[Federal Register: February 15, 2006 (Volume 71, Number 31)]
[Notices]
[Page 7959-7964]
[DOCID:fr15fe06-65]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2006-0106; FRL-7763-6]

Certain New Chemicals; Receipt and Status Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires
any person who intends to manufacture (defined by statute to include
import) a new chemical (i.e., a chemical not on the TSCA Inventory) to
notify EPA and comply with the statutory provisions pertaining to the
manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of
TSCA, EPA is required to publish a notice of receipt of a
premanufacture notice (PMN) or an application for a test marketing
exemption (TME), and to publish periodic status reports on the
chemicals under review and the receipt of notices of commencement to
manufacture those chemicals. This status report, which covers the
period from January 16, 2006 to January 31, 2006, consists of the PMNs
pending or expired, and the notices of commencement to

manufacture a new chemical that the Agency has received under TSCA
section 5 during this time period.

DATES: Comments, identified by the docket ID number EPA-HQ-OPPT-2006-
0106 and the specific PMN number or TME number, must be received on or
before March 17, 2006.

ADDRESSES: Comments/may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics (7408M), 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?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitter of the premanufacture notices
addressed in the action. 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number EPA-HQ-OPPT-2006-0106.
The official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the EPA Docket Center, Rm.
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The EPA Docket Center Reading
Room telephone number is<PHONE_NUMBER>, and the telephone number for
the OPPT Docket, which is located in the EPA Docket Center, is (202)
566-0280.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

    EDOCKET, EPA's electronic public docket and comment system was
replaced on November 25, 2005 by an enhanced federal-wide electronic
docket management and comment system located at http://www.regulations.gov/.
 Follow the on-line instructions.

    An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public

comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number and specific PMN number or TME number in
the subject line on the first page of your comment. Please ensure that
your comments are submitted within the specified comment period.
Comments received after the close of the comment period will be marked
``late.'' EPA is not required to consider these late comments. If you
wish to submit CBI or information that is otherwise protected by
statute, please follow the instructions in Unit I.D. Do not use EPA
Dockets or e-mail to submit CBI or information protected by statute.
    1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic

public docket. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.

Once in the system, select ``search,'' and then key in docket ID number
EPA-HQ-OPPT-2006-0106. The system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to<EMAIL_ADDRESS>
Attention: Docket ID Number EPA-HQ-OPPT-2006-0106 and PMN Number or TME
Number. In contrast to EPA's electronic public docket, EPA's e-mail
system is not an ``anonymous access'' system. If you send an e-mail
comment directly to the docket without going through EPA's electronic
public docket, EPA's e-mail system automatically captures your e-mail
address. E-mail addresses that are automatically captured by EPA's e-
mail system are included as part of the comment that is placed in the
official public docket, and made available in EPA's electronic public
docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Document Control Office (7407M),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
EPA-HQ-OPPT-200X-0106 and PMN Number or TME Number. The DCO is open
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the DCO is<PHONE_NUMBER>.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the technical person listed under FOR FURTHER INFORMATION CONTACT.

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

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection
activity.
    7. Make sure to submit your comments by the deadline in this
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action and the specific PMN number you are
commenting on in the subject line on the first page of your response.
You may also provide the name, date, and Federal Register citation.

II. Why is EPA Taking this Action?

    Section 5 of TSCA requires any person who intends to manufacture
(defined by statute to include import) a new chemical (i.e., a chemical
not on the TSCA Inventory to notify EPA and comply with the statutory
provisions pertaining to the manufacture of new chemicals. Under
sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a
notice of receipt of a PMN or an application for a TME and to publish
periodic status reports on the chemicals under review and the receipt
of notices of commencement to manufacture those chemicals. This status
report, which covers the period from January 16, 2006 to January 31,
2006, consists of the PMNs pending or expired, and the notices of
commencement to manufacture a new chemical that the Agency has received
under TSCA section 5 during this time period.

III. Receipt and Status Report for PMNs

    This status report identifies the PMNs pending or expired, and the
notices of commencement to manufacture a new chemical that the Agency
has received under TSCA section 5 during this time period. If you are
interested in information that is not included in the following tables,
you may contact EPA as described in Unit II. to access additional non-
CBI information that may be available.
    In Table I of this unit, EPA provides the following information (to
the extent that such information is not claimed as CBI) on the PMNs
received by EPA during this period: the EPA case number assigned to the
PMN; the date the PMN was received by EPA; the projected end date for
EPA's review of the PMN; the submitting manufacturer; the potential
uses identified by the manufacturer in the PMN; and the chemical
identity.

                                            I. 35 Premanufacture Notices Received From: 01/16/06 to 01/31/06
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-06-0241                            01/13/06                04/12/06                CBI                    (G) Additive in inks   (G) Polyester
                                                                                and coatings           acrylate

P-06-0242                            01/13/06                04/12/06                CBI                    (S) Site limited       (G)
                                                                                intermediate;          Alklyloxypropyloxypr
                                                                                surfactant             opylamine
P-06-0243                            01/17/06                04/16/06                CBI                    (S) Site limited       (G) Alkyloxypropanol
                                                                                intermediate;
                                                                                surfactant
P-06-0244                            01/17/06                04/16/06                Forbo Adhesives, LLC   (G) Hot melt           (G) Isocyanate
                                                                                polyurethane           functional polyester
                                                                                adhesive               polyether urethane
                                                                                polymer
P-06-0245                            01/17/06                04/16/06                Hanse Chemie USA,      (G) Dispersion         (G) Siloxanes and
                                                                                Inc.                   additive               silicones, di-me, 3-
                                                                                hydroxypropyl me,
                                                                                ethers with
                                                                                polyalkylene glycol
                                                                                mono[2-hydroxy-3-[[6-
                                                                                (oxiranylalkoxy)alky
                                                                                l]oxy]alkyl-
                                                                                carbomonocyclicdicar
                                                                                boxylate]
P-06-0246                            01/17/06                04/16/06                Degussa Corporation    (G) Polymer admixture  (G) Modified ketone
                                                                                for cements            resin, sodium salt
P-06-0247                            01/17/06                04/16/06                CBI                    (G) Corrosion control  (G) Alkylamine
                                                                                in oil, gas wells      ethoxylated
                                                                                and oil and gas pipe
                                                                                lines
P-06-0248                            01/17/06                04/16/06                CBI                    (S) Base resin for     (G) Poly[oxy(methyl-
                                                                                ultraviolet light      1,2-ethanediyl)],
                                                                                and electron beam      .alpha.-hydro-
                                                                                curable formulations   .omega.-hydroxy-,
                                                                                polymer with 1,3-
                                                                                diisocyanatomethylbe
                                                                                nzene, 2-
                                                                                hydroxyethyl
                                                                                acrylate- and
                                                                                hydroxy functional
                                                                                aliphatic alcohol-
                                                                                blocked
P-06-0249                            01/18/06                04/17/06                CIBA Specialty         (S) Metal deactivator  (G)
                                                                                Chemicals              for use in lubricant   Cyclohexylalkylether
                                                                                Corporation            and hydraulic          substituted
                                                                                systems                benzotriazole
P-06-0250                            01/18/06                04/17/06                CBI                    (G) Agent for screen   (G) Ethylene glycol
                                                                                printing               alkyl ether
P-06-0251                            01/20/06                04/19/06                CBI                    (G) Polymer for        (G) Sodium salt of
                                                                                cleaning               the copolymer of
                                                                                formulations           acrylic acid, methyl
                                                                                methacrylate, p-
                                                                                sulfophenymethallyet
                                                                                her, sodium salt,
                                                                                sodium
                                                                                methallysulfonate, 2-
                                                                                acrylamido-2-
                                                                                methylpropane
                                                                                sulfonic acid sodium
                                                                                salt
P-06-0252                            01/20/06                04/19/06                CBI                    (G) Open non           (G) Aliphatic
                                                                                dispersive             thermoplastic
                                                                                (plasticizer)          polyurethane
P-06-0253                            01/20/06                04/19/06                CBI                    (G) Open non           (G) Aliphatic
                                                                                dispersive             thermoplastic
                                                                                (plasticizer)          polyurethane
P-06-0254                            01/20/06                04/19/06                CBI                    (G) Open non           (G) Aliphatic
                                                                                dispersive             thermoplastic
                                                                                (plasticizer)          polyurethane
P-06-0255                            01/23/06                04/22/06                CBI                    (S) Solid matrix for   (S) Fatty acids, C18-
                                                                                fragrance in toilet    unsaturated, dimers,
                                                                                rim-block              hydrogenated,
                                                                                application            polymers with 1,4-
                                                                                cyclohexanedicarboxy
                                                                                lic acid,
                                                                                polyethylene-
                                                                                polypropylene glycol
                                                                                bis(2-aminopropyl)
                                                                                ether, polypropylene
                                                                                glycol diamine and
                                                                                propionic acid
P-06-0256                            01/23/06                04/22/06                CBI                    (S) Solid matrix for   (S) Fatty acids, C18-
                                                                                fragrance in toilet    unsaturated, dimers,
                                                                                rim-block              polymers with 1,4-
                                                                                application            cyclohexanedicarboxy
                                                                                lic acid,
                                                                                polyethylene-
                                                                                polypropylene glycol
                                                                                bis(2-aminopropyl)
                                                                                ether, polypropylene
                                                                                glycol diamine and
                                                                                propionic acid
P-06-0257                            01/23/06                04/22/06                CBI                    (S) Solid matrix for   (S) 1,4-
                                                                                fragrance in toilet    cyclohexanedicarboxy
                                                                                rim-block              lic acid, polymer
                                                                                application            with .alpha.-(2-
                                                                                aminomethylethyl)-
                                                                                .omega.-(2-
                                                                                aminomethylethoxy)
                                                                                poly [oxy(methyl-1,2-
                                                                                ethanediyl)],
                                                                                hexanedioic acid and
                                                                                methyloxirane
                                                                                polymer with oxirane
                                                                                bis(2-aminopropyl)
                                                                                ether, polyethylene-
                                                                                polypropylene glycol
                                                                                2-aminopropyl me
                                                                                ether-terminated
P-06-0258                            01/23/06                04/22/06                CBI                    (G) Industrial         (G) Isocyanate
                                                                                adhesive               functional urethane
                                                                                prepolymer
P-06-0259                            01/23/06                04/22/06                Orica Watercare        (S) Catalyst for the   (S) Escherichia coli,
                                                                                hydrolsis of           bl21 de3 (pet-opda),
                                                                                organophosphates in    lysate.
                                                                                contaminated
                                                                                solutions/surfaces
                                                                                (dispersive use).
P-06-0260                            01/24/06                04/23/06                CIBA Specialty         (S) Exhaust            (G)
                                                                                Chemicals              application to         Naphthalenesulfonic
                                                                                Corporation            cotton fabrics         acid azo substituted
                                                                                naphthyl amino
                                                                                substituted triazine
                                                                                amino phenyl
                                                                                sulfonyl alkyl salt
                                                                                compound

P-06-0261                            01/25/06                04/24/06                CBI                    (G) Ribbon or foil     (G) Alkylenediol,
                                                                                for graphic use        dialkyl-, polymer
                                                                                (thermal transfer      with isocyanato
                                                                                ribbon)                (isocyanatoalkyl)
                                                                                trialkylcycloalkane,
                                                                                dipentaerythritol
                                                                                acrylate- and
                                                                                pentaerythritol
                                                                                acrylate-blocked,
                                                                                homopolymer
P-06-0262                            01/26/06                04/25/06                Champion Technologies  (S) Intermediate for   (G)
                                                                                a hydrate inhibitor    Dialkylcocoamidoalky
                                                                                for oil and gas        lamine
                                                                                wells, production
                                                                                pipelines and
                                                                                flowlines
P-06-0263                            01/26/06                04/25/06                Champion Technologies  (S) Hydrate inhibitor  (G)Dialkyl
                                                                                for oil and gas        cocoamidoalkylate
                                                                                wells, production      dialkylcocoamidoal
                                                                                pipelines and          kylbetaine
                                                                                flowlines
P-06-0264                            01/26/06                04/25/06                Champion Technologies  (S) Hydrate inhibitor  (G)
                                                                                for oil and gas        Dialkylcocoamidoalky
                                                                                wells, production      lpropionate
                                                                                pipelines and
                                                                                flowlines
P-06-0265                            01/26/06                04/25/06                Champion Technologies  (S) Intermediate for   (G)
                                                                                a hydrate inhibitor    Dialkylcornoilamidoa
                                                                                for oil and gas        lkylamine
                                                                                wells, production
                                                                                pipelines and
                                                                                flowlines
P-06-0266                            01/26/06                04/25/06                Champion Technologies  (S) Hydrate inhibitor  (G)
                                                                                for oil and gas        Dialkylcornoilamidoa
                                                                                wells, production      crylate /
                                                                                pipelines and          dialkylcornoilamidoa
                                                                                flowlines              lkylbetaine
P-06-0267                            01/26/06                04/25/06                Champion Technologies  (S) Hydrate inhibitor  (G)
                                                                                for oil and gas        Dialkylcornoilamidop
                                                                                wells, production      ropionate
                                                                                pipelines and
                                                                                flowlines
P-06-0268                            01/26/06                04/25/06                Yh America, Inc.,      (S) Curing agents for  (S) N,n' - di (1-
                                                                                Sealant Division       epoxide and urethane   methyl-isobutylyden)
                                                                                -2,5 (or 2,6) -
                                                                                bicyclco [2,2,1]
                                                                                heptane bis
                                                                                (methylamine)
P-06-0269                            01/26/06                04/25/06                CBI                    (G) Plastic additive   (S) Fatty acids,
                                                                                C16_18, C9-rich
                                                                                C8	10-isoalkyl
                                                                                esters
P-06-0270                            01/26/06                04/25/06                CBI                    (G) Plastic additive   (S) Fatty acids,
                                                                                C16	18, isononyl
                                                                                esters
P-06-0271                            01/23/06                04/22/06                Robertet, Inc.         (S) As an odoriferous  (S) Oils, agathosma
                                                                                component of           ovata
                                                                                fragrance compounds
P-06-0272                            01/27/06                04/26/06                CBI                    (G) Adhesive           (G)
                                                                                Alkylenedicarboxylic
                                                                                dichloride, polymer
                                                                                with
                                                                                dihydroxybenzene
P-06-0273                            01/27/06                04/26/06                Huntsman LLC           (S) Surfactants for    (S) Fatty acids,
                                                                                detergents             soya, esters with
                                                                                formulations           polyethylene glycol
                                                                                mono-me ether
P-06-0274                            01/27/06                04/26/06                Huntsman LLC           (S) Surfactants for    (S) Fatty acids,
                                                                                detergents             C16	18 and C18-
                                                                                formulations           unsaturated, esters
                                                                                with polyethylene
                                                                                glycol mono-me ether
P-06-0275                            01/27/06                04/26/06                Huntsman LLC           (S) Surfactants for    (S) Poly(oxy-1,2-
                                                                                detergents             ethanediyl), .alpha.-
                                                                                formulations           (1-oxohexadecyl)-
                                                                                .omega.-methoxy-
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the
Notices of Commencement to manufacture received:

                            II. 15 Notices of Commencement From: 01/16/06 to 01/31/06
----------------------------------------------------------------------------------------------------------------
                                                                Commencement Notice
              Case No.                     Received Date             End Date                  Chemical
----------------------------------------------------------------------------------------------------------------
P-01-0457                             01/25/06                12/15/05                (G) Alkyl alkoxy silane
P-03-0641                             01/26/06                01/21/06                (S) Alcohols, C13	15-
                                                                                branched and linear,
                                                                                ethoxylated
P-04-0921                             01/20/06                01/03/06                (G) Alkaryl sulfonic acid,
                                                                                metal salts
P-05-0431                             01/20/06                01/12/06                (G) 2,5-furandione,
                                                                                polymer with ethane and 1-
                                                                                propene, reaction product
                                                                                with aryl amine
P-05-0542                             01/26/06                01/09/06                (G) Alkanedioic acid,
                                                                                polymer with 1,3-
                                                                                diisocyanatomethylbenzene
                                                                                , 2,2-dimethyl-1,3-
                                                                                propanediol, 3-hydroxy-2-
                                                                                (hydroxymethyl)-2-
                                                                                methylpropanoic acid and
                                                                                2,2'-[(1-
                                                                                methylethylidene)bis(4,1-
                                                                                phenyleneoxy)]bis[ethanol
                                                                                ], 2-ethyl-2-[[2-
                                                                                (hydroxymethyl)-2-[[(1-
                                                                                oxo-2-
                                                                                propenyl)oxy]methyl]butox
                                                                                y]methyl]-1,3-propanediyl
                                                                                diacrylate blocked,
                                                                                compounds with
                                                                                triethylamine
P-05-0644                             01/26/06                01/06/06                (G) 2-propenoic acid ester
                                                                                polymer, compound with
                                                                                substituted aromatic
                                                                                derivative
P-05-0667                             01/24/06                01/13/06                (S) Phenol, 2-ethoxy-4-
                                                                                (4,4,6-trimethyl-1,3-
                                                                                dioxan-2-yl)-
P-05-0703                             01/26/06                01/25/06                (G) 1,4-
                                                                                benzenedicarboxylic acid,
                                                                                polymer with alkenedioic
                                                                                acid, alkyl diols, and, 2-
                                                                                hydroxy-3-[(2-methyl-1-
                                                                                oxo-2-propenyl)oxy]propyl
                                                                                ester
P-05-0715                             01/26/06                01/13/06                (G) Polysulfide adduct
P-05-0764                             01/24/06                01/20/06                (G) Substituted pyrazole-3-
                                                                                carboxylic acid azo dye,
                                                                                metal salt

P-05-0765                             01/24/06                01/20/06                (G) Substituted
                                                                                benzenedicarboxylic acid
                                                                                anthraquinone dye, metal
                                                                                salt
P-05-0796                             01/30/06                01/16/06                (G) Hydroxyalkanoic acid
                                                                                polymer with alkyl
                                                                                isocyanate, oxime-
                                                                                blocked, compounds with 2-
                                                                                (dimethylamino)ethanol
P-05-0817                             01/13/06                01/11/06                (G) Alkanol, reaction
                                                                                products with
                                                                                epichlorohydrin and
                                                                                thiohydroxyalkanol
P-05-0837                             01/19/06                01/09/06                (G) Fats and glyceridic
                                                                                oils mixed with alkenyl
                                                                                ester, sulfurized
P-98-0701                             01/23/06                12/20/05                (G) Mixed alkylmetallic
                                                                                mercaptoester sulfides
----------------------------------------------------------------------------------------------------------------

List of Subjects

    Environmental Protection, Chemicals, Premanufacturer Notices.

    Dated: February 8, 2006.
Carolyn Thornton,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. E6-2155 Filed 2-14-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 56 (Thursday, March 25, 2021)]
[Notices]
[Page 15940]
[FR Doc No: 2021-06173]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0081; FRL-10022-00]

Eastern Research Group, Inc.; Transfer of Data (March 2021)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by the submitter, will be transferred to Eastern Research Group, Inc.
in accordance with the CBI regulations. Eastern Research Group, Inc.
has been awarded a contract to perform work for OPP, and access to this
information will enable Eastern Research Group, Inc. to fulfill the
obligations of the contract.

DATES: Eastern Research Group, Inc. will be given access to this
information on or before March 30, 2021.

FOR FURTHER INFORMATION CONTACT: William Northern, Information
Technology and Resources Management Division (7502P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This action applies to the public in general. As such, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

II. Contractor Requirements

    Under these contract numbers, the contractor will perform the
following:
    Under Contract No. 68HERC21D0007. The Contractor shall prepare and
deliver reports, including plans, evaluations, studies, analyses, and
manuals in accordance with Attachment 1--Performance Work Statement.
Each report shall cite the contract number, identify the U.S.
Environmental Protection Agency as the sponsoring agency, and identify
the name of the Contractor preparing the report.
    This contract involves no subcontractors.
    OPP has determined that the contract described in this notice
involve work that is being conducted in connection with FIFRA, in that
pesticide chemicals will be the subject of certain evaluations to be
made under this contract. These evaluations may be used in subsequent
regulatory decisions under FIFRA.
    Some of this information may be entitled to confidential treatment.
The information has been submitted to EPA under FIFRA sections 3, 4, 6,
and 7 and under FFDCA sections 408 and 409.
    In accordance with the requirements of 40 CFR 2.307(h)(3), the
contract with Eastern Research Group, Inc. prohibits use of the
information for any purpose not specified in these contract; prohibits
disclosure of the information to a third party without prior written
approval from the Agency; and requires that each official and employee
of the contractor sign an agreement to protect the information from
unauthorized release and to handle it in accordance with the FIFRA
Information Security Manual. In addition, Eastern Research Group, Inc.
is required to submit for EPA approval a security plan under which any
CBI will be secured and protected against unauthorized release or
compromise. No information will be provided to Eastern Research Group,
Inc. until the requirements in this document have been fully satisfied.
Records of information provided to Eastern Research Group, Inc. will be
maintained by EPA Project Officers for this contract. All information
supplied to Eastern Research Group, Inc. by EPA for use in connection
with this contract will be returned to EPA when Eastern Research Group,
Inc. has completed its work.

    Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

    Dated: March 19, 2021.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2021-06173 Filed 3-24-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19976-19978]
[FR Doc No: 2016-07840]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1099]

Inorganic Arsenic in Rice Cereals for Infants: Action Level;
Draft Guidance for Industry; Supporting Document for Action Level for
Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice
Products Risk Assessment: Report; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Inorganic
Arsenic in Rice Cereals for Infants: Action Level,'' a supporting
document entitled ``Supporting Document for Action Level for Inorganic
Arsenic in Rice Cereals for Infants'' (the supporting document), and a
risk assessment report entitled ``Arsenic in Rice and Rice Products
Risk Assessment: Report'' (the risk assessment report). The draft
guidance, when finalized, will identify for industry an action level
for inorganic arsenic in rice cereals for infants that will help
protect public health and is achievable with the use of current good
manufacturing practice. It also will describe our intended sampling and
enforcement approach. The risk assessment report includes a
quantitative component (a mathematical model) that estimates occurrence
of lung cancer and bladder cancer from long-term exposure to inorganic
arsenic in rice and rice products, and a qualitative component that
describes our review and evaluation of the scientific literature of
certain non-cancer health risks, in certain susceptible life stages,
from inorganic arsenic in rice and rice products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on this draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance, the
supporting document, or the risk assessment report by July 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-1099 for ``Inorganic Arsenic in Rice Cereals for Infants:
Action Level; Draft Guidance for Industry; Supporting Document for
Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic
in Rice and Rice Products Risk Assessment: Report; Availability.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the

docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance and
the supporting document to the Division of Plant Products and
Beverages, Office of Food Safety, Center for Food Safety and Applied
Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels
to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance,
supporting document, and risk assessment report.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Center for Food Safety
and Applied Nutrition (HFS-24), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Arsenic is present in the environment as a naturally occurring
substance or as a result of contamination from human activity. It is
found in water, air (e.g., in dust or particulates), soil, and foods.
In foods, arsenic may be present as inorganic arsenic (the primary
toxic form of arsenic) or organic arsenic. Exposure to inorganic
arsenic is associated with many adverse human health effects, including
cancer. FDA has been monitoring the levels of total arsenic in foods
for decades, as part of our Total Diet Study, an ongoing survey and
analysis of the average American diet (Ref. 1), and our Toxic Elements
in Food and Foodware and Radionuclides in Food Program (Ref. 2), but
only in recent years has methodology been available to FDA laboratories
to readily distinguish between inorganic and organic arsenic in a large
number and variety of food samples. Arsenic is inadvertently taken up
by plants through pathways for essential or beneficial nutrients, and,
compared to other cereals, such as oat, wheat, and barley, rice is much
more efficient at arsenic accumulation. In 2011, we increased our
testing for arsenic in certain foods. In 2012 and 2013, we released
analytical results for approximately 1,300 samples of rice and rice
products as part of a major effort to understand and manage arsenic-
related risks associated with the consumption of these foods in the
United States (Ref. 3). More recently, in April 2016 we released the
results of our analysis of inorganic arsenic in 526 samples collected
in 2014; the samples included rice cereals for infants, as well as non-
rice infant cereal and other foods commonly eaten by infants and
toddlers (Ref. 4).
    We have focused on rice and rice products because evidence from
FDA's Total Diet Study revealed that arsenic levels, although varying,
tend to be higher in these foods than in others, and rice products are
common in the average American diet. Collectively, our sampling
indicates that the presence of inorganic arsenic varies widely among
and within different categories of rice grain and products made from
rice grain, ranging from <1 to 545 parts per billion (ppb) inorganic
arsenic.
    We are announcing the availability of three documents: (1) A draft
guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for
Infants: Action Level;'' (2) a supporting document referenced in the
draft guidance entitled ``Supporting Document for Action Level for
Inorganic Arsenic in Rice Cereals for Infants;'' and (3) a risk
assessment referenced in the draft guidance entitled ``Arsenic in Rice
and Rice Products Risk Assessment: Report.''
    In the risk assessment report, we provide quantitative estimates of
lung and bladder cancer risk presented by long-term exposure to
inorganic arsenic in rice and rice products. We qualitatively address
certain non-cancer health risks of exposure to inorganic arsenic in
rice and rice products during pregnancy, infancy, and early childhood,
periods of high susceptibility to those risks. We also used the
mathematical cancer risk model to evaluate the impact of potential
mitigation options to reduce the risk. We conducted this risk
assessment in consultation with other Federal Agencies, including the
National Institute of Environmental Health Science, the FDA National
Center for Toxicological Research, and the Environmental Protection
Agency. External expert peer review of the risk assessment was
conducted; the risk assessment report and peer review documents are
available online (Refs. 5, 6, and 7).
    The draft guidance identifies an action level for inorganic arsenic
in rice cereals for infants of 100 micrograms/kilogram ([micro]g/kg) or
100 parts per billion (ppb), and identifies FDA's intended sampling and
enforcement approach. The supporting document reviews data on inorganic
arsenic levels in rice cereals for infants, health effects, and
achievability, and explains FDA's rationale for identifying an action
level for inorganic arsenic in rice cereals for infants of 100
[micro]g/kg.
    We conclude that the 100 [micro]g/kg action level will help protect
the public health and is achievable with the use of current good
manufacturing practice, but we especially welcome comments and
information bearing on the achievability and public health benefits and
risks of 100 [micro]g/kg, as compared with other potential action
levels (including no action level). If the guidance is finalized
consistent with the draft, we intend to consider the action level of
100 [micro]g/kg or 100 ppb inorganic arsenic, in addition to other
factors, when considering whether to bring enforcement action in a
particular case.
    We are issuing the draft guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of the FDA on this
topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternate approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
and the supporting document at either http://www.fda.gov/FoodGuidances
or http://www.regulations.gov. Use the FDA Web site listed in the
previous sentence to find the most current version of the guidance.
Persons with access to the Internet may obtain the risk assessment
report at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm485278.htm.

III. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

    1. U.S. Food and Drug Administration, ``Total Diet Study,''
2016, (http://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm2006799.htm).
    2. U.S. Food and Drug Administration, ``Toxic Elements in Food
and Foodware and Radionuclides in Food Program,'' 2016, (http://www.fda.gov/downloads/Food/ComplianceEnforcement/ucm073204.pdf).
    3. U.S. Food and Drug Administration, ``Analytical Results from
Inorganic Arsenic in Rice and Rice Products Sampling,'' 2013,
(http://www.fda.gov/downloads/Food/

FoodborneIllnessContaminants/Metals/UCM352467.pdf).
    4. U.S. Food and Drug Administration, ``Analytical Results from
Inorganic Arsenic in Rice Cereals for Infants, Non-rice Infant
Cereal and Other Foods Commonly Eaten by Infants and Toddlers,''
2016, (http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm485278.htm).
    5. U.S. Food and Drug Administration, ``Arsenic in Rice and Rice
Products Risk Assessment: Report,'' 2016, (http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm485278.htm).
    6. U.S. Food and Drug Administration, ``External Peer Review
Report. Arsenic in Rice and Rice Products Risk Assessment: Draft
Report, Addendum, and Model,'' 2015, (http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM486544.pdf).
    7. U.S. Food and Drug Administration, ``FDA's Response to
External Peer Review on FDA's Arsenic in Rice and Rice Products Risk
Assessment: Draft Report (July 2015), Addendum to FDA's Arsenic in
Rice and Rice Products Risk Assessment, and Arsenic in Rice and Rice
Products Risk Assessment Cancer Model,'' 2016, (http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM487230.pdf).

    Dated: April 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07840 Filed 4-5-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Rules and Regulations]
[Pages 6972-6975]
[FR Doc No: 2018-03251]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2017-0138; FRL-9973-19-Region 1]

Air Plan Approval; New Hampshire; Rules for Open Burning and
Incinerators

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving State
Implementation Plan (SIP) revisions submitted by the State of New
Hampshire on August 9, 2011 and July 23, 2013. These SIP revisions
establish rules for open burning and establish emission standards and
operating practices for incinerators and wood waste burners that are
not regulated pursuant to Federal incinerator standards. We are also
approving revisions to the definitions of ``Incinerator'' and ``Wood
Waste Burner,'' submitted by the State on July 23, 2013 and October 26,
2016, respectively. This action is being taken in accordance with the
Clean Air Act (CAA).

DATES: This rule is effective on March 19, 2018.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2017-0138. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., 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 at www.regulations.gov or at the U.S. Environmental
Protection Agency, EPA New England Regional Office, Office of Ecosystem
Protection, Air Quality Planning Unit, 5 Post Office

Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Alison C. Simcox, Environmental
Scientist, Air Quality Planning Unit, Air Programs Branch (Mail Code
OEP05-02), U.S. Environmental Protection Agency, Region 1, 5 Post
Office Square, Suite 100, Boston, Massachusetts, 02109-3912; (617) 918-
1684; [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Response to Comments
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background and Purpose

    On January 10, 2003, New Hampshire Department of Environmental
Services (NH DES) submitted a SIP revision for Env-A 1000 (Prevention,
Abatement and Control of Open Source Air Pollution). On August 9, 2011,
NH DES submitted an updated version of this regulation. Because the
2011 submittal superseded the previous submission, the State withdrew
the 2003 submittal on May 5, 2014. The withdrawal letter is included in
the docket for this action.
    On July 23, 2013, NH DES submitted Env-A 1900 (Incinerators and
Wood Waste Burners) and Env-A 101.104 (definition of ``Incinerator'')
to EPA for approval. Env-A 1900 is not currently part of the federally-
approved New Hampshire SIP. The definition of the term ``Incinerator''
is currently part of the New Hampshire SIP, but is codified at Env-A
101.59 \1\ and does not include a reference to ``wood-waste burners.''
The submitted definition of ``Incinerator'' adds ``wood-waste burners''
to the definition and is codified at Env-A 101.104. The current SIP-
approved version of the definition of ``Incinerator'' (Env-A 101.59)
will be replaced by the new definition of that term (Env-A 101.104) as
a result of this approval.
---------------------------------------------------------------------------

    \1\ This appears to be an error because there are two different
terms numbered 101.59 in Env-A 101, and the term ``incinerator'' is
listed after term number 48 and before term number 50.
---------------------------------------------------------------------------

    A definition of ``Wood Waste Burner'' is currently part of the New
Hampshire SIP, but is codified as Env-A 101.95 and explicitly excludes
incinerators. On October 26, 2016, NH DES submitted a revision of the
definition of ``Wood Waste Burner'' (Env-A 101.219) to EPA for
approval. This revised definition does not exclude incinerators. The
current SIP-approved version of the definition of ``Wood Waste Burner''
(Env-A 101.95) will be replaced by the new definition of that term
(Env-A 101.219) as a result of this approval.
    The version of Env-A 1900 (Incinerators and Wood Waste Burners)
submitted by the State to EPA included an affirmative defense provision
for malfunction, which is defined as a sudden and unavoidable breakdown
of process or control equipment. On April 13, 2016, NH DES sent a
letter to EPA withdrawing the affirmative defense provision in Env-A
1900 (i.e., 1902.02). In addition, an earlier SIP submission of Env-A
1900 had included an exception to the 20-percent visible emissions
limit that would have allowed these emissions to be exceeded for one
period of 6 continuous minutes in any 60-minute period during startup,
shutdown, or malfunction. However, NH DES removed this exception from
the July 23, 2013 submittal.
    These SIP revisions establish rules for open burning and establish
emission standards and operating practices for incinerators and wood
waste burners that are not regulated pursuant to Federal incinerator
standards. New Hampshire also submitted revisions to the definitions of
``Incinerator'' and ``Wood Waste Burner'' on July 23, 2013 and October
26, 2016, respectively.
    On September 6, 2017, EPA published a Notice of Proposed Rulemaking
(82 FR 42054) and Direct Final Rulemaking (DFRN) (82 FR 42037)
proposing to approve and approving, respectively, the revisions
submitted by New Hampshire on August 9, 2011, July 23, 2013, and
October 26, 2016.
    In the DFRN, EPA stated that if an adverse comment were to be
submitted to EPA by October 6, 2017, the action would be withdrawn and
not take effect, and a final rule would be issued based on the NPR. EPA
received a comment that is not relevant to this SIP action, and one
adverse comment that is relevant, before the close of the comment
period. Therefore, EPA withdrew the DFRN on November 6, 2017 (82 FR
51349).
    This action is a final rule based on the NPR. A detailed discussion
of New Hampshire's August 9, 2011; July 23, 2013; and October 26, 2016,
SIP revisions, and EPA's rationale for approving these were provided in
the DFRN and will not be restated here, except to the extent relevant
to our response to the public comments we received.

II. Response to Comments

    EPA received public comments from anonymous commenters on our
September 6, 2017 NPR. All of the comments are contained in the docket
for this final action. One commenter submitted a comment that is not
relevant to this SIP action and, therefore, requires no response. One
commenter submitted two comments that are adverse and are discussed
below.
    Comment 1: An anonymous commenter noted that the proposed revisions
to New Hampshire's Env-A 1000 (Prevention, Abatement and Control of
Open Source Air Pollution) removes the reference to National Ambient
Air Quality Standards (NAAQS) nonattainment areas for particulate
matter (PM) pollution that appears in the current SIP-approved version
of Env-A 1000. The commenter stated that ``EPA should not be allowed to
reduce emission standards just because a corporation or company
incinerator wants to burn more wood. Wood is a particularly dirty fuel
source that causes significant particulate matter pollution both 2.5
microns and 10 microns.''
    Response 1: The SIP-approved Env-A 1000 (provision 1001.02) allowed
for certain types of open burning if: (1) Not prohibited by local
ordinance or officials having jurisdiction, such as state forest fire
wardens, and (2) where the particular area has not been designated
nonattainment in relation to the NAAQS for PM. Under Env-A 1000, such
burning was allowed in NAAQS nonattainment areas for PM (when not
prohibited by local ordinance or officials having jurisdiction) if
written authorization had been obtained by the NH DES. In the revised
version of Env-A 1000, the State has removed the restriction on these
activities in nonattainment areas for particulates. EPA believes that
the version of Env-A 1000 we are approving is consistent with CAA
requirements for SIP revisions, notwithstanding the absence of
references to nonattainment areas for NAAQS as a limiting condition on
certain types of burning. Because there have never been any designated
nonattainment areas for PM in New Hampshire, the current provision is
not in fact imposing any restrictions on emissions. Thus, the emissions
reductions attributable to the revised version of Env-A 1000 we are
approving is functionally the same as the prior version. Moreover, we
note that the current ambient levels of PM within the

State are below the currently applicable PM NAAQS. In the event that
ambient PM in New Hampshire were to exceed the applicable NAAQS, we
would expect the State to add additional emissions controls to address
the appropriate sources to bring the area back into attainment.
    Comment 2: The same anonymous commenter asserted that the ``EPA
also can't remove nuisance provisions as they can cover enforcement of
NAAQS pollutants that cause nuisances to neighboring communities and
disadvantages communities. Sometimes only nuisance provisions are the
only enforcement mechanism available to the little people that can't
afford big lawyers or consent decrees with big companies.''
    Response 2: New Hampshire's revision to Env-A 1000 removes two
references to ``nuisance'' in the current SIP, which was approved in
1994. EPA believes that the State's revised version of the regulation
is approvable under the CAA because the term ``nuisance'' in Env-A
1000, as defined in state law, is a broad concept that could be applied
to prohibit impacts that bear no reasonable connection to the NAAQS and
related air-quality goals of the CAA. The fact that something may cause
a nuisance does not necessarily equate to a condition that would
interfere with attainment or maintenance of the NAAQS. The wording of
the prior version of the SIP provision was not sufficiently related to
attainment and maintenance of the PM NAAQS to warrant inclusion in the
SIP. See, for example, analogous instances in which EPA has removed
from SIPs certain regulations that prohibit odors (61 FR 47058,
September 6, 1996), or that contain a general prohibition against air
pollution (63 FR 65557, November 27, 1998).

III. Final Action

    EPA is approving and incorporating two regulations into the New
Hampshire SIP. The two regulations include revised Env-A 1000
(Prevention, Abatement and Control of Open Source Air Pollution)
submitted by the State of New Hampshire on August 9, 2011, effective on
May 1, 2011; and Env-A 1900 (Incinerators and Wood Waste Burners)
submitted by the State on July 23, 2013, effective April 23, 2013,
except for the withdrawn affirmative defense provision. The revised
version of Env-A 1000 that we are approving into the SIP will replace
the existing SIP-approved version of Env-A 1000.
    In addition, EPA is approving a revised definition of
``Incinerator'' (Env-A 101.104), submitted by the State on July 23,
2013, effective April 23, 2013, which replaces the definition of
``Incinerator'' currently in the New Hampshire SIP (numbered Env-A
101.59). We are also approving a revised definition of ``Wood Waste
Burner'' (Env-A 101.219), submitted by the State on October 26, 2016,
effective January 14, 2005, which replaces the definition of ``Wood
Waste Burner'' currently in the New Hampshire SIP (numbered Env-A
101.95). Thus, the SIP at Env-A 101.59 and at Env-A 101.95 will read
``[reserved].''
    New Hampshire organizes Env-A 101 (Definitions) alphabetically, and
also assigns a codification number, in sequential order, to each
defined term. Because the State's SIP submissions did not include the
entirety of Env-A 101, and the State has added other definitions to
Env-A 101 over time (not all of which are SIP-approved), our approval
of the two definitions in this action will result in the numbered
codification assigned to the defined terms being out of numerical
sequence in the SIP. However, the two defined terms will still be in
alphabetical order.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the New
Hampshire Code of Administrative Rules described in the amendments to
40 CFR part 52 set forth below. The EPA has made, and will continue to
make, these materials generally available through https://www.regulations.gov, and/or at the EPA Region 1 Office (please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).
    Therefore, these materials have been approved by EPA for inclusion
in the SIP, have been incorporated by reference by EPA into that plan,
are fully federally enforceable under sections 110 and 113 of the CAA
as of the effective date of the final rulemaking of EPA's approval, and
will be incorporated by reference by the Director of the Federal
Register in the next update to the SIP compilation.\2\
---------------------------------------------------------------------------

    \2\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000). The
Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a

rule may take effect, the agency promulgating the rule must submit a
rule report, which includes a copy of the rule, to each House of the
Congress and to the Comptroller General of the United States. Section
804, however, exempts from section 801 the following types of rules:
Rules of particular applicability; rules relating to agency management
or personnel; and rules of agency organization, procedure, or practice
that do not substantially affect the rights or obligations of nonagency
parties. 5 U.S.C. 804(3). Because this is a rule of particular
applicability, EPA is not required to submit a rule report regarding
this action under section 801. Under section 307(b)(1) of the Clean Air
Act, petitions for judicial review of this action must be filed in the
United States Court of Appeals for the appropriate circuit by November
20, 2017. Filing a petition for reconsideration by the Administrator of
this final rule does not affect the finality of this action for the
purposes of judicial review nor does it extend the time within which a
petition for judicial review may be filed, and shall not postpone the
effectiveness of such rule or action. This action may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: February 6, 2018.
Alexandra Dapolito Dunn,
Regional Administrator, EPA New England.

    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

     Authority: 42 U.S.C. 7401 et seq.

Subpart EE--New Hampshire

0
2. In Sec.  52.1520 paragraph (c), amend the table by:
0
a. Adding four entries for``Env-A 100'' after the entry ``Env-A 100;
Organizational Rules: Definitions'';
0
b. Revising the entry ``Env-A 1000''; and
0
c. Adding in numerical order an entry ``Env-A 1900''.
    The revision and additions read as follows:

Sec.  52.1520  Identification of plan.

* * * * *
    (c) * * *

                                     EPA-Approved New Hampshire Regulations
----------------------------------------------------------------------------------------------------------------
                                                            State       EPA approval date
         State citation              Title/subject     effective date          \1\              Explanations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Env-A 100.......................  Definition of            04/29/2003  02/16/2018, [Insert  Remove Part Env-A
                                   ``Incinerator''.                     Federal Register     101.59, definition
                                                                        citation].           of ``Incinerator''
                                                                                and replace with
                                                                                ``[reserved].''
Env-A 100.......................  Definition of            04/29/2003  02/16/2018, [Insert  Remove Part Env-A
                                   ``Wood Waste                         Federal Register     101.95, definition
                                   Burner''.                            citation].           of ``Wood Waste
                                                                                Burner'' and
                                                                                replace with
                                                                                ``[reserved].''
Env-A 100.......................  Definition of            04/23/2013  02/16/2018, [Insert  Approve Part Env-A
                                   ``Incinerator''.                     Federal Register     101.104, definition
                                                                        citation].           of ``Incinerator.''
Env-A 100.......................  Definition of            01/14/2005  02/16/2018, [Insert  Approve Part Env-A
                                   ``Wood Waste                         Federal Register     101.219, definition
                                   Burner''.                            citation].           of ``Wood Waste
                                                                                Burner.''

                                                  * * * * * * *
Env-A 1000......................  Control of Open          05/01/2011  02/16/2018, [Insert  Approve Part Env-A
                                   Burning.                             Federal Register     1000 ``Prevention,
                                                                        citation].           Abatement and
                                                                                Control of Open
                                                                                Source Air
                                                                                Pollution.''

                                                  * * * * * * *
Env-A 1900......................  Emission Standards       04/23/2013  02/16/2018, [Insert  Approve Part Env-A
                                   and Operating                        Federal Register     1900 ``Incinerators
                                   Practices for                        citation].           and Wood Waste
                                   Incinerators.                                             Burners.''

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

* * * * *
[FR Doc. 2018-03251 Filed 2-15-18; 8:45 am]
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