Monthly Update for April 2013


TSCA/FIFRA/NTP/EPCRA

EPA Previews New Website For Consolidated Chemical Data Access: The U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics (OPPT), convened an in-person and on-line public forum today to discuss OPPT's ongoing efforts to develop an interactive public website. The website would integrate a wide range of chemical data collected and EPA assessments conducted under Toxic Substances Control Act (TSCA) programs, as supplemented by additional EPA resources such as the Integrated Risk Information System (IRIS) and the Toxics Release Inventory (TRI). According to the presentation, OPPT intends to go live with the first phase of the website by Spring/Summer 2013. A more detailed memorandum is available online.

Industry Groups Release Seed Treatment Guide: On March 25, 2013, CropLife America and the American Seed Trade Association posted an online guide for seed treatment stewardship to inform growers and seed companies on best practices to reduce pesticide exposure to nontarget organisms. The Guide to Seed Treatment Stewardship contains recommendations on the planting of seeds that have been treated with pesticides, the safe handling of seed, and the storage of treated seeds. The guide is intended to be an "all-in-one resource that addresses every stage of a seed's journey from treatment to planting." The guide is available online.

EPA Announces Availability Of White Paper On ESA Consultation Process: On March 27, 2013, the EPA Office of Chemical Safety and Pollution Prevention (OCSPP) Office of Pesticide Programs (OPP) announced the availability of the final white paper describing enhanced opportunities for stakeholder input during its review of pesticide registrations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and associated consultations under the Endangered Species Act (ESA). 78 Fed. Reg. 18585. The paper was jointly prepared by EPA, the U.S. Department of Agriculture (USDA), and the National Marine Fisheries Service (NMFS) in the U.S. Department of Commerce and the U.S. Fish and Wildlife Service (USFWS) in the Department of Interior (the Services). The paper describes significant changes to EPA's registration review process intended to facilitate ESA pesticide consultations and coordination across these federal agencies, and calls for a greater role for USDA. The paper, titled Enhancing Stakeholder Input in the Pesticide Regulation Review and ESA Consultation Processes and Development of Economically and Technologically Feasible Resources and Prudent Alternatives, was revised based on public comment. Specifically, EPA, USDA, and the Services revised the paper to outline specific roles and responsibilities for each agency, and to provide clarifying information on focus meetings and the timing for public input.

EPA Announces List Of Chemicals For Assessment In 2013: On March 27, 2013, as part of the Toxic Substances Control Act (TSCA) Work Plan, EPA announced that it will begin assessments on 23 chemicals, with a specific focus on flame retardant chemicals. According to EPA's press release, EPA will evaluate 20 flame retardant chemicals, conducting full risk assessments for four of the flame retardants, three of which are on the TSCA Work Plan, and one of which was the subject of an Action Plan. In addition to the flame retardant chemicals, EPA will begin developing risk assessments on three other TSCA Work Plan chemicals: octamethylcyclotetrasiloxane (D4); 1-bromopropane; and 1,4 dioxane. The press release is available online. More information regarding the TSCA Work Plan chemicals is available online. A more detailed memorandum is available online.

EPA Convenes FIFRA Scientific Advisory Panel Meetings: On April 2, 2013, EPA announced the scheduling of a four-day meeting of the FIFRA Scientific Advisory Panel (SAP) to consider and review proposed Endocrine Disruptor Screening Program (EDSP) Tier 2 Ecotoxicity Tests. 78 Fed. Reg. 19706. FIFRA SAP serves as the primary scientific peer review mechanism of EPA's OCSPP and is structured to provide scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. The meeting will be held on June 25-28, 2013, from 9:00 a.m. to approximately 5:30 p.m. in Washington, D.C. Nominations of candidates to serve as ad hoc members of FIFRA SAP for this meeting should be provided on or before April 16, 2013. Written comments must be submitted by June 11, 2013, and requests for oral comments must be submitted by June 18, 2013.

On April 11, 2013, EPA announced the re-scheduling of a SAP meeting on Tier 1 Screening Assays and Battery Performance. 78 Fed. Reg. 21603. The meeting is scheduled May 21-23, 2013.

CPDA Ongoing Inert Ingredients Symposium: The Council of Producers & Distributors of Agrotechnology (CPDA) will convene a two-day Inert Ingredients Symposium to be held on June 4-5, 2013, at the Hilton Crystal City Hotel in Crystal City, Virginia. This symposium will provide attendees with an understanding of the evolving federal requirements affecting inert ingredients used in agrotechnology products such as pesticides, plant nutrients, adjuvants, and soil conditioners. The symposium will include topics such as: Pesticide Registration Improvement Extension Act (PRIA 3) implementation and EPA approval of inerts; industry perspectives on inert ingredient development, use, and regulation; FIFRA Section 25(b) minimum risk inerts; USDA's National Organics Program (NOP) and EPA interagency efforts to review inerts used in organic production; approved inert and proprietary mixture databases; data compensation and confidential business information (CBI); and Canada's approach to regulation of inert ingredients.

EPA conducted a PRIA 3 workshop on April 10 to present an initial "lessons learned" with implementation of PRIA. A PRIA 3 and inerts Question & Answer (Q&A) roundtable will take place at the EPA offices in Crystal City after conclusion of the Symposium. More information is available at www.cpda.com.

EPA Issues Interpretation Of PCBs From Recycling Plastics: On April 5, 2013, EPA announced an interpretation of its regulations that will generally allow for the recycling of plastic separated from shredder residue under the conditions described in the Voluntary Procedures for Recycling Plastics from Shredder Residue, relying principally on the regulatory provisions for excluded PCB products. 78 Fed. Reg. 20640. The interpretation responds to questions EPA has received about the applicability of the excluded PCB products regulations. EPA believes that it is reasonable to interpret the regulations as generally allowing the recycling of excluded PCB products. Accordingly, under the interpretation, to the extent that the feedstock (scrap materials) to a shredder consists of these kinds of materials, the plastics separated from the resulting residue can be recycled (and the resulting recycled product is also an excluded PCB product that can be processed, used, and distributed in commerce, including being further recycled), provided the PCB concentration in any resulting product is below 50 parts per million (ppm).

GREEN CHEMISTRY

DTSC Releases Revised Proposed Safer Consumer Products Regulations: On April 10, 2013, the California Department of Toxic Substances Control (DTSC) released what many believe to be the last revisions to the proposed Safer Consumer Products Regulations (Revised Proposed Regulations). The Revised Proposed Regulations are subject to a 15-day comment period, ending April 25, 2013. Memoranda providing background information are available online. The Revised Proposed Regulations are available online. A more detailed memorandum regarding the Revised Proposed Regulations is available online.

In summary, DTSC has not made many significant changes to the Regulations, which were last released and subject to comment earlier this year. The core elements of the Revised Proposed Regulations -- Chemicals of Concern (COC), Priority Products (PP), Alternative Assessments (AA), and Regulatory Responses -- remain largely the same. Below is a discussion of the substantive changes from the last proposal. DTSC has indicated that it intends to issue final regulations by October 2013.

RCRA

EPA Requests Comment On Revised RCRA Waste Analysis Guidance Document: For the first time in 19 years, EPA has revised its primary guidance document for hazardous waste analysis under the Resource Conservation and Recovery Act (RCRA). The document is available online. Entitled Waste Analysis at Facilities That Generate, Treat, Store, and Dispose of Hazardous Wastes: A Guidance Manual, the manual is intended to provide guidance on how to develop and implement a Waste Analysis Plan (WAP) suitable for managing hazardous wastes under RCRA, assist federal and state permit writers in evaluating submitted WAPs, and assist enforcement personnel in determining whether a facility is in compliance with testing requirements. Areas that EPA has provided additional guidance on include: design of characterization studies; re-characterization frequency; how to address issues of waste variability; establishing and employing data quality objectives; selection of indicator parameters to reduce testing costs; measurement uncertainty; and using statistical concepts to guide the characterization process. EPA is accepting comments on the guidance until April 30, 2013.

NANOTECHNOLOGY

Canada Publishes SNAc For Cobalt Iron Manganese Oxide, Carboxylic Acid-Modified: The March 16, 2013, Canada Gazette includes a significant new activity (SNAc) notice for cobalt iron manganese oxide, carboxylic acid-modified, which the notice states is not included on the Domestic Substances List (DSL). The notice defines SNAc as:

  1. [A]ny use where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 100 kg per calendar year other than for a use described in paragraph (b); or
     
  2. [T]he use as an ink additive in commercial or industrial settings where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 1,666 kg per calendar year.

The notice specifies data that must be provided to Canada 90 days before commencement of the proposed SNAc. Canada notes that, under the Canadian Environmental Protection Act, 1999, in circumstances where a SNAc notice is issued for a new substance, "it is the responsibility of every person who transfers the physical possession or control of the substance to notify all persons to whom the possession or control is transferred of the obligation to comply with the Significant New Activity Notice and of the obligation to notify the Minister of the Environment of any new activity and all other information as described in the Notice." Users are responsible for being aware of and complying with the SNAc notice and submitting a SNAc notification prior to the commencement of a SNAc associated with the substance. The notice is available online.

Australia Releases Research Reports On Nanotechnology Work Health And Safety Issues: On March 18, 2013, Safe Work Australia (SWA) released two research reports examining nanotechnology work health and safety issues, Investigating the Emissions of Nanomaterials from Composites and Other Solid Articles During Machining Process, available online, and Evaluation of Potential Safety (Physicochemical) Hazards Associated with the Use of Engineered Nanomaterials, available online. SWA noted the perceived safety risks of nanomaterials and that Australia is taking a precautionary approach towards nanomaterials under the National Enabling Technologies Strategy. SWA Chair Ann Sherry stated that while the risk to human health and safety from a number of nanomaterials and applications is low, some nanomaterials, such as carbon nanotubes, are potentially more hazardous. SWA's press release states: "Minimisation of exposure to nanomaterials at work is essential until there is sufficient data to rule out hazardous properties. Research has shown if conventional engineering controls are designed and maintained effectively, exposure to nanomaterials can be significantly reduced." According to the press release, as a result of the findings in the research reports, SWA intends to prepare guidance material on combustible dust hazards, including nanomaterials. The press release is available online.

Danish EPA Publishes Proposal For Technical Information Requirements For Nanomaterials: The Danish EPA published on March 20, 2013, a proposal for technical information requirements for nanomaterials. The Danish EPA states that its proposal may be used in legislation concerning nanomaterials, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Danish EPA reviewed information requirement recommendations from expert groups, associations, and authorities. According to the Danish EPA, the proposed information requirement scheme is based on the REACH methodology, i.e., a stepwise approach requiring more information at higher tonnage levels. The Danish EPA notes that the proposal "should not necessarily be seen as a proposal for updating REACH, as it could also be put forward as a stand-alone scheme for nanomaterials and used in relation to adapting other existing legislation, or it could be used for guiding."

The proposed stepwise information requirement scheme consists of four tonnage levels that could correspond to the REACH tonnage trigger levels or be lowered. The proposal includes a number of "new" information requirements as compared to those for non-nanoscale materials, most of which relate to the description/characterization of nanomaterials and other physicochemical properties. For a number of existing information requirements, the proposal would adapt the endpoints and/or modify the adaptation rules. The proposal reviews more general issues that the Danish EPA states "should be addressed in relation to a regulatory testing requirements scheme for nanomaterials, possibly in the legislation itself, but certainly in guidance." The proposal is available online.

German Agencies Publish Report And Recommendations Concerning Health And Safety Of Nanomaterials: On March 20, 2013, five German agencies published a report entitled Nanotechnology -- Health and Environmental Risks of Nanomaterials, which includes a joint set of recommendations for future safety assessments of nanomaterials. Under a joint research strategy set up in 2007, over 80 research projects on nanomaterials were reviewed. The report includes recommendations to:

  • Develop adequate measurement methods for risk assessment;
     
  • Develop reference materials for exposure assessment and studies into the effects of nanomaterials on humans and the environment;
     
  • Validate and harmonize test and evaluation strategies "in a national and international context" to allow results to be compared;
     
  • Develop screening tests for adverse health and environmental risks at an early stage of material innovation;
     
  • Develop ideas for labeling single nanomaterials; and
     
  • Work on grouping nanomaterials based on their properties to reduce the number of complex single investigations.

The report was prepared by the Federal Institute for Risk Assessment, Federal Environment Agency, Federal Institute for Occupational Safety and Health, Federal Institute for Materials Research and Testing, and Physikalisch-Technische Bundesanstalt. The report is available, in German, online.

UK Posts Guidance On Controlling Occupational Exposure To Manufactured Nanomaterials: The United Kingdom's (UK) Health and Safety Executive (HSE) has posted a guidance document describing how to control occupational exposure to manufactured nanomaterials in the workplace. HSE intends the guidance to assist in compliance with the Control of Substances Hazardous to Health Regulations 2002 (COSHH) (as amended). HSE states that the guidance is specifically about the manufacture and manipulation of all manufactured nanomaterials, carbon nanotubes (CNT), and other bio-persistent high aspect ratio nanomaterials (HARN). HSE prepared the guidance "in response to emerging evidence about the toxicity of these materials." According to HSE, the control principles described in the guidance can be applied to all nanomaterials used in the workplace. HSE highlights any differences in the approach between control of CNTs and other bio-persistent HARNs to other types of nanomaterials. More information is available online.

Nanotechnology Industries Association Announces New Website: The Nanotechnology Industries Association (NIA) has announced that a new version of its website is now online and available at www.nanotechia.org. NIA redesigned the website to serve its members better while also communicating more effectively with the public about the NIA's activities. The new website better reflects the various sectors where the NIA is present and accurately describes the services offered to members. NIA is a sector-independent, responsible voice for the industrial nanotechnologies supply chains. It supports the ongoing innovation and commercialization of the next generation of technologies and promotes their safe and reliable advancement.

FDA

FDA Posts Cosmetic Information: The U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN), the Center that regulates cosmetics, recently posted the fifth update to its "Information for Cosmetic Importers" (Information) on its website. The Information makes a number of basic, but important points about the regulation of cosmetic imports. CFSAN discusses how imported cosmetics are monitored. Product that appears to be adulterated or misbranded may be refused admission into the United States, and must be brought into compliance, destroyed, or re-exported. CFSAN points out that examination of imported cosmetics is not limited only to the types of products specified in Import Alerts. Similarly, importers of cosmetic ingredients that are also classified as food products are required to meet the registration requirements of the Bioterrorism Act of 2002. The Information points out an important consideration involving importation that has tripped up companies. Many countries define drugs and cosmetics differently from the United States. For example, in some countries, sunscreens are regulated as cosmetics. In the United States, they are regulated as drugs. Hair restoration, skin protectant, pain relief, anti-aging effects that involve the structure or function of the skin, and treatment of acne, dandruff, eczema, or irritated skin are other examples of claims that would cause products to be regulated as drugs (or in some cases, both cosmetics and drugs) in the United States, and products will be refused admission if they do not comply with requirements applicable to drugs. A variety of other information relating to cosmetics is set out on the CFSAN site, including a "Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist" that allows a manufacturer to do a self-audit that can help prepare for a visit from the FDA.

BIOBASED PRODUCTS

USDA Withdraws Final Rule Amending Guidelines For Designating Biobased Products For Federal Procurement: USDA published a notice on April 8, 2013, withdrawing its April 1, 2013, final rule (78 Fed. Reg. 19393) concerning the designation of product categories for federal procurement. 78 Fed. Reg. 20783. According to the USDA, it is withdrawing the final rulemaking, which amended the guidelines for designating biobased products for federal procurement, because it published the final rule prematurely "due to an oversight in the development process." The notice states that USDA's Office of Procurement and Property Management "anticipates republishing the rulemaking in the coming months."

CLEAN AIR ACT (CAA)

EPA Inspector General Report Finds RMP Inspectors Were Inadequately Trained: EPA's Inspector General's (IG) office on March 21, 2013, released a report finding that about one-third of EPA's inspectors under the Clean Air Act's (CAA) Risk Management Program (RMP) were not properly trained to conduct RMP inspections. The report is available online. The IG found that 15 of the 45 RMP inspectors nationwide received inspector credentials without documentation indicating that they met minimum training requirements. Six of the twelve inspection supervisors did not meet minimum training requirements. EPA's management controls did not detect or prevent the cases of missed or undocumented training, the report found. The IG also found that weaknesses in controls included limitations in training tracking systems and a lack of procedures to ensure that supervisors met their training requirements.

LEGISLATIVE DEVELOPMENTS

Senator Lautenberg Reintroduces Safe Chemicals Act: On April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act (S. 696), which would reform TSCA and is identical to legislation (S. 847) reported favorably out of the Senate Environment and Public Works Committee on a party-line vote in the 112th Congress. In his April 10, 2013, press release, Senator Lautenberg states that, compared to earlier versions of the legislation, the Safe Chemicals Act of 2013 "includes a number of significant changes that reflected input from a broad range of stakeholders including federal agencies, state governments, the chemical industry, and public health advocates." The bill would: establish a risk-based chemical management system based on sound science; focus attention on priority chemicals; secure access to health and safety data; protect Americans from harmful chemicals; and promote innovation and protect confidential business information (CBI).

A summary of the bill is available online, and the full text of the bill is available online. A detailed discussion of the 2011 legislation is available in our April 18, 2011, memorandum, which is available online, as well as our thoughts on the bill that emerged from Committee, which is available in our July 26, 2012, memorandum online. A more detailed memorandum regarding the Safe Chemicals Act reintroduced by Senator Lautenberg on April 10 is available online.

Congress Passes Resolution Avoiding Government Shutdown: On March 20, 2013, the Senate approved a Continuing Resolution (CR) to keep the government funded, avoiding a government shutdown at the end of March when the existing CR would have expired. In a 73-26 vote, the Senate approved the $984 billion measure that will keep the government funded through the end of the fiscal year (FY), September 30. The spending bill was sent to the House, where on March 21, 2013, it passed by a vote of 318-109. Subsequently, President Obama on March 26 signed into law the Consolidated and Further Continuing Appropriations Act (H.R. 933).

Senate Approves Budget Plan, Adopts Several Environmental Amendments: After an all-night debate, the Senate on March 23, 2013, passed its first budget in four years. It provides $3.7 trillion in funding for FY 2014. The plan (S. Con. Res. 8) faces an uphill battle. It passed on a 50-49 vote, with no Republicans voting for it and four Democrats opposing it. The measure would restore the budget cuts under the so-called sequester of the Budget Control Act of 2011. Over 500 amendments were considered during the debate on the bill. Senators adopted an amendment supporting construction of the Keystone XL crude oil pipeline, while rejecting an amendment by Senator Barbara Boxer (D-CA) that called for further economic analysis of the project. Senators also rejected an amendment by Senator James Inhofe (R-OK) that essentially would have prohibited EPA from issuing regulations seeking to reduce emissions of greenhouse gases (GHG).

President's Budget Cuts EPA Funding: President Obama's budget for FY 2014 cuts EPA's budget and calls for "transformational change" at EPA. The budget requests $8.153 billion, $296 million or 3.5 percent below FY 2012 enacted funding. EPA's staff would be cut to 16,870, the lowest in well over a decade. The budget clearly reflects the economic environment, with necessary reductions to programmatic spending and significant cuts to infrastructure financing. The budget request is focused on five broad goals, which are (in descending order of proposed allocated budget resources) protecting America's waters, cleaning up communities, taking action on climate change and improving air quality, enforcing environmental laws, and ensuring the safety of chemicals and preventing pollution. The budget also announces its "E Enterprise" initiative, a suite of electronic programs that EPA claims will save some $60 million.

Senate Committee Holds Hearing On Gina McCarthy Nomination: The Senate Environment and Public Works Committee on April 11, 2013, held a hearing on the nomination of Gina McCarthy as EPA Administrator. Although EPA's regulatory practices and transparency were soundly thrashed during the hearing, both Democrats and Republicans acknowledged that EPA under her leadership would likely take the lead in reducing GHGs in the absence of significant Congressional action on climate change. During the hearing, Republicans also criticized what they characterized as an "overzealous" EPA whose central functions have been "obfuscated by ideology," according to Senator David Vitter (R-LA). Vitter also criticized EPA's transparency, including a practice in which top officials used secondary e-mail accounts to communicate, and some used private e-mail accounts. Senator John Barrasso (R-WY) argued that tougher emission rules for power plants have stunted the market for domestic coal and the environmental review of overseas coal terminals has slackened demand, effectively killing the industry. Despite the negative impression Republicans hold of EPA, McCarthy is expected to pass Senate confirmation.

Senator Blocks EPA Administrator Nomination Over Flood Control Project: Senator Roy Blunt (R-MO) has placed a hold on the nomination of Gina McCarthy as the next EPA Administrator. Blunt stated that he would keep the hold on the nomination until the Obama Administration announces a timeline for completing its environmental review of a flood control project in Missouri known as the St. Johns Bayou and New Madrid Floodway Project. The project would install pumping stations and close a 1,500-foot gap in the Mississippi River levee system, according to the Senator's press release. EPA and other agencies are threatening to delay permitting for the project in part because it would threaten aquatic resources of national importance.

Regulations From The Executive In Need Of Scrutiny Bill Passes House Judiciary Panel: The House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law on March 20, 2013, approved the Regulations from the Executive in Need of Scrutiny (REINS) Act (H.R. 367). The bill moves to the full Judiciary Committee for a vote. The REINS Act would require EPA and other federal agencies to obtain approval from Congress before promulgating any regulation that has an economic impact of $100 million or more on the economy of the U.S. Such regulations would require resolutions of approval from both chambers of Congress before the rules could be issued. Even if the Judiciary Committee passes the bill, it is unlikely to get a floor vote as President Obama has vowed to veto similar legislation introduced in the last Congress.

House Subcommittee Holds Hearing On Improving EPA's Scientific Review Processes: On March 20, 2013, the House Science, Space and Technology Subcommittee on the Environment held a hearing entitled Improving EPA's Scientific Advisory Processes. The purpose of the hearing was to examine EPA's process for receiving independent scientific advice and to receive testimony on draft legislation intended to strengthen public participation, improve the process for selecting expert advisors, expand transparency requirements, and limit non-scientific policy advice among advisory bodies. The hearing witnesses were Dr. Michael Honeycutt, Chief Toxicologist, Texas Commission on Environmental Quality; Dr. Roger McClellan, Advisor, Toxicology and Human Health Risk Analysis; and Dr. Francesca Grifo, Senior Scientist and Science Policy Fellow, Union of Concerned Scientists. Witness testimony and related information is available online.

House Committee Launches Bipartisan Review Of Renewable Fuel Standard: On March 20, 2013, the House Energy and Commerce Committee released the first of five bipartisan white papers that explore important policy implications related to continued implementation of the Renewable Fuel Standard (RFS). The white papers are intended to solicit input and stimulate debate in several areas: infrastructure, fuel compatibility, blending, economics, and environmental issues. Each paper will provide a detailed policy analysis on one area and then outline a series of questions intended to engage key stakeholders on that issue.

This first white paper, The Blend Wall and Fuel Compatibility Issues, focuses on one of the most pressing and complicated policy challenges facing proponents and opponents of biofuels. The paper recognizes a changed fuels refining environment from 2007, where fuel demand has fallen dramatically and ten percent ethanol blends (the conventional ethanol blend percentage) are rapidly approaching saturation in the fuel pool. It discusses various aspects of mid-level ethanol blends (E15, E85), which have the ability to introduce higher volumes of biofuels than conventional blend levels. Some key questions posed at the end of the white paper for biofuels stakeholders relate to the feasibility of mid-level ethanol blends, the marketing and mis-fueling challenges to mid-level blends, the economics of the Blend Wall, and the intersection of new Corporate Average Fuel Economy (CAFE) vehicle standards and the RFS. The Committee asked stakeholders to respond to the first paper by April 5, 2013. More information is available online.

Bill Introduced To Increase Reporting Requirements: The Delivering Antimicrobial Transparency in Animals Act of 2013 or "DATA Act" by Representative Louise Slaughter (D-NY) (the only microbiologist in Congress) and Representative Henry Waxman (D-CA) was recently introduced. By increasing reporting requirements for antimicrobial drugs used in food animals, the DATA Act is designed to obtain information to help formulate better regulatory requirements for the antimicrobials. H.R. 820 is crafted to provide information to enable public health officials and scientists to better understand and interpret trends and variations in rates of microbial resistance to such antimicrobial drugs; improve the understanding of the relationship between antimicrobial drug use in animals used for food and antimicrobial drug resistance in microbes in and on animals and humans; and identify interventions to prevent and control such antimicrobial drug resistance. In the case of each new animal drug that contains an antimicrobial active ingredient, the sponsor of the drug would be required to submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. The reports must be submitted electronically not later than March 31 each year and cover the period of the preceding calendar year. The DATA Act provides that FDA may share the information submitted to it with the Antimicrobial Task Force established under Section 319 E of the Public Health Services Act. Not later than November 30 each year, FDA would be required to make publicly available summaries of the information reported. The legislation sets forth requirements for the content of such summaries.

Bill Would Give FDA Authority To Set Safety Standard For Cosmetics: A bill that would give FDA the authority to create and enforce a safety standard for ingredients used in cosmetics and personal care products has been introduced in Congress. Representatives Jan Schakowsky (D-IL) and Edward Markey (D-MA), the sponsors of the Safe Cosmetics and Personal Care Products Act, stated in a joint statement that the measure would close "major loopholes in the federal law that allows companies to use ingredients in cosmetics and personal care products known to damage human health and the environment." Key provisions of the bill are: the FDA would establish a list of ingredients prohibited from being used in cosmetics. This would include carcinogens and reproductive and developmental toxins; the Secretary of the Department of Health and Human Services would be required to conduct annual random sample tests for pathogens or contaminants in cosmetic products; and cosmetics companies would be required to register with the FDA and pay a registration fee based on annual gross receipts or sales. Small businesses with less than $2 million in revenues from cosmetics would be exempt from registration; businesses with less than $10 million in revenues from cosmetics would be exempt from registration fees; FDA would have authority to recall products that are "misbranded, adulterated, or otherwise fail to meet the safety standard" and can request a voluntary recall or order the stoppage of distribution of any such cosmetic product; cosmetic manufacturers, packagers, and distributors would have to provide FDA with reports of adverse health effects associated with the use of a cosmetic; and states can set more stringent standards. The measure would help close the "gaping holes in federal law that allow companies to use potentially untested and unsafe ingredients in cosmetic and personal care products," stated Markey.

Water Advanced Technologies For Efficient Resource Use Act Of 2013: Representative Rush Holt (D-NJ) introduced H.R. 123 that would establish within EPA a WaterSense program to identify and promote water efficient products, buildings and landscapes, and services to reduce water use, conserve energy, and preserve water resources. The EPA Administrator is charged with promoting, publicizing, and administering the WaterSense program, and federal agencies are required to purchase WaterSense products or services or a Federal Energy Management Program designated product through their procurement process. Finally, H.R. 123 establishes a program to provide financial incentives for consumer purchase and installation of residential water efficient products and services.

End Radon In Schools Act: Representative Bruce Braley (D-IA) introduced H.R. 275 that would direct the EPA Administrator to review, update, revise, and publish the Radon Measurements In Schools Guidelines with current information and guidance on radon testing in public elementary and secondary schools. The Administrator, subject to the availability of appropriations, would also be tasked to award grants to states to: (1) follow the updated Guidelines; (2) test radon levels in their public elementary and secondary schools; and (3) provide funds to their local educational agencies (LEA) to mitigate and re-test radon levels in schools found to have radon levels that the updated Guidelines deem unsafe. The Administrator would conduct such mitigation directly or by contract if an LEA does not certify to its state that it will use grant funds to mitigate unsafe radon levels at its schools. The measure would give highest grant priority to states whose total landmass lies in Radon Zone 1 and second highest priority to states with at least 50 percent of their landmass in Radon Zone 1. A "Radon Zone 1" is defined in the bill as areas that have a predicted average indoor radon screening level greater than four picocuries per liter.

Water Infrastructure Resiliency And Sustainability Act of 2013: Representative Lois Capps (D-CA) introduced H.R. 765 that would require the EPA Administrator to: (1) establish the Water Infrastructure Resiliency and Sustainability Program to provide grants to owners or operators of water systems for programs or projects to increase the resiliency or adaptability of the systems to any ongoing or forecasted changes to the hydrologic conditions of a U.S. region; and (2) give priority to owners or operators of water systems that are at the greatest and most immediate risk of facing significant negative impacts due to changing hydrologic conditions. The Administrator would be required to ensure that the list of grant applications funded includes a substantial number that propose to utilize innovative approaches that: (1) promote more efficient water use, water conservation, water reuse, or recycling; (2) use decentralized, low-impact development technologies and nonstructural approaches, including practices that use, enhance, or mimic the natural hydrological cycle or protect natural flows; (3) reduce stormwater runoff or flooding by protecting or enhancing natural ecosystem functions; (4) modify, upgrade, enhance, or replace existing water system infrastructure in response to changing hydrologic conditions; (5) improve water quality or quantity for agricultural and municipal uses, including through salinity reduction; and (6) provide multiple benefits, including to water supply enhancement or demand reduction, water quality protection or improvement, increased flood protection, and ecosystem protection or improvement.

Federal Advisory Committee Act Amendments Of 2013: Representative William Lacy Clay (D-MO) introduced H.R 1104 that would amend the Federal Advisory Committee Act (FACA) to require appointments to federal agency advisory committees to be made without regard to political affiliation or activity, unless otherwise required by federal statute. The head of an agency, prior to appointing members to an advisory committee, would need to give interested persons an opportunity to suggest potential committee members. The measure goes on to require an individual appointed to an advisory committee who is not a full-time or permanent part-time officer or employee of the federal government to be designated as: (1) a special government employee if the individual is providing advice based on the individual's expertise or experience; or (2) a representative if the individual is representing the views of an entity outside of the federal government. An agency is prohibited from designating committee members as representatives to avoid subjecting them to federal ethics rules and requirements. H.R. 1104 then would require each agency head to ensure that advice and recommendations of an advisory committee that reports to the agency are the result of the advisory committee's judgment, independent from the agency, and provide that an individual who is not an officer or employee of the federal government shall be regarded as a member of an advisory committee if the individual regularly attends and participates in committee meetings as if the individual were a member, even if the individual does not have the right to vote or veto the advice or recommendations of the committee. Lastly, the bill would require each agency head to make available on the agency's Internet site specified information about each of the agency's advisory committees and their activities and to designate an Advisory Committee Management Officer to be responsible for the establishment, management, and supervision of the agency's advisory committees. The Comptroller General would be designated to review compliance by agencies with FACA.

EPA Science Advisory Board Reform Act of 2013: H.R. 1422, sponsored by Representative Chris Stewart (R-TX), would amend the Environmental Research, Development, and Demonstration Authorization Act of 1978 to provide for Science Advisory Board (SAB) member qualifications, public participation, and for other purposes. The SAB would be composed of at least nine members, one of whom shall be designated Chairman. Members would need to be qualified by education, training, and experience to evaluate scientific and technical information on matters referred to the SAB. Members would be selected to ensure that the scientific and technical points of view represented on and the functions to be performed by the SAB are fairly balanced among the members of the SAB. At least ten percent of the membership of the SAB would have to come from state, local, or tribal governments and persons with substantial and relevant expertise would not be excluded due to affiliation with or representation of entities that may have a potential interest in the SAB’s advisory activities, so long as that interest is fully disclosed to the Administrator. Regarding particular matter involving a specific party, no SAB member having an interest in the specific party could participate in that activity; SAB members could not participate in advisory activities that directly or indirectly involve review and evaluation of their own work. There are provisions in the bill relating to the nomination process and disclosure of potential member financial interests.

MISCELLANEOUS

EPA Survey Finds More Than Half Of The Nation's River And Stream Miles In Poor Condition: On March 26, 2013, EPA released the results of the first comprehensive survey looking at the health of thousands of stream and river miles across the country, finding that more than half -- 55 percent -- are in poor condition for aquatic life. EPA states that the 2008 - 2009 National Rivers and Streams Assessment reflects the most recent data available and is part of EPA's expanded effort to monitor waterways in the U.S. and gather scientific data on the condition of the Nation's water resources. EPA partners, including states and tribes, collected data from approximately 2,666 sites across the country. EPA, state, and university scientists analyzed the data to determine the extent to which rivers and streams support aquatic life, how major stressors may be affecting them, and how conditions are changing over time. Findings of the assessment include:

  • Nitrogen and phosphorus are at excessive levels. Twenty-seven percent of the nation's rivers and streams have excessive levels of nitrogen, and 40 percent have high levels of phosphorus.
     
  • Streams and rivers are at an increased risk due to decreased vegetation cover and increased human disturbance. These conditions can cause streams and rivers to be more vulnerable to flooding, erosion, and pollution.
     
  • High bacteria levels were found in nine percent of stream and river miles making those waters potentially unsafe for swimming and other recreation.
     
  • More than 13,666 miles of rivers have fish with mercury levels that may be unsafe for human consumption. For most people, the health risk from mercury by eating fish and shellfish is not a health concern, but some fish and shellfish contain higher levels of mercury that may harm an unborn baby or young child's developing nervous system.

EPA plans to use this new data to inform decision making about addressing critical needs around the country for rivers, streams, and other waterbodies. This comprehensive survey will also help develop improvements to monitoring these rivers and streams across jurisdictional boundaries and enhance the ability of states and tribes to assess and manage water quality to help protect our water, aquatic life, and human health.

OEHHA Proposes To Add Hydrogen Cyanide To Prop 65: On March 25, 2013, California's Office of Environmental Health Hazard Assessment (OEHHA) announced plans to add hydrogen cyanide and cyanide salts to the list of reproductive toxicants the state maintains under the Safe Drinking Water and Toxic Enforcement of Act of 1984 (Prop 65). In a separate notice, the agency proposed a maximum allowable dose level (MADL) for oral exposure to hydrogen cyanide and cyanide salts, expressed in terms of cyanide, of 9.8 micrograms per day. For hydrogen cyanide and cyanide salts that dissociate to the cyanide ion, OEHHA is proposing that the MADL be calculated by multiplying the molecular weight of the compound by 0.38 micrograms per day. Comments are due by April 22, 2013.

D.C. Circuit Issues FOIA Decision: The U.S. Court of Appeals for the District of Columbia Circuit issued a decision on April 2, 2013, concerning procedure under the Freedom of Information Act (FOIA), defining "determination" for purposes of 5 U.S.C. Section 552(a)(6)(A)(i). Citizens for Responsibility and Ethics in Washington v. Federal Election Commission (12-5004). Under FOIA, a requester must exhaust administrative appeal remedies before challenging in federal district court an agency's failure to produce requested documents. The Justice Department argued that an agency satisfies the statutory requirement to make a determination within 20 days of receiving a FOIA request if it issues an initial statement that it will produce documents and claim exemptions over withheld documents in the future. The court held that the agency "must at least: (i) gather and review the documents; (ii) determine and communicate the scope of the documents it intends to produce and withhold, and the reasons for withholding any documents; and (iii) inform the requester that it can appeal whatever portion of the 'determination' is adverse." According to the court, if the agency fails to make such a detailed determination within 20 days, the requester will be deemed to have exhausted its administrative remedies and can bring suit in federal court. The court's opinion is available online.

OEHHA Lists BPA As Reproductive Toxicant: Effective April 11, 2013, OEHHA listed bisphenol A (BPA) on Prop 65 as known to cause reproductive toxicity. OEHHA states it based the listing on formal identification by the National Toxicology Program (NTP), an authoritative body, in a final report by the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) that BPA causes reproductive toxicity (developmental endpoint) at high doses. OEHHA will "soon" post on its website its responses to public comments. More information is available online. A frequently asked questions document is available online.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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