[Federal Register Volume 72, Number 106 (Monday, June 4, 2007)]
[Notices]
[Pages 30796-30799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10699]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2006-0794; FRL-8130-9]


Review of Draft Risk Management Evaluations and Risk Profiles for 
Chemicals Proposed for Addition under the Stockholm Convention on 
Persistent Organic Pollutants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice requests comment on draft risk management 
evaluations being developed pursuant to the Stockholm Convention on 
Persistent Organic Pollutants (POPs) for the following chemicals which 
are being reviewed for possible addition to the Stockholm Convention's 
Annexes A, B, and/or C: Chlordecone (CAS No. 143-50-0), 
hexabromobiphenyl (HBB) (CAS No. 36355-01-8), lindane (CAS No. 58-89-
9), pentabromodiphenyl ether (PeBDE) (CAS No. 32534-81-9), and 
perfluorooctane sulfonate (PFOS). Additionally, this notice requests 
comment on draft risk profiles being developed pursuant to the 
Stockholm Convention for the following chemicals which are also being 
reviewed for possible addition to the Stockholm Convention's Annexes A, 
B, and/or C: Alpha-hexachlorocyclohexane (alpha-HCH) (CAS No. 319-84-
6), beta-hexachlorocyclohexane (beta-HCH) (CAS No. 319-85-7), 
commercial octabromodiphenyl ether (octaBDE) (CAS No. 32536-52-0 ), 
pentachlorobenzene (PeCB) (CAS No. 608-93-5), and short-chained 
chlorinated paraffins (SCCP) (CAS No. 85535-84-8). EPA is issuing this 
notice in advance of the aforementioned documents' release to increase 
awareness of the status of the reviews of certain proposals under the 
Stockholm Convention, to alert interested and potentially affected 
persons of the documents' pending release, and to request comments on 
them when they are available for EPA's consideration in its development 
of comments of the documents and its submission to the Stockholm 
Convention Secretariat (hereafter Secretariat).

DATES: The Secretariat is expected to post these draft risk management 
evaluations and draft risk profiles on or about May 29, 2007, on its 
website http://www.pops.int. Comments on these draft documents must be 
received by EPA no later than 15 days after the Secretariat makes the 
draft documents available.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2006-0794, by one of the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
      Mail: Document Control Office (7407M), Office of 
Pollution Prevention and Toxics (OPPT), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
      Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2006-0794. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-0794. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, will be publicly available only in hard copy. Publicly 
available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT 
Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at 
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. 
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding Federal holidays. The telephone 
number of the EPA/DC Public Reading Room is (202) 566-1744, and the 
telephone number for the OPPT Docket is (202) 566-0280. Docket visitors 
are required to show photographic identification, pass through a metal 
detector, and sign the EPA visitor log. All visitor bags are processed 
through an X-ray machine

[[Page 30797]]

and subject to search. Visitors will be provided an EPA/DC badge that 
must be visible at all times in the building and returned upon 
departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
     For technical information contact: Ellie Clark, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-2962; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    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 FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI--i. Do not submit this information to EPA 
through regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and 
then identify electronically within the disk or CD-ROM the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
     ii. Procedures for preparing confidential information related to 
pesticides and industrial chemicals are in Unit I.B.1. Send 
confidential information about industrial chemicals using the 
submission procedures under ADDRESSES. Send confidential information 
about pesticides to: Janice K. Jensen, Office of Pesticide Programs 
(7506P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or hand delivered to: Janice K. Jensen, 
Government and International Services Branch, Office of Pesticide 
Programs, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Rm. S-
11315, Arlington, VA 22202.
     iii. Commenters should note that none of the CBI information 
received by EPA will be forwarded to the Secretariat. Information from 
submissions containing CBI may be considered by EPA in the development 
of the U.S. response. If commenters wish EPA to consider incorporating 
information in documents with CBI as part of the U.S. response, 
commenters should provide a sanitized copy of the documents. Sanitized 
copies must be complete, except that all information claimed as CBI 
must be deleted. EPA will place sanitized copies in the public docket.
     2. Tips for preparing your comments. When submitting comments, 
remember to:
     i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
     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.

II. Background

 A. What Action is the Agency Taking?

    The Agency is issuing this notice to increase awareness of the 
proposals to list certain chemicals under Annexes A, B, or C of the 
Stockholm Convention, and to provide interested persons with an 
opportunity to provide comments to EPA for its consideration in the 
development of the U. S.' comments on the draft risk profiles and risk 
management evaluations. By May 29, 2007, the Secretariat is expected to 
have invited Parties and observers to submit to the POPs Review 
Committee (POPRC) (via the Secretariat) comments on the draft risk 
profiles and draft risk management evaluations (http://www.pops.int) 
and requested that comments be submitted by July 1, 2007. The United 
States is an observer. The United States intends to submit its comments 
on the drafts by July 1, 2007, to meet the Secretariat's deadline. 
Because of the short-time period for review, EPA is issuing this notice 
in advance of the documents being posted by the Secretariat to alert 
interested parties to the upcoming opportunity to participate in the 
review and comment process. In light of the POPRC deadlines for the 
receipt of comments, the Agency's public comment period for this action 
will close 15 days after the Secretariat posts the draft risk profiles 
and risk management evaluations on its website. The chemical listing 
process is discussed in more detail in Unit II.B. Individuals or 
organizations that wish to submit information directly to POPRC via the 
Secretariat should work through their respective observer 
organizations, if any.

 B. What is the Stockholm Convention Chemical Listing Process?

    The Stockholm Convention is a multilateral environmental agreement 
designed to protect human health and the environment from persistent 
organic pollutants. The United States signed the Stockholm Convention 
in May of 2001 but has not yet ratified it (and thus is not a Party to 
the Stockholm Convention). The United States currently participates as 
an observer in Stockholm Convention activities. The Stockholm 
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 Stockholm 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 Stockholm 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 Stockholm Convention must use when considering the 
addition of new

[[Page 30798]]

chemicals to the Stockholm Convention's Annexes. Article 8 of the 
Stockholm 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.
    1. A Party to the Stockholm 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 
Stockholm 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 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 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. Draft risk profiles are prepared by ad hoc working groups under 
POPRC in accordance with Annex E for consideration by POPRC and made 
available to all Parties and observers to collect technical comments.
    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'') 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 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 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 
Stockholm Convention.).
    11. COP makes the final decision on listing the chemical in Annexes 
A, B, and/or C.
    EPA anticipates issuing Federal Register notices soliciting 
information, when appropriate.

C. What Comments Are Being Requested for the Draft Risk Management 
Evaluations?

    For the chemicals currently at the risk management stage (see Unit 
II.G.), EPA is seeking comments on whether the draft risk management 
evaluations adequately reflect the socio-economic considerations 
specified in Annex F to the Stockholm Convention, and on whether the 
risk management measures recommended in the documents are reasonably 
supported in the draft documents. The types of information that the 
Stockholm Convention directs should be considered at this stage is 
discussed in Unit II.G.
    In particular, because the possible control measures under the 
Stockholm Convention include, among others, the prohibition or 
restriction of production and use, commenters should consider whether 
accurate, high-quality information is available to support the draft 
recommendations.

D. What Information is Being Requested for the Draft Risk Profiles?

    For chemicals at the risk profile stage (see Unit II.H.), EPA is 
seeking comments on whether the draft risk profiles adequately cover 
the information types specified in Annex E to the Stockholm Convention, 
and whether the information in the document adequately supports the 
determination of whether or not 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, as required under Article 8, paragraph 7(a) of the Stockholm 
Convention.

E. How Should the Information be Provided?

    1. EPA requests that commenters include clear and precise 
references for any sources that they might refer to. Without the exact 
source of the information, POPRC will not be able to use the 
information. If the information is not readily available in the public 
literature, commenters may consider attaching the original source of 
the information to their submission. Commenters should indicate clearly 
on their comments which chemical the information concerns.
    2. Although POPRC has developed provisional arrangements for the 
treatment of CBI, as mentioned in Unit I.B.1.iii., 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.1. and ADDRESSES.
    3. Anyone wishing to have an opportunity to communicate with EPA 
orally on this issue should consult the technical person listed under 
FOR FURTHER INFORMATION CONTACT.

F. What is the Agency's Authority for Taking this Action?

    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 et seq., which directs all agencies of the Federal Government to 
``[r]ecognize the worldwide and long-range character of environmental 
problems and, where consistent with the foreign policy of the United 
States, lend appropriate support to initiatives, resolutions and 
programs designed to maximize cooperation in anticipating and 
preventing a decline in the quality of mankind's world environment.'' 
Section 17(d) of the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA) also provides additional support in that it directs the 
Administrator of EPA ``in cooperation with the Department of State and 
any other appropriate Federal agency, [to] participate and cooperate in 
any international efforts to develop improved pesticide research and 
regulations.''

G. What is the Status of Chemicals at the Risk Management Stage?

    The first meeting of POPRC took place November 7-11, 2005, in 
Geneva, Switzerland. Information about the Stockholm Convention and the 
November POPRC meeting is available at the Stockholm Convention website 
(http://www.pops.int and http://www.pops.int/documents/meetings/poprc/meeting_docs/en/default.htm), respectively. POPRC had before it five 
proposals which were submitted for its consideration by Parties to the 
Stockholm Convention, for addition to

[[Page 30799]]

Annexes A, B, and/or C of the Stockholm Convention. Three of the five 
proposals were for industrial chemicals:
     Pentabromodiphenyl ether.
     Hexabromobiphenyl.
     Perfluorooctane sulfonate.
Two of the five proposals were for pesticides:
     Lindane.
     Chlordecone.
    In accordance with the procedure laid down in Article 8 of the 
Stockholm Convention and discussed in Unit II.B., during the November 
meeting POPRC examined the proposals and applied the screening criteria 
in Annex D of the Stockholm 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, requested that Parties and observers provide information 
relevant to POPRC's development of risk profiles for the five chemicals 
listed in this unit. In the Federal Register of January 30, 2006 (71 FR 
4913) (FRL-7758-9), EPA invited commenters to provide EPA with 
information for the risk profiles.
    The second meeting of POPRC took place November 6-10, 2006, in 
Geneva, Switzerland. EPA provided notice of this meeting and POPRC's 
intention to consider risk profiles for the five chemicals in the 
Federal Register of October 6, 2006 (71 FR 59108) (FRL-8099-2). 
Information about the November POPRC meeting is available at the 
Stockholm Convention website http://www.pops.int.documents/meetings/
poprc--2/meeting--docs.htm.
    In accordance with the procedure laid down in Article 8 of the 
Stockholm Convention and discussed in Unit II.B., during the November 
2006 meeting POPRC examined the draft risk profiles with respect to the 
requirements in Annex E of the Stockholm Convention. With regard to all 
five chemicals, POPRC decided that, based on finalized risk profiles, 
these chemicals were likely, as a result of their long-range 
environmental transport, to lead to significant adverse-human health 
and environmental effects such that global action is warranted. 
Additionally, in accordance with paragraph 7(a) of Article 8 of the 
Stockholm Convention, POPRC invited Parties and observers to submit to 
the Secretariat the information specified in Annex F to the Stockholm 
Convention by February 9, 2007. In the Federal Register of December 20, 
2006 (71 FR 76325) (FRL-8109-1), EPA invited commenters to provide EPA 
with risk management information to support the development of its 
submission to the Secretariat. On February 9, 2007, EPA provided 
comments to the Secretariat.
    POPRC, through ad hoc working groups, is preparing draft risk 
management evaluations that are to include an analysis of possible 
control measures, which in accordance with Annex F of the Stockholm 
Convention (``Information on Socio-Economic Considerations'') should 
encompass ``the full range of options, including management and 
elimination.'' The risk management evaluations include socio-economic 
considerations associated with possible control measures (see Unit 
II.C.) and reflect due regard for the differing capabilities and 
conditions among the Parties. Additionally, these documents should 
discuss any specific exemptions or acceptable purposes being 
considered. Following the receipt of comments, the ad hoc working 
groups will further refine the draft risk management evaluations, which 
will then be considered by the full POPRC in November 2007 and proceed 
as discussed in Unit II.B.

H. What is the Status of Chemicals at the Risk Profile Stage?

    As stated in Unit II.G., 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 Federal Register of October 6, 
2006. Information about the November POPRC meeting is available at the 
Stockholm Convention website (http://www.pops.int and http://www.pops.int/documents/meeting/poprc_2/meeting_docs.htm), 
respectively. POPRC had before it five proposals which were submitted 
for its consideration by Parties to the Stockholm Convention, for 
addition to Annexes A, B, and/or C of the Stockholm Convention.
Two of the five proposals were for industrial chemicals:
     Octabromodiphenyl ether.
     Short-chained chlorinated paraffins.
One of the five proposals was for a chemical with both industrial and 
pesticidal uses:
     Pentachlorobenzene.
Two of the five proposals were for pesticides:
     Alpha-hexachlorocyclohexane.
     Beta-hexachlorocyclohexane.
    In accordance with the procedure laid down in Article 8 of the 
Stockholm Convention and discussed in Unit II.B., during the November 
meeting POPRC examined the proposals and applied the screening criteria 
in Annex D of the Stockholm Convention. With regard to all five 
chemicals, POPRC decided that it was satisfied that the screening 
criteria had been fulfilled and, in accordance with paragraph 4(a) of 
Article 8 of the Stockholm Convention, POPRC invited Parties and 
observers to submit to the Secretariat the information specified in 
Annex E to the Stockholm Convention by February 9, 2007. In the Federal 
Register of December 20, 2006, EPA invited commenters to provide EPA 
with risk profile information to support the development of its 
submission to the Secretariat. EPA provided comments to the Secretariat 
on February 9, 2007.
    POPRC, through ad hoc working groups, has prepared draft risk 
profiles for each of the chemicals to, as noted in Annex E of the 
Stockholm 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 draft risk profiles also further 
evaluate and elaborate on the information referred to in Annex D of the 
Stockholm Convention and include, as far as possible, the information 
listed in Annex E of the Stockholm Convention. Following the receipt of 
comments, the ad hoc working groups will further refine the draft risk 
profiles, which will then be considered by the full POPRC in November 
2007, and proceed as discussed in Unit II.B.

List of Subjects

     Environmental protection, Chemicals, Hazardous substances.


    Dated: May 23, 2007.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. E7-10699 Filed 6-1-07; 8:45 am]
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