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    Subject Term: "Toxic substances"

    8 publications with a total of 18 open recommendations including 6 priority recommendations
    Director: Andrew Sherrill
    Phone: (202) 512-7215

    2 open recommendations
    Recommendation: To enhance consistency with DOL policy and procedures in adjudicating EEOICPA Part E claims, the Secretary of Labor should strengthen internal controls by requiring district offices to take steps to ensure that all claimant correspondence for Recommended and Final Decisions receives supervisory review.

    Agency: Department of Labor
    Status: Open

    Comments: The Department of Labor agreed with our recommendation that a second level review will provide a higher degree of internal quality control. However, upon evaluating our recommendation, Labor determined that given its current staffing levels it would not be possible to conduct a supervisory review of all Recommended and Final Decisions without having an adverse impact on the issuance of timely decisions for claimants. Instead, Labor is implementing a process to review a sample of decision letters - initially 10 percent - and make procedural adjustments based on the results of those reviews. We will revisit the status of this recommendation pending the results of Labor's supervisory reviews of selected decision letters.
    Recommendation: To enhance consistency with DOL policy and procedures in adjudicating EEOICPA Part E claims, the Secretary of Labor should strengthen internal controls by requiring district offices to document that the SEM was checked for updates just prior to issuing a Recommended Decision to deny a claim in cases in which the date of the last SEM update has not changed since the claims examiner's prior check.

    Agency: Department of Labor
    Status: Open

    Comments: The Department of Labor agreed with our recommendation pertaining to documenting searches of the Site Exposure Matrix during claims processing. Labor stated that it has implemented the recommendation by updating relevant guidance in the Federal EEOICPA Procedure Manual. We will update the status of this recommendation pending verification that the Procedure Manual was revised to require claims examiners to document that, before denying a claim they checked the Site Exposure Matrix to ensure pertinent information had not changed since the examiner's prior check.
    Director: David C. Trimble
    Phone: (202) 512-3841

    5 open recommendations
    including 2 priority recommendations
    Recommendation: To improve DOE's management and oversight of the WTP project, the Secretary of Energy should, in assessing the alternatives, revise cost and schedule estimates for the Low Activity Waste Pretreatment System and the Tank Waste Characterization and Staging facility in accordance with industry best practices.

    Agency: Department of Energy
    Status: Open

    Comments: We will monitor the status of this proposed requirement.
    Recommendation: To improve DOE's management and oversight of the WTP project, the Secretary of Energy should revise the statements of mission need for the two proposed projects to allow DOE to consider a variety of alternatives without limiting potential solutions, consistent with the DOE requirement that mission need statements should not identify particular solution such as equipment, facility, or technology.

    Agency: Department of Energy
    Status: Open

    Comments: According to DOE DARTS report on 5/19/16, revision of the statement of mission for the Low Activity Waste Pretreatment System "has become overcome by events". We will continue to follow up on this recommendation.
    Recommendation: To improve DOE's management and oversight of the WTP project, the Secretary of Energy should, in accordance with DOE's Office of River Protection quality assurance policy, conduct an extent-of-condition review for WTP's High Level Waste and Low Activity Waste facilities' systems that have not been reviewed by DOE.

    Agency: Department of Energy
    Status: Open
    Priority recommendation

    Comments: DOE agreed with the recommendations and in its written responses to our report stated that it had implemented them. However, we believe additional actions are needed, as indicated in the priority recommendations letter we sent to DOE in 2017. To fully address the recommendations, DOE should conduct an extent-of-condition review for WTP's High Level Waste and Low Activity Waste facilities' systems.
    Recommendation: To improve DOE's management and oversight of the WTP project, the Secretary of Energy should consider whether or to what extent construction activities for the High Level Waste and Low Activity Waste facilities should be further limited until aggressive risk mitigation strategies are developed and employed to address technical challenges that DOE, the contractor, and others have identified but not yet resolved.

    Agency: Department of Energy
    Status: Open
    Priority recommendation

    Comments: DOE has noted that these activities were already limited and stated that a specific set of criteria has been established for resuming construction on the High Level Waste facility. However, as we noted in our report, an extent-of-condition review has not been performed on the remainder of the facility's systems, and recommendations from the facility's design and operability review have not been implemented. DOE also stated that construction on the Low Activity Waste facility is nearly complete, that the WTP Federal Project Director has a detailed risk register, and that each remaining risk is being proactively mitigated. This statement, however, does not fully reflect the extent or potential seriousness of the technical risks that remain. An extent-of-condition review may mean limiting the production of new design documents until this review is complete in order to avoid potential costly rework. We believe additional actions are needed. To fully address the recommendation, DOE should consider whether or to what extent construction activities for those facilities should be further limited until this review is completed and aggressive risk mitigation strategies are developed and employed.
    Recommendation: To improve DOE's management and oversight of the WTP project, the Secretary of Energy should enlist the services of another agency or external entity to serve as an owner's agent to assist the Office of River Protection in reviewing and evaluating the WTP contractor's design and approach to mitigating design challenges.

    Agency: Department of Energy
    Status: Open

    Comments: Congress required DOE to meet this requirement in the 2016 NDAA, and DOE reports that they issued a contract to Parsons Government Services on September 29, 2015. We have requested a copy of this contract for review to ensure that the recommendation has been addressed.
    Director: Alicia Puente Cackley
    Phone: (202) 512-8678

    2 open recommendations
    Recommendation: To achieve greater efficiency and effectiveness, Congress should consider transferring the oversight of the markings of toy and imitation firearms in 15 U.S.C. 5001 from the National Institute of Standards and Technology (within the Department of Commerce) to the Consumer Product Safety Commission.

    Agency: Congress
    Status: Open

    Comments: This matter is an action identified in GAO's annual Duplication and Cost Savings reports. There has been no legislative action identified. The Gun Look-Alike Case Act, H.R. 3224, which was introduced on July 27, 2015, in the 114th Congress, would transfer the authority to regulate the markings of toy, look-alike, and imitation firearms in section 5001 of title 15 of the U.S. Code from NIST to CPSC, as GAO suggested in November 2014. This bill was referred to the Subcommittee on Commerce, Manufacturing, and Trade of the Committee on Energy and Commerce in the United States House of Representatives, and did not pass out of committee. As of March 1, 2017, the bill has not been reintroduced in the 115th Congress.
    Recommendation: To improve existing coordination of oversight for consumer product safety, Congress should consider establishing a formal comprehensive oversight mechanism for consumer product safety agencies to address crosscutting issues as well as inefficiencies related to fragmentation and overlap such as communication and coordination challenges and jurisdictional questions between agencies. Different types of formal mechanisms could include, for example, creating a memorandum of understanding to formalize relationships and agreements or establishing a task force or interagency work group. As a starting point, Congress may wish to obtain agency input on options for establishing more formal coordination.

    Agency: Congress
    Status: Open

    Comments: This matter is an action identified in GAO's annual Duplication and Cost Savings reports. There has been no legislative action identified. No legislation was introduced as of March 1, 2017, that would establish a collaborative mechanism to facilitate communication across the relevant agencies and to help enable them to collectively address crosscutting issues, as GAO suggested in November 2014. Some of the agencies with direct regulatory oversight responsibilities for consumer product safety reported that they continue to collaborate to address specific consumer product safety topics. However, without a formal comprehensive oversight mechanism, the agencies risk missing opportunities to better leverage resources and address challenges, including those related to fragmentation and overlap.
    Director: Gomez, Jose A
    Phone: (202) 512-3841

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To ensure that EPA maximizes its limited resources and addresses the statutory, regulatory, and programmatic needs of EPA program offices and regions when IRIS toxicity assessments are not available, and once demand for the IRIS Program is determined, the EPA Administrator should direct the Deputy Administrator, in coordination with EPA's Science Advisor, to develop an agencywide strategy to address the unmet needs of EPA program offices and regions that includes, at a minimum: (1) coordination across EPA offices and with other federal research agencies to help identify and fill data gaps that preclude the agency from conducting IRIS toxicity assessments, and (2) guidance that describes alternative sources of toxicity information and when it would be appropriate to use them when IRIS values are not available, applicable, or current.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: As of October 2016, EPA indicated that the agency evaluated user needs for toxicity assessments as part of its process for developing the Multi-Year Agenda it issued in December 2015. We will continue to review additional information and documentation on EPA's agencywide strategy to address the unmet needs of EPA program offices and regions, and will update status comments as appropriate.
    Director: Trimble, David C
    Phone: (202) 512-3841

    3 open recommendations
    including 3 priority recommendations
    Recommendation: To better position EPA to collect chemical toxicity and exposure-related data and ensure chemical safety under existing TSCA authority, while balancing its workload, the Administrator of EPA should 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.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: As of July 2017, EPA is better positioned to take action to require chemical companies to report chemical toxicity and exposure-related data submitted to the European Chemicals Agency due to passage of the new TSCA law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Since the law was signed by the President on June 22, 2016, EPA finalized a rule to establish the agency's process for evaluating high priority chemicals to determine whether or not they present an unreasonable risk to health or the environment and finalized a rule to require industry reporting of chemicals manufactured or processed in the US over the past 10 years. However, EPA has not yet carried out actions consistent with the substance of our recommendation. Once EPA has carried out such actions, we will reassess the status of this open recommendation.
    Recommendation: To better position EPA to collect chemical toxicity and exposure-related data and ensure chemical safety under existing TSCA authority, while balancing its workload, the Administrator of EPA should consider promulgating a rule under TSCA section 8, or take action under another section, as appropriate, to require chemical companies to report exposure-related data from processors to EPA.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: As of July 2017, EPA is better positioned to take action to require chemical companies to report exposure-related data from processors to EPA due to passage of the new TSCA law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Since the law was signed by the President on June 22, 2016, EPA has completed some implementation activities, including finalizing a rule to require industry reporting of chemicals manufactured or processed in the US over the past 10 years. However, EPA has not yet carried out actions consistent with the substance of our open recommendation. Once EPA has carried out such actions, we will reassess the status of this open recommendation.
    Recommendation: To better position EPA to collect chemical toxicity and exposure-related data and ensure chemical safety under existing TSCA authority, while balancing its workload, and to better position EPA to ensure chemical safety under existing TSCA authority, the Administrator of EPA should direct the appropriate offices to develop strategies for addressing challenges that impede the agency's ability to meet its goal of ensuring chemical safety. At a minimum, the strategies should address challenges associated with: (1) obtaining toxicity and exposure data needed to conduct ongoing and future TSCA Work Plan risk assessments, (2) gaining access to toxicity and exposure data provided to the European Chemicals Agency, (3) working with processors and processor associations to obtain exposure-related data, (4) banning or limiting the use of chemicals under section 6 of TSCA and planned actions for overcoming these challenges--including a description of other actions the agency plans to pursue in lieu of banning or limiting the use of chemicals, and (5) identifying the resources needed to conduct risk assessments and implement risk management decisions in order to meet its goal of ensuring chemical safety.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: As of July 2017, EPA is better positioned to take action to require chemical companies to report chemical toxicity and exposure data, analyze the data, take necessary actions, and identify the resources needed for evaluating and managing risk to ensure chemical safety due to passage of the new TSCA law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Since the new law was signed by the President on June 22, 2016, EPA finalized a rule to establish the agency's process for evaluating high priority chemicals to determine whether or not they present an unreasonable risk to health or the environment and finalized a rule to require industry reporting of chemicals manufactured or processed in the U.S. over the past 10 years. However, EPA has not yet carried out actions consistent with the substance of our recommendation, including actually obtaining the data necessary to make risk-informed regulatory decisions, and then making those decisions as appropriate. Once EPA has carried out such actions, we will reassess the status of this open recommendation.
    Director: Shames, Lisa R
    Phone: (202) 512-2649

    2 open recommendations
    Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to minimize the potential for conflicts of interest in companies' GRAS determinations, including taking steps such as issuing guidance for companies on conflict of interest and requiring information in GRAS notices regarding expert panelists' independence.

    Agency: Department of Health and Human Services: Food and Drug Administration
    Status: Open

    Comments: In September 2014, FDA indicated that guidance on potential conflicts of interest for experts participating on GRAS panels is a priority for the agency. In its Final Rule on Substances Generally Recognized as Safe (81 FR 54959), issued Aug. 17, 2016, FDA stated that it had decided to issue guidance regarding conflicts of interest and that it would announce the availability of a draft guidance document through a notice in the Federal Register. As of December 2016, FDA had not yet issued this draft guidance.
    Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to monitor the appropriateness of companies' GRAS determinations through random audits or some other means, including issuing guidance on how to document GRAS determinations.

    Agency: Department of Health and Human Services: Food and Drug Administration
    Status: Open

    Comments: On Aug. 17, 2016, FDA published a final rule on Substances Generally Recognized as Safe (GRAS) (81 FR 54959). This final rule includes a section titled "Guidance on Documenting Conclusions of GRAS Status," which states that FDA is "issuing a guidance" for companies on how to document their GRAS determinations. It is not clear from the rule the time frame for issuing this guidance, whether it will be issued in draft first for comment, and whether it will part of the guidance on conflicts of interest that FDA also plans to issue at a later date, as noted elsewhere in the rule. As of December 2016, FDA had not issued this guidance.
    Director: Stephenson, John B
    Phone: (202)512-6225

    1 open recommendations
    Recommendation: Because EPA alone cannot address the complexities of the nation's challenges in addressing environmental health risks for children, Congress may wish to consider re-establishing a government-wide task force on children's environmental health risks, similar to the one previously established by Executive Order 13045 and co-chaired by the Administrator of EPA and the Secretary of Health and Human Services. Congress may wish to consider charging it with identifying the principal environmental health threats to children and developing national strategies for addressing them. Congress may also wish to consider establishing in law the Executive Order's requirement for periodic reports about federal research findings and research needs regarding children's environmental health.

    Agency: Congress
    Status: Open

    Comments: As of December 2016, we have not identified actions by the Congress to establish in law requirements such as those in EO 13025.
    Director: Trimble, David C
    Phone: (202)512-6225

    2 open recommendations
    Recommendation: Congress may wish to consider amending CSB's authorizing statute or the Inspector General Act of 1978 to permanently give Environmental Protection Agency's (EPA) Inspector General the authority to serve as the oversight body for the agency.

    Agency: Congress
    Status: Open

    Comments: Congress has not taken action yet.
    Recommendation: As Congress prepares the appropriation of the EPA Inspector General, it may wish to consider providing the Inspector General with appropriations and staff allocations specifically for the audit function of CSB via a direct line in the EPA appropriation.

    Agency: Congress
    Status: Open

    Comments: Congress has not taken action yet.