative in nature, and, according to ATSDR’s website, are used  as screening values to allow ATSDR health assessors and others to  identify contaminants at hazardous waste sites and determine whether  further investigation is needed to protect communities from exposure.  Although MRLs do not consider possible cancer effects, the agency  endorses the use of a narrative statement that conveys the agency’s  qualitative conclusions regarding cancer effects. In this regard, ATSDR  adopts the findings for chemicals addressed by the Department of Health  and Human Services’ most recent biennial Report on Carcinogens, as  coordinated by the National Toxicology Program, to the extent available.  These are described in ATSDR’s Cancer Policy Framework, which  defines what the agency has identified as scientifically credible, internally  consistent policy positions to guide ATSDR’s activities that address the  public health implications of exposure to carcinogens.
EPA toxicity assessments are generally used to determine the levels of  chemical pollutants in the air, land, and water that would not present a  significant adverse risk to the public and environment. EPA’s ability to  effectively implement its mission of protecting public health and the  environment is critically dependent on credible and timely assessments of  the risks posed by chemicals. Such assessments are the cornerstone of  scientifically sound environmental decisions, policies, and regulations  under a variety of statutes, such as the Toxic Substances Control Act  (TSCA), Safe Drinking Water Act, and the Clean Air Act. EPA  activities are also authorized by CERCLA, the Resource Conservation  and Recovery Act, the Clean Water Act,  and the Federal Insecticide,  Fungicide, and Rodenticide Act. EPA offices provide a variety of toxicity  assessments, including both quantitative and qualitative conclusions  about cancer and noncancer effects.
According to EPA officials, three EPA program offices and two EPA  regional offices develop a variety of chemical toxicity assessments to  assist the agency in fulfilling these statutory requirements. These offices  include the following:
Office of Research and Development. The Office of Research and  Development produces two types of toxicity assessments, which are  developed through its National Center for Environmental Assessment  (NCEA). These toxicity assessments provide fundamental information  for EPA’s risk management decisions, such as whether EPA should  establish air emissions standards and water quality standards to  protect the public from exposure to particular toxic chemicals. These  two types of assessments are as follows:
NCEA’s IRIS is a human health assessment program that  evaluates scientific information on human health effects that may  result from exposure to chemicals in the environment. These  assessments are used by other EPA offices, as well as federal,  state, and local environmental agencies, and some international  regulatory bodies. IRIS assessments, which currently include  information on about 550 chemicals, undergo extensive internal  and external peer review and are developed using a process that  allows for public input. According to EPA, the importance of the  IRIS Program has increased as its program and regional offices  have increasingly relied on IRIS toxicity assessments in making  environmental protection and risk management decisions.
NCEA’s Provisional Peer Reviewed Toxicity Values (PPRTV)  provide information to support cleanup decisions at Superfund  sites. NCEA prepares PPRTVs for EPA’s Office of Solid Waste  and Emergency Response when IRIS toxicity assessments are  not available. PPRTVs receive internal review by a panel of NCEA  scientists and external peer review by independent scientific  experts, but they differ from IRIS values in that they do not  undergo as extensive a process of internal and external peer  review and public participation as IRIS assessments and are  generally completed more quickly.
Office of Chemical Safety and Pollution Prevention. Two offices  within the Office of Chemical Safety and Pollution Prevention—the  Office of Pollution Prevention and Toxics and the Office of Pesticide  Programs—also conduct toxicity assessments as follows:
The Office of Pollution Prevention and Toxics is responsible for  implementing TSCA, which gives EPA the authority to obtain more  information on chemicals and to regulate those chemicals that the  agency determines pose unreasonable risks to human health or  the environment. The office sometimes uses the hazard and  dose response information described in an IRIS toxicity  assessment for a particular chemical to develop its own  subsequent toxicity assessments. We reported in March 2013 that  officials from the Office of Pollution Prevention and Toxics told us  that IRIS assessments are generally used to estimate risks  associated with continuous exposures to a pollutant in the air or  water rather than the intermittent exposures that workers and  consumers are subject to from chemicals contained in products.
The Office of Pesticide Programs, along with state agriculture  offices, registers or licenses pesticides for sale and distribution in  the United States under the authority of the Federal Insecticide,  Fungicide, and Rodenticide Act. States may also have pesticide  licensing programs. Because pesticides must be registered by  EPA, the office reviews scientific information on pesticides  submitted by pesticide registrants and comprehensive laboratory- based data on multiple routes of exposure. The office uses this  information to conduct comprehensive risk assessments for  pesticide active ingredients, among other things.
Office of Water. EPA’s Office of Water develops a limited number of  toxicity assessments to implement the Clean Water Act and Safe  Drinking Water Act. According to Office of Water officials, because the  IRIS Program can only select and develop a limited number of IRIS  assessments at one time, the Office of Water develops its own  assessments for chemicals that have less controversy surrounding  them and take less time and staff to complete in order to address  some of its programmatic needs.
Regional offices. EPA regional offices, which are responsible for the  execution of EPA programs within their respective states and  territories; EPA officials told us that two EPA regional offices develop  chemical toxicity assessments in support of their work. For example,  officials in EPA’s Region 2 told us that they rely primarily on IRIS  toxicity values. They will also use PPRTVs, values from other federal  agencies such as ATSDR, and state toxicity values where available.  When officials needed toxicity information for a chemical for which  none was available, regional officials worked with others at EPA, NTP,  and with officials from a potential responsible party to gather toxicity  information that led to the development of a PPRTV for that chemical.  Similarly, officials in Region 9 told us that they conducted toxicity  assessment activities with ATSDR and NCEA that helped identify a  previously unknown effect of a chemical commonly found in  waterways throughout the country.
NTP is an interagency program established in 1978 to coordinate  chemical toxicity assessment activities across the Department of Health  and Human Services. NTP officials told us the program was created to  coordinate toxicity testing, strengthen the science base in toxicology,  develop and validate improved testing methods, and to provide  information about potentially toxic chemicals to health-related regulatory  and research agencies, scientific and medical communities, and the  public. NTP toxicity assessment activities include these four activities.  Under the authority of the Public Health Service Act, the NTP is required  to produce the biennial Report on Carcinogens (RoC). Although the  NTP’s primary effort is to conduct toxicological testing on chemicals, it  also performs toxicity assessments drawing on both peer reviewed NTP  research and testing information and published literature to produce  reports, such as its Office of Health Assessment and Translation (OHAT)  monographs. In addition, NTP, in coordination with EPA, the Food and  Drug Administration, and the National Institutes of Health, is active in the  development of the Toxicology in the 21st Century (Tox21) program,  which generates data that are to be provided to risk assessors to use  when making decisions about protecting human health and environment.  These activities include qualitative conclusions about chemical hazards  as follows:
Report on Carcinogens: The NTP prepares the RoC in response to  a requirement that the Secretary of the Department of Health and  Human Services publish a biennial report that contains a list of known  or reasonably anticipated carcinogens and information concerning the  public’s exposure to these substances. The Secretary delegated  responsibility for preparing the RoC to the NTP. The RoC identifies  and characterizes cancer hazards for the federal government for use  by the American people. The RoC is a science-based, public health  report that identifies agents, substances, mixtures, or exposures in the  environment that may potentially put people in the United States at  increased risk for cancer. The RoC contains qualitative information  gathered from available sources, including cancer studies on humans,  animals and on possible mechanisms of action; potential sources of  exposure to humans; and current federal regulations to limit  exposures. Substances are listed in the report as either known or  reasonably anticipated human carcinogens.
OHAT Monographs: In addition to the RoC toxicity assessments, the  NTP issues OHAT Monographs. The OHAT conducts evaluations to  assess the evidence that environmental chemicals, physical  substances, or mixtures (collectively referred to as “substances”)  cause adverse health effects and provides opinions on whether these  substances may be of concern given what is known about current  human exposure levels. The OHAT also organizes workshops or  state-of-the-science evaluations to address issues of importance in  environmental health sciences.
Tox21: NTP coordinates with several other agencies on another  toxicity assessment activity called Tox21. Tox21 pools federal  resources and expertise from EPA, NTP, the National Institutes of  Health, and the Food and Drug Administration. According to NTP,  among the goals of Tox21 are to research, develop, validate, and  translate innovative chemical testing methods that characterize  toxicity pathways, to prioritize which chemicals need more extensive  toxicological evaluation, and to develop models that can be used to  more effectively predict how chemicals will affect biological  responses.
OSHA is an agency within the Department of Labor that conducts  chemical toxicity assessments as part of its regulatory responsibilities to  promulgate and enforce mandatory occupational safety and health  standards. OSHA, created by the Occupational Safety and Health Act of  1970, has the authority to set standards for toxic chemicals, including  permissible exposure limits (PEL), which adequately assure to the extent  feasible, on the basis of the best available evidence, that no employee  will suffer material impairment of health or functional capacity even if the  employee has regular exposure during his or her working life. Standards  must be reasonably necessary or appropriate, meaning that, before  issuing a standard, OSHA must demonstrate that the chemical involved  poses a significant risk under workplace conditions permitted by current  regulations and that the new limit OSHA promulgates will substantially  reduce that risk. Moreover, the standard must be technologically and  economically feasible, better able to effectuate the purposes of the OSH  Act than any relevant national consensus standards, and use the most  cost-effective protective measures. OSHA’s analysis includes both  qualitative and quantitative components and evaluates the scientific  evidence linking exposure to a variety of adverse health effects, including  both chronic disease (such as cancer) and effects that may occur over a  shorter term.
OSHA health standards are usually directed at reducing the risk of  workers developing diseases from occupational exposure to hazardous  chemicals. According to OSHA officials, before it issues a health  regulation, OSHA reviews the best available evidence pertaining to the  adverse health effects of exposure, and evaluates the risk of these effects  from exposures allowed under the current standard, as well as the  expected impact of the new or revised standard on risk. OSHA officials  noted that, because the process of promulgating health standards is  resource-intensive and time-consuming, the number of toxicity  assessments performed by the agency is limited. Its last two risk  assessments conducted as part of its regulatory responsibilities in issuing  proposed and final rules were hexavalent chromium, which was proposed  in 2004 and finalized in 2006, and crystalline silica, which was proposed  in 2013. OSHA noted that another analysis is planned for beryllium.
OSHA’s determination of the effects an occupational exposure causes,  and which of these effects cause material impairment, is primarily  qualitative and relies on evaluation of research conducted by a wide  variety of outside organizations, both governmental (such as NIOSH) and  nongovernmental. Once OSHA has identified the health effects of  concern, the agency conducts an assessment to determine whether long- term exposure at the current PEL would pose a significant risk to workers’  health, and whether adoption of a new PEL will substantially reduce this  risk. This analysis includes both qualitative and quantitative components.  The determination that a particular level of risk is significant is a policy  and legal determination, rather than a scientific determination. OSHA also  must show, among other things, that a new PEL is technologically and  economically feasible.
NIOSH, an Institute of the Centers for Disease Control and Prevention,  develops toxicity assessments of workplace chemicals and develops  recommended standards for them under the authority of the Occupational  Safety and Health Act of 1970. NIOSH develops criteria for a  recommended standard, including recommended exposure limits (REL)  to describe levels at which no employee will suffer impaired health or  functional capacities or diminished life expectancy as a result of his or her  work experience. NIOSH publishes chemical assessment information  and recommendations for preventing exposure in documents that may  contain quantitative or qualitative assessment information on the cancer  or noncancer effects of chemicals.
NIOSH officials told us that REL development is a resource-intensive  process involving comprehensive review of the scientific literature,  statistical modeling that includes sensitivity analyses, and discussion of  the health effects of the chemical and the risk assessment process. To  date, the NIOSH Pocket Guide to Chemical Hazards lists 677 chemicals  or substance groupings, some with NIOSH RELs, 135 of which are  carcinogens. In recent years, NIOSH has conducted quantitative risk  assessments as the basis of RELs. NIOSH also recommends appropriate  preventive measures to reduce or eliminate the adverse health effects of  workplace chemicals of concern. These recommendations are then  published for consideration by OSHA for use in promulgating legal  standards.
NIOSH assessments are designed to address occupational hazards and  risks to workers rather than environmental hazards and risks to the  general public. Therefore the most relevant data and results of  occupational assessments may differ from those developed to identify  environmental hazards and risks to the general public because the  population being assessed—workers— does not include young children  and has fewer elderly or infirm individuals. NIOSH occupational  assessments also consider exposure over a working lifetime—40-hour  workweek, 52 weeks per year for 45 years—as opposed to continuous  environmental exposure.
NIOSH officials told us they use the best available data as the basis for  quantitative risk assessments. These data may be from epidemiological  studies, experimental animal studies, and/or mechanistic data in the  scientific literature. Because NIOSH has statutory access to workplaces,  many NIOSH assessments have also been based on epidemiological  investigations of workplace exposures. When NIOSH conducts  quantitative assessment using published laboratory animal data for  extrapolation to humans, the human equivalent dose associated with an  adverse effect is calculated from animal data, and risk is extrapolated to a  working lifetime concentration.
section_title: Selected States Largely Rely on Federal Chemical Toxicity Assessments
paragraphs: Officials from the 10 selected states that we reviewed generally do not  produce their own chemical toxicity assessments; instead, they generally  rely on federal chemical toxicity assessments. Officials from 6 of the 10  states we reviewed—Alaska, Arizona, Delaware, Missouri, New York,  Oklahoma—told us they have limited resources and relied on chemical  toxicity assessments produced by federal agencies. Officials from the  remaining 4—California, Minnesota, New Jersey, and Texas—told us  they sometimes produce their own chemical toxicity assessment  information, but they more often rely on federal sources. Officials in all 10  states told us that they have used data in the last 5 years from some or all  of the five federal agencies we reviewed.
Officials from California, Minnesota, New Jersey, and Texas told us that  although they have the expertise and the resources to produce their own  toxicity assessments, they still rely on data from federal agencies. For  example, an official from California told us that although the state has the  capacity to develop its own toxicity assessments, state officials still  regularly consult sources from the five federal agencies we reviewed.  Officials from Minnesota told us they evaluate existing sources of toxicity  information and sometimes recommend that an existing toxicity standard  be used while they evaluate the adequacy of that standard and whether  acceptable methods were used in deriving it. They also told us they have  the capability to develop hazard identification and dose response  analyses that may then be used to evaluate an exposure and set new  standards if necessary.
An official from New Jersey told us the state reviews the existing scientific  literature for each chemical and, if it determines that the existing toxicity  assessments—often provided by a federal agency—meet its needs, it  uses them; otherwise, it develops its own. The official told us the state  may also develop toxicity assessments for chemicals that are not national  priorities, meaning that no federal agency is currently reviewing them. For  example, this New Jersey official told us the state developed an  assessment for MTBE, a chemical that it indicated was a huge problem  for many states and for which IRIS did not have a toxicity value.
An official from Texas told us the state considers several factors in  deciding whether to develop its own toxicity values. These factors include  whether a toxicity value is available; the age of existing toxicity values;  the frequency with which a particular chemical occurs in Texas; whether it  disagrees with the scientific judgment used to derive the toxicity value;  and public input or concern about a particular chemical.
section_title: Selected Federal Agencies’ Chemical Toxicity Assessment Activities Are Fragmented and Overlapping but Are Not Duplicative
paragraphs: The chemical toxicity assessment activities at the five federal agencies  we reviewed are fragmented because they address the same broad area  of national need; they overlap because they have similar goals, and some  target similar beneficiaries. We did not find evidence that the activities at  these agencies are duplicative because they do not engage in the same  activities or provide the same services to the same beneficiaries.
subsections: section_title: Fragmentation
paragraphs: Selected federal agencies’ chemical toxicity assessment activities are  fragmented because they each address the same broad area of national  need—providing information on the toxicity of chemicals. However, while  these federal agencies’ all provide information on this same broad area,  their activities differ in type and purpose. For example, although both  OSHA and EPA develop chemical toxicity assessment information, OSHA  provides information on occupational hazards that affect workers, while  EPA provides information on environmental hazards that affect the  broader population, including children and the elderly. Also, the duration  and routes of exposure that are of interest to EPA and OSHA may differ.  For example, EPA’s IRIS Program assesses the effects of lifetime or  chronic exposure to a chemical in the environment, and OSHA assesses  the effects of occupational exposure to a chemical in the workplace over  a working lifetime, as well as shorter term exposures. For example, EPA’s  toxicity value for the chemical acrolein differs from OSHA’s values  because EPA’s value is for chronic exposure in the environment, and  OSHA’s two toxicity values are for 15-minute and 8-hour exposures in the  workplace, respectively (see app. II, which contains a table of chemical  toxicity values compared across four of the five selected federal agencies  and 1 of the 12 selected state agencies). According to OSHA officials,  OSHA is primarily concerned with exposure through dermal (skin) contact  or inhalation. According to EPA officials, several EPA Offices are  concerned with all routes of exposure (dermal, inhalation, and ingestion)  for workers and the broader population.
We have previously reported on instances of fragmentation in the federal  government. For example, in April 2014, we concluded that  fragmentation may result in inefficiencies in how the government delivers  services. In March 2011, we also reported that fragmentation has the  potential to result in duplication of resources. However, in our April 2014  report, we also found that fragmentation is, by itself, not an indication that  unnecessary duplication of efforts or activities exists. For chemical toxicity  assessments, we did not find evidence that their activities were  duplicative. For example, NTP provides qualitative information to the  public on chemicals in the environment known to be or reasonably  anticipated to be human carcinogens in its RoC. In contrast, NIOSH  provides quantitative and qualitative information to OSHA to support legal  standards on both carcinogenic and noncarcinogenic effects of workplace  chemicals in its policy documents, which is summarized in the NIOSH  Pocket Guide to Chemical Hazards.
In our March 2011 report, we also stated that there can be advantages to  having multiple federal agencies involved in a broad area of national  need. Agencies can tailor initiatives to suit their specific missions and  needs, among other things. For example, OSHA primarily focuses on  occupational health issues that affect working-aged adults exposed over  an 8-hour workday, and ATSDR is required to focus on environmental  health issues that affect the broader population, including children, the  elderly, and pregnant women, who may be exposed over longer time  periods. In addition, ATSDR has developed three toxicity values for the  chemical 1,4-dioxane, a solvent, for nonoccupational environmental  exposures (see app. II). These toxicity values differ from OSHA’s toxicity  value for the same chemical, which is intended only for exposure in the  workplace.
section_title: Overlap
paragraphs: Selected federal agencies’ chemical toxicity assessment activities overlap  because some of these activities have similar goals—such as identifying  the extent to which a chemical may cause cancer—and because some  target similar beneficiaries—such as local health authorities for use in  dealing with hazardous waste sites or the general public. However, in  March 2011, we concluded that overlapping programs may be aligned in  a way that they are complementary. For example, NIOSH toxicity  assessments are designed to address occupational hazards and the risks  to workers, rather than environmental hazards and the risks to the  general public that ATSDR assesses. The population being assessed for  occupational risks includes workers who represent a subset of the  general public, and it does not include young children and has fewer  elderly or infirm individuals. For example, NIOSH developed two toxicity  values for the chemical carbon disulfide, a solvent, for workplace  exposures, and other agencies, such as ATSDR, developed its toxicity  value for environmental exposure that affects the general public (see app.  II). NIOSH occupational assessments also consider exposure over a  working lifetime—a 40-hour workweek, 52 weeks per year for 45 years— as opposed to continuous environmental exposure.
Selected federal agencies’ chemical toxicity assessment activities also  overlap in that some of these agencies target similar beneficiaries. For  example, both EPA IRIS assessments and ATSDR toxicological profiles  are used by a broad audience, including the general public, academics,  and international groups. However, beneficiaries for these agencies also  differ. EPA’s IRIS program provides scientifically supported toxicity values  for EPA’s program offices and regions for the purpose of making  regulatory and risk management decisions, and ATSDR’s toxicological  profiles target local health authorities for use in dealing with hazardous  waste sites. We have previously concluded that overlapping programs or  activities can be a harbinger of unnecessary duplication. However, in  this case, because these federal agencies develop distinct chemical  toxicity assessment information, their activities are largely  complementary. For example, as noted previously in this report in figure  3, all five selected federal agencies’ activities overlap in that they provide  information on both cancer and noncancer effects. However, as  previously noted, OSHA provides information on occupational hazards  that affect workers, and EPA provides information on the environmental  hazards that affect the broader population, including children or the  elderly. Further, we have previously concluded that funding research on  the same topic may be appropriate and necessary—for example, for  purposes of replicating or corroborating results. Likewise, officials from  two of the five selected federal agencies we reviewed similarly told us that  scientific findings are more robust if more than one agency has studied  the same chemical and arrived at similar results.
section_title: Duplication
paragraphs: We did not find evidence of duplication among selected federal agencies’  chemical toxicity assessment activities because the agencies did not  engage in the same activities or provide the same services to the same  beneficiaries. For example, we did not find duplication between NIOSH  and EPA’s chemical toxicity assessment activities because NIOSH  assesses the potential risks that chemicals pose to working-aged adults  in occupational settings (e.g., exposure by dermal contact or inhalation)  over the course of working time periods (e.g., an 8- or 10-hour workday or  a 40-hour workweek). In contrast, EPA assesses risks that chemicals  pose to a broader population as opposed to workers, which includes  children and vulnerable populations in the larger nonoccupational  environment (e.g., in the air, soil, or groundwater) typically over the  course of an entire lifetime. Such differences in the health and age of  the people exposed, the environment in which the chemical is present,  the routes in which the chemical comes into contact with people, and the  length of time people are exposed affect the chemical toxicity information  the agencies produce about the levels at which a chemical is safe.
In addition, in reviewing examples of such chemical toxicity information,  we analyzed 10 selected chemicals’ inhalation toxicity values for four of  the five selected federal agencies and 1 of the 12 selected state  agencies. We found that these values are not duplicative because they  are (1) based on different chemical toxicity assessment activities of  differing exposure durations and (2) fulfill distinct programmatic and  statutory requirements. For example, EPA and NIOSH developed  different toxicity values for the chemical hexavalent chromium, but  EPA’s values were for chronic exposure, and NIOSH’s value was for a  40-hour per week working lifetime exposure (see app. II). Also, EPA and  NIOSH’s values each responded to a need from different beneficiaries.  Specifically, EPA developed the values in response to stakeholder  chemical nominations to the IRIS program, and NIOSH developed the  value as part of its responsibilities under the Occupational Safety and  Health Act. In addition, as previously noted, both NTP and EPA assess  the potential for chemicals to cause cancer and noncancer health effects.  According to an NTP official, the agency describes such potential to the  public in a qualitative manner based on a targeted population (e.g.,  pregnant woman), and EPA does so in a qualitative and quantitative  manner, consistent with data available for the broader population that  includes all subsets (e.g., healthy adults, children, the elderly).
section_title: Selected Federal Agencies and States Coordinate Their Chemical Toxicity Assessment Activities and Reported Cross- Cutting Challenges
paragraphs: Officials from all five of the federal agencies and from 3 of the 10 states  we reviewed told us that they coordinate their chemical toxicity  assessment activities. All of the five federal agencies we reviewed have  coordinated with other agencies in the last 5 years, and all the states we  reviewed have used federal assessment information, and some have  coordinated with federal agencies in the last 5 years. In addition, both  officials from selected federal agencies and states identified cross-cutting  challenges to this coordination, such as constraints on sharing  confidential business information and reliance on informal communication  processes.
subsections: section_title: Selected Federal Agencies and States Coordinate Their Chemical Toxicity Assessment Activities
paragraphs: Officials at all five of the federal agencies and 3 of the 10 states we  reviewed told us that, in the last 5 years, they have coordinated their  chemical toxicity assessment activities using a variety of coordination  mechanisms. We found that all of the federal agencies we reviewed have  coordinated with one another, and that states largely rely on federal  chemical toxicity assessment information.
subsections: section_title: Federal Coordination
paragraphs: Agency officials at the five federal agencies we reviewed told us they  have coordinated their chemical toxicity assessment activities in the last 5  years by using four mechanisms: (1) memorandums of understanding  (MOU); (2) interagency working groups; (3) data sharing, such as  literature search results; and (4) chemical-specific coordination on an as- needed basis, meaning the agencies coordinate in an informal fashion as  the need arises for particular chemicals. According to our analysis of  structured interviews with selected federal agencies, all five federal  agencies have coordinated with at least three other federal agencies  using at least three of the four mechanisms (see fig. 4).
Agency officials told us that these interactions have had a positive effect  on their chemical toxicity assessment activities. For example:
ATSDR and EPA coordinate their chemical toxicity assessment  activities though an MOU established in 2004 and renewed in 2013.  Specifically, ATSDR and EPA’s National Center for Environmental  Assessment, within its Office of Research and Development, entered  into the MOU with a stated purpose of (1) identifying chemical-specific  priorities of mutual interest; (2) identifying potential points of  interaction that will provide opportunities for collaboration; (3)  harmonizing assessment approaches for chemicals of public health  concern; (4) increasing the pool of available scientific expertise; and  (5) avoiding duplication of effort. Examples of coordination under this  MOU include sharing information on chemicals of concern and  reviewing and commenting on draft assessments. An EPA official also  noted that this MOU enables the agencies to share chemical  nomination proposals for their respective programs—ATSDR  toxicological profiles and EPA IRIS assessments—and discuss any  overlap in chemicals they are assessing.
OSHA and NIOSH have frequently coordinated on chemical toxicity  assessment activities for a number of years by sharing information  and data pertaining to emerging occupational safety and health  issues; sharing information related to assessment methods, tools,  databases and data analysis; and developing and disseminating  collaborative and joint-publications in areas of mutual interest. In  2014, OSHA and NIOSH entered into an MOU that formalized these  coordination activities and has a stated purpose of advancing the  protection of workers, promoting best practices, and encouraging  employers to develop and utilize safety and health management  programs and effective prevention strategies and technologies.
NTP coordinates with many federal agencies through its Executive  Committee, which is an interagency advisory group that provides  programmatic and policy oversight to the NTP Director and meets  once or twice a year with high-ranking members from the other four  selected federal agencies, as well as other federal agencies. The  purpose of the Executive Committee is focused on advising on NTP  activities and policies, but NTP officials told us that the Executive  Committee has also addressed cross-cutting issues related to  chemical toxicity assessments that are beyond a single agency’s  ability to solve, such as facilitating a forum for ATSDR, NIOSH, and  OSHA to present updates of their assessment activities to the other  Executive Committee member agencies; explore interests, needs, and  capabilities among member agencies; and identify ways for enhanced  cooperation. In another Executive Committee meeting, member  agencies discussed efforts within the federal government to adopt the  Globally Harmonized System of Classification and Labeling of  Chemicals, which includes criteria for the classification of health,  physical, and environmental hazards, as well as specifying what  information should be included on labels and safety information  sheets of hazardous chemicals. NTP officials stated that the agency  was interested to hear about agencies’ plans for implementation in  regulatory programs and how NTP products would be used in the  context of the system.
Agencies also provided examples of how they have coordinated through  such mechanisms as sharing data and coordinating on specific chemicals  on an as-needed basis. For example:
According to an OSHA official, OSHA shares information informally  with EPA and other federal agencies to discuss ongoing research  efforts within federal agencies and the current state of science on  nanomaterials. Specifically, the OSHA official stated that the  agencies are examining the data on specific nanomaterials, such as  nanosilver, which, according to EPA, has been incorporated into a  variety of consumer products due to their antimicrobial properties,  such as some soaps, disinfectant sprays, and children’s toys. The  OSHA official stated that the agencies are reviewing current scientific  data and sharing information on how this type of data can be used by  regulatory agencies.
An ATSDR official stated that ATSDR sometimes refers to EPA’s  quantitative toxicity assessment information in developing new or  updating MRLs. For instance, ATSDR is adopting EPA’s chronic  toxicity values for trichloroethylene (TCE), which is used as a solvent  in industrial degreasing operations, and is also used in consumer  products such as typewriter correction fluids, paint removers and  strippers, adhesives, spot removers, and rug-cleaning fluids. For more  information on toxicity values for TCE across selected agencies,  please see appendix II.
An NTP official stated that NTP is working toward sharing data with  EPA, such as literature searches on chemicals. The official also  stated that, as part of its systematic review process, NTP is  developing web-based tools that would allow all federal agencies to  extract data from literature, assess the quality of that study, and  choose studies for a toxicity assessment in a consistent and  structured way. This tool is being funded by EPA, and earlier  iterations of these tools have been used in the ongoing EPA  assessment of arsenic.
section_title: State Use of Federal Chemical Toxicity Assessment Information and Coordination
paragraphs: Officials in the 10 states we reviewed told us that they largely rely on  federal agency chemical toxicity assessments. Specifically, officials from  agencies in all 10 of the states we reviewed told us they have used  chemical toxicity assessment information produced by the federal  agencies we reviewed in the last 5 years, even if they had developed their  own assessments. Officials from 6 of the 10 states we reviewed— Arizona, California, Delaware, Minnesota, Oklahoma, and Texas— responded that they had used data from all five federal agencies. Officials  in the other four states—Missouri, Alaska, New Jersey, and New York— responded that they had used chemical toxicity assessment information  from two to four of the five federal agencies (see fig. 5).
We also asked officials in the 10 selected states we reviewed whether  they had coordinated with federal agencies through mechanisms such as  MOUs, interagency working groups, data sharing, or chemical-specific  coordination on an as-needed basis. Officials in 3 of the 10 states we  reviewed—Alaska, Minnesota, and Oklahoma—responded that they have  coordinated with three out of the five selected federal agencies in the last  5 years. For example, officials in Minnesota responded that the state has  coordinated with ATSDR, EPA, and NTP; officials in Oklahoma  responded that the state has coordinated with EPA. An official from the  Alaska Department of Environmental Conservation, which does not  produce its own chemical toxicity assessments, stated that it coordinated  with ATSDR and EPA to assess a chemical contaminating drinking water.  The chemical, sulfolane, is an industrial solvent used to separate  compounds from chemical mixtures and, according to the Alaska  Department, has been the primary solvent used at the North Pole  Refinery since 1985. In 2009, then-owner Flint Hills found that sulfolane  levels in nearby private drinking water wells were significantly higher than  expected, although under the state standard that requires cleanup.
Because there was little toxicity assessment information available on  sulfolane, the Alaska Department contacted EPA; at the same time, the  state health department contacted ATSDR, resulting in the group of  agencies working together to assess the chemical. ATSDR conducted  evaluations in 2010 and 2011 that resulted in the establishment of a  stricter cleanup standard. After considering ATSDR’s research and its  own research on previously published data, EPA established a PPRTV  for sulfolane in 2012. The state of Alaska set a stricter groundwater  cleanup standard based on this PPRTV. The Alaska official we  interviewed stated that Alaska lacked the necessary resources to assess  sulfolane on its own and working with EPA and ATSDR provided the state  with information it needed to move forward on a remediation plan.
Officials from three states we reviewed told us that they coordinated with  federal agencies, and officials from all five selected federal agencies told  us they coordinated with a variety of state agencies. For example:
An EPA official stated that its NCEA office operates the Superfund  Technical Support Center, which provides assessment technical  support and advice to EPA program and regional offices and states on  an as-needed basis. The EPA official said that, over the last 5 years,  20 states called the center through a publicly available hotline for  information on topics related to chemical risk assessments.
Officials from ATSDR stated that the agency does not formally  coordinate with states, but that states often provide comments during  its public comment period on toxicological profiles. Also, ATSDR  officials stated that the agency has used state chemical toxicity  assessment information to develop its toxicological profiles.
Officials from OSHA stated that their largest coordination effort with  states is through NIOSH’s Adult Blood Lead Epidemiology and  Surveillance state program, a program funded through NIOSH in  which 41 states collect data on levels of blood lead levels. The  participating states provide data to NIOSH, which then publishes the  data and makes them available in summary form to OSHA. OSHA  uses the data to help target workplace inspections and other  consultations designed to reduce exposures to lead in the workplace.
Officials from some agencies from selected states responded to our  structured interviews that they also coordinate with other states on  chemical toxicity assessment activities. Officials from 4 of the 10 selected  states—Arizona, Minnesota, Missouri, and New Jersey—told us that they  coordinated with other states. For example, officials from the Minnesota  Department of Health told us that it is a member of the Federal-State  Toxicology Risk Analysis Committee (FSTRAC), an interagency working  group led by EPA’s Office of Water that includes other states and whose  stated purpose is to foster cooperation, consistency, and an  understanding of EPA’s and different states’ goals and problems in  human health risk assessment.
section_title: Selected Federal Agencies and States Identified Cross-Cutting Challenges to Coordination
paragraphs: Officials from three of the five selected federal agencies and 2 of the 10  selected states we reviewed identified three cross-cutting challenges to  coordination on chemical toxicity assessment activities, including the  following:
Constraints on sharing confidential business information.
Officials from three offices within EPA we reviewed told us that they  are limited in how they can share proprietary information about  business practices that chemical companies identify as confidential  business information (CBI). Because of legal restrictions on  dissemination of CBI, it cannot readily be shared across agencies,  which hinders the agencies’ coordination of chemical toxicity  assessment activities. For example, one official stated that each  agency and offices within agencies operate under laws that contain  varying provisions relating to CBI, and that these varying provisions  complicate their ability to share scientific data and can even make  data sharing impossible. This official also stated that these varying  provisions hinder their ability to leverage resources. As we concluded  in March 2013, when information is claimed as CBI, it limits EPA’s  ability to share it with other entities, which potentially limits the  effectiveness of these organizations’ environmental risk programs.  However, TSCA specifies when EPA may publicly disclose chemical  information it obtains from chemical companies and provides that  chemical companies can claim certain information, such as data  disclosing chemical processes, as CBI. We also reported in March  2013 that, according to EPA, 95 percent of information the agency  receives on new chemicals contains assertions of confidentiality. EPA  officials have stated that they have not had the resources that would  be needed to investigate and, as appropriate, challenge such claims.
Limited opportunities for agency officials to meet. According to  officials from ATSDR, NIOSH, EPA, and two states, there are few  opportunities to meet face-to-face among counterparts from federal  and state agencies because budgetary challenges limit their ability to  host or attend conferences. For example, one state official noted that  in-person conferences were useful because there were opportunities  to have spontaneous conversations and establish relationships with  their state and federal peers. Due to budget restrictions, however,  federal agencies have moved toward hosting webinars instead, which  the both federal and state agency officials told us allowed them to  share information between state and federal agencies on their  assessment activities without the costs associated with traveling, but  did not provide the same opportunities for coordination and  networking. Officials from one federal agency and one state told us  that webinars may preclude the kind of networking that happens at in- person conferences.
Informal communication processes. Officials from NIOSH and  three EPA offices told us that they believe that points of contact and  communication processes are too informal. For example, one federal  agency official stated that there may not be an identified point of  contact when individuals retire or leave for another position, which can  contribute to loss of continuity and disrupt the transfer of knowledge  between agencies if retiring individuals depart without a process for  ensuring a smooth transition of knowledge from incumbents to  successors. Another federal official stated that an individual in the  same position for decades may build relationships with officials in  other agencies, but that, without systematic and routine mechanisms  to coordinate, it would be challenging for a new individual to identify  the right points of contact—particularly at state and regional  government agencies. We previously concluded in November 2010  that by using informal coordination mechanisms, agencies may rely  on relationships with individual officials to ensure effective  collaboration and that these informal relationships could end once  personnel move to their next assignments. We also concluded that  agencies can strengthen their commitment to work collaboratively by  articulating their roles and responsibilities to facilitate decision making  in formal documents such as MOUs, interagency guidance, or  interagency planning documents.
section_title: The National Science and Technology Council Offers an Opportunity to Address Cross-Cutting Challenges
paragraphs: In our September 2012 report that identified mechanisms that facilitate  interagency collaboration, we found one mechanism for addressing cross- cutting challenges is through an existing interagency working group. In  that report, we concluded that interagency mechanisms or strategies to  coordinate programs that address cross-cutting issues may reduce  potentially duplicative, overlapping, and fragmented efforts. Officials from  four federal agencies told us that one such group that all five selected  federal agencies participate in is the National Science and Technology  Council (NSTC). NSTC, which was established by Executive Order in  1993, is a council of cabinet-level officials chaired by the President and  managed by the Director of the Office of Science and Technology Policy  (OSTP). NSTC has multiple committees addressing its broad  responsibilities for the scientific and technical work of the executive  branch. For example, the NSTC’s Committee on Environment, Natural  Resources, and Sustainability advises and assists NSTC on federal  research and development related to the environment, natural resources,  and sustainability. According to the NSTC Executive Order, its principal  functions are to coordinate the science and technology policymaking  process and ensure science and technology are considered in  development and implementation of federal policies and programs,  among other things. Further, all executive departments and agencies,  whether or not they are represented on the NSTC, are to coordinate  science and technology policy through the NSTC and share information  on research and development budget requests.
We noted the value of the NSTC in our May 2012 report on a federal  interagency program on nanotechnology, in which we stated that the  NSTC is the principal means by which the executive branch coordinates  science and technology policy. In August 2011, we also reported that  one of NSTC’s workgroups was involved in another interagency effort to  identify and prioritize research needed to better understand  pharmaceuticals in the environment and recommend areas of federal  collaboration to address those priorities. A July 2014 NSTC report on  data from observations of the Earth, such as its land surface and oceans,  also illustrates NSTC’s involvement in coordinating science activities  across agencies. The report was produced as a result of a statutory  requirement that OSTP establish a mechanism to ensure greater  coordination of research, operations, and activities relating to civilian  Earth observation. In response, OSTP convened a task force of 15  federal agencies, and subsequently, the NSTC published the 2014 report.  Senior officials from three agencies—ATDSR, EPA, and NIOSH— identified a committee within NSTC as an appropriate forum to address  such challenges. An official from OSTP similarly stated that NSTC could  serve an interagency coordinating function to address certain cross- cutting challenges, and it has already done so by coordinating chemical  toxicity assessment activities and providing opportunities for agency  officials to meet in person. By having an interagency body to address the  challenges the five selected agencies identified (i.e., constraints on  sharing CBI, limited opportunities for agency officials to meet, and  informal communication processes) and any future cross-cutting  challenges, the five agencies would be positioned to better coordinate  their assessment activities in the most effective and efficient manner.
section_title: Conclusions
paragraphs: With thousands of chemicals in commercial use in the United States,  decision makers rely on information derived from toxicity assessment to  examine the risks these substances may pose. Using various  mechanisms, the federal agencies and some of the state agencies we  reviewed actively coordinate their toxicity assessment activities to avoid  unnecessary fragmentation, overlap, and duplication. However, officials in  states and federal agencies identified cross-cutting challenges to  coordination, such as constraints on sharing information and informal  communication processes that hinder agencies’ ability to leverage  resources, and interfere with officials’ ability to work across agency  boundaries. By addressing these cross-cutting challenges, state and  federal agencies may be positioned to more effectively and efficiently  coordinate their chemical toxicity assessment activities.
section_title: Recommendation for Executive Action
paragraphs: To improve coordination of federal and state chemical toxicity  assessment activities, we recommend that the Director of OSTP  encourage the NSTC to support relevant federal agency officials’ efforts  to address, as appropriate, the agencies’ cross-cutting coordination  challenges, such as constraints on sharing confidential business  information, limited opportunities for agency officials to meet, and informal  communication processes.
section_title: Agency Comments and Our Evaluation
paragraphs: We requested comments on a draft of this report from the Director, Office  of Science and Technology Policy; Secretary of Health and Human  Services; Secretary of Labor; and Administrator, Environmental  Protection Agency. They did not provide official written comments to  include in our report. Instead, they provided technical comments, which  we incorporated as appropriate.
As agreed with your office, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the appropriate  congressional committees; Director, Office of Science and Technology  Policy; Secretary of Health and Human Services; Secretary of Labor;  Administrator, Environmental Protection Agency; and other interested  parties. In addition, the report will be available at no charge on the GAO  website at http://www.gao.gov.
If you or your staff members have any questions about this report, please  contact me at (202) 512-3841 or at morriss@gao.gov. Contact points for  our Offices of Congressional Relations and Public Affairs may be found  on the last page of this report. GAO staff who made key contributions to  this report are listed in appendix III.
section_title: Appendix I: Scope and Methodology
paragraphs: To describe the chemical toxicity assessment activities selected federal  and state agencies undertake, we examined the chemical toxicity  assessment activities of five federal agencies: (1) the Agency for Toxic  Substances and Disease Registry (ATSDR), (2) the Environmental  Protection Agency (EPA), (3) the National Institute for Occupational  Safety and Health (NIOSH), (4) the National Toxicology Program (NTP),  and (5) the Occupational Safety and Health Administration (OSHA), which  follow the National Academies’ four-step risk assessment process. The  four steps are (1) hazard identification, (2) dose-response assessment,  (3) exposure assessment, and (4) risk characterization. The first two  steps—hazard identification and dose-response assessment—are  commonly referred to together as toxicity assessments. We reviewed  publicly available information on these five federal agencies’ assessment  activities and information from our past reports, and compiled summaries  of these activities for each agency. We then submitted these summaries  to each agency to review for accuracy and incorporated their comments  as appropriate. We also interviewed agency officials as necessary to  clarify their comments. We selected a nonprobability sample of 12 state  agencies in 10 states that provide a range of chemical toxicity  assessment activities. An official from the Interstate Technology &  Regulatory Council (ITRC)—an organization which has expertise in the  area of state chemical toxicity assessment activities—reviewed our  questions before we interviewed agency officials, and we made changes  as appropriate. We asked officials from each state agency to describe  the activities their agency performs that might be included in those first  two steps of a risk assessment (hazard identification and dose-response),  to describe what is within its agency’s purview as opposed to the purview  of another agency within the same state, and whether it has developed its  own chemical toxicity assessment information in the last 5 years. We  asked officials from each state agency whether their agency had referred  to existing assessment information from each of the five selected federal  agencies in the last 5 years, among other entities. Because this was a  nonprobability sample, the information and perspectives that we obtained  from these state agencies are not generalizable to other state agencies. A  contractor entered all agencies’ quantitative responses into a single  spreadsheet, and their qualitative responses into a single document. We  then analyzed responses from our interviews about the extent to which  state agencies had developed their own chemical toxicity assessments in  the last 5 years, and the extent to which the agencies had used chemical  toxicity assessment information from the five federal agencies in the last 5  years.
To assess the extent to which, if at all, selected federal agencies’  chemical toxicity assessment activities are fragmented, overlapping, or  duplicative, we reviewed the summaries of federal agency assessment  activities and federal agency documentation that sets forth the scope and  purpose of their assessment activities, and we compared them with one  another and with our definitions of fragmentation, overlap, and  duplication. We also asked the five federal agencies in our structured  interviews whether consolidation—a response to duplication that involves  a reduction in either physical infrastructure or management functions—of  their agency’s chemical toxicity assessment activities with those of the  other four federal agencies could improve the federal government’s  chemical toxicity assessment activities. In addition, we spoke with  industry and environmental groups to hear their perspective on the  chemical toxicity assessment activities of the five federal agencies and  state agencies and, the extent to which, if at all, they are duplicative. We  also further reviewed a nonprobability sample of inhalation toxicity values  for 10 selected chemicals as developed by four of the five federal  agencies (ATSDR, EPA, NIOSH, and OSHA) and one state agency, the  California Environmental Protection Agency (CalEPA), that conduct  toxicity assessment activities for these inhaled chemicals. We illustrated  the differences in reported toxicity values in each agency but did not  evaluate the validity of these levels or the methods by which they were  developed. Because this was a nonprobability sample, the information  that we obtained on these 10 chemicals is not generalizable to all  chemicals. We did not include NTP among the federal agencies because  it does not develop quantitative toxicity values. We included CalEPA to  provide an illustrative example of a state’s toxicity values. We selected  these 10 chemicals to provide a diverse range of organic and inorganic  chemicals—the two major categories that comprise the universe of all  chemicals—with varying structures and chemical properties, which we  identified with the assistance of a GAO chemist and a review of chemical  toxicity values from federal agencies. We limited our sample to chemicals  for which all of the four of the five selected federal agencies and 1 of the  12 selected state agencies had developed toxicity values.
To examine federal and state agencies’ coordination on chemical toxicity  assessment activities and any challenges associated in doing so, we  administered structured interviews to the five selected federal agencies  and 12 state agencies. For EPA, which unlike most of the other federal  and state agencies has multiple components that conduct chemical  toxicity assessments, we also interviewed officials from six program or  regional offices to determine the extent to which they coordinate their  toxicity assessment activities and identify any challenges to their efforts.  We spoke with officials in two agencies within both Delaware and  Minnesota because state officials from these two states indicated that  chemical toxicity assessment responsibilities were split among different  agencies within their states. In our interviews, we asked officials from  each of the five federal agencies whether their agency had coordinated  with each of the other four federal agencies within the past 5 years. For  each federal agency that it said it had coordinated with, we asked  whether it had used each of five mechanisms: (1) memorandums of  understanding (MOU); (2) interagency working groups; (3) data sharing,  such as literature search results; (4) chemical-specific coordination on an  as-needed basis; and (5) other mechanisms. For each of the mechanisms  they said they had used, we asked whether and in what ways the  mechanism helped the agency to effectively produce chemical toxicity  assessments. For each of the mechanisms they said they did not use, we  asked whether they thought that the use of the mechanism would improve  the federal government’s chemical toxicity assessments. We asked a  similar set of questions about each federal agency’s coordination with  states; we also asked a similar set of questions about each of the 12  selected state agencies’ coordination with the five selected federal  agencies and other states. We analyzed and reported interview  responses using the state as the unit of measure, as opposed to the  particular agency. Because we used the state as the unit of measure and  not the agency, we reported the response as “yes” for a state in cases  where at least one agency official or one agency within Delaware or  Minnesota responded “yes.” Where applicable, we corroborated  coordination activities by obtaining signed MOUs and written interagency  agreements. The different mechanisms through which agencies  coordinate do not necessarily indicate better quality or more effective  coordination. Whether the type of coordination mechanism affected  quality of effectiveness is beyond the scope of this review. We combined  federal agency responses into an analysis performed by GAO  methodologists where we corroborated responses from each agency, and  found six discrepancies out of a total of 50 possibilities where an agency  reported having a mechanism with another agency, but the other agency  did not report that mechanism, which we considered reliable for our  purposes. In order to increase the reliability of our data, we did not  include these six discrepancies. Agency responses to our structured  interviews were further evaluated by considering key practices for  collaboration and key considerations for implementing interagency  collaborative mechanisms.
We conducted this performance audit from May 2013 to September 2014  in accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
section_title: Appendix II: Chemical Inhalation Toxicity Values for Select Agencies
paragraphs: The following tables (tables 1-10) compare inhalation toxicity values for  10 selected chemicals developed by four federal agencies and one state  agency: (1) the Agency for Toxic Substances and Disease Registry  (ATSDR), (2) the Environmental Protection Agency (EPA), (3) the  National Institute for Occupational Safety and Health (NIOSH), (4) the  Occupational Safety and Health Administration (OSHA), and (5) California  Environmental Protection Agency (CalEPA). Following are explanatory  points provided by the agencies that are relevant, as noted, to some or all  of the selected chemicals:
ATSDR. To describe any differences in uses between its toxicity  values and those of other selected agencies, ATSDR indicated that its  Minimal Risk Levels (MRL) are screening levels for environmental  exposures; OSHA and NIOSH values are for occupational exposure.
CalEPA. To describe any differences in uses between its toxicity  values and those of the other selected agencies, CalEPA reported  that its Office of Environmental Health Hazard Assessment (OEHHA)  is required to develop guidelines for conducting health risk  assessments under the Air Toxics Hot Spots Program. Further,  OEHHA developed a Technical Support Document for derivation of  reference exposure levels. The latest document addressing the  derivation of noncancer reference exposure levels was adopted in  December, 2008, and it describes acute, 8-hour, and chronic  reference exposure levels. The document presents methodology that  explicitly considers possible differential effects on the health of infants,  children and other sensitive subpopulations and has been used to  develop the reference exposure levels. Two additional Technical  Support Documents have been developed, including one for cancer  potency factors in May 2009, as well as a revised document for  exposure assessment and stochastic analysis in October 2012. The  Air Toxics Hot Spots Information and Assessment Act is designed to  provide information to state and local agencies and to the general  public on the extent of airborne emissions from stationary sources and  their potential public health impacts. The act requires that the OEHHA  develop risk assessment guidelines for the Air Toxics Hot Spots  Program and the most recent guidance manual is available from  August 2003. The guidance, intended to address health risks from  airborne contaminants released by stationary sources, involves a  methodology that is common to other regulatory risk assessment  applications, particularly for California programs.
EPA. To describe any differences in uses between its toxicity values  and those of other selected agencies, EPA indicated that the  agencies’ values are developed in response to specific statutory  requirements. EPA provided supplementary information about these  requirements, as well as the purposes for the values developed by  these agencies.
NIOSH. To describe differences in uses between its toxicity values  and those of other selected agencies, NIOSH indicated that its  recommended exposure limits (REL) are developed for workplace  exposures (other agencies develop values for environmental  exposure); NIOSH RELs also support OSHA rulemaking.
OSHA. For all chemicals except chromium VI, OSHA described the  following differences in uses between its toxicity values and those of  other selected agencies, and reasons why it developed its values: for  most of its regulated chemicals, OSHA has not relied on an agency  risk assessment to establish permissible exposure limits (PELs).  Rather, these PELs were adopted shortly after formation of the  agency in 1971 from approximately 400 occupational exposure limits  that were based on the American Conference of Governmental  Industrial Hygienist’s 1968 list of Threshold Value Limits. On January  19, 1989, OSHA published a final rule on air contaminants that  lowered 212 of OSHA’s existing PELs for toxic substances and set  PELs for 164 toxic substances that had been previously unregulated.  In doing so, OSHA relied heavily on the already published and widely  accepted Threshold Limit Values published by the American  Conference of Governmental Industrial Hygienists and the RELs  developed by NIOSH. In 1992, a federal appellate court vacated these  standards, holding that OSHA had failed to establish that the new  standards were technologically and economically feasible. As a  result, OSHA resumed enforcing, and employers were required to  comply with, the air contaminant exposure limits that were in effect  prior to the issuance of the new limits on January 19, 1989. In  reinstating the previous limits, OSHA said that it continued to believe  that many these old limits were out of date (they predate 1968) and  not sufficiently protective of employee health based on current  scientific information and expert recommendations. In addition, OSHA  observed that many of the substances for which OSHA had no PELs  presented serious health hazards to employees. In commenting on  the information in this appendix, OSHA officials stated that they  continue to believe the limits contained in the 1989 rulemaking  reduced significant risks of material impairment of health or functional  capacity, and were technologically and economically feasible.
GAO note: the agencies listed below have developed toxicity values  that vary in exposure. Specific terms included are “acute,” which  ATSDR defines as exposure of between 1 and 14 days, and which  CalEPA defines as exposure of 1 hour. ATSDR defines “intermediate”  exposure is being between 15 and 364 days. Both CalEPA and EPA  define “chronic” exposure as being over the course of a lifetime, and  ATSDR defines “chronic” as being exposure of 365 days or longer.  NIOSH and OSHA develop toxicity values that with exposure levels  that vary between exposure durations of 15 minutes, 8 hours, 10  hours, or a 40-hour week for a 45-year working lifetime. In addition,  some agencies may use safety or uncertainty factors that protect  susceptible populations. These factors may result in values that  cannot be compared.
section_title: Appendix III: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the individual named above, Diane B. Raynes (Assistant  Director), Marie Bancroft, Mark Braza, Alicia Cackley, David Dornisch,  Karen Howard, Richard Johnson, Summer Lingard-Smith, Alison O’Neill,  Dan C. Royer, Stuart Ryba, Stephen Betsock, Kiki Theodoropoulos, and  Sarah Veale made key contributions to this report.