To: Melissa Payne/RTP/USEPA/US@EPA
From: Susmita Dubey/DC/USEPA/US@EPA
Date: 04/07/2009 03:28PM
Subject: Re: Review of OMB changes- paints (Document link: Melissa Payne)

Melissa -- this looks fine.  If this is all we're sending back to OMB on the p. 22 issue, I don't need to run it by Wendy.  Thanks.

Susmita Dubey
U.S. Environmental Protection Agency
Office of General Counsel
(202) 564-5577
(202) 564-5603 (fax)

-----Melissa Payne/RTP/USEPA/US wrote: -----

To: Susmita Dubey/DC/USEPA/US@EPA
From: Melissa Payne/RTP/USEPA/US
Date: 04/07/2009 03:11PM
Subject: Review of OMB changes- paints

Hi Susmita,
Here are a couple of sentences for your blessing- red text highlights any changes.  As you can tell, I'm trying to keep it short and simple (hopefully not overly-simple).

pg. 66
We have determined that small entity compliance costs, as assessed by the facilities' cost-to-sales ratio, are expected to be, on average, 0.13 percent for the estimated 460 facilities that would not initially be in compliance.
-----------------
pg. 22
We recognize that standards limited to the emission points of the listed urban HAP in this area source category would be sufficient to  satisfy the requirement in section 112(c)(3) and (k)(3)(B) that EPA regulate sufficient source categories to account for 90 percent of the urban HAP emissions.  However, section 112 of the CAA does not prohibit EPA from regulating other HAP emitted from area sources listed pursuant to section 112(c)(3).  Section 112(d)(5) states that for area sources listed pursuant to section 112(c), the Administrator may, in lieu of  section 112(d)(2) "MACT" standards, promulgate standards or requirements "applicable to sources" which provide for the use of GACT or management practices "to reduce emissions of hazardous air pollutants." This provision does not limit EPA's authority to regulate only those urban HAP emissions for which the category is needed to achieve the 90 percent requirement in section 112(c)(3).  Finally, we do not expect this requirement to cause significant additional cost to the regulated facilities, while it will have added environmental benefit.

Thanks again for the quick turnaround!
Melissa Payne
Regulatory Development and Policy Analysis Group Office of Air Quality Planning and Standards U.S. Environmental Protection Agency
919.541.3609


                          THE U.S. PHASEOUT OF HCFCS:
ESTIMATED COSTS FOR REGULATORY CHANGES TO LABELING OF CONTAINERS OF HCFC FIRE SUPPRESSION AGENT

                     U.S. Environmental Protection Agency
                          Office of Air and Radiation
                       Stratospheric Protection Division
                         1200 Pennsylvania Avenue, NW
                             Washington, DC 20460

                                 Final Report
                                 December 2019
Questions concerning this memo should be directed to:

Katherine Sleasman
Stratospheric Protection Division
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW (6205T)
Washington, D.C. 20460
1-202-564-7716 (phone)
1-202-343-2338 (fax)
<EMAIL_ADDRESS>
This memo was prepared with support from ICF under contract number EP-BPA-16-H-0021.

Background
Under Title VI of the Clean Air Act (CAA), the U.S. Environmental Protection Agency (EPA) is responsible for developing and implementing programs that protect the stratospheric ozone layer. The EPA regulates the use of ozone-depleting substances (ODS) that are being phased out consistent with CAA Title VI and the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol). The EPA is also implementing complementary measures under CAA Title VI, including a Section 611 provision to require labeling to alert the public that a product contains or is manufactured with a substance known to harm public health and environment by destroying ozone in the upper atmosphere.
Hydrochlorofluorocarbons (HCFCs) are a class of ODS being phased out in the United States and globally., The United States will complete its  production and consumption phaseout of HCFCs by 2030 by following the schedule is summarized in Table 1.
              Table 1: Detailed Regulatory HCFC Phaseout Schedule
                                     Date
                                Restriction[a]
January 1, 2003
 Ban on production and import of HCFC-141b.
January 1, 2010
 Ban on production and import of HCFC-22 and HCFC-142b except for on-going servicing demand in equipment manufactured before January 1, 2010.
January 1, 2015
 Ban on production, import, and introduction into interstate commerce or use of HCFCs except where the HCFCs are used as a refrigerant in equipment manufactured prior to January 1, 2020, or where HCFCs are used as a fire suppression agent for non-residential applications.
January 1, 2020
 Ban on remaining production and import of HCFC-22 and HCFC-142b.
 Ban on production and import of all other HCFCs except for use in servicing AC, refrigeration, and fire suppresion equipment[b] manufactured before January 1, 2020.
January 1, 2030
 Ban on production and import of all HCFCs.
   [a] Exemptions apply, including exemptions for 1) HCFCs used in processes resulting in their transformation or destruction, and 2) HCFCs that are recovered and either recycled or reclaimed.
   [b] Through the rule that this report accompanies, the EPA is allowing servicing of fire suppression equipment until January 1, 2030 following the November 2018 adjustment to the Montreal Protocol (Decision XXX/2).

Product labeling is mandated by Section 611 of the CAA, and requirements are specified in Title 40 Part 82 Subpart E in the Code of Federal Regulations (40 CFR 82.100 - 82.124). Products imported or manufactured after January 1, 2015 that contain or were manufactured with HCFCs must bear a clearly legible and conspicuous warning label that can be read by consumers before they can be introduced into interstate commerce (See 58 FR 8136, February 11, 1993).
WARNING: [Contains / Manufactured with] [insert name of HCFC], a substance that harms public health and environment by destroying ozone in the upper atmosphere.
WARNING: [Contains / Manufactured with] [insert name of HCFC], a substance that harms public health and environment by destroying ozone in the upper atmosphere.

HCFC-123 -- the primary constituent in one fire suppression agent called Halotron(R)I (also referred to as HCFC Blend B) -- is currently used as a streaming agent in fire suppression equipment including handheld extinguishers, wheeled extinguishers, and aircraft rescue and firefighting (ARFF) vehicles in various commercial, industrial, transportation, and military applications in the United States. After January 1, 2020, a distinction is drawn where only recovered and recycled or reclaimed HCFC-123, as well as stockpiled material imported prior to 2020, can be used to manufacture new fire suppression equipment, and newly imported material can only be used to service existing equipment.

Since HCFC-123 imported after January 1, 2020 can only be used to service fire suppression equipment manufactured prior to January 1, 2020, the EPA is revising the existing labeling requirements in 40 CFR subpart E for containers of HCFC-123 fire suppression agent to provide clarity to the regulated community. These changes require redesign of labels already required under CAA Section 611 and the implementing regulations. The EPA is revising labels for containers of fire suppression agent made with HCFC-123 imported after January 1, 2020 by adding language to inform anyone using that fire suppression agent that the contents can only be used to service equipment manufactured before January 1, 2020. The rule that this report accompanies modifies the required label to read:

WARNING: [Contains / Manufactured with] HCFC-123, a substance that harms public health and environment by destroying ozone in the upper atmosphere. Use only for recharge of equipment manufactured before January 1, 2020.
WARNING: [Contains / Manufactured with] HCFC-123, a substance that harms public health and environment by destroying ozone in the upper atmosphere. Use only for recharge of equipment manufactured before January 1, 2020.

The EPA is also requiring a modified label for containers made with recycled or reclaimed HCFC-123 or HCFC-123 imported before January 1, 2020. The required label reads:

WARNING: [Contains / Manufactured with] HCFC-123, a substance that harms public health and environment by destroying ozone in the upper atmosphere. For use in any equipment.
WARNING: [Contains / Manufactured with] HCFC-123, a substance that harms public health and environment by destroying ozone in the upper atmosphere. For use in any equipment.

This analysis presents an estimate of the overall costs associated with these revisions to labeling for containers of fire suppression agent manufactured with HCFC-123 e.g., Halotron(R)I.
Methodology and Cost Assumptions
The costs to revise labels for fire suppression agent containers were calculated by estimating the one-time labor costs and printing preparation costs associated with redesigning the existing label for HCFC-123 fire suppression agent containers manufactured between 2020 and 2029. Products containing HCFC-123 are assumed to require one-color, vinyl sticker labels.

Companies producing HCFC-123 fire suppression agent are assumed to incur labeling redesign costs associated with the following:
 Administrative activities (e.g., work by purchasing, marketing, legal, and/or regulatory staff to initiate and approve label development or changes).
 Graphic design (e.g., work by a graphic designer to develop or alter the label).
 Prepress and engraving activities to convert the design created by the graphic designer into the film or files that are used to engrave or etch the printing plates or cylinders, and then engrave the plates or cylinders for printing.
These one-time costs for fire suppression agent labeling are assumed to be incurred on a company-level basis in response to the new labeling requirements and are estimated based on information from the U.S. Food and Drug Administration (FDA) Labeling Cost Model (RTI 2003).
Administrative and graphic design labor costs are estimated based on the total number of hours required to redesign existing labels as well as hourly labor costs. Administrative and graphic design costs (one-color printing) for redesign were assumed to require half the amount of time estimated for new design activities in the FDA Labeling Cost Model, because the redesigned labels will be similar to the existing labels -- a sentence is being added to the existing label. The average hourly labor cost for a marketing manager (administrative) is $195.34 and the average hourly labor cost for a graphic designer is $72.54 (U.S. Department of Labor 2018a and 2018b). These hourly costs include wages, overhead rates, and fringe rates.
Prepress and engraving costs vary depending on the printing method used and the number of colors. For the purposes of this analysis, which assumes printing of vinyl sticker labels, companies are assumed to use flexographic printing with one color. The EPA assumes that the redesigned labels will have similar dimensions to those already required and will be constructed with the same material (i.e., vinyl) as the existing label. Therefore, the EPA expects that printing the redesigned labels will cost the same amount as printing the existing label.
Results
The labor and printing preparation costs associated with redesigning labels for HCFC-123 fire suppression agent containers are summarized in Table 2. The calculated labor cost includes the administrative labor costs and graphic design labor costs associated with redesigning the labels. The prepress and engraving costs are estimated to be $1,363 per label. The total cost per producer includes labor costs and prepress and engraving costs for the two labels required in the rule.

Table 2. Labor and Printing Preparation Costs of Labeling Redesign (2018$)
Criteria
                                    Estimate
Administrative Hours (Redesign)[a]
                                      5.5
Administrative Labor Costs (Redesign)[b]
                                    $1,074
Graphic Design Hours (Redesign)[a]
                                      7.5
Graphic Design Labor Costs (Redesign)[b]
                                     $544
Subtotal for Labor Costs[c]
                                    $1,618
Prepress Costs (per label)
                                     $714
Engraving Costs (per label)
                                     $649
Subtotal for Prepress and Engraving Costs (per label)
                                    $1,363
Subtotal for Prepress and Engraving Costs (for two labels)
                                    $2,726
Total Cost per Producer[d]
                                    $4,344
Sources: RTI (2003), U.S. Department of Labor (2018aand 2018b) , U.S Department of Labor (2019)
[a] The hours shown are rounded to the nearest tenth of an hour.
[b] Labor cost totals may not reflect independent rounding of hours shown in the table.
[c] The labor hours and costs are assumed to cover the redesign of both labels required in the rule.
[d] Total cost per producer includes prepress and engraving costs for two labels required in the rule for containers made with HCFC-123 imported on or after January 1, 2020 and containers made with recycled or reclaimed HCFC-123.

As there is only one producer of an HCFC-123 based fire suppression agent, the total one-time cost of the modification to the required labels is estimated at $4,344.
References
RTI. 2003. FDA Labeling Cost Model: Final Report. Prepared for DHHS/PHS/FDA/CFSAN/OSAS/DMST by RTI. Revised January 2003. Available online at: http://foodrisk.org/default/assets/File/labeling_cost_model.pdf.

U.S. Department of Labor. 2018a. Occupational Employment and Wages, May 2018. 27-1024 Graphic Designers. Available online at: http://www.bls.gov/oes/current/oes271024.htm.

U.S. Department of Labor. 2018b. Occupational Employment and Wages, May 2018. 11-2021 Marketing Managers. Available online at: https://www.bls.gov/oes/current/oes112021.htm.

U.S. Department of Labor. 2019. Employer Costs for Employee Compensation - June 2019. Available online at: http://www.bls.gov/news.release/pdf/ecec.pdf.


[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Proposed Rules]
[Pages 26408-26409]
[FR Doc No: 2017-11678]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0388; Airspace Docket No. 17-AGL-13]

Proposed Amendment of Class E Airspace; Medford, WI and Waupaca,
WI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: This action proposes to modify Class E airspace extending up
to 700 feet above the surface at Taylor County Airport, Medford, WI and
Waupaca Municipal Airport, Waupaca, WI, to accommodate new standard
instrument approach procedures (SIAPS) for instrument flight rules
(IFR) operations at these airports. This action is necessary due to the
decommissioning of the Medford and Waupaca non directional radio
beacons (NDB), and cancellation of NDB approaches. This action would
enhance the safety and management of IFR operations at these airports.

DATES: Comments must be received on or before July 24, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify FAA
Docket No. FAA-2017-0388 and Airspace Docket No. 17-AGL-13, at the
beginning of your comments. You may also submit comments through the
Internet at http://www.regulations.gov.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Ron Laster, Federal Aviation
Administration, Contract Support, Operations Support Group, Central
Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone
(817) 222-5879.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace in Class E to ensure the safety
of IFR operations at Taylor County and Waupaca Municipal airports.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-
2017-0388 and Airspace Docket No. 17-AGL-13) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for address
and phone number.) You may also submit comments through the Internet at
http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this notice must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket No. FAA-2017-0388/Airspace Docket No. 17-AGL-13.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerning this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace extending
upward from 700 feet above the surface at Taylor County Airport in
Medford WI. The Agency proposes to retain the current Class E airspace
within a 6.8-mile radius of the airport and to remove the segment of
airspace within 2.7 miles each side of the 162[deg] bearing from the
airport extending from the 6.8-mile radius to 7 miles southeast of the
airport due to the decommissioning of the Medford NDB and cancellation
of the NDB approach.
    The agency also proposes to modify the Class E airspace extending
upward from 700 feet above the surface at Waupaca Municipal Airport,
Waupaca,

WI. The agency proposes to retain the current Class E airspace within a
6.4-mile radius of the airport and to remove the segment within 2.7
miles each side of the 118[deg] bearing from the airport, extending
from the 6.4-mile radius area to 7 miles southeast of the airport due
to the decommissioning of the Waupaca NDB and cancellation of the NDB
approach. This proposal would enhance the safety and management of the
SIAPs for IFR operations at these airports.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

AGL WI E5 Medford, WI [Amended]

Taylor County Airport, WI
    (Lat. 45[deg]06'05'' N., long. 90[deg]18'01'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of Taylor County Airport.

AGL WI E5 Waupaca, WI [Amended]

Waupaca Municipal Airport, WI
    (Lat. 44[deg]20'00'' N., long. 89[deg]01'23'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Waupaca Municipal Airport.

    Issued in Fort Worth, Texas on May 31, 2017.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-11678 Filed 6-6-17; 8:45 am]
 BILLING CODE 4910-13-P


Draft Document Do Not Cite Or Quote February 16, 2004 MEMORANDUM OF UNDERSTANDING BETWEEN U. S. ENVIRONMENTAL PROTECTION AGENCY AND 3M COMPANY AND DYNEON LLC FOR PERFLUOROOCTANOIC ACID ( PFOA) SITE RELATED ENVIRONMENTAL ASSESSMENT PROGRAM TABLE OF CONTENTS Page I. SIGNATORIES, SCOPE AND PURPOSE ........................................................... 1 II. EFFECTIVE DATE ............................................................................................... 1 III. LEGAL EFFECT................................................................................................... 1 IV. PERTINENT BACKGROUND............................................................................... 2 V. PFOA SITE RELATED ENVIRONMENTAL ASSESSMENT PROGRAM ............ 3 A. Program Scope.......................................................................................... 3 B. Program Work Plan Commitments ............................................................ 4 1. In General ....................................................................................... 4 2. Phase I   Work Plan Commitments Pursuant To LOI ..................... 5 3. Phase II   Additional Work Plan Commitments To Augment And Build Upon LOI Commitments And Other Related, Prior Work................................................................................................ 5 4. Status Reports.. .............................................................................. 6 5. Final Reports................................................................................... 6 C. Data Quality ............................................................................................... 7 D. Data Assessment Commitment ................................................................. 7 E. Peer Consultation Process ........................................................................ 9 F. Post Peer Consultation Commitments..................................................... 11 1. Future Work Plan .......................................................................... 11 2. Exposure Assessment .................................................................. 12 VI. MISCELLANEOUS PROVISIONS...................................................................... 12 A. Public Record .......................................................................................... 12 B. Modifications, Work Plan Amendments And Deadline Extensions .......... 13 C. Submissions And Notices .................................................................................. 13 Draft Document Do Not Cite Or Quote February 16, 2004 Page ii ii APPENDICES Appendix 1  Data, Information, Reports, Submissions And Presentations Relating To Environmental Assessment At 3M Decatur Site Property Appendix 2  Maps of 3M Decatur Site Property Appendix 3  Work Plan For 3M Decatur Site Property [ Note: A draft of the Work Plan is appended hereto; a complete Work Plan will be submitted in March 2004 as soon as available.] Draft Document Do Not Cite Or Quote February 16, 2004 I. SIGNATORIES, SCOPE AND PURPOSE A. The United States Environmental Protection Agency ( EPA or the Agency), 3M Company ( 3M) and Dyneon, LLC ( Dyneon) are the signatories to this Memorandum of Understanding ( MOU). Hereinafter, the term " the Companies" will be used when referring collectively to 3M and Dyneon.

B. This MOU memorializes the commitment of the Companies to provide EPA with information on perfluorooctaoic acid and its salts ( PFOA) through a PFOA Site Related Environmental Assessment Program. Section V of this MOU sets forth the specific obligations of the Companies under the PFOA Site Related Environmental Assessment Program. In general, this Program aims to gather data and other information that bear on following question:

Are current PFOA releases from the 3M Decatur Site Property and the presence of PFOA in environmental media on and around the Property sufficiently understood so that exposure to PFOA associated with that Property can be adequately assessed on a screening level basis.

The Program will include a Peer Consultation Process to review the sufficiency and quality of data and information gathered and the necessity of additional data and information gathering for the purpose of addressing the question posed above. After the Peer Consultation Process and upon completion of any such additional data and information gathering, the Program will conclude with a screening level Exposure Assessment using a scenario evaluation approach.

II. EFFECTIVE DATE A. This MOU becomes effective on the date signed by both the Companies and EPA.

B. It should be recognized, as described in Sections IV. and V. B. of this MOU, that certain PFOA Site Related Environmental Assessment Program activities have been completed and others have been initiated prior to this Effective Date.

III. LEGAL EFFECT A. This MOU does not supersede any current law or establish any additional legal requirements. The MOU is a voluntary agreement between the parties and is not an enforceable consent agreement or order under 40 C. F. R. Part 790. This MOU is not enforceable under 15 U. S. C. § 2603 ( TSCA § 4), 15 U. S. C. § 2614 ( TSCA § 15), 15 U. S. C. § 2615 ( TSCA § 16), or any other provision of TSCA or other federal or state statute. Draft Document Do Not Cite Or Quote February 16, 2004 Page 2 B. Nothing in this MOU precludes EPA from seeking other data and information on PFOA that is not being generated by the PFOA Site Related Environmental Assessment Program during the pendancy or upon conclusion of the Program.

IV. PERTINENT BACKGROUND A. On April 16, 2003, EPA issued a Federal Register Notice " concerning PFOA and fluorinated telomers which may metabolize or degrade to PFOA". 1 The Federal Register Notice requested public comment and solicited interested party participation in an enforceable consent agreement ( ECA) development process under Section 4 of the Toxic Substances Control Act ( TSCA), 15 U. S. C § 2105, for the purpose of obtaining " additional information [ that] could be very helpful in allowing the Agency to develop a more accurate assessment of the potential risks posed by PFOA and other compounds addressed in this Notice, and to identify what voluntary or regulatory mitigation or other actions, if any, would be appropriate". 68 Fed. Reg. 18,628.

B. The Federal Register Notice recognized that apart from the public comment and ECA process, EPA already had industry commitments that would produce " substantial additional information" through voluntary continuing research and product stewardship activities. 68 Fed. Reg. 18,631. These commitments, which are memorialized in various Letters of Intent ( LOIs) for the industry, include for the Companies an environmental monitoring commitment pertaining to certain current and former manufacturing sites. 2 As the Federal Register Notice stated, " EPA expects that industry will meet the voluntary testing commitments made in their letters of intent . . . . Therefore, EPA anticipates that the ECA process will focus generally on testing issues beyond or supplemental to those contained in the industry letters of intent." 68 Fed. Reg. 18,632.

1 Perfluorootanoic Acid ( PFOA), Fluorinated Telomers; Request for Comment, Solicitation of Interested Parties for Enforceable Consent Agreement Development, and Notice of Public Meeting, 68 Fed. Reg. 18626 ( Apr. 16, 2003) [ hereinafter " Federal Register Notice"].

2 Letter from Dr. L. Wendling of 3M to EPA Asst. Adm. S. Johnson ( Mar. 13, 2003) [ hereinafter " 3M LOI"]; letter from D. Duncan of the Society of the Plastics ( SPI) for the Fluoropolymer Manufacturers Group ( FMG) to Asst. Adm. S. Johnson ( Mar. 14, 2003) [ hereinafter " FMG LOI"]. Draft Document Do Not Cite Or Quote February 16, 2004 Page 3 C. Subsequent to issuance of the Federal Register Notice, EPA has convened a number of meetings among interested parties through the ECA process, and additional meetings are scheduled to occur in the coming months. Minutes, presentations and other documentation of these meetings are available at EPA Docket ID number OPPT 2003 0012 , online at http:// www. epa. gov/ edocket. As this documentation indicates, the Companies have presented data and information and made submissions to EPA pursuant to their own LOI commitments pertaining to environmental monitoring. Additional environmental monitoring related data, information, reports, presentations and submissions by the Companies reflect their activities prior to and separate from the LOI undertaken on a voluntary basis or pursuant to other programs, such as programs developed in cooperation with state agencies. All such data, information, reports, presentations and submissions by the Companies are available at EPA Docket ID number OPPT 2003 0012, online at http:// www. epa. gov/ edocket, or at EPA Docket ID number Administrative Record ( AR) 226, and for reference, are specifically listed as of [ ], 2004 in Appendix 1 to this MOU.

D. In the course of the meetings among interested parties through the ECA process, EPA expressed its desire for the Companies to undertake additional environmental monitoring, particularly in the areas of soil, biota and off site monitoring, not covered by past efforts or contemplated by current LOI commitments. The Companies expressed a willingness to do so through a phased approach. In the Companies' view, a phased approach would be more efficient, given that earlier phases can inform later phases from a scientific standpoint and that data collection can occur in context. The Companies also expressed a willingness to have this phased approach occur on a transparent basis, with data and information made available to the public and with a technical expert collaboration.

E. After further discussions, including the opportunity for comment on a draft of this MOU by interested parties through the ECA process, EPA and the Companies agreed to the PFOA Site Related Environmental Assessment Program set forth in Section V of this MOU and to the other terms and conditions of this MOU.

V. PFOA SITE RELATED ENVIRONMENTAL ASSESSMENT PROGRAM A. Program Scope 1. The PFOA Site Related Environmental Assessment Program will focus on the 3M Property at the Decatur, Alabama Site shown on the maps attached as Appendix 2 [ hereinafter " 3M Decatur Site Property" or " the Property"], and areas around such Property.

2. The PFOA Site Related Environmental Assessment Program is intended to address the following aspects of the 3M Decatur Site Property: Draft Document Do Not Cite Or Quote February 16, 2004 Page 4 a. PFOA releases to environmental media from the current fluoropolymer production operations of Dyneon at the 3M Decatur Site Property, and b. PFOA presence in environmental media on and around the 3M Decatur Site Property.

3. The PFOA Site Characterization Program is not designed to address the following:

a. Exposures to PFOA that may have occurred in the past as a result of activities by 3M or Dyneon at the 3M Decatur Site Property, although the Program design will take into account past activities by 3M and Dyneon, as appropriate and reasonable, to address PFOA presence in environmental media on and around the 3M Decatur Site Property.

b. Exposures to PFOA that may have occurred in the past, that are now occurring or that may occur in the future as a result of activities by Daikin America at the Decatur Site. Due to the close proximity of Daikin's fluoropolymer manufacturing and telomer manufacturing operations at the Decatur Site to the 3M Decatur Site Property, PFOA emissions and releases from the Daikin operations have and will contribute to PFOA presence in environmental media on and around the 3M Decatur Site Property. The PFOA Site Characterization Program will not determine, assess, predict or apportion the original source of PFOA on and around the 3M Decatur Site Property as between Daikin America, Dyneon and/ or 3M.

c. Exposures to PFOA that may have occurred in the past, that are now occurring or that may occur in the future from any other fluoropolymer manufacturing operations at other locations.

B. Program Work Plan Commitments 1. In General a. As indicated in Section IV. of this MOU, the Companies memorialized certain environmental monitoring commitments in the 3M LOI and the FMG LOI. The Companies also have agreed to build upon and augment their current efforts under these LOIs and other related efforts with additional commitments, particularly in the areas of soil, biota and off site monitoring, through a phrased approach. Sections V. B. 2. and V. B. 3. of this MOU describe Phases I and II of the Work Plan to implement these LOI and additional commitments. A copy of the current version of the Work Plan, along with pertinent backup documents, appears as Appendix 3 to this MOU. Draft Document Do Not Cite Or Quote February 16, 2004 Page 5 b. As indicated in Section IV. C. of this MOU, the LOIs, along with related presentations and submissions to EPA, are identified in Appendix 1 to the MOU and are available at Docket ID number OPPT 2003 0012 , online at http:// www. epa. gov/ edocket. In addition, Appendix 1 identifies other data, information, reports, presentations and submissions provided to EPA separate from the LOI commitments regarding the presence of PFOA in environmental media on and around the 3M Decatur Site Property. The Work Plan Commitments described in Sections V. B. 2. and V. B. 3. of this MOU build upon these prior data, information, reports, presentations and submissions. To the extent relevant, such data, information, reports, presentations and submissions also will be considered as part of the Data Assessment described in Section V. D. of this MOU.

2. Phase I   Work Plan Commitments Pursuant To LOI a. Groundwater Sampling. Groundwater sampling and analysis for PFOA has been ongoing since March of 2001 at various wells located on the 3M Decatur Site Property. These wells originally were selected as part of a separate investigation addressing other pollutants in cooperation with the State of Alabama and EPA Region 4 and are located to capture a range of areas around the site based on hydrogeology and other factors. Sampling and analysis for PFOA will continue at these wells on a twice annual basis in June and December of each year at least until 2007.

b. Effluent Monitoring. Effluent monitoring for PFOA at the outfall for treated process water from the 3M and Dyneon operations occurred on an annual basis between 1998 2001 and in January and May of 2003. Post May 2003, such effluent monitoring will occur on a quarterly basis and will continue at least until 2007.

c. Air Modeling. Pursuant to the FMG LOI among fluoropolymer manufacturers, Dyneon conducted site specific air modeling for PFOA using the EPA approved Industrial Source Complex Short Term 3 ( ISCSTS) model and submitted a report to EPA in December of 2003. As this report explains, Dyneon has emitted no greater than 11 pounds of PFOA per year over the past 25 years, and the resulting PFOA impacts from the Dyneon operations are minimal and do not extend offsite

3. Phase II   Additional Work Plan Commitments To Augment And Build Upon LOI Commitments And Other Related, Prior Work a. Groundwater Monitoring. In addition to the Phase I groundwater monitoring described in Section V. B. 2. a. of this MOU, groundwater monitoring for PFOA will occur at 8 wells to be located in the Southern portion of the 3M Decatur Site Property in historic wastewater treatment plant sludge incorporation areas as well as in several control areas. Draft Document Do Not Cite Or Quote February 16, 2004 Page 6 b. Soil Monitoring. Soil sampling and analysis for PFOA will occur in all groundwater monitoring locations described in Sections V. B. 2. a. and V. B. 3. a. of this MOU, with two borings in all locations and sampling at five depths in the first boring and at three depths in the second boring   i. e., estimated 100 140 samples.

c. Off Site Tennessee River And Related Biota Monitoring. Off site Tennessee River monitoring for PFOA of surface water, sediments and aquatic species was initiated prior to the LOI, with sampling events in 2000 and 2002 at locations upstream and downstream from the 3M Decatur Site Property as well as at outfall locations for the 3M and Dyneon operations. Such monitoring will occur on an expanded basis in 2004. In addition to surface water and sediments at the same upstream, downstream and outfall locations sampled in 2002, the 2004 monitoring will include ( i) lower order species   i. e., clams and mussels; and ( ii) whole fish and fillets in 2 species at 5 locations.

d. Terrestrial Biota Monitoring. A survey of terrestrial biota ( both vegetation and vertebrates) will be conducted on and around the historic wastewater treatment sludge incorporation areas on the 3M Decatur Site Property with the objective of identifying representative vegetation and vertebrate species for PFOA sampling and analysis. It is expected that sampling will focus on 2 3 vegetation species selected based on both the survey results and the dietary preferences of small mammal species in the area. It is expected that the survey results will suggest a single small mammal species for sampling ( likely the meadow vole as the common, if not dominant, member of the small mammal community) and that approximately eight samples will be taken from four different locations in the immediate vicinity of the soil borings associated with the groundwater monitoring wells described in Section V. B. 3. b. of this MOU.

4. Status Reports. The Companies will provide EPA with a semiannual report addressing the implementation status of the Work Plan in Appendix 3 to this MOU. The first status report on Work Plan implementation is due six ( 6) months after the Effective Date specified in Section II. A. of this MOU.

5. Final Reports. The Companies will submit to EPA within thirty ( 30) days of availability any final reports contemplated by the Work Plan in Appendix 3 to this MOU. Draft Document Do Not Cite Or Quote February 16, 2004 Page 7 C. Data Quality 1. The Companies recognize the importance of EPA's recently issued guidelines pursuant to the Data Quality Act. See Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency; Public Law 106 554; H. R. 5658, § 515( a) ( 2001); Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, OMB, 67 Fed. Reg. 8452 ( 2002); see also EPA Order 5360.1A2 " Policy And Program Requirements For Agency Wide Quality System" ( May 5, 2000); EPA Quality Manual For Environmental Programs, 5360A1 ( May 5, 2000).

2. The Companies commit in gathering all data and information under the PFOA Site Related Environmental Assessment Program to employ  as has been done in the past  scientific practices, protocols and procedures designed to ensure data quality, objectivity, utility and integrity.

3. Consistent with the foregoing commitments, the Work Plan for the PFOA Site Related Environmental Assessment Program set forth in Section V. B. of this MOU includes references to the various protocols, analytical methods and quality assurance measures to be employed under the Program. The Companies will include copies of all such protocols, methods and measures in the Data Assessment for the Program described in Section V. D. of this MOU.

D. Data Assessment Commitment 1. No later than ninety ( 90) days following completion of the Work Plan Commitments set forth in the Work Plan in Appendix 3 to this MOU, the Companies will submit a Data Assessment to EPA. As described in Section V. E. of this MOU, a Peer Consultation Panel also will receive and review such Data Assessment.

2. The Data Assessment shall have a three part overall objective:

a. To provide a robust summary of all data and information generated under the Work Plan in Appendix 3 to this MOU and of any other relevant data and information, including relevant data and information developed under the LOI, on a voluntary basis or under other programs as described in Section IV. C. of this MOU;

b. To assess the sufficiency of such data and information to address the following question: Are current PFOA releases from the 3M Decatur Site Property and the presence of PFOA in environmental media on and around the Property sufficiently understood so that exposure to PFOA associated with that Property can be adequately assessed on a screening level basis?; and c. To identify additional data and information, if any, that are necessary to address the foregoing question. Draft Document Do Not Cite Or Quote February 16, 2004 Page 8 3. To meet the overall objective identified in Section V. D. 2. of this MOU, the Companies will do the following in the Data Assessment:

a. Data Summary. Provide a robust summary of all data and information generated under the Work Plan in Appendix 3 to this MOU and of any other relevant data and information, including relevant data and information developed under the LOI, on a voluntary basis or under other programs as described in Section IV. C. of this MOU. Such summary shall include, consistent with the Companies' commitment in Section V. C. of this MOU, all relevant information pertinent to establish data quality, objectivity, utility and integrity.

b. Other Appropriate Information. Provide other appropriate, available information necessary for the sufficiency analysis described in Section V. D. 3. c. of this MOU.

c. Sufficiency Analysis. Provide a scientifically based interpretation of these data and other appropriate information identified in Sections V. D. 3. a. and V. D. 3. b. of this MOU with reference to the sufficiency of such data and information to address the following question:

Are current PFOA releases from the 3M Decatur Site Property and the presence of PFOA in environmental media on and around the Property sufficiently understood so that exposure to PFOA associated with that Property can be adequately assessed on a screening level basis?

Such scientifically based interpretation of these data and other appropriate information will consider the following areas:

( 1) Land use on and around the Property.

( 2) Topography and drainage on and around the Property.

( 3) Geology on and around the Property.

( 4) Hydrogeology on and around the Property.

( 5) Biota on and around the Property.

( 6) Waste handling practices by 3M and Dyneon that may bear on current PFOA levels in environmental media on and around the Property.

( 7) PFOA emissions and discharges from current manufacturing operations on the Property. Draft Document Do Not Cite Or Quote February 16, 2004 Page 9 ( 8) Levels of PFOA in environmental media on and around the Property indicated by monitoring data and/ or application of any appropriate modeling techniques.

( 9) Presence and location of potential human receptors in the vicinity of the Property.

d. Future Work Plan. Provide an outline of a Future Work Plan if the gathering of additional data and/ or other appropriate information is deemed necessary by the Companies to address the question for the sufficiency analysis set forth in Section V. D. 3. c of this MOU.

E. Peer Consultation Process 1. The Companies commit to fund and participate in a Peer Consultation Process that will review the Data Assessment prepared under Section V. D. of this MOU. The details and timing of the Peer Consultation Process are set forth in Section V. E. 2. of this MOU. In general, such Process will have the following attributes:

a. An Independent Third Party will design and administer the Peer Consultation Process.

b. The Peer Consultation Process will operate under conflict of interest guidelines and with public transparency.

c. The Peer Consultation Process will provide scientific input on an advisory basis.

2. To execute its commitment to fund and participate in a Peer Consultation Process, the Companies agree to undertake the following measures:

a. No later than ninety ( 90) days from the Effective Date of this MOU, the Companies will contract with an Independent Third Party to design and administer the Peer Consultation Process and will inform EPA, in writing, of the identity and qualifications of such Independent Third Party.

b. No later than one hundred and fifty ( 150) days from the Effective Date of this MOU, the Companies will take reasonable steps to ensure that the Independent Third Party submits to EPA, in writing, a description of the Peer Consultation Process and a copy of any procedures that will apply to the Process, including procedures to assure avoidance of a conflict of interest for Peer Consultation Panel members. Draft Document Do Not Cite Or Quote February 16, 2004 Page 10 c. No later than two hundred and ten ( 210) days from the Effective Date of this MOU, the Companies and EPA will submit separately, in writing, to the Independent Third Party proposed nominees for the Peer Consultation Panel. In proposing any nominee, the Companies and EPA will take into account both the range of different scientific, technical and other expertise required for the Panel to review the Data Assessment as well as the conflict of interest procedures that govern Panel membership. Ultimately, the decision whether to select for Panel membership a nominee or a different individual not nominated will rest with the Independent Third Party.

d. No later than ninety ( 90) days following completion of the Work Plan in Appendix 3 to this MOU, the Companies will submit the Data Assessment prepared pursuant to Section V. D. of this MOU to EPA and to the Independent Third Party for distribution to the Peer Consultation Panel e. No later than sixty ( 60) days from submission of the Data Assessment pursuant to Section V. E. 2. d. of this MOU, the Companies will take reasonable steps to ensure that the Independent Third Party submits to EPA, in writing, a schedule for the Peer Consultation Panel's review of the Data Assessment. Such schedule shall include the following components:

( 1) An initial meeting at which the Companies will present their Data Assessment to the Peer Consultation Panel and answer any questions from the Panel. Such meeting shall be open to the public, but public participation in the meeting shall have requirements and limitations ( e. g., oral statements scheduled in advance and limited to 3 minutes; written input of no more than 5 pages in length).

( 2) The release of a draft written Advisory Report by the Peer Consultation Panel to EPA and the Companies that provides scientific, technical and other expert advice on the sufficiency of the Data Assessment submitted by the Companies pursuant to Section V. D. of this MOU with reference to the question set forth in Section V. D. 3. c. of this MOU. It is expected that in providing such expert advice, the Peer Consultation Panel will take into account EPA's " Guidelines for Exposure Assessment", EPA/ 600/ Z 92/ 001 ( May 1992), at § 2.2.2, pertaining to the scenario evaluation concept.

( 3) The opportunity for EPA and the Companies to submit written technical comments on the draft Advisory Report for consideration by the Peer Consultation Panel.

( 4) The release of a final written Advisory Report by the Peer Consultation Panel to the Companies and EPA. Draft Document Do Not Cite Or Quote February 16, 2004 Page 11 f. No later than fifteen ( 15) days after release of the final written Advisory Report by the Peer Consultation Panel, EPA will announce availability of such Report to the public in the Federal Register and allow the public an opportunity to submit comments to EPA no later than thirty ( 30) days thereafter.

g. No later than thirty ( 30) days after the close of the public comment period on the Advisory Report, EPA will provide the Companies with input on the Data Assessment, including on any outline for a Future Work Plan set forth in such Assessment pursuant to Section V. D. 3. d. of this MOU.

h. No later than ninety ( 90) days thereafter, the Companies will submit an amended final Data Assessment to EPA that takes into account the final Advisory Report of the Peer Consultation Panel and the input from EPA received by the Companies pursuant to Section V. E. 2. g. of this MOU. Such amended final Data Assessment shall include a complete Future Work Plan if the gathering of additional data and/ or other appropriate information is deemed necessary by the Companies to address the question for the sufficiency analysis set forth in Section V. D. 3. c of this MOU.

F. Post Peer Consultation Commitments 1. Future Work Plan a. Implementation. Upon completion of the Peer Consultation Process pursuant to Section V. E. 2. h. of this MOU, the Companies will implement the Future Work Plan, if any, contained in the amended final Data Assessment submitted pursuant to Section V. E. 2. h. of this MOU.

b. Status Reports. The Companies will provide EPA with a semiannual report addressing the implementation status of the Future Work Plan, if any, contained in the amended final Data Assessment submitted pursuant to Section V. E. 2. h. of this MOU. The first status report on Future Work Plan implementation is due six ( 6) months after the Companies submit the amended final Data Assessment pursuant to Section V. E. 2. h. of this MOU.

c. Final Reports. The Companies will submit to EPA within thirty ( 30) days of availability any final reports contemplated by the Future Work Plan, if any, contained in the amended final Data Assessment submitted to Section V. E. 2. h. of this MOU. Draft Document Do Not Cite Or Quote February 16, 2004 Page 12 2. Exposure Assessment a. Upon completion of the Future Work Plan, if any, contained in the amended final Data Assessment submitted pursuant to Section V. E. 2. h. of this MOU, the Companies will prepare a screening level Exposure Assessment using the scenario evaluation concept set forth in EPA's " Guidelines for Exposure Assessment", EPA/ 600/ Z 92/ 001 ( May 1992), at § 2.2.2. Such Exposure Assessment will be community based and will not examine PFOA exposures for any particular individual as a direct result of activities by 3M or Dyneon at the 3M Decatur Site Property. Although individualized exposure assessment is not part of the PFOA Site Related Environmental Assessment Program, nothing in this MOU would preclude such assessment from occurring as part of other activities or proceedings.

b. No later than sixty ( 60) days after completion of the Future Work Plan, if any, contained in the amended final Data Assessment submitted pursuant to Section V. E. 2. h. of this MOU, the Companies will submit an Exposure Assessment Work Plan to EPA that sets forth the details, including a schedule for completion, and will implement such Work Plan expeditiously thereafter.

c. The Companies will submit the final Exposure Assessment to EPA upon its completion and according to the schedule established pursuant Section V. F. 2. b. of this MOU.

VI. MISCELLANEOUS PROVISIONS A. Public Record 1. EPA has established a public record at Docket Control Number OPPT [ ]. EPA has made available an electronic version of the OPPT [ ] public docket at http:// www. epa. gov/ edocket. The public also can access the OPPT [ ] docket through the EPA Docket Center, Room B102 Reading Room, EPA West, 1301 Constitution Avenue, N. W., Washington, D. C.

2. The public record will contain this MOU; all submissions by made the Companies to EPA in fulfilling their commitments under this MOU; and any other final reports contemplated by this MOU, subject to the confidentiality provisions of Section 14( b) of TSCA and 40 C. F. R. Part 2 and to the disclosure protection provisions in Section VI. A. 3. of this MOU. Draft Document Do Not Cite Or Quote February 16, 2004 Page 13 3. By signing this MOU, the Companies are not admitting that TSCA Section 4 gives EPA the authority to promulgate a test rule requiring generation of the data and information that the Companies will gather through the PFOA Site Related Environmental Assessment Program; nor are the Companies admitting that the TSCA Section 4 requirements for promulgating such a test rule have been satisfied by the Agency. The Companies believe that documents generated under the PFOA Site Related Environmental Assessment Program do not constitute studies subject to disclosure under 15 U. S. C. § 2613( a); therefore, such documents may be protected from disclosure under various laws, including under 5 U. S. C. § 552( b)( 4) and 15 U. S. C. § 2613( b), except to the extent such documents fall within the public disclosure provisions in Section VI. A. 2. of this MOU.

B. Modifications, Work Plan Amendments And Deadline Extensions 1. Modifications to this MOU, if any, must occur by mutual agreement of all signatories and will result in an amended MOU, which will be placed in the OPPT [ ] public docket for this MOU. Amendments to the Work Plan Commitments at Sections V. B. and V. F. 1. of this MOU and extensions of any deadlines in this MOU do not constitute modifications to this MOU provided that the Companies comply with Sections VI. B. 2. and VI. B. 3. of this MOU in connection with any such amendments or extensions.

2. In executing the Work Plan Commitments at Sections V. B. and V. F. 1. of this MOU, the Companies must submit to EPA as soon as practicable written notice of, along with an explanation of the reasons for, any material change to or deviation from such Work Plan.

3. In executing any commitments under this MOU, the Companies must submit to EPA as soon as practicable written notice of, along with any explanation of the reasons for, any need to modify a time schedule under this MOU. Such notice must propose a new time schedule that is reasonable, taking into account the circumstances as well as EPA's stated desire to obtain data and information from the PFOA Site Related Environmental Assessment Program as soon as possible.

4. The Companies and EPA recognize in connection with the foregoing provisions on modifications, Work Plan amendments and deadline extensions in Section VI. B. 1. 3. of this MOU that the Companies shall not be responsible for any failure to perform their commitments under this MOU that is caused by circumstances beyond their control which the Companies could not have prevented through the exercise of due diligence.

C. Submissions And Notices 1. All submissions and notices by the Companies under this MOU shall be made to EPA as follows: [ identify contact]. Draft Document Do Not Cite Or Quote February 16, 2004 Page 14 2. All submissions and notices by EPA under this MOU shall be made to the Companies as follows: [ identify contact].

Agreed to by:

____________________ on __ day of _____ 2004 For 3M Company ____________________ on __ day of _____ 2004 For Dyneon LLC ____________________ on __ day of _____ 2004 For United States Environmental Protection Agency DC\ 653338.5


2011 Technical Corrections, Clarifying and Other Amendments to the Mandatory Reporting of Greenhouse Gases Rule:
           Subparts A, W, FF, II, OO, RR and TT Economic Impacts Memo
                                 May 13, 2011
The 2009 final GHG reporting rule (2009 final rule) was signed by EPA Administrator Lisa Jackson on September 22, 2009 and published in the Federal Register on October 30, 2009 (74 FR 56260, October 30, 2009).  The 2009 final rule, which became effective on December 29, 2009, included reporting of GHGs from various facilities and suppliers, consistent with the 2008 Consolidated Appropriations Act.
Subsequent notices were published in 2010 finalizing the requirements for subparts FF, II, and TT (75 FR 39736, July 12, 2010), subpart W (75 FR 74458, November 20, 2010), and subpart RR (75 FR 75060, December 1, 2010).  Subpart OO, which was promulgated as part of the 2009 final rule was also revised in 2010 (75 FR 79092, December 17, 2010).  The source categories in 40 CFR part 98 cover approximately 85-90 percent of U.S. GHG emissions through reporting by direct emitters, as well as suppliers of certain products that would result in GHG emission when released, used, or oxidized, and those that geologically sequester or otherwise inject CO2 underground.
EPA is proposing to amend specific provisions in 40 CFR part 98, subparts A, W, FF, II, OO, RR and TT to correct certain technical and editorial errors that have been identified since promulgation and to clarify or propose amendments to certain provisions that have been the subject of questions from reporting entities.  These proposed changes include additional information to clarify compliance obligations, correct data reporting elements so they more closely conform to the information used to perform emission calculations, and make other corrections and amendments.
After review of the technical corrections and consultation with technical experts who developed the original cost and economic analysis, EPA has determined that the proposed rule amendments will not impose any new requirements that are not currently required by the rules promulgated on October 30, 2009 (i.e., calculating and reporting annual GHG emissions) or alter the cost estimates contained in the original analyses.  As a result, the original national cost estimates remain $208.7 million in the First Year and $119.9 million in subsequent years.
Table 1.  Summary of Cost Changes Associated with the Proposed Notice of Reconsideration (million, 2006$)
Rulemaking
First Year Cost Estimate
Subsequent Year Cost Estimate
Mandatory Reporting Rule National Cost Estimate (Private and Public)
                                                                         $132.0
                                                                          $89.1
Revisons to certain provisions of the Mandatory Reporting of Greenhouse Gases (GHG) Rule

     Review of revisions
                                                                           $2.5
                                                                           $0.0
     Subpart NN Change
                                                                          -$3.6
                                                                          -$2.5
     Subpart C Change
                                                                          -$1.7
                                                                          -$1.0
Reporting of Corporate Parent, NAICS Code, and Co-Generation Information
                                                                           $0.9
                                                                           $0.5
Subpart W
                                                                          $62.9
                                                                          $20.1
Subpart T, FF, II, TT
                                                                           $7.0
                                                                           $5.5
F-Gas: Subparts I, L,DD, QQ, SS
                                                                           $7.6
                                                                           $7.2
Subparts RR and UU:
                                                                           $1.1
                                                                           $1.0

Total National Cost Estimate (All Final Rules)
                                                                         $208.7
                                                                         $119.9

Proposed Technical Corrections (This Action)
                                                                           $0.0
                                                                           $0.0

Revised National Cost Estimate
                                                                         $208.7
                                                                         $119.9


UNITED STATES ENVIRONMENTAL PROTECTION  AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		May 26, 2009

Subject:		Indoxacarb.  ADDENDUM to the Health Effects Division (HED) Human Health Risk Assessment for Bushberry Crop Subgroup 13-07B and Beets (Garden).

PC Code:  067710	DP Barcode No.: D365306

Decision No.: 390597	Registration No.: 352-597

Petition No.:  8E7324	Regulatory Action: Amended Section 3 Registration

Risk Assessment Type: Single Chemical /Aggregate	Case No.: NA

TXR No.:  NA	CAS No.: 173584-44-6

MRID No.:  NA	40 CFR:  180.564

	From:	Danette Drew, Chemist

		Seyed Tadayon, Chemist

		Risk Assessment Branch V

		Health Effects Division (7509P)

	Through:	Jack Arthur, Acting Branch Chief

		Risk Assessment Branch V

		Health Effects Division (7509P)

	To:	Barbara Madden, RM Team5

		Susan Stanton, RM Team5

		Risk Integration, Minor Use & Emergency Response Branch

		Registration Division (7505P)

This document serves as an addendum to the Health Effects Division (HED) Human Health Risk Assessment for Bushberry Crop Subgroup 13-07B and Beets (Garden) for indoxacarb (dated 5/18/09, D351087). This addendum revises the refined chronic dietary assessment (Memo, S. Tadayon, 5/13/09, D364939) and the residue and exposure values presented here supersede those found in the 5/13/09 document. Specifically, the 5/13/09 dietary assessment included the available USDA PDP monitoring data for indoxacarb on grapes for the year 2005. Since indoxacarb was not registered for use on grapes until 2007, the 2005 grape monitoring data are not appropriate for use in risk assessment. The chronic assessment was revised to incorporate field trial residues for grape commodities (average value of 0.503 ppm) and 100% crop treated. All other input parameters are as outlined in the 5/13/09 memo.

Additionally, aggregate risk estimates are updated herein to include the revised chronic dietary exposures and supersede those estimates found in the 5/18/09 risk assessment. The risk conclusions are unchanged from the 5/18/09 assessment: Chronic dietary (food + water) risk estimates are below HED’s level of concern for indoxacarb. Aggregate (food + water + residential) risk estimates are also below the level of concern.

Chronic Dietary Exposure Results

Estimated chronic dietary risk to indoxacarb from food and drinking water is below HED’s level of concern (%cPAD <100).  Combined dietary exposure from food and drinking water is estimated at 0.001316 mg/kg/day (6.6 % of the cPAD) for children, 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to indoxacarb.

Table 1:	Summary of Chronic Dietary Exposure and Risk for Indoxacarb (Drinking Water Exposure Included).

Population Subgroup	cPAD (mg/kg/day)*	Chronic

Exposure (mg/kg/day)

%cPAD

General U.S. Population	0.02	0.000666	3.3

All Infants (< 1 year old)

0.000607	3.0

Children 1-2 years old

0.001316	6.6

Children 3-5 years old

0.001160	5.8

Children 6-12 years old

0.000623	3.1

Youth 13-19 years old

0.000488	2.4

Adults 20-49 years old

0.000550	2.7

Adults 50+ years old

0.000791	4.0

Females 13-49 years old

0.000571	2.9

*toxicological doses used here reflect KN128 + KN127, not adjusted for 100%KN128, since analytical methods detect combined enantiomer residues.

The population subgroup with the highest estimated exposure/risk is bolded

Aggregate Risk (food + drinking water + residential exposure)

Indoxacarb aggregate (food + water + residential) risk estimates are not  of concern for children or adults when assessing the Advion 0.045%G, Advion 0.22%G, or Provaunt 1.25SC turf scenarios (aggregate MOEs>100).

Advion 0.045%G

Table 2.  Short/Intermediate-Term Aggregate Risk Calculations for Toddlers:  Advion 0.045%G

Population	Target

MOE	Chronic Food + Water	Residential Oral	Residential Dermal	Aggregate MOE6

(food + water + residential)

Exposure

(mg/kg/day)	MOE1	Exposure2

(mg/kg/day)	MOE3	Exposure4

(mg/kg/day)	MOE5

	Children (1-2 years old)	100	0.001316	1500	0.00001	150,000	0.00026 150,000	1500

1   MOE = NOAEL (2.0 mg/kg/day; KN127+ KN128)) ÷ (chronic food + water exposure)

2   Residential oral = hand-to-mouth from contacting treated turf, the highest oral exposure scenario (ingestion of treated soil and mouthing grass exposures are not significant exposure contributors compared to hand-to-mouth activities)

3   MOE = NOAEL (1.5 mg/kg/day; KN128) ÷ (sum of residential oral exposure)

4   Residential dermal = post-application turf contact5   MOE = NOAEL (38 mg/kg/day; KN128) ÷ (residential dermal exposure)

6   Aggregate MOE = 1/[(1/1500) + (1/150,000) + (1/150,000)]

Table 3.  Short/Intermediate-Term Aggregate Risk Calculations for Adults:  Advion 0.045%G

Population1	Target

MOE	Chronic Food + Water	Residential Dermal	Aggregate MOE5

(food + water + residential)

Exposure

(mg/kg/day)	MOE2	Exposure3

(mg/kg/day)	MOE4

	U.S. Population	100	0.00666	3000	0.000156	240,000	3000

1   Adult population with highest chronic food and water exposure value was used.

2   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (chronic food + water exposure)

3   Residential dermal = post-application exposure; application exposure not a significant contributor compared to post-application.

4   MOE = NOAEL (38 mg/kg/day; KN128) ÷ (residential dermal exposure)

5   Aggregate MOE = 1/[(1/3000) + (1/240,000)]

Advion 0.22%G

Table 4.  Short/Intermediate-Term Aggregate Risk Calculations for Toddlers:  Advion 0.22%G

Population	Target

MOE	Chronic Food + Water	Residential Oral	Residential Dermal	Aggregate MOE6

(food + water + residential)

Exposure

(mg/kg/day)	MOE1	Exposure2

(mg/kg/day)	MOE3	Exposure4

(mg/kg/day)	MOE5

	Children (1-2 years old)	100	0.001316	1500	0.0088	230	0.239	210	102

1   MOE = NOAEL (2.0 mg/kg/day; KN127+ KN128)) ÷ (chronic food + water exposure)

2   Residential oral = hand-to-mouth from contacting treated turf, the highest oral exposure scenario (ingestion of treated soil and mouthing grass exposures are not significant exposure contributors compared to hand-to-mouth activities)

3   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (sum of residential oral exposure)

4   Residential dermal = post-application turf contact5   MOE = NOAEL (50 mg/kg/day;KN127+ KN128) ÷ (residential dermal exposure)6   Aggregate MOE = 1/[(1/1500) + (1/230) + (1/210)]

Table 5.  Short/Intermediate-Term Aggregate Risk Calculations for Adults: Advion 0.22%G

Population1	Target

MOE	Chronic Food + Water	Residential Dermal	Aggregate MOE5

(food + water + residential)

Exposure

(mg/kg/day)	MOE2	Exposure3

(mg/kg/day)	MOE4

	U.S. Population	100	0.000666	3000	0.137	360	320

1   Adult population with highest chronic food and water exposure value was used.

2   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (chronic food + water exposure)

3   Residential dermal = post-application; application exposure not a significant contributor compared to post-application.

4   MOE = NOAEL (50 mg/kg/day; KN127+KN128) ÷ (residential dermal exposure)

5   Aggregate MOE = 1/[(1/3000) + (1/360)]

Provaunt 1.25%SC

Table 6.  Short/Intermediate-Term Aggregate Risk Calculations for Toddlers:  Provaunt 1.25%SC

Population	Target

MOE	Chronic Food + Water	Residential Oral	Residential Dermal	Aggregate MOE6

(food + water + residential)

Exposure

(mg/kg/day)	MOE1	Exposure2

(mg/kg/day)	MOE3	Exposure4

(mg/kg/day)	MOE5

	Children (1-2 years old)	100	0.001316	1500	0.0044	460	0.022	2300	310

1   MOE = NOAEL (2.0 mg/kg/day; KN127+ KN128)) ÷ (chronic food + water exposure)

2   Residential oral = hand-to-mouth from contacting treated turf, the highest oral exposure scenario (ingestion of treated soil and mouthing grass exposures are not significant exposure contributors compared to hand-to-mouth activities)

3   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (sum of residential oral exposure)

4   Residential dermal = post-application turf contact

5   MOE = NOAEL (50 mg/kg/day;KN127+ KN128) ÷ (residential dermal exposure)

6   Aggregate MOE = 1/[(1/1500) + (1/460) + (1/2300)]

Table 7.  Short/Intermediate-Term Aggregate Risk Calculations for Adults: Provaunt 1.25%SC

Population1	Target

MOE	Chronic Food + Water	Residential Dermal	Aggregate MOE5

(food + water + residential)

Exposure

(mg/kg/day)	MOE2	Exposure3

(mg/kg/day)	MOE4

	U.S. Population	100	0.000666	3000	0.013	3800	1700

1   Adult population with highest chronic food and water exposure value was used.

2   MOE = NOAEL (2.0 mg/kg/day; KN127+KN128) ÷ (chronic food + water exposure)

3   Residential dermal = post-application; application exposure not a significant contributor compared to post-application.

4   MOE = NOAEL (50 mg/kg/day; KN127+KN128) ÷ (residential dermal exposure)

5   Aggregate MOE = 1/[(13000) + (1/3800)]

Page   PAGE  1  of   NUMPAGES  4


[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68529-68531]
[FR Doc No: 2021-26147]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0012]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to exempt eight individuals from
the vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. They are unable to meet the vision requirement in one eye for
various reasons. The exemptions enable these individuals to operate
CMVs in interstate commerce without meeting the vision requirement in
one eye.

DATES: The exemptions were applicable on November 19, 2021. The
exemptions expire on November 19, 2023.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2021-0012, in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its regulatory process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On October 19, 2021, FMCSA published a notice announcing receipt of
applications from eight individuals requesting an exemption from vision
requirement in 49 CFR 391.41(b)(10) and requested comments from the
public (86 FR 57887). The public comment period ended on November 18,
2021, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with Sec.  391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in Sec.  391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on medical reports about the applicants' vision, as well as their
driving records and experience driving with the vision deficiency. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the October 19, 2021, Federal
Register notice (86 FR 57887) and will not be repeated here.
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The eight
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, macular scar, prosthesis, and retinal
detachment. In most cases, their eye conditions did not develop
recently. Five of the applicants were either born with their vision
impairments or have had them since childhood. The three individuals
that developed their vision conditions as adults have had them for a
range of 11 to 21 years. Although each applicant has one eye that does
not meet the vision requirement in Sec.  391.41(b)(10), each has at
least 20/40 corrected vision in the other eye, and, in a doctor's
opinion, has sufficient vision to perform all the tasks necessary to
operate a CMV.
    Doctors' opinions are supported by the applicants' possession of a
valid license to operate a CMV. By meeting State licensing
requirements, the applicants demonstrated their ability to operate a
CMV with their limited vision in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. We
believe that the applicants' intrastate driving experience and history
provide an adequate basis for predicting their ability to drive safely
in interstate commerce. Intrastate driving, like interstate operations,
involves substantial driving on highways on the interstate system and
on other roads built to interstate standards. Moreover, driving in
congested urban areas exposes the driver to more pedestrian and
vehicular traffic than exists on interstate highways. Faster reaction
to traffic and traffic signals is generally required because distances
between them are more compact. These conditions tax visual capacity and
driver response just as intensely as interstate driving conditions.
    The applicants in this notice have driven CMVs with their limited
vision in careers ranging for 3 to 68 years. In the past 3 years, no
drivers were involved in crashes, and no drivers were convicted of
moving violations in CMVs. All the applicants achieved a record of
safety while driving with their vision impairment that demonstrates the
likelihood that they have adapted their driving skills to accommodate
their condition. As the applicants' ample driving histories with their
vision deficiencies are good predictors of future performance, FMCSA
concludes their ability to drive safely can be projected into the
future.
    Consequently, FMCSA finds that in each case exempting these
applicants from the vision requirement in Sec.  391.41(b)(10) is likely
to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must be physically examined every year (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in Sec.  391.41(b)(10) and
(b) by a certified medical examiner (ME) who

attests that the individual is otherwise physically qualified under
Sec.  391.41; (2) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the ME at the time of the
annual medical examination; and (3) each driver must provide a copy of
the annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must also
have a copy of the exemption when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the eight exemption applications,
FMCSA exempts the following drivers from the vision requirement, Sec.
391.41(b)(10), subject to the requirements cited above:

Ruben Ahuyon (TX)
Victor N. Crisafulli (NY)
Roger Guin (NC)
Michael H. Jorgensen (MN)
Alejandro V. Lopez (CA)
Jay D. May (AZ)
John Robison (GA)
Kenneth P. Stephens (IA)

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption
will be valid for 2 years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136(e) and 31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-26147 Filed 12-1-21; 8:45 am]
BILLING CODE 4910-EX-P