Chemical Regulation: Observations on the Toxic Substances Control Act and EPA Implementation
Released: 2013-06-13T00:00:00


Highlights: section_title: Why GAO Did This Study
paragraphs: In 1976, Congress passed TSCA to give EPA the authority to obtain more health and safety information on chemicals and to regulate chemicals it determines pose unreasonable risks of injury to human health or the environment. GAO has reported that EPA has found many of TSCA's provisions difficult to implement. In 2009, EPA announced TSCA reform principles to inform ongoing efforts in Congress to strengthen the act. At that time, EPA also initiated a new approach for managing toxic chemicals using its existing TSCA authorities.

This testimony summarizes GAO's past work describing: (1) challenges EPA has faced historically in regulating chemicals and (2) the extent to which EPA has made progress implementing its new approach, and challenges, if any, which persist. This statement is based on GAO reports issued between 1994 and 2013.

GAO is not making new recommendations in this testimony. In prior reports, GAO suggested that Congress consider statutory changes to TSCA to give EPA additional authorities to obtain information from the chemical industry and shift more of the burden to chemical companies for demonstrating the safety of their chemicals. In these reports, among other things, GAO recommended that EPA require companies to provide chemical data they submitted to foreign governments, require companies to reassert confidentiality claims, and develop strategies for addressing challenges that impeded EPA's ability to ensure chemical safety. EPA's responses to these recommendations have varied.

section_title: What GAO Found
paragraphs: GAO reported in June 2005 that EPA has historically faced the following challenges in implementing the provisions of the Toxic Substances Control Act (TSCA):

Obtaining adequate information on chemical toxicity and exposure . EPA has found it difficult to obtain such information because TSCA does not require companies to provide it; instead, TSCA requires EPA to demonstrate that chemicals pose certain risks before it can ask for such information.

Banning or limiting chemicals . EPA has had difficulty demonstrating that chemicals should be banned or have limits placed on their production or use under section 6--provisions for controlling chemicals. The agency issued regulations to ban or limit production or use of five existing chemicals, or chemical classes, out of tens of thousands of chemicals listed for commercial use. A court reversal of EPA's 1989 asbestos rule illustrates the difficulties EPA has had in issuing regulations to control existing chemicals.

Disclosing data and managing assertions of confidentiality . EPA has not routinely challenged companies' assertions that data they provide are confidential business information and cannot be disclosed. As a result, the extent to which companies' confidentiality claims are warranted is unknown.

GAO reported in March 2013 that EPA has made progress implementing its new approach to managing toxic chemicals under its existing TSCA authority but, in most cases, results have yet to be realized. Examples are as follows:

EPA has increased efforts to collect toxicity and exposure data through the rulemaking process, but because rules can take 3 to 5 years to finalize and 2 to 2 1/2 years for companies to execute, these efforts may take several years to produce results. Specifically, since 2009, EPA has (1) required companies to test 34 chemicals and provide EPA with the resulting toxicity and other data, and (2) announced, but has not yet finalized, plans to require testing for 23 additional chemicals.

EPA has increased efforts to assess chemical risks, but because EPA does not have the data necessary to conduct all risk assessments, it is too early to tell what, if any, risk management actions will be taken. In February 2012, EPA announced a plan that identified and prioritized 83 existing chemicals for risk assessment; the agency initiated assessments for 7 chemicals in 2012 and announced plans to start 18 additional assessments during 2013 and 2014. At its current pace, it would take EPA at least 10 years to complete risk assessments for the 83 chemicals.

In addition, it is unclear whether EPA's new approach to managing chemicals will position the agency to achieve its goal of ensuring the safety of chemicals. EPA's Existing Chemicals Program Strategy, which is intended to guide EPA's efforts to assess and control chemicals in the coming years, does not discuss how EPA will address identified challenges. Consequently, EPA could be investing valuable resources, time, and effort without being certain that its efforts will bring the agency closer to achieving its goal of ensuring the safety of chemicals.

section_title: Letter
paragraphs: I am pleased to be here today to discuss the Environmental Protection  Agency’s (EPA) efforts to assess and control toxic chemicals. Tens of  thousands of chemicals are listed with EPA for commercial use in the  United States, with an average of 600 new chemicals listed each year.  EPA’s ability to effectively implement its mission of protecting public  health and the environment depends on credible and timely assessments  of the risks posed by toxic chemicals. In 1976, Congress passed the  Toxic Substances Control Act (TSCA) to provide EPA with the authority to  obtain more information on chemicals and to regulate those chemicals  that EPA determines pose unreasonable risks to human health or the  environment. TSCA authorizes EPA to review chemicals already in  commerce (existing chemicals) and chemicals yet to enter commerce  (new chemicals).

We have reported in the past that EPA has found many of the provisions  of TSCA difficult to implement. In our past reports, we have suggested  that Congress consider making statutory changes to strengthen EPA’s  authority to obtain toxicity information from the chemical industry and  establish a framework for taking action that is less burdensome for EPA.  We have also made several recommendations to better position EPA to  collect chemical toxicity and exposure-related data and ensure chemical  safety under existing TSCA authority. Among other recommendations, in   we recommended that EPA strengthen its ability to regulate  June 2005, harmful chemicals under TSCA by, for example, promulgating a rule  requiring that companies submit copies to EPA of any health and safety  studies, as well as other information concerning the environmental and  health effects of chemicals that they submit to foreign governments. In  that report, we also recommended that EPA improve and validate its  models for assessing and predicting the risks of chemicals and revise its  regulations to require chemical companies to reassert confidentiality  claims within a certain period. EPA implemented our 2005  recommendation to improve its models. EPA did not disagree with our  2005 recommendations regarding obtaining health and safety studies and  other information that companies submit to foreign governments and  requiring companies to reassert confidentiality claims, but it provided  substantive comments and has not fully implemented these  recommendations.

In this testimony, exposure represents the magnitude, frequency, and duration of contact  with a chemical. Toxicity represents the degree to which a chemical is harmful. In this  testimony, the terms toxicity and hazard are used synonymously. authorities under TSCA to ensure chemical safety. In February 2012,  EPA summarized many of the activities it had initiated under its new  approach in the agency’s Existing Chemicals Program Strategy.  Collectively, these activities address the following four areas: (1)  collecting toxicity and exposure data, (2) conducting risk assessments, (3)  discouraging the use of some chemicals, and (4) expanding public access  to some chemical data.

In our most recent report in March 2013, we reported on the extent to  which EPA had made progress implementing its new approach. We  recommended, among other things, that EPA consider promulgating a  rule requiring chemical companies to report exposure-related data from  processors to EPA. EPA stated in its comments that downstream  chemical processors have little exposure-relevant data—which suggests  that it does not intend to implement that recommendation. Because EPA  has not developed sufficient chemical assessment information to limit  exposure to many chemicals that may pose substantial health risks,  among other reasons, in 2009, we added EPA’s processes for assessing  and controlling toxic chemicals to our list of programs at high risk of  waste, fraud, abuse, and mismanagement.

My testimony today is based on our prior work on EPA’s processes for  assessing and controlling toxic chemicals. Specifically, my statement  today discusses: (1) challenges EPA has faced historically in regulating  chemicals and (2) the extent to which EPA has made progress  implementing its new approach, and challenges, if any, which persist.  This statement is based on our extensive body of work on TSCA and  EPA’s programs to assess and control chemicals, including reports  issued from September 1994 to March 2013. Detailed information on our  scope and methodology is available in each issued product. We  conducted this work in accordance with generally accepted government  auditing standards.
subsections: section_title: Background
paragraphs: Federal laws have been enacted over the years to determine the health  and environmental hazards associated with toxic chemicals and to  address these problems. Even with the existence of media-specific  environmental laws enacted in the early 1970s, such as the Clean Air Act  and the Clean Water Act, problems with toxic chemicals continued to  occur. In addition, Congress became increasingly concerned about the  long-term effects of substantial amounts of chemicals entering the  environment.

TSCA was enacted to authorize EPA to collect information about the  hazards posed by chemical substances and to take action to control  unreasonable risks by either preventing dangerous chemicals from  making their way into use or placing restrictions on those already in  commerce. Under the act, EPA can control the entire life cycle of  chemicals from their production, distribution in commerce, and use to  their disposal. Other environmental and occupational health laws  generally control only disposal or release to the environment, or  exposures in the workplace. The scope of TSCA includes those  chemicals manufactured, imported, processed, distributed in commerce,  used, or disposed of in the United States but excludes certain substances  regulated under other laws. TSCA also 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 confidential business  information.

EPA’s authority to ensure that chemicals in commerce do not present an  unreasonable risk of injury to health or the environment is established in  five major sections of TSCA. The purpose and application of these  sections are shown in table 1 and described in further detail below.

Under the provisions for chemical testing in section 4 of TSCA, EPA can  promulgate rules to require chemical companies to test potentially harmful  chemicals for their health and environmental effects. However, EPA must  first determine that testing is warranted based on some toxicity or  exposure information. Specifically, to require such testing, EPA must find  that a chemical (1) may present an unreasonable risk of injury to human  health or the environment or (2) is or will be produced in substantial  quantities and that either (a) there is or may be significant or substantial  human exposure to the chemical or (b) the chemical enters or may  reasonably be anticipated to enter the environment in substantial  quantities. EPA must also determine that there are insufficient data to  reasonably determine or predict the effects of the chemical on health or  the environment and that testing is necessary to develop such data.

Under the provisions for new chemical review and significant new use  rules in section 5 of TSCA, chemical companies are to notify EPA at least  90 days before beginning to manufacture a new chemical  (premanufacture notice review). Section 5 also allows EPA to promulgate  significant new use rules, which require companies to notify EPA at least  90 days before beginning to manufacture a chemical for certain new uses  or in certain new ways (significant new use notice review). Such rules  require existing chemicals to undergo the same type of review that new  chemicals undergo. For example, EPA may issue a significant new use  rule if it learns that a chemical that has previously been processed as a  liquid is now being processed as a powder, which may change how  workers are exposed to the chemical. Section 5 of the act also authorizes  EPA to maintain a list of chemicals—called the chemicals of concern  list—that present or may present an unreasonable risk of injury to health  or the environment.

Under the provisions for chemical regulation in section 6 of TSCA, EPA is  to apply regulatory requirements to chemicals for which EPA finds a  reasonable basis exists to conclude that the chemical presents or will  present an unreasonable risk of injury to health or the environment. To  adequately protect against a chemical’s risk, EPA can promulgate a rule  that bans or restricts the chemical’s production, processing, distribution in  commerce, disposal, or use or requires warning labels be placed on the  chemical. Under TSCA, EPA must choose the least burdensome  requirement that will adequately protect against the risk.

Under the provisions for industry reporting of chemical data in section  8(a), EPA is to promulgate rules under which chemical companies must  maintain records and submit such information as the EPA Administrator  reasonably requires. This information can include, among other things,  chemical identity, categories of use, production levels, by-products,  existing data on adverse human health and environmental effects, and  the number of workers exposed to the chemical, to the extent such  information is known or reasonably ascertainable. Under section 8(a),  EPA issues rules to update the TSCA inventory. For example, in August  2011, EPA finalized its TSCA Chemical Data Reporting rule (previously  referred to as the Inventory Update Reporting Modifications Rule); the  rule requires companies to report, among other things, exposure-related  information, such as production volume and use data, on chemicals  manufactured or imported over a certain volume per year. In addition,  section 8(d) provides EPA with the authority to promulgate rules under  which chemical companies are required to submit lists or copies of  existing health and safety studies to EPA. Section 8(e) generally requires  chemical companies to report any information to EPA that reasonably  supports a conclusion that a chemical presents a substantial risk of injury  to health or the environment.

Under the provisions for disclosure of chemical data in section 14, EPA  may disclose chemical information it obtains under TSCA under certain  conditions. Chemical companies can claim certain information, such as  data disclosing chemical processes, as confidential business information.  EPA generally must protect confidential business information against  public disclosure unless necessary to protect against an unreasonable  risk of injury to health or the environment. Other federal agencies and  federal contractors can obtain access to this confidential business  information to carry out their responsibilities. EPA may also disclose  certain data from health and safety studies.

section_title: Historical Challenges EPA Has Faced Regulating Chemicals under TSCA
paragraphs: We have previously reported that EPA has historically faced challenges  implementing many of the provisions of TSCA, in particular (1) obtaining  adequate information on chemical toxicity and exposure through testing  provisions; (2) banning or limiting chemicals; and (3) disclosing chemical  data and managing company assertions of confidentiality.
subsections: section_title: Obtaining Adequate Information on Chemical Toxicity and Exposure
paragraphs: EPA has found it difficult to obtain adequate information on chemical  toxicity and exposure because TSCA does not require companies to  provide this information and, instead, requires EPA to demonstrate that  chemicals pose certain risks before it can ask for such information.

Specifically, we reported in 2005 that under section 4—provisions for  chemical testing—EPA has found its authority to be difficult, time- consuming, and costly to use. The structure of this section places the  burden on EPA to demonstrate certain health or environmental risks  before it can require companies to further test their chemicals. While  TSCA authorizes EPA to review existing chemicals, it generally provides  no specific requirement, time frame, or methodology for doing so. Instead,  EPA conducts initial reviews after it receives information from the public  or chemical companies that a chemical may pose a risk. As a result, EPA  has only limited information on the health and environmental risks posed  by these chemicals. In our June 2005 report, we suggested that Congress  consider amending TSCA to provide explicit authority for EPA to enter  into enforceable consent agreements under which chemical companies  are required to conduct testing, and give EPA, in addition to its current  authorities under section 4 of TSCA, the authority to require chemical  substance manufacturers and processors to develop test data based on  substantial production volume and the necessity for testing.

In addition, we reported in June 2005 that under section 5—provisions for  new chemical review—TSCA generally requires chemical companies to  submit a notice to EPA (known as a “premanufacture notice”) before they  manufacture or import new chemicals and to provide any available test  data. EPA estimated that most notices do not include any test data and  that about 15 percent of them included health or safety test data. These  tests may take over a year to complete and cost hundreds of thousands  of dollars, and chemical companies usually do not perform them  voluntarily. However, chemical companies are not generally required  under TSCA to limit the production of a chemical or its uses to those  specified in the premanufacture notice or to submit another  premanufacture notice if changes occur. For example, companies may  increase production levels or expand the uses of a chemical, potentially  increasing the risk of injury to human health or the environment.

section_title: Banning or Limiting Chemicals
paragraphs: EPA has had difficulty demonstrating that chemicals should be banned or  have limits placed on their production or use under section 6—provisions  for controlling chemicals. Specifically, we reported, in June 2005, that  since Congress enacted TSCA in 1976, EPA has issued regulations  under section 6 to ban or limit the production or restrict the use of five  existing chemicals or chemical classes out of tens of thousands of  chemicals listed for commercial use on the agency’s TSCA inventory.

EPA’s 1989 asbestos rule illustrates the difficulties EPA has had in  issuing regulations to control existing chemicals. In 1979, EPA started  considering rulemaking on asbestos. After concluding that asbestos was  a potential carcinogen at all levels of exposure, EPA promulgated a rule in 1989 prohibiting the future manufacture, importation, processing, and  distribution of asbestos in almost all products. Some manufacturers of  asbestos products filed suit against EPA, arguing, in part, that the rule  was not promulgated on the basis of substantial evidence regarding  unreasonable risk. In 1991, the Fifth Circuit Court of Appeals ruled for the  manufacturers and returned parts of the rule to EPA for reconsideration.  In reaching this conclusion, the court found that EPA did not consider all  necessary evidence and failed to show that the control action it chose  was the least burdensome reasonable regulation required to adequately  protect human health or the environment. Since the court’s 1989 decision,  EPA has only exercised its authority to ban or limit the production or use  of an existing chemical once—for hexavalent chromium, a known human  carcinogen widely used in industrial cooling towers—in 1990.

section_title: Disclosure of Chemical Data
paragraphs: EPA has limited ability to publicly share the information it receives from  chemical companies under TSCA. Specifically, as we reported in 2005,  EPA has not routinely challenged companies’ assertions that the  chemical data they disclose to EPA under section 14—disclosure of  chemical data—are confidential business information, citing resource  constraints. TSCA requires EPA to protect trade secrets and privileged or  confidential commercial or financial information against unauthorized  disclosures. When information is claimed as confidential business  information, it limits EPA’s ability to expand public access to this  information—such as sharing it with state environmental agencies and  foreign governments, which potentially limits the effectiveness of these  organizations’ environmental risk programs.

Because EPA has not routinely challenged these assertions, the extent to  which companies’ confidentiality claims are warranted is unknown. We  recommended, in June 2005, that EPA revise its regulations to require  that companies periodically reassert claims of confidentiality.not disagree with our recommendation but has not revised its regulations.  EPA has explored ways to reduce the number of inappropriate and over- broad claims of confidentiality by companies that submit data to EPA.

section_title: EPA Has Made Progress to Implement Its New Approach to Managing Chemicals, but Some Challenges Persist
paragraphs: In March 2013, we reported on progress EPA has made implementing its  new approach to manage toxic chemicals under its existing TSCA  authority—particularly by increasing efforts to (1) obtain toxicity and  exposure data, (2) assess risks posed by chemicals, and (3) discourage  the use of some chemicals. However, the results of EPA’s activities, in  most cases, have yet to be realized. We also reported that it is unclear  whether EPA’s new approach will position the agency to achieve its goal  of ensuring the safety of chemicals.
subsections: section_title: EPA Has Increased Efforts to Collect Data on Toxicity and Exposure, but It May Take Several Years to Produce Results
paragraphs: EPA has increased its efforts to collect toxicity and exposure data, but  because rules can take years to finalize and additional time for  companies to execute, these efforts may take several years to produce  results. Even with these efforts, EPA has not pursued all opportunities to  obtain chemical data.

We reported, in March 2013, that EPA has made progress by taking the  following actions but continues to face challenges in collecting such data,  specifically:

Since 2009, EPA has proposed or promulgated rules to require  chemical companies to test 57 chemicals. Specifically, EPA has  required companies to test 34 chemicals and provide EPA with the  resulting toxicity and other data. In addition, EPA announced, but has  yet to finalize, plans to require testing for 23 additional chemicals.

However, requirements under TSCA place the burden of developing  toxicity data on EPA. Because rulemaking can take years, EPA has  yet to obtain much of the information it has been seeking. According  to EPA officials, it can take, on average, 3 to 5 years for the agency to  promulgate a test rule and an additional 2 to 2 ½ years for the  companies to provide the data once EPA has requested them. In  addition, the toxicity data eventually obtained on the 57 chemicals  may not be sufficient for EPA to conduct a risk assessment (i.e.,  characterize risk by determining the probability that populations or  individuals so exposed to a chemical will be harmed and to what  degree). Specifically, EPA may obtain data that are considered to be  “screening level” information. Screening level information is collected  to identify a chemical’s potential hazards to human health and the  environment, but it was not intended to be the basis for assessing  whether a chemical poses an unreasonable risk of injury to human  health or the environment, according to agency documents describing  the program.

In August 2011, EPA revised its periodic chemical data reporting  requirements to obtain exposure-related information for a greater  number of chemicals. Under the revised requirements, EPA (1)  lowered the reporting thresholds, in some cases, which will allow it  to look at exposure scenarios for a larger number of chemicals than in  the past and (2) shortened the reporting cycle from every 5 years to  every 4 years. In addition, starting in 2016, the revised requirements  for reporting will be triggered when companies exceed applicable  production thresholds in any year during the 4-year reporting cycle.

Even with the increased efforts EPA has taken to collect toxicity and  exposure data, in March 2013, we reported that EPA has not pursued all  opportunities to obtain such data. For example, EPA has not sought  toxicity and exposure data that companies submit to the European  Chemicals Agency on chemicals that the companies manufacture or  process in, or import to, the United States.chemicals legislation, the European Chemicals Agency may share  information it receives from chemical companies with foreign  governments in accordance with a formal agreement concluded between  the European Community and the foreign government, but EPA has not  pursued such an agreement. In addition, EPA has not issued a rule under  section 8 of TSCA requiring companies to provide EPA with the  information provided to the European Chemicals Agency. EPA officials  told us that the agency has not sought to obtain chemical data—from  either the European Chemicals Agency or companies directly—because it  does not believe that this would be the best use of EPA or industry  resources. They also said that it is unclear whether these data would be  useful to EPA. EPA officials believe it is a more effective use of resources  to gain access to data, as needed, on a case-by-case basis from  chemical companies. As a result, we recommended that EPA consider  promulgating a rule under TSCA section 8, or take action under another  section, as appropriate, to require chemical companies to report chemical  toxicity and exposure-related data they have submitted to the European  Chemicals Agency. In its written comments on a draft of our March 2013  report, EPA stated that it intends to pursue data submitted to the  European Chemicals Agency from U.S. companies using voluntary or  regulatory means as necessary but did not provide information on its  planned approach to pursue such data. Consequently, the extent to which  EPA plans to continue to rely on voluntary efforts to obtain the needed  data is unclear.

section_title: EPA Has Begun Assessing Chemical Risks, but It Is Too Early to Tell What, If Any, Risk Management Actions Will Be Taken
paragraphs: EPA has increased its efforts to assess chemical risks, but because EPA  does not have the data necessary to conduct all risk assessments, it is  too early to tell what, if any, risk management actions will be taken. Even  with these efforts, it is unclear how EPA is going to obtain the data  necessary to continue to conduct all risk assessments.

We reported, in March 2013, that EPA has made progress to assess  chemical risks by taking the following actions but continues to face  challenges. Specifically, in February 2012, EPA announced a plan that  identified and prioritized 83 existing chemicals for risk assessment— known as the TSCA Work Plan. From this list of 83 chemicals, EPA’s  Office of Pollution Prevention and Toxics—the office responsible for  implementing TSCA—initiated risk assessments for 7 chemicals in  2012—5 of which were released for public comment—and announced  plans to start risk assessments during 2013 and 2014 for 18 additional  chemicals. EPA officials told us that they expect that all 7 risk  assessments will be finalized early in 2014. However, it may be years  before EPA initiates regulatory or other risk management actions to  reduce any chemical risks identified in these assessments. Before EPA  can determine such actions are warranted, the agency would need to  consider other factors—such as costs and benefits of mitigating the risk,  technological information, and the concerns of stakeholders—which could  require additional time and resources. Moreover, assuming EPA meets its  2014 target for completing these 7 assessments and initiating new  assessments, at its current pace, it would take EPA at least 10 years to  complete risk assessments for the 83 chemicals in the TSCA Work Plan.

As we reported, in March 2013, even with these increased efforts, it is  unclear whether EPA can maintain its current pace given that it currently  does not have the toxicity and exposure data it will need to conduct risk  assessments for all of the 83 chemicals in its TSCA Work Plan. According  to EPA officials and agency documents, the agency has started or plans  to start risk assessments on the 25 chemicals for which it has well- characterized toxicity and exposure data. However, before EPA can  initiate risk assessments for the remaining 58 chemicals, the agency will  need to identify and obtain toxicity and exposure data. According to  agency officials, to obtain the toxicity data needed, EPA may need to  promulgate rules to require companies to perform additional testing on  some of these chemicals. However, EPA has not clearly articulated how  or when it plans to obtain these needed data. Moreover, without  exposure-related data, such as those potentially available from chemical  processors, EPA may still be missing the data necessary to conduct risk  assessments. To better position EPA to ensure chemical safety under  existing TSCA authority, in our March 2013 report we recommended that  EPA develop strategies for addressing challenges associated with  obtaining toxicity and exposure data needed for risk assessments.  However, based on EPA’s written response to a draft of our 2013 report,  it is unclear what action, if any, EPA intends to pursue.

section_title: EPA Has Taken Actions That May Discourage the Use of Certain Chemicals, but It Is Too Early to Tell Whether These Actions Will Reduce Chemical Risk
paragraphs: EPA has taken actions that may discourage the use of certain chemicals,  but because many of these actions have yet to be finalized, it is too early  to tell whether they will reduce chemical risk. We reported in March 2013  that, given the difficulty that EPA has faced in the past using section 6 of  TSCA to ban existing toxic chemicals or place limits on their production or  use, the agency generally considers using this authority only after  exhausting all other available options. Since 2009, EPA has made  progress by increasing its use of certain options, including (1) making  greater use of significant new use rules under section 5 and (2) proposing  actions that use its TSCA authority in new ways as follows:

EPA is making greater use of significant new use rules under section  5 to control new uses of existing chemicals. Our analysis of TSCA  rulemaking from 2009 to 2012 shows that EPA has quadrupled its  issuance of significant new use rules since 2009. From 2009 to 2012,  EPA issued significant new use rules affecting about 540 chemicals,  about 25 percent of all 2,180 chemicals subject to significant new use  rules issued by EPA since 1976. EPA officials told us that EPA  typically recommends that companies submit testing information when  they notify EPA of their intent to manufacture or process chemicals,  which enables EPA to better evaluate the potential risks associated  with the new use. According to EPA officials, this approach allows the  agency to “chip away” at chemicals that may pose risks to human  health and the environment. Such recommendations may discourage  companies from pursuing new uses of existing chemicals that may  pose health or environmental risks either because testing itself can be  expensive, or because the testing recommendation suggests that the  agency may consider banning or limiting the manufacture or  production of the chemical on the basis of that testing.

EPA has also proposed actions that use its TSCA authority in new  ways including the following:

Creating “chemicals of concern” list. In May 2010, EPA  announced that it intended to create a list of chemicals that  present or may present ‘‘an unreasonable risk of injury to health or  the environment.’’ EPA has had the authority to create such a list  under section 5 of TSCA since its enactment in 1976 but has  never attempted to use this authority. EPA submitted the list,  which consists of three groups of chemicals, for review by the  Office of Management and Budget (OMB) in May 2010, and as of  May 2013, EPA’s proposed “chemicals of concern” list has been  under review at OMB for over 1,000 days and remains listed as  pending review by OMB.

Pairing of test and significant new use rules. In December 2010,  EPA submitted to OMB for review a proposal to pair testing rules  with significant new use rules for the first time. Specifically, EPA  has proposed single rules that combine provisions requiring  companies to develop toxicity and other data with provisions  requiring companies to provide data for new uses of chemicals.  EPA has proposed using this approach in two cases. In one case,  for example, EPA proposed this approach for certain flame  retardants that are being voluntarily phased out, effective  December 2013. Under the proposed rule, any new use of the  chemical after it has been phased out would qualify as a  significant new use, triggering a testing requirement. According to  EPA officials, the pairing of these types of rules is intended to  discourage new uses of certain chemicals that may pose a risk to  human health or the environment and create a disincentive for  companies to continue current use of the chemical—something  EPA has not done before. OMB’s review of this proposal took 422  days and was completed on February 15, 2012.

Extending significant new use rules to articles. Since 2009, EPA  has made increasing use of its ability to subject chemicals  contained in certain products, or “articles,” such as furniture,  textiles, and electronics, to significant new use rules. Generally,  those who import or process a substance as part of a product are  exempted from compliance with a significant new use rule. EPA’s  proposals would eliminate this exemption for certain chemicals.

However, it is too early to assess the impact of EPA’s proposed actions  because they have yet to be finalized. In addition, in some cases, OMB  has not met the established 90-day time for reviewing EPA’s proposed  actions—which has increased the time frames for formally proposing and  finalizing them. limited by executive order to 90 days, although it can be extended.

section_title: It Is Unclear Whether EPA’s New Approach Will Position the Agency to Achieve Its Goal of Ensuring the Safety of Chemicals
paragraphs: Any rules that EPA plans to issue under TSCA that are considered significant regulatory  actions, as defined by Executive Order 12866, are subject to review by the Office of  Information and Regulatory Affairs, an office within OMB, prior to being proposed in the  Federal Register. Among other things, a significant regulatory action may have an annual  effect on the economy of $100 million or more or raise novel legal or policy issues. case-by-case basis from chemical companies. However, the agency’s  strategy does not discuss how EPA would execute these plans or how  the data obtained would be used to inform the agency’s ongoing or  future risk assessment activities, if at all.

Banning or limiting the use of chemicals. EPA’s strategy does not  articulate how the agency would overcome the regulatory challenges  it experienced in the past. In particular, EPA officials told us that, even  if EPA has substantial toxicity and exposure data, the agency is  challenged in meeting the statutory requirement under section 6 of  TSCA to limit or ban chemicals.

Further, EPA’s strategy does not identify the resources needed to meet  its goal of ensuring chemical safety. For example, EPA’s strategy does  not identify the resources needed to carry out risk assessment activities,  even though risk assessment is a central part of EPA’s effort to manage  chemicals under its new approach. Specifically, EPA does not identify  roles and responsibilities of key staff or offices—for example which office  within EPA will develop the toxicity assessments needed to support its  planned risk assessments—or identify staffing levels or cost associated  with conducting its risk assessment activities. Without a clear  understanding of the resources needed to complete risk assessments  and other activities identified in its strategy, EPA cannot be certain that its  current funding and staffing levels are sufficient to execute its new  approach to managing chemicals under existing TSCA authorities.

When developing new initiatives, agencies can benefit from following  leading practices for federal strategic planning. Of these leading  practices, it is particularly important for agencies to define strategies that  address management challenges that threaten their ability to meet long- term goals. In our March 2013 report, we stated that without a plan that  incorporates leading strategic planning practices—particularly a plan that  clearly articulates how EPA will address management challenges—EPA  cannot be assured that it its new approach to managing chemicals, as  described in its Existing Chemicals Program Strategy, will provide a  framework to effectively guide its efforts. Consequently, EPA could be  investing valuable resources, time, and effort without being certain that its  efforts will bring the agency closer to achieving its goal of ensuring the  safety of chemicals. As a result, we recommended that the EPA  Administrator direct the appropriate offices to develop strategies for  addressing challenges that impede the agency’s ability to meet its goal of  ensuring chemical safety to better position EPA to ensure chemical safety  under its existing TSCA authority. In its written response to our March  2013 report, EPA’s Acting Assistant Administrator stated that change is  needed in every significant aspect of the program, and, while strategic  planning is a useful exercise it cannot substitute for the basic authorities  needed for a modern, effective chemicals program. Moreover, the Acting  Assistant Administrator stated that it is EPA’s position that, absent  statutory changes to TSCA, the agency will not be able to successfully  meet the goal of ensuring chemical safety now and into the future.

Chairman Shimkus, Ranking Member Tonko, and Members of the  Subcommittee, this concludes my prepared statement. I would be happy  to respond to any questions that you or Members of the Subcommittee  may have at this time.

section_title: GAO Contact and Staff Acknowledgments
paragraphs: If you or your staff members have any questions about this testimony,  please contact me at (202) 512-3841 or gomezj@gao.gov. Contact points  for our Offices of Congressional Relations and Public Affairs may be  found on the last page of this statement. Other individuals who made key  contributions include Diane LoFaro, Assistant Director; Diane Raynes,  Assistant Director; Elizabeth Beardsley; Richard Johnson; Alison O’Neill;  and Aaron Shiffrin.

section_title: Related GAO Products
paragraphs: Toxic Substances: EPA Has Increased Efforts to Assess and Control  Chemicals but Could Strengthen Its Approach, GAO-13-249 (Washington,  D.C.: Mar. 22, 2013).

Chemical Regulation: Observations on Improving the Toxic Substances  Control Act. GAO-10-292T. Washington, D.C.: December 2, 2009.

Chemical Regulation: Options for Enhancing the Effectiveness of the  Toxic Substances Control Act. GAO-09-428T. Washington, D.C.:  February 26, 2009.

High-Risk Series: An Update. GAO-09-271. Washington, D.C.: January  22, 2009.

Toxic Chemicals: EPA’s New Assessment Process Will Increase  Challenges EPA Faces in Evaluating and Regulating Chemicals.  GAO-08-743T. Washington, D.C.: April 29, 2008.

Chemical Regulation: Comparison of U.S. and Recently Enacted  European Union Approaches to Protect against the Risks of Toxic  Chemical. GAO-07-825. Washington, D.C.: August 17, 2007.

Chemical Regulation: Actions Are Needed to Improve the Effectiveness of  EPA’s Chemical Review Program. GAO-06-1032T. Washington, D.C.:  August 2, 2006.

Chemical Regulation: Approaches in the United States, Canada, and the  European Union. GAO-06-217R. Washington, D.C.: November 4, 2005.

Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess  Health Risks and Manage Its Chemical Review Program. GAO-05-458.  Washington, D.C.: June 13, 2005.

Toxic Substances: EPA Should Focus Its Chemical Use Inventory on  Suspected Harmful Substances. GAO/RCED-95-165. Washington, D.C.:  July 7, 1995.

Toxic Substances Control Act: Legislative Changes Could Make the Act  More Effective. GAO/RCED-94-103. Washington, D.C.: September 26,  1994.

Toxic Substances: EPA’s Chemical Testing Program Has Not Resolved  Safety Concern. GAO/RCED-91-136. Washington, D.C.: June 19, 1991.

Toxic Substances: EPA’s Chemical Testing Program Has Made Little  Progress. GAO/RCED-90-112. Washington, D.C.: April 25, 1990.

EPA’s Efforts To Identify and Control Harmful Chemicals in Use.  GAO/RCED-84-100. Washington, D.C.: June 13, 1984.

This is a work of the U.S. government and is not subject to copyright protection in the  United States. The published product may be reproduced and distributed in its entirety  without further permission from GAO. However, because this work may contain  copyrighted images or other material, permission from the copyright holder may be  necessary if you wish to reproduce this material separately.


Question-summary annotations: questions: question: Why does the EPA have a limited number of banned chemicals?
answer: EPA has had difficulty demonstrating that chemicals should be banned or have limits placed on their production or use under section 6--provisions for controlling chemicals.

question: What is the extent of the agency's power in terms of banning dangerous chemicals?
answer: The agency issued regulations to ban or limit production or use of five existing chemicals, or chemical classes, out of tens of thousands of chemicals listed for commercial use.
child_questions: question: What is an example of the EPA's difficulties?
answer: A court reversal of EPA's 1989 asbestos rule illustrates the difficulties EPA has had in issuing regulations to control existing chemicals.

questions: question: Why is it not certain that the EPA will take the necessary steps to identify all of the dangerous chemicals in commercial use?
answer: EPA has increased efforts to assess chemical risks, but because EPA does not have the data necessary to conduct all risk assessments, it is too early to tell what, if any, risk management actions will be taken.

question: How has the EPA addressed this issue in the past?
answer: In February 2012, EPA announced a plan that identified and prioritized 83 existing chemicals for risk assessment; the agency initiated assessments for 7 chemicals in 2012 and announced plans to start 18 additional assessments during 2013 and 2014.
child_questions: question: Why can't the EPA simply repeat this process today?
answer: At its current pace, it would take EPA at least 10 years to complete risk assessments for the 83 chemicals.

questions: question: What is the future of the EPA's success in managing dangerous chemicals?
answer: In addition, it is unclear whether EPA's new approach to managing chemicals will position the agency to achieve its goal of ensuring the safety of chemicals.

question: What is the problem with the EPA's current strategy?
answer: EPA's Existing Chemicals Program Strategy, which is intended to guide EPA's efforts to assess and control chemicals in the coming years, does not discuss how EPA will address identified challenges.
child_questions: question: Why is this a major issue within the agency?
answer: Consequently, EPA could be investing valuable resources, time, and effort without being certain that its efforts will bring the agency closer to achieving its goal of ensuring the safety of chemicals.

questions: question: What is the history of the EPA's authority to control toxic substances?
answer: In 1976, Congress passed TSCA to give EPA the authority to obtain more health and safety information on chemicals and to regulate chemicals it determines pose unreasonable risks of injury to human health or the environment.
child_questions: question: Why has the EPA had difficulty implementing the TSCA?
answer: GAO has reported that EPA has found many of TSCA's provisions difficult to implement.

question: How did the EPA attempt to make TSCA more effective?
answer: In 2009, EPA announced TSCA reform principles to inform ongoing efforts in Congress to strengthen the act.
child_questions: question: What else did the EPA do to make it easier to manage toxic substances?
answer: At that time, EPA also initiated a new approach for managing toxic chemicals using its existing TSCA authorities.

questions: question: How is GAO responding to the Toxic Substances Control Act and EPA implementation?
answer: GAO is not making new recommendations in this testimony.
child_questions: question: How did GAO respond to previous government regulations?
answer: In prior reports, GAO suggested that Congress consider statutory changes to TSCA to give EPA additional authorities to obtain information from the chemical industry and shift more of the burden to chemical companies for demonstrating the safety of their chemicals.

question: What does GAO typically recommend of the EPA in order to address chemical regulation?
answer: In these reports, among other things, GAO recommended that EPA require companies to provide chemical data they submitted to foreign governments, require companies to reassert confidentiality claims, and develop strategies for addressing challenges that impeded EPA's ability to ensure chemical safety.
child_questions: question: How does EPA respond to GAO's recommendations?
answer: EPA's responses to these recommendations have varied.