Environmental Protection Agency (EPA).
Notice.
This notice solicits information relevant to the development of risk management evaluations pursuant to the Stockholm Convention on Persistent Organic Pollutants (POPs) (hereafter Convention) for the following chemicals which are being reviewed for possible addition to the Convention’s Annexes A, B, and/or C as POPs: Commercial octabromodiphenyl ether (c-octaBDE) (CAS No. 32536–52–0 ), pentachlorobenzene (PeCB) (CAS No. 608–93–5), alpha–hexachlorocyclohexane (alpha–HCH) (CAS No. 319–84–6), and beta–hexachlorocyclohexane (beta–HCH) (CAS No. 319–85–7). Additionally, this notice solicits additional information relevant to the development of the risk profile pursuant to the Convention for the following chemical which is also being reviewed for possible addition to the Convention’s Annexes A, B, and/or C as POPs: Short–chained chlorinated paraffins (SCCP) (CAS No. 85535–84–8). EPA is issuing this notice to alert interested and potentially affected persons of these proposals and the status of their review under the Convention, and to encourage such persons to provide information relevant to the development of risk profiles and risk management evaluations under the Convention.
Comments must be received on or before January 22, 2008.
Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2006–0794, by one of the following methods:
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This action is directed to the public in general, and may be of particular interest to chemical substance and pesticide manufacturers, importers, and processors. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
The Agency is issuing this notice to increase awareness of the proposals concerning the chemicals subject to this notice, and to provide interested persons with an opportunity to provide relevant information to EPA for its consideration in the development of the United States’ submissions relevant to Convention Annexes E and F for the chemical substances under review at this time for possible addition to Annexes A, B, and/or C of the Convention. On December 3 and 4, 2007, the Secretariat invited Parties and observers to submit to the POPs Review Committee (POPRC) (via the Secretariat) information specified in Annex E and Annex F of the Convention, and other relevant information (the Secretariat’s invitation letters can be found at
The Convention is a multilateral environmental agreement designed to protect human health and the environment from persistent organic pollutants. The United States signed the Convention in May of 2001 but has not yet ratified it (and thus is not a Party to the Convention). The United States currently participates as an observer in Convention activities. The Convention, which went into force in May of 2004, requires the Parties to reduce or eliminate the production and use of a number of intentionally produced POPs used as pesticides or industrial chemicals. The Convention also calls upon Parties to take certain specified measures to reduce releases of certain unintentionally produced POPs with the goal of their continuing minimization and, where feasible, ultimate elimination. The Convention also imposes controls on the handling of POPs wastes and on trade in POPs chemicals.
In addition, there are specific science-based procedures that Parties to the Convention must use when considering the addition of new chemicals to the Convention’s Annexes. Article 8 of the Convention provides the process that must be followed for listing new chemicals in Annexes A, B, and/or C, and is described in summary in this unit with certain associated implementation procedures being followed by POPRC:
1. A Party to the Convention may submit a proposal to the Secretariat for listing a chemical in Annexes A, B and/or C of the Convention. The proposal shall contain the information specified in Annex D of the Convention (“Information Requirements and Screening Criteria”).
2. The Secretariat verifies that the proposal contains the information specified in Annex D of the Convention, and if the Secretariat is satisfied, the proposal is forwarded to POPRC.
3. POPRC examines the proposal, applies the Convention Annex D screening criteria, and determines whether the screening criteria have been fulfilled.
4. If POPRC is satisfied that the criteria have been fulfilled, POPRC, through the Secretariat, will make the proposal and POPRC’s evaluation available to all Parties and observers and invite them to submit the information specified in Annex E (“Information Requirements for the Risk Profiles”) of the Convention.
5. Draft risk profiles are prepared by ad hoc working groups under POPRC in accordance with Annex E of the
6. POPRC reviews the draft risk profile and technical comments, completes the risk profile, and determines whether the chemical is likely, as a result of its long-range environmental transport, to lead to significant adverse human health and/or environmental effects, such that global action is warranted.
7. If POPRC determines that action is warranted, then POPRC, through the Secretariat, will ask Parties and observers to provide information specified in Annex F (“Information on Socio-Economic Considerations”) of the Convention to aid in the development of risk management evaluations (that include an analysis of possible control measures).
8. Draft risk management evaluations are prepared by ad hoc working groups under POPRC in accordance with Annex F of the Convention for consideration by POPRC and made available to Parties and observers to collect technical comments.
9. POPRC reviews the draft risk management evaluation prepared by the ad hoc working group and completes it.
10. On the basis of the risk profile and the risk management evaluation for each chemical, POPRC recommends whether the chemical should be considered by the Conference of the Parties (COP) for listing in Convention Annexes A, B, and/or C. (The type(s) of control measure(s) that might be introduced for a specific chemical would dictate whether the chemical would be listed in Annex A (elimination), Annex B (restriction), and/or Annex C (unintentional production) of the Convention.)
11. The COP makes the final decision on listing the chemical in Annexes A, B, and/or C of the Convention.
EPA anticipates issuing
For the chemicals currently at the risk management stage (see Unit II.G.), EPA is seeking information that is supplementary to the information provided during previous stages in the review process; i.e., information relevant to Convention Annexes D and E; the proposals, evaluations and risk profiles. These documents, as well as the Secretariat’s letter soliciting information, are available at the Convention website (
When providing information, keep in mind that the possible control measures under the Convention include, among others, the prohibition or severe restriction of production and use. Therefore, the provision of accurate, high-quality information, as described in this notice and in the Secretariat letter soliciting information, is a priority for POPRC’s evaluation.
Commenters are invited to provide information they deem relevant to POPRC’s development of the risk management evaluation, such as that specified in Annex F of the Convention and other related information, as described in this unit and in Unit II.G. Provide summary information and relevant references for:
1. Efficacy and efficiency of possible control measures in meeting risk reduction goals:
i. Describe possible control measures.
ii. Technical feasibility.
iii. Costs, including environmental and health costs.
2. Alternatives (products and processes):
i. Describe alternatives.
ii. Technical feasibility.
iii. Costs, including environmental and health costs.
iv. Efficacy.
v. Risk.
vi. Availability.
vii. Accessibility.
3. Positive and/or negative impacts on society of implementing possible control measures:
i. Health, including public, environmental and occupational health.
ii. Agriculture, including aquaculture and forestry.
iii. Biota (biodiversity).
iv. Economic aspects.
v. Movement towards sustainable development.
vi. Social costs.
4. Waste and disposal implications (in particular, obsolete stocks of pesticides and clean-up of contaminated sites):
i. Technical feasibility.
ii. Cost.
5. Access to information and public education.
6. Status of control and monitoring capacity.
7. Any national or regional control actions taken, including information on alternatives, and other relevant risk management information.
8. Other relevant information for the risk management evaluation.
9. Other information requested by POPRC.
POPRC would also like to collect more Convention Annex E information and has requested additional or updated information for the following:
• Production data, including quantity and location.
• Uses.
• Releases, such as discharges, losses and emissions.
For chemicals at the risk profile stage (see Unit II.H.), EPA is seeking information that is supplementary to the information in the proposals on the chemicals and POPRC’s evaluation of the proposals against the Convention‘s Annex D screening criteria. The proposals and the evaluations, as well as the Secretariat’s letter inviting Parties and observers to provide information, are available at the Convention website:
Commenters are invited to provide information they deem relevant to POPRC’s development of risk profiles, such as that specified in Annex E of the Convention and other related information, as described in this unit and in Unit II.H.:
1. Sources, including as appropriate:
i. Production data, including quantity and location.
ii. Uses.
iii. Releases, such as discharges, losses and emissions.
2. Hazard assessment for the endpoint(s) of concern (as identified in the proposals and/or POPRC’s evaluation of the proposals against the screening criteria of Convention Annex D), including a consideration of toxicological interactions involving multiple chemicals.
3. Environmental fate, including data and information on the chemical and physical properties of a chemical as well as its persistence and how they are linked to its environmental transport, transfer within and between environmental compartments, degradation and transformation to other chemicals.
4. Monitoring data.
5. Exposure in local areas and, in particular, as a result of long range environmental transport, and including information regarding bio-availability.
1. EPA requests that commenters, where possible, use the questionnaire developed by POPRC to provide their information. The questionnaire with
2. Although POPRC has developed provisional arrangements for the treatment of confidential information, as mentioned in Unit I.B.3., no CBI will be forwarded to the Secretariat. EPA will, however, consider such information in development of the U.S. response to the Secretariat. Instructions on where and how to submit comments and confidential information can be found in Unit I.B.2. and 3. and
3. Anyone wishing to have an opportunity to communicate with EPA orally on this issue should consult the technical person listed under
EPA is requesting comment and information under the authority of section 102(2)(F) of the National Environmental Policy Act, 42 U.S.C. 4321
The second meeting of POPRC took place on November 6–10, 2006, in Geneva, Switzerland. EPA provided notice of this meeting and POPRC’s intention to consider proposals for the five chemicals listed in this unit in the
1. Two of the five proposals were for industrial chemicals:
i. Octabromodiphenyl ether.
ii. Short-chained chlorinated paraffins.
2. One of the five proposals was for a chemical with both industrial and pesticidal uses: Pentachlorobenzene.
3. Two of the five proposals were for pesticides:
i. Alpha-hexachlorocyclohexane.
ii. Beta-hexachlorocyclohexane.
In accordance with the procedure in Article 8 of the Convention and discussed in Unit II.B., during the November 2006 meeting, POPRC examined the proposals and applied the screening criteria in Annex D of the Convention. With regard to all five chemicals, POPRC decided that it was satisfied that the screening criteria had been fulfilled and, that further work should therefore be undertaken to develop risk profiles. Therefore, POPRC, through the Secretariat, on December 8, 2006, requested that Parties and observers provide information relevant to POPRC’s development of risk profiles for the five chemicals listed in this unit. In addition to the Convention Annex E information discussed in Unit II.D., POPRC determined, and the Secretariat requested in their December 2006 letter, that additional information on the environmental fate of SCCP or information relating to their properties which would enable a fuller evaluation of environmental fate as being particularly useful for the future process. In the
Using the information in the proposal and information submitted by Parties and observers in response to the Secretariat’s request in December 2006 in accordance with paragraph 4(a) of Article 8 of the Convention, risk profiles were prepared for each of the chemicals to, as noted in Convention Annex E, “evaluate whether the chemical is likely, as a result of its long-range environmental transport, to lead to significant adverse human health and/or environmental effects, such that global action is warranted.” The risk profile must further evaluate and elaborate on the information referred to in Annex D of the Convention and include, as far as possible, the information listed in Convention Annex E. A draft outline of the risk profile has been developed by POPRC, available at
In accordance with the procedure in Article 8 of the Convention and described Unit II.B., POPRC 3 examined the risk profiles and decided that the chemicals, except for SCCP, are likely, as a result of their long-range environmental transport, to lead to significant adverse human health and/or environmental effects such that global action is warranted. At that meeting, POPRC 3 also examined the draft risk profile for SCCP, but considered that the information available was insufficient to support the Convention Annex E-related decision on likely significant adverse effects from long-range environmental transport and did not approve the risk profile for the chemical. Therefore, POPRC 3 agreed to defer its final Convention Annex E- related decision on SCCP to its fourth meeting. POPRC, through the Secretariat, as described in Unit II.H., has asked for additional information for the SCCP risk profile.
The next step in the process for substances found by POPRC to be likely, as a result of their long-range environmental transport, to lead to significant adverse human health and/or environmental effects such that global action is warranted is for POPRC to prepare a risk management evaluation that includes an analysis of possible control measures, which as noted in Annex F (“Information on Socio-Economic Considerations”) of the Convention should encompass “the full range of options, including management and elimination.” The risk management evaluation shall further evaluate and elaborate on the information referred to in Annexes D and E of the Convention. Relevant information should include socio-economic considerations
In addition to the Convention Annex F information discussed in Unit II.C., POPRC 3 identified the following specific areas where information and data relevant to the chemicals under consideration would be particularly useful for the future process.
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i. Information on octa-BDE and nona-BDE related to risk estimation and bioaccumulation.
ii. Information on quantitative assessments of the role of debromination.
iii. Toxicological and ecotoxicological information for the commercial mixture and its components.
Further, EPA notes that:
• The POPRC 3 Convention Annex E/risk profile–related decision on c-octaBDE actually was based on the hexabromodiphenyl ether (hexaBDE) through nonaBDE congeners that are components of the commercial mixture.
• The POPRC 3 Convention Annex F/risk management-related recommendation that related to the commercial pentabromodiphenyl ether risk management evaluation actually covered the tetrabromodiphenyl ether and pentabromodiphenyl ether congener components of that commercial mixture. (These decisions will be reflected in the POPRC 3 final report which will be available at:
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i. Information related to environmental burden caused by intentional use of PeCB.
ii. Information related to environmental burden caused by unintentional releases of PeCB.
In accordance with paragraph 7(a) of Article 8 of the Convention POPRC at its third meeting in November 2007 examined the draft risk profile for SCCP and considered that the information available was insufficient to support a decision on the risk profile. Therefore, POPRC agreed to defer its final decision to its fourth meeting and in its letter of December 3, 2007, the Secretariat invited Parties and observers to submit to the Secretariat additional information specified in Annex E of the Convention, particularly information on toxicity and ecotoxicity.
In addition, EPA is interested in receiving other information that would help support a determination of whether SCCP are likely, as a result of long-range environmental transport, to lead to significant adverse human health and/or environmental effects, such that global action is warranted. In particular, EPA would be interested in comparisons of toxicity or ecotoxicity data with detected or predicted levels of the substances resulting or anticipated from long-range environmental transport.
Environmental protection, Chemicals, Hazardous substances.