[Federal Register: November 4, 2009 (Volume 74, Number 212)]
[Rules and Regulations]
[Page 57076-57078]
[DOCID:fr04no09-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1125; FRL-8350-6]

Pesticide Inert Ingredients; Revocation of Tolerance Exemption
for Sperm Oil

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing this final rule to revoke the existing obsolete
tolerance exemption for residues of sperm oil conforming to 21 CFR
172.210. There have not been any active Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) pesticide product registrations containing
this inert ingredient for many years. In addition, the sperm whale
(from which sperm oil is derived) is a federally listed endangered
species, and taking (or harming) this species is prohibited under the
U.S. Endangered Species Act. Therefore, since this exemption
corresponds to uses no longer current or registered under FIFRA in the
United States, EPA is revoking the existing tolerance exemption under
40 CFR 180.910 because it is no longer necessary.

DATES: This regulation is effective November 4, 2009. Objections and
requests for hearings must be received on or before January 4, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-1125. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Karen Samek, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act,
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2007-1125 in the subject line on the first page of your submission. All
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk as required by 40 CFR part 178 on or before January 4,
2010.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-1125, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

A. What Action Is the Agency Taking?

    EPA is revoking the existing tolerance exemption under 40 CFR
180.910 for residues of sperm oil conforming to 21 CFR 172.210 as part
of a broader administrative effort to correct errors and clarify
permitted uses of pesticide inert ingredients in the Code of Federal
Regulations. It is EPA's general practice to revoke tolerances and
tolerance exemptions for pesticide chemical residues (which include
both active and inert ingredients) for which there are no

associated active registered uses under FIFRA, or for which there are
no registered products to which the tolerance or tolerance exemption
applies, or for tolerances or tolerance exemptions that have been
superseded.
    EPA has historically been concerned that retention of tolerances
and tolerance exemptions that are not necessary to cover residues in or
on legally treated foods may encourage misuse of pesticides within the
United States. Thus, it is EPA's policy to issue a final rule revoking
those tolerances and tolerance exemptions for residues of pesticide
chemicals for which there are no active registrations or uses under
FIFRA.
     Generally, EPA will proceed with the revocation of these tolerance
and tolerance exemptions on the grounds discussed in Unit II if one of
the following conditions applies:
    1. Prior to EPA's issuance of a section 408(f) order requesting
additional data or issuance of a section 408(d) or (e) order revoking
the tolerances or tolerance exemptions on other grounds, commenters
retract the comment identifying a need for the tolerance to be
retained.
    2. EPA independently verifies that the tolerance or tolerance
exemption is no longer needed.
    3. The tolerance or tolerance exemption is not supported by data
that demonstrate that the tolerance or tolerance exemption meets the
requirements under FQPA.
    EPA issued a proposed rule in the Federal Register of May 16, 2008
(73 FR 28391) (FRL-8363-6) proposing to revoke the tolerance exemption
under 40 CFR 180.910 for residues of sperm oil conforming to 21 CFR
172.210. There were no comments received in response to the proposed
rule.
    EPA believes it is appropriate to revoke the tolerance exemption
associated with this inert ingredient because there are no longer any
active FIFRA pesticide product registrations for pesticide products
containing sperm oil. Additionally, since sperm oil is derived from the
sperm whale and the sperm whale is a federally listed endangered
species, taking (or harming) this species to obtain sperm oil is
prohibited by the Endangered Species Act. EPA does not expect there to
be existing stocks of pesticides containing sperm oil in the hands of
users because the sperm whale has been listed as an endangered species
since 1970. Also, EPA is not aware of any food or feed commodities
treated with pesticides containing sperm oil imported into the United
States.
    Therefore, for the reasons stated herein, EPA is revoking the
existing exemption from the requirement of a tolerance for residues of
sperm oil conforming to 21 CFR 172.210 under 40 CFR 180.910.

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

     This rule is issued pursuant to section 408(l) of FFDCA (21 U.S.C.
346a(l)). Section 408(l) of FFDCA authorizes the establishment of
tolerances, exemptions from the requirement of a tolerance,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or tolerance exemption, food
containing pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of the FFDCA. If food containing
pesticide residues is found to be adulterated, the food may not be
distributed in interstate commerce (21 U.S.C. 331(a) and 342(a)).
     EPA's general practice is to revoke tolerances and tolerance
exemptions for residues of pesticide chemicals on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances and tolerance exemptions that
are not necessary to cover residues in or on legally treated foods may
encourage misuse of pesticides within the United States. Nonetheless,
EPA will establish and maintain tolerances and tolerance exemptions
even when corresponding domestic uses are canceled if the tolerances,
which EPA refers to as ``import tolerances,'' are necessary to allow
importation into the United States of food containing such pesticide
residues. However, where there are no imported commodities that require
these import tolerances, the Agency believes it is appropriate to
revoke tolerances and tolerance exemptions for unregistered pesticide
chemicals in order to prevent potential misuse.

C. When do These Actions Become Effective?

    This action becomes effective on the date of publication of this
final rule in the Federal Register. Any commodities listed in the
regulatory text of this document that are treated with Sperm oil, and
that are in the channels of trade following the tolerance exemption
revocations, shall be subject to FFDCA section 408(l)(5), as
established by the FQPA. Under this section, any residues of this
pesticide chemical in or on such food shall not render the food
adulterated so long as it is shown to the satisfaction of the Food and
Drug Administration (FDA) that:
    1. The residue is present as the result of an application or use of
the pesticide chemical at a time and in a manner that was lawful under
FIFRA.
    2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under an
exemption from tolerance. Evidence to show that food was lawfully
treated may include records that verify the dates that the pesticide
chemical was applied to such food.

III. Statutory and Executive Order Reviews

    In this final rule, EPA is revoking a specific tolerance exemption
established under FFDCA section 408. EPA establishes tolerances under
FFDCA section 408(e), and also modifies and revokes specific tolerances
established under FFDCA section 408. The Office of Management and
Budget (OMB) has exempted this type of action (i.e., a tolerance
revocation for which extraordinary circumstances do not exist) from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
Pursuant to

the Regulatory Flexibility Act (RFA)(5 U.S.C. 601 et seq.), the Agency
previously assessed whether revocations of tolerances might
significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
This analysis was published on December 17, 1997 (62 FR 66020), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration. Taking into account this analysis, and available
information concerning the pesticide listed in this rule, the Agency
hereby certifies that this final rule will not have a significant
economic impact on a substantial number of small entities. Furthermore,
for the inert ingredient named in this final rule, the Agency knows of
no extraordinary circumstances that exist as to the present revocation
that would change the EPA's previous analysis. In addition, the Agency
has determined that this action will not have a substantial direct
effect on States, on the relationship between the national government
and the States, or on the distribution of power and responsibilities
among the various levels of government, as specified in Executive Order
13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive
Order 13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ''substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

IV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, to each House of the Congress and
to the Comptroller General of the United States. EPA will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of this final rule in the
Federal Register. This final rule is not a ``major rule'' as defined by
5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 23, 2009.
Donald J. Rosenblatt,
Acting Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
 1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

Sec.  180.910  [Amended]

0
2. Section 180.910 is amended by removing from the table the entry for
``Sperm oil conforming to 21 CFR 172.210.''
[FR Doc. E9-26540 Filed 11-3-09 8:45 am]

BILLING CODE 6560-50-S


U. S. Environmental Protection Agency Draft Agenda July 10, 2003 PUBLIC MEETING Enforceable Consent Agreement Development for Perfluorooctanoic acid ( PFOA) and Fluorinated Telomers Location: Environmental Protection Agency ( EPA), East Bldg. Rm. 1153 1201 Constitution Ave., NW, Washington, DC 20460 Date: Thursday, July 10, 2003, 1: 00 PM  5: 00 PM Draft Agenda 1: 00  1: 30 Introduction of Participants   Opening Remarks   Charles M. Auer, Director Office of Pollution Prevention and Toxics ( OPPT)

1: 30  2: 30 Technical Workgroup Progress and Status Reports   PFOA ECA Communications Workgroup Spokesperson: Harry Lewis, U. S. EPA   PFOA ECA Fluoropolymer Technical Workgroup Spokesperson: Greg Fritz, EPA; Dave Rurak, DuPont   PFOA ECA Telomer Technical Workgroup Spokesperson: David Lynch, EPA   PFOA ECA Monitoring Technical Workgroup Spokesperson: Phil Oshida, EPA 2: 30  2: 45 Break 2: 45  3: 30 Discussion of Topics Remaining in Plenary Session   Fluoropolymer Fate Data   Fire Fighting Foam Data   Other 3: 30  4: 00 Caucus Break 4: 00  4: 20 Next Steps 4: 20  4: 50 Public Comment ( Open mike: maximum time 3 minutes per speaker) Members of the public not registered as Interested Parties will be given preference, since Interested Parties can participate in earlier discussions.

4: 50  5: 00 OPPT Closing Remarks U. S. EPA Final " Interested Parties" List for PFOA ECA Meetings July 10, 2003 Complete List of " Interested Parties" for PFOA and Telomer ECA Negotiations The following groups and/ or individuals have requested and been granted status as " interested parties" for the purpose of monitoring or participating in ECA negotiations on PFOA and fluorinated telomers.

3M Advanced Polymer, Inc. AGA Chemicals American Council on Science and Health American Chemistry Council American Fiber Manufacturers Association, Inc. Asahi Glass Co., Ltd. Asahi Glass Fluoropolymers USA, Inc. ATOFINA Chemicals, Inc. Bennett & Williams ( Environmental Consultants) Center for Policy Research for Women and Families Chamber of Commerce of the Mid Ohio Valley Ciba Specialty Chemicals Corporation Clariant GmbH Daikin America Dainippon Ink & Chemicals Davis, Pickering & Co., Inc. Department of the Navy DuPont DuPont Textiles and Interiors, Inc. Dyneon Environmental Health Research Foundation Environmental Working Group Fire Fighting Foam Coalition Vicky Gheen ( Private Citizen) Hughes Associates, Inc. International Imaging Industry Association Little Hocking Water Association, Inc. Miteni S. p. A. Mitsubishi International Corporation Ohio Environmental Protection Agency Ohio River Valley Water Sanitation Commission OMNOVA Solutions Parkersburg Wood County Area Development Corporation Rich Purdy Regenerative Products Solvay Solexis, Inc. Society of the Plastics Industry/ Fluoropolymer Manufacturers Group Telomer Research Program Tennant Rentals The Area Roundtable The Carpet and Rug Institute The Center for Regulatory Effectiveness Tuppers Plains Chester Water District United Bank, West Virginia University of Pennsylvania Medical Center W. L. Gore & Associates, Inc. Walki Wisa Ltd. West Virginia Class Action Plaintiffs West Virginia Department of Environmental Protection U. S. Environmental Protection Agency July 10, 2003 PFOA ECA Plenary Meeting Attendee List Name Affiliation Aidala, Jim Bergeson & Campbell ( W. L. Gore) Aller, Linda Bennett & Williams Baillie, Richard W. L. Gore Beers, A. W. ( Bill) OMNOVA Solutions Biles, Blake Arnold & Porter ( Clariant) Bilott, Rob WV Class Action Plaintiffs Bittner, Patte Consumer Product Safety Commission Buck, Robert DuPont Buxton, Bill DuPont Campbell, Lisa Bergeson & Campbell ( W. L. Gore) Cardona, Mike DuPont Cortina, Tom Fire Fighting Foam Coalition DiPasquale, Tom 3M Duncan, Don Society of the Plastics Industry Dunne, Joe self Eaton, Linda Morgan, Lewis & Bockius, LLP Edouard, Lisa American Forest & Paper Association Emmet, Edward Univ. of Penn. Medical Center Flaherty, John Exygen Research Gannon, John DuPont Gibb, Steven Inside Washington Publishers Greenwood, Mark Ropes & Gray ( Daikin) Griffin, Bob Little Hocking Water Association Harris, Lynne Society of the Plastics Industry Hatcher, Julie Latham & Watkins ( 3M) Heinze, John E. Environmental Health Research Foundation Knight, Frances Ciba Specialty Chemicals Komatsu, Satoshi Daikin Korzeniowski, Stephen DuPont Lampert, Edward Daikin Lasker, Eric Spriggs & Hollingsworth Latzko, David W. L. Gore Limbach, Bonnie Society of the Plastics Industry Lloyd, Kevin Exygen Research Malinowski, Andrea DuPont Marchant, Lolly Atofina McCabe, W. Michael Consultant ( DuPont) Menotti, David Shaw Pittman ( Asahi) Millet, George Dyneon ( 3M) Misa, Noel Asahi Glass Fluoropolymers Nakamura, Takayuki Daikin U. S. Environmental Protection Agency July 10, 2003 2 Nichols, Beth National Center for Policy Research for Women and Families Nishiyama, Yukiko Daikin Parr, Michael DuPont Phibbs, Pat BNA Pennington, Tracey Geologics  EPA Contractor ( court reporter) Poley, Mary Beth Pesticide and Toxic Chemical News Poole, Donald Tuppers Plains Chester Water District Purdy, Rich Reardon, Michelle Dupont Reich, Richard Kilpatrick Stockton Roussel, Randy Daikin Rurak, David DuPont Sakanoue, Takahiko Daikin Santoro, Mike 3M Scott, Bill Mitsubishi Schneider, Ed W. L. Gore Shin ya, Seiji Asahi Glass Shomper, Diane DuPont Slaughter, Scott Center for Regulatory Effectiveness Smythe, Katie Rand ( TRP) Soiefer, Andrew I. North Jersey Toxicology Associates, LL Stennes, Libby Steptoe & Johnson ( DuPont) Sussman, Bob Latham & Watkins ( 3M) Thayre, Kris Environmental Working Group Thomas, Treye Consumer Product Safety Commission Toloken, Steve Plastics News Walrath, Stephanie Hughes Associates, Inc. Webb, Clif DuPont Weidman, Allen Society of the Plastics Industry Wiedow, Al Ciba Specialty Chemicals Williams, Steve Ohio EPA Yamatoya, Takahisa Dainippon Ink & Chemicals, Inc. Zuckerman, Diana Natl. Center for Policy Research for Women & Families U. S. Environmental Protection Agency July 10, 2003 3 U. S. Environmental Protection Agency Attendees:

Auer, Charles Collette, Tim Coutlakis, Anna Dominiak, Mary Fritz, Gregory Guo, Zhishi Heithmar, Ed Hernandez, Oscar Highsmith, Ross Hoffman, Karen Hoffman, Wendy Leczynski, Barbara Leukroth, Rich Lewis, Harry Libelo, Laurence Lynch, David Mamantov, Andy Miller, Greg Nguyen, Nhan Oshida, Phil Patel, Neil Srinivasan, Gautam Taylor, Jeffrey Washington, Annette Weber, Eric Communications Workgroup Summary Plenary Presentation July 10, 2003 Communications Workgroup ° Tasked with developing a roadmap to meaningfully communicate, within the PFOA ECA process, information regarding marketing data, test substance( s), and article identity in a way that preserves proprietary information ( confidential business information, or CBI) and satisfies the needs of EPA and the interested parties. Communications Workgroup ° CBI is:

  Proprietary information offering commercial advantage   which meets regulatory criteria found in 40 CFR Part 2.

C CBI may include:

C trade secret information, chemical identity, company name, facility identity, process, production volume, and non public intellectual property Communications Workgroup C Idea of claiming CBI often misunderstood: claim must be based in regulatory criteria and involve commercial advantage ( not, e. g., avoidance of public scrutiny).

C Under regulation criteria, emphasis on demonstrating that public disclosure is likely to cause " substantial harm" to competitive position. Communications Workgroup ° TSCA Section 14( b) allows health and safety information CBI claims for process and mixture proportion information; claims closely reviewed.

° EPA must balance need of the industry to maintain legitimate proprietary information with need of the public for protection. Communication Workgroup ° Public Interest Group Concerns:

  CAS No. s and chemical structures critical for analysis ( e. g., CAS No. Internet search can ID consumer products of concern; structures needed to determine mechanisms of toxicity).

  Questioned whether general use information would be sufficient to allow the public to judge if test samples were representative and to know which products consumers may encounter. Communication Workgroup ° Industry Concerns:

  Strategic decisions regarding market and product development are very sensitive and must be treated as confidential.

  Prepared to validate CBI claims, as necessary.

  TRP: telomer products unique by end use and by company   FMG: LOI CAS numbers are 95% of the polymers in their markets Communication Workgroup ° In generic setting, parties unable to agree about specific information that would be necessary for determining exposure.

° Parties agreed that generic discussion of CBI issues difficult; remanded specific determinations of info needed for ECAs to individual technical workgroups.

° Workgroup will reconvene if specific CBI issues raised in other Workgroups not resolved; may request ombudsman to mediate if necessary. Fluoropolymer Workgroup Plenary Report Dr. Greg Fritz July 10, 2003 FMG Commitments Under LOI ° Product Stewardship ( no ECA part)

° P Chem Properties   Data for PTFE Fluoropolymers finished   Data for other FMG products coming ° Testing Articles of Commerce   Provided Detailed Selection Criteria   Relative to Entire Product Line Data To Be Submitted ° Specific Chemical Use / PV Info ° Commitment to high MW Polymer Limits ° Additional P Chem Data for Polymers ° More Fate / Biodeg Support ( ECA later)

° Timeline for ECA member / participants xxxxxxxxxxxxxxxxxxxxxxxxxxxx ° Analysis of Selection Criteria   Determine if additional applications to be tested EPA Data Needs Aged Products ° Determining What to Test ° Simulation of Aging Process / Real Samples ° Sampling Adequacy / Product Coverage ° Adequacy / Validation Methodology Proposed Incineration ECA ° Testing Resins / Dispersions / Articles ° Establish appropriate test criteria conditions ° Look for C8 acid / possible analogs ° Tiered approach for additional information   ID degradation products (& P Chem / Fate)

  Additional test materials Based on EPA Framework # 10 Monitoring ECA # 5 PFOA Materials Balance # 9 Analysis of # 8 P Chem & Fate # 4 Degradation Product Analysis # 8 Incineration ECA # 3 Degradation Pathways # 7 PFOA in Aged Products ECA # 2 P Chem Data for Fate # 6 Articles Analysis LOI Additional Testing ???

# 1 Complete product characterization Telomers ECA Technical Workgroup Progress Report Plenary Session Enforceable Consent Agreement Development for PFOA and Fluorinated Telomers Collection of Comprehensive Telomer Market Information ° Efforts to gather this information largely complete ° Information will be used to assist representative test chemical selection Establishment of Degradation Technical Subcommittee ° Experts will convene to develop approach for degradation testing of representative telomer and telomer based products Presentation of EPA data needs for development under ECA ° Detailed discussions of information being developed by Telomers Research Program under LOI in fate and exposure areas ° Detailed explanation of EPA data needs beyond TRP LOI commitment Establishment of Incineration Technical Subcommittee ° Will work on further development of proposed Incineration ECA for telomers and telomer based products and articles Product Stewardship ° Commitment to document product stewardship activities Monitoring Technical Workgroup Summary Plenary Presentation July 10, 2003 Monitoring Workgroup ° EPA and industry presented characterizations and clarifications of FMG, 3M, and TRP environmental monitoring programs under Letters of Intent   Industry identified near term LOI deliverables:

° FMG dispersion processor mass balance by end of 2003 ° TRP release study, Aug/ Sep 2003; mill pilot study, end of 2003 ° Many questions raised and discussed; need for mutual understanding and better focus became apparent Monitoring Workgroup ° Objective of EPA activities on PFOA:

  Determine how PFOA and PFOA precursors are released into the environment;

  their fate and transport once released; and   routes and levels of human and environmental exposure. Monitoring Workgroup ° Within that overall objective, must decide objective of monitoring program, and role of environmental monitoring within the overall scope of PFOA activities   What questions do other activities ( p chem,

fate, biodeg, article/ product analyses) answer?

  What further essential questions would monitoring answer? Monitoring Workgroup ° Workgroup forming Technical Subgroup   Subgroup may consider Telomer and Fluoropolymer monitoring considerations separately, then bring together   Subgroup tasked to review all data submitted to date, and then formulate questions specifically for monitoring to answer   Subgroup to bring questions back to Workgroup Monitoring Workgroup ° EPA will develop timeline for Subgroup activities, circulate to interested parties ° Interested parties wishing to participate in Technical Subgroup will identify their technical representatives to EPA ° EPA will convene Subgroup meeting before next Workgroup meeting in September ° Future Workgroup meetings will be full day Monitoring Workgroup ° Additional issue raised, not addressed   Several interested parties expressed a strong need for human blood sampling in the vicinity of manufacturing facilities to determine whether those locations are " hot spots" with higher blood levels than general population   EPA noted that blood sampling not within purview of Workgroup or ECA process