We’re on the home stretch, now. This will be my second-to-last post on the new CSIA legislation currently in committee. I’ve talked about the basic differences between CSIA and TSCA here, addressed Sections 1-3 here, Section 4, Section 5, and Sections 6-9. I haven’t heard anything about how the committee debates are going, but I have read some testimony from experts in the field regarding the proposed legislation and will dig those up for you if you’re interested. Onward!

Section 10

This CSIA section makes only conforming changes to the corresponding section in TSCA.

Section 11

This section deals with exports, and amends TSCA by deleting a particular subsection of TSCA and creating a new one titled “Exception.” This limits the chemicals that are covered under the original exclusion for “manufacture for export only,” which will allow the EPA to exclude new and existing chemicals that it determines are unlikely to meet the safety standard. It also includes a new subsection titled “Waivers,” which covers chemical mixtures or products that contain chemicals described in the new “Exception” subsection. The EPA can determine whether or not an export exemption applies to these mixtures or products that contain these chemicals above a certain threshold.

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CSIA also adds a provision that requires a person or company to notify the EPA when they intend to export a chemical or mixture for which the EPA has a determination that this chemical:

  • Is not likely to meet the safety standard under Section 5
  • Is not likely to meet the safety standard under Section 6
  • Is a chemical for which “the United States is not obligated by treaty to provide export notification”

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These notifications will be oriented toward chemicals regulated by the EPA under CSIA because they do not meet the safety standards under intended conditions of use or are subject to export notice by treaty (this means complying with international environmental laws like REACH). The analysis of Bergeson & Campbell indicates that this section is not sufficient to address U.S. legislative changes that need to be made that will allow it to meet its obligations for:

This section also requires the EPA to promulgate regulations to implement these new rules, and they will include “any exemptions” the EPA determines to be appropriate and note whether regulations apply to exempted mixtures or products.

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(I smell the influence of big business here.)

Section 12

There are some relatively minor conforming changes made to the corresponding section in TSCA regarding the new safety determination framework that will be established by the EPA. This section defines inclusive terminology, such as “chemical substance or mixture” and “a mixture containing a chemical substance or mixture” and “an article containing a chemical substance or mixture.”

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This section also states that the Secretary of Homeland Security has the authority and obligation to refuse entry into the customs territory of the U.S. any chemical substance or mixture the EPA has determined does not meet the safety standards under the conditions of intended use, or is in violation of a rule or order under CSIA. There are procedural requirements listed in this section regarding the refusal of entry, conditions for release, and a 90-day period in which a substance held at customs must be dispositioned.

Section 12 largely addresses import certifications and retains the scope of these certifications under TSCA, with one exemption: it requires any person or company offering a chemical substance or mixture into the U.S. to notify the Secretary if the substance is a “high-priority substance,” or if the substance is a chemical for which the U.S. is obligated by treaty to provide export notification. The Secretary must consult with the EPA before issuing rules regarding this section.

Section 13

This section keeps some parts of the corresponding section in TSCA and changes other. Specifically, it addresses the core concept of protecting intellectual property and proprietary information from disclosure, as long as certain conditions are met. This is further addressed in Section 14 in general terms, listing information generally protected and generally not protected. Protected information includes specific information that describes the manufacture, processing or distribution of a chemical, marketing and sales information, customer information, and other categories of information that have historically and traditionally been protected (“specific identity of a chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify a specific chemical substance”). This kind of information is presumed confidential, but only after upfront substantiation.

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Special provisions apply for confidentiality. The generic name for a chemical substance can be disclosed provided that it discloses useful information without violating other confidentiality concerns. Confidentiality will not apply under these circumstances:

  • Law enforcement purposes
  • Disclosure is necessary for contractors to perform their work
  • Where “the Administrator determines that disclosure is necessary to protect human health and the environment”
  • To state or political subdivisions if protections are in place to keep confidential information from becoming general knowledge
  • Health professionals in emergency and non-emergency situations, if certain conditions are met

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The EPA may request “redocumentation” of confidentiality claims at any time and of any person, company or entity after a chemical is identified as a high-priority substance. Under current law, notice is required before the EPA can release confidential information and judicial action may be brought by the submitter to prevent the release of such information.

See you one last time, folks!