Safe Cosmetics Act of 2011

Legislation and issues relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148); Nurse Education, Expansion, and Development Act; Nursing provisions in potential job creation legislation; Negotiated Rulemaking on Designation of Medically Underserved and Health Professional Shortage Areas; Administration review of current regulations; Prevention and Public Health Fund; Definition of essential health benefits; Health information technology and electronic health records; HRSA nurse practitioner national sample survey; Amendments to the Consumer Product Safety Improvement Act; Menu and Nutrition Labeling; Draft legislation to reauthorize the Prescription Drug User Fee Act (PDUFA); Draft legislation on Congressional Budget Office scoring of preventive health services; Draft legislation on voluntary tandem licensing and credentialing for federal telemedicine services; Draft legislation on reauthorization of the National Quality Forum; H.R. 5/S. 218/S. 1099 - Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act; H.R. 5 - Protecting Access to Healthcare (PATH) Act; H.R. 451 - Healthcare Truth and Transparency Act of 2011; S. 248/H.R. 844 - Empowering States to Innovate Act; S. 174 - Healthy Lifestyles and Prevention Act; H.R. 10/S. 299/S. 1720/S. 1786 - Regulations From the Executive in Need of Scrutiny (REINS) Act; H.R. 1217 - to repeal the Prevention and Public Health Fund; H.R. 1683/S. 868 - State Flexibility Act; H.R. 2465 - Federal Workers' Compensation Modernization and Improvement Act; S. 261 - Federal Employees' Compensation Reform Act; H.R. 469 - Protecting Student Athletes from Concussions Act; S. 601/H.R. 1127 - Childrens Sports Athletic Equipment Safety Act; Concussion Treatment and Care Tools (ConTACT) Act; S. 54 - Supporting Child Maltreatment Prevention Efforts in Community Health Centers Act; S. 55 - Nursing School Clinics Act; H.R. 157 - Health Care Safety Net Enhancement Act; H.R. 227 - Child Gun Safety and Gun Access Prevention Act; H.R. 338 - Protecting Our Kids' Medicine Act; H.R. 469 - Protecting Student Athletes from Concussions Act; H.R. 576 - Healthy Children Through School Nutrition Education Act; H.R. 713 - Keeping Families Together Act; H.R. 751 - Mental Health in Schools Act; H.R. 1214 - to repeal mandatory funding for school-based health center construction; S. 961 - Reconnecting Youth to Prevent Homelessness Act; S. 1165, Button Cell Battery Safety Act. H.R. 1852/S. 958 - Childrens Hospital GME Support Reauthorization Act; H.R. 115 - CHAMPVA Childrens Protection Act; H.R. 364 - Common Sense Health Reform Americans Actually Want Act; H.R. 614 - Post 9/11 G.I. Bill Dependent Coverage Improvement Act; H.R. 978 - Seniors Identity Protection Act; H.R. 989 - Voluntary State Discount Prescription Drug Plan Act; H.R. 1035/S. 1504 - Medicaid Coverage for Citizens of Freely Associated States Act; H.R. 2029/S. 1131 - Birth Defects Prevention, Risk Reduction, and Awareness Act; H.R. 2758/S. 1463 - Breastfeeding Promotion Act; H.R. 2229 - Student-to-School Nurse Ratio Improvement Act. H.R. 3679 - National Nurse Act; H.R. 4274 - BPCA and PREA Reauthorization Act; S. 2289 - Better Pharmaceuticals and Devices for Children Act; H.R. 5651 - Food and Drug Administration Reform Act; H.R. 5842 - Restoring Access to Medication Act; S. 3187 - FDA Safety and Innovation Act S. 2474 - Health Equity and Accountability Act; S. 1789 - 21st Century Postal Service Act; S. 847 - Safe Chemicals Act; H.R. 2405/S. 1855/H.R. 6672 - Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; H.R. 2359 - Safe Cosmetics Act; H.R. 6482 - Preventive Health Savings Act; Supplemental Nutrition Assistance Program (SNAP) provisions of H.R. 6083, Federal Agriculture Reform and Risk Management (FARRM) Act, and S.3240, Agriculture Reform, Food, and Jobs Act; H.R. 5647/S. 3565 - Pregnant Workers Fairness Act.

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, White House Office

FDA regulation of cosmetics including Good Manufacturing Practices, import safety, and fragrance ingredients; H.R. 2359, Safe Cosmetics Act of 2011; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 4395, Cosmetics Safety Amendments Act of 2012; Implementation of Food and Drug Administration Safety and Innovation Act (PL-112-144), Prescription Drug User Fee Act (PDUFA) reauthorization

Client expense: $240,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Legislation in the 112th H.R. 432, the Ban Poisonous Additives Act of 2011( related Senate Bill, S. 136) The Breast Cancer Fund supports this legislation because bisphenol-A has been linked to increased rates of cancer, as well as other significant health problems. The Breast Cancer Fund has been meeting with staff from various offices to encourage co-sponsorship and eventual passage of this bill. Continued: Legislation in the 112th S. 847, the Safe Chemicals Act of 2011 The Breast Cancer Fund supports this legislation because it would mandate the testing of chemicals for their health risks, including potentially hazardous, cancer-causing chemicals currently being used in a variety of consumer products. H.R. 2359, the Safe Cosmetics Act of 2011 The Breast Cancer Fund supports this legislation to reform the FDA's regulation of cosmetic ingredients based on mounting evidence that several ingredients of common cosmetic products have been linked to negative environmental health impacts, including breast cancer. H.R.4395, the Cosmetic Safety Amendments Act of 2012 The Breast Cancer Fund opposes this legislation as it would further weaken the FDAs ability to regulate the safety of cosmetics. H.R. 4262, the Cosmetics Safety Enhancement Act of 2012 The Breast Cancer Fund opposes this legislation as it is not strong enough to effectively regulate the safety of cosmetics. H.R. 2521, the Endocrine-Disrupting Chemicals Exposure Elimination act of 2011 (Senate version S. 1361) and H.R. 553 Endocrine Disruptor Screening Enhancement Act of 2011 The Breast Cancer Fund supported this legislation as it would increase the coordination and resources dedicated to research on endocrine disrupting substances, an important link to increased risk of lifetime incidence of breast cancer. H.R. 1939: Enhancing CPSC Authority and Discretion Act of 2011. The Breast Cancer Fund lobbied for a provision that ensures that phthalates, when necessary in the manufacture of children's toys, are only used safely. H.R. 3067: Accelerating the End of Breast Cancer Act of 2011. The Breast Cancer Fund supported this legislation as it would increase focus on research to prevent, treat, and end breast caner. S. 3237, the Accelerating the End of Breast Cancer Act of 2012. The Breast Cancer Fund supports this legislation as it would increase focus on research to prevent, treat, and end breast cancer. House and Senate Appropriations - The Breast Cancer Fund contacted House and Senate offices about increasing federal funding for state biomonitoring programs through the CDC grants program, opposing appropriations riders limiting the work of the National Toxicology Program's Report on Carcinogens, and increasing support for health tracking and NIEHS programs related to breast cancer research. Future Legislative Proposals: The Breast Cancer Fund continues to meet with staff from various House and Senate offices to draft legislation to reform the FDAs regulation of cosmetic ingredients based on mounting evidence that several ingredients of common cosmetic products have been linked to negative environmental health impacts, including breast cancer. The Breast Cancer Fund supports ongoing efforts to reintroduce legislation that would compel manufacturers to provide complete and accurate product labeling of chemicals used in consumer products. Such labeling is a critical step in removing carcinogenic, and otherwise hazardous, materials from consumer products. The Breast Cancer Fund supports ongoing efforts to reintroduce legislation that would mandate the testing of chemicals for their health risks- including potentially hazardous, cancer-causing chemicals currently being used in a variety of consumer products. Regulation and Legislative Intent: FDA Advocacy In addition to meeting with Congressional staff on the matter of bisphenol-A (BPA), The Breast Cancer Fund has also met with Deputy Commissioner Josh Sharfstein and additional members of the FDA management team concerning the FDAs ongoing review of BPA, upcoming cosmetics legislation, and the FDAs transparency policies more generally. Presidents Cancer Panel Report The Breast Cancer Fund communicated with staff in the Executive Office of the President and the Office of Science and Technology Policy regarding the report and recommendations of the President's Cancer Panel, and continues to encourage ongoing efforts by the Executive Branch to raise awareness about breast cancer risk, prevention, and the environment. P.L. 110-314 - The Consumer Product Safety Commission Inprovement Act The Breast Cancer Fund lobbied in support of the provision that bans the use of phthalates in the manufacture of children's toys. We are now monitoring implementation of this law; working on preserving the law's phthalates provision through the legislative and regulatory process; and are submitting public comments at various stages of the law's implementation. P.L. 110-354 - Breast Cancer and Environmental Research Act of 2008 This law authorizes the Director of the National Institute of Environmental Health Sciences to make grants for the development and operation of research centers regarding environmental factors that may be related to the etiology of breast cancer. The Breast Cancer Fund was not actively involved in passage of the bill apart from coalition support but has since met with authors to discuss implementation and the appointment process to the community panel that will oversee the grant process.

Client expense: Not reported · Firm income: $30,000

Government targets: Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE

Public Law 111-353, FDA Food Safety Modernization Act, Implementation issues regarding dietary supplement issues S.216, Food Safety Accountability Act of 2011, entire bill as it relates to dietary supplements S.1310, Dietary Supplement Labeling Act, entire bill as it relates to dietary supplements H.R.1364, Free Speech About Science Act, entire bill as it relates to dietary supplements H.R.2359, Safe Cosmetics Act, entire bill as it relates to dietary supplements H.R.3380, Dietary Supplement Protection Act of 2011, entire bill as it relates to dietary supplements Issues related to New Dietary Ingredients Public Law 112-144, Food & Drug Administration Safety and Innovation Act, Provisions relating to dietary supplements

Client expense: Not reported · Firm income: $25,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2359, Safe Cosmetics Act of 2011; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 4395, Cosmetic Safety Amendments Act of 2012; S. 847, Safe Chemicals Act of 2011

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Safe Chemicals Act of 2011 (S. 847) - all aspects of bill relating to reform of the Toxic Substances Control Act. Reform of the Toxic Substances Control Act. Safe Cosmetics Act of 2011 (HR 2359) - all provisions relating to fragrance ingredient safety and disclosure. Cosmetics Safety Enhancement Act of 2012 (HR 4262) - all provisions relating to fragrance ingredient safety and disclosure. Cosmetic Safety Amendments Act of 2012 (HR 4395)

Client expense: $70,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

- Issues related to dextromethorphan - Issues related to Pseudoephedrine - Issues related to the regulation of Cosmetic Products. - HR 2359, "Safe Cosmetics Act of 2011", regarding all provisions. - HR 4395, "Cosmetic Safety Amendments Act of 2012", regarding all provisions. - HR 4262, "Cosmetic Safety Enhancement Act of 2012", regarding all provisions. - S 3376, "Prevent Abuse of Cough Treatment Act of 2012", regarding all provisions.

Client expense: $880,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

FDA regulation of cosmetics including Good Manufacturing Practices, import safety, fragrance ingredients. PDUFA: H.R. 5651, The Food and Drug Administration Reform Act of 2012 and S. 3187, The Food and Drug Administration Safety and Innovation Act. H.R. 4395, Cosmetics Safety Amendments Act of 2012. H.R. 4262, Cosmetics Safety Enhancement Act of 2012. H.R. 2359, Safe Cosmetics Art of 2011.

Client expense: Not reported · Firm income: $110,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. ____ - Legislation that would improve oversight over cosmetics safety, all sections including those pertaining to labeling and safety substantiation; H.R.2359 - Safe Cosmetics Act of 2011, all sections including those pertaining to labeling and safety substantiation; H.R.4262 - Cosmetics Safety Enhancement Act of 2012, all sections including those pertaining to safety; H.R. 6191 - Cancer-Free Label Act of 2012, all sections including those pertaining to labeling; H.R.4395 - Cosmetics Safety Amendments Act of 2012, all sections including those pertaining to registration of cosmetic establishments and adverse event reporting; and S. ____ - Bottled Water Right to Know Act, all sections including those pertaining to labeling and consumer confidence reports.

Client expense: $162,078 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 611, to foster transparency about the commercial use of personal information, provide consumers with meaningful choice about the collection, use, and disclosure of such information. H.R. 654, to direct the Federal Trade Commission to prescribe regulations regarding the collection and use of information obtained by tracking the Internet activity of an individual. H.R. 1528, to protect and enhance consumer privacy, and for other purposes; to Energy & Commerce. H.R. 1841, to protect consumers by requiring reasonable security policies and procedures to protect computerized data containing personal information, and to provide for nationwide notice in the event of a security breach; to Energy & Commerce. H.R. 1939, to provide the Consumer Product Safety Commission with greater authority and discretion in enforcing the consumer product safety laws, and for other purposes; to Energy & Commerce. H.R. 2132, to require the Food and Drug Administration to finalize a standard for broad-spectrum protection in sunscreen products, and for other purposes; to Energy & Commerce. H.R. 2359, to amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes; jointly to Energy & Commerce and Education & the Workforce. H.R. 2577, to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information, and to provide for nationwide notice in the event of a security breach. H.R. 2715, to provide the Consumer Product Safety Commission with greater authority and discretion in enforcing the consumer product safety laws, and for other purposes. H.R. 3847, to amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety. H.R. 4262, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of cosmetics; to Energy & Commerce. H.R. 4395, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes; to Energy & Commerce. H.R. 6131, to extend the Undertaking Spam, Spyware, and Fraud Enforcement With Enforcers beyond Borders Act of 2006. S. 799, to establish a regulatory framework for the comprehensive protection of personal data for individuals under the aegis of the Federal Trade Commission, and for other purposes; to Commerce. S. 913, to require the Federal Trade Commission to prescribe regulations regarding the collection and use of personal information obtained by tracking the online activity of an individual, and for other purposes; to Commerce. S. 1064, to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes. S. 1151, to prevent and mitigate identity theft, to ensure privacy, to provide notice of security breaches, and to enhance criminal penalties, law enforcement assistance, and other protections against security breaches, fraudulent access, and misuse of personally identifiable information; to Judiciary. S. 1207, to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information, and to provide for nationwide notice in the event of a security breach; to Commerce. S. 1408, to require federal agencies, and persons engaged in interstate commerce, in possession of data containing sensitive personally identifiable information, to disclose any breach of such information. S. 1434, to protect information relating to consumers, to require notice of security breaches, and for other purposes. S. 1535, to protect consumers by mitigating the vulnerability of personally identifiable information to theft through a security breach, providing notice and remedies to consumers in the wake of such a breach, holding companies accountable for preventable breaches, facilitating the sharing of post-breach technical information between companies, and enhancing criminal and civil penalties and other protections against the unauthorized collection or use of personally identifiable information, with an amendment in the nature of a substitute. S. 1652, to amend title 9 of the U.S. Code to prohibit mandatory arbitration clauses in contracts for mobile service. S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices. S. 3333, to require certain entities that collect and maintain personal information of individuals to secure such information and to provide notice to such individuals in the case of a breach of security involving such information, and for other purposes; to Commerce. S. 3410, to extend the Undertaking Spam, Spyware, And Fraud Enforcement With Enforcers beyond Borders Act of 2006, and for other purposes; to Commerce.

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

Public Law 111-353, FDA Food Safety Modernization Act, Implementation issues regarding dietary supplement issues S.216, Food Safety Accountability Act of 2011, entire bill as it relates to dietary supplements S.1310, Dietary Supplement Labeling Act, entire bill as it relates to dietary supplements H.R.1364, Free Speech About Science Act, entire bill as it relates to dietary supplements H.R.2359, Safe Cosmetics Act, entire bill as it relates to dietary supplements H.R.3380, Dietary Supplement Protection Act of 2011, entire bill as it relates to dietary supplements Issues related to New Dietary Ingredients Public Law 112-144, Food & Drug Administration Safety and Innovation Act, Provisions relating to dietary supplements

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitored issues related to regulation of cosmetics industry and effect on small businesses. H.R. 4395, Cosmetic Safety Amendments Act of 2012; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 2359, Safe Cosmetics Act of 2011.

Client expense: Not reported · Firm income: $10,000

- H.R. 965; Prevention of Antibiotics for Medical Treatment Act of 2011 (PAMTA) - S. 847; The Safe Chemicals Act of 2011 - H.R. 2359; The Safe Cosmetics Act of 2011 - Proposals related to the Clean Air Act - Proposed EPA Soot Standards - Letter to House and Senate supporting the EPA adopting strong soot standards.

Client expense: $329,405 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

Draft Cosmetic Safety Legislation. H.R. 2359; Safe Cosmetics Act of 2011; entire bill. H.R. 4262; Cosmetic Safety Enhancement Act of 2012; entire bill.

Client expense: $600,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID)

Issues related to Dextromethorphan; issues related to Pseudoephedrine; issues related to the regulation of Cosmetic Productions; HR 2359, "Safe Cosmetics Act of 2011," regarding all provisions.

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA Reform Bills - Cosmetics - H.R. 2359/H.R. 4395/H.R. 2359 - all addressing need to modernize FDA regulation of cosmetics Safety of Cosmetic/Personal Care/Household Cleaning Products & Ingredients FDA Regulation of OTC Drugs

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4395, Cosmetic Safety Amendments Act of 2012; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 2359, Safe Cosmetics Act of 2011. Issues related to regulation of cosmetics industry and effect on small businesses.

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the FDA; Issues related to pharmaceutical supply chain security; Issues related to cosmetics, including H.R. 4395 - Cosmetic Safety Amendments Act of 2012 (as well as H.R. 2359 and H.R. 4262); Issues related to the medical device tax, including H.R. 436 - Health Care Cost Reduction Act of 2012 (as well as S. 17 and S. 262).

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Dextromethorphan Abuse Reduction; Regulation of OTC drugs, devices and cosmetics; S.3376, Preventing Abuse of Cough Treatments Act of 2012 ; H.R.2359, Safe Cosmetics Act of 2011; H.R.4262, Cosmetics Safety Enhancement Act of 2012; H.R.4395, Cosmetic Safety Amendments Act of 2012;

Client expense: $1,163,138 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

HR 2359, Safe Cosmetics Act of 2011 - all provisions. HR 4262, Cosmetics Safety Enhancement Act of 2012 - all provisions. HR 4395, Cosmetic Safety Amendments Act of 2012 - all provisions.

Client expense: Not reported · Firm income: $30,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 611, to foster transparency about the commercial use of personal information, provide consumers with meaningful choice about the collection, use, and disclosure of such information. H.R. 654, to direct the Federal Trade Commission to prescribe regulations regarding the collection and use of information obtained by tracking the Internet activity of an individual. H.R. 1528, to protect and enhance consumer privacy, and for other purposes; to Energy & Commerce. H.R. 1841, to protect consumers by requiring reasonable security policies and procedures to protect computerized data containing personal information, and to provide for nationwide notice in the event of a security breach; to Energy & Commerce. H.R. 1939, to provide the Consumer Product Safety Commission with greater authority and discretion in enforcing the consumer product safety laws, and for other purposes; to Energy & Commerce. H.R. 2132, require the Food and Drug Administration to finalize a standard for broad-spectrum protection in sunscreen products. H.R. 2359, to amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes; jointly to Energy & Commerce and Education & the Workforce. H.R. 2577, to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information, and to provide for nationwide notice in the event of a security breach; to Energy & Commerce. H.R. 2715, to provide the Consumer Product Safety Commission with greater authority and discretion in enforcing the consumer product safety laws, and for other purposes; to Energy & Commerce; considered and passed. H.R. 3847, to amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, and for other purposes. H.R. 4262, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of cosmetics; to Energy & Commerce. H.R. 4395, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes; to Energy & Commerce. H.R. 6131, to extend the Undertaking Spam, Spyware, and Fraud Enforcement With Enforcers beyond Borders Act of 2006. S. 799, to establish a regulatory framework for the comprehensive protection of personal data for individuals under the aegis of the Federal Trade Commission, and for other purposes; to Commerce. S. 913, to require the Federal Trade Commission to prescribe regulations regarding the collection and use of personal information obtained by tracking the online activity of an individual, and for other purposes; to Commerce. S. 1064, to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products. S. 1151, to prevent and mitigate identity theft, to ensure privacy, to provide notice of security breaches, and to enhance criminal penalties, law enforcement assistance, and other protections against security breaches, fraudulent access, and misuse of personally identifiable information; to Judiciary. S. 1207, to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information, and to provide for nationwide notice in the event of a security breach; to Commerce. S. 1408, to require federal agencies, and persons engaged in interstate commerce, in possession of data containing sensitive personally identifiable information, to disclose any breach of such information; to Judiciary. S. 1434, to protect information relating to consumers, to require notice of security breaches. S. 1535, to protect consumers by mitigating the vulnerability of personally identifiable information to theft through a security breach, providing notice and remedies to consumers in the wake of such a breach, holding companies accountable for preventable breaches, facilitating the sharing of post-breach technical information between companies, and enhancing criminal and civil penalties and other protections against the unauthorized collection or use of personally identifiable information. S. 1652, to amend title 9 of the U.S. Code to prohibit mandatory arbitration clauses in contracts for mobile service; to Judiciary. S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars. S. 3333, to require certain entities that collect and maintain personal information of individuals to secure such information and to provide notice to such individuals in the case of a breach of security involving such information, and for other purposes. S. 3410, to extend the Undertaking Spam, Spyware, And Fraud Enforcement With Enforcers beyond Borders Act of 2006.

Client expense: $110,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Legislation in the 112th H.R. 432, the Ban Poisonous Additives Act of 2011( related Senate Bill, S. 136) The Breast Cancer Fund supports this legislation because bisphenol-A has been linked to increased rates of cancer, as well as other significant health problems. The Breast Cancer Fund has been meeting with staff from various offices to encourage co-sponsorship and eventual passage of this bill. Continued: Legislation in the 112th S. 847, the Safe Chemicals Act of 2011 The Breast Cancer Fund supports this legislation because it would mandate the testing of chemicals for their health risks, including potentially hazardous, cancer-causing chemicals currently being used in a variety of consumer products. H.R. 2359, the Safe Cosmetics Act of 2011 The Breast Cancer Fund supports this legislation to reform the FDA's regulation of cosmetic ingredients based on mounting evidence that several ingredients of common cosmetic products have been linked to negative environmental health impacts, including breast cancer. H.R.4395, the Cosmetic Safety Amendments Act of 2012 The Breast Cancer Fund opposes this legislation as it would further weaken the FDAs ability to regulate the safety of cosmetics. H.R. 4262, the Cosmetics Safety Enhancement Act of 2012 The Breast Cancer Fund opposes this legislation as it is not strong enough to effectively regulate the safety of cosmetics. H.R. 2521, the Endocrine-Disrupting Chemicals Exposure Elimination act of 2011 (Senate version S. 1361) and H.R. 553 Endocrine Disruptor Screening Enhancement Act of 2011 The Breast Cancer Fund supported this legislation as it would increase the coordination and resources dedicated to research on endocrine disrupting substances, an important link to increased risk of lifetime incidence of breast cancer. H.R. 1939: Enhancing CPSC Authority and Discretion Act of 2011. The Breast Cancer Fund lobbied for a provision that ensures that phthalates, when necessary in the manufacture of children's toys, are only used safely. H.R. 3067: Accelerating the End of Breast Cancer Act of 2011. The Breast Cancer Fund supported this legislation as it would increase focus on research to prevent, treat, and end breast caner. S. 3237, the Accelerating the End of Breast Cancer Act of 2012. The Breast Cancer Fund supports this legislation as it would increase focus on research to prevent, treat, and end breast cancer. House and Senate Appropriations - The Breast Cancer Fund contacted House and Senate offices about increasing federal funding for state biomonitoring programs through the CDC grants program, opposing appropriations riders limiting the work of the National Toxicology Program's Report on Carcinogens, and increasing support for health tracking and NIEHS programs related to breast cancer research. Future Legislative Proposals: The Breast Cancer Fund continues to meet with staff from various House and Senate offices to draft legislation to reform the FDAs regulation of cosmetic ingredients based on mounting evidence that several ingredients of common cosmetic products have been linked to negative environmental health impacts, including breast cancer. The Breast Cancer Fund supports ongoing efforts to reintroduce legislation that would compel manufacturers to provide complete and accurate product labeling of chemicals used in consumer products. Such labeling is a critical step in removing carcinogenic, and otherwise hazardous, materials from consumer products. The Breast Cancer Fund supports ongoing efforts to reintroduce legislation that would mandate the testing of chemicals for their health risks- including potentially hazardous, cancer-causing chemicals currently being used in a variety of consumer products. Regulation and Legislative Intent: FDA Advocacy In addition to meeting with Congressional staff on the matter of bisphenol-A (BPA), The Breast Cancer Fund has also met with Deputy Commissioner Josh Sharfstein and additional members of the FDA management team concerning the FDAs ongoing review of BPA, upcoming cosmetics legislation, and the FDAs transparency policies more generally. Presidents Cancer Panel Report The Breast Cancer Fund communicated with staff in the Executive Office of the President and the Office of Science and Technology Policy regarding the report and recommendations of the President's Cancer Panel, and continues to encourage ongoing efforts by the Executive Branch to raise awareness about breast cancer risk, prevention, and the environment. P.L. 110-314 - The Consumer Product Safety Commission Inprovement Act The Breast Cancer Fund lobbied in support of the provision that bans the use of phthalates in the manufacture of children's toys. We are now monitoring implementation of this law; working on preserving the law's phthalates provision through the legislative and regulatory process; and are submitting public comments at various stages of the law's implementation. P.L. 110-354 - Breast Cancer and Environmental Research Act of 2008 This law authorizes the Director of the National Institute of Environmental Health Sciences to make grants for the development and operation of research centers regarding environmental factors that may be related to the etiology of breast cancer. The Breast Cancer Fund was not actively involved in passage of the bill apart from coalition support but has since met with authors to discuss implementation and the appointment process to the community panel that will oversee the grant process.

Client expense: Not reported · Firm income: $30,000

Government targets: Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE

H.R. 2359, Safe Cosmetics Act of 2011; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 4395, Cosmetic Safety Amendments Act of 2012; S. 847, Safe Chemicals Act of 2011

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Dextromethorphan; issues related to Pseudoephedrine; issues related to the regulation of Cosmetic Productions; HR 2359, "Safe Cosmetics Act of 2011," regarding all provisions.

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Issues related to dextromethorphan - Issues related to Pseudoephedrine - Issues related to the regulation of Cosmetic Products. - HR 2359, "Safe Cosmetics Act of 2011", regarding all provisions. - HR 4395, "Cosmetic Safety Amendments Act of 2012", regarding all provisions. - HR 4262, "Cosmetic Safety Enhancement Act of 2012", regarding all provisions. - S 3376, "Prevent Abuse of Cough Treatment Act of 2012", regarding all provisions.

Client expense: $1,420,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Safe Chemicals Act of 2011 (S. 847) - all aspects of bill relating to reform of the Toxic Substances Control Act. Reform of the Toxic Substances Control Act. Safe Cosmetics Act of 2011 (HR 2359) - all provisions relating to fragrance ingredient safety and disclosure. Cosmetics Safety Enhancement Act of 2012 (HR 4262) - all provisions relating to fragrance ingredient safety and disclosure. Cosmetic Safety Amendments Act of 2012 (HR 4395)

Client expense: $80,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

Dextromethorphan Abuse Reduction; Regulation of OTC drugs, devices and cosmetics; S.3376, Preventing Abuse of Cough Treatments Act of 2012 ; H.R.2359, Safe Cosmetics Act of 2011; H.R.4262, Cosmetics Safety Enhancement Act of 2012; H.R.4395, Cosmetic Safety Amendments Act of 2012;

Client expense: $839,845 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

FDA regulation of cosmetics including Good Manufacturing Practices, import safety, fragrance ingredients and cosmetic registration; H.R. 2359, Safe Cosmetics Act of 2011; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 4395, Cosmetics Safety Amendments Act of 2012; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 3187, The Food and Drug Administration Safety and Innovation Act

Client expense: $150,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S. ____ - Legislation that would improve oversight over cosmetics safety, all sections including those pertaining to labeling and safety substantiation; H.R.2359 - Safe Cosmetics Act of 2011, all sections including those pertaining to labeling and safety substantiation; H.R.4262 - Cosmetics Safety Enhancement Act of 2012, all sections including those pertaining to safety; H.R.4395 - Cosmetics Safety Amendments Act of 2012, all sections including those pertaining to registration of cosmetic establishments and adverse event reporting; S. ____ - Bottled Water Right to Know Act, all sections including those pertaining to labeling and consumer confidence reports; and S.3187 - Food and Drug Administration Safety and Innovation Act, sections pertaining to the compliance date for a rule related to over-the-counter sunscreens.

Client expense: $75,302 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Council on Environmental Quality (CEQ), HOUSE OF REPRESENTATIVES, SENATE, White House Office

Legislation and issues relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148); Nurse Education, Expansion, and Development Act; Nursing provisions in potential job creation legislation; Anti-competitive barriers to practice; Negotiated Rulemaking on Designation of Medically Underserved and Health Professional Shortage Areas; Administration review of current regulations; Prevention and Public Health Fund; Definition of essential health benefits; Health information technology and electronic health records; HRSA nurse practitioner national sample survey; Amendments to the Consumer Product Safety Improvement Act; Menu and Nutrition Labeling; Draft legislation to reauthorize the Prescription Drug User Fee Act (PDUFA); Draft legislation on Congressional Budget Office scoring of preventive health services; Draft legislation on voluntary tandem licensing and credentialing for federal telemedicine services; Draft legislation on reauthorization of the National Quality Forum; H.R. 5/S. 218/S. 1099 - Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act; H.R. 5 - Protecting Access to Healthcare (PATH) Act; H.R. 451 - Healthcare Truth and Transparency Act of 2011; S. 248/H.R. 844 - Empowering States to Innovate Act; S. 174 - Healthy Lifestyles and Prevention Act; H.R. 10/S. 299/S. 1720/S. 1786 - Regulations From the Executive in Need of Scrutiny (REINS) Act; H.R. 1217 - to repeal the Prevention and Public Health Fund; H.R. 1683/S. 868 - State Flexibility Act; H.R. 2465 - Federal Workers' Compensation Modernization and Improvement Act; S. 261 - Federal Employees' Compensation Reform Act; H.R. 469 - Protecting Student Athletes from Concussions Act; S. 601/H.R. 1127 - Childrens Sports Athletic Equipment Safety Act; Concussion Treatment and Care Tools (ConTACT) Act; S. 54 - Supporting Child Maltreatment Prevention Efforts in Community Health Centers Act; S. 55 - Nursing School Clinics Act; H.R. 157 - Health Care Safety Net Enhancement Act; H.R. 227 - Child Gun Safety and Gun Access Prevention Act; H.R. 338 - Protecting Our Kids' Medicine Act; H.R. 469 - Protecting Student Athletes from Concussions Act; H.R. 576 - Healthy Children Through School Nutrition Education Act; H.R. 713 - Keeping Families Together Act; H.R. 751 - Mental Health in Schools Act; H.R. 1214 - to repeal mandatory funding for school-based health center construction; S. 961 - Reconnecting Youth to Prevent Homelessness Act; S. 1165, Button Cell Battery Safety Act; H.R. 1852/S. 958 - Childrens Hospital GME Support Reauthorization Act; H.R. 115 - CHAMPVA Childrens Protection Act; H.R. 364 - Common Sense Health Reform Americans Actually Want Act; H.R. 614 - Post 9/11 G.I. Bill Dependent Coverage Improvement Act; H.R. 978 - Seniors Identity Protection Act; H.R. 989 - Voluntary State Discount Prescription Drug Plan Act; H.R. 1035/S. 1504 - Medicaid Coverage for Citizens of Freely Associated States Act; H.R. 2029/S. 1131 - Birth Defects Prevention, Risk Reduction, and Awareness Act; H.R. 2758/S. 1463 - Breastfeeding Promotion Act; H.R. 2229 - Student-to-School Nurse Ratio Improvement Act. H.R. 3679 - National Nurse Act; H.R. 4274 - BPCA and PREA Reauthorization Act; S. 2289 - Better Pharmaceuticals and Devices for Children Act; H.R. 5651 - Food and Drug Administration Reform Act; H.R. 5842 - Restoring Access to Medication Act; S. 3187 - FDA Safety and Innovation Act; S. 2474 - Health Equity and Accountability Act; S. 1789 - 21st Century Postal Service Act; S. 847 - Safe Chemicals Act; H.R. 2405/S. 1855 - Pandemic and All-Hazards Preparedness Act (PAHPA); H.R. 2359 - Safe Cosmetics Act; H.R. 6482 - Preventive Health Savings Act; Supplemental Nutrition Assistance Program (SNAP) provisions of H.R. 6083, Federal Agriculture Reform and Risk Management (FARRM) Act, and S.3240, Agriculture Reform, Food, and Jobs Act.

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, White House Office

FDA Reform Bills - Cosmetics - H.R. 2359/H.R. 4395/H.R. 2359 - All addressing need to modernize FDA regulation of cosmetics Safety of cosmetic/personal care/household cleaning products & ingredients FDA regulation of OTC drugs

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Public Law 111-353, FDA Food Safety Modernization Act, Implementation issues regarding dietary supplement issues S.216, Food Safety Accountability Act of 2011, entire bill as it relates to dietary supplements S.1310, Dietary Supplement Labeling Act, entire bill as it relates to dietary supplements H.R.1364, Free Speech About Science Act, entire bill as it relates to dietary supplements H.R.2359, Safe Cosmetics Act, entire bill as it relates to dietary supplements H.R.3380, Dietary Supplement Protection Act of 2011, entire bill as it relates to dietary supplements Issues related to New Dietary Ingredients Public Law 112-144, Food & Drug Administration Safety and Innovation Act, Provisions relating to dietary supplements

Client expense: Not reported · Firm income: $25,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

FDA regulation of cosmetics including Good Manufacturing Practices, import safety, fragrance ingredients. PDUFA: H.R. 5651, The Food and Drug Administration Reform Act of 2012 and S. 3187, The Food and Drug Administration Safety and Innovation Act. H.R. 4395, Cosmetics Safety Amendments Act of 2012. H.R. 4262, Cosmetics Safety Enhancement Act of 2012. H.R. 2359, Safe Cosmetics Art of 2011.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to regulation of cosmetics industry and effect on small businesses. H.R. 4395, Cosmetic Safety Amendments Act of 2012; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 2359, Safe Cosmetics Act of 2011.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Draft Cosmetic Safety Legislation. H.R. 2359; Safe Cosmetics Act of 2011; entire bill. H.R. 4262; Cosmetic Safety Enhancement Act of 2012; entire bill.

Client expense: $200,000 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID)

H.R. 4395, Cosmetic Safety Amendments Act of 2012; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 2359, Safe Cosmetics Act of 2011. Issues related to regulation of cosmetics industry and effect on small businesses.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Public Law 111-353, FDA Food Safety Modernization Act, Implementation issues regarding dietary supplement issues S.216, Food Safety Accountability Act of 2011, entire bill as it relates to dietary supplements S.1310, Dietary Supplement Labeling Act, entire bill as it relates to dietary supplements H.R.1364, Free Speech About Science Act, entire bill as it relates to dietary supplements H.R.2359, Safe Cosmetics Act, entire bill as it relates to dietary supplements H.R.3380, Dietary Supplement Protection Act of 2011, entire bill as it relates to dietary supplements Issues related to New Dietary Ingredients Public Law 112-144, Food & Drug Administration Safety and Innovation Act, Provisions relating to dietary supplements

Client expense: Not reported · Firm income: $30,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

HR 2359, Safe Cosmetics Act of 2011 - all provisions. HR 4262, Cosmetics Safety Enhancement Act of 2012 - all provisions. HR 4395, Cosmetic Safety Amendments Act of 2012 - all provisions.

Client expense: Not reported · Firm income: $30,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to the FDA. Issues related to medical devices, including the Unique Device Identification System Proposed Rule; Issues related to pharmaceutical supply chain security; Issues related to cosmetics, including H.R. 4395 - Cosmetic Safety Amendments Act of 2012 (as well as H.R. 2359 and H.R. 4262); Issues related to the medical device tax, including H.R. 436 - Health Care Cost Reduction Act of 2012 (as well as S. 17 and S. 262).

Client expense: $20,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 965; Preservation of Antibiotics for Medical Treatment Act of 2011 (PAMTA) S. 847; The Safe Chemicals Act of 2011 H.R. 2359; The Safe Cosmetics Act of 2011 Proposals related to the Clean Air Act

Client expense: $547,767 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 4395, Cosmetic Safety Amendments Act of 2012; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 2359, Safe Cosmetics Act of 2011. Issues related to regulation of cosmetics industry and effect on small businesses.

Client expense: Not reported · Firm income: Not reported

H.R. 4395, Cosmetic Safety Amendments Act of 2012; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 2359, Safe Cosmetics Act of 2011. Issues related to regulation of cosmetics industry and effect on small businesses.

Client expense: Not reported · Firm income: Not reported

H.R. 2359, Safe Cosmetics Act of 2011; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 4395, Cosmetic Safety Amendments Act of 2012; S. 847, Safe Chemicals Act of 2011

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA regulation of cosmetics including Good Manufacturing Practices, import safety, fragrance ingredients and cosmetic registration; H.R. 2359, Safe Cosmetics Act of 2011; H.R. 4262, Cosmetics Safety Enhancement Act of 2012; H.R. 4395, Cosmetics Safety Amendments Act of 2012; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 3187, The Food and Drug Administration Safety and Innovation Act

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE