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Chemical Risk Management Issues

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High Production Volume (HPV) Chemical Testing Programs

SOCMA supports the extension to a program that will continue to provide voluntary health and environmental data on chemicals produced or imported in quantities greater than one million pounds annually. Such chemicals are categorized as High Production Volume (HPV) by the US Environmental Protection Agency (EPA).

To date, 51 SOCMA members have voluntarily sponsored 742 HPV chemicals that they manufacture or import, providing data worth approximately $185 Million. The EPA intends to use data generated by HPV testing programs for risk-based decisions in the agency's risk management activities.

SOCMA was successful in advocating flexibility for sponsors that can demonstrate a low potential for exposure to their chemicals. SOCMA supports a tiered approach to chemical testing that considers exposure potential to help design an appropriate test plan.

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Section 8 Data Collection and Section 4 Test Rules for Unsponsored HPV Chemicals

In 1998, the EPA launched the High Production Volume (HPV) Chemical Challenge that initiated a voluntary industry testing program designed to obtain health and environmental data on nearly 2,800 chemicals that are produced or imported in quantities greater than one million pounds annually. Roughly 400 American chemical companies have volunteered to sponsor testing for approximately 2,300 chemicals on this list. Chemicals that have not been sponsored voluntarily for testing will be included in a series of chemical information collection and test rules under the Toxic Substances Control Act (TSCA).

EPA published a proposed Section 4 test rule in the Federal Register on December 26, 2000. SOCMA was heavily involved in the proposal process, filing comments with the EPA that articulated a number of concerns relating to the way in which the proposal deals with the issues of risk and exposure findings. After some delay, the EPA published the final rule April 2006, requiring testing for 17 chemicals. Certain chemicals produced by SOCMA members will be included on this list. This will be followed by a series of Section 8 information collection requests (ICRs) that will require companies to submit existing data on other unsponsored HPV chemicals. EPA will determine where data gaps exist and propose a series of test rules to fill those gaps. Two of these Section 8 rules were published August 16, 2006. The first is an 8(a) Preliminary Assessment Information Rule and the second is an 8(d) data collection for existing health and safety studies.

The data requirements under the voluntary test program and the test rule will be identical, with some exceptions. Under the test rule, companies will not have the flexibility afforded by the voluntary program to negotiate the timing of compliance or the acceptance of existing data that do not meet Good Laboratory Practice (GLP) standards. In addition, companies will be required to provide EPA with periodic progress reports and full copies of studies, rather than robust summaries. For these reasons, the total cost of compliance with the mandatory test rules could be considerably higher than the costs of participation in the voluntary program. If the mandatory test rules apply to multiple chemicals at one time, the cost to the affected company will multiply accordingly.

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Endocrine Disruptor Screening Program (EDSP)

When Congress passed the Food Quality Protection Act in 1996, among the various provisions of this legislation was a mandate that the EPA develop an Endocrine Disruptor Screening Program (EDSP) to study the potential effects of chemicals on the human endocrine system. That same year, Congress amended the Safe Drinking Water Act, which requires EPA to screen drinking water sources for endocrine disruptors.

EPA has announced its intention to test a number of chemicals in phase one of an ambitious and comprehensive program. The chemicals for phase one include active pesticide ingredients and inert ingredients that are considered to be high production volume (HPV). In 2001, the agency held an organizational meeting of the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a new Federal Advisory Committee Act (FACA) group to advise EPA on screening and testing methods. SOCMA served as a panelist of the initial formation meeting, helping keep the subcommittee's focus on technical issues, versus policy, as was pushed by several non-governmental organizations.

The draft list of pesticide active ingredients and inerts has been published in the Federal Register. SOCMA supports the establishment of scientifically valid testing protocols for this program. This can not be overstated because methods used in the EDSP could provide a model and precedent for other testing programs. Current estimates indicate that the costs of testing for each chemical in this program will exceed $1 million.

Since the inception of the EDSP, SOCMA has been in close communication with EPA and other stakeholders, ensuring that the interests of the batch and specialty chemical manufacturing sector are represented, and that the views of smaller businesses are heard.

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The Precautionary Principle and Its Various Interpretations

The Precautionary Principle is a philosophy related to the protection of health and the environment and is based on the "better safe than sorry" approach to decision-making. In 1992, the United Nations Rio Declaration stated "where there are threats of serious and irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation." Since the passage of the Rio Declaration, the precautionary principle has been, or is sought to be, incorporated into the laws of the European Union (EU), Canada, individual European nations, Australia, and other countries. In February, 2000, the EU formally expanded the scope of the precautionary principle beyond the "Rio definition," stating that it is "far wider" than a simple environmental context. The EU decision went on to say that the principle should apply to all potential risks to the environment, or to human, plant or animal health, even where the science may be uncertain.

In the United States, the EPA has stated "in making risk-based decisions,… we are committed to the precautionary principle, which requires us to err on the side of safety." The agency has applied the precautionary principle in its Great Lakes "Zero Discharge" policy, as well as in work on endocrine disrupting chemicals, in creating the extra ten-fold safety factor under the FQPA, and in its carcinogen guidelines.

In Europe and the US, environmental activists are working to broaden the scope of the Rio declaration language. One proposal would go so far as to state: "When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically." In other words, this new proposal would dispense with all caveats such as the reference in the original Rio language to "cost effective measures," and would seek to shift the burden of proof completely from those who claim that injury is being done, to the private business sector.

Attempts have been made to apply this more radical version of the precautionary principle in new regulatory schemes, such as REACH, and to achieve bans on genetically modified foods, restrictions on cellular telephone towers, and prohibition on certain plasticizers in children's toys and medical devices.

SOCMA has been working with other industry trade groups to oppose the adoption of radical interpretations of the precautionary principle, and to educate others on the use of sound science, scientific limitations and common-sense for decision-making.

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Expanded Inventory Update Rule

EPA has amended the Inventory Update Rule (IUR) that appears in Section 8 (a) of TSCA. The amendments increase the threshold for exemption from 10,000 pounds per year to 25,000 pounds, which will exempt small volume chemicals from reporting. Additionally, the reporting period is expected to go from every four years to every five years. For chemicals above 300,000 pounds per year, the reporting requirements substantially increase and include reporting on downstream uses and the number of potentially exposed workers, including at downstream sites.

SOCMA submitted comments to the EPA expressing opposition to the proposed amendments on the grounds that they were overly broad, and that they imposed costs on companies that far exceeded any potential health or environmental benefits. SOCMA's comments also stated that the dramatic increase in the reporting burden that would be required by the amendments are inconsistent with the goals of the Paperwork Reduction Act.

SOCMA questions the necessity and utility of the information called for in the amendments to the IUR, especially in light of the fact that much of the downstream information cannot be readily obtained by manufacturers. In addition, SOCMA is concerned that the new burden for substantiating CBI claims may force the disclosure of information that will place small companies at a competitive disadvantage in the marketplace.

Although SOCMA disagrees with the actions taken by EPA, SOCMA supports educational programs to help members comply with the new requirements. SOCMA has featured EPA speakers covering the new IUR reporting requirements at its TSCA Fundamentals and GlobalChem programs. In addition, SOCMA is working with EPA to develop guidance materials that the agency is providing to those who must report to the IUR.

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European Union REACH System

In 2003, the European Commission prepared a draft proposal to overhaul the chemical control regulations in Europe. After much debate and many amendments, the EU Parliament and Council of Minister finalized the regulatory scheme, called REACH (Registration, Evaluation and Authorization of Chemicals). The legislation went into effect in mid-2007 with the launch of the European Chemicals Agency, which oversees the regulations. It requires:

  • up-front testing on new chemicals that will be introduced into European commerce and phased-in testing for chemicals that already exist in the marketplace. In addition,
  • the regime calls for registration and evaluation of all chemicals produced or imported at greater than 1 metric ton per year.
  • Substances produced or imported at greater than 10 metric tonnes per year will also be required to submit a Chemical Safety Report, a form of risk assessment that will be evaluated by government authorities. The evaluations could result in use restrictions and potential bans for certain substances.
  • For chemicals that are known to possess certain hazards, such as carcinogens, mutagens and reproductive toxicants, or CMRs, companies will be required to obtain authorization for their continued use and implement either a substitution plan or R&D plan to find an alternative. After a certain period, the EU expects that those substances would be withdrawn from the marketplace.

The Commission held an internet consultation, allowing the interested public to comment on the proposal. SOCMA's Chemical Risk Management Committee submitted extensive comments, calling for a tiered, risk-based approach that does not solely rely on production volume as a surrogate for exposure. The Committee also commented on Confidential Business Information provisions and targeted areas that would significantly affect small businesses. SOCMA prepared several analytical and policy papers that were distributed overseas by the Department of Commerce and US Trade Representatives Office. SOCMA received praise from various overseas industry groups and governments for the thorough analytical work, especially in the area of potential impacts on innovation. SOCMA has written articles for the European trade press, submitted letters to members of European Parliament and met with several European ministries to discuss REACH and its potential impacts.  SOCMA's focus now is primarily on compliance assistance for members, both in understanding the legislation and in forming consortia through SOCMA's new ChemSortia program.

REACH Legislation, Approved 18 December 2006
REACH Guidance

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United Nations Strategic Approach to International Chemicals Management (SAICM)

At the 2002 World Summit on Sustainable Development, delegations from over 100 governments agreed to a goal that by 2020 the significant adverse effects of chemicals are minimized during production and use. Since then, under the United Nations Environment Programme (UNEP), governments have been developing a framework for a Strategic Approach to International Chemicals Management (SAICM). The process began with a simple premise: to strategically harmonize chemical risk management approaches globally.

The SAICM process includes a series of three preparatory meetings at which government officials, environmental groups and industry have a part in the negotiating process. This is unique for a United Nations process. The third and final negotiation meeting, PrepCom 3, took place in Vienna, Austria during the third week in September 2005. SOCMA participated as part of the International Chamber of Commerce delegation to the meeting, primarily representing the interest of small chemical firms, which was missing from industry advocacy efforts.

There are several critical industry goals.

  1. All measures outlined in the Global Plan of Action must be voluntary in nature and not part of a legally binding agreement.
  2. Any approach must be based on sound science and risk.
  3. References to precaution and the Precautionary Principle must use the internationally agreed-upon language from the Rio Declaration.
  4. The "No Data/No Market" concept must be replaced with a tiered, risk-based approach.
  5. Capacity-building for developing countries must rely on existing United Nations financial instruments and not the implementation of a global chemical tax.

Industry achieved most of its goals at the PrepCom 3 negotiations; however, more work remains. During the closing sessions in Vienna, the negotiations fell apart, leaving several key elements, such as financial considerations, for further discussion. SOCMA will continue to work through the U.S. Council for International Business and International Chamber of Commerce to ensure that the concerns of small businesses are considered.

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EPA Chemical Assessment & Management Program (ChAMP)

At the Security and Prosperity Partnership (SPP) Summit in August of 2007 President Bush, Canadian Prime Minister Stephen Harper and Mexican President Felipe Calderon committed to enhance regulatory cooperation among Canada, Mexico and the US.  ChAMP encompasses US commitments. 

To fulfill its part of the SPP commitment, the United States will:

  • By 2012, complete screening-level hazard and risk characterizations and initiate action, as appropriate, on more than 6,750* chemicals produced above 25,000 pounds per year.
  • The U.S. commitment to complete assessments and initiate needed action on these chemicals will apply the results of EPA’s work on High-Production Volume (HPV) chemicals - those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year - and extend its efforts to moderate production volume (MPV) chemicals - those produced or imported in quantities above 25,000 and less than 1 million pounds per year.

As an initial effort under ChAMP, EPA began, in 2007, posting screening-level hazard characterizations and expanded this effort in 2008 by posting risk-based prioritizations (RBPs). The RBPs summarize basic hazard and exposure information on HPV chemicals, identify potential risks, note scientific issues and uncertainties, and indicate the initial priority being assigned by the Agency for potential future appropriate action.

In 2008, as part of the ChAMP commitments, EPA began developing initial evaluations of MPV chemicals. The evaluation of the first set of these chemicals consists of development of a hazard characterization and hazard-based prioritizations.

After receiving input from stakeholders and after careful consideration, EPA will proceed with the two enhancements to ChAMP including:

  • Developing an HPV Challenge-type program for "inorganic" HPV chemicals, and 
  • Resetting the TSCA Inventory to reflect the chemicals actually in commerce.

SOCMA has been monitoring developments under ChAMP, responding to any proposals that may impact members.  SOCMA supports further implementation of ChAMP and a risk-based chemical risk-management policy as an approach to looming TSCA reform, which is likely to be a Congressional priority in the next year or two.

Presentation on TSCA Reform Given to the Japan Dyestuff & Industrial Chemicals Association (JDICA), April 22, 2009.

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SOCMA Principles on Chemical Risk Management

SOCMA believes that EPA’s program to implement the Toxic Substances Control Act (TSCA), a 30+ year old law, needs some revitalization.  The chemicals management regulatory system could be made stronger and more effective by more fully utilizing the existing program and adopting appropriately tailored enhancements.

Since the enactment of TSCA, many technological advancements have greatly changed how we view chemicals management.  For example, we have seen the emergence of biotechnology and nanotechnology and improvements in quantitative analytical chemistry.  Equally important, the internet has provided people with instant access to vast amounts of information, creating a heightened awareness of chemical exposures and facilitating a fear of the unknown, particularly among consumers and the general population.

SOCMA believes that current levels of concerns are not due to current activities of chemical companies, or by bureaucratic shortcomings, as argued by some.  To the contrary, much of the heightened attention we see to chemicals issues is –through the positive activity of industry – making us more aware of the role of chemistry in today’s society.  We have seen the industry become involved in product stewardship, with a greater focus on chemical testing and basic research –which produces both answers and questions.  Fortunately, these same efforts and new innovative techniques have resulted in improvements in the physical sciences and an improved standard of living.  Chemistry is indeed all around us, and that is a good thing on balance.

TSCA has generally stood the test of time as a flexible program that has worked well to protect human health and the environment without crippling innovation.  SOCMA believes that some possible enhancements to the TSCA program are worth considering.  The following should serve as thought starters as we consider evaluating our process for managing chemicals, new and existing, in 2009 and beyond.  SOCMA believes all are worthy of fuller discussion but does not specifically endorse them.

To read the entire list of Principles, click here.

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