EPA S TSCA Inventory Reset and Champ Program

EPA S TSCA Inventory Reset and Champ Program

EPA’s TSCA Inventory Reset and TSCA Program

EPA’s TSCA Inventory Reset and TSCA Program

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The Toxic Substances Control Act of 1976 (TSCA) provides the Environmental Protection Agency (EPA) with comprehensive authority to regulate the manufacturing, importing, processing, distributing, use, and disposal of chemical substances and mixtures for commercial purposes in the United States. EPA also sets the testing requirements necessary to evaluate the safety of each chemical or mixture of chemicals to meet the TSCA safety standard of no “unreasonable risk of injury to human health or the environment”. Certain substances are excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides.

TSCA section 8(b) requires EPA to compile, keep current, and publish a list of each chemical substance that is used commercially. However, not all of these chemicals have been evaluated under the TSCA safety standard of no unreasonable risk of injury to human health or the environment. In general, the purpose of this list, the Chemical Substances Inventory (TSCA Inventory), is to identify what chemical substances exist in U.S. commerce. Substances not included on the Inventory are considered to be new chemical substances and are subject to the Premanufacture Notification (PMN), Microbial Commercial Activity Notice (MCAN), or exemption requirements set forth in TSCA section 5(a)(1).

TSCA Inventory

There are are currently almost 84,000 chemicals on the TSCA Inventory, with almost 22,000 chemicals added to the Inventory through new chemical review since 1979. In 1986, EPA promulgated the Inventory Update Rule (IUR) requiring companies to update production volume data for certain chemicals on the TSCA Inventory every 4 years providing a snapshot of currently comercialized chemicals. Since the IRU does not require reporting for all chemicals on the TSCA Inventory, EPA cannot determine which chemicals are in commerce at any given time. In 2003, comments and revisions to the rule were published and in 2006 companies were required to update the production information again. The next submission and volume update will be between June 1 and September 30 2011, reporting production of chemicals manufactured in 2010 over 25,000 pounds and manufacturing exposure related information (inorganics are no longer excluded). There is additional information required for manufacture of greater than 300,000 pounds including process or use category, North American Industry Classification System (NAICS) Code, industrial function category, percent production volume, number of use sites, number of potentially exposed workers, and consumer/commercial information such as use category, use in or on products intended for use by children, and maximum concentration.

The TSCA Inventory supports many of EPA’s TSCA regulatory functions and it must be kept current and otherwise accurate to identify substances that are manufactured, imported or processed in the United States. In order to keep the TSCA Inventory current. EPA is considering a threeyear period for “cleaning up” (i.e., resetting) the Inventory. Under this approach, a “clean” reset Inventory would be developed such that any chemical not certified as actively being manufactured commercially in the U.S. would be removed from the TSCA Inventory. Any chemical substances for which a certification was not received would be removed from the TSCA Inventory and re-instatement would require a new TSCA § 5(a) PMN/MCAN application, review and approval.

The PMN/MCAN or Exemption Application

Currently EPA does not specify a minimum or maximum set of data that must be submitted with a PMN/MCAN application. Rather, the applicant must requires the submitter to provide information about the manufacturing process and waste streams, worker and consumer exposures, mammalian and environmental risk, and physicochemical data that the applicant believes will meet the Agencies requirements when reviewed. The data submitted with the application may include laboratory data, literature citations and modeled estimates. The development of a PMN/MCAN regulatory package is approached on a case-by-case basis and the applicant tries to identify potential areas of regulatory concern in the planning stage and submit appropriate studies with the application for Agency review.

This approach, in theory, according to EPA, avoids the unnecessary expenditure of laboratory resources and regulatory delays and setbacks from TSCA Section 5(e) consent-order negotiations that may cause additional marketplace entry delays. However, in recent practice, EPA is “requesting” more and more additional data in addition to the data set the applicant chooses to submit. Conducting and providing this additional data is causing significant delays in the review and approval process in addition to EPA not being able to meet their 90-day statutory deadline for review. Even experienced applicants are finding it difficult to provide an adequate data set in the eyes of the EPA reviewers and industry may soon be asking the Agency to provide a specific data set necessary to support an application in order to avoid these extended delays. EPA regulation set a 90-day review time for PMN applications and many recent applications are taking up to a year or more for the Agency to review and issue the inventory listing. One way the applicant can avoid this data is to produce chemicals that qualify under the low risk polymer exemption.

Polymer Exemption from the Requirement of a PMN

EPA has developed criteria to assess hazards associated with new polymeric substances based on its experience that the manufacture, processing, distribution in commerce, use, and disposal of new chemical substances meeting certain criteria would not present an unreasonable risk of injury to human health or the environment, and established the Polymer Exemption in 1984. In 1995 the Agency adjusted both the criteria used to determine whether a new chemical substance could meet the exemption and the procedures to be followed by manufacturers using the exemption. It is the intention of the Agency through these exemptions to encourage manufactures to produce and use safer polymers and that the exemption rule will reduce industry's reporting burden for this category of chemical substances. This will allow the Agency to concentrate its resources on substances expected to pose higher risk.

The 1995 amendments were similar to the 1984 exemption but expanded exemptions for polymers that meet Agency's low-risk criteria. The effect was to eliminate unnecessary EPA review of eligible (low risk) polymers, to transfer the burden of ensuring eligibility from EPA to the manufacturer, to encourage the manufacture of safer chemicals and substances produced with low exposure and low release, and to reduce the number of PMN applications (34% of PMNs filed before the amendments would qualify for the revised polymer exemption).

Under the terms of the polymer exemption as amended in 1995, manufacture and distribution of polymers meeting the exemption criteria can take place without submission of a PMN/MCAN application or an exemption notice prior to commencement of manufacture for a commercial purpose. Manufacturers are required to submit information on the method of manufacture and product chemistry of the polymer and EPA responds with a qualification letter within 90-days. Recordkeeping requirements to document compliance with the exemption criteria are retained as part of the rule and manufacturers of exempted polymers are required to submit an annual report on the number of exempted polymers for which they manufacture or import under terms of the exemption during the preceding calendar year.

The exemption now relies on comprehensive recordkeeping for compliance purposes, adopts the international Organization for Economic Cooperation and Development (OECD) definition of "polymer" and amends therule allowing the "two percent" reporting rule for polymers to allow greater flexibility for polymer manufacture. The two percent rule allows up to a two percent addition to the backbone only with out requiring a change in Chemical Abstracts Service Registry Number (CASRN).

Most eligibility criteria remain the same: polymers with molecular weight (MW) of 1,000 daltons or greater and less than 10,000 daltons are eligible, with restrictions on low MW species and reactive functional groups; polymers with MW of 10,000 daltons or greater, with restrictions on low MW species. Polymers which were and remain ineligible for exemption include those which degrade, decompose, or depolymerize.

The changes made in 1995 have made the polymer exemption generally less restrictive: the list of allowable elements has been expanded to include chlorine, bromine, iodine as monatomic counterions; and fluorine, chlorine, bromine and iodine if covalently bound to carbon; biopolymers which meet the polymer definition are no longer excluded; polymers that are cationic or anticipated to become cationic in aquatic environments are now eligible for exemption if the polymer is solid, not soluble or dispersible in water and will be used only in solid phase, or equivalent weight is equal to or greater than 5,000 daltons; and there is an expanded list of specified reactants for polyesters.

New restrictions make ineligible for exemption, however, several classes of polymers: polymers that are prepared from monomers or other reactants that are not on the TSCA Inventory are ineligible, as are water-absorbing polymers with number-average MW equal to or greater than 10,000 daltons. The full definition that describes polymers that meet the exemption rule can be found in 40CFR Section 723.250.

The 2007 Montebello Agreementand The 2005 Security and Prosperity Partnership of North America (SPP)

On August 20-21, 2007, United States President George Bush, Canadian Prime Minister Stephen Harper and Mexican President Felipe Calderon met in Montebello, Quebec, to discuss the Security and Prosperity Partnership of North America (SPP). Upon conclusion of the meeting the U.S. Environmental Protection Agency announced, as part of a trilateral agreement (the Montebello Agreement), a major shift in how chemicals will be addressed and managed in the U.S. Canada and Mexico. The Montebello Agreement sets out a plan to coordinate risk assessment and risk management activities across North America, building on work done under the Canadian Chemicals Management Plan and the U.S. EPA High Production Volume (HPV) Chemical Challenge. The goal of the agreement is to enhance trade among the three countries, while ensuring protection of human health and the environment and while retaining sovereignty.

The chemicals policy debates in the U.S. accelerated several years ago when environmental groups saw the European REACh system as a model to achieve their goal of banning toxic chemicals. The Montebello Agreement provides a unique opportunity to affect the future of chemicals management policy in the NAFTA regions. It is the only regional model that is truly tiered, targeted and risk-based. The Agreement provides regions that do not currently have chemicals management policies a rational and workable alternative to REACh in the Americas.

SPP Regional Commitments

The regional commitments under the SPP provide for work on cooperative efforts such as the U.S and Canada working with Mexico to establish a Mexican chemical inventory, update and coordinate the existing inventories in the U.S. and Canada and strengthen the North American chemical management regime. EPA and the Pesticide Management Regulatory Agency (PMRA, Canada) have begun sharing data and information to aid chemical assessment and management as well as coordinate approaches to develop international standards. Both countries are working with the Mexican authorities to enhance Mexico’s capacity for chemical assessment and management.

Chemical Assessment and Management Program (ChAMP)

ChAMP has been superseded by the comprehensive approach to enhancing the Agency’s current chemicals management program announced by Administrator Lisa Jackson on September 29, 2009.

To fulfill commitments made under the SPP launched in March of 2005 between the United States, Canada and Mexico, and the Montebello Agreement of 2007 EPA created ChAMP and these commitments will now be made under the comprehensive approach. EPA has established Essential Principles for Reform of Chemicals Management Legislationby publishing the following principals for the review of chemicals regulated under TSCA:

Essential Principles for Reform of Chemicals Management Legislation

The U.S. Environmental Protection Agency (EPA) is committed to working with the Congress, members of the public, the environmental community, and the chemical industry to reauthorize the Toxic Substances Control Act (TSCA). The Administration believes it is important to work together to quickly modernize and strengthen the tools available in TSCA to increase confidence that chemicals used in commerce, which are vital to our Nation’s economy, are safe and do not endanger the public health and welfare of consumers, workers, and especially sensitive sub-populations such as children, or the environment.

The following Essential Principles for Reform of Chemicals Management Legislation (Principles) are provided to help inform efforts underway in this Congress to reauthorize and significantly strengthen the effectiveness of TSCA. These Principles present Administration goals for updated legislation that will give EPA the mechanisms and authorities to expeditiously target chemicals of concern and promptly assess and regulate new and existing chemicals.

Principle No. 1: Chemicals Should Be Reviewed Against Safety Standards That Are Based on Sound Science and Reflect Risk-based Criteria Protective of Human Health and the Environment.

EPA should have clear authority to establish safety standards that are based on scientific risk assessments. Sound science should be the basis for the assessment of chemical risks, while recognizing the need to assess and manage risk in the face of uncertainty.

Principle No. 2: Manufacturers Should Provide EPA With the Necessary Information to Conclude That New and Existing Chemicals Are Safe and Do Not Endanger Public Health or the Environment.

Manufacturers should be required to provide sufficient hazard, exposure, and use data for a chemical to support a determination by the Agency that the chemical meets the safety standard. [However EPA has not defined a specific data set needed to make such determinations, TSCA state that the manufacturer will submit the data they have or that they determine will be sufficient, thus some PNM reviews are over two years old for the 90-day statutory review]

Exposure and hazard assessments from manufacturers should be required to include a thorough review of the chemical’s risks to sensitive subpopulations. [if such populations exist, how will they be found and how much effort will be required by EPA to seek them out?]

Where manufacturers do not submit sufficient information, EPA should have the necessary authority and tools, such as data call in, to quickly and efficiently require testing or obtain other information from manufacturers that are relevant to determining the safety of chemicals. [EPA has always had this authority] EPA should also be provided the necessary authority to efficiently follow up on chemicals which have been previously assessed (e.g., requiring additional data or testing, or taking action to reduce risk) if there is a change which may affect safety, such as increased production volume, new uses or new information on potential hazards or exposures. EPA’s authority to require submission of use and exposure information should extend to downstream processors and users of chemicals.

Principle No. 3: Risk Management Decisions Should Take into Account Sensitive Subpopulations, Cost, Availability of Substitutes and Other Relevant Considerations.

EPA should have clear authority to take risk management actions when chemicals do not meet the safety standard, with flexibility to take into account a range of considerations, including children’s health, economic costs, social benefits, and equity concerns.

Principle No. 4: Manufacturers and EPA Should Assess and Act on Priority Chemicals, Both Existing and New, in a Timely Manner.

EPA should have authority to set priorities for conducting safety reviews on existing chemicals based on relevant risk and exposure considerations. Clear, enforceable and practicable deadlines applicable to the Agency and industry should be set for completion of chemical reviews, in particular those that might impact sensitive sub-populations [This is the third time Sensitive Subpopulations have been mentioned, what is the definition of a subpopulation, one person?]

Principle No. 5: Green Chemistry Should Be Encouraged and Provisions Assuring Transparency and Public Access to Information Should Be Strengthened.

The design of safer and more sustainable chemicals, processes, and products should be encouraged and supported through research, education, recognition, and other means. The goal of these efforts should be to increase the design, manufacture, and use of lower risk, more energy efficient and sustainable chemical products and processes.

TSCA reform should include stricter requirements for a manufacturer’s claim of Confidential Business Information (CBI). Manufacturers should be required to substantiate their claims of confidentiality. Data relevant to health and safety should not be claimed or otherwise treated as CBI. EPA should be able to negotiate with other governments (local, state, and foreign) on appropriate sharing of CBI with the necessary protections, when necessary to protect public health and safety. [No discussion of data compensation was made, so the data you are required to produce and pay to produce could be available publicly unless EPA addresses this issue]