II 113th CONGRESS 1st Session S. 50 IN THE SENATE OF THE UNITED STATES January 22 (legislative day, January 3), 2013 Mrs. Boxer (for herself and Mr. Crapo ) introduced the following bill; which was read twice and referred to the Committee on Environment and Public Works A BILL To direct the Administrator of the Environmental Protection Agency to investigate and address cancer and disease clusters, including in infants and children.

1. Short title This Act may be cited as the Strengthening Protections for Children and Communities From Disease Clusters Act . 2. Findings Congress finds that— (1) children are particularly at risk from environmental pollutants or toxic substances for various reasons, including because— (A) the nervous, immune, digestive, and other systems of children are still developing as the children move though several stages of rapid growth and development; (B) exposure to environmental pollutants or toxic substances can affect prenatal, infant, and childhood growth and development; (C) children may be less able to detoxify and excrete toxins than adults; (D) children eat proportionately more food, drink more fluids, breathe more air, and play outside more, which means children are more exposed to environmental pollutants and toxic substances than adults; (E) children are less able to protect themselves from exposures to environmental pollutants or toxic substances; (F) the behavior of children exposes children to different environmental pollutants and toxic substances than adults; (G) the natural curiosity and tendency of children to explore leaves children open to health risks that adults can more easily avoid; and (H) the developing brains, reproductive systems, and other organs of children are more susceptible to permanent disruption that can result in health problems during the lives of the children; (2) according to the Department of Health and Human Services, birth defects are the leading cause of infant death in the first year of life, accounting for about 20 percent of infant deaths in 2006; (3) according to the American Cancer Society, cancer is the second leading cause of death in children, exceeded only by accidents; (4) according to the Centers for Disease Control and Prevention, an estimated 1 in 110 children in the United States have an autism spectrum disorder; (5) scientific research on environmental, genetic, and other influences that may affect environmental health is a national priority; (6) Federal agencies should work to address serious environmental health problems to better protect children and other individuals in communities, both large and small, across the United States; and (7) according to the National Academy of Sciences— (A) it is in the national interest to place a higher priority on the health of children; (B) in the short term, that priority will result in children whose health and quality of life is improved and who are more ready and able to learn; (C) children have important value in their own right and are worthy of that type of societal commitment; (D) it is also in the national interest to optimize the health of children because, in the long term— (i) the continuing viability of society depends on a citizenry and a workforce that are properly equipped to be productive and committed to serving the country; and (ii) failure to improve the health of children will have a substantial long-term consequence for the health of the adult population; and (E) investing in the health of children is necessary for all of the reasons described in subparagraphs (A) through (D) and is the right thing to do. 3. Purposes The purposes of this Act are— (1) to provide to the Administrator the authority to help conduct investigations into the potential for environmental pollutants or toxic substances to cause disease clusters; (2) to ensure that the Administrator has the authority to undertake actions to help address existing and potential environmental pollution and toxic substances that may contribute to the creation of disease clusters; and (3) to enable the Administrator to integrate and work in conjunction with other Federal, State, and local agencies, institutions of higher education, and the public in investigating and helping to address the possible causes of disease clusters. 4. Goals The goals of this Act are— (1) to protect and assist pregnant women, infants, children, and other individuals who have been, are, or could be harmed by, and become part of, a disease cluster; (2) to enhance Federal resources, expertise, outreach, transparency, and accountability in responding to public and State and local government inquiries about the potential causes of a disease cluster; (3) to strengthen Federal analytical capacity and coordination, including with State and local authorities, in the investigation of the potential causes of disease clusters; (4) to develop multidisciplinary teams that undertake a systematic, integrated approach to investigate and help address the potential causes of disease clusters that State and local officials cannot address or need assistance in addressing; and (5) to help facilitate the rapid investigation of potential disease clusters and actions to address the potential causes of disease clusters. 5. Definitions In this Act: (1) Administrator The term Administrator means the Administrator of the Environmental Protection Agency. (2) Agency The term Agency means the Environmental Protection Agency. (3) Director The term Director means the Director of the National Institute of Environmental Health Sciences. (4) Disease cluster The term disease cluster means— (A) the occurrence of a greater-than-expected number of cases of a particular disease within a group of individuals, a geographical area, or a period of time; or (B) the occurrence of a particular disease in such number of cases, or meeting such other criteria, as the Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director, may determine. (5) Environmental pollutants or toxic substances The term environmental pollutants or toxic substances includes the substances described in paragraph (7). (6) Federal agency The term Federal agency means— (A) any department, agency, or other instrumentality of the Federal Government; (B) any independent agency or establishment of the Federal Government (including any Government corporation); and (C) the Government Printing Office. (7) Potential causes of a disease cluster The term potential causes of a disease cluster includes environmental and public health factors that could increase the possibility of disease clusters, including environmental pollutants or toxic substances and sources of those pollutants and substances, including— (A) emissions of air pollutants that are regulated under the Clean Air Act (42 U.S.C. 7401 et seq.); (B) water pollutants that are regulated under the Federal Water Pollution Control Act (33 U.S.C. 1251 et seq.); (C) a contaminant, as that term is defined in section 1401 of the Safe Drinking Water Act (42 U.S.C. 300f); (D) a hazardous substance, as that term is defined in section 101 of the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9601); (E) solid waste and hazardous waste, as those terms are defined in section 1004 of the Solid Waste Disposal Act ( 42 U.S.C. 6903 ); (F) a chemical substance, as that term is defined in section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ); (G) a substance that is regulated under the Emergency Planning and Community Right-To-Know Act of 1986 ( 42 U.S.C. 11001 et seq. ); and (H) any other form of environmental pollution or toxic substance that is a known or potential cause of an adverse health effect, including a developmental, reproductive, neurotoxic, or carcinogenic effect. (8) Regional Response Center The term Regional Response Center means a Regional Disease Cluster Information and Response Center established under section 7. (9) Response Team The term Response Team means a Regional Disease Cluster Information and Response Team established under section 7. (10) Secretary The term Secretary means the Secretary of Health and Human Services. 6. Guidelines for environmental investigations of disease clusters (a) Establishment (1) In general The Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry, the Secretary, and the Director, shall develop, publish, and periodically update guidelines that describe a systematic, integrated approach that uses the best available science to investigate— (A) 1 or more suspected or potential disease clusters; (B) environmental pollutants or toxic substances associated with 1 or more suspected or potential disease clusters; or (C) potential causes of 1 or more disease clusters. (2) Coordination The Administrator shall ensure that the Office of Children’s Health Protection, in consultation with appropriate advisory committees, such as the Children’s Health Protection Advisory Committee, has a prominent role on behalf of the Agency in developing and updating guidelines under paragraph (1). (b) Requirements Guidelines developed under this section shall include— (1) definitions of key concepts and actions; (2) disease cluster identification and reporting protocols; (3) standardized methods of reviewing and categorizing data, including from health surveillance systems and disease cluster reports; (4) guidance for using, in a health-protective way, an appropriate epidemiological, statistical, or other approach for the circumstances of an investigation; (5) procedures for peer review of key documents by individuals who have no direct or indirect conflict of interest; and (6) a description of roles and responsibilities of the Administrator and the Administrator of the Agency for Toxic Substances and Disease Registry in conducting investigations described in those guidelines, in accordance with this Act. (c) Timing (1) In general Draft guidelines developed under this section shall be available for public review and comment for a period of not less than 60 days. (2) Final guidelines Not later than 1 year after the date of enactment of this Act, the Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry, the Secretary, and the Director, shall publish in the Federal Register final guidelines under this section. 7. Enhanced support for environmental investigations of disease clusters (a) Establishment of Regional Disease Cluster Information and Response Centers and Teams (1) Establishment (A) In general The Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry, the Secretary, and the Director, and other appropriate Federal agencies, shall establish and operate Regional Disease Cluster Information and Response Centers and Regional Disease Cluster Information and Response Teams. (B) Principal responsibility The Administrator shall be principally responsible for directing, coordinating, and approving Federal efforts and assistance authorized under this section. (2) Coordination (A) In general The Administrator shall ensure that the Office of Children’s Health Protection, in consultation with appropriate advisory committees, such as the Children’s Health Protection Advisory Committee, has a prominent role on behalf of the Agency in establishing and operating the Regional Response Centers and the Response Teams. (B) Grants and cooperative agreements (i) In general The Administrator shall provide support (including research, program implementation, and operational support activities) to individuals on Response Teams described in subsection (b) and Community Disease Cluster Advisory Committees described in subsection (c) through grants and cooperative agreements with institutions of higher education that have programs or individuals with demonstrated expertise in research, training, studies, and technical assistance. (ii) Authorization of appropriations There are authorized to be appropriated to carry out this subparagraph such sums as are necessary. (3) Timing Not later than 1 year after the date of enactment of this Act, the Administrator shall establish at least— (A) 2 Regional Response Centers; and (B) 2 Response Teams. (b) Response Teams (1) Membership Each Response Team shall include individuals who— (A) have expertise in epidemiology, toxicogenomics, molecular biology, toxicology, pollution control requirements, data analysis, environmental health and disease surveillance, exposure assessment, pediatric health, community outreach and involvement, and other relevant fields; and (B) have no direct or indirect conflict of interest. (2) Leadership Each Response Team shall have— (A) an individual who is the leader of the Response Team and who reports to the Administrator, the Administrator of the Agency for Toxic Substances and Disease Registry, and the Director; and (B) an individual who has the skills or experience necessary to carry out community outreach and involvement activities, including— (i) the establishment of Community Disease Cluster Advisory Committees under subsection (c); and (ii) the facilitation of activities of those Committees. (3) Activities (A) In general The Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director, shall establish the scope of activities for Response Teams to ensure that the activities are consistent with achieving the goals of this Act. (B) Requirements The activities of the Response Teams shall include— (i) making guidelines, protocols, data, and other relevant information and expertise available to State and local officials and the public to assist in efforts— (I) to investigate suspected or potential disease clusters, environmental pollutants or toxic substances associated with those disease clusters, and potential causes of disease clusters; and (II) to address potential causes of disease clusters; (ii) responding rapidly to a petition described in subparagraph (C) from any person, including a State or local official, regarding the need— (I) to investigate suspected or potential disease clusters, environmental pollutants or toxic substances associated with those disease clusters, and potential causes of disease clusters; and (II) to address the potential causes of disease clusters; (iii) providing the best available environmental sampling and laboratory equipment to collect, analyze, and interpret monitoring, health surveillance, and other relevant information at scales and timelines appropriate to an action; (iv) involving community members, in accordance with established scientific methods and norms (including the preservation of the confidentiality of individuals), in— (I) investigations of suspected or potential disease clusters, environmental pollutants or toxic substances associated with those disease clusters, or potential causes of disease clusters, including through— (aa) environmental exposure assessments; (bb) biomonitoring activities; and (cc) community-based participatory research initiatives; and (II) other efforts to address the potential causes of disease clusters; (v) working with State and local agencies— (I) to help make the use and management of integrated environmental health data consistent and timely; and (II) to fill data gaps; and (vi) investigating suspected or potential disease clusters, environmental pollutants or toxic substances associated with those disease clusters, and potential causes of disease clusters, and addressing the potential causes of disease clusters that the Administrator determines State and local officials need assistance in investigating or addressing, or that the Administrator determines should be investigated or addressed. (C) Petition (i) In general Any person, including a State or local official, may submit a petition referred to in subparagraph (B)(ii) to the Administrator, the Administrator of the Agency for Toxic Substances and Disease Registry, and the Director that requests that a Response Team conduct an investigation or take other action to address the potential causes of disease clusters in accordance with this Act. (ii) Requirements Each petition submitted under clause (i) shall clearly describe the basis for the requested investigation or action, including any data supporting the request. (iii) Consideration The Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director, shall establish criteria for the consideration of petitions submitted under this section using health-protective factors, including— (I) evidence of the release of environmental pollutants or toxic substances; (II) the locations in which there appear to be potentially significant health threats from the potential causes of disease clusters; (III) cases in which existing data appear to be inadequate to fully assess the potential risks to public health; and (IV) such other factors as the Administrator determines are necessary. (iv) Response Not later than 60 days after the date of receipt of a petition under clause (iii), the Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director, shall provide a written response that describes— (I) the investigation or actions that will be undertaken in response to the petition, including the timeline and basis for the investigation or actions; and (II) the reasons for any denial or deferral in providing such a response. (v) Timing of issuance of criteria (I) In general The Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director, shall provide for public notice of draft criteria established under this subparagraph for a period of not less than 60 days. (II) Final criteria Not later than 1 year after the date of enactment of this Act, the Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director, shall publish in the Federal Register final criteria required under this subparagraph. (4) Use of publicly available reports Response Team investigations and actions shall— (A) include publicly available reports prepared by the Response Team that contain statements of facts, findings, and recommendations for actions, to the extent appropriate; and (B) be prepared in a manner that preserves the confidentiality of individuals. (5) Transparency and accountability Response Team activities shall include measures to ensure— (A) transparency and accountability to potentially affected individuals, State and local officials, the public, and other persons and agencies, while preserving the confidentiality of individuals; (B) that consistent, accurate, and meaningful information is provided to potentially affected individuals, State and local officials, the public, and other persons and agencies through the use of comprehensive, community-based communications plans; and (C) accountability to meeting goals and timetables. (6) Database (A) In general The Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry, the Secretary, and the Director, shall compile and regularly update information in a comprehensive electronic database that— (i) is publicly accessible through the Internet; (ii) provides a centralized location for information relating to— (I) disease cluster reports and investigations; (II) environmental pollutants or toxic substances that are associated with suspected or potential disease clusters; (III) illnesses associated with suspected or potential disease clusters, including locally generated information; (IV) systematic tracking of environmental pollutants or toxic substances and illnesses associated with suspected or potential disease clusters; (V) actions to help address the potential causes of disease clusters; and (VI) any other information that the Administrator determines to be necessary; and (iii) facilitates the rapid reporting and analysis of information described in clause (ii). (B) Confidentiality A database described in subparagraph (A) shall be maintained in a manner that preserves the confidentiality of individuals. (c) Community Disease Cluster Advisory Committees (1) In general The Administrator shall establish Community Disease Cluster Advisory Committees to provide oversight, guidance, and advice relating to— (A) the investigation of suspected and potential disease clusters; (B) the investigation of environmental pollutants or toxic substances associated with suspected or potential disease clusters; (C) the investigation of potential causes of disease clusters; (D) efforts to address the potential causes of disease clusters; and (E) the most effective means of ensuring outreach to and involvement of community members. (2) Membership Membership on Community Disease Cluster Advisory Committees shall be comprised of representatives that include— (A) individuals who are or may be impacted by a suspected or potential disease cluster, and the designee of such an individual who may participate with or in the place of such an individual; (B) State or local government health or environmental agencies; (C) at least 2 individuals, appointed by the Administrator in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director, with demonstrated knowledge of the activities described in paragraph (1); and (D) other appropriate individuals, as determined by the Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director. (3) Prohibition No member of a Committee may have any direct or indirect conflict of interest. (4) Technical Assistance (A) In general The Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry and the Director, may make grants available to any group of individuals that may be affected by a suspected or potential disease cluster. (B) Use of funds Grants made available under subparagraph (A) may be used to facilitate active involvement in all aspects of Committee activities and to assist Committee members in obtaining technical assistance in interpreting information with regard to— (i) the investigation of— (I) suspected or potential disease clusters; (II) environmental pollutants or toxic substances that are associated with suspected or potential disease clusters; and (III) the potential causes of disease clusters; (ii) addressing the potential causes of disease clusters; (iii) understanding the health concerns associated with suspected or potential disease clusters; and (iv) understanding other scientific and technical issues relating to the activities of a Regional Response Team and Community Disease Cluster Advisory Committee, including the potential need for and interpretation of any biomonitoring of individuals in the area. (d) Environmental research and analysis The Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry, the Secretary, and the Director, shall use available authorities and programs to compile, research, and analyze information generated by actions authorized under this section, including by— (1) using those authorities to test environmental pollutants or toxic substances identified under subsection (b)(6); and (2) incorporating environmental pollutants or toxic substances identified under subsection (b)(6) in appropriate national biomonitoring initiatives. 8. Federal reports to Congress (a) In general Not later than 1 year after the date of enactment of this Act and annually thereafter, the Administrator, in consultation with the Administrator of the Agency for Toxic Substances and Disease Registry, the Secretary, and the Director, shall prepare a report that describes— (1) the status of activities under this Act to investigate and address the suspected and potential causes of disease clusters; (2) environmental pollutants or toxic substances that are associated with suspected or potential disease clusters; (3) the potential causes of disease clusters; and (4) ways to address the potential causes of those disease clusters. (b) Requirements The report shall include a description of— (1) outreach activities to State and local officials and communities; (2) actions that the Administrator has taken to prioritize the testing of environmental pollutants or toxic substances; (3) actions that the Administrator has taken to include environmental pollutants or toxic substances identified under section 7(b)(7) in appropriate national biomonitoring initiatives; (4) actions that the Administrator is taking or plans to take to address problems in implementing this Act; (5) actions that the Secretary is taking or plans to take to address problems in implementing this Act; (6) actions that the Administrator of the Agency for Toxic Substances and Disease Registry has undertaken or is considering taking with respect to any disease clusters under subparagraphs (D) and (E) of section 104(i)(1) of Comprehensive Environmental Response, Compensation, and Liability Act ( 42 U.S.C. 9604(i)(1) ) and other provisions of that section; (7) actions that the Director is taking or plans to take to address problems in implementing this Act; and (8) other relevant information. (c) Submission and availability The Administrator shall— (1) submit the report under this subsection to— (A) the Committees on Environment and Public Works and Health, Education, Labor, and Pensions of the Senate; and (B) the Committee on Energy and Commerce of the House of Representatives; and (2) make the report available to the public. 9. Authorization of appropriations There are authorized to be appropriated such sums as are necessary to carry out this Act. 10. Effect on other law Nothing in this Act modifies, limits, or otherwise affects the application of, or obligation to comply with, any law, including any environmental or public health law.