Chemical Risk Management Issues

For more information or updates, please contact Dan Newton.

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 U.S., 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.

Chemical Data Reporting (CDR) Rule (formerly known as the Inventory Update Reporting (IUR) rule)

EPA proposed this periodic information collection rule, historically known as the Inventory Update Reporting (IUR) rule, in August of 2010 to amend reporting requirements via Section 8(a) of the Toxic Substances Control Act (TSCA).  A host of new requirements were proposed, including but not limited to lowering of the production volume trigger.  The next reporting cycle, known as the submission period, is in 2016.

Noteworthy changes to watch out for in the upcoming cycle include further lowering of the production volume threshold to 25,000 lbs. for processing and use activities and 2,500 lbs. for chemicals subject to regulatory action.  

SOCMA anticipates that the number of chemicals to be reported will increase substantially from previous years.  Many smaller companies will now be required to report, which can be a challenge, since employees at smaller companies tend to wear many different hats. Additionally, the episodic nature of batch and custom manufacturing may have a pointed effect on SOCMA members.  Due to the “on-demand” nature of batch and custom manufacturing, production volumes often fluctuate depending on market need.  While commodity chemicals make up most of the production volume (by weight) in the global marketplace, specialty chemicals make up most of the diversity (number of different chemicals) in commerce at any given time.  What may seem to be a straight forward reporting procedure for large commodity manufacturers, may not be so for smaller batch manufacturers.  

Despite some clear improvements to the CDR, it is not clear whether this next go around will produce any added benefit to previous reporting cycles.  To access the EPA website click here.

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

EPA’s Existing Chemicals Program

In 2009 EPA announced an approach to enhancing its chemicals management program.  Some of the major elements of the program include prioritizing chemicals in commerce that warrant additional review.  The chemicals are selected for risk assessment via a set of risk-based criteria.  This is activity is called EPA’s Work Plan.  The agency is also making efforts to enhance its Design for the Environment (DfE) program.  According to EPA, the DfE program helps consumers, businesses, and institutional buyers identify cleaning and other products that perform well and are safer for human health and the environment.  Finally, EPA has been developing a tool called ChemView that is part of its effort to increase transparency on chemicals.  ChemView is a one stop shop that contains a variety of information on chemicals.  

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