Environmental Health & Safety Manual (EHS)

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Effective: 11/1/2014
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EHS 407: Toxic Substances Control Act Import and Research Exemption Certification Requirements

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Purpose

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To ensure that the importation of chemical substances and microorganisms are in compliance with the requirements of the Toxic Substance Control Act (TSCA) and the Research and Development (R&D) Exemption

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Sources

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40 Code of Federal Regulations § 707
40 Code of Federal Regulations § 720.36
Toxic Substances Control Act, Section 5, “New Chemical Substances”
Toxic Substances Control Act, Section 6, “Regulation of Hazardous Chemical Substances and Mixtures”
Toxic Substances Control Act, Section 7, “Imminent Hazards”
Toxic Substances Control Act, Section 13, “Import Certification”

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Applicability

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All uses of chemical substances by ASU all employees, students, visiting faculty, and researchers, at all ASU facilities

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Background

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Under the TSCA importers receiving chemical substances, mixtures or articles from sources outside the United States must meet the same requirements as industrial chemical manufacturers. TSCA was established by the EPA to ensure the protection of human health and the environment from unreasonable risks associated with chemical substances prior to commercial introduction. Under Section 13 of TSCA, a chemical importer must certify that the chemical substances being imported comply with all applicable rules and orders under TSCA (positive certification) or certify that the chemical substances are not subject to TSCA (negative certification). In addition the certification process specifically requires the importer to comply with TSCA Sections 5, 6, and 7 when claiming the R&D Exemption.

The R&D Exemption allows for laboratory scale quantities of chemicals to be imported for non-commercial research purposes. The chemicals must be under the control of a technically qualified individual, using prudent laboratory practices.

For more information, refer to the R&D Exemption (40 CFR § 720.36): http://www.epa.gov/oppt/newchems/pubs/randdexemp.htm.

All imported chemical substances including microorganisms received by the university must be certified under TSCA by either a positive or negative certification. Failure to comply with TSCA requirements can result not only in detained shipments and/or denied entry, but can lead to significant fines and penalties.

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Policy

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No person may receive or use a chemical substance which is imported or used under the TSCA exemption except as identified in this policy.

Anyone who intends to import a new chemical substance (one that is not already in commerce or being imported into the United States, based on EPA’s TSCA Inventory of Chemical Substances: http://www.epa.gov/oppt/existingchemicals/pubs/tscainventory/index.html) must complete an Import Certification Form and submit it to EH&S for review.

Note: The EPA has communicated that nano- materials and particles will be reviewed as a “TSCA new chemical” on a case by case basis.

Responsibilities

Colleges, Schools, and Other University Departments

It is the responsibility of each college, school, and administrative department to conduct its operations in accordance with all applicable laws and regulations, and to implement this policy as follows, including but not limited to:

  1. informing all employees involved in specifying and procuring chemical substances
  2. participating in required training
  3. enforcing the requirements of this policy

    and

  4. documenting shipping and receiving activities.

Environmental Health & Safety (EH&S)

EH&S will:

  1. provide training as requested for the ASU community to support this policy
  2. verify that known importers have met the requirements for exempted chemicals substances by certifying TSCA compliance to import these substances

    and

  3. maintain all records related to this policy.

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Cross-References

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For related information, see:

  1. EHS 005, “Management Policy”
  2. EHS 103, “Hazard Communication Program”
  3. EHS 104, “Laboratory Use of Hazardous Chemicals”
  4. EHS 112, “Biosafety Policy Governing the Possession, Use, and Transfer of Biological Agents and Toxins of Biological Origin”
  5. EHS 401, “Hazardous Waste Management”

    and

  6. EHS 406, “Shipping and Receiving Hazardous Materials.”

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