Daily Rules, Proposed Rules, and Notices of the Federal Government
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 technical person listed under
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.
-Although the United States has not ratified the Convention, it has an opportunity, as an observer, to provide submissions for review. The Agency is issuing this notice on behalf of USG to increase awareness of the proposals concerning chemicals for addition to the Convention, to make interested persons aware of the process for adding chemicals to the Convention, to indicate at which steps receiving comments or information from interested parties would be useful to USG, and to indicate for those steps the type of information sought and the due date. EPA is issuing this notice in order to improve the process used for soliciting comments on chemicals being reviewed for addition to the Convention.
-In the future, EPA, on behalf of USG, intends to issue a
-On behalf of USG, 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 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, i.e., those listed in Annex A or B. The Convention also calls upon Parties to take certain specified measures to reduce releases of unintentionally produced POPs listed in Annex C 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 certain procedures and science-based criteria that Parties to the Convention use when considering the addition of new chemicals to the Convention’s Annexes. Article 8 of the Convention provides the process to be followed for listing new chemicals in Annexes A, B, and/or C, and is described in summary in this unit:
-1. A Party to the Convention may submit a proposal to the Secretariat for listing a chemical in Annexes A, B, and/or C. 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, and if the Secretariat is satisfied, the proposal is forwarded to the POPs Review Committee (hereafter POPRC).
-3. POPRC examines the proposal, applies the 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 the 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”).
-5. A draft risk profile is prepared by an ad hoc working group under POPRC in accordance with Annex E for consideration by POPRC and made available to all Parties and observers to collect technical comments. The penultimate final draft is distributed to obtain public comment from Parties and observers. The outline to be used in developing the risk profile can be found on the Convention website (
-6. POPRC reviews the final draft risk profile and technical comments, finalizes the risk profile, includes a determination as to 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 decides that 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, then POPRC, through the Secretariat, will ask Parties and observers to provide information specified in Annex F (“Information on Socio-Economic Considerations”) to aid in the development of risk management evaluations (that include an analysis of possible control measures).
-8. A draft risk management evaluation is prepared by an ad hoc working group under POPRC in accordance with Annex F for consideration by POPRC and made available to Parties and observers to collect technical comments. The penultimate final draft is distributed to obtain public comment from Parties and observers. The outline to be used in developing the risk management evaluation can be found on the Convention website.
-9. POPRC reviews the draft risk management evaluation prepared by the ad hoc working group and finalizes it.
-10. On the basis of the risk profile and risk management evaluation for each chemical, POPRC recommends whether the chemical should be considered by the Conference of the Parties (COP) for listing in Annexes A, B, and/or C, depending on the control measures.
-11. Parties may be asked by the Secretariat, prior to the COP meeting, to provide any specific concerns they have regarding listing a chemical in a particular annex.
-12. COP makes the final decision whether to list the chemical in Annexes A, B, and/or C.
-Risk profiles, as noted in Annex E of the Convention, “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 also further evaluates and elaborates on the information referred to in Annex D of the Convention and includes, as far as possible, the information listed in Annex E.
-Risk management evaluations include an analysis of possible control measures, which in accordance with Annex F of the Convention (“Information on Socio-Economic Considerations”) should encompass “the full range of options, including management and elimination.” The risk management evaluation includes socio-economic considerations associated with possible control measures and reflects due regard for the differing capabilities and conditions among the Parties. Additionally, the document should discuss any specific exemptions or acceptable purposes being considered.
-2. The Convention website is the location of all the chemical proposals, risk profiles, risk management evaluations, information and comments submitted by Parties and observers, meeting documents, etc.
-i. Information such as the Secretariat’s invitation letters, requests for information, and outlines for the risk profiles and risk management evaluations, can be found on the Convention website by selecting the tab for Convention, selecting POPRC, and then selecting Information Requests.
-ii. Meeting documents can be found by selecting:
-a. The Convention tab.
-b. POPRC (or COP).
-d. The particular meeting needed.
-iii. Submissions from Parties and observers of Annex E information, etc., can be found by selecting:
-c. Submissions (yr).
-d. The type of information being looked for.
-iv. Copies of the risk profiles, risk management evaluations, and new proposals can be found by selecting:
-c. Chemicals under review.
-1. USG seeks information that is supplementary to the information in the proposals and POPRC’s evaluation of the proposals against the Annex D screening criteria. The proposals and the evaluations are available on the Convention website.
-2. 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 paragraphs i. through v. of this unit:
-i. Sources, including as appropriate:
-a. Production data, including quantity and location.
-c. Releases, such as discharges, losses, and emissions.
-ii. Hazard assessment for the endpoint or endpoints of concern (as identified in the proposals and/or POPRC’s evaluation of the proposals against the screening criteria of Annex D), including a consideration of toxicological interactions involving multiple chemicals.
-iii. 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. (POPRC is to make a determination of the bioconcentration factor or bio-accumulation factor, based on measured values, available, except when monitoring data are judged to meet this need.)
-iv. Monitoring data.
-v. Exposure in local areas and, in particular, as a result of long-range environmental transport, and including information regarding bio-availability.
-1. For the chemicals entering the risk management stage, USG seeks 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, can be found on the Convention website.
-2. 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. The provision of accurate, high quality information is a priority for POPRC’s evaluation.
-3. 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 paragraphs i. through viii. of this unit. Summary information and relevant references should be provided for:
-i. Efficacy and efficiency of possible control measures in meeting risk reduction goals:
-a. Describe possible control measures.
-b. Technical feasibility.
-c. Costs, including environmental and health costs.
-ii. Alternatives (products and processes):
-a. Describe alternatives.
-b. Technical feasibility.
-c. Costs, including environmental and health costs.
-iii. Positive and/or negative impacts on society of implementing possible control measures:
-a. Health, including public, environmental and occupational health.
-b. Agriculture, including aquaculture and forestry.
-c. Biota (biodiversity).
-d. Economic aspects.
-e. Movement towards sustainable development.
-f. Social costs.
-iv. Waste and disposal implications (in particular, obsolete stocks of pesticides and clean-up of contaminated sites):
-a. Technical feasibility.
-v. Access to information and public education.
-vi. Status of control and monitoring capacity.
-vii. Any national or regional control actions taken, including information on alternatives, and other relevant risk management information.
-viii. Other relevant information for the risk management evaluation.
-The first meeting of POPRC (POPRC 1) took place November 7-11, 2005, in Geneva, Switzerland. Information about the Convention, POPRC meetings, and the meeting reports are available on the Convention website. Five chemical proposals were submitted for consideration for addition to Annexes A, B, and/or C of the Convention. Three of the five proposals were for industrial chemicals:
-• Pentabromodiphenyl ether (PeBDE).
-• Hexabromobiphenyl (HBB).
-• Perfluorooctane sulfonate (PFOS).
Two of the five proposals were for pesticides:
-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 for the five chemicals. Therefore, POPRC, through the Secretariat, requested that Parties and observers provide information, per Annex E, relevant to POPRC’s development of risk profiles for the five chemicals listed in this unit. See the
-The second meeting of POPRC (POPRC 2) took place on November 6-10, 2006, in Geneva, Switzerland. See the
-Also at POPRC 2, five new chemicals were submitted for consideration for addition to the Convention.-
-1. Two of the five proposals were for industrial chemicals:
-i. Commercial octabromodiphenyl ether (c-octaBDE).
-ii. Short-chained chlorinated paraffins (SCCPs).
-2. One of the five proposals was for a chemical with both industrial and pesticidal uses: Pentachlorobenzene (PeCB).
-3. Two of the five proposals were for pesticides:
-i. Alpha-hexachlorocyclohexane (alpha-HCH).
-ii. Beta-hexachlorocyclohexane (beta-HCH).
-EPA provided notice of POPRC 2 and POPRC’s intention to consider proposals for the five chemicals listed in this unit in the October 6, 2006
-In accordance with the procedure in Article 8 of the Convention, POPRC 3 examined the risk profiles for the chemicals in this unit and decided that the chemicals, except for SCCPs, 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. POPRC 3 directed the collection of information, per Annex F, to be used in the development of the risk management evaluations and also requested additional information related to commercial octaBDE and its congeners, and PeCB. Initial draft risk management evaluations were developed during the spring of 2008 for consideration at POPRC 4 in October 2008. At POPRC 4, the risk management evaluations for c-octaBDE, PeCB, alpha-HCH, and beta-HCH were approved. POPRC decided to recommend, for c-octaBDE, that COP consider listing in Annex A hexa- and heptaBDEs present in c-octaBDE, using BDE-153, BDE-154, BDE-175, and BDE-183 as markers for enforcement purposes. For PeCB, it was decided to recommend to COP that the substance be listed in Annexes A and C. POPRC also decided to recommend to COP that it consider listing alpha- and beta-HCH in Annex A, giving due consideration to the by-production of these substances from the production of lindane. Those recommendations are expected to be presented to COP 4 in May 2009.
-The draft risk profile for SCCPs was also examined at POPRC 3, but POPRC considered the information available to be insufficient to support the Convention Annex E-related decision that 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 and therefore did not agree upon a risk profile for the chemical. POPRC agreed to the further development of the risk profile, asked Parties and observers for additional information for the SCCP risk profile, and delayed the Convention Annex E- related decision on SCCPs to POPRC 4. A revised risk profile was prepared for consideration at POPRC 4. POPRC 4 agreed to consider the risk profile, as revised, at POPRC 5.
-In the period between POPRC 3 and POPRC 4, two additional chemicals were proposed for consideration to be listed in Annex A, B, and/or Annex C to the Convention. Proposals were submitted for endosulfan, a pesticide, and for hexabromocyclododecane (HBCDD), an industrial chemical. The Secretariat reviewed the proposals and verified that they contain the information specified in Annex D. Those evaluations are posted on the Convention website. At POPRC 4, it was decided to not take action on the HBCDD proposal since the relevant documentation was not submitted sufficiently in advance of the meeting. POPRC 5 will consider the HBCDD proposal. Regarding the endosulfan proposal, POPRC 4 decided that alpha endosulfan, beta endosulfan, and technical endosulfan, fulfill the screening criteria, established a working group to prepare a draft risk profile in accordance with Annex E of the Convention, and invited Parties and observers to submit the information specified in Annex E to the Secretariat.
Environmental protection, Chemicals, Hazardous substances.