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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.




[Federal Register: June 4, 2007 (Volume 72, Number 106)]
[Notices]
[Page 30796-30799]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn07-40]

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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. Exit Disclaimer 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: 
TSCA-Hotline@epa.gov.
     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: clark.ellie@epa.gov.

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) Exit Disclaimer
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 Exit Disclaimer and http://www.pops.int/documents/meetings/
poprc/meeting_docs/en/default.htm), Exit Disclaimer respectively. POPRC had
before it five ectively. POPRC had before it five 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. 
Exit Disclaimer
    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 Exit Disclaimer and 
http://www.pops.int/documents/meetings/poprc_2/meeting_docs.htm),
Exit Disclaimer 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]
BILLING CODE 6560-50-S

 
 


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